Food Canning Establishment, Process Filing for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541e

Instructions for Paper Submission of
Form FDA 2541e (Food Process Filing
for Acidified Method)

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Month Year

Page 1 of 41

Table of Contents
I.
II.

Introduction ................................................................................................................. 5
How to Submit Process Filing Form FDA 2541e by Paper .................................... 6
A. General Information ............................................................................................ 6
B. Step 1: Top of Form - Food Canning Establishment Number and Submission
Identifier ...................................................................................................................... 8
1. Food Canning Establishment (FCE) Number: ................................................. 8
2. Submission Identifier (SID): ............................................................................ 8
C. Step 2 – Section A. Product Information ............................................................. 9
1. Food Product Group (Optional): ...................................................................... 9
2. Enter Product Name. ........................................................................................ 9
3. What is the form of the product? .................................................................... 10
4. What is the packing medium? ........................................................................ 10
D. Step 3 – Section B. Governing Regulation........................................................ 10
E. Step 4 – Section C. Container Type ................................................................... 11
1. Aluminum/Tinplate/Steel Can........................................................................ 11
2. Ceramic/Glass ................................................................................................ 12
3. Flexible Pouch ................................................................................................ 13
4. Retortable Paperboard Carton ........................................................................ 15
5. Rigid Container (10 pounds or more of product) ........................................... 16
6. Semi-Rigid ..................................................................................................... 17
7. Other Container .............................................................................................. 19
F. Step 5 – Section D. Container Size .................................................................... 19
1. Dimensions:.................................................................................................... 20
2. Volume: .......................................................................................................... 20
Page 2 of 41

3. Net Weight (Optional):................................................................................... 21
G. Step 6 – Section E. Processing Method: Acidification .................................... 21
1. What is the natural pH of the product before acidification? ............................. 21
2. What is the finished equilibrium pH of the product after acidification? .......... 21
3. What is the maximum time it takes for the product to achieve the finished
equilibrium pH of 4.60 or lower? ......................................................................... 21
4. Method of Acidification.................................................................................... 22
5. Acidifying agent(s) ........................................................................................... 22
6. Microbial Preservative(s) critical to the scheduled process .............................. 22
H. Step 7 – Section F. Process Source .................................................................. 22
1. What is the Process Source?........................................................................... 22
2. What is the Date of the Process Source Document? ...................................... 23
I. Step 8 – Section G. Process Mode ..................................................................... 23
J. Step 9 – Section H. Container and Container Closure Treatment ..................... 24
1. Aseptically Filled: .......................................................................................... 24
2. Heating Tunnel: .............................................................................................. 24
3. Hot Fill and Hold: .......................................................................................... 25
4. Water Spray: ................................................................................................... 25
5. Other: .............................................................................................................. 25
K. Step 10 – Section I. Scheduled Process ............................................................ 26
1. Column 1. Process No. .................................................................................. 26
2. Column 2. Step .............................................................................................. 26
3. Column 3. Temperature................................................................................. 26
4. Column 4. Process Time ............................................................................... 27
5. Column 5. Process Temperature ................................................................... 27
6. Column 6. F value ......................................................................................... 27
Page 3 of 41

7. Column 7. Thruput (Containers per Minute) ................................................ 28
8. Column 8. Headspace .................................................................................... 28
9. Column 9a. Reel Speed ................................................................................. 28
10. Column 9b. Reel Diameter .......................................................................... 28
11. Column 9c. Steps per Turn of the Reel ....................................................... 29
12. Column 9d. Chain / Conveyor Speed .......................................................... 29
13. Column 9e. Cooker Capacity ...................................................................... 29
14. Column 9f. Frequency Strokes per Minute (Oscillation Agitating ONLY) 29
15. Column 10. Maximum Fill Weight ............................................................. 29
16. Column 11. Other ........................................................................................ 30
L. Step 11 – Section J. Additional Information (Optional) ................................... 30
1. Comments: ..................................................................................................... 30
2. Full Name, Signature, Establishment Name and Date ................................... 30
III. How to Contact FDA or Obtain Help ......................................................................... 30
IV.
V.

References ............................................................................................................. 32
Appendix ................................................................................................................... 32
A. Container Types and Shapes ............................................................................. 32
B. Container Dimension Measurements................................................................. 37
1. Cylindrical Measurement ............................................................................... 38
2. Oval Shape Measurement............................................................................... 38
3. Rectangular Shape, Rectangular Tray and Low-Profile Measurement .......... 39
4. Rectangular Shape Measurement ................................................................... 40
5. Rectangular Tray Measurement ..................................................................... 40
6. Low-Profile Measurement.............................................................................. 40
C. Abbreviations..................................................................................................... 40

Page 4 of 41

Table of Figures
Figure 1 – Cylindrical Shape 2-Piece Aluminum Containers Depicting Double Seams .. 32
Figure 2 – Low-Profile Rectangular Shape 2-Piece Aluminum Containers ..................... 33
Figure 3 – Cylindrical Shape 3-Piece Steel Containers with a Double Seam and Side
Seam .................................................................................................................................. 33
Figure 4 – Cylindrical Shape 2-Piece Steel Containers with a Double Seam .................. 34
Figure 5 – Flexible Pouch ................................................................................................. 34
Figure 6 – Glass Containers .............................................................................................. 35
Figure 7 – Semi Rigid Body, Oval Shape Containers with Heat Seal .............................. 35
Figure 8 – Semi Rigid Body, Rectangle Shape Containers .............................................. 36
Figure 9 – Semi Rigid Body with an Aluminum Double Seam ....................................... 36
Figure 10 – Semi Rigid Body, Cylinder Shape Containers with Induction Weld Seal. ... 37
Figure 11 – Semi Rigid Body with Heat Seal ................................................................... 37
Figure 12 – Measurement of a Cylindrical Shape Container. ........................................... 38
Figure 13 – Measurement of an Unusual Shape Cylindrical Container. .......................... 38
Figure 14 – Measurement of an Oval Shape Container .................................................... 39
Figure 15 – Measurement of Outer Edges of Container ................................................... 39
Figure 16 – Measurement of a Rectangular Shape Container .......................................... 40
Figure 17 – Measurement of a Rectangular Tray Shape Container .................................. 40
Figure 18 – Measurement of a Low-Profile Container ..................................................... 40

I.

Introduction

This document is intended for:
•

Commercial processors who manufacture, process, or pack thermally processed
acidified foods (AF) packaged in hermetically sealed containers ;

Page 5 of 41

•

Persons who are authorized to act on behalf of such commercial processors 1.

Commercial processors who manufacture, process, or pack AF are subject to the
registration requirements of 21 CFR 108.25(c)(1), as well as the process filing
requirements of 21 CFR 108.25(c)(2). These provisions require two basic types of
submissions:
•
•

Food Canning Establishment Registration using Form FDA 2541; and
Process filings using the following form:
• Form FDA 2541e (Food Process Filing for Acidified Method)

This document provides detailed instructions on how to submit process filings by using a
paper Form FDA 2541e (Food Process Filing for Acidified Method). Form FDA 2541e
is intended for acidified foods as defined in 21 CFR 114.3(b).
This document does not provide:
•
•
•

Instructions for electronic submission of Form FDA 2541e (Food Process Filing for
Acidified Method);
Instructions for submitting process filing Forms FDA 2541d, FDA 2541f, and FDA
2541g for Low-Acid Foods in either electronic or paper format; or
Instructions for submitting plant registration Form FDA 2541 in either electronic or
paper format.

For additional information about registration and process filing for commercial
processors of AF and LACF, see our guidance entitled “Guidance for Industry:
Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA
2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in
Electronic or Paper Format” (Ref. 1 and the appendices in Reference 1). For a list of
abbreviations used in this document and other FDA documents relating to commercial
processors who manufacture, process, or pack AF and that are subject to 21 CFR Part
108, refer to Appendix C.

II. How to Submit Process Filing Form FDA 2541e by
Paper
A.

General Information

The paper Form FDA 2541e contains 10 sections (Sections A through J).

1

Individuals who are authorized to act on behalf of commercial processors may do so for more than one
commercial processor. Reference 1 addresses our electronic system for submitting process filing and
identifies the responsibilities of each type of authorized user for that system.

Page 6 of 41

•

•
•

•

•

•

All mandatory fields on Form FDA 2541e must be completed. Only three sections
include optional information:
• Section A, Question 1 (Food Product Group) is optional.
• Section D, Question 3 (Net Weight (Optional)) is optional.
• Section J, Additional Information (Optional) is optional.
When you manufacture, process, or pack a product in more than one container size or
type, you are required to submit a separate Form FDA 2541e for each container size
and type.
You may report multiple forms of the product (e.g., diced, chunks, cut, fillet) on the
same Form FDA 2541e, provided that:
• Other factors (e.g., container type or size) do not require separate filing; and
• The process information you provide in Section I of Form FDA 2541e applies to
each product variation. If the heat transfer rates are different for each product
variation, the process for the slowest heating formulation of the product form
must be filed. The comment section of the filing form should state which
formulation product form heats the slowest.
You may report multiple product packing mediums on the same Form FDA 2541e
provided that:
• Factors other than “product packing medium” (e.g., container type or size) do not
require separate filing; and
• The process information you provide in Section I of Form FDA 2541e applies to
each product variation. If the heat transfer rates are different for each product
variation, the process for the slowest heating formulation of the product packing
medium must be filed. The comment section of the filing form should state which
formulation packing medium heats the slowest.
You may report multiple products with minor formulation changes (e.g., a shake base
that you produce to have a strawberry-flavored version, and a shake base that you
produce to have a vanilla-flavored version) on the same Form FDA 2541e provided
that:
• Other factors (e.g., container type or size) do not require separate filing; and
• The process information you provide in Section I of Form FDA 2541e applies to
each formulation of the product. If the heat transfer rates are different for each
product formulation variation, the process for the slowest heating formulation of
the product must be filed. The comment section of the filing form should state
which formulation heats the slowest.
Brand names of products generally should not be part of the Product Name.
However, you may need to include the brand name as part of the Product Name if it is
necessary to distinguish products that are produced using different scheduled
processes. You need not submit a separate Form FDA 2541e for each brand name of
a product that is manufactured, processed, or packed under more than one brand name
if the scheduled process for each brand is exactly the same.

When preparing separate forms that contain much of the same information (such as for a
product that you manufacture, process, or pack in multiple container sizes), you may save
time by using photocopying. Specifically, you may enter the information that applies to
all the products, photocopy the form, and then complete the product-specific information
Page 7 of 41

on the photocopies. Each submitted form must be complete. Importantly, each submitted
form must have a unique SID (see Step One) and must have an original (not photocopied)
signature of an authorized company representative.
We recommend that the authorized representative make and keep a copy of each process
filing form.

B.
Step 1: Top of Form - Food Canning Establishment Number and
Submission Identifier
Provide the FCE number and SID at the top of Form FDA 2541e, before Section A.
Leave the “Date Received by FDA” blank (this is for FDA internal use only).
1.

Food Canning Establishment (FCE) Number:

We assign a Food Canning Establishment (FCE) number to each physical processing
facility that registers using Form FDA 2541 (Ref. 1). Enter the five digit FCE number we
provide for the specific establishment (processing location) where the product(s) are
manufactured, processed, or packed after you register that establishment using Form
FDA 2541. If you are submitting a process filing at the same time as you are registering
your establishment for the first time, you may leave the FCE number blank.
2.

Submission Identifier (SID):

Each process filing is identified by a unique Submission Identifier (SID). The SID is a
unique number associated with each new process filing. You assign the SID. The
combination of the FCE number and the SID identifies a specific process filing form.
The SID is a combination of:
•
•

(1) The date (i.e., year, month, and day of the month) that a process filing form is
created; and
(2) A sequence number that would distinguish multiple forms created on the same
date. The sequence number starts with 001 and continues (002, 003) for as long as
necessary to uniquely identify all forms created on the same date.

If you create multiple types of process filing forms on the same date (e.g., if you create
three Forms FDA 2541e and three Forms FDA 2541d on the same date), the sequence
number would increase by 001 for each created form rather than begin again at 001 for
each type of form (see examples immediately below).
When you submit paper forms, you assign the SID and include it on the form using the
following format:
YYYY-MM-DD/SSS
Where:

Page 8 of 41

YYYY represents the calendar year (e.g., 2013, 2014)
MM represents the month (e.g., 02 for February, 10 for October)
DD represents the day of the month (e.g., 02, 19, 30)
SSS represents the assigned sequence number (e.g., 001, 002, 003).
Examples of SIDs include:
2013-02-22/001: The first Form FDA 2541e created on February 22, 2013
2013-02-22/002: The second Form FDA 2541e created on February 22, 2013
2013-02-22/003: The third Form FDA 2541e created on February 22, 2013
2013-02-22/004: The fourth process filing form, this one a Form FDA 2541d,
created on February 22, 2013
2013-02-22/005: The fifth process filing form, this one a Form FDA 2541d,
created on February 22, 2013
2013-02-22/006: The sixth process filing form, this one a Form FDA 2541d,
created on February 22, 2013

C.

Step 2 – Section A. Product Information

1.

Food Product Group (Optional):

We request information about “Food Product Groups” to help us understand the nature of
your products. The information you provide helps FDA prioritize which commercial
processing facilities to inspect. The Food Product Group is optional information (i.e.,
you are not required to identify the Food Product Group.) If you choose to fill in this
information and there is no single best Food Product Group applicable to the product,
select “Other.”
2.

Enter Product Name.

Describe the actual food commodity or formulated food in the container (e.g., salsa
(mild), artichokes (marinated)).
•

If the product is named in a foreign language, provide its English equivalent first and
then provide the foreign language name in parentheses (e.g., green kidney beans
(flageolets) in brine).
The product name may include scientific names. When a scientific name is in Latin,
the product name should also include the common English translation or description
of the scientific name (e.g., mushrooms (Agaricus bisporus) pieces and stems, in
brine; Beans (Phaseolus vulgaris) in brine)
Page 9 of 41

•

Brand names should not be part of the product name unless a brand name is necessary
to distinguish products that are produced using different scheduled processes.

Some product names may include qualifying terms that identify unique species,
processing methods, or organoleptic or visual properties. Some products may be
compartmentalized, and include multiple types of foods. For such products, specify these
unique properties. If, however, you are submitting the same Form FDA 2541e for
multiple products with minor formulation differences indicate those minor formulation
differences with the product name. (See section II.A of these instructions.) For
example, if you are submitting the same Form FDA 2541e for salsa that you make in
mild, medium, and hot varieties, indicate those varieties as part of the product name.
Some examples of product names:
•
•
•
•
•
•
•
3.

Enter “Salsa (mild, medium, or hot)” not “Salsa”
Enter “Artichokes (marinated)” not “Artichokes”
Enter “Jalapeno Peppers (red or green)” not “Jalapeno Peppers”
Enter “Radishes, pickled (Szechuan)” not “Radishes”
Enter “Mixed vegetables, pickled (matsutake meshi-no-moto)” not “Mixed
vegetables”
Enter “Beans (green or wax)” not “Beans”
Enter “Mushrooms (button)” not “Mushrooms”
What is the form of the product?

The product form relates to the shape or appearance of the product itself (e.g., cut, pieces
and stems, whole) rather than the characteristics of the container.
Select one or more product forms listed on the filing form. You may report multiple
forms of the product on the same Form FDA 2541e with the caveats discussed in section
II.A of this document. If none of the product forms listed on the form apply, select
“Other” and enter the product form in the space provided.
4.

What is the packing medium?

In general, “packing medium” refers to the liquid portion(s) of a product when the liquid
is added over, or added to, the solid portion(s) of a product. You may report multiple
product packing mediums on the same Form FDA 2541e with the caveats discussed in
section II.A of this document.
Select one or more packing mediums listed on the form. If a product is all liquid, select
“None (i.e., the product is all liquid).” If there is no packing medium, select “Solid (no
packing medium).”

D.

Step 3 – Section B. Governing Regulation

The paper Form FDA 2541e applies to two categories of products: (1) Acidified Foods;
and (2) foods that the processor has determined are not subject to the regulations for
Page 10 of 41

acidified foods, but for which the processor has decided to voluntarily submit process
information to facilitate FDA determinations regarding the regulatory status of the foods.
With respect to the first category of products (i.e., acidified foods), these foods are
regulated pursuant to 21 CFR 108.25 and 21 CFR Part 114. Refer to Part 114 and Ref. 3
of this document for information on whether a product is an acidified food. If your
product is an acidified food within the meaning of Part 114, select “Acidified.”
With respect to the second category of products (i.e., foods that the processor has
determined are not subject to the regulations for acidified foods), these foods can be the
subject of voluntary submissions. If FDA has information about such foods in our files,
we can evaluate that information and determine whether it is consistent with the
processor’s conclusion that a product is not subject to the requirements applicable to
acidified foods. For more information about the voluntary submission process, and to
identify whether your product falls into this second category, refer to “Guidance for
Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and
forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing
Forms) to FDA in Electronic or Paper Format” (Ref. 1).
If your product falls into this second category and you choose to inform us about your
product using Form FDA 2541e, select “Voluntary.”
If you select “Voluntary,” attach documentation to support the determination that the
product is not an acidified food, and in the space provided enter the document name for
the attachment. If the product appears to be a fermented food, include a detailed process
flow diagram of fermentation processes, including the pH at each step.

E.

Step 4 – Section C. Container Type

Each different container type and each different size of the same container type should be
filed as a separate Form FDA 2541e. Therefore, for any Form FDA 2541e that you
submit, select a single container type. For additional technical information about
container types, refer to Appendix – A, Container Types and Shapes.
1.

Aluminum/Tinplate/Steel Can

The first container type listed on Form FDA 2541e is for a container of all non-flexible
metal (i.e., aluminum, 2 tinplate, or steel can). Do not select Aluminum/Tinplate/Steel
Can if the container combines metal in one layer with other materials (e.g., paperboard or
a polymer) in other layers. 3

2

Note that we consider an aluminum can to be a non-flexible metal container rather than a semi-rigid
container.

3

Note that we consider a combination of metal and other material containers to be a retortable paperboard
or semi-rigid container.

Page 11 of 41

a) What is the shape of the container?
Select the shape that best applies to the container. If the container is asymmetrical in
shape, select “Irregular”, attach a picture or schematic, and in the space provided enter
the document name for the attachment. If none of the shapes apply, select “Other”,
attach a picture or schematic, and in the space provided enter the document name for the
attachment.
b) How many pieces are used to construct the container?
A 2-piece container is a container where one end is made as part of the can body. There
is no side seam and only one end is attached through the formation of a double seam.
A 3-piece container consists of a can body and two attached ends. A 3-piece container
can be identified by the presence of a side seam. The side seam runs the length of the
cylinder from one end to the other. Side seams are either cemented or welded.
You may select “2 piece container”, “3 piece container” or both, as applicable. Divider
plates are any material used to separate layers of containers. If divider plates are used,
select “Yes.” Otherwise, select “No.” For 3-piece containers, select “cemented” or
“welded” to indicate how the side seam is sealed.
2.

Ceramic/Glass

The second container type listed on Form FDA 2541e is for a container of ceramic or
glass.
a) What is the shape of the container?
Select the shape that best applies to the container. If the container is asymmetrical in
shape (e.g., boot, hat, tree), select “Irregular”, attach a picture or schematic, and in the
space provided enter the document name for the attachment. If the shape choices listed
on the form are not applicable, select “Other”, attach a picture or schematic, and in the
space provided enter the document name for the attachment.
b) Do you use perforated divider plates?
Select “Yes” or “No.” Divider plates are any material used to separate layers of
containers.
c) Is overpressure used during processing of the product to maintain container
integrity?
Overpressure is the additional external pressure often used to maintain the hermetic seal
during the processing cycle (heating and cooling). This additional pressure is generated
by the addition of compressed air into the processing vessel or by steam when using a
Rotomat type cooker.

Page 12 of 41

Select “Yes” or “No.” If yes, continue to question c.i. If no, continue to c.ii through c.iv.
Question c.i: What is the total overpressure used during processing?
The total overpressure used during processing is the total gauge pressure (psig) during
heating and cooling. Enter the overpressure in pounds per square inch gauge (psig) using
a maximum of two digits before the decimal point and one digit after the decimal point
and continue to Section D – Container Size.
Question c.ii: What is the percent (%) headspace?
Percent headspace is the fraction of volume of the void (where there is no food product)
in the container divided by the volume of the entire container multiplied by 100. Enter
the headspace using a maximum of two digits before the decimal point and one digit after
the decimal point and continue to the next question.
Question c.iii: What is the minimum initial temperature?
Minimum initial temperature (IT) is the average temperature of the contents of the
coldest container to be processed at the time the thermal process cycle begins. Enter the
minimum initial temperature in degrees Fahrenheit using a maximum of three digits
before the decimal point and one digit after the decimal point and continue to the next
question.
Question c.iv: What is the vacuum?
Control of the internal pressure depends upon the vacuum in the container. Enter the
minimum vacuum in inches of mercury (Hg) using a maximum of two digits before the
decimal point and one digit after the decimal point.
3.

Flexible Pouch

The third container type listed on Form FDA 2541e is for a container of flexible material.
A flexible pouch is a food container that has no fixed shape. Its final shape is defined by
the product placed inside it during the filling and sealing process. It is constructed of
flexible panels composed of laminated polymers. The composition of laminated polymers
varies depending on the food product, the processing method, and the intended use. Some
flexible pouches contain a foil layer.
a) What is the shape of the container?
Select the shape that applies to the container. For “Irregular” or “Other” shapes, attach a
picture or schematic of the pouch, and in the space provided enter the document name for
the attachment.
b) Is the container physically restricted during the processing of the product to
control the container thickness?

Page 13 of 41

During processing, the pressure inside the pouch often exceeds the pressure inside the
processing vessel. In this instance, the pouch can expand---resulting in under processing
from poor heat penetration or rupturing from structural stresses. In place of overpressure,
physical restraints can be used to inhibit the pouch from expanding.
Select “Yes” or “No.” If yes, continue to question b.i to indicate how the container is
restricted. If no, continue to question c.
Question b.i: Racks: For containers that are physically restricted during
the processing of the product to control container thickness, this field provides a
place to indicate whether the container is restricted by racks. Pouches can be
restrained by closely placed flat racks or racks that have indentations.
Other: For containers that are physically restricted during the processing
of the product to control container thickness, this field provides a place to indicate
whether the container is restricted by means other than racks. If racks are not
used, select “Other”, attach a picture of the restraint used, and in the space
provided enter the document name for the attachment.
c) Is overpressure used during the processing of the product to control container
thickness?
With flexible pouches, some additional external pressure may be required to conform the
container to its maximum dimensions for proper heat penetration and to avoid structural
stresses on the sealing surfaces. This additional pressure is generated by the addition of
compressed air into the processing vessel or by steam when using a Rotomat type cooker.
Select “Yes” or “No.” If yes, continue to question c.i. If no, continue to question d.
Question c.i: What is the total overpressure used during processing?
The total overpressure used during processing is the total gauge pressure (psig) during
heating and cooling. Enter the overpressure in pounds per square inch gauge (psig) using
a maximum of two digits before the decimal point and one digit after the decimal point.
d) What is the maximum thickness during retort processing?
Pouches can be processed without any physical restraints. Maximum thickness during
processing is critical for either overpressure or physical restraints. Enter the maximum
thickness in inches using a maximum of two digits before the decimal point and two
digits after the decimal point (e.g., 1.25 is a representation of 1 inch and ¼ of an inch,
10.00 is a representation of exactly 10 inches).
e) What is the maximum residual air?
Residual air trapped inside a flexible pouch can cause significant package expansion
during processing. If the package position (e.g., vertical, on edge, etc.) or physical
restraint in the retort does not allow residual air to affect the heating rate, select “Not
Page 14 of 41

Applicable.” Otherwise, enter the maximum residual air in cubic centimeters (cc) using
a whole number with a maximum of three digits and no decimal point.
4.

Retortable Paperboard Carton

The fourth container type listed on Form FDA 2541e is for a container of retortable
paperboard material.
Paperboard is a thick, paper-based material. While there is no rigid differentiation
between paper and paperboard, paperboard is generally thicker than paper (usually more
than 0.25 mm thicker (equal to 0.010 inches or 10 points)). A paperboard container is a
container where the structure of the container is based on a wood pulp-based core which
has the consistency of thick paper or cardboard.
a) What is the shape of the container?
Select the shape that best applies to the container. If the container is rectangular (e.g.,
juice box, soup box) in shape, select “Rectangular.” Otherwise, select “Other”, attach a
picture or schematic, and in the space provided enter the document name for the
attachment.
b) Is the container physically restricted during the processing of the product to
control the container thickness?
During processing, the pressure inside the retortable paperboard carton often exceeds the
pressure inside the processing vessel. In this instance, the retortable paperboard carton
can expand---resulting in under processing from poor heat penetration or rupturing from
structural stresses. In place of overpressure, physical restraints can be used to inhibit the
retortable paperboard carton from expanding.
Select “Yes” or “No.” If yes, continue to question b.i to indicate how the container is
restricted. If no, continue to question c.
Question b.i: Racks: For containers that are physically restricted during
the processing of the product to control container thickness, this field provides a
place to indicate whether the container is restricted by racks. Retortable
paperboard cartons can be restrained by closely placed flat racks or racks that
have indentations.
Other: For containers that are physically restricted during the processing
of the product to control container thickness, this field provides a place to indicate
whether the container is restricted by means other than racks. If racks are not
used, then select “Other”, attach a picture of the restraint that is used, and in the
space provided enter the document name for the attachment.
c) Is overpressure used during the processing of the product to control container
thickness?

Page 15 of 41

Overpressure is extra external pressure to avoid structural stresses on the sealing surfaces.
This additional pressure is generated by the addition of compressed air into the
processing vessel or by steam when using a Rotomat type cooker.
Select “Yes” or “No.” If yes, continue to question c.i. If no, continue to question d.
Question c.i: What is the total overpressure used during processing?
The total overpressure used during processing is the total gauge pressure (psig)
during heating and cooling. Enter the overpressure in pounds per square inch gauge
(psig) using a maximum of two digits before the decimal point and one digit after the
decimal point
d) What is the maximum thickness during retort processing?
Retortable paperboard carton can be processed without any physical restraints. Maximum
thickness during processing is critical for either overpressure or physical restraints.
Enter the maximum thickness in inches using a maximum of two digits before the
decimal point and two digits after the decimal point (e.g., 1.25 is a representation of 1
inch and ¼ of an inch, 10.00 is a representation of exactly 10 inches).

e) What is the maximum residual air?
Residual air trapped inside a retortable paperboard carton can cause significant package
expansion during processing. If the package position (e.g., vertical, on edge, etc.) or the
physical restraint in the retort does not allow residual air to affect the heating rate, select
“Not Applicable.” Otherwise, enter the maximum residual air in cubic centimeters (cc)
using a whole number with a maximum of three digits and no decimal point.
5.

Rigid Container (10 pounds or more of product)

The fifth container type listed on Form FDA 2541e is for a commercial-size container of
rigid material that contains 10 pounds or more of product.
A rigid container is a large, industrial sized container that maintains its shape with 10
pounds per square inch (PSI) or less of pressure. A rigid container may have a liner that
may be either removable or non-removable.
a) What is the shape of the container?
Select the shape that best applies to the container. If none of the shapes apply, select
“Other”, attach a picture or schematic, and in the space provided enter the document
name for the attachment.
b) What kind of rigid container is used?

Page 16 of 41

Select one of the referenced containers that best describes the container (i.e., drum, pail,
or tote) and select the material that makes up the kind of container. If none of the listed
materials make up the container, select “Other” and enter the name of the material. If
none of the referenced containers are applicable, select “Other”, enter the name of the
container, attach a picture or schematic of the container, and in the space provided enter
the document name for the attachment.
6.

Semi-Rigid

The sixth container type listed on Form FDA 2541e is for a container of semi-rigid
material.
A semi rigid container is a container where the shape of the container is not altered by
filling of product at atmospheric pressures---but can be altered by additional external
pressure.
a) What is the shape of the container?
Select the shape that best fits the container. For “Irregular” or “Other” shapes, attach a
picture or schematic, and in the space provided enter the document name for the
attachment.
b) Is this a compartmentalized container?
Compartmentalized containers are containers that hold more than one food product (e.g.,
corn and green beans where corn and green beans are held in separate sections within a
single container) and the food is processed in the single container.
If the container consists of more than one compartment and the compartments contain
different food products, select “Yes” and identify the number of compartments.
Otherwise, select “No.”
c) What is the predominant material used to make the body of the container?
Select the material that, based on weight, is the predominant material used to make the
container stock. If you select “Other,” enter the information next to “Other.”
d) What is the predominant material used to make the lid of the container?
Select the material that, based on weight, is the predominant material used to make the lid
stock. If you select “Other,” enter the information next to “Other.” If the container is a
web fed paperboard brick pack, without a lid, select “Not Applicable.”
e) How is the lid sealed to the body of the container?
Select the appropriate mechanism for how the lid is sealed to the body of the container..
If you select “Other,” enter the information next to “Other.” If the container is a web fed
paperboard brick pack, without a lid, select “Not Applicable.”

Page 17 of 41

f) Is the container physically restricted during the processing of the product to
control container thickness?
During processing, the pressure inside the semi-rigid container often exceeds the pressure
inside the processing vessel. In this instance, the semi-rigid container can expand--resulting in under processing from poor heat penetration or rupturing from structural
stresses. In place of overpressure, physical restraints can be used to inhibit the semi-rigid
container from expanding.
Select “Yes” or “No.” If yes, continue to question f.i to indicate how the container is
restricted. If no, continue to question g.
Question f.i: Racks: For containers that are physically restricted during the
processing of the product to control container thickness, this field provides a place
to indicate whether the container is restricted by racks. Semi-rigid containers can
be restrained by closely placed flat racks or racks that have indentations.
Other: For containers that are physically restricted during the processing
of the product to control container thickness, this field provides a place to indicate
whether the container is restricted by means other than racks. If racks are not
used, then select “Other”, attach a picture of the restraint that is used, and in the
space provided enter the document name for the attachment.
g) Is overpressure used during the processing of the product to control container
thickness?
Overpressure is additional external pressure required to conform the semi-rigid container
to its maximum dimensions for proper heat penetration and to avoid structural stresses on
the sealing surfaces. This additional pressure is generated by the addition of compressed
air into the processing vessel or by steam when using a Rotomat type cooker.
Select “Yes” or “No.” If yes, continue to question g.i. If no, continue to question h.
Question g.i: What is the total overpressure used during processing?
The total overpressure used during processing is the total gauge pressure (psig) during
heating and cooling. Enter the overpressure in pounds per square inch gauge (psig) using
a maximum of two digits before the decimal point and one digit after the decimal point.
h) What is the maximum thickness during retort processing?
Semi-rigid containers can be processed without any physical restraints. Maximum
thickness during processing is critical for either overpressure or physical restraints. Enter
the maximum thickness in inches using a maximum of two digits before the decimal
point and two digits after the decimal point (e.g., 1.25 is a representation of 1 inch and ¼
of an inch, 10.00 is a representation of exactly 10 inches).
i) What is the maximum residual air?
Page 18 of 41

Residual air trapped inside a semi-rigid container can cause significant package
expansion during processing. If the package position (e.g., vertical, on edge, etc.) or
physical restraint in the retort does not allow residual air to affect the heating rate, select
“Not Applicable.” Otherwise, enter maximum residual air in cubic centimeters (cc) using
a whole number with a maximum of three digits and no decimal point.
7.

Other Container

The seventh container type listed on Form FDA 2541e is for a container of a type other
than the ones listed above.
Select “Other” when none of the container types listed on the form applies and enter the
container type.
a) Attach a schematic or picture of the container and in the space provided enter
the document name for the attachment.
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. If the container does not
have a lid, specify Not Applicable.

F.

Step 5 – Section D. Container Size

Section D includes information on Container Size. 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 (Process Mode) of Form 2541e as: 1) High
Temperature Short Time (HTST); 2) Hot Fill and Hold; or 3) Steam Jacketed Kettle.
In your response to D.2, you may only select “Not Applicable” if 1) your product is a
cheese product under Section A.1,2) you have identified “Other” under Step 3 (Section
C) (Container Type) of Form FDA 2541e, and 3) you intend to select HTST, Hot Fill and
Hold or Steam Jacketed Kettle. In all other circumstances, you may not select “Not
Applicable” in your response to D.2.
For all other circumstances, complete D.1. Section D.3 (net weight) is optional
information.
Products come in a variety of container shapes (see section II.E of these instructions for
information about container shapes). For cylindrical (including bowl and oval) shapes,
select “a” to report the container size. For rectangular (including trays) shapes, irregular
shapes, or pouches, select “b” to report the container size. Report container dimensions
Page 19 of 41

in English units (number of whole inches and sixteenths of an inch). When reporting
volume in D.2 instead of dimensions in D.1, report the volume using a maximum of three
digits before the decimal point and one digit after the decimal point.
Refer to Appendix – B Container Dimension Measurements for examples.
1.

Dimensions:
a) Diameter and Height.

Enter information for Diameter and Height only for cylindrical (including bowl
and oval) shaped containers
b) Length, Width, and Height/Thickness.
Enter information for Length, Width, and Height/Thickness for container shapes
other than cylindrical.

When entering dimensions for diameter, length, width, and height/thickness, express the
dimensions by creating a round number that is a code reflecting the dimensions in inches.
The first part of the code represents the whole number of inches and the last two digits
represent the fraction of an inch in sixteenths. For example:
•
•
•
•
•

If the dimension is 12 and 8/16 inches, create the code from 12 and 08 – i.e., 1208.
If the dimension is 5 and 15/16 inches, create the code from 5 and 15 - i.e., 515.
If the dimension is 3 and ¾ inches, first express the ¾ inches in sixteenths - i.e.,
12/16. Then create the code from 3 and 12 - i.e., 312.
If the dimension is 4 inches, create the code from 4 and 00 - i.e., 400.
If the dimension is 4 and 1/8 inches, first express the 1/8 inches in sixteenths - i.e.,
2/16. Then create the code from 4 and 2 - i.e., 402.

Rounding may be necessary for sizes that are less than one sixteenth of an inch.
Rounding can be up or down depending on the measurement. If the measurement is
closer to the “higher” sixteenth, round up; if the measurement is closer to the “lower”
sixteenth, round down. For example:
•
•

2.

If the diameter is 3 and 7/16 inches and the width is 2 inches and 1/4 of one 16th
inches, the rounded dimensions will be 307 x 200
If the diameter is 4 5/16 inches, the width 3 and 1/16 inches, and height is 0.906
(14/16ths and 1/2 of one 16th of an inch), the rounded dimensions will be 405 x 301 x
015
Volume:

Enter the volume using a maximum of three digits before the decimal point and one digit
after the decimal point and select the applicable units.

Page 20 of 41

3.

Net Weight (Optional):

This question provides the opportunity for you to include the net weight of your product.
Although you are not required to enter this information on this filing form, entering the
information can help FDA inspectors examining product in matching a product under
examination to the product described in this filing form.
Only the quantity of food in the container or package is stated in the net quantity
statement. Do not include the weight of the container, or wrappers and packing materials.
To determine the net weight, subtract the average weight of the empty container, lid and
any wrappers and packing materials from the average weight of the container when filled
with food.
Enter the net weight in ounces if you choose to provide this optional information using a
maximum of three digits before the decimal point and two digits after the decimal point.
If you selected “Voluntary” under Section B of the form, proceed to the signature section
at the bottom of the form. Otherwise, continue with Step 6.

G.

Step 6 – Section E. Processing Method: Acidification

Processing method is a general description of how the product and the container are
treated.
1. What is the natural pH of the product before acidification?
Enter the pH value of the low-acid ingredient (i.e. pH above 4.60) with the highest pH in
its natural state before processing or acidification, using a maximum of two digits before
the decimal point and two digits after the decimal point. In instances where there is no
decimal value, the decimal portion will be two zeros.
2. What is the finished equilibrium pH of the product after acidification?
Enter the representative pH value of the product after processing using a maximum of
two digits before the decimal point and two digits after the decimal point. In instances
where there is no decimal value, the decimal portion will be two zeros.
3. What is the maximum time it takes for the product to achieve the finished
equilibrium pH of 4.60 or lower?
Enter the amount of time it takes for all locations of the product in the container to
achieve the same pH value. This includes the geometric center of any solid
pieces/particulates of the product.

Page 21 of 41

4. Method of Acidification
Select the method of acidification. In accordance with CFR 114.80(a)(3), procedures for
acidification to attain acceptable equilibrium pH levels in the final food include the
following:
•
•
•
•

•
•

Addition of Acid Foods: Addition of acid foods to low-acid foods in controlled
proportions to conform to specific formulations.
Blanch: Blanching of the food ingredients in acidified aqueous solutions.
Direct Batch: Direct batch acidification, which can be achieved by adding a known
amount of an acid solution to a specified amount of food during acidification.
Direct In Container: Direct addition of a predetermined amount of acid to individual
containers during production. Liquid acids are generally more effective than solid or
pelleted acids. Care must be taken to ensure that the proper amount of acid is added to
each container.
Immersion: Immersion of the blanched food in acid solutions. Although immersion of
food in an acid solution is a satisfactory method for acidification, care must be taken
to ensure that the acid concentration is properly maintained.
Other: Use this choice when none of the other choices apply. Identify what
acidification method is used in the area next to “Other.”

5. Acidifying agent(s)
Select one or more acidifying agents as listed on the form. A microbial preservative
added to the product is not considered an acidifying agent and should be identified under
microbial preservatives in Question e.6. If none of the choices apply, select “Other” and
enter the acidifying agent in the space provided.
6. Microbial Preservative(s) critical to the scheduled process
Select all microbial preservatives incorporated into the finished product that are critical to
the scheduled process and indicate the concentration of the preservative as a percent of
the finished product using a maximum of two digits before the decimal point and two
digits after the decimal point. If a microbial preservative in the product is not listed,
select “Other” and enter the microbial preservative in the space provided. If there are no
microbial preservatives, select “None.”

H.

Step 7 – Section F. Process Source

1.

What is the Process Source?

The process source is the individual or entity (e.g., organization, company, individual,
university, or other entity) that establishes the scheduled process. Scheduled processes
for acidified foods must be established by qualified persons having expert knowledge
acquired through appropriate training and experience in the acidification and processing
of acidified foods (21 CFR 114.83).

Page 22 of 41

Enter the name of the process source who scientifically established the scheduled
process(es), attach the support documentation containing the process recommendations
(e.g., letter, bulletin, scientific paper) , and in the space provided enter the document
name for the attachment. Below, we provide some examples of how to name the process
source.
•

If the process was established by your facility, enter the facility’s name.

•

If the process was established by an organization, individual, university or other
entity, enter the name of that entity (followed by the name of an individual, as
appropriate).

•

If the process was established by a reference source document or publication, enter
the reference source document.

2.

What is the Date of the Process Source Document?

Enter the date of the process source document that is attached in month/day/year format.

I.

Step 8 – Section G. Process Mode

In an acidified processing method, acidified foods shall be thermally processed to an
extent that is sufficient to destroy the vegetative cells of microorganisms of public health
significance and those of non-health significance capable of reproducing in the food
under the conditions in which the food is stored, distributed, retailed and held by the user.
Permitted preservatives may be used to inhibit reproduction of microorganisms of nonhealth significance (in lieu of thermal processing) (21 CFR 114.80(a)(1)).
Select a single process mode. The process mode you select should be the primary
processing mode.

•
•

In a High Temperature Short Time (HTST) and Steam Jacketed Kettle process mode,
the product is thermally processed outside of the container.
In a Hot Fill and Hold process mode, the product is thermally processed outside the
container and the container is filled with the hot processed product. The product
contact surface of the container is subsequently thermally treated by introduction of
the heated product.

•

For process modes listed in sections G.4 and G.6-G11 of the form, the food is placed
in the container and the container is heated with the food inside, treating both the food
and the container simultaneously.

•

The Cold Fill and Hold process mode (G.5) is sometimes used for products that have
inherent qualities (such as pH) that destroy vegetative cells of microorganisms of
public health significance and those of nonhealth significance at ambient
temperatures. In the Cold Fill and Hold process mode, the containers do not require a
Page 23 of 41

heat treatment. If this process mode is selected, attach a challenge study (refer to Ref.
2 for detailed explanation of what is needed in a challenge study) demonstrating that
the product, as formulated, will result in the destruction of vegetative cells of
microorganisms of public health significance and those of nonhealth significance, and
in the space provided enter the document name for the attachment. Permitted
preservatives may be used to inhibit reproduction of microorganisms of nonhealth
significance
If none of the listed process modes fit the process mode for your product, select “Other”,
attach the support documentation, and in the space provided enter the document name for
the attachment.
If you select either HTST, Steam Jacketed Kettle, or Hot Fill and Hold, you must
complete Section H of the form about container and container closure treatment.

J.

Step 9 – Section H. Container and Container Closure Treatment

This section only applies to process modes of: 1) High Temperature Short Time (HTST),
2) Hot Fill and Hold, and 3) Steam Jacketed Kettle. If you selected any other process
mode in Section G of the form, skip Section H of the form and continue to Section I.
Select a single container and container closure treatment. The treatment you select should
be the primary treatment.
In completing Section H of the form, describe how the container, headspace, and interior
surface (i.e., surfaces that are in contact with the food) of the container closure are treated
by selecting one of the choices listed. If none of the choices listed apply, select “Other”
and enter the information adjacent to “Other.”
1.

Aseptically Filled:

If the container is treated in an aseptic environment before being filled with a chemical
sterilant, heat, or some other means (e.g., radiation) and the food is filled into the
container and sealed in an aseptic environment, select aseptically filled as your container
treatment.
a) What is the filler name and model?
Enter the name of the filler and model of the filler used.
2.

Heating Tunnel:

The heating medium in the tunnel can be hot air, steam, or water.
a) What is the process time?

Page 24 of 41

If you select “Minutes,” enter the time using a maximum of two digits before the decimal
point and one digit after the decimal point. If you select “Seconds,” enter the time using
a maximum of two digits before the decimal point and zero as the decimal portion.
b) What is the temperature in the heating tunnel?
Enter the temperature in degrees Fahrenheit using a maximum of three digits before the
decimal point and one digit after the decimal point.
3.

Hot Fill and Hold:

In addition to being a process mode under Section G of the form, Hot Fill and Hold can
function as a method for container and container closure treatment in Section H of the
form---both for processors that select Hot Fill and Hold as a process mode under Section
G, and for processors that select High Temperature Short Time (HTST) or Steam
Jacketed Kettle under Section G.
a) What is the temperature of the product in the container at the end of the hold
time?
Enter the temperature of the product in the container at the end of the hold time in
degrees Fahrenheit using a maximum of three digits before the decimal point and one
digit after the decimal point.
Question a.i: Select one of the container closure and treatments.
Select one of the available choices listed and, when applicable, complete the information
next to the selected choice. If none of the choices apply, select “Other” and enter the
information next to “Other.”
4.

Water Spray:
a) What is the process time?

If you select “Minutes,” enter the time using a maximum of two digits before the decimal
point and one digit after the decimal point. If you select “Seconds,” enter the time using
a maximum of two digits before the decimal point and zero as the decimal portion.
b) What is the temperature of the water spray?
Enter the temperature in degrees Fahrenheit using a maximum of three digits before the
decimal point and one digit after the decimal point.
5.

Other:

Select “Other” when none of the choices apply. Enter a description of how the container,
headspace, and interior surface of the container closure are treated in the area next to
“Other.”

Page 25 of 41

K.

Step 10 – Section I. Scheduled Process

Under 21 CFR 114.3(e), scheduled process means the process selected by a processor as
adequate for use under the conditions of manufacture for a food in achieving and
maintaining a food that will not permit the growth of microorganisms having public
health significance. It includes control of pH and other critical factors equivalent to the
process established by a competent processing authority. For more information about
establishing the scheduled process, see section II.H.1 of this document.
List each process on a single line, except for a multiple-step process. In a multiple-step
process, only list the minimum initial temperature for the first step. In addition, only list
the cumulative lethality value (i.e., total F value for all steps) for the last step.
In the instructions, we identify the processing systems that require data entry in the
applicable columns.
1.

Column 1. Process No.

Each process has its own process number. Enter the number 1 in the first row, the
number 2 in the second row, and continue entering numbers in increments of 1 for each
scheduled process that you list. The process number increases by increments of 1
regardless of the number of steps in each scheduled process.
2.

Column 2. Step

A process may have one or more steps. For a single-step process, enter the number 1 in
column 2. When the process has multiple steps, enter the number 1 for the first step, the
number 2 for the second step, and continue entering numbers in increments of 1 for each
subsequent step.
3.

Column 3. Temperature

If you selected HTST or Steam Jacketed Kettle as your process mode in Section G of the
form, skip this column. This information applies to all other process modes. There are
two choices available under the column heading, and you should only select one of these
choices: 1) Minimum Initial; or 2) Fill.
Minimum Initial temperature (IT) is the lowest initial temperature permitted in the
scheduled process. IT is the average temperature of the contents of the coldest container
to be processed at the time the thermal process cycle begins. This may be calculated by
agitating/shaking the filled, sealed container to mix the contents before obtaining this
value.
Fill Temperature is the temperature at the end of the hold time for a Hot Fill and Hold
process mode. Only select Fill Temperature if you selected Hot Fill and Hold as a
process mode in Section G.

Page 26 of 41

Enter the value in degrees Fahrenheit using a maximum of three digits before the decimal
point and one digit after the decimal point.
4.

Column 4. Process Time

There are three choices available under the column heading, and you should only select
one of these choices: 1) Seconds; 2) Minutes; 3) Hours. If you selected Cold Fill and
Hold as your process mode in Section G of the form, enter the process time in units of
hours. For all other process modes, select the “Seconds” or “Minutes” and do not select
“Hours.”
Enter the duration of the process time based on the choice selected above using a
maximum of three digits before the decimal point and two digits after the decimal point.
If the duration is a whole minute, enter the number of minutes and two zeros for the
decimal portion.
Examples of how to enter process time:
•

If the process time is 15 minutes and 30 seconds, enter 15.50 and select “Minutes.”

•

If the process time is 150 minutes and 0 seconds, enter 150.00 and select “Minutes.”

•

If your process mode is Cold Fill and Hold and the process time is 2 days, enter 48.00
and select “Hours.”

•

If the process time is 45 seconds, enter 45.00 and select “Seconds.”

5.

Column 5. Process Temperature

If you selected Hot Fill and Hold as your process mode in Section G of the form, skip this
column. This information applies to all other process modes. Enter the temperature of
the step in degrees Fahrenheit using a maximum of three digits before the decimal point
and one digit after the decimal point.
6.

Column 6. F value

There are two choices available under this column heading: “Fo,” and “Other F.” Select
one of these choices, based on the scheduled process.
•
•

If you are using a z value of 18 degrees and a reference temperature of 250 degrees
Fahrenheit to achieve commercial sterility, select “Fo.”
If the F value used is not based on a z value of 18 degrees Fahrenheit and a reference
temperature of 250 degrees Fahrenheit, select “Other F.”

Enter the reference temperature in degrees Fahrenheit using a maximum of three digits
before the decimal point and one digit after the decimal point and enter the z value in
degrees Fahrenheit using a maximum of two digits before the decimal point and one digit
after the decimal point.

Page 27 of 41

Enter the number of minutes using a maximum of two digits before the decimal point and
two digits after the decimal point for each process.
7.

Column 7. Thruput (Containers per Minute)

Answer this question if you selected “Sterilmatic” or “Heating Tunnel” in Section G of
the form.
Enter the number of food containers going through the processing system per minute
using a whole number with a maximum of four digits and no decimal point. The value
entered should be the maximum number of containers per minute that provides the basis
for the filed process time.
8.

Column 8. Headspace

Answer this question only if you selected “Batch Agitating Retort” or “Sterilmatic” in
Section G of the form.
Select one of the following: 1) Net, 2) Gross, or 3) NA.
Net headspace is the vertical distance between the level of the product (generally the
liquid surface) in an upright rigid container and the lowest inside surface of the lid. Gross
headspace is the vertical distance between the level of the product (generally the liquid
surface) in an upright rigid container and the top edge of the container (the top of the
double seam of a can or the top edge of a glass jar).
If you select net or gross headspace, enter the value in inches using one digit before the
decimal point and four digits after the decimal point. If you enter a zero as the digit
before the decimal point, you must follow the zero with a decimal value (e.g., 0.125). If
you select “NA,” do not enter any numerical values in this column.
9.

Column 9a. Reel Speed

Answer this question only if you selected “Batch Agitating Retort” or “Sterilmatic” in
Section G of the form.
Enter the reel speed in rotations per minute (rpm) of the agitation that provides the basis
for the filed process time and report the value using a maximum of two digits before the
decimal point and two digits after the decimal point.
10.

Column 9b. Reel Diameter

Answer this question only if you selected “Sterilmatic” in Section G of the form.
Enter the diameter of the reel in inches using a whole number with a maximum of three
digits and no decimal point.

Page 28 of 41

11.

Column 9c. Steps per Turn of the Reel

Answer this question only if you selected “Sterilmatic” in Section G of the form.
Enter the number of containers held in a 360 degree rotation of the reel that provides the
basis for the filed process time, using a whole number with a maximum of two digits and
no decimal point.
12.

Column 9d. Chain / Conveyor Speed

If process time relies on chain or conveyor speed, select one of the following: 1) Feet; 2)
Carriers; 3) Flights. In this column, enter the value for the speed per minute using a
maximum of three digits before the decimal point and three digits after the decimal point.
13.

Column 9e. Cooker Capacity

Answer this question only if you selected “Sterilmatic” in Section G of the form.
Enter the maximum number of containers that each cooker shell holds that provides the
basis for the filed process time, using a whole number with a maximum of four digits and
no decimal point. Do not include infeed or discharge valves. For processes with multiple
shells in a multiple step process, enter the cooker capacity for each step on the
appropriate step.
14.

Column 9f. Frequency Strokes per Minute (Oscillation Agitating ONLY)

A stroke is the single movement in any direction up or down or side to side. The
frequency is the number of strokes per period of time. Oscillating Agitating includes
rocking or planar agitation. Answer this question only if you selected “Batch Agitating
Retort” in Section G of the form and the agitating is by oscillation.
Enter the strokes per minute using a maximum of three digits before the decimal point
and two digits after the decimal point.
15.

Column 10. Maximum Fill Weight

There are two choices available under this column heading: “Fill” and “NA.” Select one
of these choices.
If “Fill” is selected, the maximum fill weight includes the weight of the entire product in
the container, including brine or sauce, but does not include the weight of the container.
The maximum fill weight is recorded before processing. Enter the maximum fill weight
in ounces using a maximum of three digits before the decimal point and two digits after
the decimal point.
If the process authority determines that maximum weight is not critical to the process,
select “NA” under the column heading and do not enter any numerical values in this
column.

Page 29 of 41

16.

Column 11. Other

If there are any other critical factors whose values have been specified by the process
source as critical to the delivery of the scheduled process, enter them in the column
heading and provide the applicable values for each scheduled process. If no additional
critical factors have been identified by the process source, leave this column blank.
Example for Other:
Cooling Water Temperature – 100 degrees F

L.

Step 11 – Section J. Additional Information (Optional)

Under this section of the form, you may provide optional attachments. Select one or
more choices and identify the document name adjacent to the appropriate choice(s).
1.

Comments:

Enter any additional information you consider pertinent to the product and/or the
scheduled process critical factor(s). Comments are optional unless you report multiple
forms of the product, multiple packing mediums, or multiple product variations, in which
case comments may be required in some circumstances as discussed under section II.A
(General Information) in this document.
If you report multiple forms of a product (e.g., diced, chunks, cut, fillet), multiple
packing mediums, or multiple products with minor formulation changes on a single form,
the heat transfer rates may differ for each product variation. In such cases, the process
for the slowest heating formulation of the product or its packing medium must be filed
and you should use the comment box section to specify which formulation packing
medium heats the slowest.
If you consider any additional information pertinent to the product and/or the scheduled
process critical factor(s), enter that information in the comment box and/or attach one or
more documents containing the additional information as discussed in section II.J.
2.

Full Name, Signature, Establishment Name and Date

Print the first and last name of the person authorized to represent the facility, as well as
the FCE facility name, state (for US) or province (for foreign countries), and country.
The person authorized to represent the facility must sign and date the form and provide
the authorized person’s telephone number.

III. How to Contact FDA or Obtain Help
You may contact us:
•

By email at LACF@fda.hhs.gov;

Page 30 of 41

•
•

By telephone at 240-402-2411; and
By mail at the address immediately below.

Food and Drug Administration
LACF Registration Coordinator (HFS-303)
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, Maryland 20740-3835

Page 31 of 41

IV. References
1. Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment
Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food
Process Filing Forms) to FDA in Electronic or Paper Format
2. National Advisory Committee on Microbiological Criteria for Foods, (2010).
Parameters for determining inoculated pack/challenge study protocols. Journal of Food
Protection 73 (1): 140–202.
3. LACF/AF Precursor Questions

V.

Appendix

A.

Container Types and Shapes

Figure 1 – Cylindrical Shape 2-Piece Aluminum Containers Depicting Double Seams

Page 32 of 41

Figure 2 – Low-Profile Rectangular Shape 2-Piece Aluminum Containers

Figure 3 – Cylindrical Shape 3-Piece Steel Containers with a Double Seam and Side Seam

Page 33 of 41

Figure 4 – Cylindrical Shape 2-Piece Steel Containers with a Double Seam

Figure 5 – Flexible Pouch

Page 34 of 41

Figure 6 – Glass Containers

Figure 7 – Semi Rigid Body, Oval Shape Containers with Heat Seal

Page 35 of 41

Figure 8 – Semi Rigid Body, Rectangle Shape Containers

Figure 9 – Semi Rigid Body with an Aluminum Double Seam

Page 36 of 41

Figure 10 – Semi Rigid Body, Cylinder Shape Containers with Induction Weld Seal.

Figure 11 – Semi Rigid Body with Heat Seal

B.

Container Dimension Measurements

Container dimension measurements should always be measured from the outside edge of
the container. Below, we list different types of materials and descriptions of how to
properly measure the container dimensions.

Page 37 of 41

1.

Cylindrical Measurement

Measure the diameter from the outside of the double seam on the container. Measure the
height from the top of the double seam to the opposing double seam top. If the can is a
two piece can, measure from the top of the double seam to the furthest point on the other
end. For glass bottles or unusually shaped cylindrical containers, always measure the
widest part of the container.
For heat-sealed, semi-rigid containers, do not measure the sealing flange as part of the
container dimensions. Only measure from the inner edge of the flange where the seal
edge meets the chamber holding the food.
When measuring cylindrical shaped containers, list diameter x height (e.g., 0211 x 0400
for a 2 11/16 inch x 4 inch container.

Figure 12 – Measurement of a Cylindrical Shape Container.

When measuring unusually shaped cylindrical containers, always measure the widest part
of the container.

Figure 13 – Measurement of an Unusual Shape Cylindrical Container.

2.

Oval Shape Measurement

When measuring unusually shaped oval containers, always measure the widest part of the
container.

Page 38 of 41

Figure 14 – Measurement of an Oval Shape Container

Figure 15 – Measurement of Outer Edges of Container

3.

Rectangular Shape, Rectangular Tray and Low-Profile Measurement

For all rectangular containers (including trays), list length (longest dimension) x width
(second longest dimension) x height; for example, list 0405 x 0301 x 0014 for a container
that is 4 5/16 inches long, 3 1/16 inches wide, and 14/16 of an inch.
For a rectangular can, measure the length and width from outside of the double seam.
When measuring the height of the container, measure from the top of the double seam to
the furthest point on the bottom.
For a rectangular pouch, measure from the inner edge of the seams for the length and
width. For the height, measure the thickness at the thickest point.
For paper board rectangular containers, measure the length, width, and height from the
outside edge of the container.

Page 39 of 41

4.

Rectangular Shape Measurement

Figure 16 – Measurement of a Rectangular Shape Container

5.

Rectangular Tray Measurement

Figure 17 – Measurement of a Rectangular Tray Shape Container

6.

Low-Profile Measurement

Figure 18 – Measurement of a Low-Profile Container

C.

Abbreviations

Abbreviation

Full Term

AF

Acidified Food

Page 40 of 41

AR

Authorized Representative

ECP

Establishment Contact Person

FCE

Food Canning Establishment

FFR

Food Facility Registration

FIS

FDA Industry System

FURLS

FDA Unified Registration and Listing Systems

LACF

Low-Acid Canned Foods

ROAR

Read Only Authorized Representative

SID

Submission Identifier

SUPER AR

Super Authorized Representative

Page 41 of 41