[Federal Register Volume 89, Number 117 (Monday, June 17, 2024)]
[Proposed Rules]
[Pages 51281-51284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13236]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2024-N-1939]
Requirements for Additional Traceability Records for Certain
Foods; Proposed Exemption for Cottage Cheese Regulated by the National
Conference on Interstate Milk Shipments Grade ``A'' Pasteurized Milk
Ordinance
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed exemption.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to grant an exemption for certain cottage cheese products
from the requirements of the Requirements for Additional Traceability
Records for Certain Foods rule (the Food Traceability Rule). The Agency
is taking this action in accordance with the FDA Food Safety
Modernization Act and FDA's implementing regulations.
DATES: Submit either electronic or written comments on the notice by
September 16, 2024 to ensure that the Agency considers your comment on
the proposed exemption.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-N-1939 for ``Requirements for Additional Traceability Records
for Certain Foods; Proposed Exemption for Cottage Cheese Regulated by
the National Conference on Interstate Milk Shipments Grade ``A''
Pasteurized Milk Ordinance.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Katherine Vierk, Office of Analytics
and Outreach, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2122, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On November 21, 2022, FDA published in the Federal Register (87 FR
70910) a final rule entitled ``Requirements for Additional Traceability
Records for Certain Foods'' (the Food Traceability Rule), which
established additional recordkeeping requirements for persons who
manufacture, process, pack, or hold foods the Agency has designated for
inclusion on the Food Traceability List (FTL). In the preamble to the
final rule, we announced our intention to consider initiating a process
under the new regulation (codified in subpart S of part 1 of title 21
of the Code of Federal Regulations (CFR)) to determine whether to
exempt cottage cheese regulated under the Grade ``A'' Pasteurized Milk
Ordinance (PMO) (Grade ``A'' cottage cheese) from the requirements of
the Food Traceability Rule (87 FR 70910 at 70932).
As contemplated in the preamble to the final rule, we are
initiating a process in accordance with Sec. 1.1360 (21 CFR 1.1360) et
seq. to determine whether it would be appropriate to exempt Grade ``A''
cottage cheese that appears on the Interstate Milk Shippers (IMS) List
(``IMS listed Grade ``A'' cottage cheese'') from the requirements of
the Food Traceability Rule. Section 1.1360(a) states, in part, that FDA
will exempt a food or type of entity from the requirements of subpart S
when we determine that application of the requirements that would
otherwise apply to the food or type of entity is not necessary to
protect the public health. Under Sec. 1.1385 (21 CFR 1.1385), if FDA,
on our own initiative, determines that granting an exemption from
subpart S for a food or type of entity is appropriate, we will publish
a notice in
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the Federal Register setting forth the proposed exemption and the
reasons for the proposal. The notice will establish a public docket so
interested persons may submit written comments on the proposal.
Currently, cottage cheese is covered by the Food Traceability Rule
because it is included on the FTL in the commodity ``Cheese (made from
pasteurized milk), fresh soft or soft unripened.'' However, FDA
recognizes that much of the cottage cheese produced in the United
States is regulated through the National Conference on Interstate Milk
Shipments (NCIMS). NCIMS is a cooperative program among the U.S. Public
Health Service (USPHS), FDA, the States, and the dairy industry, with
the objective of promoting the availability of a high quality milk
supply (Refs. 1 and 2). FDA and NCIMS have together developed a
cooperative, Federal-State program (the IMS Program) to ensure the
sanitary quality of milk and milk products shipped interstate. All 50
States and the District of Columbia participate in the IMS Program.
The IMS Program is implemented and enforced by the States, with FDA
providing oversight, including scientific, technical, and inspection
expertise as set forth in an active 1977 Memorandum of Understanding
(MOU) between FDA and NCIMS (Ref. 2). As described in the MOU, the IMS
Program relies on the PMO, which incorporates relevant Federal
requirements, and related technical documents for the sanitary
standards, requirements, and procedures it follows to ensure the safety
and wholesomeness of Grade ``A'' milk and milk products, including
cottage cheese. FDA considers these standards, requirements, and
procedures to be adequate for the protection of the health and safety
of the consumer (Ref. 2). The NCIMS recommends changes and
modifications to the PMO and other related technical documents at its
biennial conferences (Ref. 3). This ensures that the PMO represents the
most current science-based knowledge and experience concerning the safe
production and processing of Grade ``A'' milk products and incorporates
the latest Federal requirements for food safety (Ref. 3).
Interstate milk and milk product shippers who have been certified
by Milk Sanitation Rating Officers as having attained certain
identified sanitation compliance and enforcement ratings are listed on
the IMS List. Such certification is based on compliance with the
requirements of the PMO. Cottage cheese--including lowfat, nonfat, and
dry curd--is identified using product code 7 in the IMS sanitation
compliance and enforcement ratings (Ref. 4). The proposed exemption
would only apply to manufacturers of cottage cheese that are both
regulated under PMO requirements and IMS listed for cottage cheese.
As discussed above, cottage cheese is on the FTL because it is
included in the commodity ``Cheese (made from pasteurized milk), fresh
soft or soft unripened.'' FDA developed a Risk-Ranking Model for Food
Tracing (RRM-FT) to inform the FTL. The RRM-FT is a semiquantitative
risk-ranking model that evaluates known or reasonably foreseeable
hazards in a wide range of commodities for FDA-regulated human foods,
and scores commodity-hazard pairs according to data and seven criteria
consistent with the requirements in the FDA Food Safety Modernization
Act (FSMA), section 204(d)(2)(A) (Ref. 5). Results from the RRM-FT
provide a risk ranking of commodities and commodity-hazard pairs. Based
on data and results from the RRM-FT, the Agency considered commodities
and associated commodity-hazard pairs with criteria scores in the
moderate to strong range and identified commodities for inclusion on
the FTL (Ref. 6). The risk score for the commodity ``Cheese (made from
pasteurized milk), fresh soft or soft unripened'' is 430, which is
driven by the risk score for the commodity-hazard pair associated with
Listeria monocytogenes (Ref. 7). Because of this risk score, the
commodity ``Cheese (made from pasteurized milk), fresh soft or soft
unripened'' is included on the FTL (Ref. 6).
As explained in the preamble to the final rule, products such as
soft cheeses made from pasteurized milk and nut butters made from
roasted nuts can be on the FTL regardless of the fact that some or all
of their ingredients were previously subjected to a kill step (87 FR
70910 at 70931-32, responses 60 and 64). This is because the RRM-FT
considers potential hazards that may be introduced from exposure to the
processing environment after a lethality treatment (id.). In the case
of the commodity ``Cheese (made from pasteurized milk), fresh soft or
soft unripened,'' which includes cottage cheese, the RRM-FT took into
account the risk from contamination with environmental pathogens, such
as L. monocytogenes, which could occur during the manufacturing
process, after the pasteurization steps. Thus, while pasteurization of
the incoming ingredients provides a significant level of risk-
reduction, this commodity nonetheless appears on the FTL because of the
risk from post-pasteurization in-process contamination, most notably
with L. monocytogenes.
We are proposing to exempt IMS listed Grade ``A'' cottage cheese
from the requirements of the Food Traceability Rule because of the
specific processing requirements specified in the PMO that address the
risk factors that resulted in the commodity ``Cheese (made from
pasteurized milk), fresh soft or soft unripened'' being on the FTL, and
because of the enhanced regulatory oversight of the manufacturing of
such products. As discussed in the following paragraphs, manufacturers
of IMS listed Grade ``A'' cottage cheese must comply with requirements
intended to control pathogens during pasteurization and to prevent
contamination during post-pasteurization processing. Additionally,
there are requirements pertaining to information that must be
documented in records, and provisions that dictate inspectional and
sampling frequencies (Ref. 3).
Pasteurization. Both the milk and creaming mixture used in making
cottage cheese must be pasteurized. The PMO requires that all
pasteurization equipment be tested and inspected by the relevant
Regulatory Agency every 3 months.
Post-pasteurization processing requirements. The cottage cheese
processing steps that occur after milk pasteurization prior to
packaging can be performed in vessels that are open to the environment,
which presents a risk for contamination of in-process food with
environmental pathogens, such as L. monocytogenes, if sanitary
conditions are not maintained. The PMO contains specific requirements
for the control of critical factors including, but not limited to, pH,
filling temperature, and the use of microbial inhibitors and
preservatives to address post-pasteurization contamination (Refs. 3 and
6). These requirements include:
Ensuring that all critical factors are monitored and
documented by the processing facility, the records of which are
verified by the Regulatory Agency;
Ensuring that capping, closing, and sealing of containers
is done in a sanitary manner by approved mechanical equipment (hand
capping of IMS listed Grade ``A'' cottage cheese is not permitted);
Ensuring that Grade ``A'' cottage cheese is at a pH of 5.2
or below and is either:
[cir] Hot-filled at a temperature at or above 145 [deg]F for
containers of 4 ounces or larger, and at a temperature of 155 [deg]F or
above for containers of 2.9 ounces (these temperatures prevent the
survival of L. monocytogenes, a pathogen that
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might have been introduced into the product from the environment); or
o cold-filled at a temperature of 55 [deg]F or less, with addition
of the microbial inhibitor potassium sorbate at a minimum concentration
of 0.06 percent, or another approved inhibitor that provides sustained
inhibition of L. monocytogenes; and
Communicating to the Regulatory Agency if there are any
formulation or processing changes that affect critical food safety
factors (Ref. 3).
Enhanced regulatory oversight. IMS listed Grade ``A'' cottage
cheese manufacturers are subject to stringent regulatory oversight. All
milk and milk products manufacturers regulated by the PMO, including
IMS listed cottage cheese manufacturers, are subject to a three-tier
inspection oversight program that includes inspections by the
Regulatory Agency every 3 months, a rating performed by FDA-certified
State Rating Officers every 2 years for IMS listing purposes, and check
ratings performed by FDA Milk Specialists every 3 years (Refs. 1, 3,
and 8). Additionally, during any consecutive 6 months, at least four
samples of packaged cottage cheese made from pasteurized milk from each
plant that manufactures IMS listed cottage cheese is collected by the
Regulatory Agency for analysis (Ref. 3).
Considering the aforementioned features of regulation of IMS-listed
Grade ``A'' cottage cheese, we tentatively conclude that application of
the subpart S requirements to IMS listed Grade ``A'' cottage cheese is
not necessary to protect the public health. As described above, the
primary hazard associated with ``Cheese (made from pasteurized milk),
fresh soft or soft unripened,'' which includes cottage cheese, is the
risk of post-pasteurization, in-process contamination, specifically
with L. monocytogenes. This hazard is well controlled when cottage
cheese is manufactured in accordance with the PMO. The post-
pasteurization processing requirements in the PMO (e.g., requirements
for processing steps, including container filling, to be performed
under sanitary conditions; requirements relating to pH; requirements
for hot-filling and cold-filling; and the requirement that all critical
factors are monitored and documented by the manufacturing facility, the
records of which are verified by the Regulatory Agency) provide
effective control measures for this hazard. Furthermore, cottage cheese
with a maximum pH of 5.2 and containing a minimum of 0.06 percent
potassium sorbate, when stored at appropriate refrigeration
temperature, will prevent L. monocytogenes growth. More generally, the
PMO imposes stringent food safety requirements at every stage of the
manufacturing process, covering both pasteurization and post-
pasteurization processing, and also requires labeling to include the
plant name or IMS number for product traceability. Frequent inspections
that include reviewing production records documenting control of
critical factors by both the States and FDA Milk Specialists provide a
high level of oversight of these cottage cheese manufacturers. FDA's
own involvement in the PMO and the Grade ``A'' program--along with the
involvement of other public health governmental entities, such as USPHS
and our State, Territorial, and municipal partners--provides a high
degree of confidence regarding the safety of Grade ``A'' dairy
products. Therefore, we propose to exempt from the Food Traceability
Rule IMS listed Grade ``A'' cottage cheese that is produced and
distributed in accordance with the PMO.
The discussion of the PMO in this document is based on the 2019
Revision.\1\ However, this proposed exemption would apply to any IMS
listed Grade ``A'' cottage cheese, including Grade ``A'' cottage cheese
regulated under past revisions of the PMO (in jurisdictions that might
not have adopted the 2019 Revision) and any IMS listed Grade ``A''
cottage cheese manufacturers regulated under future revisions of the
PMO, once such revisions are released and adopted. We do not expect
future revisions of the PMO to deviate from the 2019 Revision in
material ways that would affect our conclusion that IMS listed Grade
``A'' cottage cheese should be exempt from the requirements of subpart
S, nor do we think that past revisions were materially different in
ways that would affect this conclusion. If this exemption is finalized
but we subsequently determine that it is necessary to revise or revoke
the exemption in order to protect the public health--either because of
changes to the PMO or for any other reason--we will follow the
procedures set forth in 21 CFR 1.1395 and 1.1400.
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\1\ The PMO is typically updated every 2 years. However, due to
the COVID-19 pandemic, the NCIMS Conference was postponed to April
2023, so there was no 2021 Revision.
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In accordance with Sec. 1.1385, we request comments on this
proposed exemption. Interested persons may submit written comments on
the proposed exemption in the docket established by this notice in
accordance with the instructions in the ADDRESSES section of this
notice. In accordance with Sec. 1.1385(b), after considering any
comments timely submitted, we will publish a notice in the Federal
Register stating whether we are granting the proposed exemption for IMS
listed Grade ``A'' cottage cheese and the reasons for our decision.
II. References
The following references are on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, and are available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at http://www.regulations.gov.
Although FDA verified the website addresses in this document, please
note that websites are subject to change over time.
1. FDA and NCIMS, ``Procedures Governing the Cooperative State-
Public Health Service/Food and Drug Administration Program of the
National Conference on Interstate Milk Shipment (2019 Revision)'',
2019. Available at https://www.fda.gov/media/138115/download?attachment. Accessed June 3, 2024.
2. FDA and NCIMS, ``Memorandum of Understanding Between the National
Conference on Interstate Milk Shipments and the Food and Drug
Administration'', 1977. Available at: https://www.fda.gov/about-fda/mou-225-78-1000. Accessed June 3, 2024.
3. FDA, ``Grade ``A'' Pasteurized Milk Ordinance (2019 Revision),''
2019. Available at: https://www.fda.gov/media/140394/download?attachment. Accessed June 3, 2024.
4. FDA, ``2024 Interstate Milk Shippers List,'' 2024. Available at:
https://www.fda.gov/media/177531/download?attachment. Accessed June
3, 2024.
5. FDA Memorandum, ``Methodological Approach to Developing a Risk-
Ranking Model for Food Tracing FSMA Section 204 (21 U.S.C. 2223),''
September 2022. Available at: https://www.fda.gov/media/142247/download?attachment. Accessed June 3, 2024.
6. FDA Memorandum, ``Designation of the Food Traceability List Using
the Risk-Ranking Model for Food Tracing,'' October 2022. Available
at: https://www.fda.gov/media/142282/download?attachment. Accessed
June 3, 2024.
7. FDA, ``Risk-Ranking Model for Food Tracing: Web-based Tool for
Criteria and Results,'' 2022. Available at: https://cfsanappsexternal.fda.gov/scripts/FDARiskRankingModelforFoodTracingfinalrule/. Accessed June 3, 2024.
8. FDA, ``Compliance Program Guidance Manual 7318.003: National
Conference on Interstate Milk Shipments (NCIMS) Milk Safety
Program,'' 2012. Available at: https://www.fda.gov/media/142503/download?attachment. Accessed June 3, 2024.
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Dated: June 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13236 Filed 6-14-24; 8:45 am]
BILLING CODE 4164-01-P