[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47642-47648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19241]



[[Page 47642]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1119]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Canning 
Establishment Registration, Process Filing, and Recordkeeping for 
Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically 
Sealed Containers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 15, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0037. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Food Canning Establishment Registration, Process Filing, and 
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid 
Foods in Hermetically Sealed Containers--21 CFR 108.25 and 108.35, and 
Parts 113 and 114 (OMB Control Number 0910-0037)--Revision

    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 life-threatening 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 (Sec. Sec.  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 (Sec. Sec.  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)).
    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 (Sec. Sec.  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 (Sec. Sec.  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 (Sec. Sec.  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 (Sec. Sec.  
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.
    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 mail completed paper forms to us. 
However, processors who are subject to Sec. Sec.  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

[[Page 47643]]

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.
    In accordance with 5 CFR 1320.8(d), we requested public comment on 
the proposed information collection in 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.
    (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. The scope 
of the voluntary submission discussed in this document is limited to 
certain food products (that is, fermented foods that have a finished 
equilibrium pH of 4.6 or below and acid foods with small amounts of 
added low-acid ingredients) whose regulatory classification is not 
obvious when we look at the product and the product label. 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 institute the voluntary consultation process discussed in 
this document. 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. The ability to submit a voluntary submission fosters 
communication by encouraging manufacturers to submit their processing 
techniques to FDA for an early evaluation of whether their product 
satisfies the criteria for being excluded from the coverage of part 
114. Such communication will help to ensure that any potential food 
safety issues are resolved before the product is marketed and will help 
to ensure that processing techniques used by manufacturers are in full 
compliance with the standards of the FD&C Act. FDA is instituting this 
voluntary consultation process under our broad statutory authority, 
found in section 1003 of the FD&C Act (21 U.S.C. 393), to protect the 
public health by ensuring that foods are safe, wholesome, sanitary, and 
properly labeled and the prohibitions regarding adulterated food in 
section 402(a)(1) of the FD&C Act (21 U.S.C. 342(a)(1)).
    (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 to FDA on Form FDA 
2541e allows manufacturers to submit their processing techniques to FDA 
for an early evaluation of whether their product satisfies the criteria 
for being excluded from the coverage of part 114. If the product 
satisfies the criteria for being excluded from the coverage of part 
114, the product is not subject to the inspection and recordkeeping 
regulations in part 114 and has not become subject to those regulations 
as a result of the submission and consultation. However, if after 
careful review of the voluntary submission we conclude that the product 
does not satisfy the criteria for being excluded from the coverage of 
part 114, then we would advise the manufacturer of our determination 
that the product is an acidified food subject to part 114 and that a 
process filing as an acidified food must be submitted for the product.
    (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 excluded 
from the coverage of part 114 to voluntarily file, thereby making the 
process effectively mandatory.
    (Response) The voluntary submission process is only available to 
manufacturers of certain food products (that is, fermented foods that 
have a finished equilibrium pH of 4.6 or below and acid foods with 
small amounts of added low-acid ingredients) whose regulatory 
classification is not obvious when we look at the product and the 
product label. For example, we can easily determine that products such 
as refrigerated foods and carbonated beverages are excluded from the 
coverage of part 114 by looking at the product or the product label. In 
response to comments, we have revised our guidance and the instructions 
for voluntary submissions to clarify those products for which a 
voluntary

[[Page 47644]]

submission would or would not be accepted. In the event that we receive 
a voluntary submission for a product that is not eligible for the 
review, we will respond to the submission by notifying the manufacturer 
of the error. We will not add the product to our database. Thus, 
ineligible submissions will be rejected and will not result in 
additional information in our database. In summary, our inspectors will 
not expect all manufacturers to submit voluntary submissions because 
not all products are eligible for the process and no advantage is 
obtained from a voluntary submission for an ineligible product.
    (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 
satisfies the criteria for being excluded from the coverage of part 
114, the product is not subject to the inspection and recordkeeping 
regulations in part 114 and will not become subject to those 
regulations as a result of a voluntary submission. We can easily 
determine that some products such as refrigerated foods and carbonated 
beverages are excluded from the coverage of part 114 by looking at the 
product or the product label. The voluntary submission process is only 
available to manufacturers of certain food products (that is, fermented 
foods that have a finished equilibrium pH of 4.6 or below and acid 
foods with small amounts of added low-acid ingredients) whose 
regulatory classification is not obvious when we look at the product 
and the product label.
    (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) As discussed in section III.C of the guidance, fermented 
foods (such as some kinds of sauerkraut, cucumber pickles, and green 
olives) are low acid foods that have been subjected to the action of 
microorganisms to reduce the pH of the food to 4.6 or below.
    (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 to participate in the voluntary consultation process. Such 
consultation may enable us to more easily determine the regulatory 
classification of a product. For a domestic product, this may reduce 
the time it takes for us to complete a facility inspection. With regard 
to a food product that will be offered for import into the United 
States, this may enable us to reduce the time it takes to authorize 
release of the product at the border. 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) As discussed in the response to Comment 4, a voluntary 
process filing submission to FDA on Form FDA 2541e allows manufacturers 
to submit their processing techniques to FDA for an early evaluation of 
whether their product satisfies the criteria for being excluded from 
the coverage of part 114. If we conclude that the product does not 
satisfy the criteria for being excluded from the coverage of part 114, 
then we would advise the manufacturer of our determination that the 
product is an acidified food subject to part 114 and that a process 
filing as an acidified food must be submitted for the product. This 
results in proper regulatory classification of the product and 
appropriate FDA review of the processing technique, thereby enhancing 
food safety.
    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. The 
paperwork reduction analysis only estimates the additional paperwork 
burden associated with voluntary submission on Form FDA 2541e of 
information for food products, limited to those the regulatory 
classification of which is not obvious when we look at the product and 
the product label.
    (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 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

[[Page 47645]]

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 to prevent the detention of product 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.
    (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 Sec.  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.
    (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 provides 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

[[Page 47646]]

dressings and sauces with a pH of 4.6 or below should be considered 
acid foods.
    (Response) The definition of acidified foods in Sec.  114.3(b) only 
excludes from the coverage of part 114 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. 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.
    (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) The definition of acidified foods in Sec.  114.3(b) 
excludes from the coverage of part 114 those fruit and vegetable juices 
that meet the definition of 21 CFR 120.1(a) and have a finished natural 
pH of 4.6 or below. We included ``Food Product Group'' categories for 
various fruit and vegetable juices on all the forms (forms for low-acid 
foods as well as forms for acidified foods) to accommodate the 
possibility that some fruit and vegetable juices may not satisfy these 
criteria.
    (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.
    We interpret the comment regarding ``facility profiles'' as 
objecting to our intent to permit manufacturers to voluntarily self-
categorize the product for which they are submitting a process filing 
as one of several optional ``Food Product Group'' categories. When this 
optional information about the ``Food Product Group'' category is 
provided, we will use it to help us understand the nature of the 
products covered by the process filing as we review the scheduled 
process described in the filing for adequacy to control microbial 
contamination to ensure safe manufacturing, processing, and packing 
procedures. We will also use the ``Food Product Group'' category 
information, in addition to our general knowledge of the industry and 
the reports we receive, such as those under Sec. Sec.  108.25(d) and 
108.35(d) regarding instances of potential health-endangering spoilage, 
process deviation, or contamination with microorganisms, to 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 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

[[Page 47647]]

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.
    (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 rather than to 
``select companies.'' Thus, interested parties had sufficient 
opportunity to comment.
    As discussed in our responses to the comments, we have modified the 
paper-based versions of the four proposed replacement forms and their 
instructions. We have also modified the electronic submission system to 
mirror the paper forms. At this time, these documents are available for 
review on OMB's Web site as part of the Information Collection Request 
we submitted to OMB.
    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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Number of
              21 CFR section                   FDA form        Number of     responses per   Total annual       Average burden per response       Total
                                                number        respondents     respondent       responses                                          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
108.25(c)(1) and 108.35(c)(2); Food                   2541             645               1             645  0.17 (10 mins.)...................       110
 canning establishment registration.
108.25(c)(2); Food process filing for                2541e             726              11           7,986  0.33 (20 mins.)...................     2,659
 acidified method.
108.35(c)(2); Food process filing for low-           2541d             336              12           4,032  0.33 (20 mins.)...................     1,343
 acid retorted method.
108.35(c)(2); Food process filing for                2541f              37               6             222  0.33 (20 mins.)...................        74
 water activity/formulation control method.
108.35(c)(2); Food process filing for low-           2541g              42              22             924  0.75 (45 mins.)...................       693
 acid aseptic systems.
108.25(d); 108.35(d) and (e); Report of                N/A               1               1               1  4.................................         4
 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.................................  ..............  ..............  ..............  ..............  ..................................     4,883
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 hours per response reporting estimates are based on our 
experience with similar programs and information received from 
industry. The reporting burden for Sec. Sec.  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 Sec. Sec.  
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.

[[Page 47648]]



                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                      Average  burden
                           21 CFR section                               Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
113.100 and 114.100................................................          10,392                1           10,392              250        2,598,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 double-
counting, we have not included estimates for Sec.  108.25(e), (g), and 
(h) because they merely cross-reference 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 (Sec.  
113.60(c)) and acidified foods (Sec.  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 
Sec. Sec.  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 Sec. Sec.  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.

    Dated: August 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19241 Filed 8-13-14; 8:45 am]
BILLING CODE 4164-01-P