2541d Food Process Filing for Low-Acid Retorted Method

Form Approved: OMB NO. 0910-0037; Expiration Date 10/31/2023 (See PRA Statement on last page)

Food Process Filing for Low-Acid Retorted Method

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

(Form FDA 2541d)

Note: There are separate process filing forms for each of the following: Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d); Food Process Filing for Acidified Method (Form
FDA 2541e); Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f); and Food Process Filing for Low-Acid Aseptic Systems (Form FDA 2541g).
USE FDA INSTRUCTIONS ENTITLED “Instructions for Paper Submission of Form FDA 2541d (Food Process Filing for Low-Acid Retorted Method)”
FDA USE ONLY

Date Received by FDA:

/

/

(MM/DD/YYYY)

Food Canning Establishment (FCE) Number (Enter number assigned by FDA)

Submission Identifier (SID) (YYYY-MM-DD/SSS)

20
A. Product Information

Gelatin, Pudding Filling for Pies, Pie Filling (liquid form ready-to-eat such as apple pie
filling, etc.)
Gravies/Sauces (spaghetti sauce, mushroom gravy)

Aquaculture Seafood (e.g., farming of aquatic organisms including fish, mollusks,
crustaceans, etc.)

Imitation Dairy (includes soy-based products)

Baby Food (infant/junior foods including infant formula)

Imitation/Pit/Mixed/Subtropical Fruit

Bakery Products (canned brown bread, bakery glazes)

Imitation/Pit/Mixed/Subtropical Fruit

Beans, Corn, or Peas

Imitation/Pit/Mixed/Subtropical Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping

Beans, Corn, Peas - Fresh Succulent

Leafy/Stem Vegetables

Berry/Citrus/Core Fruit

Leafy/Stem Vegetable
Leafy/Stem Vegetable as a Juice or Drink (e.g., spinach juice, etc.)

Berry/Citrus/Core Fruit
Berry/Citrus/Core Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping

Meal Replacement/Medical Foods (e.g., supplemental liquid nutrition, etc.)

Breakfast Foods (liquid form – ready-to-eat, such as porridge, gruel)

Cheese (does not include soy cheese or imitation dairy)
Cocoa

/

Fungi (e.g., mushrooms, pleurotus, truffles, etc.)

1. (Optional) Select one Food Product Group. If there is no single best Food Product
Group that applies, select Other.

Beverage Base

-

A.1 (Food Product Group) (Continued)

Note: Section A.1 (Food Product Group) requests optional information.

Beans or Peas - Dry or Mature Soaked

-

Mixed Vegetables (e.g., carrots and peas, etc.)

Dairy (milk-based)

Mixed Vegetables as a Juice or Drink (e.g., carrot and green bean juice, etc.)

Dietary Supplement and/or herbal and botanical teas
Dressings/Condiments (e.g., salad dressing, chutney, salsa, pepper sauce, etc.)
Engineered Seafood (e.g., shelf-stable imitation crab, surimi, etc.)

Mixed Fishery (e.g., seafood salad, etc.)

Mixed Vegetables

Coffee/Teas (excluding herbal and botanical teas)

Crustacean (e.g., crab, shrimp, lobster, etc.)

Meat Products (Exotic Meat (emu, elk, etc.))

Fishery (finfish)

Fishery (other aquatic (e.g., alligator, cuttlefish, frog legs, squid, etc.)

Multiple Food (one container with a separate compartment for each product item (e.g.,
lasagna dinner, chop suey dinner, etc.)
Noodle/Pasta
Other Vegetables
Nut Spread and Nut Topping
Pet Food (e.g., dog/cat food, etc.)

Fruit as a Vegetable

Rice, Wheat, Oat or Grain (liquid form – ready-to-eat such as grits)

Fruit as a Vegetable (e.g., eggplant, pumpkin, etc.)
Fruit as a Vegetable Juice or Drink (e.g., eggplant juice, pumpkin juice, etc.)

FORM FDA 2541d (02/21)

Page 1 of 9

PSC Publishing Services (301) 443-6740

EF

Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d)

C. Container Type (Select one)

A.1 (Food Product Group) (Continued)
Root and Tuber Vegetables

Note: If the product is not packaged in one of the container types identified below,
select Other.

Root/Tuber Vegetables (e.g., carrots, leeks, potatoes, etc.)
Root/Tuber Vegetables as a Juice or Drink (e.g., carrot juice, etc.)
Shelled Egg

Shellfish (e.g., clams, mussels, oysters, etc.)

1.

Aluminum/Tinplate/Steel Can
a) What is the shape of the container? (Select one)

Soup

Cylindrical

Sweet Goods/Dessert (liquid form – ready-to-eat, such as pudding)

Oval

Rectangular

Irregular (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Vegetable Protein Products (e.g., imitation meat analog)
Vine/Other Fruit
Vine/Other Fruit

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Vine/Other Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping
Wine Cooler

b) How many pieces are used to construct the container? (Select one or more choices,
as applicable)
i.
2-pieces – Do you use perforated divider plates?
Yes
No

Other (Specify below)

ii.

2. Enter Product Name (e.g., beans, green; mushrooms (button); tuna (light); sardines (sild))

3-pieces – Do you use perforated divider plates?

Yes

No

How is the side seam sealed? (Select one)
Cemented
3. What is the form of the product? (Select all that are applicable)
Chunks (e.g., chunks, nuggets, etc.)
Liquid (i.e., all liquid no solids)
Round/Spheres
Spears/Stalks

Cut

Diced

On the Cob

Shredded/Julienne

Filet

Paste/Puree

Yes (If yes, answer either question c.i or c.ii.)

French cut
Pieces

Other (Enter product form)

Heat penetration test was conducted with nested containers. (Attach study and
picture or diagram. Provide name or a brief description of attachment below.)

ii.

Nesting of containers prevented by: (Select one)
Brick Stacked
Racks

4. What is the packing medium? (Select all that are applicable)
Cream/Sauce/Gravy

Syrup

Water

Oil

Solid (no packing medium)

2.

No (If no, continue to Section D.)

i.

Sliced (e.g., slices, quarters, strips, etc.)

Whole

Brine

Welded

c) Is the container a low-profile container?

Lid to Lid/Bottom to Bottom

Perforated Divider Plates

Spiral

Ceramic/Glass
a) What is the shape of the container? (Select one)

None

Cylindrical

Other (Enter packing medium)

Rectangular

Irregular (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Continue to Section B.
Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

B. Governing Regulation (Refer to the precursor questions in the
instructions)
x Low-acid (21 CFR 108.35 and 21 CFR Part 113)

b) Do you use perforated divider plates?

Continue to Section C.
FORM FDA 2541d (02/21)

Yes

No

(Continue next page – Glass/Ceramic)
Page 2 of 9

Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d)
C. Container Type: 4. Retortable Paperboard Carton (Continued)

C. Container Type: 2. Ceramic/Glass (Continued)
c) Is overpressure used during the processing of the product to maintain container integrity?
i.

b) Is the container physically restricted during the processing of the product to control
container thickness?

Yes (Continue to c.i)
No (Continue to c.ii-c.iv)
What is the total overpressure used during processing? _ _._
(enter in pounds per square inch gauge (psig)) (Continue to Section D)

No (Continue to c)

Yes (Continue to b.i)
i.

ii. What is the percent (%) headspace? _ _._

Racks
Other (Attach a picture. Provide name or a brief description of attachment
below.)

iii. What is the minimum initial temperature? _ _ _._ (enter in Fahrenheit)
iv. What is the vacuum? _ _._ (enter in inches of mercury (Hg))
3.

Flexible Pouch

c) Is overpressure used during the processing of the product to control container thickness?

a) What is the shape of the container? (Select one)
Flat pouch

Gable top

Gable top/side gusseted

i.

Irregular (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

What is the total overpressure used during processing? _ _._ (enter in pounds
per square inch gauge (psig))

d) What is the maximum thickness during retort processing? _ _ ._ _ (enter in inches)
e) What is the maximum residual air? _ _ _ (enter in cubic centimeters)

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

5.

Not Applicable

Semi-Rigid
a) What is the shape of the container? (Select one)

b) Is the container physically restricted during the processing of the product to control
container thickness?
No (Continue to c)
Yes (Continue to b.i)
i.

No (Continue to d)

Yes (Continue to c.i)

Gusseted

Bowl

Cylindrical

Oval

Rectangular

Tray

Irregular (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Racks
Other (Attach a picture. Provide name or a brief description of attachment
below.)

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

c) Is overpressure used during the processing of the product to control container thickness?
Yes (Continue to c.i)
i.

No (Continue to d)

b) Is this a compartmentalized container? (Select one)

What is the total overpressure used during processing? _ _._ (enter in pounds
per square inch gauge (psig))

Yes

4.

Not Applicable

Retortable Paperboard Carton
a) What is the shape of the container? (Select one)

HDPE (high-density polyethylene)
Paperboard

HDPP (high-density polypropylene)

PET (polyethylene teraphthalate)

Other (Enter material)

Rectangular

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

FORM FDA 2541d (02/21)

No

c) What is the predominant material used to make the body of the container? (Select one)

d) What is the maximum thickness during retort processing? _ _ ._ _ (enter in inches)
e) What is the maximum residual air? _ _ _ (enter in cubic centimeters)

How many compartments? _ _

(Continue next page – Semi Rigid)

Page 3 of 9

Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d)
C. Container Type: 5. Semi Rigid (Continued)

C. Container Type: 6. Other (Continued)
b) Specify the material that, based on weight, is the predominant material used to make the
container stock. This is the material that constitutes the highest weight value of the
container stock.

d) What is the predominant material used to make the lid of the container? (Select one)
Aluminum/Steel

HDPE (high-density polyethylene)

HDPP (high-density polypropylene)

Nylon

PET (polyethylene teraphthalate)

c) Specify the material that, based on weight, is the predominant material used to make the
lid stock. This is the material that constitutes the highest weight value of the lid stock. If
the container does not have a lid, specify Not Applicable.

Not Applicable
Other (Enter material)

d) Specify the method used to seal the lid to the body of the container. If the container does
not have a lid, specify Not Applicable.

e) How is the lid sealed to the body of the container? (Select one)
Heat Seal

Double Seam
Snap On

Threaded Closure

Induction Weld

Press Twist

Continue to Section D.

Ultrasonic Seal

Not Applicable

D. Container Size

Other (Enter seal type)

Note: Section D.1 (dimensions) is required information. However, section D.2
(net weight) is optional information.
1. Dimensions:

f) Is the container physically restricted during the processing of the product to control
container thickness?
Yes (Continue to f.i)
i.

a) _ _ _ _ Diameter _ _ _ _ Height (Use for cylindrical shapes) (see accompanying
instructions for proper coding)

No (Continue to g)

b) _ _ _ _ Length _ _ _ _ Width _ _ _ _ Height/Thickness (Use for container shapes
other than cylindrical) (see accompanying instructions for proper coding)

Racks
Other (Attach a picture. Provide name or a brief description of attachment
below.)

2. Net Weight (Optional): _ _ _._ _ (enter in ounces)

Continue to Section E.
g) Is overpressure used during the processing of the product to control container thickness?
Yes (Continue to g.i)
i.

No (Continue to h)

1. What is the finished equilibrium pH of the product after processing?

What is the total overpressure used during processing? _ _._ (enter in pounds
per square inch gauge (psig))

6.

a)

Not Applicable

High pressure assisted

Microwave

Ohmic (electrodes)

Steam-air (Attach a heat distribution study. Provide name or a brief
description of attachment below.)

Other (Enter container type)
Water cascade

a) Attach schematic or picture of container. (Provide name or a brief description of
attachment below.)

Water immersion

Other (Enter heating medium)

Continue to Section F.
FORM FDA 2541d (02/21)

_ _ ._ _

2. Heating Medium (Select one)

h) What is the maximum thickness during retort processing? _ _ ._ _ (enter in inches)
i) What is the maximum residual air? _ _ _ (enter in cubic centimeters)

E. Processing Method: Thermally Processed Non-Aseptic System

Page 4 of 9

Water spray

Steam

Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d)

F. Process Mode

G. Process System Critical Factors (Continued)

1. Mode (Select One). Only 1 Process Mode, either Agitating or Still, should be selected.
a) Agitating (Select one)
i.

4.

Axial (Select one)
Batch

Brick Stacked
Lid Down

ii.

End over End (Only batch)

iii.

Oscillation (Only batch) (Select one)

Horizontal

ii.

Vertical

Low frequency

5.

6.

Crateless: Bottom Surface (Select one)
Hydrolock

c)

Hydrostatic

d)

Retort

e)

Rotomatic/Rotary

f)

Sterilmatic

g)

Other (Enter cooker type)

Lid Up

Jumbled/Random
Vertical

Minimum Come-Up-Time: _ _._ (enter in minutes) (Attach a temperature distribution
study. Provide name or a brief description of attachment below.)

Minimum Water Flow Rate: _ _ _ _ _._ (enter using gallons per minute (gpm))
Not Applicable (Attach an explanation. Provide name or a brief description of
attachment below.)

Perforated

b)

Horizontal

When heating medium of steam-air is selected in Section E, skip G.6

2. Cooker: What type of cooker do you use? (Select one)
Solid

No

When heating medium of high pressure assisted, microwave, ohmic, or steam is
selected in Section E, skip G.5 and G.6.

b) Still (Select one)
i.

Yes

What is the container position in retort? (Select one) (Under Section F.1 when
Agitating is selected, skip this question.)

Continuous

High frequency

a)

3. Is the product vacuum packed?

Continue to Section H.

H. Product Critical Factors: (Complete all product critical factor questions
as delineated by process authority to assure commercial sterility.)
1. Does the product contain particulates?

Yes (Continue to a)

No (Continue to H.2)

a) Is controlling the particulate size a critical factor?

(For Other cooker type choice, attach documentation. Provide name or a
brief description of attachment below.)

Yes (Continue to b-d)

No (Continue to H.2)

b) What is the shape and dimension of the particulate size to be controlled? If more than
one, list all that apply.

Continue to Section G.

G. Process System Critical Factors

c) Does your product contain fines?

1. What is the filling method(s) used to fill the product into the container? (Select all that apply)
Hand filling

Piston filling

Vibrating/Tumble filling

Pocket filler

Two Phase

Three Phase

Yes

2. Does the product contain any dry ingredients?
Yes (Continue to a)

(Continue to a)

No (Continue to H.3)

a) What is the minimum % moisture of the hydrated dry ingredients before
processing? _ _._ _

a) Enter the number of ounces added in each Phase. Phase 1: _ _ _._ _
Phase 2: _ _ _._ _ Phase 3: _ _ _._ _

FORM FDA 2541d (02/21)

No (Continue to d)

What is the maximum percent? _ _ _._

d) Is full rehydration of the particulate a critical factor?

Volumetric filling

2. How many phases are used to fill the container with the product? (Select one)
Single Phase

i.

Yes (Continue to c.i)

Not Applicable

Page 5 of 9

No

Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d)
H. Product Critical Factors (Continued)

H. Product Critical Factors (Continued)
8. Are other binders added?

3. How are pieces arranged in the container? (Select one)
Head to Tail

Heads/Tips Down

Layered

Vertical

Heads/Tips Up

Yes (Continue to a-b)
a) What is the maximum % binder added? _ _._ _

Horizontal

No (Continue to H.9)

b) What is the type of binder added?

Not Applicable
Other (Enter arrangement of pieces)

9. Does syrup strength affect the heat penetration during processing of the product?
Yes (Continue to a)

For Other arrangement of pieces choice, attach documentation. Provide name or a
brief description of attachment below.)

No (Continue to Section I)

a) What is the brix measurement? _ _._

Continue to Section I.
4. Does the % total solids affect the heating of the product during processing?
Yes (Continue to a)

No (Continue to H.5)

a) What is the % total solids? _ _._ _
5. Is the finished equilibrium pH of the product after processing (identified in Section E)
critical to the process?
Yes

No

I. Process Source (Complete the questions below)
*Note: If you selected “Still” as the mode in Section F.1, and “Steam” as the
heating medium in Section E.1, you may select “Unknown” or “Locally Made” for
sterilizer if applicable.
1. Process Source
a) What is the Process Source?

6. Does consistency/viscosity affect the heating of the product?
Yes (Continue to a-c)

No (Continue to H.7)

(Attach support documentation. Provide name or a brief description of attachment
below.)

a) What instrument is used to measure the consistency/viscosity?

b) What is the temperature when you measure the consistency/viscosity?
(enter in Fahrenheit) _ _ _._
c) What is the consistency/viscosity? _ _ _._ _ _

b) What is the date of the Process Source Document (mm/dd/yyyy)? _ _ / _ _ / _ _ _ _
2. What is the Manufacturer's Name and the Sterilizer Model?

What is the unit of measure? (Select one)

*Unknown/Locally Made (Attach pictures and documentation. Provide name or a
brief description of attachment below.)

Centipoise
Other (Enter units of measure)

7. Is starch added to maintain consistency/viscosity of the product?
Yes (Continue to a-b)

Continue to Section J.

No (Continue to H.8)

a) What is the maximum % starch added? _ _._ _
b) What type of starch is added?

FORM FDA 2541d (02/21)

Page 6 of 9

Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d)

J. Scheduled Process: (Do not write in shaded areas -- Check appropriate box under column heading, when applicable, and enter numerical values on
dashed lines.)
In the section below, please do NOT enter decimal points. They are already on the form. No blank spaces are allowed, therefore, enter leading zeros, where necessary.
Col. 1

Col. 2

Col. 3

Col. 4

Col. 5

Col. 6

Col. 7

Col. 8

Process
No

Step

Minimum
Initial Temp.

Process
Time

Process
Temp.

Fo
(F18/250)

Thruput
(Containers
per Minute)

Headspace

Col. 9
a. Reel
Speed

b. Reel
Diameter

c. Steps per
Turn
of Reel

d. Chain/
Conveyer
Speed

Net

Feet

Gross

Carriers

NA

Flights

e. Cooker
Capacity

f. Frequency
Strokes per
Minute

Col. 10

Col. 11

Col. 12

Col. 13

Maximum
Fill Weight

Minimum
Free Liq.
at Closing

Minimum
Container
Closing
Machine
Gauge
Vacuum

Other

NA

Temp.
(+/- 3◦ F)

_ _ _._

(per minute)
Number

Number

°Fahrenheit

Minutes

°Fahrenheit

Minutes

Number

Inches

RPM

Inches

Number

Number

Number

Number

Ounces

Ounces

In. Hg.

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FORM FDA 2541d (02/21)

Page 7 of 9

Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d)

K. Additional Information (Optional)
Heat Penetration Data (optional) :
Enter applicable values:

1. j value _ _._ _

2. fh value _ _ _._ _

3. f2 value _ _ _._ _

4. jc value _ _._ _

5. fc value _ _ _._ _

6. x (Xbh) value _ _ _._ _

Heat Penetration Study (Attach document. Provide name or a brief description of attachment below.)

Temperature Distribution Study (Attach document. Provide name or a brief description of attachment below.)

Other (Attach document. Provide name or a brief description of attachment below.)

Comments:

Note: Under the terms and provisions of Title 18, Section 1001, United States
Code, in any matter within the jurisdiction of the executive branch of the
Government of the United States it is a criminal offense to falsify, conceal, or
cover up a material fact; make any materially false, fictitious, or fraudulent
statement or representation; or make or use any false writing or document
knowing the same to contain any materially false, fictitious, or fraudulent
statement or entry.

when it contains parameters that cannot be reconciled with one another, such
that the filing does not describe a process that could actually be carried out. If
we determine that your process filing appears fabricated, we will delete the
filing from our system and notify you. We will not consider you to have
complied with 21 CFR 108.35(c)(2) until you submit a completed process filing
that does not appear to be fabricated.

If your process filing appears to be fabricated, the product on this form will not
be in compliance with 21 CFR 108.35(c)(2). A process filing appears fabricated
Full Name (Please Type or Print)
Establishment Name

FORM FDA 2541d (02/21)

Signature
State or Province

Country (other than U.S.)

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Date

Telephone No.

Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d)

LACF Contact Information
For more information, contact the LACF Registration Coordinator by e-mail at [email protected] or phone: 240-402-2411.
For paper submissions, send completed forms to:
Food and Drug Administration
LACF Registration Coordinator (HFS-303)
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park, MD 20740-3835

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
PAPERWORK REDUCTION ACT NOTICE
The time required to complete this collection of information is estimated to average 20 minutes per response,
including the time to review instructions, search existing data sources, gather and maintain the data needed and
complete and review the collection of information. Send comments regarding this burden estimate or any other
aspect of this information collection, including suggestions for reducing this burden, to:
FDA PRA Staff
Office of Operations
Food and Drug Administration
email to [email protected]
“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 number.”

FORM FDA 2541d (02/21)

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