FORM FDA 2541e

Food Process Filing for Acidified Method

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB NO. 0910-0037; Expiration Date 10/31/2023 (See PRA Statement on last page)
Food Process Filing for Acidified Method (Form FDA 2541e)

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 2541e (Food Process Filing for Acidified 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

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

1. (Optional) Select one Food Product Group. If there is no single best Food Product Group that applies, select Other.
Aquaculture Seafood (e.g., farming of aquatic organisms including fish, mollusks, crustaceans, etc.) Baby Food (infant/junior foods including infant formula)
Bakery Products (canned brown bread, bakery glazes)

Beans, Corn, or Peas Beans or Peas - Dry or Mature Soaked

Beans, Corn, Peas - Fresh Succulent

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

Beverage Base

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

Cheese (does not include soy cheese or imitation dairy)

Cocoa

Coffee/Teas (excluding herbal and botanical teas)

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

Dairy (milk-based)

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.)

Fishery (finfish)

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

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

A.1 (Food Product Group) (Continued) Fungi (e.g., mushrooms, pleurotus, truffles, etc.)
Gelatin, Pudding Filling for Pies, Pie Filling (liquid form ready-to-eat such as apple pie filling, etc.) Gravies/Sauces (spaghetti sauce, mushroom gravy)
Imitation Dairy (includes soy-based products)

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

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

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

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

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

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

Multiple Food (one container with a separate compartment for each product item (e.g., lasagna dinner, chop suey dinner, etc.)

Noodle/Pasta

Nut Spread and Nut Topping

Other Vegetables

Pet Food (e.g., dog/cat food, etc.)

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

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

FORM FDA 2541e (12/20)

Page 1 of 9

PSC Publishing Services (301) 443-6740 EF

Food Process Filing for Acidified Method (Form FDA 2541e)

A.1 (Food Product Group) (Continued)

C. Container Type (Select one)

Shelled Egg

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

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

Vegetable Protein Products (e.g., imitation meat analog)

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

Wine Cooler

Soup

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

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

Cylindrical

Oval

Rectangular

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

Other (Specify below)
2. Enter Product Name (e.g., salsa (mild, medium, hot), artichokes (marinated), peppers (red or green), etc.).

3. What is the form of the product? (Select all that are applicable)

Chunks (e.g., chunks, nuggets, etc.)

Cut

Diced

Filet

French cut

Liquid (i.e., all liquid no solids)

On the Cob

Paste/Puree

Pieces

Round/Spheres

Shredded/Julienne

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

Spears/Stalks

Whole

Other (Enter product form)

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

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

ii.

3-pieces ­ Do you use perforated divider plates?

Yes

No

How is the side seam sealed? (Select one)

Cemented

Welded

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

4. What is the packing medium? (Select all that are applicable)

Brine

Cream/Sauce/Gravy

Oil

Solid (no packing medium)

Cylindrical

Rectangular

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

Syrup

Water

None

Other (Enter packing medium)

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

Continue to Section B.

B. Governing Regulation: (Select one)

b) Do you use perforated divider plates?

Yes

No

1. Acidified (Product is an acidified food and is governed by 21 CFR 108.25 and 21 CFR Part 114)
2. Voluntary (The processor has concluded that the product is not an acidified food. The processor is voluntarily submitting process information about the product to facilitate FDA determinations regarding the regulatory status of the product.) If you select this choice, attach documentation to support the determination that the product is not an acidified food such as a list of ingredients with the pH and weight % of each ingredient and the finished equilibrium pH. If the product appears to be a fermented food, include a detailed process flow diagram of fermentation processes, including the pH at each step.
(Attach document. Provide name or a brief description of attachment below.)

c) Is overpressure used during the processing of the product to maintain container integrity?

Yes (Continue to c.i)

No (If using a Process Mode of: Batch Agitating, Hydrostatic Retort, or Still Retort; continue to c.ii-c.iv; otherwise, continue to Section D).

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

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

iii. What is the minimum initial temperature? _ _ _._ (enter in Fahrenheit)

Continue to Section C.

iv. What is the vacuum? _ _._ (enter in inches of mercury (Hg))

FORM FDA 2541e (12/20)

Page 2 of 9

Food Process Filing for Acidified Method (Form FDA 2541e)

C. Container Type (Continued)

3. Flexible Pouch

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

Flat pouch

Gable top

Gable top/side gusseted

Gusseted

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

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

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

Yes (Continue to b.i)

No (Continue to c)

i.

Racks

Other (Attach a picture. 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)

No (Continue to d)

i. 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)

Not Applicable

e) What is the maximum residual air? _ _ _ (enter in cubic centimeters)

Not Applicable

4. Retortable Paperboard Carton

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

Rectangular

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

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

Yes (Continue to b.i)

No (Continue to c)

i. Racks

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

C. Container Type: 4. Retortable Paperboard Carton (Continued)

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

Yes (Continue to c.i)

No (Continue to d)

i. 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)

Not Applicable

e) What is the maximum residual air? _ _ _ (enter in cubic centimeters)

Not Applicable

5. Rigid Container (industrial size)

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

Cylindrical

Rectangular

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

b) What kind of rigid container is used? (Select the description that best applies to the container (i.e., drum, pail, or tote) and select the material that makes up that container)

Drum (Large industrial cylinder container) (Select one)

Aluminum/Steel

Fiberboard

Plastic

Other (Enter material)

Pail (Select one) Aluminum/Steel

Fiberboard

Other (Enter material)

Plastic

Tote (Large industrial rectangular container) (Select one)

Aluminum/Steel

Fiberboard

Plastic

Other (Enter material)

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

FORM FDA 2541e (12/20)

Page 3 of 9

Food Process Filing for Acidified Method (Form FDA 2541e)

C. Container Type (Continued) 6. Semi-Rigid

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

Bowl

Cylindrical

Oval

Rectangular

Tray

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

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

b) Is this a compartmentalized container?

Yes How many compartments? _ _

No

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

HDPE (high-density polyethylene)

HDPP (high-density polypropylene)

Paperboard

PET (polyethylene teraphthalate)

Other (Enter material)

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)

Not Applicable

Other (Enter material)

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

Double Seam

Heat Seal

Induction Weld

Snap On

Threaded Closure

Ultrasonic Seal

Not Applicable

Other (Enter seal type)

Press Twist

C. Container Type: 6. Semi-Rigid (Continued)

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

Yes (Continue to f.i)

i.

Racks

No (Continue to g)

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

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

Yes (Continue to g.i)

No (Continue to h)

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

h) What is the maximum thickness during retort processing?

_ _ ._ _ (enter in inches)

Not Applicable

i) What is the maximum residual air? _ _ _ (enter in cubic centimeters) Not Applicable

7. Other (Enter container type)

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

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.
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.
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.

Continue to Section D.

FORM FDA 2541e (12/20)

Page 4 of 9

Food Process Filing for Acidified Method (Form FDA 2541e)

D. Container Size
Note: You are required to complete either D.1 (Dimensions) or D.2 (Volume). You may complete D.2 if you intend to select the thermal process mode in Section G as: 1) High Temperature Short Time (HTST); 2) Hot Fill and Hold; or 3) Steam Jacketed Kettle.
If you are completing D.2 because you intend to select HTST, Hot Fill and Hold, or Steam Jacketed Kettle, and if 1) your product is a cheese product under Section A.1, and 2) you have identified "Other" under Section C, you may indicate "Not Applicable" in your response to D.2. In all other circumstances, if you are completing D.2 in accordance with the directions in paragraph 1, you may not select "Not Applicable."

E. Processing Method: Acidification: (Continued)

5. Acidifying Agent(s): (Select all that apply)

Acetic Acid

Acid Food(s)

Apple Product(s) (other than vinegar)

Citric Acid

Fruit Juice(s)

Fumaric Acid

Gluconic Acid

Hydrochloric Acid

Lactic Acid

Malic Acid

Phosphoric Acid

Sodium Acid Sulfate

Tamarind Product(s)

Tartaric Acid

Tomato Product(s)

Vinegars (All Types)

Wine

Other (Enter one or more agents not listed)

For all other circumstances, complete D.1. Section D.3 (net weight) is optional information.

6. Microbial Preservative(s) critical to the scheduled process: (Select all that apply and enter percent concentration(s))

1. Dimensions:
a) _ _ _ _ Diameter _ _ _ _ Height (Use for cylindrical shapes) (see accompanying instructions for proper coding)
b) _ _ _ _ Length _ _ _ _ Width _ _ _ _ Height/Thickness (Use for container shapes other than cylindrical) (see accompanying instructions for proper coding)

2. Volume: _ _ _._ (Select one)

Fluid Ounces

Gallons

Liters

Milliliters

Not Applicable

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

Submissions for Acidified Foods: Continue to Section E. Voluntary Filing: Stop here and go to the signature section at the bottom of the form.

E. Processing Method: Acidification:

1. What is the natural pH of the low-acid ingredient(s) before acidification? _ _ ._ _

2. What is the finished equilibrium pH of the product after acidification? _ _ ._ _

3. What is the maximum time it takes for the product to achieve the finished equilibrium pH of 4.60 or lower? _ _ _

Minutes

Hours

4. Method of Acidification (Select One)

Addition of Acid Foods

Blanch

Direct Batch

Direct In Container

Immersion

Other (Enter acidification method)

Microbial Preservative Alcohol Ascorbic Acid Benzoic Acid Butylated Hydroxyanisole Butylated Hydroxytoluene Calcium Chloride Calcium Propronate Calcium Sorbate Erythorbic Acid Ethanol Gucono Delta Lactone Polysorbate Potassium Benzoate Potassium Bisulphate Potassium Metabisulphite Potassium Propionate Potassium Sorbate Potassium Sulphite Propylparaben Salt Sodium Benzoate Sodium Bisulphate Sodium Chloride Sodium Erythorbate Sodium Metabisulfite Sodium Polyphosphate Sodium Propionate

Concentration (%) _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _

(Continue next page ­ Microbial Preservative(s))

FORM FDA 2541e (12/20)

Page 5 of 9

Food Process Filing for Acidified Method (Form FDA 2541e)

E. Processing Method: 6. Microbial Preservative(s) (Continued)

Microbial Preservative
Sodium Sorbate Sodium Sulfite Sorbic Acid Trisodium Citrate Other: (Enter preservative)
(Enter preservative) (Enter preservative) None

Concentration (%) _ _._ _ _ _._ _ _ _._ _ _ _._ _
No data

Continue to Section F. F. Process Source 1. What is the Process Source?

H. Container and Container Closure Treatment: (Complete this section ONLY for Process Modes: 1) High Temperature Short Time (HTST); 2) Hot Fill and Hold; 3) Steam Jacketed Kettle
Describe how the container, headspace, and interior surface (the surfaces that are in contact with the food) of the container closure are treated. (Select one)
1. Aseptically Filled
a) What is the filler name and model?

2. Heating Tunnel

a) What is the process time? _ _._ (Select one)

Seconds

Minutes

b) What is the temperature in the heating tunnel? _ _ _._ (enter in Fahrenheit)

(Attach support documentation)
2. What is the date of the Process Source Document (mm/dd/yyyy)? _ _ / _ _ / _ _ _ _
Continue to Section G. G. Process Mode (Select one) 1. High Temperature Short Time (HTST) 2. Hot Fill and Hold 3. Steam Jacketed Kettle When process mode 1, 2, or 3 is selected, continue to Section H. 4. Batch Agitating Retort 5. Cold Fill and Hold (Attach support documentation. Provide name or a brief
description of attachment below.)
6. Crateless Retort 7. Heating Tunnel - Hot Air, Steam or Water (water cascade, water immersion, water spray) 8. Hydrostatic Retort 9. Sterilmatic 10. Still Retort (Steam or Water) 11. Bath (Steam or Water) 12. Other (Attach support documentation). Provide name or a brief description of
attachment below.

3. Hot Fill and Hold

a) What is the temperature of the product in the container at the end of the hold time? _ _ _._ (enter in Fahrenheit)

i. Select one of the container closure treatments.

Inversion/Laydown of Container: How long is the product inverted/laid-down? _ _._ (Select one)

Seconds

Minutes

Steam Flow Closure

Other (Enter container closure treatment)

What is the exposure time? _ _._ (Select one)

Seconds

Minutes

4. Water spray

a) What is the process time? _ _._ (Select one)

Seconds

Minutes

b) What is the temperature of the water spray? _ _ _._ (enter in Fahrenheit)

5. Other (Specify)

When process mode 4-12 is selected, continue to Section I. FORM FDA 2541e (12/20)

Continue to Section I. Page 6 of 9

Food Process Filing for Acidified Method (Form FDA 2541e)
I. 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

Process Process Temperature Process

No

No

Time

Col. 5

Col. 6

Process

F value

Temperature (only one)

Col. 7

Col. 8

Thruput

Headspace

(Containers

per Minute)

Col. 9a.
Reel Speed

Col. 9b.
Reel Diameter

Col. 9c.
Steps per Turn of Reel

Col. 9d.
Chain/ Conveyer Speed

Col. 9e.
Cooker Capacity

Col. 9f.
Frequency Strokes per Minute

Col. 10
Maximum Fill Weight

Col. 11 Other

Number _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Min. Initial
Lowest Hold Temp.

Seconds Minutes Hours

Number Fahrenheit

_ _ _ _ _._

_ _ _ _ _._

_ _

_ _ _._

_ _ _ _ _._

_ _ _ _ _._

_ _ _ _ _._

_ _ _ _ _._

_ _ _ _ _._

_ _ _ _ _._

_ _ _ _ _._

_ _ _ _ _._

_ _ _ _ _._

_ _ _ _ _._

_ _ _ _ _._

_ _ _ _ _._

_ _ _ _ _._

_ _ _ _ _._

See above Fahrenheit _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._

Fo (F18/250)
Other F Ref T _____ z: _ _._ (F only)

Minutes

Number

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

_ _._ _

_ _ _ _

Net Gross NA

Inches _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _

RPM _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _ _ _._ _

Inches _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Number _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Feet

Fill

Carriers

NA

Flights

(per minute)

Number _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _ _ _ _._ _ _

Number _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Number _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _

Ounces _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _ _ _ _._ _

FORM FDA 2541e (12/20)

Page 7 of 9

Food Process Filing for Acidified Method (Form FDA 2541e) J. Additional Information (Optional)
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.
If your process filing appears to be fabricated, the product on this form will not be in compliance with 21 CFR 108.25(c)(2). A process filing appears fabricated

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 108.25(c)(2) until you submit a completed process filing that does not appear to be fabricated.

Full Name (Please Type or Print)

Signature

Establishment Name

State or Province

Country (other than U.S.)

Date

Telephone No.

FORM FDA 2541e (12/20)

Page 8 of 9

Food Process Filing for Acidified Method (Form FDA 2541e)
LACF Contact Information
For more information, contact the LACF Registration Coordinator by e-mail at LACF@FDA.HHS.GOV 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 PRAStaff@fda.hhs.gov
"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 2541e (12/20)

Page 9 of 9