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(Use FDA booklet titled: "Instructions for Establishment
Registration and Process Filing for Acidified and Low-Acid FORM APPROVED: OMB NO. 0910-0037
Canned Foods" for completing Form FDA 2541a.)
EXPIRATION DATE: 6/30/08

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION

FOOD PROCESS FILING FOR ALL METHODS EXCEPT LOW-ACID ASEPTIC

A. PRODUCT

See OMB Statement on back of page.

Name, Form or Style, and Packing Medium:

pH:
(Before Acidification)
Governing Regulation:
low-acid (21 CFR 108.35/113)
acidified (21 CFR 108.25/114)

20
Type of Submission:
new
replaces
cancels

B. PROCESSING METHOD
1.
a.

FCE

Still
Horizontal
b.
Vertical
Divider Plates (complete for a. or b.)
None
Perforated

2.
a.

Crateless
Bottom Surface (complete for c.)
Solid
Perforated

Agitating
End over End
Axial

3.

Hydrostatic
Inner Chain only
Outer Chain only
Both Inner and
Outer Chain
Single Chain
Multiple Chain

Continuous
Batch

4.

Flame

5.

Other (explain)

6.

Acidified
Maximum Equilibrium pH:
Method of Acidification:
Acidifying Agent:
Pasteurization Method:
Preservative Used:

CONTAINER TYPE:
Tinplate/Steel Can
Aluminum Can

D D

S S S

SID

. , . , .

Concentration:

1.
2.

M M

NAME OF STERILIZER (MFR. & TYPE)

HEATING MEDIUM (e.g., Steam, water, immersion or spray, steam-air)

b.
c.

Y Y Y Y

Process Use:
scheduled
alternate for
emergency for

2-piece
3-piece

3.
4.

Welded
Cemented

Glass or Ceramic
Flexible Pouch (specify material):

5.
6.

PROCESS ESTABLISHMENT SOURCE (Limit entry to 30 characters)

DATE LAST ESTABLISHED

Semirigid (specify material):

Seal Method
Other (specify):

Lid

Body

PROCESS RECOMMENDATIONS ATTACHED?

YES

NO

C. CRITICAL FACTORS: AS DILINEATED BY PROCESS AUTHORITY TO ASSURE COMMERCIAL STERILITY (Check or Describe)
None of the following . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maximum Water Activity (a w) . . . . . . . . . . . . . . . . . . . . . . . .
Consistency / Viscosity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Method Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Container Position in Retort . . . . . . . . . . . . . . . . . . . . . . . . . .
Nesting of Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fill Method (check applicable method) . . . . . . . . . . . . . . . . . .
Hand or Volumetric . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vibrating or Tumble . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other (specify) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
% Solids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Solid to Liquid Ratio (wt. to wt.) . . . . . . . . . . . . . . . . . . . . . . .
Drained wt./Net wt. Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

FORM FDA 2541a (10/05)

Page 1

NO
MW
CV

.)

(
CP
NC
FM

SO
SL
DW

(
(
(

PREVIOUS EDITION IS OBSOLETE

.
.

)
)
)

Arrangements of Pieces in Container . . . . . . . . . . . . . . . . . . .

Formulation Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preparation Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Product Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Matting Tendency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Layer Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Max. Flexible Pouch/Semirigid Container Thickness in Retort
Max. Residual Air (Flexible Pouch/Semigrid Container) . . . . .
Particle Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Syrup Strength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Starch Added . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Max. % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other Binder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Min. % Moisture of Dry Ingredients . . . . . . . . . . . . . . . . . . . .
Other (specify) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

AP
FC
PM
PQ
MT
LP
MP
MR
PS
SS
SA

(
(
(
(

OB
MM
OT

NOTE: No commercial processor shall engage in the processing of low-acid or acidified foods unless completed Forms FDA 2541 and
FDA 2541a have been filed with the Food and Drug Administration, 21CFR 108.25(c)(1) and (2) and 108.35(c)(1) and (2).

.
.
.
.

)
) c.c.
)
)

)
PSC Graphics: (301) 443-1090

EF

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D. SCHEDULED PROCESS
CONTAINER
DIMENSIONS
Cont.
No.

Diameter
or Length

Height
or Width

Previous Page

SCHEDULED PROCESS
(Check Only One in Each Column)
Step
No.

Temp (F)

Process Time
(Minutes)

LACF
Oz.
Gal.
ML
Other

Min.IT

Process
Time

Process
Temp.

Min.IT

Center

Process
Time

Process
Temp.

N/A

N/A

Minutes

.
.
.
.
.
.
.
.
.
.

Thruput

Reel Speed

Reel
Diameter

Other F Value

Steps
Per Turn
of Reel

OTHER
(Specify)

Minimum
Net
Weight

Minimum
Free Liq.
at Closing

Chain /
Conveyer
Speed

Minimum
Container
Closing
Machine
Gauge
Vacuum

Feet

Death Rate (z):

Carriers
Flights

Net

(per minute)

Gross

Temp.
( 3 F)

Drained
Fill

IS Value
N/A

Other:

.
.
.
.
.
.
.
.
.
.

N/A

N/A

Containers
per Minute

Inches

.
.
.
.
.
.
.
.
.
.

N/A

RPM

Inches Number

Inches

.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.

N/A

N/A

N/A

N/A

Ounces

Ounces

Ounces

In. Hg.

.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.

.
.
.
.
.
.
.
.
.
.

FOR FDA USE ONLY

COMMENTS:

PLANT NAME / ADDRESS

AUTHORIZED
INDIVIDUAL

PREFERRED
MAILING
ADDRESS

FORM FDA 2541a (10/05)

Maximum
Weight

Speed

Headspace

F0

Ref. Temp.(T):

Hold
Time
Other

SID:

OTHER CRITICAL FACTORS TO ASSURE

COMMERCIAL STERILITY PER SOURCE AUTHORITY

Sterilzation Least Sterilizing Value

Temp (F)
of the Scheduled
Process

Acidified or a w Controlled

Fill

Inches &
Inches &
Inches &
Sixteenths Sixteenths Sixteenths

FCE:

(Do not write in shaded areas -- Check appropriate box and enter numerical values on dashed lines.)

CAPACITY
UNITS
Height or
Maximum
Pouch or
Semirigid
Container
Thickness

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FULL NAME (Please Type or Print)

TELEPHONE NUMBER

SIGNATURE

DATE

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Public reporting burden for this collection of information is estimated to average .333 hours per response, including the
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding this burden estimate or any other
aspect of this collection of informa- tion, including suggestions for reducing this burden, to:
Food and Drug Administration
LACF Registration Coordinator (HFS-618)
Center for Food Safety & Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

FORM FDA 2541a (10/05)

Page 3