Contamina(on

Preven(on in the
Manufacture of Crop Protec(on Products

Guidelines and Best Prac(ces

June 2014

This Presenta2on is Made on Behalf of

and its Corporate Members

June 2014


Contamina2on Preven2on
What are the CropLife Requirements?
Ensure that

No extraneous ac2ve ingredients are present in products
In compliance with legal requirements and local legisla2on
External Manufacturers are provided adequate informa2on to
adhere to the requirements

June 2014

Contamina2on Preven2on
Example Of An Actual Incident
The situa2on.

Rush order for a bulb treatment fungicide

Product formulated
Unlabeled ex hose used for transfer, previously contained a herbicide
Crop treatment failed
Claim led, expensive court case and loss of a customer

June 2014

Contamina2on Preven2on
Example Of An Actual Incident

The situa2on.

Soil herbicide was preceded by a highly ac2ve broad leaf herbicide

Cleaning procedure not followed
Cleaning conducted over two dierent shiXs
Produc2on started without draining rinsate
Herbicide used on poZed roses, severe chlorosis (leaf bleaching), seven expensive claims and exhaus2ve
rework

June 2014

Contamina2on Preven2on
Example Of An Actual Incident

The situa2on.

Residue content could not be determined due to analy2cal equipment breakdown

Decision made to con2nue produc2on with change management approval
Subsequent analysis determined residue above cleaning limit
Soybeans treated did not germinate causing mul2ple expensive claims

2000 ppm
vs
1000 ppm

June 2014

Contamina2on Preven2on
Example Of An Actual Incident

The situa2on.

A high mel2ng point ac2ve ingredient required the use of a heat exchanger during the formula2on.
Cleaning did not include the heat exchanger as it was not needed for the next formula2on.
Five weeks later, the next formula2on requiring the heat exchanger became contaminated because the
heat exchanger had not been cleaned.
The batch had to be discarded

June 2014

Dont bypass
equipment during
cleaning steps

Contamina2on Preven2on
Example Of An Actual Incident

The situa2on.

Fungicide was packaged following a potent insec2cide

EPA default limit for change over (<1000 ppm) was used
No considera2on was given to the ecotoxicological risks
Massive kill of predatory insects occurred

Is the default
limit always low
enough?

June 2014

Contamina2on Preven2on
Example Of An Actual Incident

The situa2on.

An operator wrongly connected and transferred a formula2on (vessel should be locked if not in use)
The operator did not tell anyone of the error
Thousands of liters of product had to be recalled and destroyed
The wrong formula2on transferred was extremely toxic to benecial insects

June 2014

Contamina2on Preven2on
Example Of An Actual Incident

The situa2on.

During the packaging of a corn herbicide, an operator no2ced an unusual color and packing was stopped
Material resampled and an unexpected ac2ve ingredient detected
The packaging line shared a nitrogen purge with another produc2on line
The purge was open when a transfer occurred at the other line resul2ng in material being siphoned into
the corn herbicide

If it doesnt look normal stop

June 2014

10

Contamina2on Preven2on
What is Needed?

Applying the following requirements in

mul8-product facili8es will
mi8gate the risks


Avoid cross
contamina2on
Separa2on of herbicides and
with rework
non-herbicides
or recycle

Documented Risk
Assessments
June 2014

Clear labelling

Cleaning procedures
and analy2cal methods
11

Contamina2on Preven2on
What is Needed?

Addi8onal Requirements
Dene Residual
Cleaning Limits

Promptness in
Clean out

Rellable container
maintenance
June 2014

1,000

1,000

1,000

67

100

1,000

1,000

1.0

1,000

1,000

1,000

1,000

1,000

100

100

1,000

NA

1.0

1,000

1,000

1,000

1,000

1,000

67

100

500

NA

1.0

1,000

1,000

1,000

1,000

1,000

33

100

1,000

NA

1.0

1,000

1,000

NA

1,000

1,000

100

100

1,000

1,000

1.0

1,000

1,000

NA

1,000

1,000

100

100

1,000

1,000

1.0

1,000

1,000

NA

1,000

1,000

100

100

500

1,000

1.0

1,000

1,000

NA

1,000

1,000

100

100

1,000

1,000

1.0

1,000

1,000

NA

1,000

1,000

100

100

1,000

1,000

1.0

1,000

1,000

1,000

1,000

1,000

119

NA

417

833

20

1,000

1,000

1,000

1,000

1,000

167

NA

833

1,000

20

1,000

1,000

1,000

1,000

1,000

167

NA

833

1,000

20

1,000

1,000

1,000

1,000

1,000

250

NA

1,000

1,000

20

1,000

1,000

1,000

1,000

1,000

250

NA

1,000

1,000

20

1,000

1,000

1,000

1,000

1,000

250

NA

1,000

1,000

20

1,000

1,000

1,000

1,000

1,000

250

NA

1,000

1,000

20

1,000

1,000

1,000

1,000

1,000

250

NA

1,000

1,000

20

1,000

1,000

1,000

1,000

1,000

250

NA

1,000

1,000

20

1,000

1,000

1,000

1,000

1,000

50

100

1,000

1,000

1.0

1,000

1,000

1,000

1,000

1,000

50

100

1,000

1,000

1.0

1,000

1,000

1,000

1,000

1,000

50

100

1,000

1,000

1.0

1,000

1,000

1,000

1,000

1,000

100

100

1,000

1,000

1.0

1,000

1,000

1,000

1,000

1,000

100

100

1,000

1,000

1.0

1,000

1,000

Portable equipment
must be dedicated

Assess common raw

material vessels
12

Contamina2on Preven2on
What Should Management Do?

The requirements apply to CropLife member companies and external manufacturers.

Company Expert
Appointed

Good Housekeeping

Ensure

Training and
Awareness

Conden2ally of
Exchanged Informa2on

Resource Availability

Applica2on of
Requirements and Best
Prac2ces

June 2014

13

The Details
The following slides outline the specic how with each element of
contamina(on preven(on.

June 2014

Risk Assessment Elements

Cleaning level determina2on
Manufacturing Prac2ces
Produc2on Unit Cleaning
Analysis of Residual Impuri2es

14

External Manufacturing
Informa2on Exchange
The External Manufacturer must supply the succeeding client the following:

All crop protec2on ac2ve ingredients handled at the site (contact person if
secrecy agreements in place)
Produc2on unit congura2on, conrmed cleaning out documenta2on
The physical layout that impacts Contamina2on Preven2on
Parallel opera2ons (focusing on the separa2on elements)
Loca2on of the facility (GPS coordinates)
List of Ac2ves

Layout of Unit

Loca2on of Facility

Metosulam
Mesotrione
S-Metolachlor
Haloxyfop-p-methyl

June 2014

15

External Manufacturing
Informa2on Exchange
Requestor

Provider

External
Manufacturing

Succeeding
Client

Preceding Client

Analy2cal standards*
Analy2cal methods*
Cleaning methods*

Ac2ve present in products

NOEL**, ED5 or ED10 of succeeding
products
Classica2on data
Sample of products to develop NOEL data

Succeeding Client

Cleaning limits

*If requested and available for the previous product

**NOEL No Observable Eect Level
June 2014

16

Minimum Requirements
for External Manufacturers
Client is responsible for

External Manufacturer is responsible for

Specify the method to achieve cleaning level

(succeeding product or ushes)

Cooperate in a full audit for Contamina2on Preven2on

Conduct site audits and due diligence ..

Trace materials and records for traceability purposes..

Ensure that there is a clear agreement that includes contamina2on preven2on

expecta2ons
Appoint a person responsible for Contamina2on Preven2on
Understand contamina2on risk in your facility
See Contamina2on Preven2on booklet for details

June 2014

17

Minimum Requirements
for External Manufacturers
The following should be incorporated into the agreement/contract between the client and external manufacturer.

Client is responsible for

External Manufacturer is responsible for

Specify the method to achieve cleaning level (succeeding product

or ushes)

Cooperate in a full audit for Contamina2on Preven2on

Conduct site audits and due diligence

Trace materials and records for traceability purposes

Only use preceding client informa2on for purposes of

Contamina2on Preven2on

Appoint a person responsible for Contamina2on Preven2on

Inform External Manufacturers of special risks (highly ac2ve

Herbicides)

Separa2on of opera2ons based on the clients risk assessment

Review/update contracts or agreements with best prac2ces in

Contamina2on Preven2on

Ensure adequate analy2cal capabili2es

Ensure wriZen changeover procedures
Ensure Contamina2on Preven2on training and records of said records
Ensure labeling of equipment, materials and containers
Obtain approval of changes that impact contamina2on preven2on
Not recycling or returning samples to the process
Rework is approved by the client
Maintain good housekeeping
Reten2on and storage of retained specied by client

June 2014

18

Procurement/Purchasing of
Ac2ve Ingredients

If Ac2ve Ingredients are purchased, the following are minimum items to be included
in a supply contract:

The deni2on of cross contamina2on and contamina2on

preven2on (as dened in the booklet)
Product supplied must meet all regulatory requirements
Agreement reached that
EITHER

v Any non-listed compound in the supplied product must be < 1000 ppm or below,
in case of biological ac<vity at lower levels if there are adverse eects on crops,
users and/or environment.
OR
v Informa2on exchange for other ac2ve ingredients manufactured on the same
produc2on and packaging line, and a cleaning matrix in place (provided by
customer) and cleaning limits will be achieved (by supplier).

Detailed sales specica2on

Chemical analysis and agreement on items on cer2cate of analysis
No2ca2on of process changes
Recommended to complete a self-assessment followed by an audit
June 2014

19

Separa2on of Produc2on Units

Produc2on Unit combina2on of equipment to manufacture a product

Separa2on no shared common equipment that could cause contamina2on

Equipment separa2on is key to

contamina2on preven2on.

June 2014

When sharing services such as

nitrogen or air, measures to
prevent backow need to be
part of the design.

20

Separa2on of Produc2on Units

A key to contamina2on preven2on is to
have dedicated units
Reduce contamina2on risk
Reduce cleaning costs
Reduce down2me

Herbicides
Non-herbicides
e.g. herbicides, defoliants, and
desiccants

June 2014

e.g. fungicides, insec2cides, acaricides,

molluscicides, nema2cides, pheromones,
plant ac2vators, herbicide safeners,
roden2cides, crop oils and adjuvants

21

Cleaning Capability
Two cri2cal elements which must always be evaluated
1. Design of the
produc(on unit
(look for dead spaces)

2. Cleaning procedures
Cleaning
Levels

June 2014

Cleaning
Methods

Analy(cal
Documenta(on

22

Cleaning Level Determina2on

Key items needed to calculate levels

The No Observable Eect Level (NOEL)
The applica2on rates of the succeeding product on all crops
US EPA Pes2cide Regula2on No2ce 96-8 classica2on
For insec2cides, the LD50 honeybee

June 2014

23

NOEL data for Herbicides

NOELs are typically determined from greenhouse studies

Recommended to appoint a
specialist to calculate cleaning
levels

June 2014

Greenhouse studies determine

the dose and adverse eect
levels that will be used as a basis
for cleaning levels

24

Safety Factors and

Applica2on Rates
Safety factors in cleaning level calcula2ons further mi2gate poten2al adverse
eects.

Reasons for a factor

Studies are typically conducted in greenhouses
Dierent crop varie2es
Overlapping in elds
Spray volume uctua2on
Weather condi2ons

Highest single or seasonal

applica2on rates are used in the
calcula2on of cleaning limits

June 2014

25

Cleaning Level Calcula2on

The Cleaning Level is inversely propor2onal to the Applica2on Rate (AR)!

3 elements in the equa2on
AR
NOEL
Safety factor (SF)

Cleaning Level [
ppm]
=106 /

If the preceding herbicide formula2on contains 2 or more ac2ves, cleaning

limits for all ac2ves need to be calculated.

June 2014

26

Ac2ve Ingredients NOELs

Example of a table created to show the NOELs of ac2ve ingredients on
dierent crops

Herbicide A
Metosulam

Herbicide B
Mesotrione

S-Metolachlor

Haloxyfop-p-methyl

Classica2on based on US EPA PRN 96-8

low applica2on rate
herbicide

low applica2on rate

herbicide

Crop

April 2014

Herbicide C

normal applica2on rate

herbicide

low applica2on rate

herbicide

NOEL [g AI / ha]

Corn (Maize)

50
(registered crop)

500
(registered crop)

2500
(registered crop)

0.015

Oilseed Rape

0.005

1.70

800

> 200
(registered crop)

Sugar beet

0.005

1.70

500

> 200
(registered crop)

Tomatoes

0.2

0.40

> 200
(registered crop)

Turf
(golf courses)

25
(registered crop)

280

1500

0.01

27

Cleaning Matrix

Example of a table created to show required cleaning levels of previous ac2ve

ingredients
Succeeding Herbicide

(Poten(ally Contaminated Herbicide)

Herbicide A

Preceding Herbicide

AI Preceding Herbicide

Herbicide A

Metosulam
Mesotrione

Herbicide B
S-Metolachlor
Herbicide C

Haloxyfop-p-methyl

Herbicide A

Metosulam

Herbicide B

Mesotrione
S-Metolachlor

Herbicide C

Haloxyfop-p-methyl

Herbicide B
Herbicide C
Treated Crop
Maize (Corn), Turf
Maize (Corn)
OSR, S-beet, tomato
Max. Applica8on Rate [g Formulated Product/ha]
200
5000
500





Biology Based ARILs (ppm)
5000
N/A
5.0
< 1000
700000
400
< 1000
N/A
15000000
5000
< 1000
< 1000
25
1
N/A
US EPA PRN 96-8 based ARILs (ppm)
100
N/A
20
5
100
100
N/A
250
250
100
20
N/A
25
1

[1] If the value of the ARIL is higher than the legally accepted one, this value has to default to < 1000 ppm.

June 2014

28

Produc2on Sequencing
There may be preferred op2ons in sequencing produc2on, avoid low cleaning limits.
Op2mum sequencing can reduce cleaning 2me and waste.

void

a
d to
e
c
n
e
sequ vels

y
l
r
e
e
Prop leaning l
c
low

Produc8on Sequences Biology based ARILs

Sequence

Herbicide A

Metosulam

Sequence

Herbicide A

Metosulam

Sequence
3

Herbicide B
< 1000

Metolachlor

400
< 1000

Herbicide C
5

Haloxyfop-p-

25

methyl

Herbicide A
Metosulam

Herbicide C
Haloxyfop-p-

Mesotrione + S-
Metolachlor
Herbicide B

< 1000

25

methyl
Herbicide B

methyl

Herbicide C
Haloxyfop-p-

Mesotrione + S-

Mesotrione + S-
Metolachlor

Herbicide A
Metosulam

< 1000

Herbicide A

< 1000

Metosulam

< 1000

Herbicide A

< 1000

Metosulam

Produc8on Sequences US EPA PRN 96-8 based ARILs

Sequence 1

Sequence 2

Herbicide A
Metosulam
Herbicide A
Metosulam

Herbicide B
20

Metolachlor

Haloxyfop-p-
methyl

June 2014

250

Herbicide C
5

Haloxyfop-p-

25

Herbicide A
Metosulam

Herbicide C
Haloxyfop-p-

Mesotrione + S-
Metolachlor
Herbicide B

20

25

methyl
Herbicide B

methyl

Herbicide C
Sequence 3

Mesotrione + S-

100

Mesotrione + S-
Metolachlor

Herbicide A
Metosulam

100

Herbicide A

250

Metosulam

100

Herbicide A

250

Metosulam

29

Insec2cide Cleaning Levels

The purpose is to ensure op2mal safety to non-target organisms
such as pollinators visi2ng the treated crop.

Honey bee LD50 values are typically available for all ac2ve ingredients.

An equa2on for calcula2ng Insec2cide Cleaning Levels can be found in
the booklet in more detail (see chapter 6.3).
June 2014

30

Fungicide Cleaning Levels

If a fungicide has herbicidal and/or growth regulator characteris2cs
(e.g. members of the azole family), addi2onal tests on selec2vity are
recommended. The regulatory maximum allowed limit is <1000 ppm.

June 2014

31

Manufacturing Prac2ces
Iden2ca2on of Incoming Goods

A few steps need to be completed when receiving goods into a facility

Check
Check
Verify

June 2014

1. Bill of lading against a purchase order

2. Cer2cate received with specica2on

3. Iden2ty or perform Quality Control tests

prior to release in manufacturing

32

Changeover and release of equipment

Ensure produc2on equipment is clean and documenta2on is available prior to start up

WriZen records to be maintained and include
Dates of previous produc2on and cleaning
Conrma2on of each cleaning step
Analy2cal evidence verifying content of AI is below the RIL
Verica2on that cleaning procedure has been followed, visual inspec2on, second
person sign o, etc.
Formal release of equipment

June 2014

33

Staging Material(s)
Store herbicide ac2ves and associated raw
materials separately from non-herbicide
ac2ves and associated raw materials

At the warehouse, verify the name and batch number of material

when picking
Use FIFO
Produc2on to verify the material received is the same as indicated
on the batch record
Personnel performing tasks should sign documenta2on

June 2014

34

Shared Equipment
Create a procedure for using shared equipment, iden2fying steps to
take when transferring from one area to another.

Use of shared equipment in a non-herbicide area, once it has been in

contact with a herbicide, should not be permiZed.

June 2014

35

Shared Equipment
Direct contact

No Direct Contact

Verify appropriate cleanliness

If in contact with an ac2ve, clean
similar to other equipment.
If permeable,
porous, or dicult
to clean dedicate
to a specic ac2ve.

June 2014

If transferred, verify clean

(no residue or dust).
Assess risk when sharing between
herbicide and non-herbicide
areas.

36

Tools
Sharing tools is permiZed but
check to be sure they are
clean (no residue present)

In a solids plant, vacuum cleaners for

equipment must be dedicated when the
solids are returned to the process.

June 2014

37

Dedicated Rellable Containers

As a minimum, the following must be in place:
Process to track containers (status, loca2on, etc.) including serial
numbers and labeling
Visual inspec2on upon return to a plant
Backow preven2on in place to avoid cross-contamina2on during
ooads

June 2014

38

Non-dedicated Rellable Containers

As a minimum, the following must be in place:
Date of rst use and number of 2mes relled
A process to track containers including serial numbers, labeling, previous product,
and cleaning date
If cleaned within a manufacturing facility, a wriZen cleaning procedure
If cleaning is outsourced, verica2on checks at manufacturing loca2on
Inspec2on prior to use
Containers used for herbicides not to be used for non-herbicides

June 2014

39

Labeling Rellable Containers

In addi2on to the legal requirements, at a minimum

the label should include

Name of material
Product code
Batch number
Produc2on date
Quan2ty

When the container is empty, the label should indicate

Cleaning status and previous product
Date of last cleaning
For aqueous products, empty containers should be dry and closed, to avoid
microbial growth

June 2014

40

Storage of Materials
Raw materials for herbicide and non herbicide opera2ons may be stored together if:

The outside of the package is clean
Herbicide and non-herbicide ac2ve
ingredients are physically separated
Non-herbicide inert raw materials are
physically separated from herbicide ac2ve
ingredients
Separa2ons clearly marked
Clear labeling in place
Par2ally used materials must be returned
to appropriate storage areas and wrapped

June 2014

41

Storage Tanks
Feeding from a common inert raw material tank can be a risk

2 layers of protec2on should be part
of the design:

Mul2ple isola2on valves in series
Blanked/blind anges
Isola2on valve and blanked/blind
ange
Isola2on valve with a physical
break

Opera2ng procedures should conrm that processes cannot be fed

simultaneously.

June 2014

42

Reworking, Blending, and Recycling

Applying these prac(ces will minimize risks
A

If collected from external

surfaces, discard.

Dust and over-size

materials collected from
solids processing may be
returned.
June 2014

If storing rework,
quaran2ne, segregate and
only store the same product
on the pallet.
If seal on returned
material is not intact,
discard. If intact, conduct
risk assessment.

Product release
samples must
not be recycled.

43

Reworking, Blending and Recycling

Con(nued prac(ces

O-spec

If not contained within produc2on

equipment, discard the dust.

Rinsates may be recycled if

treated like an ac2ve or raw
material.
June 2014

O spec material must be

labeled.

Recycling cleaning
medium, rst includes
a risk/benet
discussion.

WriZen procedure is needed for

reworking o-spec or over-aged
product.

At external manufacturers,
rework can only occur with
wriZen approval from client.
44

Final Product Labeling

Product Label X

Material Name:
Product Code:
Batch Number:
Produc2on Date:
Quan2ty:

Good Stu
XYM985
AC151406
03-14-14
50.2 kg

If temporary labels are

needed, the product name,
batch and quan2ty should be
included

To avoid mix-ups,
label control needs to
be in place

June 2014

45

Traceability
Traceability must be in place for produc2on,
lling and packaging opera2ons.
Items to consider:

June 2014

Ingredients used (lot numbers/quan22es)

Manufacturing condi2ons
Batch/lot of the product
Date, names and ini2als of personnel
responsible for charging and verica2on

46

Modica2ons
When a produc2on unit is modied or updated, ensure that

Yes or No

Verify cleaning
procedures aXer change
Before rst use, ensure
cleanliness

A Management of Change
procedure is in place.

The design change includes the cleaning

process.

June 2014

47

Self-Assessment
Plan

Act

June 2014

Do

Comple2ng the Contamina(on Preven(on

self-assessment provides a good baseline for
measuring improvement in quality prac2ces.

Check

48

Produc2on Scheduling
Items to consider when scheduling
produc2on:

Using dedicated lines
Moving low rate and/or highly ac2ve
herbicides together with comparable
products
Consolida2ng highly ac2ve products
in one unit
Low rate refers to herbicides with an applica<on rate of to 560 g AI/ha.
Highly ac<ve refers to herbicides with an applica<on rate of < 50 g AI/ha

June 2014

49

Cleaning Procedures
WriZen procedures for cleaning must detail:

Cleaning medium used
The order in which parts/lines are cleaned
How the cleaning medium is applied
Flush quan2ty
Dismantling and manual cleaning
Flush sample loca2ons
Internal equipment drying
Instruc2ons for handling cleaning medium
(dispose/recycle)

There are specic guidelines for cleaning liquid versus solid produc2on units.

June 2014

50

Visual Inspec2on
Visual inspec2on is a key step in
cleaning

If residue is present, repeat
cleaning step as appropriate.
Use tools, like mirrors, to
inspect for dead spaces.

June 2014

51

Wet Cleaning
Depending on the design, wet cleaning is recommended for liquid
products and can also be applied in solid products cleanout.

June 2014

52

Dry Cleaning
A solid ush uses an inert material.
AXer solid ushing:

Deposits are removed by opening or dismantling equipment.
Brushing or vacuuming interiors

June 2014

53

Cleanout Capability
Cleanout capability is demonstrated when the cleaning level is
consistently achieved using the cleaning procedure.
Capability is demonstrated through:

Deni2on of cri2cal parameters (design, process condi2ons)
Selec2on of low level or dicult cleanouts
Adherence to procedures
Analyses of mul2ple cycles of residue material
Analysis of the succeeding product for RI of previous product

If any of the cri2cal parameters change, re-evalua2on is needed.
Training of all personnel involved is key to ensure
eec2ve repeatable cleanouts.

June 2014

54

Cleaning Medium
Recycling used cleaning medium should be based on a risk assessment.

Re-use savings

Ecological

June 2014

Labeling errors

Storage stability

55

Residual Impurity Analysis

Can be performed on the ush or in the succeeding
product.
Analysis in the succeeding product versus the ush
medium is preferred.

Flush results are not a guarantee.

June 2014

56

Sampling
Determine sampling loca2ons...
Formula2on vessels

Packaging line

Last rinsate

Do not re-use sampling containers

Establish storage and reten2on of samples
Retain all analy2cal data

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Analy2cal Methods
Analy2cal methods need to be developed for the determina2on of
residual impuri2es.
Valida2on of methods should include:

Specicity
Recovery
Repeatability
Linearity
Contamina(on can occur in the lab;
systems should be in place to use
clean glassware, vials, etc.
Understand the cleaning levels and choose the appropriate analy2cal approach.

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Contamina2on Preven2on
Making it Sustainable
Keep all the Pieces Together

June 2014

Believe in the Philosophy of Contamina2on Preven2on

Do not become complacent
Do not allow short cuts
Build contamina2on preven2on into the design

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Disclaimer

The informa2on contained in this presenta2on is accurate to the best

knowledge of the CropLife Interna2onal Opera2ons CommiZee, but
no liability whatsoever can be accepted by this Group, CropLife
Interna2onal or their member companies and associa2ons in respect
of the use of this informa2on, nor in respect of any advice contained
herein.
All contents of this presenta2on are best prac2ces, which are
recommended by the Opera2ons CommiZee. Implementa2on of
Contamina2on Preven2on measures is the responsibility of individual
member companies represented in CropLife Interna2onal in
coopera2on with their external manufacturers, or any other
manufacturer.

June 2014

June 2014

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