Federal Register / Vol. 85, No. 151 / Wednesday, August 5, 2020 / Proposed Rules

47536 Federal Register / Vol. 85, No.
151 / Wednesday, August 5, 2020 / Proposed Rules
DEPARTMENT OF AGRICULTURE Regulatory Information Number (RIN) Act’’).1 If implemented, this proposed
0581–AD09 for this rulemaking. You rule will improve organic integrity
Agricultural Marketing Service should clearly indicate the topic and across the organic supply chain, and
section number of this proposed rule to benefit stakeholders throughout the
7 CFR Part 205 which your comment refers, state your organic industry. The proposed
[Document Number AMS–NOP–17–0065; position(s), offer any recommended amendments will close gaps in the
NOP–17–02] language change(s), and include current regulations to build consistent
relevant information and data to support certification practices to deter and
RIN 0581–AD09 your position(s) (e.g., scientific, detect organic fraud, and improve
environmental, manufacturing, transparency and product traceability.
National Organic Program;
industry, or industry impact In addition, the proposed amendments
Strengthening Organic Enforcement
information, etc.). All comments and will assure consumers that organic
AGENCY: Agricultural Marketing Service, relevant background documents posted products meet a robust, consistent
USDA to https://www.regulations.gov will standard and reinforce the value of the
ACTION: Proposed rule. include any personal information organic label.
provided. The need for more consistent
SUMMARY: The United States Department In addition to the questions following oversight to protect organic integrity is
of Agriculture (USDA) Agricultural each topic in the Overview of Proposed a product of the rapidly expanding
Marketing Service (AMS) proposes Amendments section of this proposed organic market, increasingly complex
amending the USDA organic regulations rule, AMS is requesting comments on organic supply chains, and price
to strengthen oversight and enforcement the following general topics: premiums for organic products. Total
of the production, handling, and sale of 1. The clarity of the proposed sales of organic agricultural products in
organic agricultural products. The requirements. Can certified operations, the United States grew from $3.4 billion
proposed amendments are intended to handlers, and certifying agents readily in 1997 to $55.1 billion in 2019.2 This
protect integrity in the organic supply determine how to comply with the substantial market growth has allowed
chain and build consumer and industry proposed regulations? many additional types of business to
trust in the USDA organic label by 2. The implementation timeframe. participate in the organic supply chain,
strengthening organic control systems, AMS is proposing that all requirements and organic agricultural products are
improving farm to market traceability, in this proposed rule be implemented now traded on a global scale. Today’s
and providing robust enforcement of the within ten months of the effective date global organic marketplace is marked by
USDA organic regulations. Topics of the final rule (this is also one year a multifaceted supply chain with
addressed in this proposed rule include: after publication of the final rule). organic products increasingly sold and
Applicability of the regulations and 3. The accuracy of the estimates in the handled by entities not regulated by the
exemptions from organic certification; Regulatory Impact Analysis and USDA. The absence of direct
National Organic Program Import Regulatory Flexibility Analysis, which enforcement authority over some
Certificates; recordkeeping and product describe the expected costs of this entities in the organic supply chain, in
traceability; certifying agent personnel proposed rule on all affected entities combination with price premiums for
qualifications and training; standardized and on small businesses, respectively. organic products, presents the
certificates of organic operation; 4. Are there alternatives to opportunity and incentive for organic
unannounced on-site inspections of regulations, or less stringent fraud, which has been discovered in the
certified operations; oversight of requirements, that could achieve the organic sector by both the National
certification activities; foreign same objectives as this proposed rule? Organic Program (NOP) and organic
conformity assessment systems; 5. How will certifying agents cover stakeholders. The amendments in this
certification of grower group operations; the costs of additional actions required proposed rule are designed to mitigate
labeling of nonretail containers; annual under this rule, such as the required the occurrence of organic fraud.
update requirements for certified unannounced inspections and the In response to their experiences in the
operations; compliance and appeals issuing of NOP Import Certificates? Will organic system, stakeholders have
processes; and calculating organic certifying agents charge fees that are repeatedly called for the NOP to take
content of multi-ingredient products. consistent for expanded handlers, steps to improve oversight of organic
DATES: Send comments on or before brokers, importers and exporters? systems and enforcement of the USDA
October 5, 2020. FOR FURTHER INFORMATION CONTACT: organic regulations. Commonly cited
ADDRESSES: You may send comments on Jennifer Tucker, Ph.D., Deputy areas for improvement include
this proposed rule to the Federal Administrator, National Organic certification of excluded handlers,
eRulemaking Portal at https:// Program. Telephone: 202–720–3252. organic import oversight, fraud
www.regulations.gov/. You can access Email: Jennifer.Tucker@usda.gov. prevention, organic trade arrangements,
this proposed rule and instructions for and organic inspector qualifications. In
SUPPLEMENTARY INFORMATION:
submitting public comments by addition, public discussions on many
searching for document number, AMS– Executive Summary proposals included in this action
NOP–17–0065. Comments may also be occurred during multiple National
A. Purpose of the Proposed Rule
sent to Jennifer Tucker, Deputy
Administrator, National Organic This proposed rule would amend 1 The Organic Foods Production Act of 1990, 7
jbell on DSKJLSW7X2PROD with PROPOSALS4
several sections of the USDA organic U.S.C. 6501–6524, is the statute from which the
Program, USDA–AMS–NOP, 1400 Agricultural Marketing Service derives authority to
Independence Ave. SW, Room 2642-So., regulations, 7 CFR part 205, to administer the NOP, and authority to amend the
Ag Stop 0268, Washington, DC 20250– strengthen oversight of the production, regulations as described in this proposed rule. This
0268; (202) 260–9151 (Fax). handling, certification, marketing, and document is available at: https://uscode.house.gov/
sale of organic agricultural products as view.xhtml?path=/prelim@title7/
Instructions: All comments received chapter94&edition=prelim.
must include the docket number AMS– established by the Organic Foods 2 Organic Trade Association, Organic Industry
NOP–17–0065; NOP–17–02, and/or Production Act of 1990 (OFPA, or ‘‘the Survey, 2018–2020.
VerDate Sep<11>2014 18:43 Aug 04, 2020 Jkt 250001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\05AUP4.SGM 05AUP4
Federal Register / Vol. 85, No. 151 / Wednesday, August 5, 2020 / Proposed Rules 47537
Organic Standards Board (NOSB) oversight of certifying agents and their and requiring continuing education will
meetings.3 activities. ensure quality and consistency of
The NOP identified the need for many Additionally, this proposed rule certification activities performed by
of the proposed amendments as part of includes several discretionary actions certifying agents.
its direct experience in administering that work in alignment with the 9. Clarify conditions for establishing,
this program, particularly during provisions above to further strengthen evaluating, and terminating equivalence
complaint investigations and audits of enforcement of the USDA organic determinations with foreign government
certifying agents. Other proposed regulations: organic programs, based on an
amendments are based on recent 4. Clarify the labeling of nonretail evaluation of their organic foreign
amendments to the OFPA included in containers used to ship or store organic
conformity systems. This will ensure
the Agriculture Improvement Act of products. Requiring additional
the compliance of organic products
2018; 4 the recommendations of a 2017 information on nonretail containers will
imported from countries that have
Office of Inspector General audit; the clearly identify organic products, reduce
organic equivalence determinations
recommendations of a federal advisory the mishandling of organic products,
with the United States.
committee, the NOSB; and industry and support traceability. This is needed
stakeholder feedback. The amendments to maximize the linkage between 10. Clarify requirements to strengthen
in this proposed rule are intended to: (1) operation certificates and import and streamline enforcement processes,
Strengthen organic control systems; (2) certificates and the organic product. specifically noting that the NOP may
improve organic import oversight; (3) 5. Specify the minimum number of initiate enforcement action against any
clarify organic certification standards; unannounced inspections of certified violator of the OFPA, including
and (4) enhance supply chain operations that must be conducted responsible parties; defining the term
traceability. annually by accredited certifying agents, adverse action to clarify what actions
and require that supply chain audits be may be appealed and by whom; and
B. Summary of Provisions completed during on-site inspections. clarifying NOP’s appeal procedures and
This proposed rule will strengthen 6. Require certifying agents to issue options for alternative dispute
enforcement of the USDA organic standardized certificates of organic resolution.
regulations through several actions operation generated from the USDA’s 11. Specify certification requirements
mandated by the Agriculture Organic Integrity Database (INTEGRITY) for grower group operations, to provide
Improvement Act of 2018: and to keep accurate and current consistent, enforceable standards and
1. Reduce the types of uncertified certified operation data in INTEGRITY. ensure compliance with the USDA
entities in the organic supply chain that Standardization will simplify the organic regulations. Grower group
operate without USDA oversight— verification of valid organic certificates certification would be restricted to crop
including importers, brokers, and and import certificates. It will also production and handling only, and
traders of organic products. This will reduce reporting, by eliminating the would require the use of an internal
safeguard organic product integrity and need to provide notices of approval or control system to monitor compliance.
improve traceability. denial of certification and annual lists of
2. Require the use of NOP Import 12. Clarify the method of calculating
certified operations to USDA.
Certificates, or equivalent data, for all 7. Clarify that certified operations the percentage of organic ingredients in
organic products entering the United only need to submit changes to their a multi-ingredient product to promote
States. This proposed change will organic system plan during annual consistent interpretation and
expand the use of NOP Import updates, and clarify that certifying application of the regulation.
Certificates to all organic products agents must conduct annual inspections 13. Require certified operations and
imported into the United States, of certified operations. This will reduce certifying agents to develop improved
improving the oversight and traceability paperwork burden for organic recordkeeping, organic fraud
of imported organic products. operations and ensure that all organic prevention, and trace-back audit
3. Clarify the NOP’s authority to operations are inspected at least once a processes. Information sharing between
oversee certification activities, year. certifying agents and documented
including the authority to act against an 8. Establish specific qualification and organic fraud prevention procedures are
agent or office of a certifying agent. training requirements for certifying also required.
Additionally, certifying agents must agent personnel, including inspectors C. Costs and Benefits
notify the NOP upon opening a new and certification reviewers. Requiring
office, which will allow the NOP to that personnel meet minimum AMS estimates the following costs
provide more effective and consistent education and experience qualifications and benefits of this proposed rule:
Economic impact of SOE proposed rule
Annualized a Total b
Costs .................................................................................................................... $7,205,815–$7,351,910 $65,629,941–$87,766,628

Benefits ................................................................................................................ $83,992,975–$86,874,833 $765,000,793–$1,037,106,112
a Estimated 15-year annualized domestic costs for affected industry discounted at 3 and 7 percent.
b Estimated total domestic costs for affected industry in Net Present Value discounted at 3 and 7 percent, 15 year.
3 The April 2019 NOSB meeting is the most www.ams.usda.gov/event/national-organic- bill,’’ is available at https://www.congress.gov/115/
recent example of a public discussion to address standards-board-nosb-meeting-seattle-wa. plaws/publ334/PLAW-115publ334.pdf. Organic
fraud concerns in the organic supply chain. A 4 The Agriculture Improvement Act of 2018 (Pub. certification is discussed in Title X, Section 10104.
discussion document, meeting transcripts, and
L. 115–334), commonly known as the ‘‘2018 farm
public comments are available at: https://
47538 Federal Register / Vol. 85, No. 151 / Wednesday, August 5, 2020 / Proposed Rules
Table of Contents This listing is not intended to be complicate traceability, yet these
I. General Information
exhaustive but identifies key entities elements are essential to trust in the
A. Does this proposed action apply to me? likely to be affected by this proposed organic label. In addition, businesses
II. Background action. Other types of entities may also that operate in the organic supply chain
III. Overview of Proposed Amendments be affected. To determine whether you without oversight from the NOP pose
1. Applicability and Exemptions From or your business may be affected by this risks to organic integrity. This can lead
Certification proposed action, you should carefully to mishandling of organic product, loss
2. Imports to the United States examine the proposed regulatory text. of organic integrity, and fraud. The
3. Labeling of Nonretail Containers provisions in this proposed rule are
4. On-Site Inspections II. Background
designed to address these risks.
5. Certificates of Organic Operation The Organic Foods Production Act of
6. Continuation of Certification 1990 (OFPA) (7 U.S.C. 6501–6524), Complex Organic Supply Chains
7. Paperwork Submissions to the
authorizes the Agricultural Marketing The need for this proposed rule is
Administrator
8. Personnel Training and Qualifications
Service (AMS) to establish and maintain driven partially by the increasing
9. Oversight of Certification Activities national standards governing the complexity of organic supply chains.
10. Accepting Foreign Conformity marketing of organically produced When the organic regulations were
Assessment Systems agricultural products. AMS administers published in 2000, organic products
11. Compliance—General these standards through the National were marketed mostly locally or
12. Noncompliance Procedure for Certified Organic Program (NOP). Final regionally, and supply chains tended to
Operations regulations implementing the NOP, also be short and transparent; for example,
13. Mediation referred to as the USDA organic
14. Adverse Action Appeal Process— farm to wholesale to retail to consumer.
regulations, were published on Demand and sales have grown
General
December 21, 2000 (65 FR 80548) and considerably since then. This significant
15. Adverse Action Appeal Process—
Appeals
became effective on October 21, 2002.5 market growth has attracted more
16. Grower Group Operations Through these regulations, AMS producers, handlers, product suppliers,
17. Calculating the Percentage of oversees national standards for the importers, brokers, distributors, and
Organically Produced Ingredients production, handling, labeling, and sale others to the organic market.
18. Supply Chain Traceability and Organic of organically produced agricultural Consider the example of an organic
Fraud Prevention products. egg supply chain in the United States,
19. Technical Corrections Since full implementation of the
20. Additional Amendments Considered beginning with the production of
USDA organic regulations, the organic
But Not Included in This Proposed Rule certified organic corn and ending with
industry has experienced significant
IV. Statutory and Regulatory Authority the sale of eggs to the consumer. This
change. Both demand for and sales of
A. Summary of Economic Analyses demonstrates the typical entities and
organic products have risen steadily;
B. Executive Order 12988 transactions in an organic supply chain
C. Paperwork Reduction Act total U.S. sales of organic products
under the existing regulations:
reached more than $55 billion in 2019.6
D. Executive Order 13175
The number of businesses producing, • A certified organic farm produces
E. Civil Rights Impact Analysis organic corn.
handling, marketing, and selling organic
I. General Information products has also grown to meet • The corn is transported via an
consumer demand. Rapid growth has uncertified truck to a local grain
A. Does this proposed action apply to elevator, where it is aggregated with
me? attracted many businesses to the USDA
organic label and increased the other organic corn from nearby
You may be affected by this proposed producers.
complexity of the global organic supply
action if you are engaged in the organic
chain. • An uncertified commodity trader
industry. Potentially affected entities AMS is confident in the integrity and buys the corn.
may include, but are not limited to, the value of the USDA organic seal. • The corn is transported via
following: Consumers can trust the organic label uncertified truck to an uncertified
• Individuals or business entities that storage facility; both transport and
due to a rigorous oversight system that
are considering organic certification; storage are subcontracted and are not
• Existing production and handling operates globally. However, the growth
and complexity of the modern organic owned by the commodity trader.
operations that are currently certified • The commodity trader sells the corn
organic under the USDA organic industry has exposed the limitations of
the current organic regulations, to a certified organic grain supplier; the
regulations; two parties remain anonymous because
• Brokers, traders, and importers of revealing gaps in oversight and
enforcement that the original they use an uncertified broker to
organic products that are not currently facilitate the transaction.
certified under the USDA organic regulations do not address. A lack of
clear and specific standards in portions • The corn is transported via
regulations;
of the regulations has sometimes led to uncertified rail and river barge to the
• Operations that use non-retail
different interpretations of the grain supplier; it is transloaded and
containers for shipping or storing
regulations, inconsistent practices, and stored temporarily several times before
organic products;
• Retailers that sell organic products; unequal enforcement across the being delivered to the certified grain
• Operations that receive or review industry. Increasingly complex organic supplier.
supply chains reduce transparency and • The certified organic grain supplier
organic certificates to verify compliance

with USDA organic regulations; stores the corn and combines it with
• USDA-accredited certifying agents, 5 7 CFR part 205 National Organic Program; Final imported organic corn purchased from
inspectors, and reviewers; Rule. December 21, 2000. Available on the AMS an importer via an uncertified broker.
• Operations that import organic website: https://www.federalregister.gov/ • The certified grain supplier sells the
documents/2000/12/21/00-32257/national-organic-
products into the United States; and/or program. corn to a certified organic feed
• Operations that export organic 6 Organic Trade Association, Organic Industry processer; the corn is transported via an
products to the United States. Survey, 2020. uncertified truck.
• The certified processer combines defendant pled guilty to defrauding involved, and the transactions where
the corn with several other ingredients customers in a scheme involving at least fraud occurred. It is also useful to
to create organic chicken feed. $142 million in nonorganic grains sold consider the types of entities involved:
• The certified processer sells the as organic. The lead defendant sold • Certified organic farms thought to
feed to a certified organic egg producer fraudulent grain to customers over a supply little or none of the feedstuffs
and transports it via an uncertified period of seven years, claiming the later sold as organic.
truck. product was organically grown in • Uncertified farms supplying non-
• The certified organic egg producer Nebraska and Missouri. GMO feedstuffs to uncertified grain
sells organic eggs to an uncertified In February 2020, a federal grand jury elevators.
distributor. indicted an individual in South Dakota • Uncertified grain elevators
• The uncertified distributor sells the for allegedly selling $71 million of currently excluded from certification
organic eggs to a retailer prior to final nonorganic grains and oilseeds falsely requirements.
sale to the consumer. labeled organic over five years. The • Certified handlers that brokered the
This is just one example of a complex fraud ring spanned multiple states. After sale of nonorganic feedstuffs through an
organic supply chain. It becomes even the NOP revoked the organic business’ uncertified elevator to certified buyers,
more complex if one considers that the organic certificates, the responsible falsifying paperwork to represent the
processer combines several ingredients parties established new brokerage firms products for sale as organic.
into the final chicken feed, sourced both to continue their fraud. Under the • Certified organic handlers that
domestically and imported. Each current organic regulations, these consolidated fraudulent products from
ingredient has its own unique supply brokerages did not require organic previous handlers, thinking the product
chain—and together they weave a certification; the NOP had no oversight was organic.
complex and dense web converging on of their activities. This proposed rule • Certified feed mills that purchased
a single organic product. would require the certification and the nonorganic feedstuffs believing the
oversight of brokers like those involved products were organic.
Organic Fraud
in this case. This would allow the NOP • Livestock and poultry operations
The risk of organic fraud has grown to identify and prevent the fraud, that purchased feed rations from the
due to high demand for organic minimizing damage to the U.S. market. mills and thus unknowingly fed
products, the absence of direct In addition to the examples above, the nonorganic feed to their animals, which
enforcement authority over some NOP continues to investigate multiple are required to eat a diet of 100%
entities in the organic supply chain, and cases of organic grain and oilseed fraud certified organic feed.
price premiums for organic products. at the production and handling levels. The proposed rule would require the
Both the NOP and organic stakeholders Continuing complaints of organic grain certification of some types of currently
have uncovered organic fraud in the fraud received by the NOP demonstrate uncertified entities, such as the grain
organic supply chain. The following an ongoing need for stronger elevators in this example. Organic
examples highlight the extent and enforcement provisions to ensure certification would subject these entities
complexity of organic fraud in organic integrity in organic supply chains. to regular, systematic oversight from
grain and oilseed supply chains.
Fraud Within Complex Supply Chains accredited certifying agents and allow
Organic Grain and Oilseed Fraud in the Cases of organic fraud are often the NOP to monitor these entities’
United States compounded by a complex supply activities through on-site investigations,
In recent years, the NOP has chain. Uncertified entities acting within ensuring faster detection and prevention
identified fraud in both domestic and a complex supply chain can create of millions of dollars in organic fraud.
foreign organic grain and oilseed supply significant oversight and enforcement Terminology and Objectives
chains. These supply chains are challenges for both the NOP and
generally complex and involve multiple Throughout this proposed rule, AMS
accredited certifying agents. Recent
changes in product ownership, creating refers to four concepts—organic
fraud investigations have shown that the
additional risk and opportunity for integrity, organic fraud, audit trails, and
use of uncertified handlers can decrease
fraud. Demand for organic grain and supply chain traceability—which are
the NOP’s ability to prevent fraudulent
oilseed (especially for organic livestock integral to the purpose of this proposed
grain sales in the organic market.
feed) currently exceeds domestic Fraudulent actors may obtain organic rule. AMS is explaining these concepts
production. In 2019, a private organic handler certification solely to take upfront to assist reader understanding: 7
outlook firm predicted a double-digit advantage of the regulatory exclusions 1. Organic integrity: The unique
decline in domestic organic corn and at 7 CFR 205.101. Investigations have attributes that make a product organic,
soybean production. The shortage of found fraudulent actors using these and define its status as organic. A
domestic organic commodities, exclusions to funnel nonorganic product that fully complies with the
combined with a projected shrinking feedstuffs through uncertified grain USDA organic regulations has integrity,
supply, increases the incentive for elevators. Because organic certifying and its organic qualities have not been
organic fraud. Federal investigations agents sometimes consider elevators to compromised.
show that organic grain and oilseed be transportation, they are not required 2. Organic fraud: Intentional
fraud can lead to tens of millions of to obtain organic certification. In deception for illicit economic gain,
dollars in fraudulent sales within just a addition, because some grain elevators where nonorganic products are labeled,
few months. Below are several examples are not certified, the NOP cannot sold, or represented as organic. This
which outline the different actors, compel organic certifying agents to may include substitutions or deliberate
market complexities, and indicators of investigate the onsite activities at these mislabeling; falsified records; and/or
an increase in fraud. elevators. false statements given in applications or
In 2019, the U.S. Attorney’s office of The above examples of actual fraud 7 These terms are explained only for use in this
Northern Iowa sentenced five investigations demonstrate the proposed rule and are not intended to represent any
individuals to prison for their role in an complexity of organic supply chains, addition to 7 CFR part 205 or revision to the term
organic grain fraud ring. The lead the certification status of the entities audit trail.
organic system plans, or during supply chain traceability for specific • Recommendations of a 2017 Office
inspections, investigations, and audits. products, verifying whether records of Inspector General report; 9
3. Audit trail: Documentation that is show all movement, transactions, • Recommendations of the NOP’s
sufficient to determine the source, custody, and activities involving the federal advisory committee, the
transfer of ownership, and products. National Organic Standards Board
transportation of any agricultural The objective of this proposed rule is
(NOSB); and
product labeled as ‘‘100 percent to strengthen enforcement of the USDA
organic,’’ the organic ingredients of any organic regulations and protect the • Industry stakeholder and consumer
agricultural product labeled as integrity of the organic label by (1) feedback.
‘‘organic’’ or ‘‘made with organic strengthening organic control systems; If implemented, AMS expects the
(specified ingredients)’’ or the organic (2) improving organic import oversight; amendments proposed in this rule will
ingredients of any agricultural product (3) clarifying organic certification bring more effective oversight and
containing less than 70 percent organic standards; and (4) enhancing supply enforcement, improve organic integrity
ingredients identified as organic in an chain traceability. AMS identified the and product traceability, clarify existing
ingredients statement (7 CFR 205.2). need for these proposed changes from standards to ensure fair competition,
4. Supply chain traceability: The the following sources: bolster consumer trust in the organic
ability to identify and track a product • Direct experience in administering label, reduce organic fraud, and support
(including its location, history, and the NOP, particularly complaint continued industry growth. Information
organic nature) along its entire supply investigations and audits of accredited about each amendment is described in
chain, from source to consumption, certifying agents; more detail below.
and/or ‘‘backwards’’ from consumption • The Agriculture Improvement Act
to source. A supply chain audit assesses of 2018,8 which amended the OFPA. III. Overview of Proposed Amendments
1—APPLICABILITY AND EXEMPTIONS FROM CERTIFICATION

Section Action Proposed text
205.2 ............................. Revise ......................... Handle. To sell, process, or package agricultural products, including but not limited to trad-
ing, facilitating sale or trade, brokering, repackaging, labeling, combining, containerizing,
storing, receiving, or loading.
205.2 ............................. Revise ......................... Handler. Any person engaged in the business of handling agricultural products.
205.2 ............................. Revise ......................... Handling operation. Any operation or portion of an operation that handles agricultural prod-
ucts, except for operations that are exempt from certification.
205.2 ............................. Revise ......................... Retail operation. An operation that sells agricultural products directly to final consumers
through in-person and/or virtual transactions.
205.100(a) ..................... Revise ......................... Except for the exempt operations described in § 205.101, each operation, or portion of an
operation, that produces or handles agricultural products that are intended to be sold, la-
beled, or represented as ‘‘100 percent organic,’’ ‘‘organic,’’ or ‘‘made with organic (speci-
fied ingredients or food group(s))’’ must be certified according to the provisions of subpart
E of this part and must meet all other applicable requirements of this part.
205.101 ......................... Revise ......................... Exemptions from certification.
205.101 ......................... Revise ......................... The following operations in subparagraphs (a) through (e) of this section are exempt from
certification under subpart E of this part and from submitting an organic system plan for
acceptance or approval under § 205.201 but must comply with the applicable organic pro-
duction and handling requirements of subpart C of this part, including the provisions for
prevention of contact of organic products with prohibited substances set forth in
§ 205.272, and the specific additional requirements stipulated in § 205.101(a) through (f).
205.101(a) ..................... Revise ......................... A production or handling operation that sells agricultural products as ‘‘organic’’ but whose
gross agricultural income from organic sales totals $5,000 or less annually. The products
from such operations must not be used as ingredients identified as organic in processed
products produced by another handling operation. Such operations must comply with the
labeling provisions of § 205.310.
205.101(b) ..................... Revise ......................... A retail operation or a portion of a retail operation that sells, but does not process, organi-
cally produced agricultural products.
205.101(c) ..................... Revise ......................... A retail operation or portion of a retail operation that processes agricultural products that
were previously labeled for retail sale as ‘‘100 percent organic,’’ ‘‘organic,’’ or ‘‘made with
organic (specified ingredients or food group(s)),’’ provided that the products are processed
onsite at the point of sale to the final consumer. Such operations must comply with the la-
beling provisions of § 205.310, and must maintain records sufficient to:
(1) Prove that agricultural products identified as organic were organically produced and han-
dled; and
(2) Verify quantities produced or sold from such agricultural products.
205.101(d) ..................... Add ............................. A handling operation or portion of a handling operation that only handles agricultural prod-
ucts that contain less than 70 percent organic ingredients (as described in § 205.301(d)),
or that only identifies organic ingredients on the information panel. Such operations must
comply with the labeling provisions of §§ 205.305 and 205.310 and must maintain records
sufficient to:
8 The Agriculture Improvement Act of 2018, 9 USDA Office of Inspector General Audit Report September 2017: https://www.usda.gov/oig/
Public Law 115–334, is available at: https:// 01601–0001–21: National Organic Program webdocs/01601-0001-21.pdf.
www.congress.gov/115/plaws/publ334/PLAW- International Trade Arrangements and Agreements.
115publ334.pdf.
1—APPLICABILITY AND EXEMPTIONS FROM CERTIFICATION—Continued

(1) Prove that agricultural products identified as organic were organically produced and han-
dled; and
(2) Verify quantities produced or sold from such agricultural products.
205.101(e) ..................... Add ............................. An operation that only stores, receives, and/or loads agricultural products, but does not
process or alter such agricultural products.
205.101(f) ...................... Add ............................. Records described in subparagraphs (a)–(d) of this section must be maintained for no less
than 3 years beyond their creation, and the operations must allow representatives of the
Secretary and the applicable State organic programs’ governing State official access to
these records for inspection and copying during normal business hours to determine com-
pliance with the applicable regulations set forth in this part.
AMS proposes amending §§ 205.2 and section 205.101’’ of the organic and loaders. As such, these handlers
205.100–101 of the USDA organic regulations.10 were not required to be certified. At that
regulations to clarify the applicability of This proposed amendment clarifies time, marketing was mostly local or
the regulations and limit the types of the terms handle, handler, and handling regional, and organic market sales
operations excluded from organic operation to better align with the OFPA totaled a fraction of today’s figures.
certification in the global supply chain. definition of handle, ‘‘to sell, process, or Additionally, the percentage of organic
This includes revising the definitions of package agricultural products’’ (7 U.S.C. product handled by excluded entities
handle, handler, handling operation, 6502(8)). Limiting handler exemptions was relatively low.
is necessary to meet the basic purposes The organic market has grown
and retail food establishment. The
delineated in 7 U.S.C. 6501(2)–(3), ‘‘to considerably since the USDA organic
proposed amendments would require
assure consumers that organically regulations took effect in 2002. The
certification of operations that facilitate Organic Trade Association reports that
produced products meet a consistent
the sale or trade of organic products, total U.S. organic sales grew from $3.4
standard, and to facilitate interstate
including but not limited to brokers, billion in 1997 to $55.1 billion in
commerce in fresh and processed food
importers, and traders. that is organically produced.’’ As the 2019.11 This significant market growth
In general, this proposed rule requires current exclusions at § 205.101(b)(1) are has created the opportunity for
the certification of any handling no longer appropriate, AMS is additional domestic and international
operation whose activities may affect exercising its authority, as mandated in producers, handlers, product suppliers,
the organic status of agricultural the 2018 farm bill, to limit those importers, brokers, distributors, and
products they handle or represent after exclusions in order to fully implement others to participate in the organic
production, as the products move from the national standards authorized by 7 market. Interpretation of the current
production source through a supply U.S.C. 6504 and to ensure compliance regulations has allowed many of these
chain. The amendments also clearly with the OFPA and the USDA organic operations to remain uncertified. This
regulations. has resulted in increased complexity of
specify which entities and activities are
organic supply chains. Today’s organic
exempt from certification. Most notably, History and Justification for marketplace is marked by multifaceted
this includes exemptions for retail Amendments supply chains with organic products
operations and entities that only store increasingly coordinated by entities not
In addition to the 2018 farm bill,
organic products; the current exclusions several factors compel regulatory regulated by the USDA, creating risks
at § 205.101(b)(1) would be removed. changes to require the certification of that could impact the integrity of
Authority many currently excluded operations. organic products.
The present need for expanded Other contributors to risk include
AMS’ authority to modify §§ 205.2, oversight to protect organic integrity is entities in the middle of supply chains
205.100, and 205.101 of 7 CFR is primarily due to the emergence of that facilitate the sale or trade of organic
established in the OFPA. The statute complex global supply chains and products. These include domestic
allows AMS to ‘‘establish an organic business relationships, and price importers of products, brokers/traders,
certification program for producers and premiums for organic products. These distributors, and other handlers who
handlers of agricultural products’’ (7 factors present the opportunity and represent a link between certified
U.S.C. 6503(a)) and ‘‘require such other incentive for organic fraud, which has parties. Although some of these
materialized in the organic sector, and handlers voluntarily seek certification,
terms and conditions as may be
which would be mitigated by reducing the current organic regulations do not
determined . . . necessary’’ (7 U.S.C.
the types of entities excluded from require their certification. Handlers are
6506(a)(11)). The OFPA and the USDA responsible for the integrity of the
organic regulations state that any certification.
Following full implementation of the organic products they handle, even if
operation that produces or handles they never take ownership or possession
certified organic agricultural products is NOP in 2002, AMS believed that organic
product integrity would not be of a product, because they frequently
required to be certified (7 U.S.C. 6503
compromised or altered when handled make decisions impacting the integrity

and 7 CFR 205.100). Additionally, the of organic products. For example, they
by entities such as brokers, distributors,
Agriculture Improvement Act of 2018 traders, storage professionals, receivers, may file import and export permits;
(the ‘‘2018 farm bill’’) requires that the arrange sales to both certified and
USDA ‘‘issue regulations to limit the 10 See section 10104(a) of the Agriculture uncertified entities; and comply with
type of organic operations that are Improvement Act of 2018, Public Law 115–334,
excluded from certification under available at: https://www.congress.gov/115/plaws/ 11 Organic Trade Association, Organic Industry
publ334/PLAW-115publ334.pdf Survey, 2018–2020.
mandatory import conditions such as NOP 5031 only addresses handlers of operation to include any person or
fumigation or irradiation. The current unpackaged organic products, it has not operation that handles agricultural
lack of certification requirements for eliminated the audit trail gaps that products. This includes handling
excluded handlers can negatively affect prevent full product traceability from operations such as importers, brokers,
the organic status of products, and farm gate to consumer. Furthermore, and traders. Accountability from these
reduce the availability of auditable NOP 5031 has not been consistently operations is required to maintain the
records needed to assess organic status. implemented by certifying agents, integrity of organic products. Even if
The evolution of the organic industry particularly with respect to less-typical these operations do not take physical
has made clear that the current terms handling activities (e.g., auguring possession or ownership of the product
handle, handler, and handling commodities from vessels to rail cars at they represent, their decisions affect the
operation, as defined at § 205.2 of the ports). status of organic products; the
organic regulations, no longer operation’s records are essential to
Clarification of Applicability
adequately represent the full scope of demonstrate a product’s compliance at
The proposed rule clarifies the that point in the supply chain. For
organic supply chains. The allowance of
applicability of the regulations by example, uncertified brokers may
uncertified handlers creates gaps in the
revising § 205.100 and the definitions of receive notices of organic products
organic supply chain, breaking chains of
handle, handler, and handling being treated with substances prohibited
custody and complicating the
operation. These proposed revisions for use on organic products, but might
verification of product origin.
clearly state which entities, operations, not provide those notices to certified
Expanding organic certification to cover and activities require certification under
a wider range of handling operations is importers or accredited certifying
the USDA organic regulations. agents. Such critical breaks in the audit
critical to supply chain traceability. It Specifically, the proposed rule revises
would make more parties visible and trail could allow products to be sold as
the definition of handle by including organic, after being treated with
accountable, require the generation and additional activities, most notably
maintenance of auditable records, and substances prohibited for use on organic
trading, brokering, and facilitating sale products.
improve the usefulness of audit trails or trade. The revised definition of Similarly, uncertified storage facilities
and product verification. The NOP handle reflects the broad range of may store and split or combine lots and
believes improved supply chain handling activities that take place in the loads. Certifying agents and certified
traceability is critical to the continuing modern organic industry, and can be importers may not be informed of the
success of the program and its ability to generally described to include activities full range of activities conducted at such
ensure the integrity of organic products. that affect the organic status or facilities; however, handlers at these
Supply chain traceability is discussed in ownership of an agricultural product locations have a critical role in
more detail later in this proposed rule. after production as it moves from maintaining the integrity and
Previous Actions by AMS, the NOSB, production source through a supply traceability of organic products. For this
and Stakeholders chain. reason, the proposed rule would require
Unless specifically exempted from the certification of these types of
In 2010, the NOSB provided AMS certification, as discussed in a later handlers.
recommendations to address the risks to section, any person or operation that Finally, because uncertified handlers
organic integrity created by handler conducts activities described in the are not required to maintain auditable
exclusions.12 The NOSB determined revised definition of handle would need records for five years, sales or transit
that handlers of unpackaged bulk to be certified and comply with all records might not be available for
agricultural products should not be applicable requirements for handlers. inspection by the USDA or certifying
excluded from certification and This would require the certification of agents. The U.S. Government has
requested that the NOP define the scope certain types of excluded handlers that limited ability to obtain records from
of handling activities addressed by currently operate without regular foreign businesses who are not certified
§ 205.101(b) of the organic regulations. systematic oversight from the USDA, to the USDA regulations. The current
In 2014, the NOP issued guidance on most notably intermediate market actors exclusion of these brokers from organic
the certification requirements for such as brokers, traders, and importers. certification creates risks for organic
handling unpackaged organic products Certified organic products that are integrity when they facilitate the sale of
(NOP 5031) 13 and provided clarification handled by an uncertified, non-exempt USDA-organic products produced
about the circumstances under which a operation at any point in the supply overseas, prior to export to the United
handling operation is excluded from chain will lose their certified organic States.
certification requirements. This status and may no longer be sold,
guidance was based upon both the 2010 Clarification of Exemptions From
labeled, or represented as organic. In Certification
NOSB recommendations and the turn, certified organic operations that
findings of two Office of Inspector receive products from uncertified, non- In addition to clearly stating who
General audits of the NOP’s oversight of exempt handlers and subsequently label requires organic certification, the
organic milk.14 Because the guidance in the products as organic, use as feed for proposed rule also describes the
organic livestock, or use as ingredients activities that would not require
12 NOSB Formal Recommendation: Clarifying the
for organic products are in violation of certification to produce, handle, or sell
Limits of 205.101(b), October 28, 2010: https:// organic agricultural products. The
www.ams.usda.gov/sites/default/files/media/ USDA organic regulations, and may be
proposed rule modifies § 205.101 by
NOP%20CACC%20Final% subject to proposed suspension or

20Rec%20Clarifying%20the%20Limitations.pdf. revocation of certification and possible renaming the section ‘‘Exemptions from
13 NOP 5031—Guidance, Certification
civil penalties. certification,’’ eliminating the
Requirements for Handling Unpackaged Organic
The proposed rule also modifies the exclusions currently listed at
Products, January 22, 2014: https:// § 205.101(b), and listing in revised
www.ams.usda.gov/sites/default/files/media/ definitions of handler and handling
5031.pdf. § 205.101 all operations that are exempt
14 USDA Office of Inspector General Audit Report Organic Milk, February 2012: https:// from organic certification. Eliminating
01601–0001–Te: National Organic Program— www.usda.gov/oig/webdocs/01601-0001-Te.pdf. reference to exclusion and excluded
operations, and categorizing as exempt chain and reduce the potential eat agricultural products to sell, label, or
those operations that do not require mishandling of packaged organic represent these products as organic. In
organic certification, will reduce products by uncertified operations. This the future, under its existing authority,
confusion and misinterpretation about modification also addresses many AMS could consider requirements for
who needs to be certified. stakeholders’ request that everyone in the certification of retailers that process
Although they do not require the supply chain producing or handling agricultural products intended to be
certification, exempt operations must organic products must be certified, with sold, labeled, or represented as organic.
comply with portions of the organic very limited exceptions. Requiring We are retaining the exemption from
regulations. Exempt operations that are certification of additional types of certification for retailers that process
producing or handling organic products handling operations, including those unless and until we have more input
are responsible for maintaining organic previously excluded by the ‘‘packaged from stakeholders on the need for and
integrity and must follow the product’’ condition, would substantially impact of removing this exemption and
production and handling requirements enhance the integrity of organic recommended standards for retailers.
of the organic regulations that relate to products by eliminating record gaps in The proposed rule would exempt
their activities. Stakeholders have the supply chain and enabling more retail operations from certification,
expressed concern about the clarity and complete audit trails. Expanded including retail operations that sell, but
consistent implementation of these certification also would reduce the risk do not process, organic agricultural
requirements. The proposed rule of exposure of packaged organic products (proposed § 205.101(b)), and
addresses this concern by clearly stating products to prohibited methods such as retail operations that process
what requirements each exempt ionizing radiation and fumigation with agricultural products previously labeled
operation must follow. In general, all prohibited materials, processes that may for retail sale as organic (proposed
exempt operations must follow the compromise the product’s organic § 205.101(c)). These exemptions are very
applicable organic production and status. similar to the current exemption and
handling requirements of subpart C of exclusion for retail food establishments
the regulations, including the provisions Clarification of the Retail Operation at current §§ 205.101(a)(2) and (b)(2). To
for prevention of contact of organic Exemption qualify for the exemption at proposed
products with prohibited substances The proposed rule renames the term § 205.101(c), any processing of organic
(§ 205.272). In addition, specific retail food establishment as retail products performed by a retail operation
additional requirements are included for operation and expands the definition to must occur in connection with the
some exemptions, and recordkeeping include current modes of direct-to- direct sale to the final consumer. This
requirements are explained in revised consumer sales that commonly occur in means that the products must be
§ 205.101. the modern marketplace. The term retail processed and sold in the same physical
operation is defined as an operation that location. An operation processing a
Exemptions Retained by the Proposed sells agricultural products directly to product for sale at another site would
Rule final consumers through in-person and/ require certification. This would
The current exemption for operations or virtual transactions. This amended include retailers that sell virtually; the
with $5,000 or less in annual income term is required to capture the full range organic products which they sell, label
from organic sales is retained at revised of direct-to-consumer sales that may or represent as organic must have been
§ 205.101(a). To ensure the integrity of occur in the current era of electronic produced and processed by certified
organic products, these operations are and internet commerce. ‘‘Virtual operations.
required to comply with the provisions transaction’’ is used to describe any Retail operations may present risks to
for the prevention of contact of organic form of transaction that does not occur organic integrity. For example, a grocery
products with prohibited substances in person (e.g., telephone, mail-order, store may accidentally mix or combine
(§ 205.272) and the labeling provisions and/or online sales). Additionally, organic and nonorganic produce of the
of § 205.310. The current exemptions for expanding the term to include food and same type, or they may unintentionally
operations that handle products with other agricultural products is necessary place an organic label on a shelf that
less than 70 percent organic ingredients to reflect the full range of certified holds nonorganic products. Further,
and operations that only identify organic products that may be sold storing organic produce in a container
organic ingredients on product labels directly to consumers in today’s retail that was previously used for nonorganic
are also retained at new § 205.101(d). marketplace. Examples of retail produce without first cleaning the
These exempt handlers are required to operations include but are not limited to container may expose the organic
comply with the labeling requirements restaurants, delicatessens, bakeries, produce to a prohibited pesticide.
of §§ 205.305 and 205.310, the grocery stores, or any retail business Therefore, all exempt retail operations
comingling requirements of § 205.272, with a restaurant, delicatessen, bakery, must comply with the requirements of
and must maintain records that (1) salad bar, bulk food self-service stations § 205.272, which describe handling
prove that agricultural products (e.g., grains, nuts), or other eat-in, carry- requirements to prevent comingling and
identified as organic were organically out, mail-order, or delivery service of contact with prohibited substances.
produced and handled, and (2) verify raw or processed agricultural products. Additionally, exempt retail operations
quantities produced or sold from such The OFPA excludes final retailers that that process organic products must
agricultural products. do not process agricultural products follow the labeling provisions of
from the definition of ‘‘handler’’ and § 205.310, and maintain records to (1)
Exclusions Removed From the Proposed ‘‘handling operation.’’ (7 U.S.C. 6502). demonstrate that agricultural products
Rule Therefore, these types of retailers are identified as organic were organically
The current exclusion at not required to be certified in order to produced and handled; and (2) verify
§ 205.101(b)(1), for operations that only sell organic products. In the proposed quantities received, sold, or produced
handle packaged organic products, is rule, AMS is modifying and expanding from such agricultural products.
omitted from the proposed rule. This the current provision in the USDA Following these requirements will help
amendment will improve traceability of organic regulations which permits maintain organic integrity, even in the
organic products through the supply retailers that process raw and ready-to- absence of certification.
Exemption for Storage of Organic opening, enclosing, or labeling/ organic status of the product being
Agricultural Products relabeling. These activities are handling transported and/or stored. Records
There are many operations that store and would require certification. could include clean truck affidavits;
organic products; however, these Permitted activity that does not require records of cleaning and sanitizing
operations are generally considered low- certification would be restricted to materials, and procedures used to clean
risk because of the type of activities they movement of agricultural products only. trucks; bills of lading, manifests,
perform and because they may be transaction certificates, shipping
Certified Operations’ Verification and
identified in the organic system plan of records, delivery records, invoices, lot
Recordkeeping Responsibilities
a certified operation. Given that these numbers, and other audit trail
The exempt activities described in documents; and records documenting
operations are lower-risk and are subject
this proposed rule present relatively low the audit trail, chain of custody, tanker
to oversight by certified handlers in
risk to organic integrity; however, seals, wash tags, truck and trailer
adjacent segments of the supply chain,
exempted operations are not without numbers. Records such as these can be
AMS proposes exempting from organic
risk. To address this risk, AMS proposes used by a certified operation to verify
certification operations that only store
that certified operations include in their that organic products are properly
agricultural products, but do not process
organic system plans monitoring handled by exempt transport or storage
or alter such agricultural products
practices and procedures to verify their operations. Records can also be used for
(proposed § 205.101(e)).15 This
supply chains and the organic status of traceability, both by certified operations
approach is consistent with risk-based
products they receive (see proposed to verify the source of a product they
oversight models.
This exemption would apply to amendments to § 205.201 and receive, and by certifying agents to
warehouses, storage facilities, and other discussion on Supply Chain verify the origin of a product during a
operations whose only function is the Traceability and Fraud Prevention later trace-back audit.
temporary holding or storage of organic in this proposed rule). This includes These recordkeeping requirements
products, and the associated receiving verifying the organic status of products will ensure that certified operations
and loading of organic products. An that are handled by exempt operations maintain documents to demonstrate that
operation that processes or alters the in a supply chain. Certified operations the organic integrity of products is not
organic products they store would not should carefully review the practices compromised during transport and/or
qualify for the exemption and must be and records of operations in their storage. Additionally, records will show
certified. Storage operations claiming supply chain, including transportation the quantities of organic products
this exemption must not label/relabel, and storage operations. Certified transported and/or stored, and facilitate
combine, split, containerize, pack/ operations that load/sell/export organic certifying agents in performing trace-
repack, treat, sort, open, enclose, or products and certified operations that back and mass-balance audits through a
otherwise alter the organic products receive/purchase/import organic supply chain. Clarifying what activities
they handle. Like other exempt products are ultimately responsible for that are exempt from certification—and
operations, the proposed rule would verifying that organic status has not clarifying recordkeeping
require storage operations exempted at been compromised during transport or responsibility—will enhance
proposed § 205.101(e) to comply with storage. accountability for the integrity of both
In addition to procedures in an domestic and imported organic products
the requirements of § 205.272 for the
organic system plan, certified operations by bolstering the NOP’s oversight of
prevention of commingling and contact
must also maintain records to support handlers that affect the status of organic
with prohibited substances.
the verification of organic integrity and products.
Transport of Organic Agricultural facilitate supply chain audits. The
Products current organic regulations at § 205.103 Request for Comment
Like storage, transport also qualifies state that certified operations ‘‘must AMS seeks comment regarding the
as a low-risk activity and may be maintain records concerning the proposed amendments to §§ 205.2 and
identified in the organic system plan of production, harvesting, and handling’’ 205.100–101 discussed above, including
a certified handler. Because transport of their products. Certified operations answers to the following questions:
alone is not a handling activity (see 7 must keep records of these activities to 1. Are there additional activities that
U.S.C. 6502(8) and 7 CFR 205.2), ‘‘Fully disclose all activities and should be included in the proposed
operations that only transport organic transactions of the certified operation in definition of handle (i.e., are there
products are not required to be certified. sufficient detail’’ to ‘‘demonstrate additional activities that require
Certifying agents have expressed compliance with the Act and the certification)? Are there any activities in
confusion about which activities regulations.’’ Therefore, to demonstrate the proposed definition of handle that
constitute transport versus which compliance, certified operations must should be exempt from certification?
activities qualify as handling and, thus, maintain records of products that were 2. Are there specific activities not
require certification. Transport handled by operations in their supply included in the proposed rule that you
chain, including transportation and believe should be exempt from organic
commonly refers to the movement of
storage operations.16 certification?
products in commerce; any activity that
As a best practice, records covering 3. Are there additional requirements
alters an agricultural product during
these types of handling activities should that exempt handlers described in this
transport would qualify as handling, (1) demonstrate that the organic
and would require certification. Other proposed rule should follow?
integrity of the product is maintained 4. Activities at ports may present a
activities that could occur adjacent to during transport and/or storage, and (2) threat to the integrity of organic
transport include, for example, verify both the quantities and the products due to the multiple types of
combining, splitting, containerizing,
handling activities performed in these
packing/repacking, treating, sorting, 16 7 U.S.C. 6519(a)(1) ‘‘. . .each person who sells,
locations. It is common for independent
labels, or represents any agricultural product as
15 Processing, as defined by 7 CFR 205.2, includes having been produced or handled using organic
operations to perform specific physical
‘‘packaging. . .or otherwise enclosing food in a methods shall make available. . .all records handling activities within a port (e.g.,
container.’’ associated with the agricultural product.’’ loading, unloading, or transfer of
packaged, unpackaged, or bulk organic require certification of these operations, activities performed at ports should
product). The proposed rule would who are often contractors. What other require certification and why?
2—IMPORTS TO THE UNITED STATES

205.2 ............................. Add new term ............. Organic exporter. The owner or final exporter of the organic product who facilitates the trade
of, consigns, or arranges for the transport/shipping of the organic product from a foreign
country.
205.2 ............................. Add new term ............. Organic importer of record. The operation responsible for accepting imported organic prod-
ucts within the United States.
205.273 ......................... Add new section ......... Imports to the United States.
205.273 ......................... Add ............................. Each shipment of organic products imported into the United States through U.S. Ports of
Entry must be certified pursuant to subpart E of this part, labeled pursuant to subpart D of
this part, be declared as organic to U.S. Customs and Border Protection, and be associ-
ated with a valid NOP Import Certificate (Form NOP 2110–1) or equivalent data source.
205.273(a) ..................... Add ............................. Persons exporting organic products to the United States must request an NOP Import Cer-
tificate, or provide data through an equivalent data source, from a certifying agent, for
each physical shipment of certified organic products prior to their export. Only certifying
agents accredited by the USDA or foreign certifying agents authorized under an organic
trade arrangement may issue an NOP Import Certificate or approve a listing in an equiva-
lent data source (e.g., a third-party export system).
205.273(b) ..................... Add ............................. The certifying agent must review an NOP Import Certificate request, determine whether the
shipment complies with the USDA organic regulations, and issue the NOP Import Certifi-
cate or equivalent within 30 calendar days of receipt if the shipment complies with the
USDA organic regulations.
205.273(c) ..................... Add ............................. Each compliant organic shipment must be declared as organic to U.S. Customs and Border
Protection through a U.S. Port of Entry by uploading the unique NOP Import Certificate, or
equivalent electronic data entry, into the U.S. Customs and Border Protection’s Automated
Commercial Environment system.
205.273(d) ..................... Add ............................. Upon receiving a shipment with organic products, the organic importer of record must en-
sure the shipment is accompanied by a verified NOP Import Certificate or equivalent;
must verify that the shipment contains only the quantity and type of certified organic prod-
uct specified on the NOP Import Certificate or equivalent; and must verify that the ship-
ment has had no contact with prohibited substances pursuant to § 205.272 or exposure to
ionizing radiation pursuant to § 205.105, since export.
205.273(e) ..................... Add ............................. The use of the term equivalent in this section refers to electronic data, documents, identi-
fication numbers, databases, or other systems verified as an equivalent data source to the
NOP Import Certificate.
205.300(c) ..................... Revise ......................... Products produced in a foreign country and exported for sale in the United States must be
certified pursuant to subpart E of this part, labeled pursuant to this subpart D, and must
comply with the requirements in § 205.273, Imports to the United States.
AMS proposes amending the USDA import and export systems that facilitate NOP Import Certificates are currently
organic regulations by adding a new information exchange between used for organic products imported from
section (205.273) discussing the use of governments or authorized entities. countries that the NOP has determined
the National Organic Program Import to be equivalent (OMB Approval No.
What is an NOP import certificate?
Certificate (‘‘NOP Import Certificate’’). 1651–0022). The USDA has established
Currently, NOP Import Certificates are The NOP Import Certificate, or equivalency with Canada, the European
only required for organic products equivalent, is a type of transaction Union, Switzerland, Japan, South Korea,
imported from a country that the NOP certificate, or equivalent data source, Taiwan, and the United Kingdom.17
has determined uses an equivalent that contains detailed information about Organic imports from Canada are
system of organic certification, e.g., NOP the quantity and origin of organic accompanied by an attestation statement
Import Certificates are currently used product being imported into the United that the products comply with the terms
for imports from the European Union, States. The purpose of the NOP Import of the United States-Canada Organic
Switzerland, Japan, and South Korea. Certificate is to document the organic Equivalency Arrangement. Organic
This proposed rule would require that status and quantity of a specific imports from the European Union,
any organic agricultural product physical shipment of imported organic Switzerland, Japan, South Korea,
imported to the United States be products. The NOP Import Certificate is Taiwan, and the United Kingdom are
associated with a valid NOP Import associated with a specific shipment of accompanied by an NOP Import
Certificate or equivalent data source. imported organic products as it travels Certificate. The certifying agent
The use of the term ‘‘equivalent’’ in this from a certified organic exporter in a evaluates the request for an NOP Import
section refers to data and systems that foreign country to a certified organic Certificate, and upon verification of the
are created, issued, or used by the importer in the United States. The NOP organic shipment, completes and issues
United States or foreign governments to Import Certificate is used to ensure a an NOP Import Certificate. Form NOP
share trade-related information. smooth, auditable business transaction 2110–1 (OMB Control Number 0581–
Allowing for equivalent data and by documenting that the products in the 0191) is currently used for this purpose.
systems that harmonize with U.S. shipment are organic and may be sold,
Government trade systems allows for represented, and distributed as organic 17 The United States–United Kingdom
the future development of interoperable within the United States. equivalency will be effective in January 2021.
AMS does not currently require NOP and the USDA organic regulations facilitating the trading, selling,
Import Certificates for organic imports require certifying agents to maintain and consigning, shipping or exporting of
from countries that the United States make available to the Secretary records organic product from a foreign country
does not have organic equivalency with. concerning its activities (7 U.S.C. 6519, to the United States. An organic
This proposed rule would expand and 7 CFR 205.501(a)(9), 7 CFR 205.510(b)). exporter must be certified organic by
make compulsory the use of NOP certifying agents accredited by the
Import Certificates, regardless of an NOP Import Certificate Format and USDA or certifying agents authorized by
imported product’s country of origin. Tracking System a trade arrangement, and must maintain
Specifically, this proposed rule would AMS proposes that NOP Import records required under § 205.103.
require that all imported products Certificates must be provided in a Organic exporters may be the final
intended to be sold, represented, or standardized electronic format to ensure physical handler of organic products
labeled as organic in the United States consistency. AMS anticipates that Form within a foreign country or they may be
must be declared as organic to U.S. NOP 2110–1, or an electronic equivalent the entities that facilitate, sell, or
Customs and Border Protection (CBP), that provides the same data, will serve arrange the sale of organic products
and that each physical shipment passing this purpose, because it includes fields shipped to the United States.
through a U.S. Port of Entry must be for the information needed to meet the An organic importer of record is the
associated with an NOP Import requirements of an NOP Import entity responsible for receiving organic
Certificate, or equivalent data source. Certificate as defined in the OFPA: products within the United States. An
Requiring an NOP Import Certificate Origin; destination; the certifying agent organic importer of record must be
provides trackable and auditable issuing the NOP Import Certificate; certified and must maintain records
verification that a specific shipment of harmonized tariff code, when required under 7 CFR 205.103. The
imported organic products complies applicable; total weight; and the organic proposed rule would specify that there
with the USDA organic regulations. It standard the product was certified to (7 is a consistent party, the organic
will also support investigations if U.S.C. 6502(13)). For the purposes of importer of record, that is responsible
noncompliant products are exported uploading and tracking NOP Import for ensuring the compliance of organic
and misrepresented as organic for sale Certificates, Form 2110–1 must be agricultural products imported into the
in the United States. available as an electronic format to meet United States.
the requirements of the OFPA (7 U.S.C. This proposed rule would require that
Authority and Justification for the a certified organic exporter sending
Mandatory Use of NOP Import 6514(d)(1)).
The OFPA, as amended by the 2018 organic products to the United States
Certificates request an NOP Import Certificate, or
farm bill, also states that AMS must
The mandatory use of NOP Import establish a system of tracking NOP equivalent, from their certifying agent
Certificates is authorized by the OFPA, Import Certificates, and that AMS ‘‘may for the organic products intended for
as amended by the Agriculture integrate the system into any existing export. As discussed in the proposed
Improvement Act of 2018.18 The OFPA information tracking systems for amendments to the USDA organic
specifies what information an NOP imports of agricultural products’’ (7 regulation at § 205.2, Terms defined,
Import Certificate must include (7 U.S.C. 6514(d) and 6522(c)).19 Because and § 205.101, Exemptions from
U.S.C. 6502(13)), and also stipulates that the OFPA enables AMS to access certification, entities that facilitate the
the NOP Import Certificate must ‘‘be information available in CBP’s sale of organic products and arrange for
available as an electronic record’’ and Automated Commercial Environment the transport of organic products into
captured in a tracking system system (ACE) (7 U.S.C. 6521(c)), AMS the United States (e.g., organic
maintained by the U.S. Government (7 expects that ACE will be used to track exporters) would need to be certified.
U.S.C. 6514(d)). The OFPA also and store NOP Import Certificates, or The request for an NOP Import
provides the Secretary with broad equivalent electronic data.20 ACE is an Certificate must include information
authority to establish appropriate and automated and electronic system for required for the organic exporter’s
adequate enforcement procedures and processing commercial trade data. ACE certifying agent to complete the NOP
any other requirements that the is the primary system through which the Import Certificate or equivalent.
Secretary may determine to be necessary global trade community files The organic exporter’s certifying agent
(7 U.S.C. 6506). information about imports and exports would issue the NOP Import Certificate,
Both the OFPA and the USDA organic or equivalent, provided it has verified
so that admissibility into the United
regulations require certified operations that the shipment complies with the
States may be determined by
to maintain and make available to the USDA organic regulations or an
government agencies (including AMS)
Secretary records concerning the equivalent standard. This means that:
to ensure compliance.
production, harvesting, and handling of (1) The information submitted on the
agricultural products that are or that are Use of the NOP Import Certificate NOP Import Certificate, or equivalent, is
intended to be sold, labeled, or The proposed rule includes two new accurate, including confirmation of the
represented as organic (7 U.S.C. 6519, 7 terms, organic exporter and organic organic status of each product listed on
CFR 205.103, and 7 CFR 205.400(d)). importer of record, that describe the NOP Import Certificate; and (2) the
This includes sufficient records to businesses that facilitate the final handler has the capacity to
provide an audit trail to determine the international trade of organic products. produce or handle the quantity of
source, type and quantity, transfer of An organic exporter is responsible for organic product to be exported. The
ownership, and transportation of any final handler would typically be the
agricultural product labeled as organic 19 See section 10104(c) of the Agriculture exporter or the last handler that
(7 CFR 205.2). Likewise, both the OFPA Improvement Act of 2018, Public Law No: 115–334. processed the product. Verifying that
Available at: https://www.congress.gov/115/plaws/ the product complies with the organic
18 See sections 10104(b)(3) and 10104(c) of the publ334/PLAW-115publ334.pdf. standards includes, but is not limited to,
20 See sections 10104(h) and (j) of the Agriculture
Agriculture Improvement Act of 2018, Public Law verifying that the import has not been
No: 115–334. Available at: https:// Improvement Act of 2018, Public Law No: 115–334.
www.congress.gov/115/plaws/publ334/PLAW- Available at: https://www.congress.gov/115/plaws/ exposed to a prohibited substance,
115publ334.pdf. publ334/PLAW-115publ334.pdf. treated with a prohibited substance as a
result of fumigation or treated with containing organic products may enter with more data to identify specific
ionizing radiation at any point in the the United States without an NOP shipments of organic imports.
products’ movements across country Import Certificate at the time of entry.
Alignment With Other Supply Chain
borders. However, the NOP Import Certificate, or
Upon receiving a shipment, an Traceability Norms
equivalent data, must be uploaded into
organic importer of record must verify the ACE system within 10 calendar days One of the goals of this action is to
that the organic product(s) comply with of the shipment entering the United harmonize USDA regulatory
the USDA organic regulations. This States. This is consistent with existing requirements for importing organic
includes, but is not limited to, verifying trade filing timeframes in ACE using the products with international guidelines
that the import has not been treated Entry Summary process.21 AMS expects and norms. NOP considered
with a prohibited substance as a result that this 10-day timeframe will result in international standards established by
of fumigation or treated with ionizing little to no impact to the timely the Codex Alimentarius Commission
radiation at any point in the products’ importation of organic products. (Codex) 23 and norms published by the
movements across country borders. Regardless of when an NOP Import International Federation of Organic
Both the organic exporter and organic Certificate is completed, the organic Agriculture Movements (IFOAM).24
importer of record must maintain exporter and organic importer of record Both provide for and support the use of
records of NOP Import Certificates, and are fully accountable for the compliance transaction shipment certificates such as
these records must be available for of the imported product(s). the NOP Import Certificate.
inspection by the NOP and certifying
Cooperation With U.S. Customs and Future Harmonization With Sanitary
agents in accordance with § 205.103.
Border Protection and Phytosanitary Data Systems
Only certifying agents accredited by
the USDA, or foreign certifying agents The OFPA, as amended by the Further, the use of health certificates,
authorized by a trade arrangement, may Agriculture Improvement Act of 2018, sanitary certificates, phytosanitary
prepare and issue an NOP Import requires the establishment of an Organic certificates, and other regulatory
Certificate or equivalent. Once Agricultural Product Imports requirements in place to contain certain
completed by the certifying agent, an Interagency Working Group, consisting plant and animal pests or diseases may
NOP Import Certificate or equivalent is of members of both the USDA and CBP offer a possible resource for the NOP
provided to the organic exporter, and (see 7 U.S.C. 6521a).22 The mandatory and other government agencies to
the organic exporter must provide the use of NOP Import Certificates supports document the movement of organic
data associated with the NOP Import products across national borders. Over
the working group’s goal to ensure the
Certificate to CBP by uploading the data time, it is expected that the United
compliance of organic agricultural
into the ACE system as an electronic States and foreign countries will
products imported to the United States,
record. automate and harmonize systems to
and builds upon ongoing cooperation
An NOP Import Certificate, or support the more seamless exchange of
between the USDA and CBP.
equivalent, would also require use of AMS is working with CBP to verify electronic import and export data in
the 10-digit NOP operation ID, or that shipments of imported organic organic trade. AMS will continue to
equivalent ID, name, and address of the work to improve, adapt to, and support
products are associated with unique
organic importer of record in the United seamless electronic paperless supply
NOP Import Certificates. In April 2020,
States, and the 10-digit NOP operation chain traceability and transparency
the electronic version of the NOP Import
ID, or equivalent ID issued by a foreign using the International Trade Data
Certificate (or ‘‘message set’’) was
certifying agent authorized under a System (ITDS) and other technologies as
deployed in ACE as an optional filing
trade arrangement, for the organic they evolve.
step for organic imports. The use of the
exporter of the product to be exported Request for Comment
electronic NOP Import Certificate will
to the United States. The NOP
be mandatory when the SOE final rule AMS seeks comment regarding the
Operation ID, or an equivalent ID, is a
is implemented. use of NOP Import Certificates
critical piece of data because it is a AMS expects some of the information
unique number generated in the Organic discussed in this proposed rule,
collected via the NOP Import Certificate including answers to the following
INTEGRITY Database for certifying may be modified. In addition to the
agents accredited by the USDA, or in an questions:
NOP Operation ID mentioned above, 1. Is the 30-day timeframe for
equivalent system for foreign certifying AMS is considering adding fields for the
agents authorized under a trade certifying agents to review and issue an
U.S. Customs Entry Number and the NOP Import Certificate appropriate?
arrangement. This unique ID for each Purchase Order (PO) number to assist
certified operation will link the Why or why not?
with tracking organic imports. 2. How could the mode of
exported organic product to the organic Other fields may be eliminated to transportation and frequency of
importer of record in the United States. avoid collecting duplicate information shipments affect the use of the NOP
This will strengthen the audit trail by already collected through the ACE Import Certificate?
ensuring that handlers on both sides of database.
the transaction are known to Federal Once established, the availability of 23 Section 7 of the Codex Guidelines for the
agents and can be linked when an the electronic NOP Import Certificate in Production, Processing, Labelling and Marketing of
organic product is imported into the ACE would notify CBP officials of Organically Produced Foods recommends imported
United States. organic products to be marketed only where the
organic shipments and provide AMS competent authority or designated body in the
AMS acknowledges the concern that
exporting country has issued a certificate of

using NOP Import Certificates may slow 21 CBP Form 7501: Entry Summary. Available on inspection stating that the lot designated in the
the importation of organic product. the U.S. Customs and Border Protection website: certificate was obtained within an organic system
Therefore, AMS is requiring that organic https://www.cbp.gov/trade/programs- of production, preparation, marketing and
imports that pass through U.S. Ports of administration/entry-summary/cbp-form-7501. inspection.
22 See section 10104(i) of the Agriculture 24 IFOAM Norms define a transaction certificate
Entry be associated with, but not Improvement Act of 2018, Public Law No: 115–334. as a ‘‘document issued by a certification body or by
accompanied by, an NOP Import Available at: https://www.congress.gov/115/plaws/ the operator, declaring that a specified lot or
Certificate. This means that a shipment publ334/PLAW-115publ334.pdf. consignment of goods is certified.’’
3—LABELING OF NONRETAIL CONTAINERS

205.307 ......................... Revise title .................. Labeling of nonretail containers.

205.307 (a) .................... Revise ......................... Nonretail containers used to ship or store certified organic product must display the fol-
lowing:
(1) The term, ‘‘100 percent organic,’’ ‘‘organic,’’ or ‘‘made with organic (specified ingredients
or food group(s)),’’ as applicable, to identify the product;
(2) The statement, ‘‘Certified organic by (name of certifying agent),’’ or similar phrase, to
identify the name of the certifying agent that certified the producer of the product, or, if
processed, the certifying agent that certified the last handler that processed the product;
and
(3) The production lot number of the product, shipping identification, or other information
needed to ensure traceability.
205.307 (b) .................... Revise ......................... Nonretail containers used to ship or store certified organic product may display the following:
(1) Special handling instructions needed to maintain the organic integrity of the product;
(2) The USDA seal. Use of the USDA seal must comply with § 205.311;
(3) The name and contact information of the certified producer of the product, or if proc-
essed, the last certified handler that processed the product;
(4) The seal, logo, or other identifying mark of the certifying agent that certified the producer
of the product, or if processed, the last handler that processed the product; and/or
(5) The business address, website, and/or contact information of the certifying agent.
Accurate labeling of non-retail 2. Boxes, crates, cartons, and master nonretail container labeled with only a
containers used to ship or store organic cases of wholesale packaged products. production lot number is at risk of
products is critical to organic integrity. Section 205.307 does not apply to having its organic integrity
Detailed labeling reduces large nonretail containers that are compromised, including treatment with
misidentification and mishandling, associated with a mode of transportation a prohibited substance during border
facilitates traceability through the or storage, such as trailers, tanks, crossings, or comingling with
supply chain, reduces the potential for railcars, shipping containers, grain conventional product during transport
organic fraud, and allows accurate elevators/silos, vessels, cargo holds, and aggregation.
identification of organic product by freighters, barges, or other method of This proposed amendment will
customs officials and transportation bulk transport or storage. As labeling of provide an additional safeguard for
agents. Therefore, AMS proposes these types of large containers may be organic integrity by alerting certifying
amending § 205.307 to add new impractical, they do not need to be agents, handlers, and border agents to
requirements for the labeling of labeled with the information described the contents of nonretail containers, and
nonretail containers. in § 205.307. However, this information by helping prevent unintentional
If implemented, this proposed action must be evident in documentation mishandling of organic product. This
will require that nonretail containers associated with and traceable to the proposed action also aligns with the
used to ship or store organic products container, to ensure that organic OFPA requirement that an agricultural
are labeled with two additional pieces integrity is maintained during transport, product which is sold or labeled as
of information: (1) A statement storage, and handling. organic must have been produced and
identifying the product as organic; and The current regulations require only handled without prohibited synthetic
(2) the name of the certifying agent that one piece of information on nonretail chemicals (7 U.S.C. 6504(1)).
certified either the producer of the container labeling: A production lot Some stakeholders have asked AMS
product, or, if the product is processed, number. Other information elements— to limit the applicability of § 205.307 to
the last handler that processed the such as identification of the product as packaged organic products described in
product. In addition, the current organic, certifying agent information, §§ 205.303–304, i.e., products labeled
requirement to show the production lot and special handling instructions—are ‘‘100% organic,’’ ‘‘organic,’’ or ‘‘made
number on nonretail containers will be optional, but not required on nonretail with organic (specified ingredients or
expanded, the option to include the container labels. Lack of this food group(s)).’’ AMS believes that
name of the certified operation that information creates gaps in the organic amending the regulations to require a
produced or handled the product will chain of custody, complicates the statement of organic status on all
be added, and the use of the USDA seal verification of organic integrity, and nonretail containers, including those
on nonretail containers will be clarified. increases the vulnerability to organic which contain unpackaged and/or
Nonretail containers are defined fraud. unlabeled product, is a more
under § 205.2 of the USDA organic Nonretail containers labeled with comprehensive and enforceable
regulations as ‘‘any container used for only a production lot number provide solution. Further, this will support the
shipping or storage of an agricultural no identifying information about the requirement for certified operations to
product that is not used in the retail entity that provided that number. This maintain auditable records
display or sale of the product.’’ can create problems when nonretail (§ 205.103(b)(2)). An audit trail, as
Nonretail containers are used to ship or containers are used to store or ship defined by the regulations, includes
store either packaged or unpackaged unlabeled unpackaged product (e.g., documents that show the source,
organic products, and may include the produce or bulk commodities), because transfer of ownership, and
following: a production lot number alone is not transportation of any agricultural
1. Produce boxes, totes, bulk sufficient to immediately identify the product with an organic label (§ 205.2).
containers, bulk bags, flexible bulk product as organic or conventional. An Obscuring the ‘‘organic’’ status of any
containers, harvest crates and bins; and organic product stored or shipped in a product during a segment of the supply
chain disrupts the audit trail. By clearly 2. If a product is processed after Clearly labeling a nonretail container
stating that nonretail containers must be production, then the certifying agent of with organic identification, certifying
labeled with the product’s organic status the processer must be listed on the agent, and production lot number will
and the name of the certifying agent nonretail container label; ease product traceability during audits,
(both currently optional), this proposed 3. If a product is processed help to prevent unintentional contact
amendment will ensure that all organic sequentially by different operations (A, with prohibited substances (e.g.,
product in nonretail containers is B, and C) after production, then only the fumigation) and comingling with
identifiable. certifying agent of the last processer conventional product, and help to
Organic products often pass through (operation C) must be listed on the ensure accurate representation of the
multiple handlers in the supply chain as nonretail container label; and product at the point of sale. In addition,
they move from production source to
consumer. However, the proposed rule 4. The certifying agents of operations this proposed amendment is also
does not require nonretail container that handle, but do not process, organic expected to reduce the vulnerability to
labels to list the certifying agent of every products after production do not need to organic fraud by ensuring that organic
operation that handled the product. The be listed on the nonretail container product status is visible throughout the
proposed amendments to § 205.307 label. supply chain.
require that nonretail container labels Listing the certifying agent of the
Request for Comment
list either (1) the certifying agent that producer or last processer on nonretail
certified the producer, or, if the product container labels will provide a point of AMS seeks comment regarding the
is processed, (2) the certifying agent that contact to verify the organic status of a proposed amendments to the labeling of
certified the operation that last product, without adding surplus nonretail containers, specifically
processed the product.25 This means information to the label. However, to whether or not the certified operation
that: maintain a complete audit trail, all that produced or last processed the
1. If a product is not processed operations that produced, processed,
product must be listed (i.e., not
between production and sale, then the handled, or transported the organic
optional) on all nonretail container
certifying agent of the producer must be product must be visible in the product’s
labels.
listed on the nonretail container label; audit trail documentation.
4—ON-SITE INSPECTIONS
205.403(b)–(e) ............... Redesignate ................ Redesignate paragraphs (b)–(e) as paragraphs (c)–(f).

205.403(b) ..................... Add ............................. Unannounced inspections.
205.403(b)(1) ................. Add ............................. A certifying agent must, on an annual basis, conduct unannounced inspections of a min-
imum of five percent of the operations it certifies, rounded up to the nearest whole num-
ber.
205.403(b)(2) ................. Add ............................. Certifying agents must be able to conduct unannounced inspections of any operation it cer-
tifies and must not accept applications or continue certification with operations located in
areas where they are unable to conduct unannounced inspections.
205.403(c) ..................... Redesignate as Verification of information. The on-site inspection of an operation must verify:
205.403(d).
205.403(d)(4) ................. Add ............................. That sufficient quantities of organic product and ingredients are produced or purchased to
account for organic product sold or transported; and
205.403(d)(5) ................. Add ............................. That organic products and ingredients are traceable by the operation from the time of pro-
duction or purchase to sale or transport; and that certifying agents can verify traceability
back to the source per § 205.501(a)(21).
Unannounced Inspections inspections, which recommends that organic regulations to ensure

Unannounced inspections are a certifying agents conduct unannounced compliance across certified operations
critical enforcement tool for ensuring inspections of 5 percent of their total and bolster consumer trust in the
ongoing compliance by organic certified operations per year as a tool in organic label. Therefore, AMS is
operations. AMS proposes amending ensuring compliance with the proposing to codify a requirement for
§ 205.403 of the organic regulations to regulations.26 This NOP instruction was certifying agents to conduct a minimum
require a minimum number of supported by a recommendation made number of unannounced inspections
unannounced inspections that certifying by the NOSB in December 2011.27 The annually of certified operations. This
agents must perform annually. The majority of USDA-accredited certifying proposed amendment, consistent with
current regulations allow for, but do not agents currently complete unannounced NOP Instruction 2609, would require
require, unannounced inspections, inspections at this frequency.28 This certifying agents to conduct
leaving this to the discretion of the provision would make these inspections unannounced inspections annually on a
certifying agent. NOP has issued an a regulatory requirement. minimum of 5 percent of operations
instruction to certifying agents (NOP Unannounced inspections are an they certify. The operations may be
Instruction 2609) on unannounced effective and useful tool in the USDA selected randomly, risk-based, and/or in
25 See definition of processing in § 205.2 of the www.ams.usda.gov/sites/default/files/media/ NOP%20CACC%20Final%20Rec%20
USDA organic regulations. 2609.pdf. on%20Unannounced%20Inspections.pdf.
26 NOP 2609, Instruction, Unannounced 27 NOSB Recommendation, Unannounced 28 42 of the 49 USDA-accredited certifying agents
Inspections. September 12, 2012. Available in the Inspections. December 2, 2011. Available on the the NOP audited in calendar years 2018 and 2019
NOP Program Handbook: https:// AMS website: https://www.ams.usda.gov/sites/ completed unannounced inspections of 5% of the
default/files/media/ operations they certify.
response to a complaint or investigation. AMS proposes this requirement to does not exceed the quantity of organic
The proposed requirement specifies that ensure that all certified operations are product that is produced or purchased.
the number of unannounced inspections subject to unannounced inspections, Second, AMS proposes a requirement
should be calculated by rounding up to regardless of location. A certifying agent that certifying agents verify that organic
the nearest whole number, so that that cannot conduct unannounced products and organic ingredients are
certifying agents with very few certified inspections in an applicant’s or certified traceable from the time of production or
operations (e.g., under 20 operations) operation’s location due to logistical purchase to the time of sale or
would still be required to conduct at challenges, staffing, security, or other movement of product from the
least one unannounced inspection per reasons, is considered to not have or no operation and vice versa. These new
year. longer have the administrative capacity verification requirements are also
The OFPA requires that organic for certification activities in that area, referred to as ‘‘mass-balance’’ and
operations make their records available consistent with § 205.501(a)(19). In this ‘‘trace-back’’ audits. Certifying agents
at all times for inspection by the case, the certifying agent would need to should determine the minimum number
Secretary, the certifying agent, and State document the specific reasons it does of products to review to assess whether
officials (7 U.S.C. 6506(b)(1)(B)). not have, or no longer has, the the operation is compliant with the
Additionally, the OFPA requires that administrative capacity to certify in that regulations. This should involve a risk-
certifying agents employ a sufficient area, and would need to inform the based sampling of products that span
number of inspectors to implement the applicant or certified operation to seek different time ranges and products.
organic regulations (7 U.S.C. 6515(b)). certification from another certifying
By establishing a baseline requirement agent. If new certification is not For example, the inspection of a grain
for unannounced inspection activities, obtained, the operation’s certification milling operation is to include an
AMS can verify that certifying agents would be suspended. This process examination of the transaction and
employ a sufficient number of would be similar to the current processing records for various
inspectors (i.e., enough inspectors to procedures used when a certifying agent commodities and time ranges. An
perform annual inspections and surrenders its accreditation or is inspection of a manufacturer of organic
unannounced inspections) and will suspended; however, it would be frozen meals, or other multi-ingredient
ensure, through unannounced limited to a specific well-defined products, is to examine records for
inspections, that organic operations location, with justifications specific to various types of products to cover a
keep records related to their organic that area. range of ingredients and production
activities and comply with other dates.
requirements of the OFPA and the Supply Chain Audits During On-Site
Inspections During an on-site inspection, a
USDA organic regulations. certifying agent may also choose to
AMS also proposes a requirement that Additionally, AMS proposes two new conduct a broader review of an entire
certifying agents only accept requirements in § 205.403 to clarify the supply chain for an operation’s
applications for certification from responsibilities of inspectors and
product(s), to fulfill the proposed
operations located where the certifying certifying agents related to on-site
requirement at § 205.501(a)(21) to
agent is able to conduct unannounced inspections. AMS has consistently
conduct risk-based supply chain audits
inspections. Further, certifying agents provided training to certifying agents
according to the certifying agent’s
must be able to conduct unannounced which specifies that supply chain audits
written procedures to meet that audit
inspections of any operation it must be conducted at on-site
requirement (see proposed
continues to certify. To ensure inspections, but the types of audits
consistency, transparency, and § 205.504(b)(7)). Full supply chain
required are not explicit in the current
accountability, certifying agents would audits are discussed in more detail later
regulations. Audits can help detect
be expected to describe the areas where in this proposed rule.
organic fraud and should be routine
they operate in the written materials practice during inspections. These The OFPA requires that organic
they provide to both applicants and proposed audit requirements are needed operations maintain all records
certified operations, and review the to ensure that AMS can take appropriate associated with the production and
locations of all operations during their action against certifying agents that are handling of organic products and make
application review or annual review. not conducting adequate audits during these records available to certifying
This proposed requirement is also based inspections. agents at all times (7 U.S.C. 6519(a) and
on recommended practice in the NOP First, AMS proposes a requirement 6506(b)(1)(B)). The proposed inspection
Instruction 2609 and was recommended that certifying agents must verify that requirements support the review and
by the NOSB in December 2011. the quantity of organic product sold verification of these required records.
5—CERTIFICATES OF ORGANIC OPERATION

205.2 ............................. Add new term ............. INTEGRITY. The National Organic Program’s electronic, web-based reporting tool for the
submission of data, completion of certificates of organic operation, and other information,
or its successors.
205.404(b) ..................... Revise ......................... The certifying agent must issue a certificate of organic operation. The certificate of organic
operation must be generated from INTEGRITY and may be provided to certified oper-
ations electronically.
205.404(c) ..................... Redesignate ................ Redesignate as paragraph (d).
205.404(c) ..................... Add ............................. In addition to the certificate of organic operation provided for in § 205.404(b), a certifying
agent may issue its own addenda to the certificate of organic operation. If issued, any ad-
denda must include:
(1) Name, address, and contact information for the certified operation;
5—CERTIFICATES OF ORGANIC OPERATION—Continued

(2) The certified operation’s unique ID number/code that corresponds to the certified oper-
ation’s ID number/code in USDA Organic INTEGRITY;
(3) A link to USDA Organic INTEGRITY or a link to the certified operation’s profile in USDA
Organic INTEGRITY, along with a statement, ‘‘You may verify the certification of this oper-
ation at USDA Organic INTEGRITY,’’ or a similar statement;
(4) Name, address, and contact information of the certifying agent;
(5) ‘‘Addendum issue date;’’ and
(6) ‘‘Addendum expiration date,’’ which must not exceed the expiration date of the certificate
of organic operation.
The certificate of organic operation facilitate interstate commerce of organic currently use INTEGRITY to generate
(‘‘organic certificate’’) communicates foods (7 U.S.C. 6501(3)). The proposed organic certificates. This proposed rule
information about the organic changes are also consistent with would require all certifying agents to
certification of an operation and the raw recommendations made by the NOSB generate organic certificates through
and processed products it is permitted between 2005 and 2007, including a INTEGRITY. Foreign-based certifying
to represent as organic. The proposed recommendation that all certifying agents that are accredited to and certify
rule would require certifying agents to agents use a common database to issue operations to the USDA organic
provide organic certificates that are and maintain organic certificates and regulations would be required to enter
uniform in appearance. To achieve this that organic certificates include data in INTEGRITY to generate the
uniformity, the proposed rule would expiration dates.29 organic certificates for USDA-certified
require that certifying agents create and The Organic INTEGRITY Database operations. The proposed changes
provide organic certificates that are would adopt a March 2005 NOSB
generated from a USDA-hosted The OFPA was amended in 2014 to, recommendation that the NOP establish
electronic web-based system known as among other things, require the USDA a common database for all certifying
the Organic INTEGRITY Database to modernize database and technology agents to issue and maintain organic
(‘‘INTEGRITY’’). In this way, AMS systems. To that end, the NOP created certificates and that the database allow
would be responsible for the the Organic Integrity Database. certifying agents to upload data from
functionality of INTEGRITY and ensure INTEGRITY contains information about their existing systems.30 INTEGRITY is
consistent content and style of all certified operations as well as the system that certifying agents would
organic certificates. Buyers of organic information about operations that have use to perform these functions.
products would be able to recognize and surrendered their organic certification Once created in INTEGRITY, an
validate legitimate organic certificates. or had their organic certification organic certificate is available online via
This is currently difficult due to wide suspended or revoked. The data or a unique link where it can be
variability in the content and style of information is provided directly from electronically downloaded or printed as
certifying agent-generated organic certifying agents. The information can a hard copy. A permalink to the online
certificates. be viewed and searched by the general certificate is included on every organic
The appearance and format of current public online at https:// certificate, including downloaded and
organic certificates vary depending organic.ams.usda.gov/Integrity/ printed organic certificates. If an
upon which certifying agent issued the Default.aspx. operation’s certification has been
organic certificate. Currently, AMS INTEGRITY and Organic Certificates suspended, revoked, or surrendered,
accredits almost 80 certifying agents; In 2016, NOP enhanced the information from the linked web page
only a few create organic certificates functionality of INTEGRITY to allow for will indicate that a valid organic
through INTEGRITY. As a result, more the generation of organic certificates. certificate is no longer available.
than 70 distinct formats of organic AMS expects the proposed changes
When the currently optional function is
certificates exist in the market. This would promote access to robust
activated, INTEGRITY generates a one-
variation increases the chance of information about individual operations
page organic certificate and an
alteration and organic fraud. In and support timely verification of the
accompanying detailed product list
addition, AMS consistently cites organic status of operations and
(together referred to as the ‘‘organic
noncompliances to certifying agents certificate’’). Few certifying agents products. Additionally, we expect the
who do not currently include all the changes would encourage a move
required information on their own 29 NOSB Formal Recommendation: Information toward sharing of real-time electronic
organic certificates. Of the 49 USDA- on Certificates of Organic Operation, March 2005: documents and away from paper-based
accredited certifying agents audited by https://www.ams.usda.gov/sites/default/files/ documents, which can quickly become
media/NOSB%20Rec%20 outdated and can be more easily
the NOP in calendar years 2018 and Standardize%20Organic%20Certifications%20
2019, 16 were cited for issuing organic Certificates.pdf. falsified. AMS also expects that the
certificates not consistent with USDA NOSB Formal Recommendation: Expiration Dates proposed change would reduce the
organic regulation and instruction. The on Certificates of Organic Operation, November administrative burden on operations in
2006: https://www.ams.usda.gov/sites/default/files/ the supply chain that must verify the

use of a uniform organic certificate media/NOP%20Final%20Rec%20Use%20
generated through INTEGRITY would of%20Expiration%20Dates%20on% validity of organic certificates,
eliminate these inconsistencies. 20Certificates%20of%20Organic%20Op.pdf.
NOSB Formal Recommendation: Standardized 30 NOSB Formal Recommendation: Information
The changes are proposed under
Certificates, November 2007: https:// on Certificates of Organic Operation; March 2005:
AMS’ authority provided in the OFPA www.ams.usda.gov/sites/default/files/media/ https://www.ams.usda.gov/sites/default/files/
to establish a program for organic NOP%20Final%20Rec% media/NOSB%20Rec%20Standardize%20O
certification (7 U.S.C. 6503(a)) and to 20Standardization%20of%20Certificates.pdf. rganic%20Certifications%20Certificates.pdf.
especially for companies that purchase the generation of an updated organic compliance of the operation’s crops or
from many different organic operations. certificate, rather than to void or have products with various international
Certifying agents that are not any effect on the operation’s organic standards that may not be
currently using INTEGRITY to generate certification status; an operation could included on the INTEGRITY organic
organic certificates would need to remain certified even if their organic certificate. AMS is proposing six
modify their practices to routinely enter certificate has expired. required elements (proposed
information in INTEGRITY before AMS intends to allow organic § 205.404(c)) on any organic certificate
issuing organic certificates. Specifically, certificates to remain valid for 12 addenda issued by certifying agents to
these certifying agents may need to months from the date they are issued. deter organic fraud and provide
provide additional information in The expiration date would be calculated consistency across certifying agents.
INTEGRITY to populate all fields that automatically by INTEGRITY and Primarily, the proposed requirements
appear on the organic certificate, appear on all organic certificates. are intended to ensure that someone
including: Effective date of certification Certifying agents could validate viewing the document is aware that the
status, scope of organic certification information and create a new organic certification may be verified in
(e.g., crops, handling), details about certificate in INTEGRITY at any time to INTEGRITY.
certified products (e.g., organic labeling generate a new organic certificate with
As with organic certificates from
category, brands), acreage, and livestock a new expiration dated 12 months from
INTEGRITY, this proposed rule requires
details. AMS would be responsible for the creation of the certificate. AMS
that any organic certificate addenda
the functionality of INTEGRITY, believes this flexibility would allow
include an expiration date. Certifying
including the style and content of certified operations to obtain valid
organic certificates. organic certificates from their certifying agents would need to ensure that the
agent in a timely fashion. Operations expiration date of the addendum does
Expiration Dates on Organic Certificates not extend beyond the expiration date of
that are certified (i.e., that have not
The USDA organic regulations do not surrendered their certification or had the most recent organic certificate
currently require expiration dates on their certification suspended or generated by INTEGRITY, to ensure an
organic certificates, and an operation’s revoked) would continue to have a right operation does not simultaneously
organic certification does not expire— to obtain a valid organic certificate from possess a valid addendum and an
once granted, it may only be suspended, their certifying agent to demonstrate expired organic certificate, which could
revoked, or surrendered. Through this their certification. cause confusion.
proposed rule, AMS intends to include Request for Comment
certificate expiration dates on the Allowance for Additional Addenda to
organic certificates generated via Certificates of Organic Operation AMS seeks comment on the proposed
INTEGRITY. AMS sees this as an AMS recognizes that certifying agents amendments regarding certificates of
important measure to establish a clear have invested in systems to create their organic operation discussed above,
and consistent method for assessing own unique addenda to organic including answers to the following
whether an organic certificate is current certificates; AMS is not seeking to questions:
and valid. This change was eliminate these unique sources of value 1. How frequently should accredited
recommended by the NOSB in a offered by certifying agents. Under the certifying agents update the information
November 11, 2006 recommendation proposed rule, certifying agents could in an operation’s organic certificate?
titled ‘‘Expiration Dates on Certificates continue to provide their own
of Organic Operation.’’ 31 Expiration certification addenda that would 2. Should a minimum reporting
dates would ensure the data on an communicate additional information frequency (e.g., monthly, quarterly, etc.)
organic certificate is up to date and about an operation’s certification in a be added to the regulations?
current. Using current (i.e., unexpired) different format than generated by 3. Should an expiration date be
certificates would support verification INTEGRITY. included on all certificates of organic
of an operation’s organic status. For example, an addendum may operation? Would this make them more
Expiration dates are intended to prompt include information about the useful?
6—CONTINUATION OF CERTIFICATION
205.406(a) ..................... Revise ......................... To continue certification, a certified operation must annually pay the certification fees and
submit the following information to the certifying agent:
(1) A summary statement, supported by documentation, detailing any deviations from,
changes to, modifications to, or other amendments made to the organic system plan sub-
mitted during the previous year; and
(2) Any additions or deletions to the previous year’s organic system plan, intended to be un-
dertaken in the coming year, detailed pursuant to § 205.201;
(3) Any additions to or deletions from the information required pursuant to § 205.401(b); and
(4) Other information as deemed necessary by the certifying agent to determine compliance
with the Act and the regulations in this part.
205.406(b) ..................... Revise ......................... The certifying agent must arrange and conduct an on-site inspection, pursuant to § 205.403,
of the certified operation at least once per calendar year.
31 NOSB Formal Recommendation: Expiration default/files/media/ Expiration%20Dates%20on%20

Dates on Certificates of Organic Operation, NOP%20Final%20Rec%20Use%20of%20 Certificates%20of%20Organic%20Op.pdf.
November 2006: https://www.ams.usda.gov/sites/
AMS proposes amending § 205.406 to inspection must verify that the entire flexibility they require to verify
clarify the annual update requirements OSP is implemented as described. compliance.
for certified operations and to clarify AMS also proposes removing current Additionally, AMS proposes revising
that certifying agents must conduct paragraph § 205.406(a)(3) to reduce paragraph § 205.406(b) to simplify the
annual inspections of certified paperwork and simplify the certification regulatory text and to clarify that
operations. process. Section 205.406(a)(3) requires inspections are to be conducted on an
The current regulations require that that certified operations provide, along annual basis. Current requirements at
certified operations annually submit an with their annual update, an update on paragraph (b) could be interpreted to
updated organic production or handling mean that an operation may be
the correction of minor noncompliances
system plan (§ 205.400(b)). Some inspected once every 18 months on an
previously identified by the certifying
certifying agents require that certified ongoing basis (i.e., two inspections over
agent as requiring correction for
operations submit an organic system a 36-month period compared to three
continued certification. This
plan (OSP) in its entirety every year, inspections if conducted annually).
requirement is duplicative and
while other certifying agents only Revision of paragraph (b) would clarify
require that operations annually submit unnecessary, as certifying agents (when that all certified operations must be
revisions to the OSP. Clarifying in the issuing a notice of noncompliance) must inspected at least annually, regardless of
regulations that operations are only specify a date by which a certified (1) when the certified operation was last
required to submit sections of the OSP operation must rebut or correct inspected and (2) when, or if, the
that have changed will eliminate noncompliances (§§ 205.662(a)(3) and certified operation provided its annual
unnecessary paperwork without 205.404(a)). Certifying agents should updates. Additional inspections may be
compromising oversight of organic establish this due date in accordance needed to ensure full compliance of
operations. The NOP previously with the severity of the noncompliance. complex operations (e.g., during and
described this approach in published If a certified operation does not resolve outside the grazing season for livestock
certifying agent Instructions (NOP 2615 noncompliances by the due date, their operations). This requirement does not
and NOP 2601).32 These proposed certifying agent should take further replace the need for additional
changes are necessary to ensure legal action (i.e., issue a notice of proposed unannounced inspections.
enforceability, consistent practices suspension); therefore, AMS sees no This revision would allow certifying
between certifying agents, and reduce benefit to requiring a partial response agents flexibility to conduct on-site
the paperwork burden of organic (i.e., an update) as part of the annual inspections at any time during the year
certification. The proposed changes in renewal. While removing this (essential for verifying activities
this section will not impact the requirement, AMS proposes to maintain throughout the growing season, for
requirements for certified operations to the allowance in this section for example) while ensuring that an
maintain an updated OSP or the certifying agents to require other inspection is conducted every single
requirement for an operation to notify information from certified operations calendar year. Annual inspection cycles
their certifying agent of changes in their during the annual renewal process that are essential to vigilant oversight and
operation that may affect its compliance they determine is necessary to assess AMS seeks to eliminate confusion
with the organic regulations compliance. AMS believes this will around and deviations from alternative
(§ 205.400(f)). Further, the on-site provide certifying agents with the timing of on-site inspections.
7—PAPERWORK SUBMISSIONS TO THE ADMINISTRATOR

Section Current text Action Proposed text
205.405(c)(3) ... Provide notice of approval or denial to the Adminis- Remove.

trator, pursuant to § 205.501(a)(14).
205.501(a)(15) Submit to the Administrator a copy of: Revise ......... Maintain current and accurate data in INTEGRITY for
each operation which it certifies;
(i) Any notice of denial of certification issued pursuant
to § 205.405, notification of noncompliance, notifica-
tion of noncompliance correction, notification of pro-
posed suspension or revocation, and notification of
suspension or revocation sent pursuant to
§ 205.662 simultaneously with its issuance; and
(ii) A list, on January 2 of each year, including the
name, address, and telephone number of each op-
eration granted certification during the preceding
year;
AMS proposes amending § 205.405 accurate and current information about need to provide notices of approval or
and § 205.501 to reduce the paperwork certified operations is an essential tool denial of certification to the
burden of accredited certifying agents. for certifying agents and operations in Administrator following the issuance of
In addition, AMS is proposing that the organic supply chain to support the a notice of noncompliance to an
certifying agents must maintain current verification of specific organic products. applicant for certification. The proposed
data in INTEGRITY on all operations The proposed removal of paragraph rule would also amend provisions at
which they certify. The availability of (c)(3) of § 205.405 will eliminate the § 205.501(a)(15) regarding information
32 NOP 2601 The Organic Certification Process, NOP 2615 Organic System Plans, Organic System December 16, 2013: https://www.ams.usda.gov/
December 16, 2013: https://www.ams.usda.gov/ Plan Updates, and Notification of Changes, sites/default/files/media/2615.pdf.
sites/default/files/media/2601.pdf.
that accredited certifying agents must items and certified acreage, among other proposed rule, amendments to § 205.662
submit to the Administrator. The data fields. This proposed rule would would require certifying agents to
proposal removes the requirement for require certifying agents to generate update INTEGRITY within three
submission of any notices of denial of organic certificates in INTEGRITY, as business days of accepting an
certification, notifications of discussed above in the proposed operation’s surrender, or suspending or
noncompliance, notification of amendments to § 205.404. The organic revoking an operation’s certification.
noncompliance correction, notification industry, including certifying agents, AMS believes the availability of
of proposed suspension or revocation, certified operations, consumers, AMS,
or notification of suspension or complete data on certified operations,
and other regulatory agencies, use including complete information on
revocation. Also, the proposed rule
INTEGRITY to confirm the certification certified items and acreage, will reduce
removes the annual requirement for
status of an operation, organic status of the time certifying agents and AMS
certifying agents to submit by January 2
an annual list of operations certified a product, find product information spend responding to inquiries about
during the preceding year. about specific operations, and obtain specific operations and will enable
These two requirements will be data for investigation and enforcement. interested parties to obtain information
replaced by a requirement for certifying Timely updates to maintain data with less time and effort. Therefore, we
agents to maintain updated data in reflecting an operation’s current status, propose including INTEGRITY reporting
INTEGRITY for each operation they including certified products and as a general requirement for
certify; these mandatory data acreage, is critical to commerce and accreditation to reinforce that data
requirements will include listings of enforcement. As discussed later in this reporting is a mandatory practice.
8—PERSONNEL TRAINING AND QUALIFICATIONS
205.2 ............................. Add new term ............. Certification review. The act of reviewing and evaluating a certified operation or applicant for
certification and determining compliance with the USDA organic regulations. This does not
include performing an inspection.
205.501(a)(4) ................. Revise ......................... Continuously use a sufficient number of qualified and adequately trained personnel, includ-
ing inspectors and persons who conduct certification review, to comply with and imple-
ment the USDA organic standards;
(i) Certifying agents must demonstrate that all inspectors, including staff, volunteers, and
contractors, have the required knowledge, skills, and experience to inspect operations of
the scope and scale as assigned and to evaluate compliance with the applicable regula-
tions of this part; and
(A) Certifying agents must demonstrate that inspectors continuously maintain adequate
knowledge and skills about the current USDA organic standards, production and handling
practices, certification and inspection, import and/or export requirements, auditing prac-
tices and skills in written and oral communications, sample collection, investigation tech-
niques, and preparation of technically accurate inspection documents; and
(B) Initially and every year thereafter, inspectors must demonstrate successful completion of
a minimum of 20 hours of training in topics that are relevant to inspection. Training may
include material delivered via the NOP learning management system, certifying agents, or
other relevant training provider; and
(C) Certifying agents must demonstrate that inspectors have a minimum of 1 year of field-
based experience related to both the scope and scale of operations they will inspect be-
fore assigning inspection responsibilities;
(ii) Certifying agents must demonstrate that all persons who conduct certification review, in-
cluding staff, volunteers, or contractors, have the knowledge, skills, and experience re-
quired to perform certification review of operations of the scope and scale assigned and to
evaluate compliance with the applicable regulations of this part; and
(A) Certifying agents must demonstrate that all certification review personnel continuously
maintain adequate knowledge and skills in the current USDA organic standards, certifi-
cation and compliance processes, and practices applicable to the type, volume, and range
of review activities assigned; and
(B) Initially and every year thereafter, all persons who conduct certification review activities
must demonstrate successful completion of a minimum of 20 hours of training in topics
that are relevant to certification review. Training may include material delivered via the
NOP learning management system, certifying agents, or other relevant training provider;
and
(iii) Certifying agents must maintain current training requirements, training procedures, and
training records for all inspectors and persons who conduct certification review activities.
205.501(a)(5) ................. Revise ......................... Demonstrate that all persons with inspection or certification review responsibilities have suf-
ficient expertise in organic production or handling techniques to successfully perform the
duties assigned;
(i) Sufficient expertise must include knowledge of certification to USDA organic standards
and evidence of formal education, training, or professional experience in the fields of agri-
culture, science, or organic production and handling that directly relates to assigned du-
ties.
205.501(a)(6) ................. Revise ......................... Conduct an annual performance evaluation of all persons who conduct inspections, certifi-
cation review, or implement measures to correct any deficiencies in certification services;
(i) On-site evaluation of inspectors—Certifying agents must observe each inspector per-
forming on-site inspections at least once every three years, or more frequently if war-
ranted; and
8—PERSONNEL TRAINING AND QUALIFICATIONS—Continued

(A) On-site inspector evaluations must be performed by certifying agent personnel who are
qualified to evaluate inspectors;
(ii) Certifying agents must maintain documented policies, procedures, and records for annual
performance evaluations and on-site inspector evaluations.
The USDA organic regulations at 7 knowledge base. This diversity of year from certifying agents on topics
CFR 205.501, General Requirements for background and training creates an related to the USDA organic
Accreditation, require certifying agents inconsistent baseline of knowledge and regulations.34 In 2018, the NOSB
and their inspection and certification skill, exposing a potential weakness at provided recommendations for the
personnel to have sufficient expertise in one of the most critical points in the specific qualification and training
organic production and handling organic certification system. requirements for inspectors and persons
techniques to fully comply with and This proposed rule would clearly performing certification review.35 AMS
implement the USDA organic define expertise requirements to ensure has considered these recommendations
regulations. The OFPA establishes AMS’ that all inspectors are capable of and determined that the proposed
authority to modify the USDA organic verifying an organic operation’s changes align with the OFPA and would
regulations at 7 CFR 205.501. The compliance with the USDA organic bolster the integrity of organic products.
proposed rule amends § 205.501 to regulations. The requirements would The USDA organic regulations
specify minimum qualifications and ensure that all inspectors can identify
training requirements for inspectors and stipulate that accredited certifying
non-compliant or fraudulent practices agents must have sufficient expertise in
persons who perform certification when observed during inspection and
review activities. The OFPA states that organic production and handling
produce a technically accurate
to be accredited as a certifying agent, the techniques to fully comply with and
inspection report that is sent to the
certifying agent will have sufficient implement the terms and conditions of
certifying agent. The requirements
expertise in organic farming and the organic certification program. The
would also ensure that persons
handling techniques as determined by regulations at § 205.501(a)(4) require
performing certification review are
the Secretary (7 U.S.C. 6514(b)(2)). that certifying agents use a sufficient
competent in identifying any non-
Organic inspectors and review staff number of adequately trained personnel,
compliant or fraudulent practices of
are the most direct form of enforcement including inspectors and certification
operations when reviewing inspection
and verification in the organic system. review personnel, to comply with and
reports prepared by an inspector,
Inspectors protect organic integrity by fully implement the organic certification
organic system plans, or other
inspecting certified organic operations program. It is essential that certifying
certification documents. Examples of
onsite and reporting their findings to agents maintain adequate staffing levels
certification review includes reviewing
certifying agents. Persons performing and the range of expertise needed to
applications for certification, reviewing
certification review activities also perform the full range of certification
certification documents, evaluating
ensure organic integrity by reviewing activities, including inspections and
qualifications for certification, making
organic system plans, inputs, inspection reviews. This includes maintaining an
recommendations concerning
reports, and other certification inspection staff to timely complete
certification, or making certification
documents. It is essential that these initial on-site inspections, annual
decisions and implementing measures
personnel have knowledge, skills, and inspections for all operations it certifies,
to correct any deficiencies in
experience related to the scope and unannounced inspections on a
certification services. Establishing
scale of the organic operations they minimum of 5 percent of the operations
baseline criteria for qualifications and
inspect and review. The role of it certifies annually, and any other
training of inspectors and certification
inspectors and reviewers has grown inspections that may be warranted for
review personnel would create a
more critical as organic operations and investigations or reinstatements. If
uniform level of scrutiny in inspections
supply chains become more complex certifying agents reduce staffing levels,
and certification compliance reviews for
and diverse. if the number of certified operations
all USDA certified organic operations,
The USDA organic regulations increases, or if certifying agents add
leading to greater consistency and
currently require that certifying agents new certification scopes to the
integrity in organic certification.
‘‘have sufficient expertise in organic certification services they provide, then
In a 2012 memo, the NOP notified
production or handling techniques,’’ the number and qualifications of
certifying agents that all inspectors and
and maintain ‘‘a sufficient number of personnel used by certifying agents may
reviewers, whether staff or independent
adequately trained personnel.’’ become insufficient to fully comply
contractors, must possess the expertise
However, the regulations lack specific with the organic regulations.
and qualifications needed to evaluate
detail about qualifications, experience,
compliance with the USDA organic
and continual training for inspectors 34 Paperwork burden attributed to current training
standards.33 During audits performed
and reviewers. Certifying agents set is accounted for in the NOP’s 2020 Information
twice every five years, AMS has Collections Renewal (ICR) (AMS–NOP–19–0090;
their own policies and minimum
observed that inspectors and OMB Control #: 0581–0191). Also, please see
qualifications to hire inspectors and Paperwork Reduction Act chapter and Information
certification review staff currently
reviewers. This can result in variability Collection Request (ICR) package associated with
receive at least 10 hours of training per
of inspection and certification review this proposed rule for additional details regarding
between certifying agents. Further, this proposed burden.
33 NOP Memo: Criteria and Qualifications for 35 NOSB Formal Recommendation, Inspector
many inspectors are independent Organic Inspectors; April 2012: https:// Qualifications and Training, May 29, 2018: https://
contractors who are responsible for www.ams.usda.gov/sites/default/files/media/NOP- www.ams.usda.gov/sites/default/files/media/
establishing and maintaining their own Notice-OrganicInspectorCriteria.pdf. CACSInspectorQualificationsRec.pdf.
Therefore, this proposed rule amends and contractors) and further requires and continuously update knowledge,
§ 205.501(a)(4) to clarify that certifying certifying agents to provide evidence of skills, and experience relevant to the
agents must continuously use a inspectors’ qualifications, matching the types of operations they inspect.
sufficient number of qualified and scope and scale of inspection Organic training hours should include:
adequately trained personnel. This assignments. Organic and general agricultural
proposed rule also specifies and This proposed rule at practices; USDA organic regulations and
strengthens requirements for organic § 205.501(a)(4)(i)(A) describes the guidance; inputs allowed for organic
inspectors and certification review general scope of the knowledge and production and handling (i.e., changes
personnel. These additional skills required for inspectors to be to the National List); new technology
qualification and training requirements deemed adequately qualified. that may be used in organic production
will help certifying agents meet their Inspections of organic operations and handling; investigation and
obligation to provide sufficient expertise provide information to certifying agents auditing techniques; and new
in organic production and handling to verify whether the practices and developments in marketing organic
techniques. The new proposed inputs used in an operation’s products. To ensure consistency in
requirements would specify the areas of implemented organic system plan are inspector training and qualifications
knowledge, skills, and expertise compliant with the USDA organic across the organic industry, this
required for certifying agents in using regulations. To ensure an adequate proposed rule requires that inspectors
adequately trained inspection and organic inspection, each inspector must initially, and every year thereafter,
certification review personnel for be knowledgeable and competent both complete at least 20 hours of training
organic inspection and review activities. in inspection and auditing procedures, that may include material delivered via
as well as in the processes of organic the NOP learning management system,
Inspector Qualifications and Training certification and inspection. Organic certifying agents, or other relevant
The regulations at § 205.501(a)(4) inspectors must know the USDA organic training providers.
currently do not contain requirements regulations and have expertise in the In their 2018 recommendation, NOSB
for specific qualifications or training of scope of the agricultural or processing did not specify the number of hours of
inspectors. Certifying agents depend on system (i.e., crops, wild crops, livestock, training that inspectors must complete
qualified inspectors who are or handling) being inspected. annually. However, they requested that
experienced with the complexity of the In addition, inspectors must have the NOP set the minimum training
organic market to verify the integrity of sufficient knowledge of organic and guidelines. A minimum of 20 hours of
organic products. Organic inspections, a general agricultural practices, as well as annual training for inspectors is
critical component for ensuring organic a general awareness of other rules and consistent with standards established by
integrity, are an assessment of an entire regulations that may be applicable to the other agencies or organizations (e.g.,
production system, not just the final operation being inspected. Qualified Preventive Controls Qualified
product. Therefore, when conducting organic inspectors must also have skills Individuals per 2011 Food Safety
organic inspections, inspectors must in written and oral communications, Modernization Act; ISO 9001 Global
continuously maintain adequate auditing, investigation and observation Certified Lead Auditor). The proposed
knowledge and skills about the current techniques which support fraud training requirements will ensure that
USDA organic standards, production detection, and sample collection. inspectors meet the training
and handling practices, certification and Inspectors must be proficient in orally requirements recommended by the
inspection, import and/or export communicating inspection findings both NOSB, which state that continuing
requirements, auditing practices and during the inspection closing meeting
education is essential to ‘‘professional
skills in written and oral with the inspected operation, and in
competence.’’ 36 Establishing baseline
communications, sample collection, writing to provide detailed and
training criteria for inspectors across the
investigation techniques, and technically accurate descriptions of the
organic industry is essential for
preparation of technically accurate inspection findings in the report to the
ensuring that compliance with USDA
inspection documents. In addition, the certifying agent. The inspection report is
organic standards would be assessed in
knowledge, skills, and experience in a critical tool used by certifying agents
these areas must be relevant to the scope all sectors of this rapidly growing and
to verify if on-site practices are in
and scale of the operation seeking or diversifying global industry.
continuing organic certification. regulations. As such, the quality and Additionally, requiring inspectors to
Given that certifying agents may use depth of the inspection report directly continuously supplement their
a variety of inspectors, including staff, affects the integrity of organic products. knowledge with a minimum annual
volunteers, and contract inspectors, An adequately qualified inspector training requirement is vital to ensuring
there is variability in the level of would know how to independently the integrity of organic products amidst
experience and qualifications of apply knowledge in the above areas to rapidly changing technologies and
inspectors performing the key function assess whether an operation is product supply chain practices.
of ensuring organic integrity at the complying with all applicable parts of Each scope of organic certification, as
source of production and through the the regulations and clearly well as the scale and type of operation
supply chain. This proposed rule adds communicate those findings to the being inspected, provides different
subparagraph (i) requiring certifying certifying agent. challenges to ensuring a comprehensive
agents to ensure all inspectors have the AMS proposes strengthening and and sufficient organic inspection.
level of knowledge, skills, and specifying training requirements to Inspectors who are inexperienced with
experience needed to conduct the § 205.501(a)(4)(i)(B) for all inspectors an agricultural production or handling
specific inspections assigned, based on currently inspecting organic operations system may underestimate the scale of
the scope and scale of the operations to or seeking to become qualified to an operation or may miss components of
be inspected. The proposed rule conduct organic inspections. For 36 NOSB Formal Recommendation, Inspector
clarifies that the requirement applies inspectors to remain qualified or to Qualifications and Training, May 29, 2018: https://
not only to staff inspectors, but to all become qualified in any scope of www.ams.usda.gov/sites/default/files/media/
inspectors (i.e., including volunteers organic inspection, they must obtain CACSInspectorQualificationsRec.pdf.
that system during the inspection. needed to conduct the specific reviews training requirements, procedures, and
Varied quality of inspections can result assigned. records for all inspectors and
in an inconsistent organic certification This proposed rule at certification review personnel. This
process. In addition, to enhance § 205.501(a)(4)(ii)(A) specifies the types requirement would enable the NOP to
inspection consistency and organic of knowledge and essential skills in verify if accredited certifying agents are
certification integrity, this rule proposes which certification review personnel meeting the requirement in
to add the requirement, in must be proficient to be deemed § 205.501(a)(4) to maintain a sufficient
§ 205.501(a)(4)(i)(C), that certifying qualified. To verify the integrity of number of qualified and adequately
agents must ensure and demonstrate an organic products, reviewers must be trained personnel to comply with and
inspector has a minimum of one year of knowledgeable and competent in implement the organic certification
on-site experience related to the scope current USDA organic regulations, program established under the Act.
and size of the operation being guidance, and instructions; certification
procedures; and practices specific to the Expertise
inspected. The proposed requirement
aligns with recommendations developed type, volume, and range of review The regulations in § 205.501(a)(5)
by the NOSB. activities assigned by the certifying require that certifying agents ensure that
agent. To remain current with changes all persons with inspection, analysis,
Certification Review Personnel in technology, new developments in and decision-making responsibilities
Qualifications and Training marketing or importing organic have sufficient expertise in organic
The regulations in § 205.501(a)(4) products, changes in organic standards, production and handling techniques.
currently do not contain requirements novel input materials, or changes to the However, the regulations currently do
for specific qualifications or training of National List, reviewers must not contain requirements for specific
persons who conduct certification continuously update knowledge, skills, expertise areas needed to ensure the
review. Certification review personnel and experience directly related to their integrity of organic products. This
are critical to ensuring organic integrity. specific review responsibilities. proposed rule adds § 205.501(a)(5)(i) to
Certification review activities include, To ensure consistency in reviewer clarify the areas of expertise required.
but are not limited to, review of organic training and qualifications across the The change specifies that expertise must
system plans, inputs (e.g., production organic industry, this proposed rule in include knowledge of certification to
aids, fertilizers, pesticides), seeds, § 205.501(a)(4)(ii)(B) requires that all USDA organic standards, as well as
planting stock, inspection reports, and persons conducting certification review evidence of formal education, training,
residue tests for compliance with the activities initially, and every year or professional experience in the fields
USDA organic standards. Certification thereafter, complete at least 20 hours of of agriculture, science, or organic
review personnel are responsible for training that can include material production and handling that directly
verifying whether the procedures being delivered via the NOP learning relates to assigned duties. This
implemented at the point of production management system, certifying agents, clarification will assist certifying agents
or handling are compliant with the or other relevant training providers. A in evaluating potential hires for
USDA organic standards. Certification minimum of 20 hours of annual training adequate expertise needed to perform
review personnel must continuously for certification review personnel is certification duties. The added
maintain adequate knowledge about the consistent with training required by specificity regarding areas of expertise
current USDA organic standards, other agencies or organizations (e.g., and the need for formal education or
certification and compliance processes, Preventive Controls Qualified training aligns with recommendations
and practices applicable to the type, Individuals per 2011 Food Safety proposed by the NOSB.37 AMS
volume, and range of review activities Modernization Act; ISO 9001 Global evaluated the proposed
assigned. The level of knowledge, skills, Certified Lead Auditor). Establishing recommendations and found them to be
and experience of certification review baseline training criteria for certification consistent with the OFPA and therefore
personnel must be relevant to the scope review personnel across the organic has included similar requirements in
and scale of the operations seeking or industry is essential for ensuring that this proposed rule.
continuing organic certification. compliance with USDA organic
In addition, certification review Performance Evaluations
standards would be assessed in all
personnel play a crucial role in sectors of this rapidly growing and The proposed rule also revises the
determining if an operation is granted diversifying global industry. requirements for annual performance
organic certification initially, if Additionally, requiring certification evaluations, described in
continued certification is warranted, review personnel to continuously § 205.501(a)(6), to include requirements
and/or if issuing a non-compliance, supplement their knowledge with a for regular field evaluation of inspectors
proposed suspension, or revocation. In minimum annual training requirement and documentation of annual
cases where an operation has been is vital to ensuring the integrity of performance and field evaluation
issued a non-compliance or has been organic products amidst rapidly procedures and results. The proposed
suspended, the certification review changing technologies and product rule amends § 205.501(a)(6) to clarify
personnel determine if sufficient supply chain practices. the requirements for annual
corrective actions have been taken to performance evaluations conducted by
bring the operation into compliance. As Documented Training Requirements accredited certifying agents.
such, the certification review personnel and Procedures Subparagraph (i) is added to address the
are integral to maintaining organic The current regulations at § 205.504(a) evaluation of inspectors while
integrity. Therefore, this proposed rule require certifying agents to provide performing on-site inspections. The
adds a requirement at § 205.501(a)(4)(ii) descriptions of personnel qualifications proposed rule ensures that inspectors
that certifying agents are responsible for and training but do not contain
37 ‘‘Training and Oversight of Inspector and
demonstrating that all certification requirements for documenting training
Certification Review Personnel’’ proposal, August
review personnel, whether staff, procedures. This proposed rule adds 17, 2018: https://www.ams.usda.gov/sites/default/
volunteers, or contractors, have the § 205.501(a)(4)(iii) to require certifying files/media/CACSTrainingOversightInspectors
knowledge, skills, and experience agents to maintain current documented ProposalOct2018Web.pdf.
are evaluated regularly in the field (i.e., requiring more frequent on-site conducted. The text also requires
while performing an inspection on a evaluations. However, the NOSB has certifying agents to document results of
farm, in a processing facility, etc.). The indicated that requiring inspector on- on-site inspector performance
proposed change specifies a minimum site evaluations on a more frequent basis evaluations and results of annual
frequency of every three years for on- worldwide may pose undue financial performance evaluations for all persons
site inspection evaluation, unless higher burden on certifying agents. AMS also who review applications for
frequency is warranted based on determined that inspector evaluations certification, perform on-site
experience level or past performance of every year would create a significant inspections, review certification
the individual inspector. For inspectors resource constraint on certifying agents. documents, evaluate qualifications for
that work for or contract with multiple On-site evaluations of inspectors are certification, make recommendations
certifying agents, the on-site evaluation necessary to verify that inspectors concerning certification, or make
conducted by one certifying agent may possess the knowledge and skills to certification decisions and implement
fulfill the on-site evaluation evaluate the compliance of certified measures to correct any deficiencies in
requirements for all certifying agents, organic operations and to produce certification services. This change
provided that the report of the technically accurate inspection reports. would ensure uniformity in scope and
evaluation is shared. Another certifying Requiring recurring, on-site evaluations frequency of performance evaluations
agent may choose to independently of inspectors would enhance the implemented across certifying agents,
conduct an on-site evaluation in integrity of organic products by thereby enhancing organic integrity.
addition to one performed by another verifying competence of organic
Request for Comment
certifying agent within the 3-year inspectors and ensuring consistency in
period. All certifying agents are required organic certification inspections. AMS seeks comment regarding
to ensure that all inspectors they Subparagraph (i)(A) is added to ensure certifying agent personnel qualifications
employ or contract with have been that inspector on-site evaluations are and training, including answers to the
evaluated during an on-site inspection performed by certifying agent personnel following questions:
at least once every three years. The who are qualified to evaluate inspectors. 1. Is 20 training hours a year an
proposed frequency of on-site This could include for example, a appropriate amount of continuing
inspection evaluation is based upon the person who has prior experience as an education for organic inspectors and
frequency recommended in the NOSB inspector, conducts training for certification review personnel?
proposal ‘‘Personnel Performance inspectors, and/or evaluates inspection 2. Should organic inspectors be
Evaluations of Inspectors’’ 38 and aligns reports to determine compliance. evaluated on-site more frequently than
with the ‘‘Guidance on Organic Subparagraph (ii) is added to address once every three years?
Inspector Qualifications’’ published by the need for certifying agents to 3. Should any other types of
the Accredited Certifiers Association, maintain detailed procedures regarding knowledge, skills, and experience be
Inc.39 (February 2018). AMS considered how performance evaluations are specified?
9—OVERSIGHT OF CERTIFICATION ACTIVITIES

205.2 ............................. Add new term ............. Certification activity. Any business conducted by a certifying agent, or by a person acting on
behalf of a certifying agent, including but not limited to: Certification management; admin-
istration; application review; inspection planning; inspections; sampling; inspection report
review; material review; label review; records retention; compliance review; investigating
complaints and taking adverse actions; certification decisions; and issuing transaction cer-
tificates.
205.2 ............................. Add new term ............. Certification office. Any site or facility where certification activities are conducted, except for
certification activities that occur at certified operations or applicants for certification, such
as inspections and sampling.
205.501(a)(22) ............... Add ............................. Notify AMS not later than 90 calendar days after certification activities begin in a new certifi-
cation office. The notification must include the countries where the certification activities
are being provided, the nature of the certification activities, and the qualifications of the
personnel providing the certification activities.
205.640 ......................... Revise ......................... Fees and other charges equal as nearly as may be to the cost of the services rendered
under the regulations, including initial accreditation, review of annual reports, and renewal
of accreditation, shall be reviewed, assessed, and collected from applicants in accordance
with the following provisions:
205.665(a) ..................... Revise ......................... Notification. (1) A written notification of noncompliance will be sent to the certifying agent
when:
(i) An inspection, review, or investigation of an accredited certifying agent by the Program
Manager reveals any noncompliance with the Act or regulations in this part; or
(ii) The Program Manager determines that the certification activities of the certifying agent,
or any person performing certification activities on behalf of the certifying agent, are not
compliant with the Act or the regulations in this part; or
(iii) The Program Manager determines that the certification activities at a certification office,
and/in specific countries, are not compliant with the Act or the regulations in this part.
(2) Such notification must provide:
(i) A description of each noncompliance;
38 ‘‘Personnel Performance Evaluations of 39 The Accredited Certifiers Association, Inc. is a agent community and the organic industry: https://
Inspectors’’ proposal, December 13, 2016: https:// 501(c)(3) non-profit educational organization www.accreditedcertifiers.org/.
www.ams.usda.gov/sites/default/files/media/ created to benefit the accredited organic certifying
CACSInspectorsProposal.pdf.
9—OVERSIGHT OF CERTIFICATION ACTIVITIES—Continued

(ii) The facts upon which the notification of noncompliance is based; and
(iii) The date by which the certifying agent must rebut or correct each noncompliance and
submit supporting documentation of each correction when correction is possible.
AMS proposes amending §§ 205.2, certification activities, including those requirements to notify the NOP of the
205.501, and 205.665 of the USDA of a person acting on behalf of the opening of new certification offices.
organic regulations to strengthen certifying agent. Because of this, the NOP has difficulty
oversight and enforcement of certifying readily quantifying how many
Certifying Agents With Multiple Offices
agents and their activities. These certification offices exist; this is
of Operation
proposed changes are primarily compounded by reports of offices
intended to address recent changes to Certifying agents commonly operate opening and closing frequently and
the OFPA, as amended by the multiple offices to ensure adequate unpredictably, complicating the NOP’s
Agriculture Improvement Act of 2018 service (e.g., sufficient capacity or ability to effectively oversee the
(see 7 U.S.C. 6515(i)–(j)).40 Clarifying proximity) to the operations they certify. activities of these offices. To ensure
the oversight of certifying agents is a This can result in a single certifying more robust enforcement of certification
critical component of this proposed agent with multiple offices spread offices, AMS proposes adding a new
rule, because it will allow the NOP to across several different countries, many paragraph, (a)(22), to § 205.501, which
provide robust enforcement of the of which act independently and are will require that certifying agents notify
USDA organic regulations, and ensure a quite remote from the central office. the NOP within 90 calendar days of the
level playing field for all accredited NOP is aware that several certifying opening of any office performing
certifying agents and certified agents accredited by the USDA use certification activities. The notification
operations. multiple offices to perform certification must include basic information to assist
activities. As part of our ongoing efforts the NOP in effectively overseeing the
General Clarification of Oversight to improve enforcement, AMS has office, including the countries serviced,
requested information about location and nature of the certification
To clarify the USDA’s oversight of the certification offices and the types of
certifying agents it accredits, AMS activities, and the qualifications of the
certification activities that are personnel that will provide the
proposes adding the new term conducted at those offices. The lack of
certification activities to the organic certification activities. Information on
specificity in the USDA organic the location of new offices will enable
regulations. This new term defines the regulations and the dynamic nature of
general activities which are considered AMS to more efficiently utilize
relationships between a certifying agent personnel and travel resources to
essential to the function of a certifying and its offices create oversight
agent, and therefore subject to oversight schedule on-site evaluations, and to
challenges for the USDA. This has led specify countries in which the certifying
by the NOP. Any business operation to inconsistent application and
conducted by a certifying agent as they agent’s certification activities must
enforcement of the regulations amongst
implement the USDA organic cease should a certifying agent’s office
certifying agents and offices.
regulations is considered a certification To clarify the USDA’s authority to be suspended or revoked based on
activity, including review, inspection, oversee certification offices, AMS failure to resolve its noncompliances.
and certification of organic operations. proposes the addition of the new term Information on the types of certification
The new term also clarifies that NOP certification office, and the previously activities being conducted will allow
oversight extends to the activities of any mentioned term certification activities. AMS to better evaluate the need for
person performing work on behalf of the A certification office is defined as any additional oversight; for instance, a new
certifying agent (e.g., a specific office site or facility where certification office located in a high-risk area with a
operating in specific countries, or a activities take place (except for activities history of organic fraud may require
subcontractor or subcontractor that take place at certified operations or additional oversight.
organization). Because the use of other specialized facilities, such as The proposed rule, if finalized, will
subcontractors is very common in the inspection, sampling, and testing). In codify this practice and ensure that
organic industry, effective enforcement combination with the proposed certifying agents are providing complete
depends upon oversight that reaches all revisions to § 205.665 at paragraph information about their certification
persons involved in the certification of (a)(1)(iii), this allows the NOP to send offices in a timely manner. Accurate and
organic operations. This is reinforced by notices of noncompliance to a certifying timely reporting of information about
the proposed revision of § 205.665, at agent, based upon the certification certification activities will bolster the
paragraph (a)(1)(ii), which clarifies the activities at a specific certification office NOP’s ability to oversee certifying
Program’s authority to send and in specific countries. agents, and provide for more equitable
notifications of noncompliance to a Another gap in the oversight of enforcement of the Act and the USDA
certifying agent based upon review of certification offices is the current lack of organic regulations.
40 See section 10104(d) of the Agriculture available at: https://www.congress.gov/115/plaws/

Improvement Act of 2018, Public Law No: 115–334, publ334/PLAW-115publ334.pdf.
10—ACCEPTING FOREIGN CONFORMITY ASSESSMENT SYSTEMS

205.2 ............................. Add new term ............. Conformity assessment system. All activities undertaken by a government to ensure that the
applicable technical requirements for the production, handling, and processing of organic
agricultural products are fully and consistently applied from product to product.
205.2 ............................. Add new term ............. Technical requirements. A system of relevant laws, regulations, regulatory practices, and
procedures that address the production, handling, and processing of organic agricultural
products.
205.500(c) ..................... Remove ......................
205.511 ......................... Add new section ......... Accepting foreign conformity assessment systems.
205.511(a) ..................... Add ............................. Foreign product may be certified under the USDA organic regulations by a USDA-accredited
certifying agent and imported for sale in the United States. Foreign product that is pro-
duced and handled under another country’s organic certification program may be sold, la-
beled, or represented as organically produced in the United States if AMS determines that
such organic certification program provides technical requirements and a conformity as-
sessment system governing the production and handling of such products that are at least
equivalent to the requirements of the Act and the regulations in this part (‘‘equivalence de-
termination’’).
205.511(b) ..................... Add ............................. Countries desiring to establish eligibility of product certified under that country’s organic cer-
tification program to be sold, labeled or represented as organically produced in the United
States may request an equivalence determination from AMS. A foreign government must
maintain compliance and enforcement mechanisms to ensure that its organic certification
program is fully meeting the terms and conditions of any equivalence determination pro-
vided by AMS pursuant to this section. To request this determination, the requesting
country must submit documentation that fully describes its technical requirements and
conformity assessment system. If AMS determines it can proceed, AMS will conduct an
assessment of the country’s organic certification program to evaluate whether it is equiva-
lent.
205.511(c) ..................... Add ............................. AMS will describe the scope of an equivalence determination.
205.511(d) ..................... Add ............................. AMS will conduct reviews on a two-year cycle, beginning at the close of the prior review, to
assess the effectiveness of the foreign government’s organic certification program. AMS
will reassess a country’s organic certification program that AMS has recognized as equiv-
alent every five years to verify that the foreign government’s technical requirements and
conformity assessment program continue to be at least equivalent to the requirements of
the Act and the regulations of this part, and will determine whether the equivalence deter-
mination should be continued.
205.511(e) ..................... Add ............................. AMS may terminate an equivalence determination if the terms or conditions established
under the determination are not met; if AMS determines that the country’s technical re-
quirements and/or conformity assessment program are no longer equivalent; if AMS deter-
mines that the foreign government’s organic control system is inadequate to ensure that
the country’s organic certification program is fully meeting the terms and conditions under
the determination; or for other good cause.
AMS proposes adding a new section other U.S. government agencies and arrangements facilitate trade and are an
to the USDA organic regulations, foreign trading partners, and on important mechanism for ensuring
§ 205.511, on accepting foreign guidelines from international robust oversight of imported organic
conformity assessment systems that organizations such as the World Trade products. The most common type of
oversee organic production in foreign Organization (WTO), the International trade arrangement is a full organic
countries. If this proposed rule is Standards Organization (ISO), the Food equivalence determination, in which
implemented, new § 205.511 will and Agriculture Organization (FAO), AMS determines a country’s entire
replace current § 205.500(c), which will and the International Federation of organic certification program to be
be removed. Organic Agriculture Movements equivalent to that of the United States.
International trade is critically (IFOAM). AMS’ process was roughly AMS has also established recognition
important to the economic vitality of the described in two previous certifying agreements, where AMS determines that
organic sector. The OFPA, under 7 agent Instruction documents in the a foreign government’s ability to
U.S.C. 6505(b), allows imported National Organic Program Handbook: accredit certifying agents and enforce
products to be sold or labeled as NOP 2100—Equivalence Determination standards is equivalent and authorizes
organically produced if the Secretary Procedure; and NOP 2200—Recognition that government to oversee certification
determines that the products have been and Monitoring of Foreign Government of products to the USDA organic
produced and handled under an organic Conformity Assessment Systems. standards.
certification program with requirements AMS has used its equivalence The USDA has direct oversight over
and oversight determined to be at least determination process to establish trade the certifying agents it accredits under
equivalent to those described in the arrangements for organic products with the NOP. In contrast, certifying agents
OFPA. Under this authority, AMS has 10 other countries.41 These accredited by a foreign government
developed a process for determining the whose organic certification program has
41 The United States has seven organic
equivalence of foreign organic been determined to be equivalent are
equivalence arrangements: Canada, the European
certification programs. AMS’ Union, Japan, South Korea, Switzerland, Taiwan,
equivalence determination process is and the United Kingdom. The United Kingdom United States also has three recognition agreements:
based on the similar processes used by equivalency will be effective in January 2021. The India, Israel, and New Zealand.
accredited by the foreign government or § 205.2: Conformity assessment system; upon AMS’ evaluation of each foreign
by an agent of that government. The and technical requirements. These terms government’s unique technical
USDA has no direct oversight of these are defined to ensure that the process requirements and conformity
certifying agents and relies upon the and requirements described in new assessment system and are important to
conditions of the equivalence § 205.511 are clear. AMS’ ability to ensure the integrity of
determination to ensure compliance The term conformity assessment organic products produced under
with the Act and the regulations. system would be defined as all activities different systems.
The current USDA organic regulations undertaken by a government to ensure
address the USDA’s authority to make that the applicable technical New § 205.511(d) lays out the current
equivalence determinations in general requirements for the production, process that AMS and other foreign
terms under § 205.500(c), but do not handling, and processing of organic governments use to monitor equivalence
describe the criteria, scope, and other agricultural products are fully and determinations that have been made.
parameters to establish, oversee, or consistently applied from product to The review cycles mirror ISO standards,
terminate such equivalence product. Technical requirements would which include a five-year reassessment
determinations, all of which are critical be defined as a system of relevant laws, cycle and mid-cycle reviews. The
to the enforcement of organic imports. regulations, regulatory practices, and section provides some flexibility in the
This proposed new section is necessary procedures that address the production, timing of the mid-cycle reviews to
to adequately address AMS’ authority handling, and processing of organic accommodate unavoidable factors in
and clarify the procedures that the agricultural products. A government’s both countries that can impact timing
agency follows for organic equivalence conformity assessment system and (e.g., federal budgets, election cycles,
determinations. Importantly, the section technical requirements would cover the growing seasons).
codifies the agency’s existing practices full range of activities associated with New § 205.511(e) describes the
and does not establish any new administering a federal organic program conditions under which AMS may
requirements. The new regulatory (i.e., development of standards, policies terminate equivalence determinations.
language will strengthen AMS oversight and procedures, accreditation and These conditions for termination are
and enforcement capacity of organic oversight of certifying agents, and commonly accepted among countries
imports. Clear language in the compliance and enforcement activities). that maintain equivalence
regulations regarding equivalence New § 205.511(a) describes AMS’ determinations and are based upon the
determination will support AMS authority under the OFPA to make core concepts underlying equivalence.
authority to determine the scope of equivalence determinations. New AMS must be able to terminate
equivalence determinations. It will also § 205.511(b) describes the process for equivalence determinations under these
support AMS’ authority in reassessing, initiating a request for equivalence used conditions in order to fulfill its statutory
and either continuing or terminating by AMS and other foreign governments. obligation to assure that organic
equivalence determinations, as Since there are several factors that may products sold in the United States are
necessary. Finally, additional clarity in impact whether AMS moves forward to
compliant with OFPA and the USDA
the regulations will increase review an equivalence request (i.e.,
organic regulations and maintain a level
transparency for stakeholders and agency resources, capacity to oversee
playing field for U.S. farms and
foreign governments by establishing a the potential trade arrangement, relative
businesses.
foundation for AMS to develop more benefits for the U.S. organic sector), this
detailed documents that describe the section clarifies that AMS will Request for Comment
process and requirements for determine if it can proceed with the
equivalence determinations. Without evaluation process in each case. AMS seeks comment regarding
adding this new section to the New § 205.511(c) clarifies that AMS whether the public sees a differential
regulations, AMS could face challenges will determine the scope of each risk to enforcement associated with
establishing and enforcing terms under equivalence determination that it certain organic trade relationships.
current and future equivalence makes. It is important to make this Specifically, compared with organic
determinations that are critical to clarification because not all equivalence determinations, are there
ensuring the integrity of imported determinations must cover the same increased risks associated with
organic products. organic products and activities and they recognition agreements where other
To support proposed new § 205.511, may include different terms or countries’ governments oversee the
AMS proposes adding two new terms to conditions. These differences depend implementation of NOP certification?
11—COMPLIANCE—GENERAL
205.660(c)–(d) ............... Redesignate ................ Redesignate paragraphs (c)–(d) as paragraphs (d)–(e).

205.660(c) ..................... Add ............................. The Program Manager may initiate enforcement action against any person who sells, labels,
or provides other market information concerning an agricultural product if such label or in-
formation implies, directly or indirectly, that such product is produced or handled using or-
ganic methods, if the product was produced or handled in violation of the Organic Foods
Production Act or the regulations in this part.
205.661 ......................... Revise section title ..... Investigation.
AMS proposes adding new paragraph of the OFPA, as amended (7 U.S.C. 6501 Act against any violator, regardless of
(c) to § 205.660, to clarify that the NOP et. al). The proposed change will clarify certification status. This clarification is
Program Manager may initiate an that the OFPA grants the Secretary important because noncertified status
enforcement action against any violator administrative powers to enforce the does not protect an operation that
commits organic fraud from may affix a label to, or provide other Secretary administrative powers to
enforcement action. The NOP currently market information concerning, an enforce the Act against any violator,
pursues enforcement actions against agricultural product if such label or regardless of the person’s certification
uncertified parties for which AMS has information implies, directly or status.
evidence of OFPA violations. indirectly, that such product is The proposed changes are necessary
This proposed change is consistent produced and handled using organic to emphasize the Secretary’s
with the enforcement authority granted methods, except in accordance with this administrative powers to investigate and
to the Secretary in the OFPA. All chapter. Further, the OFPA at 7 U.S.C. enforce against operations who are not
agricultural products sold, labeled, or 6506(a)(7) requires that the NOP provide certified to the USDA organic standards.
represented as organic must be for appropriate and adequate During calendar years 2011–2017, over
produced and handled in compliance enforcement procedures, as determined 70% of complaints received by the NOP
with the USDA organic regulations. The by the Secretary to be necessary and alleging violations of the OFPA
OFPA at 7 U.S.C. 6505(a)(1) states: (A) consistent with this chapter. involved uncertified operations
A person may sell or label an AMS also proposes amending the title representing products as organic.
agricultural product as organically of § 205.661 from ‘‘Investigation of Therefore, continued AMS enforcement
produced only if such product is certified operations’’ to ‘‘Investigation.’’ against uncertified operations is central
produced and handled in accordance The proposed change is intended to to the effective administration of the
with this chapter; and (B) no person further clarify that the OFPA grants the OFPA.
12—NONCOMPLIANCE PROCEDURE FOR CERTIFIED OPERATIONS

205.100(c) ..................... Revise ......................... Any person or responsibly connected person that:
205.662(e)(3) ................. Add ............................. Within 3 business days of issuing a notification of suspension or revocation, or the effective
date of an operation’s surrender, the certifying agent must update the operation’s status in
INTEGRITY.
205.662(f)(1) .................. Revise ......................... A certified operation or a person responsibly connected with an operation whose certification
has been suspended may at any time, unless otherwise stated in the notification of sus-
pension, submit a request to the Secretary for reinstatement of its certification, or submit a
request for eligibility to be certified. The request must be accompanied by evidence dem-
onstrating correction of each noncompliance and corrective actions taken to comply with
and remain in compliance with the Act and the regulations in this part.
205.662(g)(1) ................. Revise ......................... Knowingly sells or labels a product as organic, except in accordance with the Act, shall be
subject to a civil penalty of not more than the amount specified in § 3.91(b)(1)(xxxvii) of
this title per violation.
AMS proposes amending §§ 205.100 labels a nonorganic product as organic, subject to fines and/or imprisonment
and 205.662 to clarify that a person who or makes a false statement to the (18 U.S.C. 1001). This will enable AMS
is responsibly connected to an operation Secretary, a State organic program, or a to take comprehensive enforcement
that violates the OFPA or the USDA certifying agent, shall be subject to civil action to hold all responsible
organic regulations may be subject to a penalty fines or imprisonment, individuals accountable and prevent
suspension of certification (if the respectively (7 U.S.C. 6519(c)(1)–(2)). persons that enable or assist in activities
responsibly connected person is This proposed rule clarifies that a that violate the OFPA from continuing
certified), or civil penalties or criminal person responsibly connected to a that activity.
charges and/or may be ineligible to violator of the OFPA may be complicit AMS also proposes adding new
receive certification. This will bolster in the OFPA violation(s) because of that paragraph § 205.662(e)(3) to require
the enforcement capacity of AMS by association, and may be ineligible to certifying agents to timely update the
ensuring that penalties for violations of receive certification. This parallels the status of an operation that has been
the OFPA extend to all accountable current provisions in the USDA organic suspended or revoked, or that has
parties. regulations for revocation of surrendered its certification. The
The USDA organic regulations, at certification, where a certified operation updates should be completed within
section § 205.2, define responsibly or person responsibly connected with three business days of issuing a
connected as ‘‘Any person who is a an operation whose certification has notification of suspension or revocation,
partner, officer, director, holder, been revoked will be ineligible to or from the effective date of a surrender.
manager, or owner of 10 percent or more receive certification for 5 years Timely updates to INTEGRITY are
of the voting stock of an applicant or a (§ 205.662(f)(2)). AMS expects that critical to inform other certifying agents,
recipient of certification or when issuing a proposed suspension, operations in the supply chain, and
accreditation.’’ The OFPA provides that certifying agents will identify all consumers when an operation is no
any person who (1) attempts to label a persons responsibly connected, and longer certified and can help prevent
product as organic and who knows or when such persons exist, notify the noncompliant products from entering or
should have known that the product is appropriate certifying agent(s) or the continuing in the stream of commerce.
noncompliant; or (2) makes a false NOP, as applicable. Finally, AMS proposes amending
statement to the USDA; or (3) otherwise This proposed rule also clarifies that § 205.662(g)(1) to update the citation
does not comply with the USDA organic a person responsibly connected to a which specifies the maximum civil
regulations is ineligible to receive person that knowingly sells nonorganic penalty amount for violations of the
organic certification for 5 years (7 U.S.C. product as organic or makes a false OFPA. This aligns with the Federal
6519(c)(3)). In addition, the OFPA states statement to authorities about Civil Penalties Inflation Adjustment Act
that any person who knowingly sells or compliance with the OFPA, may be Improvements Act of 2015. On March
14, 2018, the USDA published in the most recent adjustment increased the which occurred on or after March 14,
Federal Register its annual inflation civil penalty amount from $11,000 to 2018.
adjustment for 2018 (83 FR 11129). This $17,952 for violations of the OFPA
13—MEDIATION
205.663 ......................... Revise ......................... (a) A certifying agent must submit with its administrative policies and procedures provided in
§ 205.504(b): Decision criteria for acceptance of mediation, and a process for identifying
personnel conducting mediation and setting up mediation sessions.
(b) A certified operation or applicant for certification may request mediation to resolve a de-
nial of certification or proposed suspension or proposed revocation of certification issued
by a certifying agent or State organic program.
(1) A certified operation or applicant for certification must submit any request for mediation
in writing to the applicable certifying agent or State organic program within 30 calendar
days of receipt of the notice of proposed suspension or proposed revocation of certifi-
cation or denial of certification.
(2) A certifying agent or State organic program may accept or reject a request for mediation
based on its own decision criteria.
(i) If a certifying agent rejects a mediation request, it must provide this rejection in writing to
the applicant for certification or certified operation. The rejection must include the right to
request an appeal, pursuant to § 205.681, within 30 calendar days of the date of the writ-
ten notification of rejection of the request for mediation.
(c) Both parties must agree on the person conducting the mediation.
(d) If a State organic program is in effect, the parties must follow the mediation procedures
established in the State organic program and approved by the Secretary.
(e) The parties to the mediation have a maximum of 30 calendar days to reach an agree-
ment following a mediation session. Successful mediation results in a settlement agree-
ment agreed to in writing by both the certifying agent and the certified operation. If medi-
ation is unsuccessful, the applicant for certification or certified operation has 30 calendar
days from termination of mediation to appeal the denial of certification or proposed sus-
pension or revocation pursuant to § 205.681.
(f) Any settlement agreement reached through mediation must comply with the Act and the
regulations in this part. The Secretary may review any mediated settlement agreement for
conformity to the Act and the regulations in this part and may reject any agreement or
provision not in conformance with the Act or the regulations in this part.
(g) The Program Manager may propose mediation and enter into a settlement agreement at
any time to resolve any adverse action notice that it has issued.
AMS proposes revising § 205.663 to The USDA organic regulations require applicants to engage in mediation
improve the general readability of this certifying agents and State organic without a third-party mediator,
section and to more clearly explain how programs to notify operations of the provided that all parties agree upon the
mediation may be used in option to request mediation as an person who will serve as the mediator.
noncompliance procedures. When alternative dispute resolution to resolve After a certifying agent issues a denial
successful, mediation is an efficient way noncompliance findings that have led to of certification, proposed suspension, or
to bring operations into compliance and a proposed suspension, revocation, or revocation of certification, a certified
resolve conflicts among certifying agents denial of certification. This will operation and certifying agent may
and operations. The USDA organic facilitate resolution of these issues discuss the option of mediation prior to
regulations require that certifying agents before they escalate to an appeal to AMS receiving a request for mediation.
and State organic programs provide or a State organic program. However, for mediation to proceed as a
applicants for certification and certified form of alternative dispute resolution,
AMS proposes revising the existing
operations the right to request an operation must request mediation in
requirements for mediation to support a
mediation when they issue a denial of writing to the certifying agent. This
process that is efficient and accessible to
certification, notice of proposed proposed rule provides 30 calendar days
producers and handlers who want to
suspension, or proposed revocation of to request mediation. This aligns with
resolve a denial of certification,
certification (§§ 205.405(d) and the length of time provided to submit an
proposed suspension, or revocation of
205.662(c)). Section 205.663 provides appeal of a proposed adverse action.
certification. Mediation should be a
requirements for requesting mediation,
collaborative process between a A certifying agent determines whether
responding to a mediation request, the
certifying agent and an operation. A to accept or reject a written request for
time frame for reaching an agreement,
successful mediation addresses the mediation. This proposed rule requires
and what happens when mediation is
noncompliance(s) and leads to full certifying agents to include mediation
unsuccessful.42
compliance with the USDA organic acceptance decision criteria as part of
42 The OFPA does not specifically mention regulations. In summary, the proposed the administrative policies and
mediation. The OFPA does require that the USDA changes would clarify the process for procedures which certifying agents are
have procedures for producers and handlers to engaging in mediation and would clarify required to submit under § 205.504(b).
appeal adverse determinations. The right to request that a settlement agreement is the Parties to the mediation may develop
mediation in the regulations provides an additional
opportunity for producers and handlers to resolve
outcome of successful mediation. The conditions, such as cost, timeframes to
adverse actions while preserving their right to revised rule would permit certifying reach a settlement agreement, and any
appeal if mediation in unsuccessful. agents and certified operations or incremental steps, only after a certifying
agent accepts a mediation request. A between the operator and the certifying mediation between operations and
certifying agent must not impose any agent to discuss the terms of a certifying agents or State organic
preconditions for the acceptance of settlement offer prior to signing the programs. This does not change the
mediation (i.e., the certifying agent agreement. authority of the Secretary to review an
cannot require that the operation take a In some cases, the use of a mediator agreement that results from the
specific action—other than submitting a may be appropriate, either because the mediation for conformity to the OFPA
written request for mediation—before it operation initially requested this, or the and the USDA organic regulations and
will consider mediation). operation rejected a settlement offer and reject any nonconforming provision or
In accepting mediation, a certifying then requested a mediator. To agreement.
agent may also, at its discretion, offer a accommodate this situation, the
This proposed change is needed to
settlement agreement for an operation to proposed rule would require each
consider. A settlement offer may be clarify and emphasize that mediation
certifying agent submit a process to
useful when the corrective action(s) is under the USDA organic regulations is
identify a qualified mediator and set the
clear and the noncompliance(s) is not an alternative dispute resolution
time and location of mediation
recurrent. As part of the mediation, an mechanism, conducted between a
session(s), mediation format (in-person,
operation may accept or reject the certified operation or applicant for
video, phone), and mediation fees and
settlement agreement, negotiate the certification and a certifying agent or
payment.
terms with the certifying agent, or The outcome of a successful State organic program. The Secretary is
request a mediator to try and reach a mediation is a settlement agreement that not involved in determining the
settlement agreement. Settlement brings an operation into compliance outcome of a mediation,
agreements may impose additional with the USDA organic regulations. A notwithstanding his or her authority to
compliance requirements or may settlement agreement must clearly review dispute resolution terms for
include agreed-upon suspensions or describe the corrective actions and conformity with the OFPA and the
revocations of organic certificates, as timeframes for implementing corrective USDA organic regulations.
appropriate to the noncompliance. actions, and may impose additional This proposed change would not
This proposed rule clarifies that actions (e.g., unannounced inspections, affect AMS’ ability to carry out
mediation does not require a third-party sampling for residue testing) to ensure oversight, compliance, and enforcement
mediator to reach a settlement the operation maintains compliance. A activities on behalf of the Secretary. For
agreement. The certifying agent and settlement may also include a example, AMS may conduct informal
operation may agree that mediation will suspension of organic certification. mediation, at its discretion, and enter
be between only those two parties. For This proposed rule would also clarify into mutually agreeable settlement
example, mediation may consist of a that the Secretary does not require, agreements with parties that receive an
phone call or series of phone calls manage, or otherwise participate in NOP-issued proposed adverse action.
14—ADVERSE ACTION APPEAL PROCESS—GENERAL

205.2 ............................. Add new term ............. Adverse action. A noncompliance decision that adversely affects certification, accreditation,
or a person subject to the Act, including a proposed suspension or revocation; a denial of
certification, accreditation, or reinstatement; a cease and desist notice; or a civil penalty.
205.680(a) ..................... Revise ......................... Persons subject to the Act who believe they are adversely affected by an adverse action of
the National Organic Program’s Program Manager, may appeal such decision to the Ad-
ministrator.
205.680(b) ..................... Revise ......................... Persons subject to the Act who believe they are adversely affected by an adverse action of
a State organic program may appeal such decision to the State organic program’s gov-
erning State official who will initiate handling of the appeal pursuant to appeal procedures
approved by the Secretary.
205.680(c) ..................... Revise ......................... Persons subject to the Act who believe they are adversely affected by an adverse action of
a certifying agent may appeal such decision to the Administrator, Except, That when the
person is subject to an approved State organic program, the appeal must be made to the
State organic program.
205.680(d) ..................... Redesignate ................ Redesignate as paragraph (f).
205.680(d) ..................... Add ............................. Persons subject to the Act who believe they are adversely affected by an adverse action of
a certifying agent or a State organic program may request mediation as provided in
§ 205.663.
205.680(e) ..................... Revise and redesig- All appeals must be reviewed, heard, and decided by persons not involved with the adverse
nate as paragraph action being appealed.
(g).
205.680(e) ..................... Add ............................. All appeals must comply with the procedural requirements in § 205.681(c) and (d) of the
USDA organic regulations.
AMS proposes to revise and clarify appeal, and reinforce that appeal adversely affect the person(s) (7 U.S.C.
parts of the adverse action appeals submissions need to comply with the 6520). The current USDA organic
process in §§ 205.680 and 205.681. In basic requirements in the regulations. regulations describe how certified
summary, these changes will clarify We expect that these changes will operations, accredited certifying agents,
which actions can be appealed, support an expedited appeals process. and applicants for certification or
recognize the use of alternative dispute The OFPA authorizes an expedited accreditation may appeal a
resolution practices in lieu of a formal appeals procedure that gives persons the noncompliance decision that would
administrative proceeding to resolve an opportunity to appeal actions that affect their certification or accreditation
status or eligibility to become certified outcomes of an appeal in NOP 4011, has issued an adverse action. The option
or accredited (§ 205.680(a)). The current Adverse Action Appeal Process.44 to request mediation is provided in
regulations explain when an appeal may The proposed rule would add the new addition to the option to appeal
be submitted, how it must be submitted, term adverse action to clarify which (mediation is covered in § 205.663, and
and what the appeal submission must actions may be appealed under the proposed changes to this section are
contain. Specifically, appeals of USDA organic regulations. Adverse discussed above). The mediation
noncompliance decisions of a certifying action would be defined as a process can be a viable path to resolve
agent or the NOP are appealable to the noncompliance decision that adversely noncompliances that are correctable,
AMS Administrator, or to the State affects certification, accreditation, or a and not willful or recurrent. If
organic program if the appellant is person subject to the Act, including a mediation is rejected or is not
located in a State with an approved proposed suspension or revocation; a successful, the operation maintains the
State organic program.43 In addition, the denial of certification, accreditation, or right to appeal.
reinstatement; a cease and desist notice; Finally, this proposed rule would add
current regulations explain that a
or a civil penalty.45 This term would an explicit requirement that appeals
decision to sustain an appeal results in
replace the use of ‘‘noncompliance must be properly filed, as described in
a favorable action with respect to the decision’’ throughout this section. AMS paragraphs (c) and (d) of § 205.681. This
appellant’s certification or accreditation, is proposing to change ‘‘noncompliance means that an appeal must be timely
and a decision to deny an appeal decision’’ in the current regulation to filed, sent to the correct address,
requires AMS to initiate a formal adverse action. This clarifies the scope include a copy of the adverse action,
administrative proceeding (i.e., a of actions which may be appealed. and explain why the adverse action is
hearing). AMS explains how it This proposed rule would add a new incorrect. In effect, this requirement will
administers the adverse action appeal provision that reminds operations of the help to expedite the review of appeals
process, the status of an appellant option to request mediation when a and supports AMS’ decisions to dismiss
during an appeal, and the possible certifying agent or State organic program appeals which are not timely filed.
15—ADVERSE ACTION APPEAL PROCESS—APPEALS

205.681(a) ..................... Revise ......................... Adverse actions by certifying agents. An applicant for certification may appeal a certifying
agent’s notice of denial of certification, and a certified operation may appeal a certifying
agent’s notification of proposed suspension or proposed revocation of certification to the
Administrator, Except, That, when the applicant or certified operation is subject to an ap-
proved State organic program, the appeal must be made to the State organic program
which will carry out the appeal pursuant to the State organic program’s appeal procedures
approved by the Secretary.
205.681(a)(2) ................. Revise ......................... If the Administrator or State organic program denies an appeal, a formal administrative pro-
ceeding may be initiated to deny, suspend, or revoke the certification. Such proceeding
must be conducted pursuant to the U.S. Department of Agriculture’s Uniform Rules of
Practice, 7 CFR part 1, subpart H, or the State organic program’s rules of procedure.
205.681(b) ..................... Revise ......................... Adverse actions by the NOP Program Manager. A person affected by an adverse action, as
defined by 205.2, issued by the NOP Program Manager, may appeal to the Administrator.
205.681(b)(1) ................. Revise ......................... If the Administrator sustains an appeal, an applicant will be issued accreditation, a certifying
agent will continue its accreditation, or an operation will continue its certification, a civil
penalty will be waived and a cease-and-desist notice will be withdrawn, as applicable to
the operation.
205.681(b)(2) ................. Revise ......................... If the Administrator denies an appeal, a formal administrative proceeding may be initiated to
deny, suspend, or revoke the accreditation or certification and/or levy civil penalties. Such
proceeding must be conducted pursuant to the U.S. Department of Agriculture’s Uniform
Rules of Practice, 7 CFR part 1, subpart H.
205.681(c) ..................... Revise ......................... Filing period. An appeal must be filed in writing within the time period provided in the letter
of notification or within 30 days from receipt of the notification, whichever occurs later.
The appeal will be considered ‘‘filed’’ on the date received by the Administrator or by the
State organic program. An adverse action will become final and nonappealable unless an
appeal is timely filed.
205.681(d)(1) ................. Revise ......................... Appeals to the Administrator and Requests for Hearing must be filed in writing and ad-
dressed to: 1400 Independence Ave. SW, Room 2642, Stop 0268, Washington, DC
20250, or electronic transmission, NOPAppeals@ams.usda.gov.
205.681(d)(3) ................. Revise ......................... All appeals must include a copy of the adverse action and a statement of the appellant’s
reasons for believing that the action was not proper or made in accordance with applica-
ble program regulations, policies, or procedures.
AMS is proposing several changes to certifying agents,’’ and the title of the NOP Program Manager may issue
§ 205.681 to revise and clarify appeal paragraph (b) from ‘‘Accreditation different types of adverse actions, and
procedures. We propose revising the appeals’’ to ‘‘Adverse actions by the the respective appeal decisions will
title of paragraph (a) from ‘‘Certification NOP Program Manager.’’ This is have different effects.
appeals’’ to ‘‘Adverse actions by necessary because certifying agents and
43 As of the publication of this proposed rule, 44 NOP 4011, Adverse Action Appeal Process. 45 Only AMS issues civil penalties.
California is the only approved State organic December 23, 2011: https://www.ams.usda.gov/
program. sites/default/files/media/4011.pdf.
AMS proposes clarifying the process enter into a settlement agreement prior become final’’ with ‘‘An adverse action
when the Administrator denies an to the hearing. This proposed revision will become final’’ because the use of
appeal and upholds an adverse action. provides flexibility to resolve appeals the term ‘‘adverse action’’ is broader and
The current regulations, at outside of the formal administrative includes denials of reinstatement, cease
§§ 205.681(a)(2) and (b)(2), state that the process. and desist notices, and other actions
USDA will initiate a formal AMS also proposes revising current that could affect certification.
administrative proceeding (hearing) to paragraph (b), ‘‘Accreditation appeals,’’
Additionally, this proposed rule
finalize the action, i.e., suspend, revoke to address the scope of adverse actions
would update the address for filing
or deny certification. AMS proposes issued by the NOP which may be
appeals and provide an email address
changing ‘‘will’’ to ‘‘may’’ to reflect appealed to the Administrator. This
for submitting appeals electronically in
actual practice and to recognize that could include appeals of proposed
§ 205.681(d)(1). The address in the
AMS may pursue the resolution of suspensions or revocations of
current regulation is outdated and does
appeals through expedited, alternative accreditation or certification, denials of
means, such as settlement agreements, not provide an option for electronic
accreditation, denials of reinstatement,
before initiating a formal administrative or civil penalties. submission, even though this occurs in
proceeding. In current practice, an AMS proposes clarifying the practice.47
appellant whose appeal is denied by the requirement for the appeal filing period Finally, this proposed rule would
Administrator has the option to request in paragraph § 205.681(c). The wording, revise the term ‘‘adverse decision’’ to
or waive a hearing. If the appellant does ‘‘noncompliance decision’’ is removed ‘‘adverse action’’ in § 205.681(d)(3) to be
not request a hearing, AMS does not because that term is being removed or consistent with the use of the term
initiate a formal administrative replaced throughout the Adverse Action ‘‘adverse action’’ throughout this
proceeding and the Administrator’s Appeal Process section. In addition, we section. This maintains the requirement
appeal decision is final and takes are proposing to replace the phrase, ‘‘A that an appellant must submit a copy of
effect.46 When an appellant requests a decision to deny, suspend, or revoke the adverse action which they are
hearing, AMS and the appellant may certification or accreditation will contesting with their appeal.
16—GROWER GROUP OPERATIONS

205.2 ............................. Add new term ............. Grower group member. A person engaged in the activity of growing or gathering a crop and/
or wild crop as a member of a grower group operation.
205.2 ............................. Add new term ............. Grower group operation. A single producer consisting of grower group members in geo-
graphical proximity governed by an internal control system under an organic system plan
certified as a single crop and/or wild crop production and handling operation.
205.2 ............................. Add new term ............. Grower group production unit. A defined subgroup of grower group members in geo-
graphical proximity as a part of a single grower group operation that use similar practices
and shared resources to grow or gather similar crops and/or wild crops.
205.2 ............................. Add new term ............. Internal control system. An internal quality management system that establishes and gov-
erns the review, monitoring, training, and inspection of the grower group operation and the
procurement and distribution of shared production and handling inputs and resources, to
maintain compliance with the USDA organic regulations as a single producer.
205.201(c) ..................... Add ............................. In addition to paragraph (a) of this section, a grower group operation’s organic system plan
must describe its internal control system. The description of the internal control system
must:
(1) Define the organizational structure, roles, and responsibilities of all personnel;
(2) Identify grower group production units and locations;
(3) Define geographical proximity criteria for grower group members and grower group pro-
duction units;
(4) Describe characteristics of high-risk grower group members and grower group production
units;
(5) Describe shared production practices and inputs;
(6) Describe the internal monitoring, surveillance, and auditing methods used to assess the
compliance of all grower group members;
(7) Describe the system of sanctions for noncompliant grower group members, including
procedures to address noncompliances detected among grower group members, impose
sanctions, and remove grower group members when warranted, and procedures for re-
porting noncompliances to the certifying agent;
(8) Describe measures to protect against potential conflicts of interest;
(9) Describe how training, production and handling inputs, and other resources are procured
and provided to all grower group members and personnel;
(10) Have clear policies and procedures to verify the grower group operation’s and grower
group members’ compliance with the USDA organic regulations; and
(11) Address any other terms or conditions determined by the Administrator to be necessary
to enforce compliance with the USDA organic regulations and the Act.
205.400(g) ..................... Add ............................. In addition to paragraphs (a) through (f) of this section, a grower group operation must:
(1) Be a single producer organized as a person;
(2) Sell, label, or represent only crops and/or wild crops as organic;
(3) Use centralized processing, distribution, and marketing facilities and systems;
(4) Be organized into grower group production units;
46 This is described in NOP 4011. 47 The AMS website has the current information https://www.ams.usda.gov/services/enforcement/
for filing an appeal either by mail or electronically: organic/appeals.
16—GROWER GROUP OPERATIONS—Continued

(5) Ensure that all crops and/or wild crops sold, labeled, or represented as organic are from
grower group members only;
(6) Ensure that grower group members do not sell, label, or represent their crops and/or wild
crops as organic outside of the grower group operation unless they are individually cer-
tified;
(7) Report to the certifying agent on an annual basis the name and location of all grower
group members and grower group production units, and the crops, wild crops, estimated
yield, and size of production and harvesting areas of each grower group member and
grower group production unit;
(8) Conduct internal inspections of each grower group member, at least annually, by internal
inspectors, which must include mass-balance audits and reconciliation of each grower
group member’s and grower group production unit’s production yield and group sales;
(9) Document and report to the certifying agent the use of sanctions to address noncompli-
ant grower group members, at least annually; and
(10) Implement procedures to ensure all production and handling by the grower group oper-
ation is compliant with the USDA organic regulations and the Act, including recordkeeping
requirements to ensure a complete audit trail from each grower group member and grow-
er group production unit to sale and distribution.
205.403(a)(2) ................. Redesignate ................ Redesignate as paragraph (a)(3).
205.403(a)(2) ................. Add ............................. Initial and annual on-site inspections of a grower group operation as defined in § 205.2
must:
(i) Assess the compliance of the internal control system of the organic system plan, or its
capability to comply, with the requirements of § 205.400(g)(8). This must include review of
the internal inspections conducted by the internal control system.
(ii) Conduct witness audits of internal control system inspectors performing inspections of
the grower group operation.
(iii) Individually inspect at least 1.4 times the square root of the total number of grower
group members. This must include an inspection of all grower group members determined
to be high risk according to criteria in 205.201(c)(4). At least one grower group member in
each grower group production unit as defined in § 205.2 must be inspected.
(iv) Inspect each handling facility.
AMS proposes clarifying regulatory seeds), and post-harvest handling ICS is responsible for direct
requirements for crop and/or wild crop practices. There is one organic enforcement of the grower group and its
production and handling operations certificate for the grower group members, including inspection of all
with multiple member growers that are operation and the certification applies grower group members. In grower group
certified as a single producer. only to the grower group operation as a certification, the certifying agent’s
Operations with multiple grower and whole; individual members do not primary role is to assess and enforce the
gatherer members can pose higher risks independently sell or market their own function of the ICS, not the individual
to traceability and organic integrity crops and/or wild crops using the members.
because of their unique structure and grower group’s organic certificate. There
Unique Certification Challenges of
composition, longer and more complex is one organic system plan for the
Grower Groups
supply chains, and reliance upon grower group operation as a single
internal quality control systems. producer using shared handling and Grower group operations present
Specific certification requirements are marketing facilities, and a common unique certification challenges relative
therefore needed to ensure adequate and recordkeeping system. to traditional, individually certified
consistent oversight of these types of Grower group structure is different organic operations. Grower groups are
operations and facilitate enforcement than traditional, individually certified inherently more complex because they
action. organic operations. As such, they are collectives of many members
require special controls to ensure organized under a single organic
Grower Group Structure and Function
compliance with the USDA organic certification. Grower groups commonly
In this proposed rule, operations with regulations. Central to the function of a have thousands of members spread
multiple growers organized and grower group is an internal control across a large area, and utilize
certified as a single crop and/or wild system (ICS). An ICS consists of both centralized collection, handling,
crop producer are referred to as grower personnel and procedure that act a processing, and marketing. This
group operations, also commonly grower group’s internal governance and complicates all aspects of enforcement,
known as grower groups. Individual verification system. The ICS is including inspection, product
growers, known as grower group described in the grower group traceability, and mass-balance
members, grow or gather the same crops operation’s organic system plan, and assessment. Most significantly, this
and/or wild crops in geographical ensures that grower group production complexity demands the use of an ICS
proximity to one another using similar and handling activities are compliant as an additional tier of enforcement.
practices with centralized handling, with the USDA organic regulations. The The current USDA organic regulations
processing, and marketing. Shared ICS is unique to grower groups; it acts do not include specific provisions
farming or gathering practices may as a third tier of enforcement and addressing the certification of grower
include fertility management, pest verification between the grower group groups. In particular, the regulations
control, acceptable inputs (including members and the certifying agent. The lack grower group eligibility criteria and
requirements describing ICS function to export products to the United States and 2008 NOSB recommendations, and
and organization. As a result, the NOP and Europe. Presently, growers adds several requirements, including
regularly observes inconsistent grower organized as grower group operations more detail about documentation
group certification practices during export many organic agricultural requirements and inspection methods.
audits and certification appeals. products to the United States, such as AMS and certifying agents need clear
NOP staff accompanying certifying coffee, cocoa, bananas, tea, and spices. standards for the certification of grower
agents during witness audits frequently This method of certification gives small group operations as a single producer to
report that grower groups lack a growers or gatherers organized into effectively identify and enforce against
functioning ICS. This often results in grower groups access to organic markets noncompliant activities. Grower group
poorly trained ICS personnel that do not while expanding consumer choices. operations present an elevated risk to
use effective sanctions policies to Grower group certification supports U.S. organic integrity because of their
enforce against noncompliant members, consumer demand for organic products structure (numerous growers conform to
fail to inspect all members, and do not that are not produced in the United one organic system plan), longer and
complete mass-balance audits. The lack States, such as coffee, cacao, and more complex supply chains, and use of
of specific requirements in the organic bananas. an internal control system for oversight
regulations inhibits the effective The International Federation of of grower group members, grower group
function of an ICS, which in turn Organic Agriculture Movements production units, and handling
threatens the integrity of products (IFOAM) 48 Organics International facilities. Therefore, requirements for
produced by grower group operations. started to develop criteria for grower consistent certification practices for
The NOP also often cites group certification in 1994, and in 2003 grower group operations are critical.
noncompliances to certifying agents published its position on ‘‘Small Holder AMS’ proposed requirements for grower
who fail to adequately assess the Group Certification for organic group operations will strengthen the
structure of a grower group and the production and processing’’ to support oversight of organic supply chains by
function of an ICS. In the absence of the concept.49 The criteria formed the enabling certifying agents to more
specific regulation, some certifying basis for acceptance of grower group readily assess whether a grower group
agents struggle to define the acceptable certification in the European Union and operation is complying with the USDA
limits of grower groups (geographical, United States. Grower group operation organic regulations and supporting
numerical, and scope). This can result certification is also utilized by other enforcement actions when necessary.
in too many members distributed over standards organizations, such as the
too large an area, complicating effective Definitions
International Accreditation Forum and
enforcement. A lack of specific GlobalG.A.P., to provide small-holder AMS proposes adding four new terms
requirements also makes it difficult for farming operations access to markets to the USDA organic regulations to
certifying agents to adequately assess while ensuring the integrity of the clarify the certification of a grower
the ICS’s ability to enforce all members supply chain.50 group operation as a single producer:
of a grower group operation. Some On January 21, 2011, the NOP issued grower group operation, internal control
certifying agents also attempt to directly Policy Memorandum 11–10, system, grower group member, and
enforce grower group members, not the ‘‘Certification of Grower Groups,’’ 51 grower group production unit.
ICS, leading to inadequate oversight. A grower group operation would be
which specified how certifying agents
There is a clear need for specific criteria defined as a single producer consisting
could certify grower group operations,
grower groups must meet to qualify for of grower group members in
using 2002 and 2008 NOSB
organic certification, and practices geographical proximity governed by an
recommendations.52 The NOSB internal control system under an organic
certifying agents should use to inspect recommendations identified criteria for
grower groups and assess compliance of system plan certified as a single crop
grower group operations to qualify for and/or wild crop production and
an ICS. Describing these requirements in certification, and auditing practices and
the organic regulations would allow for handling operation. Therefore, the
methodologies for certifying agents to requirements for production and
more effective oversight of grower inspect grower groups and assess the
groups and their organic products. handling operations throughout the
compliance of the internal control regulations would apply to a grower
Authority and Background system. group operation as a single producer.
The OFPA authorizes the certification This proposed rule codifies many of AMS has not committed to a specific
of groups because it defines person as the requirements described in the 2002 maximum distance for geographic
an ‘‘individual, groups of individuals, 48 http://www.ifoam.bio/.
proximity and is not proposing
corporation, association, organization, 49 https://www.ifoam-eu.org/sites/default/files/
parameters for the physical extent of a
cooperative, or other entity.’’ (7 U.S.C. page/files/small_holder_group_certification_0.pdf. grower group operation. Certifying
6502). The OFPA also defines handler 50 https://www.iaf.nu/;https://www.globalgap.org/ agents will need to determine if the
and producer as persons. Further, the uk_en/. locations of grower group members
51 Policy Memorandum 11–10, Certification of
OFPA provides for producers and within a grower group production unit
Grower Groups. January 21, 2011: https://
handlers to seek certification (7 U.S.C. www.ams.usda.gov/sites/default/files/media/NOP-
and grower group operation meet the
6503(a)). Therefore, grower group 11-10-GroupGrowerCert.pdf. ‘‘geographical proximity’’ requirement
operations are production and handling 52 NOSB Recommendation: Criteria for based on the conditions of an operation.
operations which are eligible for organic Certification of Grower Groups. October 20, 2002: Generally, this will vary depending on
certification as a single producer. https://www.ams.usda.gov/sites/default/files/ site-specific conditions and crops.
media/Rec%20Criteria%20for%20Certification%
Grower group certification was 20of%20Grower%20Groups.pdf. NOSB
A grower group member would be
developed in the 1990s to reduce Recommendation: Certifying Operations with defined as a person engaged in the
barriers for small-scale farms in Multiple Production Units, Sites, and Facilities activity of growing or gathering a crop
developing countries entering the global under the National Organic Program. November 19, and/or wild crop as a member of a
2008: https://www.ams.usda.gov/sites/default/files/
organic market. Initially, organic farmer media/NOP%20Final%
grower group operation. The practices of
associations obtained group certification 20Rec%20Certifying%20Operations% each grower group member would need
for organic coffee and cacao operations 20with%20Multiple%20Sites.pdf. to align with the organic system plan.
The requirements for producers and basic regulatory unit. The organization be submitted at least annually as part of
handlers throughout the regulations of a grower group operation as a person the organic system plan.
would also apply to grower group clarifies that certification is granted to
The Internal Control System
members, although some requirements the grower group operation as a single
may be met collectively by the grower producer, rather than individual grower This proposed rule would add an
group operation, such as the organic members engaged in the activity of additional requirement for organic
production and handling system plan. growing or gathering within the grower system plans for grower group
The proposed rule defines an internal group operation. operations. Specifically, an organic
control system (ICS) as an internal Under the proposed rule, a grower system plan (OSP) for a grower group
quality management system that group operation may sell, label, or operation would need to include a
establishes and governs the review, represent only crops or wild crops as description of the internal control
monitoring, training, and inspection of organic; any non-crop agricultural system (ICS) and how it verifies the
the grower group operation and the products (e.g., livestock or livestock operation’s compliance with the USDA
procurement and distribution of shared products) would not be eligible for organic regulations. For all operations,
production and handling inputs and certification under the grower group the OSP describes shared farming and
resources, to maintain compliance with operation. AMS acknowledges that handling practices, inputs to be used
the USDA organic regulations as a single many organic farming systems utilize (including seeds), monitoring practices
producer. The ICS is a key component integrated crop-livestock systems— and procedures, recordkeeping systems,
of a grower group operation certified as especially operations in developing and practices to prevent commingling
a single producer. The ICS verifies that areas where grower group operation and contact with prohibited substances
the grower group operation is certification is more likely to occur. (§ 205.201(a)).
implementing the organic system plan, Therefore, the use of integrated or The ICS serves as the grower group
ensuring that growers or gatherers and mixed crop-livestock systems is operation’s internal governance and
handling facilities know how to comply. compatible with and would be verification system to ensure that
The ICS is responsible for the overall permitted in certified grower group grower group operation production and
compliance of the grower group operations. However, the management handling activities at every level are
operation and its adherence to the of any non-crop agricultural products implemented in accordance with the
organic system plan. must not affect the integrity of the OSP and are compliant with the USDA
Finally, this rule proposes adding the organic regulations. A grower group
organic crops or wild crops produced
term grower group production unit: A operation’s OSP must describe the
and handled by the operation, and non-
defined subgroup of grower group function of the ICS. This description
crop agricultural products must not be
members in geographical proximity as a must:
sold, labeled, or represented as organic
part of a single grower group operation (1) Define the organizational
by the grower group operation.
that use similar practices and shared structure, roles and responsibilities of
Individual grower group members
resources to grow or gather similar crops
seeking to sell non-crop agricultural all personnel;
and/or wild crops. Adding this
products would need their non-crop (2) Identify grower group production
proposed term will clarify that each
agricultural products certified units and locations;
grower group production unit within a
grower group operation requires an independently from the grower group (3) Define geographical proximity
initial and annual inspection by the operation. criteria for grower group members and
certifying agent, as required by The proposed rule also specifies that grower group production units;
§ 205.403(a)(1) of the organic grower group operations must use (4) Describe characteristics of high-
regulations. The term also clarifies that centralized processing, distribution, and risk grower group members and grower
a grower group operation may produce marketing facilities and systems. In group production units;
and market more than one type of crop addition, AMS proposes a requirement (5) Describe shared production
or wild crop, with each grower group that all crops and/or wild crops sold, practices and inputs;
production unit described and managed labeled, or represented as organic by a (6) Describe the internal monitoring,
under a single organic system plan of a grower group operation must be grown surveillance, and auditing methods used
grower group operation. or gathered by grower group members to assess the compliance of all grower
only. A grower group operation may not group members;
Certification Requirements for Grower buy crops and/or wild crops from non- (7) Describe the system of sanctions
Group Operations member growers and sell, label, or for noncompliant grower group
This proposed rule would add represent them as organic using the members, including procedures to
provisions to the general requirements grower group certification. In turn, AMS address noncompliances detected
for certification (§ 205.400) which are also proposes that grower group among grower group members, impose
specific to grower group operations. members must not market crops and/or sanctions, and remove grower group
These criteria would clarify the wild crops as organic outside of the members when warranted; and
eligibility requirements for grower grower group operation unless they are procedures for reporting
group operations. Entities that do not individually certified. noncompliances to the certifying agent;
meet all criteria would need to be Finally, this proposed rule would add (8) Describe measures to protect
certified separately in order to sell, a requirement that grower group against potential conflicts of interest;
label, or market agricultural products operations provide their certifying agent (9) Describe how training, production
certified to the USDA organic with the name and location of all grower and handling inputs, and other
regulations. group members, grower group resources are procured and provided to
The proposed rule would require that production units, and the crops, wild all grower group members and
a grower group operation is a single crops, estimated yield, and growing/ personnel;
producer legally organized as a person. gathering areas (acreage) of each grower (10) Have clear policies and
The OFPA and the USDA organic group member and grower group procedures to verify the grower group
regulations apply to a person as the production unit. This information must operation’s and grower group members’
compliance with the USDA organic On-Site Inspections by the Certifying operations. The certifying agent should
regulations; and Agent apply the risk assessment procedures to
(11) Address any other terms or This proposed rule would establish determine and instruct the inspector on
conditions determined by the requirements for how certifying agents which grower group members to
Administrator to be necessary to enforce must conduct annual on-site inspections inspect. When assessing the risks of the
compliance with the USDA organic of grower group operations. The grower group operation to determine
regulations and the Act. certifying agent would need to inspect which grower group members to
This proposed rule would set the ICS, review internal inspections inspect, the certifying agent should
inspection and oversight requirements conducted by the ICS, and observe ICS consider:
for the ICS. Specifically, the ICS would personnel conducting inspections. • Noncompliance history;
need to use qualified internal inspectors Certifying agents would need to inspect • The criteria used to designate a
(ICS personnel) free of conflicts of each handling facility and inspect at collection of grower group members as
interest to conduct independent and least 1.4 times the square root of the a single grower group production unit;
impartial inspections, at least annually. total number of grower group members. • Application of prohibited materials
Consistent with the scope of an on-site This number must include all high-risk adjacent to member fields;
inspection of any organic producer, the • Split or parallel operations (i.e.,
members (determined according to the
inspection of a grower group member they are also producing nonorganic
criteria in proposed § 205.400(g)(8)), and
should cover all areas of the organic crops and/or wild crops);
at least one grower member in each
system plan, including a review of all • Integrated crop-livestock systems;
grower group production unit (as • Grower group members with
production or gathering areas managed defined in § 205.2), to ensure all grower
by each grower group member, all post- incomes greater than $5000 USD per
group production units are inspected. year;
harvest handling and storage facilities, Inspections should include a full
• The procurement, availability and
inputs and resources used, and records inspection of the growing or gathering
distribution of inputs and resources to
maintained by each grower group areas and records of the grower group
members;
member and grower group production members selected. Selection of members • The prevalence of nonorganic
unit. ICS personnel must also conduct should include all high-risk members; production of similar crops in the
mass-balance audits of each grower however, the certifying agent should region;
group member, grower group also select members from across the risk • Geographic proximity of grower
production unit, and handling facility, spectrum—including lower-risk group members and grower group
including reconciliation of individual members. This may require a sample production units;
grower group member and grower group size larger than the minimum required • Post-harvest handling practices
production unit production with the by the proposed regulation (i.e., more designed to prevent comingling and
grower group operation’s sales. ICS than 1.4 times the square root of the contact with prohibited substances;
personnel conducting inspections number of grower group members). As • New entrants to the grower group
should focus on critical organic control a best practice, after all risk-based and operation;
points such as buffer areas, condition of other inspection selection criteria are • Size of grower group member’s
crops and/or wild crops, soil quality satisfied, certifying agents should production or gathering areas; and
indicators, input and equipment use randomly select the remaining member • Significant expansion of a grower
and storage areas, and level of inspections so that different lower-risk group member’s production area.
understanding of organic requirements grower group members are inspected As a best practice, the inspection of
by the grower group members AMS each year. the ICS should also include: Document
expects that qualified ICS personnel The square root sampling review; auditing of production and
would be familiar with the local methodology was formalized for use by sales/distribution records; reconciliation
production practices, general organic agricultural regulatory inspectors by the of product inventory; review of
production and handling practices, the Association of Official Agricultural procurement and distribution of inputs;
USDA organic regulations, ICS Chemists (AOAC) in 1927.53 The review of the inspections conducted by
procedures and regulations, and be formula used was the square root (Sqrt) the ICS; review of ICS personnel
fluent in the language(s) of the grower of the lot size (N) + 1. The 1.4 multiplier qualifications; witness audits to observe
group members and the ICS. aligns with the highest minimum ICS inspectors; review of
Finally, AMS proposes a requirement sampling number under the IFOAM noncompliance actions for grower group
that the ICS must develop and accreditation system and therefore members; examination of organic
implement procedures to ensure that all provides a common minimum sampling control points and high-risk areas;
production and handling activities of number for all grower group operations interviews with managers responsible
the grower group operation are around the world. All numbers must be for the OSP, governance of the ICS, and
compliant with the USDA organic rounded up to the next whole number grower group members and individuals
regulations. This includes (e.g., 50 members = 10 inspections, 100 overseen by the ICS; and review of
recordkeeping which demonstrates members = 14 inspections, 500 members training provided to ICS staff and
complete audit trails for all crops and/ = 32 inspections, and 1000 members = grower group members.
or wild crops sold, labeled, or 45 inspections).
represented as organic by the grower Risk-based inspections rely upon Request for Comment
group operation, and a system to certifying agents having policies and AMS seeks public comment regarding
sanction noncompliant members, procedures to determine the risk factors the certification of grower group
production units, and handling facilities associated with grower group operations, including answers to the
of the grower group operation so that following questions:
53 Blanck, F.C. (1927). ‘‘Report of the Committee
those members, production units, and 1. Should there be limits on gross
on Sampling,’’ J. Assoc. Official Agricultural
handling facilities do not jeopardize the Chemists, 10, 92–98. The square root sampling
sales or field sizes of individual grower
compliance status of the grower group scheme was developed in the 1920s as a sampling group members? If yes, please describe
operation. scheme for agricultural regulatory inspectors. these limits.
2. Should there be a limit on the 3. Should there be a limit to the group production or gathering areas, or
maximum number of members allowed geographical distribution of members? grower group production units within a
in a grower group operation or in a This includes limits to the maximum single grower group operation. If yes,
grower group production unit? If yes, geographical proximity or distance please describe these limits.
please describe these limits. between grower group members, grower
17—CALCULATING THE PERCENTAGE OF ORGANICALLY PRODUCED INGREDIENTS

205.302(a)(1) ................. Revise ......................... Dividing the total net weight (excluding water and salt) of combined organic ingredients at
formulation by the total weight (excluding water and salt) of all ingredients.
205.302(a)(2) ................. Revise ......................... Dividing the fluid volume of all organic ingredients (excluding water and salt) at formulation
by the fluid volume of all ingredients (excluding water and salt) if the product and ingredi-
ents are liquid. If the liquid product is identified on the principal display panel or informa-
tion panel as being reconstituted from concentrates, the calculation should be made
based on single-strength concentrations of the ingredients and all ingredients.
205.302(a)(3) ................. Revise ......................... For products containing organically produced ingredients in both solid and liquid form, divid-
ing the combined weight of the solid organic ingredients and the weight of the liquid or-
ganic ingredients (excluding water and salt) at formulation by the total weight (excluding
water and salt) of all ingredients.
While most of this proposed rule Section 205.302(a) currently refers to the weight of the finished product (after
focuses on certification and compliance ‘‘finished product’’ and includes the processing) could result in a calculation
provisions, clarification of standards is phrase ‘‘total weight of the finished of organic content in excess of 100
also a critical element of organic product.’’ This terminology has created percent, which is not possible. The
integrity. To ensure cross-industry confusion, unnecessary paperwork same can be true of calculations based
consistency in the certification of multi- burden, and enforcement challenges for on fluid volume, as allowed at
ingredient processed products, AMS certifying agents and organic handlers, § 205.302(a)(2). AMS is proposing these
proposes revising § 205.302, which as it is not clear if ‘‘finished product’’ changes to ensure accurate and
describes how to calculate the organic is meant to specifically describe the consistent calculation of organic content
content of multi-ingredient products. product after processing or if it simply by requiring calculation at the time of
This calculation is performed by means the sum of all ingredients at the formulation.
certifying agents to classify products as time of formulation. The proposed
changes would clarify that the In December 2016, AMS published
‘‘100% organic,’’ ‘‘organic,’’ or ‘‘made draft guidance 54 on the topic of
with organic (specified ingredients or calculation of organic content is to be
made at the time of formulation, calculating organic content to respond
food group(s)).’’ The proposed revisions to an April 2013 NOSB
regardless of whether processing
would streamline calculations and recommendation,55 inform the public of
(currently defined at § 205.2) occurs
ensure consistent enforcement of the AMS’ current thinking, and to invite
after formulation.
USDA organic regulations. When ingredients are combined and public comment.56 The calculation of
The USDA organic regulations subsequently processed (e.g., cooked, organic content described in this
(§ 205.302(a)) describe how to measure baked, dehydrated, freeze dried), the proposed rule is consistent with NOP
or quantify the organic content in a post-processing weight of all ingredients 5037. AMS received no objections via
multi-ingredient product. To calculate can be less than the weight of all public comments to calculating organic
organic content, the weight or volume of ingredients at the time of formulation content based on the weight of
the organic ingredients is divided by the due to loss of water from ingredients ingredients at the time of formulation.
total weight or volume of the product. (i.e., not added water). Calculating The proposed changes are consistent
Water and salt added as ingredients are organic content based on the weight of with the NOSB recommendation to
excluded from the calculation. ingredients at formulation divided by amend § 205.302(a)(1)–(3).
18—SUPPLY CHAIN TRACEABILITY AND ORGANIC FRAUD PREVENTION

205.2 ............................. Add new term ............. Organic fraud. Intentional deception for illicit economic gain, where nonorganic products are
labeled, sold, or represented as ‘‘100 percent organic,’’ ‘‘organic,’’ or ‘‘made with organic
(specified ingredients or food group(s)).’’
205.103(b)(2) ................. Revise ......................... Fully disclose all activities and transactions of the certified operation in sufficient detail as to
be readily understood and audited, including identification in records of products as
‘‘100% organic,’’ ‘‘organic,’’ or ‘‘made with organic (specified ingredients or food
group(s)),’’ as applicable;
205.103(b)(3) ................. Redesignate ................ Redesignate as paragraph (b)(4).
54 The draft guidance and comments can be 55 NOSB Recommendation, Calculating Ingredient Products, December 6, 2016: https://
viewed at https://www.regulations.gov/document Percentage Organic in Multi-Ingredient Products, www.federalregister.gov/documents/2016/12/06/
?D=AMS-NOP-16-0085-0001 and in the NOP April 11, 2013: https://www.ams.usda.gov/sites/ 2016-29173/national-organic-program-notice-of-
Program Handbook: https://www.ams.usda.gov/ default/files/media/NOP%20CACC%20 draft-guidance-for-calculating-the-percentage-of-
Final%20Rec%20Calculating%20Percentage.pdf.
sites/default/files/media/NOP5037DraftGuidance 56 Notice of Draft Guidance for Calculating the
organic.
PercentCalculations.pdf.
Percentage of Organic Ingredients in Multi-
18—SUPPLY CHAIN TRACEABILITY AND ORGANIC FRAUD PREVENTION—Continued

205.103(b)(4) ................. Redesignate ................ Redesignate as paragraph (b)(5).

205.103(b)(3) ................. Add ............................. Include audit trail documentation for product handled or produced by the certified operation;
205.201(a)(3) ................. Revise ......................... A description of the monitoring practices and procedures to be performed and maintained,
including the frequency with which they will be performed, to verify that the plan is effec-
tively implemented. This must include a description of the monitoring practices and proce-
dures to verify suppliers in the supply chain and organic status of products received, and
to prevent organic fraud, as appropriate to the certified operation’s activities;
205.501(a)(10) ............... Revise ......................... Maintain strict confidentiality with respect to its clients under the applicable organic certifi-
cation program and not disclose to third parties (except for the Secretary or the applicable
State organic program’s governing State official or their authorized representatives) any
business-related information concerning any client obtained while implementing the regu-
lations in this part, except:
205.501(a)(10)(i) ........... Add ............................. For information that must be made available to any member of the public, as provided for in
§ 205.504(b)(5);
205.501(a)(10)(ii) ........... Add ............................. For enforcement purposes, certifying agents must exchange any compliance-related infor-
mation that is credibly needed to certify, decertify, or investigate an operation, including
for the purpose of verifying supply chain traceability and audit trail documentation; and
205.501(a)(10)(iii) .......... Add ............................. If a certified operation’s proprietary business information is compliance-related and thus
credibly needed to certify, decertify, or investigate that operation, certifying agents may
exchange that information for the purposes of enforcing the Act, but the information in
question still retains its proprietary character even after it is exchanged and all of the certi-
fying agents that are involved in the exchange still have a duty to preserve the confiden-
tiality of that information after the exchange.
205.501(a)(13) ............... Revise ......................... Accept the certification decisions made by another certifying agent accredited or accepted
by USDA pursuant to § 205.500. Certifying agents must provide information to other certi-
fying agents to ensure organic integrity or to enforce organic regulations, including to
verify supply chain integrity, authenticate the organic status of certified products, and con-
duct investigations;
205.501(a)(21) ............... Redesignate ................ Redesignate as paragraph (a)(23).
205.501(a)(21) ............... Add ............................. Annually, conduct risk-based supply chain audits to verify organic status of a product(s) of a
certified operation(s) it certifies, back to the source(s).
205.504(b)(4) ................. Revise ......................... A copy of the procedures to be used for sharing information with other certifying agents and
for maintaining the confidentiality of any business-related information as set forth in
§ 205.501(a)(10);
205.504(b)(7) ................. Add ............................. A copy of the criteria to identify high-risk operations and products; and procedures to con-
duct risk-based supply chain audits, as required in § 205.501(a)(21); and procedures to re-
port credible evidence of organic fraud to the Administrator.
This proposed rule addresses many risk—including opportunities for • Clarifying who needs to be certified,
different sections of the USDA organic mishandling and fraud. including previously excluded
regulations to enhance oversight, protect Underlying the value of the USDA operations (§ 205.101);
the integrity of the organic label, and organic label is an assumption that • NOP Import Certificates (§ 205.273);
assure consumers that organic products organic products are not compromised • Clear identification of organic status
meet a consistent standard (see 7 U.S.C. at any step in the supply chain. To and lot numbers on nonretail containers
6501). Perhaps the most critical (§ 205.307);
verify the source at any step in the
component, and one which affects all • Trace-back audits and mass-balance
supply chain would require complete
aspects of this proposed rule, is supply audits during on-site inspections
visibility of the entire supply chain.
chain traceability from source to (§ 205.403);
However, certified operations and • Specific qualification and training
consumer (i.e., ‘‘farm to table’’). certifying agents do not generally have
Because organic products are standards for organic inspectors and
access to this information. Organic certification review personnel
credence goods, the organic system certification is typically verified back to
relies upon on trust between entities in (§ 205.501); and
the last certified organic operation in • Additional reporting of information
organic supply chains.57 Therefore, the supply chain. In complex supply
traceability and verification are essential about certified organic operations in the
chains, where products and ingredients Organic INTEGRITY Database
to the function of a healthy organic are often handled multiple times,
market. This is especially true today, (§ 205.501).
information about a product’s source These proposed amendments will
with organic supply chains growing may be difficult to verify, especially
longer and more complex. Organic improve the industry’s ability to
where source information/origin is perform trace-back audits (and therefore
products and ingredients are often intentionally obscured by some parties ensure organic integrity). However,
handled by dozens of operations, in the supply chain to protect

including many uncertified entities, on AMS also proposes several additional
confidential business information. amendments to more directly address
their way to the consumer. This may
expose organic products to greater Many parts of this proposed rule have traceability. AMS expects both certified
already discussed ways to address and operations and accredited certifying
57 A credence good is something with value or improve supply chain traceability, agents to share responsibility for
qualities that cannot be easily determined by the largely through indirect methods. These product traceability. The following
consumer before, or even after, purchase. include: proposed amendments will clarify
expectations for trace-back audits and audit trail definition in § 205.2) and to in their supply chain and to prevent
product verification: take measures to verify that the organic organic fraud. Such procedures and
• Organic operations must maintain product they receive is legitimately practices are often referred to as ‘‘fraud
audit trail documentation to facilitate represented as organic. These proposed prevention plans.’’ Under the current
supply chain traceability, including amendments are intended to support organic regulations, certified operations
identification of products as organic on AMS’ goal of full supply chain are already required to describe in their
documents (§ 205.103); traceability. organic system plan (OSP) ‘‘monitoring
• Organic operations must describe in Although all entities in a supply practices and procedures’’ to ‘‘verify
their organic system plan the chain are responsible for organic that the [OSP] is effectively
monitoring practices and procedures integrity, these proposed amendments implemented’’ (7 CFR 205.201(a)(3)).
used to prevent organic fraud and verify do not intend to shift liability from one This proposed rule would explicitly
suppliers and organic product status operation to another. An operation that state that an OSP must describe how
(§ 205.201); encounters fraud committed by a existing monitoring and verification
• Certifying agents must share supplier may not be liable for that fraud, practices are used to verify suppliers
information with other certifying agents provided that the operation, while and products and detect and prevent
to verify supply chains and conduct following adequate detection and fraud. This will ensure that certified
investigations (§ 205.501 and § 205.504); prevention procedures, did not detect operations use appropriate and effective
and the fraud or deliberately continue to means to prevent organic fraud, help
• Certifying agents must have represent a fraudulent product as maintain organic integrity as products
procedures for (1) identifying high-risk organic. travel along a supply chain, and help
operations and agricultural products to AMS proposes amending the certifying agents to assess the
conduct risk-based supply chain audits recordkeeping requirements at effectiveness of certified operations’
and for (2) reporting credible evidence § 205.103(b)(2) to clarify that records anti-fraud efforts.
of organic fraud to the USDA maintained by certified operations must
(§ 205.504). identify agricultural products as ‘‘100% Traceability is a shared responsibility
All successful systems of traceability organic,’’ ‘‘organic,’’ or ‘‘made with across all entities in a supply chain, but
include three common elements: (1) organic (specified ingredients or food the use of effective procedures at the
Traceability within a single operation; group(s)), as applicable. This proposed operation level is especially critical.
(2) traceability one step forward and one amendment is needed to ensure that a Certified operations have first-hand
step back from an operation in a supply product’s organic status is clear knowledge of their supply chains and
chain; and (3) bidirectional traceability throughout the audit trail. AMS are therefore better able to detect and
along an entire supply chain, source to anticipates that most organic operations prevent fraud than a third party.
consumer, by a third party. The already maintain records that meet this Operation-level traceability is also key
proposed rule supports traceability by requirement, because product-specific to full supply chain trace backs; a gap
clarifying who is responsible for each records are generally a good business or deficiency of information at any step
element: Certified organic operations are practice and are necessary to ensure that may prevent a full trace-back. As part of
responsible for traceability within their records are auditable. This proposed a larger integrated system of traceability,
operation, back to their suppliers, and action is not intended to limit an fraud prevention plans and procedures
forward to their customers; certifying operation’s flexibility to use alternative allow certified operations to verify that
agents are responsible for tracing abbreviations or indicators of a the products in their supply chains are
products along a supply chain back to product’s organic status on nonretail compliant with the USDA organic
their origin, and assessing the labels or other recordkeeping. This may regulations, and have been handled only
traceability efforts of operations. include use of abbreviations such as by certified organic operations (see 7
This proposed rule would also add ‘‘MWO’’ (i.e., ‘‘made with organic’’), U.S.C. 6506(a)(1)).
the new term organic fraud, defined as ORG (i.e., ‘‘organic’’), color The scope and complexity of a fraud
intentional deception for illicit designations, or other tracking systems prevention plan will depend on the type
economic gain, where nonorganic that are used internally within a of operation. For example, AMS does
products are labeled, sold, or certified organic operation to denote a not expect a producer who does not
represented as organic. AMS is product’s organic status. Retail labels handle products produced by another
including organic fraud to clarify must continue to comply with the operation to develop supplier
actions this proposed rule is intended to requirements at Subpart D—Labels, verification practices, beyond verifying
reduce. Labeling, and Market Information. that any purchased inputs meet organic
The USDA organic regulations requirements. In contrast, a processer
Certified Operations currently require certified operations to that receives many organic ingredients
This proposed rule would require maintain records that fully disclose all from numerous suppliers would need to
certified operations to maintain an audit activities and transactions in sufficient augment their organic system plan to
trail for products that they produce, detail to be readily understood and describe practices to minimize organic
receive, and/or handle. In addition, audited (§ 205.103(b)(2)). The fraud risks in lengthy supply chains.
certified operations would be required regulations also define the term audit In general, AMS expects that a robust
to describe and implement a plan to: (1) trail but do not use this term within the plan for supply chain oversight and
Detect and prevent organic fraud in any regulations. By inserting audit trail into organic fraud prevention would include:
organic product that they produce, the recordkeeping requirements, this
receive and/or handle; and (2) identify, proposed rule clarifies the type and • A map or inventory of the
verify, and document their suppliers. extent of records that a certified operation’s supply chain which
These changes are proposed to ensure operation needs to maintain. identifies suppliers;
that certified operations keep Lastly, AMS proposes that certified • Identification of critical control
documentation that is sufficient to operations must describe and points in the supply chain where
verify the source, ownership history, implement practices to verify the organic fraud or loss of organic status
and movement of organic products (see organic status of suppliers and products are most likely to occur;
• A vulnerability assessment to exchanged, and all certifying agents proactive fraud prevention and
identify weaknesses in the operation’s involved in the exchange still have a detection.
practices and supply chain; duty to preserve the confidentiality of The proposed rule does not establish
• Practices for verifying the organic that information after the exchange. a specific metric for the number of
status of any product they use; AMS expects that this change will annual supply chain audits that a
• A process to verify suppliers and support verification of the organic certifying agent needs to conduct,
minimize supplier risk to organic integrity of product as it moves through because the quantity and types of high-
integrity; the supply chain while maintaining risk operations will vary by certifying
• Mitigation measures to correct confidentiality of information outside of agent. The supply chain audits should
vulnerabilities and minimize risks; the required parties. adequately assess high-risk areas. AMS
• Monitoring practices and Finally, AMS is proposing a recognizes that certifying agents’ ability
verification tools to assess the requirement that certifying agents to conduct supply chain audits depends
effectiveness of mitigation measures; develop and maintain procedures and on the implementation of other
and criteria for identifying which operations requirements in this proposed rule, for
• A process for reporting suspected and products among those it certifies are example, certification of previously
organic fraud to certifying agents and at high risk for organic fraud. excluded operations (e.g., brokers,
the NOP. Identifying organic fraud is a key role of traders, importers, and other trade
AMS is aware of private initiatives in certifying agents, and the OFPA requires facilitators) and the mandatory use of
the organic sector to develop best that certifying agents fully implement NOP Import Certificates. Therefore, we
practices for organic operations to detect organic law and regulations (7 U.S.C. expect that certifying agents will
and prevent organic fraud.58 We predict 6515(a)) and that appropriate and increase the number of supply chain
that these best practices will provide adequate enforcement procedures be audits they conduct annually as this
organic operations with practical tools employed (7 U.S.C. 6506(a)(7)). The rule is fully implemented and use of
to assess, monitor, and mitigate organic proposed rule would require that technology for supply chain traceability
fraud risks within their organic supply certifying agents conduct supply chain is more widely adopted among certified
chains. audits on a sample of operations and operations. By requiring written
products which it determines to be procedures, AMS expects that certifying
Certifying Agents high-risk. agents will make better use of
To facilitate trace-back audits, AMS expects that certifying agents information sharing with other
investigations, and verification, AMS would need to develop risk-assessment certifying agents to assess organic
proposes amending the organic criteria by identifying the characteristics integrity. As a requirement of
regulations to clarify that certifying of operations, agricultural products, and accreditation, certifying agents’
agents must share information with one supply chains which are vulnerable to processes and procedures would be
another for the purposes of certification organic fraud or unintentional reviewed during regular accreditation
and enforcement. This change would mishandling. These could include: audits.
not affect the existing requirement that Products for which there is a relatively A final proposed change requires that
certifying agents maintain strict high demand, low supply, and high certifying agents report credible
confidentiality with respect to its clients organic premium; products which may evidence of organic fraud to AMS. This
and not disclose business-related be subject to treatment with prohibited requirement is expected to help AMS
information to third parties that are not substances after production; take action against bad actors more
involved in the regulation or unpackaged products which are not quickly and is required by the OFPA at
enclosed in final retail containers; 7 U.S.C. 6519(c)(4). Certifying agents
certification of operations, as required
products with multiple handlers in the will need to develop procedures for
by the OFPA (7 U.S.C. 6515(f)). For
supply chain; products from a supplier evaluating evidence to determine if
enforcement purposes, certifying agents
that lacks a record of compliance; a evidence is credible and develop
must exchange any compliance-related
sudden increase in the available supply procedures for reporting suspected
information that is credibly needed to
of an organic product or commodity; organic fraud. USDA will review these
investigate an operation to determine
operations which change certifying procedures and examine specific cases
agents frequently; and operations which during regular accreditation audits.
regulations. Certifying agents must share
are certified by more than one certifying
information during any investigation to Electronic Supply Chain Traceability
agent. A certifying agent could rank or
make a compliance determination, Systems
weight these vulnerabilities and
including assessment of applications for determine that the presence of a certain In addition to the amendments
certification, noncompliance number of these factors equates to high proposed above, AMS will continue to
investigations, and suspension/ risk, while also considering the total work toward its goal of full supply
revocation of certification. volume of product produced or handled chain traceability and fully verifiable
If a certified operation’s proprietary by the operation. The vulnerability organic products to support and enforce
business information is compliance- criteria would change based on market the OFPA requirements (see 7 U.S.C.
related and thus credibly needed to trends, enforcement actions, and 6506(a)(1)). Looking forward, AMS
certify, decertify, and/or investigate that changing practices within the organic expects electronic tracking systems,
operation, certifying agents are to industry; certifying agents would need including digital ledger technology
exchange that information for the to ensure that the procedures and (DLT), will play an essential role in
purposes of enforcing the Act; however, criteria remain applicable and accurate. supply chain traceability. DLT can
the information in question still retains Because a product or operation’s level of provide secure, verifiable, transparent,
its proprietary character even after it is risk may change over time, it is and near-instantaneous tracking at the
58 A good example is the Organic Trade
important that certifying agents conduct item level in complex supply chains.
Association’s ‘‘Organic Fraud Prevention
supply chain audits of lower-risk Critically, DLT can also protect
Solutions’’ project: https://ota.com/ products (in addition to supply chain confidential business information and
OrganicFraudPrevention. audits of high-risk products) to support trade secret information by
automatically restricting sensitive across the organic industry. Barriers to Request for Comment
information to authorized entities. The widespread adoption of an electronic AMS seeks comment from the public
utility of electronic tracking in food tracking system include inadequate and organic stakeholders regarding the
systems has been demonstrated by access to technology and connectivity in proposed amendments to address
several successful, high-profile pilot rural areas, acceptance of universal supply chain traceability and organic
programs.59 AMS expects interest electronic standards (interoperability), fraud, including answers to the
within the community to grow as and distribution of costs. Despite these following questions:
stakeholders realize the potential of this barriers, AMS encourages the 1. Does the proposed definition of
technology. development and use of electronic organic fraud encompass the types of
Electronic supply chain tracking tracking systems. We anticipate that fraudulent activities you witness in the
systems have the potential to address electronic tracking technologies will organic supply chain?
many of the issues discussed in this allow AMS to achieve its goal of full 2. Should certifying agents be
proposed rule. However, they are often supply chain traceability, and foresee required to perform a minimum number
based on emergent technology; incorporation of electronic tracking of trace-back audits each year?
additional time and development is systems into future enforcement 3. Should more specific fraud
required before a universal electronic strategies. prevention criteria be included in the
system could feasibly be implemented regulation?
19—TECHNICAL CORRECTIONS
Section Current text Action Proposed text
205.301(f)(2) .... Be produced using ionizing radiation, pursuant to Revise ......... Be processed using ionizing radiation, pursuant to
§ 205.105(f); § 205.105(f);
205.301(f)(3) .... Be processed using sewage sludge, pursuant to Revise ......... Be produced using sewage sludge, pursuant to
§ 205.105(g); § 205.105(g);
205.400(b) ....... Establish, implement, and update annually an organic Revise ......... Establish, implement, and update annually an organic
production or handling system plan that is sub- production or handling system plan that is sub-
mitted to an accredited certifying agent as provided mitted to an accredited certifying agent as provided
for in § 205.200; for in § 205.201;
205.401(a) ....... An organic production or handling system plan, as re- Revise ......... An organic production or handling system plan, as re-
quired in § 205.200; quired in § 205.201;
AMS proposes amending § 205.301 to 20. Additional Amendments Considered better align with the proposed updates
correct a technical error in the but not Included in This Proposed Rule to §§ 205.100–101 and clarify who is
description of the prohibition of responsible for the compliance of
Packaged Product Labeling
ionizing radiation and sewage sludge. A private-labeled organic products.
previous technical correction (80 FR If implemented, the proposed Amending the labeling requirements of
6429) contained an error in the language amendments to §§ 205.2 and 205.100– §§ 205.303–304 may also improve
101 would require the certification of traceability and transparency, and ease
used to describe the prohibition on
operations that sell or represent organic verification of organic status. Although
ionizing radiation and sewage sludge.
products. This would include AMS has chosen not to include
The terms ‘‘produced’’ and ‘‘processed’’ operations in ‘‘private-label’’
are erroneously used to describe the use packaged product labeling amendments
relationships; both the operation that in this proposed rule, we seek public
of ionizing radiation and sewage sludge, produced/processed the organic product
respectively, in the current regulatory comment on the following questions
(the ‘‘contract manufacturer’’), and the regarding private-labeled organic
text. This proposed action would correct operation that sells the product under products. Please explain how your
the language at paragraphs (f)(2) and its own label (the ‘‘brand name’’ or answers could improve organic integrity
(f)(3) to clarify that all products labeled ‘‘distributor’’), would require and transparency, and facilitate the
as ‘‘100% organic’’ or ‘‘organic’’ and all certification under this proposed rule. verification and traceability of organic
ingredients identified as organic in the However, the current regulations, at products.
ingredient statement of any product §§ 205.303–304, do not clearly specify
which certified operation and certifying 1. For private-label packaged
must not be processed using ionizing
agent must be listed on the label of a products, which certified operation(s)
radiation or produced using sewage should be listed on the retail label
sludge. private-label organic product. This
causes inconsistent interpretation of the (brand name/distributor, contract
AMS also proposes amending manufacturer, or both)?
regulation and variable labeling
§§ 205.400(b) and 205.401(a), to correct 2. Which certifying agent(s) should be
practices. Part of the challenge is
the reference to organic system plans variation in the terms used to describe listed?
(§ 205.201), which is incorrectly cited in the operations involved in the 3. Should the certifying agent listed
the current organic regulation. manufacturing, labeling, and on a label always be the certifying agent
distribution of packaged products. AMS of the certified operation listed on the

considered amending the labeling label (i.e., should the certifying agent
requirements for packaged products to match the operation)?
59 Walmart partnered with IBM to create and-mango-pilots-with-ibm. Nestle is testing a chain/#7a89053b5f0f. Bumble Bee Foods partnered
blockchain traceability systems for mangos and public blockchain for milk supply chains: https:// with SAP to trace yellowfin tuna with blockchain
pork: https://jbba.scholasticahq.com/article/3712- www.forbes.com/sites/benjaminpirus/2019/07/09/ technology: https://news.sap.com/2019/03/bumble-
food-traceability-on-blockchain-walmart-s-pork- nestle-tests-public-blockchain-for-dairy-supply- bee-foods-sap-create-blockchain-track-fish/.
4. Should listing contract the Act allows the NOP to include fees promoting flexibility.64 Executive Order
manufacturers on labels be mandatory? from producers, certifying agents and 13771 directs Agencies to identify at
Should it be optional? handlers. AMS periodically reviews the least two existing regulations to be
5. What terminology should be used fees for accreditation and accreditation repealed for every new regulation unless
to describe private-labeled organic services to ensure that they are in prohibited by law. The total incremental
products? compliance with Circular A–25.60 AMS cost of all regulations issued in a given
6. What terminology should be used also oversees the NOP fees that fiscal year must have costs within the
to describe the operations involved in certifying agents and others charge for amount of incremental costs allowed by
packaged product or private labeling their services. AMS is seeking public the Director of OMB, unless otherwise
(e.g., brand name manufacturer, contract comments in this proposed rule on how required by law or approved in writing
manufacturer, and distributor)? fees in the NOP could strengthen testing by the Director of OMB.
and enforcement across all stakeholders The Regulatory Flexibility Act (5
Expiration of Certification U.S.C. 601–612) requires agencies to
to ensure that the NOP keeps pace with
In this proposed rule, AMS proposes the rapid growth and better serves the consider the economic impact of each
requiring expiration dates on organic industry. rule on small entities and evaluate
certificates (without the expiration date alternatives that would accomplish the
affecting the status of an operation’s IV. Statutory and Regulatory Authority objectives of the rule without unduly
certification). AMS also considered A. Summary of Economic Analyses burdening small entities or erecting
proposing expiration of certification, in barriers that would restrict their ability
which an operation’s certification This rule is regulatory meets the to compete in the market.
would expire on an annual basis if the definition of a significant regulatory AMS proposes amending several
operation did not submit fees and action under Executive Order 12866, portions of the USDA organic
update its certificate of organic therefore triggering the requirements set regulations (7 CFR part 205) to
operation. Expiration of certification forth in Executive Order 13771. The strengthen oversight and enforcement of
would fundamentally shift the current Executive Order 13771 value is $7.3 the production, handling, sale, and
process of certification, which allows million, discounted at 7 percent, marketing of organic agricultural
organic certification to continue until annualized over a 15-year time horizon. products in the United States. Parts of
certification is surrendered, suspended, The impact of benefits are likely to the current regulations lack
or revoked. Although AMS has decided result in a rule that would have an requirements for traceability and
not to include annual expiration of annual effect of $100 million or more on oversight throughout the organic supply
certification in this proposed rule, AMS the economy. See Office of Management chain. This creates vulnerabilities for
seeks comment on the following and Budget’s (OMB) Memorandum fraud in the organic market and
questions: titled ‘‘Interim Guidance Implementing inconsistent certification practices to
1. How might annual expiration of Section 2 of the Executive Order of mitigate that risk. The proposed
certification improve organic integrity? January 30, 2017, titled ‘Reducing amendments would reduce the types of
2. What are the limitations of Regulation and Controlling Regulatory operations exempt from organic
requiring expiration of certification? Costs’ ’’ (February 2, 2017).61 certification (e.g., brokers, traders,
3. What minimum requirements must importers, and exporters); require the
be met before renewing certification? Executive Orders 12866, 13563, and mandatory use of NOP Import
4. Could an operation with 13771 control regulatory review.62 63 Certificates for all shipments of organic
unresolved adverse actions renew Executive Orders 12866 and 13563 products imported to the United States;
certification? direct agencies to assess all costs and and clarify recordkeeping and fraud
5. Would a grace period be benefits of available regulatory prevention procedures. Additional
appropriate for operations that failed to alternatives, and, if regulation is amendments would further clarify
renew by the expiration date? If so, what necessary, to select regulatory organic labeling, accreditation, and
length grace period would be approaches that maximize net benefits certification requirements. Collectively,
appropriate? (including potential economic, these proposed amendments would
6. What process should exist for an environmental, public health and safety address gaps in the organic standards to
operation to regain organic certification effects, distributive impacts, and deter organic fraud and create a level
should it allow its certification to equity). Executive Order 13563 playing field for farms and businesses.
expire? emphasizes the importance of This will assure consumers and
7. Should certifying agents notify quantifying both costs and benefits, stakeholders that organic products meet
certified operations of their upcoming reducing costs, harmonizing rules, and a robust, consistent standard, and
expiration of certification? reinforce the value of the organic label.
60 https://www.whitehouse.gov/wp-content/
Fees to AMS and Oversight of Certifying The new and modified organic
uploads/2017/11/Circular-025.pdf.
Agents’ Fees 61 Interim Guidance Implementing Section 2 of
standards in this proposed rule would
the Executive Order of January 30, 2017, titled affect: Certifying agents; certified
Since the final rule establishing the ‘Reducing Regulation and Controlling Regulatory operations (farms, processers, and
National Organic Program (NOP) was Costs’: https://www.whitehouse.gov/sites/ handlers); and operations that are
first published in the Federal Register whitehouse.gov/files/briefing-room/presidential- currently excluded or exempt from
in 2000, the production, marketing, and actions/related-omb-material/eo_iterim_guidance_
reducing_regulations_controlling_regulatory_ organic certification (e.g., brokers,
sale of organic foods has undergone
costs.pdf. traders, importers, exporters).

tremendous growth. The proposed rule 62 Executive Order 12866, Regulatory Planning The costs associated with this
is intended to strengthen enforcement of and Review, September 30, 1993: https:// proposed rule are primarily due to new
the USDA organic regulations through www.reginfo.gov/public/jsp/Utilities/EO_12866.pdf.
or additional reporting and
63 Executive Order 13771, Reducing Regulation
many actions, including strengthened recordkeeping (paperwork) activities. In
and Controlling Regulatory Costs, January 30, 2017:
certification processes and coverage of https://www.whitehouse.gov/presidential-actions/
importers, brokers, and traders of presidential-executive-order-reducing-regulation- 64 https://www.federalregister.gov/executive-
organic products. Section 2107 (a)(10) of controlling-regulatory-costs/. order/13563.
addition, there is some cost associated submitted to, and approved by, the Title: National Organic Program.
with currently excluded and exempt Secretary as meeting the requirements of OMB Control Number: 0581–NEW.
operations becoming certified to handle the OFPA. Expiration Date of Approval: 3 years
organic products. AMS estimated the Pursuant to § 6507(b)(2) of the OFPA, from OMB date of approval.
benefits of this proposed rule by a state organic certification program that Type of Request: New collection.
quantifying the organic fraud that will has been approved by the Secretary
be prevented by implementation of the Abstract
may, under certain circumstances,
proposed rule; the potential benefits are contain additional requirements for the Information collection and
expected to outweigh the estimated production and handling of agricultural recordkeeping are necessary to
costs. Total costs and benefits of the products organically produced in the implement reporting and recordkeeping
proposed rule are summarized in Table state and for the certification of organic necessitated by amendments to §§ 205.2,
1 in the Executive Summary of this farm and handling operations located 205.100, 205.101, 205.103, 205.201,
document. within the state. Such additional 205.273, 205.300–205.302, 205.307,
AMS also performed additional requirements must (a) further the 205.310, 205.400, 205.403–205.404,
analysis to determine the proposed purposes of the OFPA, (b) not be 205.406, 205.500–501, 205.504, 205.511,
rule’s impact to small businesses. This inconsistent with the OFPA, (c) not be 205.660–205.663, 205.665, 205.680, and
analysis revealed that small businesses discriminatory toward agricultural 205.681 of the USDA organic
producing, selling, handling, and commodities organically produced in regulations to protect organic product
marketing organic products would not other States, and (d) not be effective integrity and build consumer and
be adversely affected by the until approved by the Secretary. industry trust in the USDA organic
amendments proposed in this rule. AMS label. The proposed rule would
In addition, pursuant to § 6519(c)(6)
expects that most of the entities affected strengthen organic control systems,
by this proposed rule are small of the OFPA, this final rule does not
supersede or alter the authority of the improve organic import oversight,
businesses as defined by Small Business clarify organic certification standards,
Administration criteria. For each Secretary under the Federal Meat
Inspection Act (21 U.S.C. 601–624), the and enhance farm to market traceability,
category of affected entity (certifying using a risk-based approach to oversight
agents, certified operations, and exempt Poultry Products Inspection Act (21
U.S.C. 451–471), or the Egg Products to assure consumers that organically
or excluded operations that need to produced products meet a consistent
become certified), AMS estimates that Inspection Act (21 U.S.C. 1031–1056),
concerning meat, poultry, and egg standard.
the costs of the proposed rule for each
products, respectively, nor any of the This proposed rule would amend
business type would be less than 1
authorities of the Secretary of Health several sections of the USDA organic
percent of the annual revenue.
A full economic analysis of this and Human Services under the Federal regulations, 7 CFR part 205, to
proposed rule is available at https:// Food, Drug and Cosmetic Act (21 U.S.C. strengthen the NOP’s ability to oversee
www.regulations.gov/. AMS invites the 301 et seq.), nor the authority of the and enforce the production, handling,
public to comment on the economic Administrator of the Environmental marketing, and sale of organic
analysis. You may submit comments on Protection Agency under the Federal agricultural products as established by
this proposed rule and economic Insecticide, Fungicide and Rodenticide the OFPA. This proposed rule would
analysis to the Federal eRulemaking Act (7 U.S.C. 136 et seq.). improve organic integrity throughout
Portal at https://www.regulations.gov/. the organic supply chain and benefit
C. Paperwork Reduction Act stakeholders at all levels of the organic
You can access this proposed rule,
economic analysis, and instructions for In accordance with the Paperwork industry. The proposed amendments
submitting public comments by Reduction Act of 1995 (44 U.S.C. 3501– would close gaps in the current
searching for document number AMS– 3520) (PRA), AMS is requesting OMB regulations to build consistent
NOP–17–0065. approval for a new information certification practices, deter organic
collection totaling 275,417 hours for the fraud, and improve transparency and
B. Executive Order 12988 reporting and recordkeeping product traceability. The NOP identified
Executive Order 12988 instructs each requirements contained in this proposed the need for many of the proposed
executive agency to adhere to certain rule. OMB previously approved amendments as part of its direct
requirements in the development of new information collection requirements experience in administering this
and revised regulations in order to avoid associated with the NOP and assigned program, particularly via complaint
unduly burdening the court system. OMB control number 0581–0191. AMS investigation and audits of certifying
This proposed rule is not intended to intends to merge this new information agents. Other proposed amendments are
have a retroactive effect. To prevent collection, upon OMB approval, into the based on recent amendments to the
duplicative regulation, states and local approved 0581–0191 collection. Below, OFPA included in the Agriculture
jurisdictions are preempted under the AMS has described and estimated the Improvement Act of 2018; 66 the
OFPA from creating programs of annual burden, i.e., the amount of time recommendations of a 2017 Office of
accreditation for private persons or state and cost of labor, for entities to prepare Inspector General audit; 67 the
officials who want to become certifying and maintain information to participate
agents of organic farms or handling in this proposed voluntary labeling view.xhtml?path=/prelim@title7/
operations. A governing state official program. The Organic Foods Production chapter94&edition=prelim.
66 The Agriculture Improvement Act of 2018
would have to apply to USDA to be Act of 1990 (OFPA), as amended,
(Public Law No: 115–334), commonly known as the

accredited as a certifying agent, as provides authority for this action.65 ‘‘2018 farm bill,’’ is available at https://
described in section 6514(b) of the www.congress.gov/115/plaws/publ334/PLAW-
OFPA. States are also preempted under 65 The Organic Foods Production Act of 1990, 7 115publ334.pdf. Organic certification is discussed
§§ 6503 through 6507 of the OFPA from U.S.C. 6501–6524, is the statute from which the in Title X, Section 10104.
Agricultural Marketing Service derives authority to 67 The National Organic Program International
creating certification programs to certify administer the NOP, and authority to amend the Trade Arrangements and Agreements Audit Report
organic farms or handling operations regulations as described in this proposed rule. This 01601–0001–21, September 2017: https://
unless the state programs have been document is available at: https://uscode.house.gov/ www.usda.gov/oig/webdocs/01601-0001-21.pdf.
recommendations of the federal equivalent data source.70 The NOP not add to current paperwork impacts
advisory committee to the NOP, the Import Certificate contains specific for grower group operations to prepare
National Organic Standards Board information about the quantity and an OSP and maintain their certification,
(NOSB); and industry stakeholder source of a specific physical shipment or for certifying agents and inspectors
feedback. of imported organic products. NOP auditing and inspecting these operations
This proposed rule will strengthen Import Certificates are currently used for compliance with organic standards
enforcement with amendments to the for organic products imported from (§§ 204.400 and 204.403).
USDA organic regulations and will countries with which the NOP holds 6. Requires certifying agents to create
modify the reporting and recordkeeping equivalency arrangements. This fraud prevention procedures to: (1)
burdens as summarized below. proposed rule would expand and make Identify high-risk operations, supply
1. Reduces the types of uncertified compulsory the use of NOP Import chains, and agricultural products, (2)
handling operations in the organic Certificates, regardless of an imported conduct risk-based unannounced
supply chain that operate without product’s country of origin. AMS inspections and supply chain trace-back
USDA oversight.68 The proposed estimates that exporters and certifying and mass-balance audits, (3) share
amendments would require certification agents would need 30 minutes to report information with other certifying agents
of operations that facilitate the sale or mandatory data, and prepare and review to verify supply chains and conduct
trade of organic products, including but the NOP Import Certificate, respectively. investigations, and (4) report credible
not limited to, brokers, importers, and AMS estimates that importers would evidence of organic fraud to the USDA.
traders. These handlers would be need an average of one-tenth (0.1) of an AMS estimates each certifying agent
required to obtain organic certification hour, or 6 minutes, to compare the would spend one hour documenting
by developing an organic system plan shipping manifest with the NOP Import these procedures (§§ 205.403, 205.501
(OSP) to describe the practices and Certificate to verify the accuracy and and 205.504).
procedures used in their operations. organic compliance of each shipment 7. Requires that certifying agents
Certifying agents customize the format (§§ 205.273 and 205.300). conduct unannounced inspections on at
of the OSP to cover standards applicable 4. Clarifies that previously optional least 5% of the operations they certify,
to the operations seeking certification. information must now be provided on which is the current recommended
Because traders and brokers do not farm nonretail container labels used to ship practice in NOP Instruction 2609.72 For
or manufacture organic products, the or store organic products. Along with the purposes of estimating paperwork
OSPs for traders and brokers would the production lot number that is impacts, AMS expects that half of the
address fewer sections of the current already required, nonretail labels would unannounced inspections (2.5% of total
rule than OSPs for operations that farm need: (1) The word ‘‘organic’’ to identify inspections) would meet the
or manufacture organic products. the product as organic; and (2) the name requirement for a full annual inspection
Therefore, reporting impacts for traders of the certifying agent that certified the and would not impact current
and brokers are estimated at 40 hours product. These changes would help paperwork burden. The remaining half
for each uncertified handling operation maintain the integrity of organic of the unannounced inspections (2.5%
to prepare its initial OSP. AMS products by reducing misidentification of total inspections) would target high-
estimates a recordkeeping burden of 10 and mishandling, facilitating risk operations and supply chains and
hours annually. The estimated annual traceability through the supply chain, would not count as a full annual
reporting burden for each entity to reducing organic fraud, and allowing inspection. Examples of targeted,
update its OSP in future years is 20 accurate identification of organic limited-scope unannounced inspections
hours (§§ 205.2, 205.100, 205. 101, and product by customs officials and include, but are not limited to, verifying
205.103). transportation agents. AMS estimates livestock on pasture or performing
2. Requires all currently certified that producers and/or processers would targeted mass-balance and trace-back
organic operations and new applicants need one-tenth (0.1) of an hour, or 6 audits. AMS estimates that the
to describe their procedures for minutes, to add the word ‘‘organic’’ and paperwork impacts associated with
monitoring, verifying, and the name of the certifying agent to the these unannounced inspections would
demonstrating the organic status of their labels that are displayed on nonretail average inspectors 5 hours per
suppliers and the products received to containers (§ 205.307). inspection; half of the estimated 10
prevent organic fraud. This information 5. Codifies current practices for the hours for a full annual inspection
would be part of the OSP. AMS certification of groups of crop producers (§ 205.403).
estimates that each currently certified as a single operation.71 The proposed 8. Requires certifying agents to issue
operation and applicant seeking rule describes the criteria to qualify as standardized certificates of organic
certification would need 30 minutes to a grower group, how grower group operation generated from the USDA’s
describe the supply chain verification operations can comply with the existing publicly available Organic Integrity
procedures and monitoring practices USDA organic regulations, and how Database (INTEGRITY).73 This would
proposed by this regulation (§§ 205.103 certifying agents should inspect these require an initial upload of mandatory
and 205.201). operations. It also sets a risk-based data for each operation and
3. Requires that each shipment of benchmark to determine how many maintenance, at least annually, to
organic products imported into the grower group members in an operation ensure that data in INTEGRITY are
United States through U.S. Ports of need to be inspected annually. AMS current and accurate. Currently, all
Entry must be declared as organic to expects that these requirements would certifying agents have voluntarily
U.S. Customs and Border Protection uploaded and maintain 50% or more
(CBP) and associated with an NOP 70 Mandated by The Organic Foods Production
Import Certificate (NOP 2110–1) 69 or an Act of 1990 (OFPA), as amended by the Agriculture 72 NOP 2609, Instruction, Unannounced
Improvement Act of 2018. See sections 10104(b)– Inspections. September 12, 2012. Available in the
68 Mandated by the Agriculture Improvement Act (c). NOP Program Handbook: https://
of 2018. See section 10104(a). 71 NOP Policy Memo 11–10, Grower Group www.ams.usda.gov/sites/default/files/media/
69 Office of Management and Budget (OMB)- Certification, October 31, 2011: https:/ 2609.pdf.
approved form NOP 2110–1 NOP Import Certificate: www.ams.usda.gov/sites/default/files/media/NOP- 73 Organic Integrity Database: https://
https://www.ams.usda.gov/resources/nop-2110-1. 11-10-GroupGrowerCert.pdf. organic.ams.usda.gov/integrity/.
data on all certified operations per the evaluators meet knowledge, skills, and period and would result in new periodic
recommendations found in the NOP’s experience qualifications. AMS paperwork impacts for foreign
Data Quality Best Practices.74 The estimates that each certifying agent governments. AMS estimates the
proposed amendments would require a would spend 60 minutes to draft paperwork impacts for foreign
new, one-time burden of reporting hours policies and procedures for conducting governments when USDA reviews the
for certifying agents to upload inspector field evaluations. Further, applicable trade arrangement to be 60
remaining data pertaining to currently certifying agents must observe an hours per year, which is comparable to
certified operations into INTEGRITY for inspector performing an on-site the estimated paperwork impacts for
the first time. It is estimated that inspection at least once every three AMS audits of certifying agents
uploading these data into INTEGRITY years. AMS estimates each certifying (§ 205.511).
would require 30 minutes for each agent would conduct an average of four
inspector field evaluations per year and Respondents
operation and would be performed by
administrative support personnel who that this activity would require 7.5 AMS has identified four primary
have a lower wage rate than review and hours per evaluation (§§ 205.2 and types of entities (respondents) that
compliance staff. 205.501). would need to submit and maintain
The proposed amendments would 12. Requires inspectors and information as a result of this proposed
simultaneously eliminate the certification review staff to complete an rule: Certified organic operations;
requirement to physically mail the additional 10 hours of training accredited certifying agents; organic
Administrator or State Organic Program annually.75 Through two audits every 5 inspectors; and foreign governments.
paper copies of: (1) The list of years, AMS estimates that inspectors Three respondent types—certified
operations certified annually; (2) and certification review staff currently operations (producers and handlers),
notifications of proposed adverse receive at least 10 hours of training per certifying agents, and inspectors—have
actions, approvals, or denials of year from certifying agents on topics been identified in a currently approved
corrective actions; and (3) notifications related to the USDA organic regulations. information collection (0581–0191). To
of executions of adverse actions Inspectors and certification review implement a 2018 Farm Bill mandate,
regarding certified operations or personnel play a crucial role in AMS is requiring certification of
operations applying for certification determining whether an operation is additional types of operations in the
(§§ 205.404 and 205.501). AMS is not granted organic certification initially organic supply chain and regular audits
seeking to modify the estimate of and whether certified operations are of trade arrangements with foreign
paperwork burden associated with these compliant with the USDA organic governments.77 This adds new types of
changes in requirements because any regulations. Certification review handlers as a subcategory of certified
change would be trivial and these personnel may also serve as inspectors. operations and foreign governments as a
activities and tasks are still occurring AMS is proposing an additional 10 new type of respondent.
electronically as a part of maintaining hours of training annually, calculated as To more precisely understand the
the data on all operations over time. two (2) five-hour trainings. Training paperwork impacts of this proposed
9. Requires certifying agents to submit offered by the NOP through its new rule, AMS has divided the categories of
their decision criteria for acceptance of online Organic Integrity Learning Center respondents into domestic and foreign,
mediation, and a process for identifying (OILC) and training provided by the as appropriate, to show the potential
personnel conducting mediation and certifying agents or other providers may impacts on domestic-based versus
setting up mediation sessions with its qualify towards the total of 20 hours of foreign-based USDA-accredited
administrative policies and procedures required training (§§ 205.2 and 205.501). certifying agents, inspectors, and
provided in § 205.504(b). AMS estimates 13. Clarifies AMS responsibilities for certified operations, along with foreign-
each certifying agent would spend one equivalent organic conformity with accredited certifying agents, and
hour documenting these procedures that foreign governments.76 The OFPA at foreign- governments serving as
they are already implementing. § 6505(b), and the current USDA organic accrediting bodies. For each type of
10. Clarifies how certified operations regulations at § 205.500(c), provide the respondent, we describe the general
may submit annual updates to their authority to establish organic paperwork submission and
OSP. This includes practices or equivalency. The proposed regulations recordkeeping activities and estimate:
procedures that have changed since describe the criteria, scope, and other (1) The number of respondents; (2) the
their last approved OSP, rather than parameters for ongoing peer review hours they spend, annually, creating
submitting an OSP in its entirety. This audits of foreign organic conformity and storing records to meet the
would reduce unnecessary paperwork systems to determine whether the USDA paperwork requirements of the organic
without compromising oversight should continue, revise, or terminate labeling program; and (3) the costs of
because operations would continue to such trade arrangements. These peer those activities based on prevailing
maintain an OSP that accurately reflects review audits of trade arrangements domestic and foreign wages and
current practices and procedures of the would occur twice within a five-year benefits.
operation. This codifies current policy 1. Certifying agents. Certifying agents
and does not modify the paperwork 75 Ten hours of training are accounted for in the
are State, private, or foreign entities
burden (§ 205.406). 2020 Information Collections Renewal for the NOP
(AMS–NOP–19–0090; OMB Control Number: 0581–
accredited by the USDA, or by
11. Requires certifying agents to 0191). Our internal onsite accreditation audit accreditation bodies of foreign
establish inspection oversight checklist used by our accreditation audit team governments with whom USDA has
procedures and demonstrate that they includes a question on training. With the equivalency, to certify domestic and
are sufficiently staffed with qualified implementation of this rule, the specific hours of
training offered by our 78 certifying agents will be
foreign producers and handlers as
personnel and that all inspectors, documented. organic in accordance with the OFPA
certification reviewers, and in-field 76 Currently, the United States has established
organic trade arrangements with Canada, the 77 See Section 10104(a) of the Agriculture
74 Data
Quality Best Practices: https:// European Union, the United Kingdom (effective Improvement Act of 2018, Public Law No: 115–334,
www.ams.usda.gov/sites/default/files/media/ January 2021), India, Israel, Japan, New Zealand, available at: https://www.congress.gov/115/plaws/
INTEGRITY%20Data%20Quality.pdf. South Korea, Taiwan, and Switzerland. publ334/PLAW-115publ334.pdf.
and the USDA organic regulations. documents regarding imports during the Certifying Agents). AMS estimates the
Certifying agents determine whether a accreditation audits of USDA-accredited annual collection cost per domestic-
producer or handler meets the organic certifying agents. AMS estimates 30 based USDA-accredited certifying
requirements, using detailed minutes for: (1) USDA-accredited agents would be $12,788.95.82 This cost
information from the operation about its domestic-based certifying agents to is based on an estimated 123.36 labor
specific practices and on-site inspection work with their foreign-based hours per certifying agent per year for
reports from organic inspectors. operations to prepare the NOP Import staff with certification review
Currently, there are 78 USDA-accredited Certificate (Form NOP 2110–1) for 8% responsibilities at $45.91 per labor hour,
certifying agents (46 are based in the of 67,023 annual shipments; (2) USDA- including 31.7% benefits, for a total
United States and 32 are headquartered accredited foreign-based certifying
salary component of $5,663.55 per
in foreign countries). Both domestic- agents to work with their foreign-based
year.83 The estimated cost for domestic
and foreign-based USDA-accredited operations to prepare the NOP Import
certifying agents certify operations Certificate for 46% of 67,023 annual certifying agents also includes 300.24
based in the United States and abroad. shipments; and (3) foreign-accredited labor hours per certifying agent per year
AMS assumes all currently accredited certifying agents to work with their for administrative support staff to
certifying agents evaluate all types of foreign-based operations to prepare the upload data about certified operations to
production and handling operations for NOP Import Certificate for 46% of INTEGRITY at $23.73 per labor hour,
compliance with the USDA organic 67,023 annual shipments. including 31.7% benefits, for a total
regulations and would be subject to the AMS is proposing amendments that salary component of $7,125.40 per
reporting and recordkeeping burdens of would reduce the current paperwork year.84
the proposed amendments. In addition, burden of accredited certifying agents In addition, AMS estimates the
AMS assumes there are 32 foreign by eliminating the need to provide annual collection cost for all domestic-
government-accredited foreign-based notices of approval or denial of based USDA-accredited certifying
certifying agents that certify handlers to certification to the Administrator
agents would be $589,458.85. This cost
the USDA organic regulations and that following the issuance of a notice of
is based on a total of 5,720.60 hours for
would issue NOP Import Certificates, or noncompliance or adverse action to an
applicant for certification. Also, the all staff with certification review
their equivalent, for organic product
shipments to the United States.78 proposed rule removes the annual responsibilities at $45.91 per labor hour,
Certifying agents of operations that requirement for certifying agents to including 31.1% benefits, for a total
export to the United States would need submit by January 2 an annual list of salary component of $262,636.29 for all
to issue import certificates for all operations certified. Certifying agents staff with certification review and
shipments of imported organic would instead be required to update procedure writing responsibilities of all
products. The USDA Foreign data in INTEGRITY for each operation domestic-based USDA-accredited
Agricultural Service (FAS) Global they certify. AMS is not seeking to certifying agents. The estimated cost for
Agricultural Trade System (GATS) modify the estimate of paperwork all domestic-based certifying agents also
showed 67,023 shipments of organic burden with these changes in includes 13,771.19 hours total hours for
product coming into the U.S. in 2017.79 requirements because any change would administrative support staff uploading
Thirty-two (32) USDA-accredited be trivial. These activities and tasks are data about certified operations to
certifying agents based in foreign still occurring electronically as a part of INTEGRITY at $23.73 per labor hour,
countries certify 92% of the foreign maintaining the data on all operations including 31.7% benefits for a total
operations certified under USDA over time. In addition, all USDA- salary component of $326,822.56.
organic standards. Of the 46 domestic- accredited certifying agents would need
based USDA accredited certifying to write procedures to identify high-risk
agents, 16 certifying agents certify 8% of operations and products they certify and 82 In this assessment, all domestic labor rates are
the foreign operations certified under procedures to conduct supply-chain sourced from the U.S. Bureau of Labor Statistics
USDA.80 This means that 30 domestic- audits of those high-risk products. National Compensation Survey, Occupational
Employment and Wages, May 2018: https://
based USDA-accredited certify agents Certifying agents would also be required www.bls.gov/oes/current/oes_nat.htm. Domestic
only certify domestic-based operations to issue organic certificates generated by benefits are based on a Bureau of Labor Statistics
that do not import foreign organic INTEGRITY. Certifying agents would be News Release on Employer Costs for Employee
products or ingredients. AMS estimates required to write procedures to Compensation, which states that benefits account
for 31.7% of total average employer compensation
32 foreign-accredited certifying agents demonstrate how they are sufficiently
costs. December 14, 2018: https://www.bls.gov/
that certify foreign operations under staffed and that all persons who perform news.release/ecec.nr0.htm.
trade agreements.81 AMS would review certification review activities and on- 83 The labor rate for certification review staff is
site inspections (inspectors) are based on Occupational Employment Statistics

78 An estimate based on the number of foreign-
qualified and complying with annual group 13–1041, Compliance Officers. Compliance
based USDA accredited certifying agents. training requirements increased from 10 officers examine, evaluate, and investigate
79 Data source: USDA Foreign Agricultural eligibility for or conformity with laws and
Service (FAS) Global Agricultural Trade System
hours to 20 hours per year. Certifying regulations governing contract compliance of
(GATS). Select: Partners, World Total, Product agents would also be required to write licenses and permits, and perform other compliance
Type, Imports—General, Products: All Aggregates; mediation procedures as per and enforcement inspection and analysis activities
Product Groups: Organic—Selected: https:// § 205.504(b). not classified elsewhere.
apps.fas.usda.gov/gats/default.aspx. 84 The labor rate for administrative support staff
80 Organic Integrity Database: https://
AMS projects that the proposed
is based on Occupational Employment Statistics
changes would increase the overall
organic.ams.usda.gov/integrity/. group 43–9199, Office and Administrative Support

81 An estimate based on the number of foreign- reporting and recordkeeping burden for Workers, who support general office work and data
based USDA-accredited certifying agents. certifying agents (See Summary Table 1: entry functions.
SUMMARY TABLE 1—CERTIFYING AGENTS

Cost/
Number of Wages + Hours per
Respondent categories respondent Total all hours Total all costs
respondents benefits respondent type
U.S.-Based USDA Certifying Agents ....... 46 $45.91 124.36 $5,709.37 5,720.60 $262,636.29
U.S.-Based USDA Certifying Agents—
data entry ............................................. 46 23.73 300.24 7,124.70 13,771.19 326,822.56
Subtotal U.S.-Based USDA Certi-

fying Agents .................................. 46 ........................ ........................ 12,834.06 19,491.79 589,458.85
Foreign-Based USDA Certifying Agents .. 32 24.59 547.74 13,468.93 17,527.63 430,181.78

Foreign-Based USDA Certifying
Agents—data entry ............................... 32 12.71 300.24 3,816.05 9,569.81 121,633.35
Subtotal Foreign-Based USDA Certi-

fying Agents .................................. 32 ........................ ........................ 17,286.98 27,097.44 551,815.13
Total USDA-Accredited Certifying Agents 78 ........................ ........................ 30,119.04 46,589.23 1,141,273.98

Foreign-Accredited Certifying Agents ...... 32 24.59 481.73 11,844.69 15,415.29 379,030.04
Total All Certifying Agents ................ 110 ........................ ........................ ........................ 62,004.52 1,520,304.02
For foreign-based USDA-accredited administrative support staff uploading independent contractors or employees
certifying agents, AMS estimates the data about certified operations to of certifying agents. Certified operations
annual cost per certifying agent would INTEGRITY at $12.71 per labor hour, must be inspected annually, and a
be $17,527.63 per year. This cost is including 35.92% benefits, for a total certifying agent may call for additional
based on an estimated 547.74 labor salary component of $121,633.35. inspections or unannounced inspections
hours for staff with certification review For foreign-accredited certifying on an as-needed basis (§ 205.403(a)).
and procedure writing responsibilities agents, AMS estimates the annual cost Any individuals who apply to conduct
at $24.59 per labor hour, including will be $11,844.69 per certifying agent. inspections of operations would need to
35.92% benefits, for a total salary This cost is based on an estimated submit information documenting their
component of $13,468.93 per foreign- 481.73 labor hours per year for staff to qualifications to the certifying agent
based USDA-accredited certifying agent issue and review NOP Import (§ 205.504(a)(3)). Inspectors must also
per year. These estimated costs Certificates, or an equivalent data complete 20 hours of standardized
primarily pertain to the issuance and source, at $24.59 per labor hour plus organic training every year. AMS
review of NOP Import Certificates. The 35.92% benefits. The total for all estimates that 10 hours per year for each
estimated cost for foreign-based USDA- foreign-accredited certifying agents is inspector is a new paperwork burden
accredited certifying agents also estimated to be $379,030.04. The cost is associated with the proposed rule.
includes 300.24 labor hours per based on an estimated 15,415.29 total
certifying agent per year for hours for all staff involved in the Inspectors provide an inspection
administrative support staff to upload issuance and review of NOP Import report to the certifying agent for each
data about certified operations to Certificates, or an equivalent data operation inspected (§ 205.403(e)) but
INTEGRITY at $12.71 per labor hour, source, at $24.59 per labor hour plus are not expected to store the record.
including 35.92% benefits, for a total 35.92% benefits. Currently, AMS estimates that
salary component of $3,816.08 per The total cost for all certifying agents inspectors spend 10 hours on average to
year.85 as a whole includes all costs for all 78 complete an inspection report for a full
AMS estimates the annual collection USDA-accredited certifying agents, annual inspection of an organic
cost for all foreign-based USDA domestic- and foreign-based, and all operation. The additional unannounced
accredited certifying agents would total costs for the 32 foreign-accredited inspections that would be newly
$551,815.13. This cost is based on a certifying agents who certify operations required by this proposed rule are likely
total of 17,527.63 hours for all staff with that export products to the U.S. The to be more limited in scope (such as
certification review responsibilities at total costs for all certifying agents is pasture or dairy surveillance, or mass-
$24.59 per labor hour, including 35.92% $1,520,304.02. This cost is based on balance and trace-back audits). AMS
benefits, for a total salary component of 62,004.52 total hours at their respective projects, on average, that inspectors
$430,181.78 for staff with certification wage rates and benefits to comply with would spend 5 hours to complete an
review and procedure writing the proposed requirements. inspection report for the unannounced
responsibilities of all foreign-based 2. Organic Inspectors. Inspectors targeted scope inspection. AMS
USDA-accredited certifying agents. The conduct on-site inspections of certified Inspectors do not have recordkeeping
estimated cost for all foreign-based operations and operations applying for obligations; certifying agents maintain
USDA-accredited certifying agents also certification and report the findings to the records of inspection reports (see
includes 9,569.81 hours total hours for the certifying agent. Inspectors may be Summary Table 2: Inspectors).
85 In this assessment, all foreign labor rates are https://data.worldbank.org/indicator/ compensation in foreign countries with USDA-
based on a review of World Bank data, which NY.GDP.PCAP.PP.CD. Benefits are based on a accredited certifying agents: https://stats.oecd.org/
indicates that labor rates in foreign countries with review of data from the Organisation for Economic Index.aspx?DataSetCode=AWCOMP.
USDA-accredited certifying agents are Co-Operation and Development (OECD), which
approximately 52% of equivalent U.S. labor rates: indicates that benefits account for 35.92% of total
SUMMARY TABLE 2—INSPECTORS

Cost per
Number of Wages + Hours per
USDA U.S.-based Inspectors .................. 148 $28.45 33.34 $948.43 4917.80 $139,897.57
USDA Foreign-based inspectors ............. 102 15.27 33.34 508.99 3417.45 52,172.66
All USDA Inspectors ......................... 250 ........................ ........................ ........................ 8335.25 192,070.23
According to the International costs for inspectors. The total annual organic products so the OSPs for traders
Organic Inspectors Association (IOIA), cost for all foreign-based inspectors is and brokers would address fewer
there are approximately 250 inspectors $52,172.66 at $15.27 per labor hour, sections of the current rule than OSPs
currently inspecting crop, livestock, including 35.92% benefits. The total for operations that produce or
handling, and/or wild crop operations annual cost for all inspectors working manufacture organic products.
that are certified or have applied for for USDA-accredited certifying agents is Certifying agents customize the format
certification. AMS estimates that 148 $192,070.23, at their respective wage of the OSP to cover standards applicable
inspectors are working for USDA- rates and benefits. to the operations seeking certification.
accredited certifying agents in the U.S. 3. Producers and handlers. Domestic Therefore, AMS estimates that
For the additional training and and foreign producers and handlers preparation of an initial OSP would
unannounced targeted-scope seeking organic certification must require 40 reporting hours, plus 10
inspections, AMS estimates the annual submit an OSP that details the practices hours of annual recordkeeping. The
paperwork impact cost per domestic- and activities specific to their operation. estimated annual reporting burden for
based inspector to be $948.43. This is Once certified, operations are required each entity to update its OSP in future
based on an estimated 33.34 labor hours to update any changes in their operation years is 20 hours (See Summary Table
per year at $28.45 per labor hour, or practices to their certifying agent at 3a: Uncertified Handlers).
including 31.7% benefits. The total least annually. All operations that export organic
annual cost for all domestic-based (a) Uncertified Handlers. This products to the United States would
inspectors is $139,897.57. This cost is proposed rule would require that need to request an NOP Import
based on 3,417 total hours for all operations that facilitate the sale or Certificate, or its equivalent, from their
domestic based inspectors at $28.45 per trade of organic products—including, certifying agent for each organic
labor hour, including 31.7% benefits.86 but not limited to, brokers, importers, shipment imported to the United States.
AMS estimates that 102 inspectors are and traders—obtain certification and Further, operations that import organic
working for USDA-accredited certifying submit and maintain an OSP. AMS products would need to verify that each
agents in foreign countries. AMS estimates that 961 domestic,87 and an shipment is associated with and
estimates the annual paperwork impact equal number of foreign-based, matches the data on an NOP Import
cost per foreign-based inspector to be operations would need to become Certificate, and that organic integrity
$508.99. This estimate is based on an certified as a result of this rule. As was maintained throughout the import
estimated 33.34 labor hours per year at stated previously, the OSPs for these process. In addition, domestic and
$15.27 labor hour, including 35.92% handling operations would address foreign handlers that would be required
benefits for attending 10 hours of fewer sections of the current rule than to obtain organic certification as a result
training and conducting 4.67 OSPs for operations that farm or of this proposed rule may also need to
unannounced targeted scope manufacture organic products. Traders comply with the proposed requirements
inspections. There are no recordkeeping and brokers do not farm or manufacture for labeling nonretail containers.
SUMMARY TABLE 3a—UNCERTIFIED HANDLERS

Total cost per
Number of Wages + Total hours per
Formerly Excluded Handlers—Domestic 961 $50.86 56.97 $2,897.49 54,752.30 $2,784,701.98

Formerly Excluded Handlers—Foreign .. 961 27.13 84.87 2,302.56 81,561.50 2,212,763.50
All Formerly Uncertified Handlers ... 1,922 ........................ .......................... ........................ 136,313.80 4,997,465.47
AMS estimates the annual paperwork and to verify that imported shipments on an estimated 56.97 labor hours at
impact for each domestic handler to match their respective NOP Import $50.86 per labor hour, including 31.7%
prepare their initial organic system plan Certificates is $2,897.71. This is based benefits. The total cost to all previously
86 The labor rate for inspectors is based on 87 These businesses are identified by NAICS Please refer to the ‘‘Applicability and Exemptions
Occupational Employment Statistics group 45– Category 425: Wholesale Electronic Markets and from Certification (§§ 205.100–101)’’ chapter in the
2011, Agricultural Inspectors. Agricultural Agents and Brokers. These businesses arrange for Regulatory Impact Analysis (RIA) for an
inspectors inspect agricultural commodities, the sale of goods owned by others, generally on a explanation of how previously excluded domestic
processing equipment, facilities, and fish and fee or commission basis. They act on behalf of the
handlers were estimated.
logging operations to ensure compliance with buyers and sellers of goods. This subsector contains
regulations and laws governing health, quality, and agents and brokers as well as business-to-business
safety. electronic markets that facilitate wholesale trade.
uncertified domestic handlers is domestic and foreign, is $4,997,465.47, operations based in foreign countries,
$2,784,701.98. This cost is based on based on 136,313.80 total labor hours at including the respective applicants for
55,752.30 total labor hours at $50.86 per their respective domestic and foreign certification, will be impacted by this
labor hour, including 31.7% benefits.88 wage rates and benefits to prepare and proposed rule.
AMS estimates the annual paperwork keep their initial OSP and related All currently certified organic
impact for each foreign-based handler to records, and to prepare and review NOP operations and projected new applicants
prepare their initial organic system plan Import Certificates for compliance. would need to describe their procedures
and to work with their certifying agent (b) Certified Operations and New for monitoring, verifying and
to prepare their NOP Import Certificates Applicants under Current Rules. There demonstrating the organic status of their
for the products they export is currently are 42,259 organic operations suppliers and products received to
$2,302.56. This is based on an estimated worldwide that are certified to the prevent organic fraud as part of their
84.87 labor hours per year at $27.13 per USDA organic standards. Over the next initial or updated OSP. All certified
labor hour, which includes 35.92% for 12 months, AMS expects 2,501 organic operations would need to
benefits. The total cost to all previously operations will seek organic comply with the proposed nonretail
uncertified foreign handlers is certification, based on the 5.9% rate of labeling requirements, and would be
$2,784,701.98. This cost is based on growth in number of operations required to keep all records about their
55,752.30 total labor hours at $27.13 per observed in the last 12 months under organic production and/or handling for
labor hour, which includes 35.92% for current rules.89 Therefore, AMS five years (§ 205.103(b)(3)). See
benefits. Total costs to the 1922 estimates that 26,408 operations based Summary Table 3b: Certified Organic
previously uncertified handlers, in the United States, and 18,352 Operations and New Applicants.
SUMMARY TABLE 3b—CERTIFIED ORGANIC OPERATIONS AND NEW APPLICANTS

Total cost/
Number of Wages + Total hours/
Certified Producers & Handlers—New

and Existing Domestic .......................... 26,408 $50.86 1.54 $78.33 47,815.50 $2,432,017.86
Certified Producers & Handlers—New
and Existing Foreign ............................ 18,352 27.13 1.54 41.78 20,466.00 555,242.58
All New and Existing Producers &

Handlers ........................................ 44,760 ........................ ........................ ........................ 68,281.50 2,987,260.44
AMS estimates that the average based on 20,446 labor hours year at AMS determines that the technical
annual paperwork impact for domestic $27.13 per labor hour, including 35.92% requirements and conformity
certified organic producers and handlers benefits. The total cost for the 44,760 assessment system under which foreign
to create a fraud prevention procedure current certified organic and projected products labeled as organic are
and to comply with nonretail labeling new producers and handlers under produced and handled are at least
requirements is $78.33. This is based on current rules, both domestic and equivalent to the requirements of the
an estimated 1.54 labor hours at $50.86 foreign, is $2,987,260. This cost is based OFPA and the USDA organic
per labor hour, including 31.7% on 68,281.50 labor hours at their regulations. The proposed rule would
benefits. The total cost for all domestic respective domestic and foreign wages also require periodic assessment.
certified organic producers and handlers and benefits, to create their new fraud AMS expects these periodic peer
to comply with these new requirements prevention procedures and comply with review assessments would be similar in
is $2,432,017.86. This cost is based on new nonretail label requirements. depth and frequency to the audits of
47,815.50 labor hours at $50.86 per 4. Foreign Governments. The USDA accrediting certifying agents under
labor hour, including 31.7% benefits.90 has arrangements with 10 foreign USDA organic regulations and estimates
AMS estimates the average annual governments to facilitate the a comparable level of reporting and
paperwork impact for foreign-based international trade of organic recordkeeping burden by foreign
USDA-certified organic producers and products.91 The current regulations governments with whom AMS has
handers to create a fraud prevention address this authority in general terms negotiated trade arrangements. AMS
procedure and to comply with nonretail under § 205.500(c) but do not describe estimates the annual collection cost per
labeling requirements to be $41.78. This the criteria, scope, and other parameters foreign government would be $1,721.15.
is based on an estimated 1.54 labor to establish, oversee, or terminate such This cost is based on an estimated 60
hours per year at $27.13 per labor hour, arrangements. The proposed rule reporting labor hours and an estimated
including 35.92% benefits. The total describes equivalency determinations in 10 hours of recordkeeping per foreign
cost for all foreign producers and more detail; this creates a new type of government per year at $24.59 per labor
handlers certified to the USDA organic PRA respondent category. The proposed hour, including 35.92% benefits, for a
standards is $555,242.58. This cost is rule would allow a trade arrangement if total salary component of $1,721.15 per
88 For uncertified handlers, AMS chose to use the 90 The labor rate for producers and handlers is Japan, New Zealand, South Korea, Taiwan, and
same labor rate as certified producers and handlers: based on Occupational Employment Statistics Switzerland. Taiwan is not included in this
Occupational Employment Statistics group 11– group 11–9013, Farmers, Ranchers, and Other assessment because costs were calculated prior to
9013, Farmers, Ranchers, and Other Agricultural Agricultural Managers, who plan, direct, or May 2020, when the United States-Taiwan
Managers. coordinate the management or operation of farms,
equivalency arrangement became effective.
89 Organic Integrity Database: https:// ranches, or other agricultural establishments.
organic.ams.usda.gov/integrity/. Calculated on 91 Canada, the European Union, the United
April 3, 2019. Kingdom (effective January 2021), India, Israel,
year. The total cost for all foreign Estimated Total Annual Burden on Respondents: Certifying agents,
governments, with whom AMS has Reporting Respondents: 244,927 hours. certified operations, and inspectors.
negotiated trade arrangements, to allow Estimated Total Annual Reporting Estimated Number of Domestic
AMS to determine whether their foreign Responses per Reporting Respondents: Reporting Respondents: 27,563.
products labeled as organic are 13.69 reporting responses per reporting Estimated Number of Domestic
produced and handled are at least respondents. Reporting Responses: 380,119.
equivalent to the requirements of the Total All Recordkeeping Burden Cost: Estimated Total Annual Reporting
OFPA and the USDA organic $1,214,620 Burden on Domestic Respondents:
regulations is $13,768.24. This cost is 110,719 hours.
based on 560 total labor hours for all Estimate of Burden: Public
Estimated Total Domestic Reporting
foreign governments at $24.59 per labor recordkeeping burden is estimated to be
Responses per Reporting Respondents:
hour, including 35.92% benefits.92 an annual total of 0.65 hours per year
per respondent. 13.79 reporting response per reporting
Total (Domestic and Foreign) Respondents: Certifying agents, respondents.
Information Collection Cost (Reporting certified operations, and foreign Total Domestic Only Recordkeeping
and Recordkeeping) of Proposed Rule: governments. Burden Cost: $826,677
$9,711,656 (Also, see Summary Table 4: Estimated Number of Recordkeeping
All Reporting and Recordkeeping Hours Respondents: 46,768. Estimate of Burden: Public domestic
and Costs, and All Domestic Reporting Estimated Total Recordkeeping only recordkeeping burden is estimated
and Recordkeeping Hours and Costs) Burden on Respondents: 30,568 hours. to be an annual total of 0.59 hours per
Estimated Total Recordkeeping year per respondent.
Total All Reporting Burden Cost: Responses per Recordkeeping Respondents: Certifying agents and
$8,497,036 Respondents: 1 recordkeeping response certified operations.
Estimate of Burden: Public reporting per recordkeeping respondents. Estimated Number of Domestic
burden for the collection of information Recordkeeping Respondents: 27,415.
Total Domestic Only Information
is estimated to average .38 hours per Collection Cost (Reporting and Estimated Total Annual
year per response. Recordkeeping) of Proposed Rule: Recordkeeping Burden on Domestic
$5,946,076 Respondents: 16,288 hours.
Respondents: Certifying agents,
Estimated Number of Domestic
certified operations, inspectors, and Total Domestic Only Reporting Burden Recordkeeping Responses: 27,542.
foreign governments. Cost: $5,119,399 Estimated Total Domestic
Estimated Number of Reporting Estimate of Burden: Public domestic Recordkeeping Responses per
Respondents: 47,050. only reporting burden is estimated to be Recordkeeping Respondents: 1
Estimated Number of Reporting an annual total .29 hours per year per recordkeeping response per
Responses: 644,269. domestic respondent. recordkeeping respondents.
SUMMARY TABLE 4—ALL REPORTING AND RECORDKEEPING HOURS AND COSTS AND ALL DOMESTIC REPORTING AND
RECORDKEEPING HOURS AND COSTS
Number of
Hours Costs Respondent types
respondents
Total Reporting & Record- 275,495 $9,711,656 47,050 Certifying agents, certified operations, inspectors, and for-
keeping. eign governments.
All Reporting ........................... 244,927 8,494,137 47,050 Certifying agents, certified operations, inspectors, and for-
eign governments.
All Recordkeeping ................... 30,568 1,214,620 46,768 Certifying agents, certified operations, and foreign govern-
ments.
Reporting & Recordkeeping— 126,977 5,946,076 27,563 Certifying agents, certified operations, and inspectors.
Domestic.
Domestic Reporting ................ 110,719 5,119,399 27,563 Certifying agents, certified operations, and inspectors.
Domestic Recordkeeping ........ 16,258 826,677 27,415 Certifying agents and certified operations.
Comments information would have practical appropriate automated, electronic,

utility. mechanical, or other technological
AMS is inviting comments from all 2. The accuracy of the agency’s collection techniques or other forms of
interested parties concerning the estimate of the burden of the proposed information technology.
information collection and collection of information, including the
recordkeeping required as a result of the 5. AMS estimates that the total
validity of the methodology and number of certified organic operations
proposed amendments to 7 CFR part assumptions used.
205. AMS seeks comment on the will grow by 5.6% annually, based on
3. Ways to enhance the quality, the increase in operations recorded in
following subjects: utility, and clarity of the information to
INTEGRITY during the last 12 months.

1. Whether the proposed collection of be collected. Is this a reasonable and accurate
information is necessary for the proper 4. Ways to minimize the burden of the projection of future growth, given the
performance of the functions of the collection of information on those who
agency, including whether the are to respond, including the use of
92 The labor rate for foreign governments is Employment Statistics group 13–1041, Compliance
estimated at 52% of the labor rate for Occupational Officers.
additional burdens imposed by this modifications identified herein are not Certification activity. Any business
proposed rulemaking? 93 expressly mandated by Congress. conducted by a certifying agent, or by a
Comments that specifically pertain to person acting on behalf of a certifying
E. Civil Rights Impact Analysis
the information collection and agent, including but not limited to:
recordkeeping requirements of this AMS has reviewed this proposed rule Certification management;
proposed rule may be sent to the in accordance with the Department administration; application review;
Federal eRulemaking Portal at https:// Regulation 4300–4, Civil Rights Impact inspection planning; inspections;
www.regulations.gov/. You can access Analysis, to address any major civil sampling; inspection report review;
rights impacts the proposed rule might material review; label review; records
this proposed rule and instructions for
have on minorities, women, and persons retention; compliance review;
submitting public comments by
with disabilities. AMS has determined investigating complaints and taking
searching for document number, AMS–
that this proposed rule has no potential adverse actions; certification decisions;
NOP–17–0065. Comments may also be
for affecting producers, handlers, and issuing transaction certificates.
sent to Valeria Frances, Agricultural
certifying agents, or inspectors in Certification office. Any site or facility
Marketing Specialist, National Organic
protected groups differently than the where certification activities are
Program, USDA–AMS–NOP, Room
general population of producers, conducted, except for certification
2642-So., Ag Stop 0268, 1400
handlers, certifying agents, or activities that occur at certified
Independence Ave. SW, Washington,
inspectors. operations or applicants for
DC 20250–0268 and to the Desk Officer
for Agriculture, Office of Information List of Subjects in 7 CFR Part 205 certification, such as inspections and
and Regulatory Affairs, Office of Administrative practice and sampling.
Management and Budget, New procedure, Agriculture, Animals, * * * * *
Executive Office Building, 725 17th Archives and records, Imports, Labeling, Certification review. The act of
Street NW, Room 725, Washington, DC Organically produced products, Plants, reviewing and evaluating a certified
20503. Comments on the information Reporting and recordkeeping operation or applicant for certification
collection and recordkeeping requirements, Seals and insignia, Soil and determining compliance with the
requirements should reference the date conservation. USDA organic regulations. This does
and page number of this issue of the For the reasons set forth in the not include performing an inspection.
Federal Register. All responses to this preamble, the United States Department * * * * *
notice will be summarized and included of Agriculture proposes to amend 7 CFR Conformity assessment system. All
in the request for OMB approval. All part 205 as follows: activities undertaken by a government
comments will become a matter of to ensure that the applicable technical
public record. The comment period for 7 CFR PART 205—NATIONAL requirements for the production,
the information collection and ORGANIC PROGRAM handling, and processing of organic
recordkeeping requirements contained agricultural products are fully and
in this proposed rule is 60 days. ■ 1. The authority citation for 7 CFR
consistently applied from product to
Part 205 continues to read as follows:
D. Executive Order 13175 product.
Authority: 7 U.S.C. 6501–6524.
* * * * *
This rule has been reviewed in ■ 2. Amend § 205.2 by:
accordance with the requirements of Grower group member. A person
■ a. Revising the definitions ‘‘Handle’’, engaged in the activity of growing or
Executive Order 13175, Consultation ‘‘Handler’’, and ‘‘Handling operation’’;
and Coordination with Indian Tribal gathering a crop and/or wild crop as a
■ b. Removing the term ‘‘Retail food
Governments. Executive Order 13175 member of a grower group operation.
establishment’’; and Grower group operation. A single
requires Federal agencies to consult and ■ c. Adding in alphabetical order the
coordinate with tribes on a government- producer consisting of grower group
terms ‘‘Adverse action,’’ ‘‘Certification
to-government basis on policies that members in geographical proximity
activity,’’ ‘‘Certification office,’’
have tribal implications, including governed by an internal control system
‘‘Certification review,’’ ‘‘Conformity
regulations, legislative comments or under an organic system plan certified
assessment system,’’ ‘‘Grower group
proposed legislation, and other policy as a single crop and/or wild crop
member,’’ ‘‘Grower group operation,’’
statements or actions that have production and handling operation.
‘‘Grower group production unit,’’
substantial direct effects on one or more INTEGRITY,’’ ‘‘‘‘Internal control Grower group production unit. A
Indian tribes, on the relationship system,’’ ‘‘Organic exporter,’’ ‘‘Organic defined subgroup of grower group
between the Federal Government and fraud,’’ ‘‘Organic importer of record,’’ members in geographical proximity as a
Indian tribes or on the distribution of ‘‘Retail operation,’’ and ‘‘Technical part of a single grower group operation
power and responsibilities between the requirements’’. that use similar practices and shared
Federal Government and Indian tribes. The revisions and additions read as resources to grow or gather similar crops
follows: and/or wild crops.
The USDA’s Office of Tribal Relations
(OTR) has assessed the impact of this Handle. To sell, process, or package
§ 205.2 Terms defined. agricultural products, including but not
rule on Indian tribes and determined
that this rule does not have tribal * * * * * limited to trading, facilitating sale or
Adverse action. A noncompliance trade, brokering, repackaging, labeling,
implications that require consultation at
decision that adversely affects combining, containerizing, storing,
this time. If a tribe requests consultation

certification, accreditation, or a person receiving, or loading.
AMS will work with the OTR to ensure
subject to the Act, including a proposed Handler. Any person engaged in the
meaningful consultation is provided
suspension or revocation; a denial of business of handling agricultural
where changes, additions, and
certification, accreditation, or products.
93 Organic Integrity Database: https://
reinstatement; a cease and desist notice; Handling operation. Any operation or
organic.ams.usda.gov/integrity/. Calculated on
or a civil penalty. portion of an operation that handles
April 3, 2019. * * * * * agricultural products, except for
operations that are exempt from (c) Any person or responsibly (e) An operation that only stores,
certification. connected person that: receives, and/or loads agricultural
* * * * * * * * * * products, but does not process or alter
INTEGRITY. The National Organic ■ 4. Revise § 205.101 to read as follows: such agricultural products.
Program’s electronic, web-based (f) Records described in
reporting tool for the submission of § 205.101 Exemptions from certification. subparagraphs (a)–(d) of this section
data, completion of certificates of The following operations in must be maintained for no less than 3
organic operation, and other paragraphs (a) through (e) of this section years beyond their creation, and the
information, or its successors. are exempt from certification under operations must allow representatives of
Internal control system. An internal subpart E of this part and from the Secretary and the applicable State
quality management system that submitting an organic system plan for organic programs’ governing State
establishes and governs the review, acceptance or approval under § 205.201 official access to these records for
monitoring, training, and inspection of but must comply with the applicable inspection and copying during normal
the grower group operation and the organic production and handling business hours to determine compliance
procurement and distribution of shared requirements of subpart C of this part, with the applicable regulations set forth
production and handling inputs and including the provisions for prevention in this part.
resources, to maintain compliance with of contact of organic products with ■ 5. Amend § 205.103 by:
the USDA organic regulations as a single prohibited substances set forth in ■ a. Revising paragraph (b)(2);
producer. § 205.272, and the specific additional ■ b. Redesignating paragraphs (b)(3)and
* * * * * requirements stipulated in § 205.101(a) (4) as paragraphs (b)(4) and (5); and
Organic exporter. The owner or final through (f). ■ c. Adding new paragraph (b)(3).
exporter of the organic product who (a) A production or handling The revision and addition read as
facilitates the trade of, consigns, or operation that sells agricultural follows:
arranges for the transport/shipping of products as ‘‘organic’’ but whose gross § 205.103 Recordkeeping by certified
the organic product from a foreign agricultural income from organic sales operations.
country. totals $5,000 or less annually. The * * * * *
Organic fraud. Intentional deception products from such operations must not (b) * * *
for illicit economic gain, where be used as ingredients identified as (2) Fully disclose all activities and
nonorganic products are labeled, sold, organic in processed products produced transactions of the certified operation in
or represented as ‘‘100 percent organic,’’ by another handling operation. Such sufficient detail as to be readily
‘‘organic,’’ or ‘‘made with organic operations must comply with the understood and audited, including
(specified ingredients or food labeling provisions of § 205.310. identification in records of products as
group(s)).’’ (b) A retail operation or a portion of ‘‘100% organic,’’ ‘‘organic,’’ or ‘‘made
Organic importer of record. The a retail operation that sells, but does not with organic (specified ingredients or
operation responsible for accepting process, organically produced food group(s)),’’ as applicable;
imported organic products within the agricultural products. (3) Include audit trail documentation
United States. (c) A retail operation or portion of a for product handled or produced by the
* * * * * retail operation that processes certified operation;
Retail operation. An operation that agricultural products that were * * * * *
sells agricultural products directly to previously labeled for retail sale as ‘‘100 ■ 6. Amend § 205.201 by:
final consumers through in-person and/ percent organic,’’ ‘‘organic,’’ or ‘‘made ■ a. Removing ‘‘or excluded’’ in
or virtual transactions. with organic (specified ingredients or paragraph (a) introductory text;
* * * * * food group(s)),’’ provided that the ■ b. Revising paragraph (a)(3); and
Technical requirements. A system of products are processed onsite at the ■ c. Adding paragraph (c).
relevant laws, regulations, regulatory point of sale to the final consumer. Such The revision and addition read as
practices, and procedures that address operations must comply with the follows:
the production, handling, and labeling provisions of § 205.310, and
processing of organic agricultural must maintain records sufficient to: § 205.201 Organic production and
products. (1) Prove that agricultural products handling system plan.
* * * * * identified as organic were organically (a) * * *
■ 3. Amend § 205.100 by revising produced and handled; and (3) A description of the monitoring
paragraphs (a) and (c) introductory text (2) Verify quantities produced or sold practices and procedures to be
to read as follows: from such agricultural products. performed and maintained, including
(d) A handling operation or portion of the frequency with which they will be
§ 205.100 What has to be certified. a handling operation that only handles performed, to verify that the plan is
(a) Except for the exempt operations agricultural products that contain less effectively implemented. This must
described in § 205.101, each operation, than 70 percent organic ingredients (as include a description of the monitoring
or portion of an operation, that produces described in § 205.301(d)), or that only practices and procedures to verify
or handles agricultural products that are identifies organic ingredients on the suppliers in the supply chain and
intended to be sold, labeled, or information panel. Such operations organic status of products received, and
represented as ‘‘100 percent organic,’’ must comply with the labeling to prevent organic fraud, as appropriate
‘‘organic,’’ or ‘‘made with organic provisions of §§ 205.305 and 205.310 to the certified operation’s activities;
(specified ingredients or food group(s))’’ and must maintain records sufficient to: * * * * *
must be certified according to the (1) Prove that agricultural products (c) In addition to paragraph (a) of this
provisions of subpart E of this part and identified as organic were organically section, a grower group operation’s
must meet all other applicable produced and handled; and organic system plan must describe its
requirements of this part. (2) Verify quantities produced or sold internal control system. The description
* * * * * from such agricultural products. of the internal control system must:
(1) Define the organizational source (e.g., a third-party export § 205.302 Calculating the percentage of
structure, roles, and responsibilities of system). organically produced ingredients.
all personnel; (b) The certifying agent must review (a) * * *
(2) Identify grower group production an NOP Import Certificate request, (1) Dividing the total net weight
units and locations; determine whether the shipment (excluding water and salt) of combined
(3) Define geographical proximity complies with the USDA organic organic ingredients at formulation by
criteria for grower group members and regulations, and issue the NOP Import the total weight (excluding water and
grower group production units; Certificate or equivalent within 30 salt) of all ingredients.
(4) Describe characteristics of high- calendar days of receipt if the shipment (2) Dividing the fluid volume of all
risk grower group members and grower complies with the USDA organic organic ingredients (excluding water
group production units; regulations. and salt) at formulation by the fluid
(5) Describe shared production (c) Each compliant organic shipment volume of all ingredients (excluding
practices and inputs; must be declared as organic to U.S. water and salt) if the product and
(6) Describe the internal monitoring, Customs and Border Protection through ingredients are liquid. If the liquid
surveillance, and auditing methods used a U.S. Port of Entry by uploading the product is identified on the principal
to assess the compliance of all grower unique NOP Import Certificate, or display panel or information panel as
group members; equivalent electronic data entry, into the being reconstituted from concentrates,
(7) Describe the system of sanctions U.S. Customs and Border Protection’s the calculation should be made based
for noncompliant grower group Automated Commercial Environment on single-strength concentrations of the
members, including procedures to system. ingredients and all ingredients.
address noncompliances detected (3) For products containing
(d) Upon receiving a shipment with
among grower group members, impose organically produced ingredients in
organic products, the organic importer both solid and liquid form, dividing the
sanctions, and remove grower group of record must ensure the shipment is
members when warranted, and combined weight of the solid organic
accompanied by a verified NOP Import ingredients and the weight of the liquid
procedures for reporting Certificate or equivalent; must verify
noncompliances to the certifying agent; organic ingredients (excluding water
that the shipment contains only the and salt) at formulation by the total
(8) Describe measures to protect quantity and type of certified organic
against potential conflicts of interest; weight (excluding water and salt) of all
product specified on the NOP Import ingredients.
(9) Describe how training, production
Certificate or equivalent; and must
and handling inputs, and other * * * * *
verify that the shipment has had no
resources are procured and provided to ■ 11. Amend § 205.307 by:
contact with prohibited substances ■ a. Revising the section heading;
all grower group members and
pursuant to § 205.272 or exposure to ■ b. Revising paragraphs (a) and (b); and
personnel;
ionizing radiation pursuant to § 205.105, ■ c. Removing ‘‘and excluded’’ in
(10) Have clear policies and
since export. paragraph (c)
procedures to verify the grower group
(e) The use of the term equivalent in The revisions read as follows:
operation’s and grower group members’
this section refers to electronic data,
compliance with the USDA organic § 205.307 Labeling of nonretail containers.
documents, identification numbers,
regulations; and (a) Nonretail containers used to ship
(11) Address any other terms or databases, or other systems verified as
an equivalent data source to the NOP or store certified organic product must
conditions determined by the display the following:
Administrator to be necessary to enforce Import Certificate.
■ 8. Amend § 205.300 by revising (1) The term, ‘‘100 percent organic,’’
compliance with the USDA organic ‘‘organic,’’ or ‘‘made with organic
regulations and the Act. paragraph (c) to read as follows:
(specified ingredients or food
■ 7. Add § 205.273 to subpart C to read § 205.300 Use of the term, ‘‘organic.’’ group(s)),’’ as applicable, to identify the
as follows: * * * * * product;
§ 205.273 Imports to the United States. (c) Products produced in a foreign (2) The statement, ‘‘Certified organic
country and exported for sale in the by (name of certifying agent),’’ or similar
Each shipment of organic products phrase, to identify the name of the
imported into the United States through United States must be certified pursuant
to subpart E of this part, labeled certifying agent that certified the
U.S. Ports of Entry must be certified producer of the product, or, if
pursuant to subpart E of this part, pursuant to this subpart D, and must
comply with the requirements in processed, the certifying agent that
labeled pursuant to subpart D of this certified the last handler that processed
part, be declared as organic to U.S. § 205.273, Imports to the United States.
the product; and
Customs and Border Protection, and be * * * * * (3) The production lot number of the
associated with a valid NOP Import ■ 9. Amend § 205.301 by revising
product, shipping identification, or
Certificate (Form NOP 2110–1) or paragraphs (f)(2) and (f)(3) to read as other information needed to ensure
equivalent data source. follows: traceability.
(a) Persons exporting organic products (b) Nonretail containers used to ship
§ 205.301 Product composition.
to the United States must request an or store certified organic product may
NOP Import Certificate, or provide data * * * * *
display the following:
through an equivalent data source, from (f) * * * (1) Special handling instructions
a certifying agent, for each physical (2) Be processed using ionizing needed to maintain the organic integrity
shipment of certified organic products radiation, pursuant to § 205.105(f); of the product;

prior to their export. Only certifying (3) Be produced using sewage sludge, (2) The USDA seal. Use of the USDA
agents accredited by the USDA or pursuant to § 205.105(g); seal must comply with § 205.311;
foreign certifying agents authorized * * * * * (3) The name and contact information
under an organic trade arrangement may ■ 10. Amend § 205.302 by revising of the certified producer of the product,
issue an NOP Import Certificate or paragraphs (a)(1), (2), and (3) to read as or if processed, the last certified handler
approve a listing in an equivalent data follows: that processed the product;
(4) The seal, logo, or other identifying (8) Conduct internal inspections of basis, conduct unannounced
mark of the certifying agent that each grower group member, at least inspections of a minimum of five
certified the producer of the product, or annually, by internal inspectors, which percent of the operations it certifies,
if processed, the last handler that must include mass-balance audits and rounded up to the nearest whole
processed the product; and/or reconciliation of each grower group number.
(5) The business address, website, member’s and grower group production (2) Certifying agents must be able to
and/or contact information of the unit’s production yield and group sales; conduct unannounced inspections of
certifying agent. (9) Document and report to the any operation it certifies and must not
(c) Shipping containers of certifying agent the use of sanctions to accept applications or continue
domestically produced product labeled address noncompliant grower group certification with operations located in
as organic intended for export to members, at least annually; and areas where they are unable to conduct
international markets may be labeled in (10) Implement procedures to ensure unannounced inspections.
accordance with any shipping container all production and handling by the (d) * * *
labeling requirements of the foreign grower group operation is compliant (4) That sufficient quantities of
country of destination or the container with the USDA organic regulations and organic product and ingredients are
labeling specifications of a foreign the Act, including recordkeeping produced or purchased to account for
contract buyer: Provided, That, the requirements to ensure a complete audit organic product sold or transported; and
shipping containers and shipping trail from each grower group member (5) That organic products and
documents accompanying such organic and grower group production unit to ingredients are traceable by the
products are clearly marked ‘‘For Export sale and distribution. operation from the time of production or
Only’’ and: Provided further, That, proof purchase to sale or transport; and that
of such container marking and export § 205.401 [Amended] certifying agents can verify traceability
must be maintained by the handler in ■ 14. Amend § 205.401(a) by removing back to the source per § 205.501(a)(21).
‘‘§ 205.200’’ and adding in its place ■ 16. Amend § 205.404 by:
accordance with recordkeeping
‘‘§ 205.201’’. ■ a. Revising paragraph (b);
requirements for exempt operations ■ b. Redesignating paragraph (c) as
under § 205.101. ■ 15. Amend § 205.403 by:
■ a. Redesignating paragraph (a)(2) as paragraph (d); and
§ 205.310 [Amended] paragraph (a)(3); ■ c. Adding new paragraph (c).
■ b. Adding new paragraph (a)(2);
The revisions and additions read as
■ 12. Amend § 205.310 by removing ‘‘or
■ c. Redesignating paragraphs (b) follows:
excluded’’ wherever it appears.
■ 13. Amend § 205.400 by: through (e) as paragraphs (c) through (f); § 205.404 Granting certification.
■ a. In paragraph (b), removing ■ d. Adding new paragraph (b);
* * * * *
‘‘§ 205.200’’ and adding in its place ■ e. In newly redesignated (d)(2),
(b) The certifying agent must issue a
‘‘§ 205.201’’; and remove ‘‘§ 205.200’’ and add in its place certificate of organic operation. The
■ b. Adding new paragraph (g). ‘‘§ 205.201’’; and certificate of organic operation must be
The addition reads as follows: ■ f. Adding new paragraphs (d)(4) and
generated from INTEGRITY and may be
(5). provided to certified operations
§ 205.400 General requirements for The additions read as follows:
certification. electronically.
§ 205.403 On-site inspections. (c) In addition to the certificate of
* * * * * organic operation provided for in
(g) In addition to paragraphs (a) (a) * * *
(2) Initial and annual on-site § 205.404(b), a certifying agent may
through (f) of this section, a grower issue its own addenda to the certificate
group operation must: inspections of a grower group operation
as defined in § 205.2 must: of organic operation. If issued, any
(1) Be a single producer organized as addenda must include:
a person; (i) Assess the compliance of the
internal control system of the organic (1) Name, address, and contact
(2) Sell, label, or represent only crops information for the certified operation;
and/or wild crops as organic; system plan, or its capability to comply,
(2) The certified operation’s unique ID
(3) Use centralized processing, with the requirements of § 205.400(g)(8).
number/code that corresponds to the
distribution, and marketing facilities This must include review of the internal
certified operation’s ID number/code in
and systems; inspections conducted by the internal
USDA Organic INTEGRITY;
(4) Be organized into grower group control system. (3) A link to USDA Organic
production units; (ii) Conduct witness audits of internal
INTEGRITY or a link to the certified
(5) Ensure that all crops and/or wild control system inspectors performing
operation’s profile in USDA Organic
crops sold, labeled, or represented as inspections of the grower group
INTEGRITY, along with a statement,
organic are from grower group members operation.
‘‘You may verify the certification of this
only; (iii) Individually inspect at least 1.4
operation at USDA Organic
(6) Ensure that grower group members times the square root of the total number
INTEGRITY,’’ or a similar statement;
do not sell, label, or represent their of grower group members. This must (4) Name, address, and contact
crops and/or wild crops as organic include an inspection of all grower information of the certifying agent;
outside of the grower group operation group members determined to be high (5) ‘‘Addendum issue date;’’ and
unless they are individually certified; risk according to criteria in (6) ‘‘Addendum expiration date,’’
(7) Report to the certifying agent on an 205.201(c)(4). At least one grower group which must not exceed the expiration
annual basis the name and location of member in each grower group date of the certificate of organic
all grower group members and grower production unit as defined in § 205.2 operation.
group production units, and the crops, must be inspected. * * * * *
wild crops, estimated yield, and size of (iv) Inspect each handling facility.
production and harvesting areas of each * * * * * § 205.405 [Amended]
grower group member and grower group (b) Unannounced inspections. (1) A ■ 17. Amend § 205.405 by removing
production unit; certifying agent must, on an annual paragraph (c)(3).
■ 18. Amend § 205.406 by revising inspection, import and/or export production and handling that directly
paragraphs (a) and (b) to read as follows: requirements, auditing practices and relates to assigned duties.
skills in written and oral (6) Conduct an annual performance
§ 205.406 Continuation of certification. communications, sample collection, evaluation of all persons who conduct
(a) To continue certification, a investigation techniques, and inspections, certification review, or
certified operation must annually pay preparation of technically accurate implement measures to correct any
the certification fees and submit the inspection documents; and deficiencies in certification services;
following information to the certifying (B) Initially and every year thereafter, (i) On-site evaluation of inspectors—
agent: inspectors must demonstrate successful Certifying agents must observe each
(1) A summary statement, supported completion of a minimum of 20 hours inspector performing on-site inspections
by documentation, detailing any of training in topics that are relevant to at least once every three years, or more
deviations from, changes to, inspection. Training may include frequently if warranted; and
modifications to, or other amendments material delivered via the NOP learning (A) On-site inspector evaluations
made to the organic system plan management system, certifying agents, must be performed by certifying agent
submitted during the previous year; and or other relevant training provider; and personnel who are qualified to evaluate
(2) Any additions or deletions to the (C) Certifying agents must inspectors;
previous year’s organic system plan, demonstrate that inspectors have a (ii) Certifying agents must maintain
intended to be undertaken in the minimum of 1 year of field-based documented policies, procedures, and
coming year, detailed pursuant to experience related to both the scope and records for annual performance
§ 205.201; scale of operations they will inspect evaluations and on-site inspector
(3) Any additions to or deletions from before assigning inspection evaluations.
the information required pursuant to responsibilities; * * * * *
§ 205.401(b); and (ii) Certifying agents must (10) Maintain strict confidentiality
(4) Other information as deemed demonstrate that all persons who with respect to its clients under the
necessary by the certifying agent to conduct certification review, including applicable organic certification program
determine compliance with the Act and staff, volunteers, or contractors, have the and not disclose to third parties (except
the regulations in this part. knowledge, skills, and experience for the Secretary or the applicable State
(b) The certifying agent must arrange required to perform certification review organic program’s governing State
and conduct an on-site inspection, of operations of the scope and scale official or their authorized
pursuant to § 205.403, of the certified assigned and to evaluate compliance representatives) any business-related
operation at least once per calendar with the applicable regulations of this information concerning any client
year. part; and obtained while implementing the
* * * * * (A) Certifying agents must regulations in this part, except:
§ 205.500 [Amended] demonstrate that all certification review (i) For information that must be made
personnel continuously maintain available to any member of the public,
■ 19. Amend § 205.500 by removing as provided for in § 205.504(b)(5);
adequate knowledge and skills in the
paragraph (c). (ii) For enforcement purposes,
current USDA organic standards,
■ 20. Amend § 205.501 by:
certification and compliance processes, certifying agents must exchange any
■ a. Revising paragraphs (a)(4), (5), (6),
and practices applicable to the type, compliance-related information that is
(10), (13), and (15); credibly needed to certify, decertify, or
volume, and range of review activities
■ b. Redesignating paragraph (a)(21) as
assigned; and investigate an operation, including for
paragraph (a)(23); and the purpose of verifying supply chain
■ c. Adding new paragraphs (a)(21) and
(B) Initially and every year thereafter,
all persons who conduct certification traceability and audit trail
(a)(22). documentation; and
The amendments read as follows: review activities must demonstrate
successful completion of a minimum of (iii) If a certified operation’s
§ 205.501 General requirements for 20 hours of training in topics that are proprietary business information is
accreditation. relevant to certification review. Training compliance-related and thus credibly
(a) * * * may include material delivered via the needed to certify, decertify, or
(4) Continuously use a sufficient NOP learning management system, investigate that operation, certifying
number of qualified and adequately certifying agents, or other relevant agents may exchange that information
trained personnel, including inspectors training provider; and for the purposes of enforcing the Act,
and persons who conduct certification (iii) Certifying agents must maintain but the information in question still
review, to comply with and implement current training requirements, training retains its proprietary character even
the USDA organic standards; procedures, and training records for all after it is exchanged and all of the
(i) Certifying agents must demonstrate inspectors and persons who conduct certifying agents that are involved in the
that all inspectors, including staff, certification review activities. exchange still have a duty to preserve
volunteers, and contractors, have the (5) Demonstrate that all persons with the confidentiality of that information
required knowledge, skills, and inspection or certification review after the exchange.
experience to inspect operations of the responsibilities have sufficient expertise * * * * *
scope and scale as assigned and to in organic production or handling (13) Accept the certification decisions
evaluate compliance with the applicable techniques to successfully perform the made by another certifying agent
regulations of this part; and duties assigned; accredited or accepted by USDA

(A) Certifying agents must (i) Sufficient expertise must include pursuant to § 205.500. Certifying agents
demonstrate that inspectors knowledge of certification to USDA must provide information to other
continuously maintain adequate organic standards and evidence of certifying agents to ensure organic
knowledge and skills about the current formal education, training, or integrity or to enforce organic
USDA organic standards, production professional experience in the fields of regulations, including to verify supply
and handling practices, certification and agriculture, science, or organic chain integrity, authenticate the organic
status of certified products, and conduct regulations in this part (‘‘equivalence in accordance with the following
investigations; determination’’). provisions:
* * * * * (b) Countries desiring to establish * * * * *
(15) Maintain current and accurate eligibility of product certified under that ■ 24. Amend § 205.660 by:
data in INTEGRITY for each operation country’s organic certification program ■ a. Redesignating paragraphs (c) and
which it certifies; to be sold, labeled or represented as (d) as paragraphs (d) and (e); and
organically produced in the United
* * * * * ■ b. Adding new paragraph (c).
(21) Annually, conduct risk-based States may request an equivalence
determination from AMS. A foreign The addition read as follows:
supply chain audits to verify organic
status of a product(s) of a certified government must maintain compliance § 205.660 General.
operation(s) it certifies, back to the and enforcement mechanisms to ensure * * * * *
source(s). that its organic certification program is
(c) The Program Manager may initiate
(22) Notify AMS not later than 90 fully meeting the terms and conditions
enforcement action against any person
calendar days after certification of any equivalence determination
who sells, labels, or provides other
activities begin in a new certification provided by AMS pursuant to this
market information concerning an
office. The notification must include the section. To request this determination,
agricultural product if such label or
countries where the certification the requesting country must submit
information implies, directly or
activities are being provided, the nature documentation that fully describes its
indirectly, that such product is
of the certification activities, and the technical requirements and conformity
produced or handled using organic
qualifications of the personnel assessment system. If AMS determines
methods, if the product was produced
providing the certification activities. it can proceed, AMS will conduct an
or handled in violation of the Organic
assessment of the country’s organic
* * * * * Foods Production Act or the regulations
certification program to evaluate
■ 21. Amend § 205.504 by: in this part.
whether it is equivalent.
■ (a) Revising paragraph (b)(4); and ■ 24. Amend § 205.661 by revising the
(c) AMS will describe the scope of an
■ (b) Adding paragraph (b)(7).
equivalence determination. section heading to read as follows:
The revision and addition read as (d) AMS will conduct reviews on a § 205.661 Investigation.
follows: two-year cycle, beginning at the close of
* * * * *
§ 205.504 Evidence of expertise and the prior review, to assess the
■ 26. Amend § 205.662 by:
ability. effectiveness of the foreign
■ a. Adding new paragraph (e)(3);
* * * * * government’s organic certification
program. AMS will reassess a country’s ■ b. Revising the first sentence of
(b) * * * paragraph (f)(1); and
(4) A copy of the procedures to be organic certification program that AMS
has recognized as equivalent every five ■ c. Revising paragraph (g)(1).
used for sharing information with other
years to verify that the foreign The amendments read as follows:
certifying agents and for maintaining the
confidentiality of any business-related government’s technical requirements
§ 205.662 Noncompliance procedure for
information as set forth in and conformity assessment program certified operations.
§ 205.501(a)(10); continue to be at least equivalent to the
requirements of the Act and the * * * * *
* * * * * regulations of this part, and will (e) * * *
(7) A copy of the criteria to identify determine whether the equivalence (3) Within 3 business days of issuing
high-risk operations and products; and determination should be continued. a notification of suspension or
procedures to conduct risk-based supply (e) AMS may terminate an revocation, or the effective date of an
chain audits, as required in equivalence determination if the terms operation’s surrender, the certifying
§ 205.501(a)(21); and procedures to or conditions established under the agent must update the operation’s status
report credible evidence of organic determination are not met; if AMS in INTEGRITY.
fraud to the Administrator. determines that the country’s technical (f) * * *
* * * * * requirements and/or conformity (1) A certified operation or a person
■ 22. Adding § 205.511 to subpart F to assessment program are no longer responsibly connected with an
read as follows: equivalent; if AMS determines that the operation whose certification has been
foreign government’s organic control suspended may at any time, unless
§ 205.511 Accepting foreign conformity
assessment systems. system is inadequate to ensure that the otherwise stated in the notification of
country’s organic certification program suspension, submit a request to the
(a) Foreign product may be certified Secretary for reinstatement of its
is fully meeting the terms and
under the USDA organic regulations by certification, or submit a request for
conditions under the determination; or
a USDA-accredited certifying agent and eligibility to be certified. * * *
for other good cause.
imported for sale in the United States. ■ 23. Amend § 205.640 by revising the
Foreign product that is produced and * * * * *
introductory paragraph to read as (g) * * *
handled under another country’s follows:
organic certification program may be (1) Knowingly sells or labels a
sold, labeled, or represented as § 205.640 Fees and other charges for product as organic, except in
organically produced in the United accreditation. accordance with the Act, shall be
States if AMS determines that such Fees and other charges equal as nearly subject to a civil penalty of not more
organic certification program provides as may be to the cost of the services than the amount specified in
technical requirements and a conformity rendered under the regulations, § 3.91(b)(1)(xxxvii) of this title per
assessment system governing the including initial accreditation, review of violation.
production and handling of such annual reports, and renewal of * * * * *
products that are at least equivalent to accreditation, shall be reviewed, ■ 27. Revise § 205.663 to read as
the requirements of the Act and the assessed, and collected from applicants follows:
§ 205.663 Mediation. resolve any adverse action notice that it (e) All appeals must comply with the
(a) A certifying agent must submit has issued. procedural requirements in § 205.681(c)
with its administrative policies and ■ 28. Amend § 205.665 by revising and (d) of the USDA organic regulations.
procedures provided in § 205.504(b): paragraph (a) to read as follows: (f) All written communications
decision criteria for acceptance of between parties involved in appeal
§ 205.665 Noncompliance procedure for
mediation, and a process for identifying certifying agents.
proceedings must be sent to the
personnel conducting mediation and recipient’s place of business by a
(a) Notification. (1) A written delivery service which provides dated
setting up mediation sessions. notification of noncompliance will be
(b) A certified operation or applicant return receipts.
sent to the certifying agent when: (g) All appeals must be reviewed,
for certification may request mediation (i) An inspection, review, or
to resolve a denial of certification or heard, and decided by persons not
investigation of an accredited certifying
proposed suspension or proposed involved with the adverse action being
agent by the Program Manager reveals
revocation of certification issued by a appealed.
any noncompliance with the Act or ■ 29. Amend § 205.681 by:
certifying agent or State organic regulations in this part; or ■ a. Revising paragraphs (a)
program. (ii) The Program Manager determines
(1) A certified operation or applicant introductory text and (a)(2);
that the certification activities of the ■ b. Revising paragraphs (b) and (c)
for certification must submit any request certifying agent, or any person ■ c. Revising paragraph (d)(1); and
for mediation in writing to the performing certification activities on ■ d. Revising paragraph (d)(3).
applicable certifying agent or State behalf of the certifying agent, are not The amendments read as follows:
organic program within 30 calendar compliant with the Act or the
days of receipt of the notice of proposed regulations in this part; or § 205.681 Appeals.
suspension or proposed revocation of (iii) The Program Manager determines (a) Adverse actions by certifying
certification or denial of certification. that the certification activities at a agents. An applicant for certification
(2) A certifying agent or State organic certification office, and/in specific may appeal a certifying agent’s notice of
program may accept or reject a request countries, are not compliant with the denial of certification, and a certified
for mediation based on its own decision Act or the regulations in this part. operation may appeal a certifying
criteria. (2) Such notification must provide: agent’s notification of proposed
(i) If a certifying agent rejects a (i) A description of each suspension or proposed revocation of
mediation request, it must provide this noncompliance; certification to the Administrator,
rejection in writing to the applicant for (ii) The facts upon which the Except, That, when the applicant or
certification or certified operation. The notification of noncompliance is based; certified operation is subject to an
rejection must include the right to and approved State organic program, the
request an appeal, pursuant to (iii) The date by which the certifying
appeal must be made to the State
§ 205.681, within 30 calendar days of agent must rebut or correct each
organic program which will carry out
the date of the written notification of noncompliance and submit supporting
the appeal pursuant to the State organic
rejection of the request for mediation. documentation of each correction when
program’s appeal procedures approved
correction is possible.
(c) Both parties must agree on the by the Secretary.
person conducting the mediation. * * * * *
■ 29. Revise § 205.680 to read as
* * * * *
(d) If a State organic program is in (2) If the Administrator or State
effect, the parties must follow the follows:
organic program denies an appeal, a
mediation procedures established in the § 205.680 General. formal administrative proceeding may
State organic program and approved by (a) Persons subject to the Act who be initiated to deny, suspend, or revoke
the Secretary. believe they are adversely affected by an the certification. Such proceeding must
(e) The parties to the mediation have adverse action of the National Organic be conducted pursuant to the U.S.
a maximum of 30 calendar days to reach Program’s Program Manager, may Department of Agriculture’s Uniform
an agreement following a mediation appeal such decision to the Rules of Practice, 7 CFR part 1, subpart
session. Successful mediation results in Administrator. H, or the State organic program’s rules
a settlement agreement agreed to in (b) Persons subject to the Act who of procedure.
writing by both the certifying agent and believe they are adversely affected by an (b) Adverse actions by the NOP
the certified operation. If mediation is adverse action of a State organic Program Manager. A person affected by
unsuccessful, the applicant for program may appeal such decision to an adverse action, as defined by 205.2,
certification or certified operation has the State organic program’s governing issued by the NOP Program Manager,
30 calendar days from termination of State official who will initiate handling may appeal to the Administrator.
mediation to appeal the denial of of the appeal pursuant to appeal (1) If the Administrator sustains an
certification or proposed suspension or procedures approved by the Secretary. appeal, an applicant will be issued
revocation pursuant to § 205.681. (c) Persons subject to the Act who accreditation, a certifying agent will
(f) Any settlement agreement reached believe they are adversely affected by an continue its accreditation, or an
through mediation must comply with adverse action of a certifying agent may operation will continue its certification,
the Act and the regulations in this part. appeal such decision to the a civil penalty will be waived and a
The Secretary may review any mediated Administrator, Except, That when the cease-and-desist notice will be
settlement agreement for conformity to person is subject to an approved State withdrawn, as applicable to the
the Act and the regulations in this part organic program, the appeal must be operation.
and may reject any agreement or made to the State organic program. (2) If the Administrator denies an
provision not in conformance with the (d) Persons subject to the Act who appeal, a formal administrative
Act or the regulations in this part. believe they are adversely affected by an proceeding may be initiated to deny,
(g) The Program Manager may adverse action of a certifying agent or a suspend, or revoke the accreditation or
propose mediation and enter into a State organic program may request certification and/or levy civil penalties.
settlement agreement at any time to mediation as provided in § 205.663. Such proceeding must be conducted
pursuant to the U.S. Department of nonappealable unless an appeal is (3) All appeals must include a copy of
Agriculture’s Uniform Rules of Practice, timely filed. the adverse action and a statement of
7 CFR part 1, subpart H. (d) Where and what to file. (1) the appellant’s reasons for believing that
(c) Filing period. An appeal must be the action was not proper or made in
Appeals to the Administrator and
filed in writing within the time period accordance with applicable program
Requests for Hearing must be filed in
provided in the letter of notification or regulations, policies, or procedures.
within 30 days from receipt of the writing and addressed to: 1400
notification, whichever occurs later. The Independence Ave. SW, Room 2642, Bruce Summers,
appeal will be considered ‘‘filed’’ on the Stop 0268, Washington, DC 20250, or Administrator, Agricultural Marketing
date received by the Administrator or by electronic transmission, NOPAppeals@ Service.
the State organic program. An adverse ams.usda.gov. [FR Doc. 2020–14581 Filed 8–4–20; 8:45 am]
action will become final and * * * * * BILLING CODE 3410–02–P

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47536 Federal Register / Vol. 85, No.

151 / Wednesday, August 5, 2020 / Proposed Rules

Economic impact of SOE proposed rule

Costs .................................................................................................................... $7,205,815–$7,351,910 $65,629,941–$87,766,628

organic certificates to verify compliance

1—APPLICABILITY AND EXEMPTIONS FROM CERTIFICATION

1—APPLICABILITY AND EXEMPTIONS FROM CERTIFICATION—Continued

compromised or altered when handled make decisions impacting the integrity

publ334/PLAW-115publ334.pdf Survey, 2018–2020.

NOP%20CACC%20Final% subject to proposed suspension or

2—IMPORTS TO THE UNITED STATES

exporting country has issued a certificate of

3—LABELING OF NONRETAIL CONTAINERS

205.307 ......................... Revise title .................. Labeling of nonretail containers.

205.403(b)–(e) ............... Redesignate ................ Redesignate paragraphs (b)–(e) as paragraphs (c)–(f).

Unannounced Inspections inspections, which recommends that organic regulations to ensure

5—CERTIFICATES OF ORGANIC OPERATION

5—CERTIFICATES OF ORGANIC OPERATION—Continued

2006: https://www.ams.usda.gov/sites/default/files/ the supply chain that must verify the

of the certified operation at least once per calendar year.

31 NOSB Formal Recommendation: Expiration default/files/media/ Expiration%20Dates%20on%20

7—PAPERWORK SUBMISSIONS TO THE ADMINISTRATOR

205.405(c)(3) ... Provide notice of approval or denial to the Adminis- Remove.

8—PERSONNEL TRAINING AND QUALIFICATIONS—Continued

9—OVERSIGHT OF CERTIFICATION ACTIVITIES

9—OVERSIGHT OF CERTIFICATION ACTIVITIES—Continued

40 See section 10104(d) of the Agriculture available at: https://www.congress.gov/115/plaws/

10—ACCEPTING FOREIGN CONFORMITY ASSESSMENT SYSTEMS

205.660(c)–(d) ............... Redesignate ................ Redesignate paragraphs (c)–(d) as paragraphs (d)–(e).

12—NONCOMPLIANCE PROCEDURE FOR CERTIFIED OPERATIONS

14—ADVERSE ACTION APPEAL PROCESS—GENERAL

15—ADVERSE ACTION APPEAL PROCESS—APPEALS

16—GROWER GROUP OPERATIONS

16—GROWER GROUP OPERATIONS—Continued

17—CALCULATING THE PERCENTAGE OF ORGANICALLY PRODUCED INGREDIENTS

18—SUPPLY CHAIN TRACEABILITY AND ORGANIC FRAUD PREVENTION

205.103(b)(3) ................. Redesignate ................ Redesignate as paragraph (b)(4).

18—SUPPLY CHAIN TRACEABILITY AND ORGANIC FRAUD PREVENTION—Continued

205.103(b)(4) ................. Redesignate ................ Redesignate as paragraph (b)(5).

handled by dozens of operations, in the supply chain to protect

distribution of packaged products. AMS of the certified operation listed on the

costs.pdf. traders, importers, exporters).

organic products. Section 2107 (a)(10) of controlling-regulatory-costs/. order/13563.

(Public Law No: 115–334), commonly known as the

https://www.ams.usda.gov/resources/nop-2110-1. 11-10-GroupGrowerCert.pdf. organic.ams.usda.gov/integrity/.

site inspections (inspectors) are based on Occupational Employment Statistics

organic.ams.usda.gov/integrity/. group 43–9199, Office and Administrative Support

SUMMARY TABLE 1—CERTIFYING AGENTS

Subtotal U.S.-Based USDA Certi-

Foreign-Based USDA Certifying Agents .. 32 24.59 547.74 13,468.93 17,527.63 430,181.78

Subtotal Foreign-Based USDA Certi-

Total USDA-Accredited Certifying Agents 78 ........................ ........................ 30,119.04 46,589.23 1,141,273.98

SUMMARY TABLE 2—INSPECTORS

SUMMARY TABLE 3a—UNCERTIFIED HANDLERS

Formerly Excluded Handlers—Domestic 961 $50.86 56.97 $2,897.49 54,752.30 $2,784,701.98

SUMMARY TABLE 3b—CERTIFIED ORGANIC OPERATIONS AND NEW APPLICANTS

Certified Producers & Handlers—New

All New and Existing Producers &

April 3, 2019. Kingdom (effective January 2021), India, Israel,

Comments information would have practical appropriate automated, electronic,

INTEGRITY during the last 12 months.

this time. If a tribe requests consultation

shipment of certified organic products radiation, pursuant to § 205.105(f); of the product;