[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