Notice2026-03362
Requirements for Additional Traceability Records for Certain Foods; Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade “A” Pasteurized Milk Ordinance
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Published
February 20, 2026
Effective
February 20, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing that we are granting an exemption for certain cottage cheese products from the requirements of the rule titled "Requirements for Additional Traceability Records for Certain Foods" (the Food Traceability Rule). The Agency is taking this action in accordance with the FDA Food Safety Modernization Act and FDA's implementing regulations.
Full Text
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<title>Federal Register, Volume 91 Issue 34 (Friday, February 20, 2026)</title>
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[Federal Register Volume 91, Number 34 (Friday, February 20, 2026)]
[Notices]
[Pages 8256-8259]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03362]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1939]
Requirements for Additional Traceability Records for Certain
Foods; 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: Notification of exemption.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing that we are granting an exemption for certain cottage cheese
products from the requirements of the rule titled ``Requirements for
Additional Traceability Records for Certain Foods'' (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: This exemption is effective on February 20, 2026.
ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: Katie Vierk, Office of Surveillance
Strategy and Risk Prioritization, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2122,
<a href="/cdn-cgi/l/email-protection#cf84aebba7aabda6a1aae199a6aabda48fa9abaee1a7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="a9e2c8ddc1ccdbc0c7cc87ffc0ccdbc2e9cfcdc887c1c1da87cec6df">[email protected]</span></a>; or Alissa Van Wie, Office of Policy and
International Engagement, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-654-7524,
<a href="/cdn-cgi/l/email-protection#a2e3cecbd1d1c38cf4c3ccf5cbc7e2c4c6c38ccacad18cc5cdd4"><span class="__cf_email__" data-cfemail="f5b4999c868694dba3949ba29c90b5939194db9d9d86db929a83">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
On November 21, 2022, FDA published in the Federal Register (87 FR
70910) a final rule titled ``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) from the requirements of the Food Traceability Rule (87
FR 70910 at 70932).
On June 17, 2024, FDA published a notice in the Federal Register
(89 FR 51281) (``2024 Notice'') announcing that the Agency was
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 Food Traceability
Rule. FDA received several comments in response to the notice of the
proposed exemption, as discussed below. In this notice we are
announcing our determination that granting this exemption is
appropriate, and we are therefore granting the exemption.
This action exempts entities that handle IMS listed Grade ``A''
cottage cheese from the regulatory requirements of the Food
Traceability Rule that would otherwise apply to their handling of that
product.
II. IMS Listed Grade ``A'' Cottage Cheese
As noted in the 2024 Notice, cottage cheese is currently 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 United States Public Health Service (USPHS), FDA, the
States, and the dairy industry, with the objective of promoting the
availability of a high-quality milk supply (Ref. 1 and Ref. 2). FDA and
NCIMS have together developed a cooperative, Federal-State program (the
Interstate Milk Shippers Program, or 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 Pasteurized Milk Ordinance (PMO). The PMO
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).
The discussion of the PMO in the 2024 Notice was based on the 2019
Revision of the PMO. On August 9, 2024, FDA announced the availability
of the 2023 Revision of the PMO (Ref. 4 and Ref. 5). This revision does
not include any significant changes to the processing requirements for
cottage cheese. We noted in the 2024 Notice that we did 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 did we think past revisions were materially different in ways
that would affect this conclusion. This continues to be our
expectation, and after reviewing the 2023 Revision we have concluded
that it does not deviate from the 2019 Revision in ways that are
material to our conclusion that IMS listed Grade ``A'' cottage cheese
should be exempt from the requirements of subpart S.
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. The 2024 Notice proposed 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
[[Page 8257]]
(and that therefore resulted in cottage cheese being on the FTL), and
because of the enhanced regulatory oversight of the manufacturing of
IMS listed Grade ``A'' cottage cheese. As discussed below, this
document affirms that conclusion.
III. Comments on Notice of Proposed Exemption
FDA received several comments in response to the 2024 Notice. We
summarize and respond to relevant portions of comments in this notice.
To make it easier to identify comments and FDA's responses to the
comments, the word ``Comment'' will appear in parentheses before the
description of the comment, and the word ``Response'' will appear in
parentheses before FDA's response. We have also numbered each comment
to help distinguish between different comments. The number assigned to
each comment is for organizational purposes only and does not signify
the comment's value, importance, or the order in which it was
submitted.
(Comment 1) Several comments assert that an exemption for IMS
listed Grade ``A'' cottage cheese would reduce the regulatory burden
without compromising food safety. These comments also maintain that
that the primary risks associated with cottage cheese, specifically
contamination with Listeria monocytogenes, are adequately mitigated
through the PMO's requirements for pasteurization, environmental
controls, and regular inspections. Comments also assert that enhanced
regulatory oversight through the IMS Program provides ample safeguards
that render additional traceability records unnecessary for IMS listed
Grade ``A'' cottage cheese.
(Response 1) FDA agrees. As discussed in the 2024 Notice, with
regard to IMS listed Grade ``A'' cottage cheese, we believe an
exemption is appropriate because of the processing requirements
specified in the PMO that address the risk factors that ultimately
resulted in cottage cheese being included on the FTL as part of the
commodity ``Cheese (made from pasteurized milk), fresh soft or soft
unripened,'' and because of the enhanced regulatory oversight of the
manufacturing of IMS listed Grade ``A'' cottage cheese through the IMS
Program.
(Comment 2): One comment maintains it will be important to ensure
that future revisions of the PMO continue to uphold these stringent
standards and that if any changes in the PMO weaken safety controls,
the exemption should be reconsidered to ensure ongoing protection of
public health.
(Response 2) FDA agrees with this comment. As noted in the 2024
Notice, this exemption applies to any IMS listed Grade ``A'' cottage
cheese, including Grade ``A'' cottage cheese regulated under the 2019
Revision of the PMO or earlier revisions of the PMO (in jurisdictions
that might not have adopted the 2019 Revision) and any IMS listed Grade
``A'' cottage cheese regulated under future revisions of the PMO, once
such revisions are released and adopted. As discussed above, we have
reviewed the 2023 Revision of the PMO and concluded that it does not
deviate from the 2019 Revision in ways that are material to our
conclusion that IMS listed Grade ``A'' cottage cheese should be exempt
from the requirements of subpart S. Given that the PMO's requirements
are based on well-established scientific principles and processes, and
given FDA's own involvement in the PMO and the Grade ``A'' program
(along with the involvement of other public health governmental
entities), we do not expect future revisions of the PMO to deviate from
the 2019 and 2023 Revisions in material ways that would affect this
conclusion. If 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 Sec. Sec. 1.1395 and 1.1400 (21 CFR 1.1395
and 1.1400).
(Comment 3) Some comments maintain that given the rise in
popularity of cottage cheese as a protein source, the exemption could
lower manufacturing costs and increase production and sales. They
assert that these cost reductions should be passed on to consumers, and
the exemption should not come at the risk of public health.
(Response 3) FDA agrees that any exemption from the requirements of
the Food Traceability Rule should be based on the risk to public
health. As noted above, FDA is finalizing this exemption in accordance
with Sec. 1.1360 et seq. Section 1.1360(a) states, in part, that FDA
will exempt a food or type of entity from the Food Traceability Rule
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. We are exempting IMS listed Grade ``A''
cottage cheese from the requirements of the Food Traceability Rule
because the processing requirements specified in the PMO address the
risk factors that resulted in cottage cheese being included on the FTL,
and because of the enhanced regulatory oversight of the manufacturing
of IMS listed Grade ``A'' cottage cheese through the IMS Program. The
popularity of cottage cheese as a protein source and the potential
impact of the exemption on manufacturers' production costs are not
relevant to the standard set forth in Sec. 1.1360(a) and therefore
were not considered in our evaluation to determine whether an exemption
is appropriate.
(Comment 4) One comment notes that the inclusion of cottage cheese
on the FTL was based on a comprehensive risk-ranking model, which
identified ``Cheese (made from pasteurized milk), fresh soft or soft
ripened'' as having a significant risk of contamination by Listeria
monocytogenes, primarily based on the potential for post-pasteurization
contamination. The comment expresses concern that the proposed
exemption overlooks that environmental risks associated with such
contamination are still substantial, and maintains that ensuring
traceability is essential for promptly identifying and mitigating
public health risks. The comment also contends that the effectiveness
of the IMS Program heavily depends on consistent implementation and
enforcement across all states.
(Response 4) FDA disagrees with this comment insofar as it argues
that exempting IMS listed Grade ``A'' cottage cheese would have an
adverse effect on the public health. As described in detail in the 2024
Notice, manufacturers of IMS listed Grade ``A'' cottage cheese must
comply with PMO requirements intended to control pathogens during
pasteurization and to prevent contamination during post-pasteurization
processing (Ref. 5). Additionally, there are requirements in the PMO
pertaining to information that must be documented in records, and
provisions that dictate inspectional and sampling frequencies (Ref. 5).
We have concluded that these measures provide protections adequate to
address the risk factors that resulted in the commodity ``Cheese (made
from pasteurized milk), fresh soft or soft unripened'' being on the
FTL.
More specifically, FDA recognizes that the cottage cheese
processing steps that occur after milk pasteurization but prior to
packaging can present a risk for contamination of in-process food with
environmental pathogens, such as L. monocytogenes, if sanitary
conditions are not maintained. However, we believe the post-
pasteurization processing requirements included in the PMO adequately
address these risk factors. The PMO contains specific
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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 (Ref. 3).
Finally, we note that this exemption from the Food Traceability
Rule's enhanced recordkeeping requirements does not alter the
applicability of other laws and regulations related to the
manufacturing, processing, packing, or holding of food. Furthermore, in
accordance with Sec. 1.1360(b), if a person to whom this exemption
applies (including a person who manufactures, processes, packs, or
holds IMS listed Grade ``A'' cottage cheese) is required to register
with FDA under section 415 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (per the requirements of 21 CFR part 1, subpart H) with
respect to the manufacturing, processing, packing, or holding of the
applicable food, such person must maintain records identifying the
immediate previous source of such food and the immediate subsequent
recipient of such food in accordance with Sec. Sec. 1.337 and 1.345
(21 CFR 1.337 and 1.345). Such records must be maintained for 2 years.
(Comment 5) One comment questions the need to exempt cottage cheese
from the Food Traceability Rule while other dairy products are not
exempted. The comment maintains that despite the controls put in place
by the PMO, cottage cheese still falls into the category of higher-risk
dairy products. This comment also asserts that despite the enhanced
regulatory oversight provided by the IMS Program and the PMO, cottage
cheese manufactured in the U.S. is already below international quality
standards, and it is unclear how lowering the safety standards could be
beneficial for end consumers.
(Response 5) There are many dairy products that are not included on
the FTL and therefore are not subject to the Food Traceability Rule. Of
the dairy products that are on the FTL, cottage cheese is the only one
that is addressed by the PMO. As noted above, FDA has concluded that
the requirements and other provisions associated with IMS listed Grade
``A'' cottage cheese are adequate to address the risk factors that
resulted in the commodity ``Cheese (made from pasteurized milk), fresh
soft or soft unripened'' being on the FTL.
The comment does not indicate which international quality standards
they are referring to; regardless, food quality measures do not
necessarily ensure food safety. In addition, we note that exempting IMS
listed Grade ``A'' cottage cheese from the Food Traceability Rule does
not lower safety standards; rather, it reflects the determination that
existing regulatory requirements applicable to these products make it
unnecessary to apply the recordkeeping requirements of the Food
Traceability Rule.
(Comment 6) One comment maintains that in modern society, consumers
value transparency and accountability in the food supply chain. The
comment asserts that the proposal to exempt certain products from a
rule previously in place could erode consumer confidence, particularly
if there are subsequent food safety incidents involving cottage cheese
or similar products. The comment argues that ensuring full traceability
aligns with FDA's mission to protect public health and reinforces the
Agency's credibility.
(Response 6) In the preamble to the Food Traceability Rule, FDA
announced that we were considering initiating a process to determine
whether to exempt cottage cheese regulated under the PMO from the
rule's requirements (87 FR 70910 at 70932). We have taken steps to
finalize this exemption prior to the rule's compliance date. We
therefore do not agree with the comment's implication that this
exemption will be inconsistent with consumers' expectations.
More generally, while we acknowledge the goals expressed in the
comment, FDA's authority to promulgate the Food Traceability Rule stems
from section 204(d) of the FDA Food Safety Modernization Act (FSMA),
under which the rule's requirements must be limited to foods Sec. Sec.
the Agency designates for inclusion on the Food Traceability List. The
rule's procedures in 21 CFR 1.1360 et seq. for granting modified
requirements and exemptions stem from section 204(d)(6)(E) of FSMA. In
keeping with both of those provisions, FDA may exempt a food or type of
entity from the rule's requirements 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. As stated above,
we believe an exemption for IMS listed Grade ``A'' cottage cheese is
appropriate because of the processing requirements specified in the PMO
that address the risk factors that resulted in cottage cheese being
included on the FTL, and because of the enhanced regulatory oversight
of the manufacturing of IMS listed Grade ``A'' cottage cheese through
the IMS Program. If we subsequently determine that it is necessary to
revise or revoke the exemption for these products in order to protect
the public health, we will follow the procedures set forth in
Sec. Sec. 1.1395 and 1.1400.
(Comment 7) One comment asserts that while cottage cheese is
currently strictly monitored under the NCIMS based on the PMO
standards, there have not been any significant changes to the current
PMO regulations that would prompt the potential exclusion of cottage
cheese from the Food Traceability Rule.
(Response 7) This exemption is not based on changes to the PMO
requirements. As discussed in Response 6, FDA's announcement that we
were considering initiating the process for this exemption was
simultaneous with our publication of the Food Traceability Rule.
Moreover, as discussed in Response 2, this exemption applies to IMS
listed Grade ``A'' cottage cheese regulated under earlier revisions of
the PMO (in jurisdictions that might not have adopted the 2019 Revision
or the 2023 Revision), because we do not think that past revisions were
materially different in ways that would affect our conclusion that this
exemption is appropriate.
IV. Conclusion
As discussed above and as set forth in the 2024 Notice, we proposed
exempting IMS listed Grade ``A'' cottage cheese from the requirements
of the Food Traceability Rule because we tentatively concluded that
application of the Food Traceability Rule to IMS listed Grade ``A''
cottage cheese is not necessary to protect the public health in light
of how such cottage cheese is regulated. Based on the comments received
on the 2024 Notice, and as discussed above, we conclude an exemption
for IMS listed Grade ``A'' cottage cheese is appropriate because of the
processing requirements specified in the PMO that address the risk
factors that resulted in cottage cheese being included on the FTL, and
because of the enhanced regulatory oversight of the manufacturing of
IMS listed Grade ``A'' cottage cheese through the IMS Program.
Having considered all timely submitted comments, and in accordance
with 21 CFR 1.1385(b), we are publishing this document to state that we
are granting an exemption from the Food Traceability Rule for IMS
listed Grade ``A'' cottage cheese, for the reasons stated above.
We note that, in accordance with Sec. 1.1360(b), if a person to
whom this exemption applies (including a person who manufactures,
processes, packs, or holds IMS listed Grade ``A'' cottage cheese) is
required to register with FDA under section 415 of the FD&C Act (per
the requirements of 21 CFR part 1, subpart H) with respect to the
[[Page 8259]]
manufacturing, processing, packing, or holding of the applicable food,
such person must maintain records identifying the immediate previous
source of such food and the immediate subsequent recipient of such food
in accordance with Sec. Sec. 1.337 and 1.345. Such records must be
maintained for 2 years.
In accordance with 21 CFR 1.1390, this exemption is effective as of
the date this document publishes in the Federal Register.
V. 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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 <a href="https://www.fda.gov/media/138115/download?attachment">https://www.fda.gov/media/138115/download?attachment</a>. Accessed April 17, 2025.
2. FDA and NCIMS, ``Memorandum of Understanding Between the National
Conference on Interstate Milk Shipments and the Food and Drug
Administration'', 1977. Available at: <a href="https://www.fda.gov/about-fda/mou-225-78-1000">https://www.fda.gov/about-fda/mou-225-78-1000</a>. Accessed March 26, 2025.
3. FDA, ``Grade ``A'' Pasteurized Milk Ordinance (2019 Revision),''
2019. Available at: <a href="https://www.fda.gov/media/140394/download?attachment">https://www.fda.gov/media/140394/download?attachment</a>. Accessed April 17, 2025.
4. FDA Memorandum, ``2023 Revision of the Grade ``A'' Pasteurized
Milk Ordinance (PMO),'' M-I-24-02, August 9, 2024. Available at:
<a href="https://gams.fda.gov/active/M-I-24-02-PMO-2023-Revision.pdf">https://gams.fda.gov/active/M-I-24-02-PMO-2023-Revision.pdf</a>.
Accessed May 1, 2025.
5. FDA, ``Grade ``A'' Pasteurized Milk Ordinance (2023 Revision),''
2023. Available at: <a href="https://www.fda.gov/media/180975/download?attachment">https://www.fda.gov/media/180975/download?attachment</a>. Accessed April 17, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03362 Filed 2-19-26; 8:45 am]
BILLING CODE 4164-01-P
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