4164-01-P
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.
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 [INSERT DATE 90
DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER] 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, Katherine.Vierk@fda.hhs.gov.
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 § 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
§ 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 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, FederalState 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 RiskRanking 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 postpasteurization 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:
o Hot-filled at a temperature at or above 145° F for containers of 4 ounces or larger,
and at a temperature of 155° F or above for containers of 2.9 ounces (these
temperatures prevent the survival of L. monocytogenes, a pathogen that might have
been introduced into the product from the environment); or

o cold-filled at a temperature of 55° 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.

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.
In accordance with § 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 § 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, 240-4027500, 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 RiskRanking 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.

Dated: June 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.

[FR Doc. 2024-13236 Filed: 6/14/2024 8:45 am; Publication Date: 6/17/2024]