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

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Food Process Filing for Low-Acid Retorted Method (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)”
Date Received by FDA _ _ /_ _/_ _ _ _ (MM/DD/YYYY) (FDA USE ONLY)
Food Canning Establishment (FCE) Number: _ _ _ _ _ _
Submission Identifier (SID) 20_ _-_ _-_ _/_ _ _ (YYYY-MM-DD/SSS)
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.);
Bakery Products (canned brown bread, bakery glazes); Beans, Corn, or Peas (Select one):
Berry/Citrus/Core Fruit (Select one):
Beverage Base;
Cocoa;

Berry/Citrus/Core Fruit;

Beans, Corn, Peas - Fresh Succulent;

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

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

Dressings/Condiments (e.g., salad dressing, chutney, salsa, pepper sauce, etc.);
Fishery (finfish)

Beans or Peas - Dry or Mature Soaked;

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

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

Coffee/Teas (excluding herbal and botanical teas);

Baby Food (infant/junior foods including infant formula);

Dairy (milk-based);

Dietary Supplement and/or herbal and botanical teas;

Engineered Seafood (e.g., shelf-stable imitation crab, surimi, etc.);

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

Fruit as a Vegetable (Select one):

Fruit as a Vegetable (e.g., eggplant, pumpkin, etc.)

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

Fruit as a Vegetable Juice or Drink (e.g., eggplant juice, pumpkin juice, 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 (Select one):
Imitation/Pit/Mixed/Subtropical Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping;
Leafy/Stem Vegetables (Select one):

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Leafy/Stem Vegetable;

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Imitation/Pit/Mixed/Subtropical Fruit;

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

Form FDA 2541d

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
Meal Replacement/Medical Foods (e.g., supplemental liquid nutrition, etc.);
Mixed Vegetables (Select one):

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

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

Noodle/Pasta;

Nut Spread and Nut Topping;

Other Vegetables;

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

Root and Tuber Vegetables (Select one):
Shelled Egg;

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

Root/Tuber Vegetables (e.g., carrots, leeks, potatoes, etc.);

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

Soup;

Root/Tuber Vegetables as a Juice or Drink (e.g., carrot juice, etc.);

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

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

Vine/Other Fruit;

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

Wine Cooler;

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

3. What is the form of the product?

Chunks (e.g., chunks, nuggets, etc.)
Cut
Diced
Fillet
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) ___________________________________________________________

4. What is the packing medium?

Brine
Cream/Sauce/Gravy
Oil
Solid (no packing medium)
Syrup
Water
None (i.e., the product is all liquid)
Other (Enter packing medium) ________________________________________________________

Continue to Section B.
________________________________________________________________________________________________________________________________________________________________
B. Governing Regulation: (Refer to the precursor questions in the instructions)
Low-acid (21 CFR 108.35 and 21 CFR Part 113)
Continue to Section C.
______________________________________________________________________________________________________________________________________________________________
C. Container Type: (Select one)
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
Irregular (Attach a picture or schematic) __________________________________________________________________
Rectangular
Other (Attach a picture or schematic) ___________________________________________________________________________
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

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Form FDA 2541d

Oval

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
c)

2.

3.

Is the container a low-profile container?
Yes (If yes, answer either question c.i or c.ii)
No (If no, continue to Section D)
i.
Heat penetration test was conducted with nested containers. (Attach study and picture or diagram) ________________________________________________________________________
ii.
Nesting of Containers prevented by: (Select one)
Brick Stacked
Lid to Lid / Bottom to Bottom
Perforated Divider Plates
Racks
Spiral

Ceramic/Glass
a) What is the shape of the container? (Select one)
Cylindrical
Irregular (Attach a picture or schematic) ___________________________________________________ __________
Other (Attach a picture or schematic) _________________________________________________________________________________________
b) Do you use perforated divider plates?
Yes
No
c) Is overpressure used during the processing of the product to maintain container integrity?
Yes (Continue to c.i)
No (Continue to c.ii-c.iv)
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)
iv. What is the vacuum? _ _._ (enter in inches of mercury (Hg))

Rectangular

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)______________________________________________________________________________________
Other (Attach a picture or schematic) ________________________________________________________________________________________
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) _______________________________________________________________________________________
c) Is overpressure used during the processing of the product to control container thickness?
Yes (Continue to c.i)
i. What is the total overpressure used during processing? _ _._ (enter in pounds per square inch gauge (psig))

No (Continue to d)

d) What is the maximum thickness during retort processing? _ _._ _ (enter in inches)
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) _____________________________________________________________________
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) ________________________________________________________________________________________________
c) Is overpressure used during the processing of the product to control container thickness?
Yes (Continue to c.i)
i. What is the total overpressure used during processing? _ _._ (enter in pounds per square inch gauge (psig))

No (Continue to d)

d) What is the maximum thickness during retort processing? _ _._ _ (enter in inches)
e) What is the maximum residual air? _ _ _ (enter in cubic centimeters)
Not Applicable
5.

Semi-Rigid
a) What is the shape of the container? (Select one)
Bowl
Cylindrical
Irregular (Attach a picture or schematic) ___________________________________________________________ Oval
Rectangular
Tray
Other (Attach a picture or schematic) __________________________________________________________________________
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)

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Form FDA 2541d

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
Aluminum/Steel
HDPE (high-density polyethylene)
HDPP (high-density polypropylene)
Nylon
PET (polyethylene teraphthalate)
Other (Enter material) _______________________
___________________
Not Applicable
e) How is the lid sealed to the body of the container? (Select one)
Double Seam
Heat Seal
Induction Weld
Press Twist
Snap On
Threaded Closure
Ultrasonic Seal
Other (Enter seal type) __________________________________________
Not Applicable
f) Is the container physically restricted during the processing of the product to control container thickness?
Yes (Continue to f.i) No (Continue to g)
i.
Racks
Other (Attach a picture) ______________________________________________________________________________
g) Is overpressure used during the processing of the product to control container thickness?
Yes (Continue to g.i)
i. What is the total overpressure used during processing? _ _._ (enter in pounds per square inch gauge (psig))

No (Continue to h)

h) What is the maximum thickness during retort processing? _ _._ _ (enter in inches)
i) What is the maximum residual air? _ _ _ (enter in cubic centimeters)
Not Applicable
6.

Other (Enter container type) ______________________________
a) Attach schematic or picture of container._________________________________________________________________________________________
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.

_______________________________________________________________________________________________________________

D. Container Size:
Note: Section D.1 (dimensions) is required information. However, section D.2 (net weight) is optional information.
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. Net Weight (Optional): _ _ _._ _ (enter in ounces)
Continue to Section E.
_____________________________________________________________________________________________________________________________________________________
E. Processing Method: Thermally Processed Non-Aseptic System:
1. What is the finished equilibrium pH of the product after processing? _ _._ _
2. Heating Medium (Select one)
a)
High pressure assisted
Microwave
Ohmic (electrodes) Steam
Steam-air (Attach a heat distribution study) ______________________________________________
Water cascade
Water immersion
Water spray
Other (Enter heating medium) __________________________________________________________
Continue to Section F.

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Form FDA 2541d

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
_____________________________________________________________________________________________________________________________________________________
F. Process Mode: (Select one)
1. Mode
a)

b)

Agitating: (Select one) i.
ii.
iii.

Axial (Select one)
Batch
Continuous
End over End (Only batch)
Oscillation (Only batch) (Select one)
High frequency

Still: (Select one)

Horizontal
Vertical

i.
ii.

Low frequency

2. Cooker: What type of cooker do you use? (Select one)
a)
Crateless: Bottom Surface: (Select one)
Solid
Perforated
b)
Hydrolock
c)
Hydrostatic
d)
Retort
e)
Rotomatic/Rotary
f)
Sterilmatic
g) Other (Enter cooker type) _____________________________________________ (Attach documentation) _________________________________________________________________
Continue to Section G.
___________________________________________________________________________________________________________________________________________________________
G. Process System Critical Factors:
1. What is the filling method(s) used to fill the product into the container? (Select all that apply)

Hand filling

2. How many phases are used to fill the container with the product? (Select one)
Single Phase
Two Phase
a) Enter the number of ounces added in each Phase. Phase 1: _ _ _._ _ Phase 2: _ _ _._ _ Phase 3:_ _ _._ _
3. Is the product vacuum packed?
4.

Yes

Piston filling

Pocket filler

Vibrating/Tumble filling

Volumetric filling

Three Phase (Continue to a)

No

What is the container position in retort? (Select one) (Under Section F.1 when Agitating is selected, skip this question).
Brick Stacked
Horizontal
Jumbled/Random
Lid Down
Lid Up
Vertical

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

Minimum Come-Up-Time: _ _._ (enter in minutes) (Attach a temperature distribution study) ________________________________________________________________________

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

Minimum Water Flow Rate: _ _ _._ (enter using gallons per minute (gpm))

Not Applicable (Attach an explanation) __________________________________________________________

Continue to Section H.
_________________________________________________________________________________________________________________________________________________________

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Form FDA 2541d

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
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?
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. ________________________________________________________________
__________________________________________________________________________________________________________________________________________________________
c) Does your product contain fines?
Yes (Continue to c.i)
No (Continue to d)
i. What is the maximum percent? _ _ _._
d) Is full rehydration of the particulate a critical factor?
Yes
No
2. Does the product contain any dry ingredients?
Yes (Continue to a)
No (Continue to H.3)
a) What is the minimum % moisture of dry ingredients before processing? _ _._ _
Not Applicable
3. How are pieces arranged in the container? (Select one)
Head to Tail
Heads/Tips Down
Heads/Tips Up
Horizontal
Layered
Vertical
Other (Enter arrangement of pieces) _____________________________________________(Attach an explanation) ______________________________________________________________
Not Applicable
4. Does the % total solids affect the heating of the product during processing?
a) What is the % total solids? _ _._ _

Yes (Continue to a)

No (Continue to H.5)

5. Is the finished equilibrium pH of the product after processing (identified in Section E) critical to the process?

Yes

No

6. Does consistency/viscosity affect the heating of the product?
Yes (Continue to a-c)
No (Continue to H.7)
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? _ _ _._ _ What is the unit of measure? (Select one)
Centipoise
Other_(Enter units of measure) _______________________________________________
7. Is starch added to maintain consistency/viscosity of the product?
Yes (Continue to a-b)
No (Continue to H.8)
a) What is the maximum % starch added? _ _._ _
b) What type of starch is added? ____________________________________________________
8. Are other binders added?
Yes (Continue to a-b)
No (Continue to H.9)
a) What is the maximum % binder added? _ _._ _
b) What is the type of binder added? __________________________________________________
9. Does syrup strength affect the heat penetration during processing of the product?
a) What is the brix measurement? _ _._

Yes (Continue to a)

No (Continue to Section I)

Continue to Section I.
_______________________________________________________________________________________________________________________________________________________________
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? _____________________________________________ (Attach support documentation) ________________________________________________
b) What is the date of the Process Source Document (mm/dd/yyyy)? _ _/_ _/_ _ _ _

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Form FDA 2541d

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
2. What is the Manufacturer’s Name and the Sterilizer Model: ______________________________________________________________________________________
* Unknown/Locally Made (Attach pictures and documentation) ______________________________________________________________
Continue to Section J.
_______________________________________________________________________________________________________________________________________________________________
J. Scheduled Process: (Do not write in shaded areas -- Check appropriate box under column heading, when applicable, and enter numerical values on dashed lines.)
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

Headspace

(Containers
per Minute)

Col. 9
a. Reel
Speed

Agitating
- End
Over End
or
Agitating
– Axial
ONLY

AgitatingAxial
Continuous
ONLY

b. Reel
Diameter

c. Steps
per Turn
of Reel

Sterilmatic
Cooker
ONLY

AgitatingAxial
Continuous
Hydrolock or
ONLY

d. Chain /
Conveyer
Speed

Hydrostatic
ONLY

Net
Gross
NA

e. Cooker
Capacity

Sterilmatic
Cooker
ONLY

f. Frequency
Strokes per
Minute

Col. 10

Col. 11

Col. 12

Maximum
Fill Weight

Minimum
Free Liq.
at Closing

Minimum
Container
Closing
Machine
Gauge
Vacuum

Oscillation
Agitating ONLY

Feet
Carriers
Flights
(per minute)

NA

Temp.
(+/- 3◦ F)
___.__

Number

Number

◦Fahrenheit

Minutes

◦Fahrenheit

Minutes

Number

Inches

RPM

Inches

Number

Number

Number

Number

Ounces

Ounces

In. Hg.

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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) ________________________________________________________________________________________________
Temperature Distribution Study (Attach document) __________________________________________________________________________________________

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Form FDA 2541d

Col.
13
Other

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
Other (Attach document) _____________________________________________________________________________________________________________

Comments:

Full Name (Please Type or Print)

Signature

Establishment Name

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State or Province

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Country (other than U.S.)

Date

Telephone No

Form FDA 2541d

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
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
5100 Paint Branch Parkway
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.*
The burden time for this collection of information is estimated to average .333 hour 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:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff
1350 Piccard Drive, Room 400
Rockville, MD 20850
“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.”

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Form FDA 2541d