0037 Supporting Statement 2014

Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified
Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
OMB Control No. 0910-0037
SUPPORTING STATEMENT
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for
three years. In future requests, the agency should make sure that burden changes are correctly
classified in the data entered in ROCIS.
A. Justification
1. Circumstances Making the Collection of Information Necessary
Section 402 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342)
deems a food to be adulterated, in part, if the food bears or contains any poisonous or
deleterious substance which may render it injurious to health. Section 301(a) of the FD&C
Act (21 U.S.C. 331(a)) prohibits the introduction or delivery for introduction into interstate
commerce of adulterated food. Under section 404 of the FD&C Act (21 U.S.C. 344), our
regulations require registration of food processing establishments, filing of process or other
data, and maintenance of processing and production records for acidified foods and thermally
processed low-acid foods in hermetically sealed containers. These requirements are intended
to ensure safe manufacturing, processing, and packing procedures and to permit us to verify
that these procedures are being followed. Improperly processed low-acid foods present lifethreatening hazards if contaminated with foodborne microorganisms, especially Clostridium
botulinum. The spores of C. botulinum need to be destroyed or inhibited to avoid production
of the deadly toxin that causes botulism. This is accomplished with good manufacturing
procedures, which must include the use of adequate heat processes or other means of
preservation.
To protect the public health, our regulations require that each firm that manufactures,
processes, or packs acidified foods or thermally processed low-acid foods in hermetically
sealed containers for introduction into interstate commerce register the establishment with us
using Form FDA 2541 (§§108.25(c)(1) and 108.35(c)(2) (21 CFR 108.25(c)(1) and
108.35(c)(2))). In addition to registering the plant, each firm is required to provide data on
the processes used to produce these foods, using Form FDA 2541a for all methods except
aseptic processing, or Form FDA 2541c for aseptic processing of low-acid foods in
hermetically sealed containers (§§108.25(c)(2) and 108.35(c)(2)). Plant registration and
process filing may be accomplished simultaneously. Process data must be filed prior to
packing any new product, and operating processes and procedures must be posted near the
processing equipment or made available to the operator (21 CFR 113.87(a)).
Description of proposed revisions to forms and electronic submission system:
As described in our regulations, processors may obtain the paper versions of Forms FDA
2541, FDA 2541a, and FDA 2541c by contacting us at a particular address. Processors may
mail completed paper forms to us. However, processors who are subject to §§108.25, 108.35,

or both, have an option to submit Forms FDA 2541, FDA 2541a, and FDA 2541c
electronically (see 76 FR 11783 at 11785, March 3, 2011).
In a notice published in the Federal Register of September 18, 2013 (78 FR 57391) (the
September 18, 2013 notice), we provided notice that we are updating the process filing
portion of the electronic submission system to incorporate “smartform” technology. The
updated process filing portion of the electronic submission system will query the processor
about the processes used to produce the food and present only those data entry fields that are
applicable. This will reduce the burden on processors and reduce errors in process filing
because processors will no longer need to evaluate whether particular data entry fields are
applicable to their products. For example, when a processor submits a process filing for a
product that is processed using a low-acid retorted method with a process mode of “agitating,”
smartform technology would bypass questions that are not applicable to this process mode
option.
Although we encourage commercial processors to use the electronic submission system for
plant registration and process filing, we will continue to make paper-based forms available.
To standardize the burden associated with process filing, regardless of whether the process
filing is submitted electronically or using a paper form, we are proposing to eliminate Forms
FDA 2541a and FDA 2541c and replace these two forms with a total of four forms. Each of
the four proposed replacement forms will pertain to a specific type of commercial processing
and will be available both on the electronic submission system and as a paper-based form.
The electronic submission system and the paper-based form will “mirror” each other to the
extent practicable.
The four proposed replacement process filing forms are as follows:
• Form FDA 2541d (Food Process Filing for Low-Acid Retorted Method);
• Form FDA 2541e (Food Process Filing For Acidified Method);
• Form FDA 2541f (Food Process Filing for Water Activity/Formulation Control Method);
and
• Form FDA 2541g (Food Process Filing for Low-Acid Aseptic Systems).
Some of the data entry fields on the four proposed replacement process filing forms are not on
current Forms FDA 2541a and FDA 2541c. We added certain data entry fields to improve the
efficiency of our review of the process filings. For example, the four proposed replacement
forms include data entry fields for the “food product group” (such as liquid, ready-to-eat
“breakfast foods”). We estimate that any time it would take to provide such information not
already on Form FDA 2541a or FDA 2541c would be offset by the time processors will save
by not having to evaluate whether certain data entry fields on Form FDA 2541a or FDA
2541c are applicable to their products.
We request OMB approval of the paper and/or electronic versions of Forms FDA 2541, FDA
2541a, and FDA 2541c, which were previously approved in 2011; the paper and electronic versions
of new Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g, which we will implement as
soon as the new electronic submission system is operational; the guidance document “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

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or Paper Format;” and, finally, the reporting and recordkeeping burdens contained in the following
citations:
21 CFR 108.25(c)(1) - Reporting (Establishment Registration)
Commercial processors file information on each establishment engaged in processing
acidified foods not later than 10 days from start-up.
21 CFR 108.25(c)(2) - Reporting (Process Filing)
Provide information on the scheduled processes before packing any new acidified food
product not later than 60 days after registration.
21 CFR 108.25(d) - Reporting
Requires packers to report any instance of potential health endangering significance wherein
the food has entered distribution in interstate commerce.
21 CFR 108.25 (e) - Recordkeeping
Requires processors of acidified foods to develop and keep on file plans for recalling products
that may endanger the public health.
21 CFR 108.25(g) - Recordkeeping
Requires packers to prepare, review, and retain all production records for 3 years from date of
manufacture.
21 CFR 108.35(c)(1) - Reporting (Establishment registration)
Commercial processors file information on each establishment engaged in processing
low-acid foods not later than 10 days from start-up.
21 CFR 108.35(c)(2) - Reporting (Process Filing)
Provide information on the scheduled processes for low-acid foods prior to packing any new
product.
21 CFR 108.35(c)(2)(ii) - Reporting (Process Filing)
Intentionally modified process shall be substantiated as to its adequacy and recorded in
writing in the packer's files prior to its use and to report process changes to FDA within 30
days after first use.
21 CFR 108.35(c)(2)(ii) - Recordkeeping
Requires packer to record and file full information on any change of a previously filed
scheduled process.
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21 CFR 108.35(d) - Reporting
Requires packers to report any instance of spoilage or process deviation the nature of which
indicates potential health significance wherein the food has entered distribution.
21 CFR 108.35(e) - Reporting
Requires packer to report any instance wherein such food, which may be injurious to health
because of microbial contamination, has entered distribution.
21 CFR 108.35(f) - Recordkeeping
Requires processors of thermally processed low-acid foods sealed in hermetically sealed
containers develop and keep on file plans for recalling products that may endanger the public
health.
21 CFR 108.35(h) - Recordkeeping
Requires a commercial processor to prepare, review, and retain all records of processing,
processing deviations, container closure inspections, and other records for a period of 3 years.
21 CFR 113.60(c)- Recordkeeping
Requires thermally processed low-acid foods in hermetically sealed containers be marked
with an identifying code to permit lots to be traced after distribution.
21 CFR 113.83 - Recordkeeping
Requires preparation and permanent retention of complete records covering process
establishment by the person or organization establishing the process.
21 CFR 113.87(a) - Recordkeeping
Requires that process data must be filed prior to packing any new product, and operating
processes and procedures must be posted near the processing equipment or made available to
the operator.
21 CFR 113.89 - Recordkeeping
Requires a record of evaluation procedures used for process deviation evaluations for
thermally processed low-acid foods; a separate file or log identifying process deviations, and
the actions taken.
21 CFR 113.100 - Recordkeeping
Specifies processing and production information to be observed and recorded by retort or
processing operator.
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21 CFR 114.80(b) – Recordkeeping
Requires acidified foods be marked with an identifying code to permit lots to be traced after
distribution.
21 CFR 114.89 - Recordkeeping
Retention of records of procedures and results of evaluating acidified finished food products
for potential hazard to public health.
21 CFR 114.100(a) through (d) - Recordkeeping
Specifies three year retention of records and reports dealing with production processes and
controls.
2. Purpose and Use of the Information Collection
As more fully described in section 1, above, our regulations require that each firm that
manufactures, processes, or packs acidified foods or thermally processed low-acid foods in
hermetically sealed containers for introduction into interstate commerce register the
establishment with us and provide data on the processes used to produce these foods.
Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and 114) require firms to
maintain records showing adherence to the substantive requirements of the regulations. These
records must be made available to FDA on request. Firms also must document corrective
actions when process controls and procedures do not fall within specified limits (§§113.89,
114.89, and 114.100(c)); report any instance of potential health-endangering spoilage, process
deviation, or contamination with microorganisms where any lot of the food has entered
distribution in commerce (§§108.25(d) and 108.35(d) and (e)); and develop and keep on file
plans for recalling products that may endanger the public health (§§108.25(e) and 108.35(f)).
To permit lots to be traced after distribution, acidified foods and thermally processed low-acid
foods in hermetically sealed containers must be marked with an identifying code (§§113.60(c)
(thermally processed foods) and 114.80(b) (acidified foods)).
The records of processing information are periodically reviewed during factory inspections by
FDA to verify fulfillment of the requirements in 21 CFR parts 113 or 114. Scheduled thermal
processes are examined and reviewed to determine their adequacy to protect public health. In
the event of a public health emergency, records are used to pinpoint potentially hazardous
foods rapidly and thus limit recall activity to affected lots.
Description of Respondents: The respondents to this information collection are commercial
processors and packers of acidified foods and thermally processed low-acid foods in hermetically
sealed containers. Respondents are from the private sector (for-profit businesses).
3. Use of Improved Information Technology and Burden Reduction
FDA permits electronic registration of food canning establishments (FCE) on the Internet via the
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FCE online registration system. The agency estimates that about eighty percent (80%) of the
registrations will be submitted electronically in the next three years. FDA permits electronic
process filing on the Internet via the Low Acid Canned Food (LACF) Program. Food canning
establishments can communicate with the LACF Program by sending an email to [email protected].
The agency estimates that about eighty percent (80%) of the process filings will be submitted
electronically in the next three years. Both applications are available through the FDA Unified
Registration and Listing System (FURLs).
4. Efforts to Identify Duplication and Use of Similar Information
To the best of our knowledge, no other federal government agency is engaged in the collection of
this information. There can be no duplicative collection of this information because the information
maintained in fulfilling the statutory requirements under section 404 of the FD&C Act is unique to
each establishment.
5. Impact on Small Businesses or Other Small Entities
FDA estimates that ten percent (10 %) of respondents are small businesses. The information
collected is of a regulatory nature and the requirements are the same for small or large food
processing establishments. FDA aids small businesses in complying with its requirements through
the agency’s Regional Small Business Representatives and through the administrative and scientific
staffs within the agency. FDA has provided a Small Business Guide on the agency’s website at
http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. The information cannot be collected less frequently.
Commercial processors engaging in the manufacture, processing, or packing of acidified foods or
thermally processed low-acid foods in hermetically sealed containers are required to register with
FDA within 10 days of so engaging, and to file scheduled processes within 60 days of registration
and prior to the packing of a new product. This timing for reporting assures against improperly or
inadequately processed or packed acidified foods or thermally processed low-acid foods in
hermetically sealed containers being introduced into interstate commerce and becoming a public
health threat to the nation.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The collection fully complies with 5 CFR 1320.5(d)(2). There are no special circumstances
associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we requested public comment on the proposed information
collection in a notice published in the Federal Register of September 18, 2013 (78 FR 57391) (the
September 18, 2013 notice). We extended the comment period for an additional 90 days on
November 18, 2013. We received five comments in response to the notice, each addressing one or
more topics.
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(Comment 1) One comment expressed concern that it would have to resubmit all previously
submitted process filings.
(Response) There is no need to resubmit previously submitted process filings. Previously submitted
process filings will remain valid provided that the information in the previously submitted filings is
still current.
(Comment 2) One comment expressed concern that we are planning to eliminate electronic
submission.
(Response) We are not planning to eliminate electronic submission for process filing and
registration. When we published the notice on September 18, 2013, we made the revised paper
forms available for review so that interested parties could comment on their content and format. As
a result of the comments, we have updated the draft revised forms. Once we receive OMB approval
of the revised information collection, we will update the electronic system so that the information
requested in the electronic system mirrors the information requested on the revised paper forms.
(Comment 3) One comment asserted that we do not have legal authority to use Form FDA 2541e
for the purpose of submitting a voluntary process filing.
(Response) We disagree with the comment’s assertion that we do not have the legal authority to
permit a manufacturer to provide a voluntary process filing submission to FDA on Form FDA
2541e. FDA has long regarded it to be a prudent practice for manufacturers of foods to work
cooperatively with FDA to ensure that their products are safe and comply with all applicable legal
requirements. Consequently, we have proposed to provide for the voluntary registration and Form
FDA 2541e submission process. The draft guidance document, “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
(January 2014),” available on FDA's Web site at http://www.fda.gov/FoodGuidances, describes the
scope and purpose of this process in section II.C, and we expect to issue final guidance on or about
the date that Form FDA 2541e becomes operational, along with the other revised forms discussed in
this document. FDA has authority to implement the voluntary submission process under sections
402 and 404 of the FD&C Act.
(Comment 4) One comment expressed concern that a manufacturer of a product that satisfies the
criteria for being excluded from the coverage of part 114 who submits a voluntary submission will
be held to the same regulations that acidified products are held to with regard to inspections and
recordkeeping. As a result, we would be making substantial changes to part 114 without notice and
comment rulemaking.
(Response) A voluntary process filing submission will not result in part 114 applying to products
that are not acidified foods as defined in 21 CFR 114.3(b). Further, the voluntary process filing
submission process will not result in any changes to part 114.
(Comment 5) One comment expressed concern that the “voluntary process filing” is not
“voluntary” because it asserted our inspectors will expect all manufacturers of products that are

7

excluded from the coverage of part 114 to voluntarily file, thereby making the process effectively
mandatory.
(Response) Our inspectors will not expect all manufacturers to submit voluntary submissions.
(Comment 6) One comment expressed concern that voluntary submitters who choose to use the
electronic submission system would not be able to access and view their submissions.
(Response) A voluntary submission on Form FDA 2541e that is submitted electronically may be
accessed and viewed in the same manner as a required process filing on Form FDA 2541e that is
submitted electronically.
(Comment 7) One comment suggested that voluntary submission may create confusion by
subjecting a non-covered product (that is a refrigerated food or a fermented food) to the acidified
food regulations.
(Response) As discussed in the response to Comment 4, if a product is not an acidified food, the
product is not subject to the good manufacturing practice requirements in part 114 and will not
become subject to those regulations as a result of a voluntary submission.
(Comment 8) One comment stated that the current, “Acidified and Low-Acid Canned Foods: Draft
Guidance: Acidified Foods (September, 2010),” does not provide guidance on what constitutes a
fermented food.
(Response) The draft guidance did address the issue of what constitutes a fermented food. We
expect that the acidified foods guidance, when finalized, will provide guidance on what constitutes
a fermented food
(Comment 9) One comment suggested that the voluntary submission process creates unnecessary
burdens for both industry and FDA and that there will be no benefit derived from the consultation
process.
(Response) Manufacturers are free to decide whether to make a voluntary submission, and we
believe that some manufacturers may choose to do so. For FDA, the voluntary submission results
in increased efficiency.
(Comment 10) Because FDA Form 2541e does not have to be filled out in its entirety, the comment
argued that voluntary filing does not result in benefits to food safety. The comment suggested that a
better voluntary program would be one in which a processor could submit a scheduled process for a
food to seek our assessment of the systems in place to assure the safety of the food, not just as a
way to determine if a product is acidified or not.
(Response) We appreciate the comment’s suggestions for expanding the voluntary submission
program, but we note that the expansion suggested by the comment is not within the scope of the
revisions to Form FDA 2541e.
(Comment 11) One comment suggested that Form FDA 2541e does not provide the flexibility
needed for manufacturers to report their processes. The comment indicated that the draft form only
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provides “one size fits all” mandatory processing parameters by listing limited options for
processors to choose from.
(Response) When we revised Form FDA 2541e, we listed all the current processing methods used
by industry, and included an “Other” choice for many fields to permit manufacturers to report new
and emerging methods that may be developed in the future. As a result of these revisions, the form
provides the flexibility needed to describe any process. In addition, we issued a draft guidance
describing the revised forms and provided interested parties an opportunity to comment on
alternative processes that we should include on the forms.
(Comment 12) One comment suggested that a processor should be able to submit one Form FDA
2541e that describes a process for multiple forms of a product (e.g., “fresh pack pickles (whole, cut
or sliced)”), multiple product packing mediums, and multiple product names that indicate minor
formulation changes, provided that the preparation of these products follows the identical scheduled
process.
(Response) We agree that, under the appropriate circumstances, a processor should be able to
submit one paper Form FDA 2541e that describes a process for multiple forms of a product. In the
past, a processor could complete Form FDA 2541e in the manner described. The revised paper
version of Form FDA 2541e may still be prepared in this manner, provided that the multiple forms
of the product all follow the identical scheduled process and other factors (e.g., container type or
size) do not make it necessary to submit a separate filing. The paper version of revised Form FDA
2541e will allow a processor to enter (1) multiple product forms (e.g., “fresh pack pickles (whole,
cut or sliced)”), (2) multiple product packing mediums (such as brine, oil, sauce), and (3) multiple
product names that indicate minor formulation changes (such as hot, medium, mild salsa).
(Comment 13) One comment stated that we do not need percent headspace information on a
process filing for an acidified product and, if the form includes the data element, then we should
provide enough room on the form for a processor to identify multiple percent headspace figures
associated with multiple container sizes.
(Response) Information regarding the percent headspace information on a process filing for an
acidified product may help us analyze a processing method that uses overpressure. While
overpressure typically is used for low acid products that are thermally processed at elevated
temperatures, overpressure may also be used for an acidified product. Thus, revised Form FDA
2541e includes a data field for percent headspace. If overpressure is not being used, the correct
response is “N/A.”
We also disagree that we should allow a processor to identify multiple figures associated with
multiple container sizes on a single process filing. A process filing may not be submitted for
multiple container types or sizes where multiple types or sizes are on one submission and only part
of the submission (e.g., one container size and/or type) is questionable from a food safety
perspective. A separate Form FDA 2541e is needed for each container type or size. Because a
separate Form FDA 2541e is needed for each container type or size, room for multiple entries for
headspace associated with multiple container sizes is not necessary.

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(Comment 14) One comment suggested that we clarify how to complete the data field, “What is the
vacuum,” in section C.2 of revised Form FDA 2541e when the processor has a range of values to
report.
(Response) We revised the instructions for section C.2 of Form FDA 2541e to clarify that the
processor of an acidified food that is vacuum packed should report the minimum value if there is a
range of values for the vacuum.
(Comment 15) One comment suggested that we add “Center Temperature” as a thermal process
mode in section G of revised Form FDA 2541e. The comment described “Center Temperature” as a
process in which the processor punctures the lid and inserts a thermometer into the container to take
a center temperature reading. When the center temperature reaches the appropriate temperature, the
processor begins the time count. The comment explained that the center temperature method differs
from the other methods because the time count does not begin when the container is filled or the lid
is placed on the container but instead begins when the center temperature reaches the specified
temperature. In addition, the comment requests that center temperature be added as a choice in the
“Note” under Section D (Container Size) that references specific thermal processing mode for
which the processor may choose to report volume rather than container dimensions.
(Response) We disagree with the comment’s suggestion to add “Center Temperature” as a thermal
process mode in section G and as a choice in the “Note” under section D of revised Form FDA
2541e. “Center temperature” is not a thermal process mode because it does not include a defined
scheduled process. A scheduled process for acidified foods can consist of a minimum of two
components as in the case of a “hot fill and hold” or as many as three components for products that
are processed using one of the other processing modes selected. The term “center temperature” or
“center can temperature” refers to the temperature of the product achieved at the end of the
completed scheduled process and not a thermal process mode in and of itself.
(Comment 16) One comment suggested that we clarify where to report the maximum pH value on
Form FDA 2541e.
(Response) We no longer request the maximum pH value of the product on draft Form FDA 2541e.
We revised the form to refer to the “finished equilibrium pH” value of the product for consistency
with the use of that term in § 114.80. We revised the instructions for section E.2 of Form FDA
2541e to clarify that the finished equilibrium pH should be reported.
(Comment 17) One comment suggested that we add “critical to the scheduled process” to the term
“Microbial Preservative(s)” in section E.6 of draft Form FDA 2541e. The comment explained that
some preservatives are added for purposes other than controlling the growth of microorganisms and
should not be part of the scheduled process.
(Response) We revised the title of section E.6 of draft Form FDA 2541e to read “Microbial
Preservative(s) Critical to the Scheduled Process.”
(Comment 18) One comment suggested we clarify that trade associations are an appropriate source
for a scheduled process.

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(Response) Trade associations may provide the scientific support for a scheduled process. In
response to the comment, we have revised our instructions to include a reference to “organization”
which by definition would include trade associations in the list of examples for the term “process
source.”
(Comment 19) One comment asked us to clarify how to fill out section I on Form FDA 2541e for
companies that use center temperature, particularly with respect to columns 1, 2, 3, 5, and 7.
(Response) As discussed in the response to Comment 15, we disagree that “center temperature” is a
thermal process mode. The term “center temperature” or “center can temperature” refers to the
temperature of the product achieved at the end of the completed scheduled process and not a
thermal process mode in and of itself. The center temperature is the end point achieved by the
scheduled process and is not the scheduled process itself. The instructions for Form FDA 2541e
provide step-by-step directions for how to fill out each section of the form.
(Comment 20) One comment noted that the draft guidance document, “Acidified and Low-Acid
Canned Foods: Draft Guidance: Acidified Foods (September, 2010),” has not been finalized and
suggested that we should refrain from revising the process filing forms until the guidance has
become final. The comment expressed concern that the “Food Product Group” categories might be
affected by possible changes to the draft guidance.
(Response) The draft acidified foods guidance is intended to help commercial food processors in
determining whether their food products are subject to the regulations for acidified foods and, when
finalized, will provide our thinking on several topics related to the processing of, and process filings
for, acidified foods. We have prepared a separate draft guidance document that focuses on
procedures for submitting the revised process filing forms. The draft 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 (January 2014),” is available on FDA's Web site at
http://www.fda.gov/FoodGuidances. As discussed in the response to Comment 3, we expect to
issue this guidance as final guidance on or about the date that the revised forms become operational.
Further, we disagree that the “Food Product Group” categories might be affected by possible
changes to the draft acidified foods guidance. The “Food Product Group” categories correspond to
the first two digits of the FDA Product Code and would not be affected by changes to the draft
acidified foods guidance.
(Comment 21) One comment suggested that we remove the “Food Product Groups” category of
“Dressings/condiments (e.g. salad dressing, chutney, salsa, pepper sauce, etc.)” from all process
filing forms because all dressings and sauces with a pH of 4.6 or below should be considered acid
foods.
(Response) The definition of acidified foods in § 114.3(b) only excludes those dressing and
condiments that are acid foods that contain small amounts of low-acid ingredients and have a
resultant finished equilibrium pH that does not significantly differ from that of the predominant acid
or acid food or that do not otherwise meet the definition of acidified food. We included the “Food
Product Group” category, “Dressings/condiments (e.g. salad dressing, chutney, salsa, pepper sauce,
etc.),” on the forms to accommodate the possibility that some dressings and condiments may not
satisfy these criteria.
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(Comment 22) One comment expressed concern that the “Food Product Group” categories for
various fruit and vegetable juices indicates that FDA considers all fruit and vegetable juices to be
subject to the acidified foods regulations and, therefore, will require process filings for all fruit and
vegetable juices.
(Response) FDA does not agree that the “Food Product Group” categories in any way indicates
FDA’s thinking as to whether all fruit and vegetable juices are acidified foods and therefore subject
to the acidified foods regulations in parts 108 and 114. Rather, the “Food Product Group”
categories are designed to help FDA understand the nature of products. For more information on
what constitutes an acidified food, we recommend manufacturers consult the definition of acidified
foods in § 114.3(b).
(Comment 23) One comment suggested we should eliminate the optional “Food Product Group”
categories from the process filing forms to make the forms easier to complete.
(Response) Because the “Food Product Group” information is optional, a manufacturer or packer
that chooses not to provide the information may simply skip that section of the form.
(Comment 24) One comment questioned the value of the optional “Food Product Group” category
information. Another comment asserted that parts of the revised forms appear to be directed toward
generating what it characterized as facility profiles, which it further characterized as extraneous
information not relevant to public safety and, thus, unnecessary.
(Response) As discussed in section I of this notice, improperly processed low-acid foods present
life-threatening hazards if contaminated with foodborne microorganisms, especially C. botulinum.
The spores of C. botulinum need to be destroyed or inhibited to avoid production of the deadly
toxin that causes botulism. This is accomplished with good manufacturing procedures, which must
include the use of adequate heat processes or other means of preservation. To protect the public
health, our regulations in parts 108, 113, and 114 require registration of food processing
establishments, filing of process or other data, and maintenance of processing and production
records for acidified foods and thermally processed low-acid foods in hermetically sealed
containers. We review the process filings to determine their adequacy to protect public health. In
the event of a public health emergency, records are used to pinpoint potentially hazardous foods
rapidly and thus limit recall activity to affected lots.
When optional information about the “Food Product Group” category is provided, we will use it to
help us understand the nature of the products and to help us prioritize which facilities to inspect.
(Comment 25) One comment suggested that, to eliminate confusion, we should use “import codes”
from the U.S. International Trade Commission to clarify the “Food Product Group” categories.
(Response) We disagree that using a coding system such as the “Harmonized Tariff Schedule of the
United States Annotated”, which provides the applicable tariff rates and statistical categories for all
merchandise imported into the United States, would eliminate confusion. The “Food Product
Group” categories identifies to FDA a “group” of foods that will help us determine the product
submission (such as Baby Food or Soup) and prioritize facilities to inspect from a food safety
perspective. The “Food Product Group” categories correspond to the first two digits of the FDA
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Product Code, also referred to as the Product Industry Code. We have been using this coding
system for decades, and so we believe that using “import codes” rather than our longstanding
coding system would not enhance our ability to track and identify potentially adulterated products
as well as groups of foods for potential health hazards.
(Comment 26) One comment asserted that we have increased the information being requested by 30
percent and, since this increase should be reflected in the time needed to complete the forms, we
underestimated the reporting burden in table 1.
(Response) We disagree that we have increased the information being requested or underestimated
the time it takes to complete the paper forms. We updated the paper forms to provide responsive
information in the form of check boxes. This responsive information has been reported by industry
for decades without being provided as check boxes on the paper forms. Adding these check boxes
makes the forms longer, but does not increase the information being requested. Instead, the new
forms should reduce the time it takes to complete the process filing because a submitter may check
a box rather than prepare and manually enter on the paper form a written description of a process.
We note that substantial time may be saved by submitters that use the electronic submission system.
The electronic submission system will present only those sections of the form that are relevant to
the subject matter of the submission, as determined by the information submitted in response to the
initial questions. The system will also minimize the submission of incomplete forms, thus saving
time that paper form submitters will spend if it becomes necessary to correct a form and submit it
again. Finally, we note that, to the extent that the comment is referring to the optional “Food
Product Group” categories, we estimate that the information is readily available to a submitter and
easily provided by checking a box. In summary, we have not increased or decreased our estimate of
the total time necessary to complete the new process filing forms because: (1) We have not
increased the required information in a process filing; (2) the new forms should reduce the time it
takes to complete the process filing because a submitter may check a box rather than prepare and
manually enter on the form a written description of a process; and (3) the “Food Product Group”
category information is optional, readily available, and provided by checking a box.
(Comment 27) One comment asserted that we underestimated the number of hours it takes to
comply with recordkeeping requirements in parts 108, 113, and 114, as reported in table 2. The
comment stated that a canning establishment running a single line operation with one 8-hour shift 5
days a week for 52 weeks each year would conduct manufacturing operations for 2,080 hours each
year, and the recordkeeping would occupy 25 percent of the time of one full-time employee, or 520
hours per year, which is greater than our estimate of 250 hours. The comment added that, for a
facility operating multiple processing lines and/or multiple shifts per day, the recordkeeping burden
would be greater.
(Response) We appreciate the information provided by the comment. Since the information relates
the recordkeeping experience of a single line operation, without additional information we do not
have a sufficient basis for revising the estimated average number of hours of recordkeeping
undertaken by all respondents, across various sizes and types of processing facilities. Accordingly,
for the purpose of this information collection request, we are retaining our previous estimate.
However, in preparation for the next regular information collection request, we will consult with
several establishments of varying sizes and types to obtain additional data on the recordkeeping
burdens and reevaluate our estimates. We will then publish the revised estimates for comment and
consider additional information submitted in response.
13

(Comment 28) One comment asked us to consult select companies before finalizing the revised
forms, in order to obtain these companies’ recommendations regarding the content of the forms, as
part of a transparent, collaborative effort.
(Response) Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires us to provide
notice and a 60-day comment period before submitting the information collection to OMB. Section
3507(a)(1)(D) of the PRA (44 U.S.C. 3507(a)(1)(D)) requires us to publish a second notice
announcing our submission of the Information Collection Request to OMB and providing a 30-day
comment period during which interested parties may submit their comments directly to OMB.
These processes are open to all interested parties including “select companies.”
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
All production records and inspection reports collected from establishments by FDA during
inspections are maintained in FDA District Compliance files which have limited access. The food
processing information contained on the process filing forms submitted to FDA is privileged and
confidential. The process filing information is safeguarded in locked files at the Center for Food
Safety and Applied Nutrition, FDA, and are accessible only to properly authorized FDA and
contractor personnel. Any records that the agency may copy or take possession of would be
protected from disclosure under the Freedom of Information Act (FOIA) under sections 552(a) and
(b) (5 U.S.C. 552(a) and (b)), and by part 20 of the agency’s regulations (21 CFR part 20). The
information also is safeguarded by Section 301(j) of the act (21 U.S.C. 331(j)).
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
Description of Respondents: The respondents to this information collection are commercial
processors and packers of acidified foods and thermally processed low-acid foods in hermetically
sealed containers.
12 a. Annualized Hour Burden Estimate
FDA estimates the burden of this information collection as follows:

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Table 1.--Estimated Annual Reporting Burden1
21 CFR Section

FDA
Form
No.

No. of
Respondents

No. of
Responses per
Respondent

Total
Annual
Responses

Average
Burden
per
Response
0.17
(10 mins.)

108.25(c)(1) and 108.35(c)(2);
2541
645
1
645
Food canning establishment
registration
108.25(c)(2); Food process filing
2541e
726
11
7,986
0.33
for acidified method
(20 mins.)
108.35(c)(2); Food process filing
2541d
336
12
4,032
0.33
for low-acid retorted method
(20 mins.)
108.35(c)(2); Food process filing
2541f
37
6
222
0.33
for water activity/formulation
(20 mins.)
control method
108.35(c)(2); Food process filing
2541g
42
22
924
0.75
for low-acid aseptic systems
(45 mins.)
108.25(d); 108.35(d) and (e);
N/A
1
1
1
4
Report of any instance of potential
health-endangering spoilage,
process deviation, or contamination
with microorganisms where any lot
of the food has entered distribution
in commerce
Total
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

Total
Hours

110

2,659
1,343
74

693
4

4,883

FDA bases its estimate of the number of respondents in table 1 on registrations, process filings, and
reports received over the past 3 years. The average burden per response estimates are based on our
experience with similar programs and information received from industry. The reporting burden for
§§ 108.25(d) and 108.35(d) and (e) is minimal because notification of spoilage, process deviation,
or contamination of product in distribution occurs less than once a year. Most firms discover these
problems before the product is distributed and, therefore, are not required to report the occurrence.
We estimate that we will receive one report annually under §§ 108.25(d) and 108.35(d) and (e).
The report is expected to take 4 hours per response, for a total of 4 hours.
Although, as more fully described in section 1, some of the data entry fields on the four proposed
replacement process filing forms are not on current Forms FDA 2541a and FDA 2541c, we have not
modified our average burden per response estimates. We estimate that any time it would take to
provide such information not already on Form FDA 2541a or FDA 2541c would be offset by the
time processors will save by not having to evaluate whether certain data entry fields on Form FDA
2541a or FDA 2541c are applicable to their products.

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Table 2.--Estimated Annual Recordkeeping Burden1
21 CFR Section

No. of
Recordkeepers

No. of Records
per
Recordkeeper
1

Total Annual
Records

Average Burden
per Recordkeeping

Total Hours

113.100 and
10,392
10,392
250
2,598,000
114.100
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA bases its estimate of 10,392 recordkeepers in table 2 on its records of the number of registered
firms, excluding firms that were inactive or out of business, yet still registered. To avoid doublecounting, we have not included estimates for § 108.25(e), (g), and (h) because they merely crossreference recordkeeping requirements contained in parts 113 and 114 and have been accounted for
in the recordkeeping burden estimate. We estimate that 10,392 firms will expend approximately
250 hours per year to fully satisfy the recordkeeping requirements in parts 108, 113 and 114, for a
total of 2,598,000 hours.
Finally, our regulations require that processors mark thermally processed low-acid foods in
hermetically sealed containers (§ 113.60(c)) and acidified foods (§ 114.80(b) (21 CFR 114.80(b))
with an identifying code to permit lots to be traced after distribution. We seek OMB approval of the
third party disclosure requirements in §§ 113.60(c) and 114.80(b). However, we have not included
a separate table to report the estimated burden of these regulations. No burden has been estimated
for the third party disclosure requirements in §§ 113.60(c) and 114.80(b) because the coding
process is done as a usual and customary part of normal business activities. Coding is a business
practice in foods for liability purposes, inventory control, and process control in the event of a
problem. Under 5 CFR 1320.3(b)(2)), the time, effort, and financial resources necessary to comply
with a collection of information are excluded from the burden estimate if the reporting,
recordkeeping, or disclosure activities needed to comply are usual and customary because they
would occur in the normal course of activities.
12 b. Annualized Cost Burden Estimate
The annual hour cost burden to respondents is approximately $157,370,306.18 per year. FDA
estimates that the average hourly wage for the employee preparing and submitting the registrations
and process filings would be equivalent to a GS-11/Step-1 level in the locality pay area of
Washington-Baltimore in 2014, approximately $30.23/hour. Doubling this wage to account for
overhead costs, FDA estimates the average hourly cost to respondents to be $60.46/hour. Thus, the
overall estimated cost incurred by the respondents is $157,370,306.18 (2,602,883 burden hours x
$60.46/hr = $157,370,306.18).
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating, or maintenance costs associated with this collection.
14. Annualized Cost to the Federal Government
The annualized costs to the Federal government are $895,820. Approximately 2.5 person years
16

(PY) are expended by food technologists for technical review of the process filing forms (FDA
2541a and 2541c). In addition, approximately 1.5 PY are expended for administration, coordination
and computer programming. A contractor provides new system development, computer data entry
and administrative support (filing, mail handling) for the project. The cost of the contract is
$230,000 per year. The estimated annual cost of printing forms and instructions is $1,000.00.
The annual burden for on-site review of the manufacturers records is approximately 2
hours at $71.26 an hour, or $142.52, for each on-site records inspection. On average, a
total of 400 inspections are performed each year for a total cost of $57,008. The burden
for the review of records which have been copied and forwarded to CFSAN because of
potential problems is approximately 6 hours at $71.26 an hour, or $427.56 per event. On
average, records for 35 inspections each year are reviewed by CFSAN for a total cost of
$14,964. Thus, the total cost for FDA inspection and review is $71,972.
One person year (PY) for a fully supported FDA employee equals 2080 hours at a cost of
$148,212. The estimated costs incurred by the Government are listed below:
o Contract (annual expense)
o Food Technologists - 1.5 PY
o Technicians - 2.5 PY
o Printing
o On-site Inspections
o Records Inspections
Total

$230,000
$222,318
$370,530
$ 1,000
$ 57,008
$ 14,964
$895,820

15. Explanation for Program Changes or Adjustments
This information collection request has been revised. The annual burden hours increased by
222,416, while the number of responses decreased by 62,676. Respectively, these adjustments
reflect an increase in the estimated number of recordkeepers and the consolidation of previously
itemized recordkeeping requirements.
With regard to the increase in burden hours specifically, we have not changed the average burden
per response because we estimate that any time it would take to provide additional information
would be offset by the time saved in not having to evaluate whether certain data entry fields are
applicable to particular products.
With regard to the decrease in responses specifically, in its last approval request FDA itemized the
recordkeeping burden to show the impact of new regulatory requirements upon firms who, at that
time, did not keep the now-requisite records. Because these recordkeeping requirements are now
mandatory for all respondents, we have consolidated the recordkeeping requirements and believe
the estimated annual responses most accurately reflects the burden.

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16. Plans for Tabulation and Publication and Project Time Schedule
The information obtained from this data collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the information
collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

18