Notice2025-01103
Availability of Revised Guideline for Controlling Retained Water in Raw Meat and Poultry
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Published
January 17, 2025
Issuing agencies
Agriculture DepartmentFood Safety and Inspection Service
Abstract
FSIS is announcing updates to and responding to comments on its guideline to assist meat (including Siluriformes fish and fish products) and poultry establishments in meeting the regulatory requirements for calculating the correct retained water percentage in raw livestock, poultry, and Siluriformes fish carcasses and parts resulting from post-evisceration processing. FSIS is providing clarification based on arithmetic errors commonly encountered in protocol reviews.
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<title>Federal Register, Volume 90 Issue 11 (Friday, January 17, 2025)</title>
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[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Notices]
[Pages 5809-5812]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-01103]
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Notices
Federal Register
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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 /
Notices
[[Page 5809]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2022-0014]
Availability of Revised Guideline for Controlling Retained Water
in Raw Meat and Poultry
AGENCY: Food Safety and Inspection Service (FSIS), U.S. Department of
Agriculture (USDA).
ACTION: Notice of availability; response to comments.
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SUMMARY: FSIS is announcing updates to and responding to comments on
its guideline to assist meat (including Siluriformes fish and fish
products) and poultry establishments in meeting the regulatory
requirements for calculating the correct retained water percentage in
raw livestock, poultry, and Siluriformes fish carcasses and parts
resulting from post-evisceration processing. FSIS is providing
clarification based on arithmetic errors commonly encountered in
protocol reviews.
DATES: Establishments will have until March 3, 2025, to submit their
revised protocols to the Risk Management and Innovations Staff (RMIS)
via askFSIS for review.
Establishments will have until January 1, 2026, to make any
necessary label changes.
The Office of Field Operations will start reviewing establishments'
retained water protocols on October 1, 2025.
ADDRESSES: A downloadable version of the guideline is available at
<a href="https://www.fsis.usda.gov/policy/fsis-guidelines">https://www.fsis.usda.gov/policy/fsis-guidelines</a>.
FOR FURTHER INFORMATION CONTACT: Rachel A. Edelstein, Assistant
Administrator, Office of Policy and Program Development, FSIS; USDA,
Telephone: (202) 205-0495.
SUPPLEMENTARY INFORMATION:
Background
On April 1, 2024, FSIS published a revised guideline to assist meat
and poultry establishments in meeting the regulatory requirements found
in the final rule ``Retained Water in Raw Meat and Poultry Products;
Poultry Chilling Requirements'' (66 FR 1750), which set limits for
water retained by raw, single-ingredient, meat and poultry products
from post-evisceration processing, such as carcass washing and
chilling. Under 9 CFR 441.10, raw livestock, poultry, and Siluriformes
fish carcasses and parts (hereinafter, ``meat and poultry products'')
are not permitted to retain water from post-evisceration processing
unless the establishment preparing those carcasses and parts
demonstrates to FSIS, with data collected in accordance with a written
Retained Water Protocol (RWP) that any water retained is from
addressing food safety requirements. In addition, the establishment is
required to disclose on the product's label the maximum percentage of
retained water in the raw product (9 CFR 441.10(b)). The required
labeling statement is intended to help consumers make informed
purchasing decisions.
In the Federal Register notice announcing the availability of the
revised guideline (89 FR 22331), FSIS explained that it revised its
guidance because it conducted a review of older RWPs and found that
establishments were not correctly applying formulas when determining
changes in total moisture percentage in products after water spray or
immersion processing. For example, many establishments subtract the
pre-pack moisture percentages from the post-evisceration moisture
percentages to calculate the retained water. However, these percentages
are represented by different bases (or denominators).
After review and consideration of all comments, FSIS has made
changes to and clarified certain aspects of the guideline. The
revisions to the guideline are summarized below in FSIS' responses to
comments. The updated guideline is available on the FSIS guidance web
page at: <a href="https://www.fsis.usda.gov/policy/fsis-guidelines">https://www.fsis.usda.gov/policy/fsis-guidelines</a>. Although
comments on this guideline will no longer be accepted through
<a href="http://www.regulations.gov">www.regulations.gov</a>, FSIS will continue to update this document as
necessary.
The updated guideline represents the Agency's current thinking on
retained water requirements. FSIS is encouraging establishments that
have been using the previous version of the guideline to update their
RWPs following the recommendations in the new guideline to ensure their
data are reproducible and statistically verifiable.
Summary of Comments and Responses
The Agency received three comments on the guideline from
organizations representing the meat and poultry industry and one
comment from an individual. The individual supported FSIS' retained
water regulations but did not specifically comment on the revised
guideline.
Use of Guidance To Clarify Retained Water Policy
Comment: Two organizations representing the poultry industry stated
that the changes included in the revised guideline are significant, and
that the Agency should undertake rulemaking to propose the changes. One
commenter stated that the revised guideline will impose new and
additional requirements for establishments to calculate retained water
amounts in products that substantively differ from FSIS' previous
requirements. The commenter further stated that the Agency should
provide specific direction on how establishments may satisfy existing
regulatory requirements other than by using the formulas for
calculating retained water provided in the revised guideline.
Response: As stated in the preface to the revised guideline, the
document clarifies how establishments can meet requirements to collect
and use data to demonstrate the amount of retained water in the product
covered by the RWP and how to accurately label product to reflect the
amount of water retained. The guidance also provides information on how
to correctly apply formulas to calculated retained water. The contents
of the document, as with all Agency guidance, do not have the force and
effect of law and are not meant to bind the public in any way. The
document is intended only to provide clarity to industry regarding
existing requirements under the regulations in 9 CFR 441.10.
The revised guideline provides examples of acceptable methods for
calculating retained water, including
[[Page 5810]]
discussion of safe harbors and common errors or unsupportable
approaches. As stated in the revised guideline, establishments may
decide to develop alternative methods for calculating retained water to
demonstrate that they meet the regulatory requirements in 9 CFR 441.10.
Scope of Products and Processes Subject to Retained Water Labeling
Requirements
Comment: Three commenters representing the meat and poultry
industry stated that additional information from FSIS is needed to
clarify which meat and poultry products and production processes may be
subject to retained water labeling changes based on the revised
guideline. For example, two of these commenters stated that in the 2001
retained water final rule, FSIS stated that the requirements in 9 CFR
441.10 apply to all amenable products, including offal (66 FR
1750,1759). However, the commenters noted, the Agency later clarified
through guidance that certain products are not subject to the
requirements under 9 CFR 441.10 and, therefore, do not need to be
covered by an RWP.
Response: The 2001 final rule (66 FR 1750) addresses which products
are subject to 9 CFR 441.10. However, FSIS does note that the 2001
final rule does not cover which processes are subject to 9 CFR 441.10,
and that FSIS Directive 6700.1 is the only source of that information.
As such, FSIS is clarifying in this Federal Register notice and the
guideline that the following processes are subject to 9 CFR 441.10:
<bullet> Carcass washing with or without an antimicrobial;
<bullet> Spray chilling carcasses, parts, trimmings, byproducts,
bones, or other edible parts with or without an antimicrobial;
<bullet> Water or ice chilling with or without an antimicrobial;
<bullet> Post-chill spraying with or without an antimicrobial; and
<bullet> Application of any aqueous antimicrobial or processing
aid.
FSIS further clarifies that the following processes are not subject
to 9 CFR 441.10:
<bullet> Scalding or flushing gastrointestinal organs to remove
digestive tract contents;
<bullet> Flushing beef heads to remove digestive tract contents;
and
<bullet> Washing parts to remove excess blood.
FSIS updated the guideline with this information.
Comment: One commenter representing the meat industry recommended
including the Agency's longstanding position that product containing
retained water at <= 0.49 percent is not required to have a retained
water label statement earlier in the guideline.
Response: FSIS agrees and moved the statement up in the document.
Agency Support for Revised Formula To Calculate Retained Water
Percentages
Comment: Three organizations representing the meat and poultry
industry stated that, before implementing the revised guideline, FSIS
should more sufficiently explain the reasoning behind its determination
that the mathematical formula for calculating retained water
percentages for the purposes of the regulatory requirements under 9 CFR
441.10 is incorrect. Two commenters stated that standard industry
practice, when using moisture percentages instead of weights, is to
subtract the moisture content of the post-evisceration sample from the
moisture content of the pre-packaging sample to determine the
difference and, therefore, the added moisture. The commenters noted
that the Agency approved retained water protocols using this method for
more than 20 years.
One organization representing the poultry industry noted that the
Agency stated in the revised guideline that the changes to the prior
version of the guideline are based on the latest scientific
information. However, the commenter stated, FSIS failed to explain that
science to industry and, instead, only provided the revised formula.
The commenter concluded that, for industry to adequately submit
comments on the revised guideline, FSIS should explain what the new
science is and why the new science supports the determination that the
existing Agency guidance needed to be revised.
Response: The updated guideline explains basic math. A difference
in moisture percentages does not equal the amount of retained water as
a percentage of the product weight, as defined in the 2001 Federal
Register final rule (66 FR 1750). The side-by-side comparison in the
Appendix of the guideline clearly demonstrates that subtraction grossly
underrepresents the percentage of retained water in a product when
compared to the uncontested formula used to calculate retained water
from product weights. The formula provided in the guideline
demonstrates that it provides the same retained water percentage as
when using product weights. FSIS has provided an attachment in the
guideline that goes through the math step-by-step.
Differences Between Existing and Revised Retained Water Calculations
Comment: Three organizations representing the meat and poultry
industry stated that the new mathematical formula discussed in the
revised guideline will result in significantly different calculated
results in retained water percentages than the formula used in the
Agency's existing guidance. Commenters stated that these different
results will cause confusion and concern for customers and industry, as
the same product may be labeled with different retained water
declarations before and after implementation of the revised guideline.
One organization representing the poultry industry stated that this
confusion could lead to consumer distrust in both industry and FSIS.
One organization representing the poultry industry specifically
stated that the new formulas will result in different retained water
calculations for a variety of reasons unrelated to the calculation
methodology including, but not limited to dwell time, antimicrobial
used, pH of the chiller, amount of time from the chiller to point of
pack, temperature in second processing, and type of chicken part. The
commenter stated that some of the percentages resulting from following
the revised guideline represent water retention that is physically
impossible to achieve.
Response: FSIS provided a formula that allows establishments to
compare moisture percentages and still provide the same result as if
they were using product weights. FSIS disagrees that the results would
be physically impossible to achieve. If the establishment used product
weights instead of moisture percentages, they would get the same
results as when using the formula in the guideline. There is nothing
new for consumers to understand. FSIS is still requiring establishments
to provide the maximum amount of retained water as a percentage of the
product weight. If the retained water amounts are different, before and
after implementation of the revised guideline, the establishment
previously used incorrect math to calculate their products' retained
water. Correcting this miscalculation is important so that consumers
receive truthful and accurate information on product labels.
Comment: Two organizations representing the meat and poultry
industry stated that the dry and wet methods will return different
results. One organization representing the poultry industry stated that
industry findings demonstrate that using the
[[Page 5811]]
revised guideline results in values that increase the retained moisture
percentage from 50% to over 400%, even though products were
manufactured at the same facility using the same production process and
contain a substantially similar amount of retained water. The commenter
stated that the only change which accounts for the difference is the
revised guideline formula, which consists of an additional step on top
of the existing guideline.
Response: Members of industry may have been underrepresenting their
retained water percentages for as long as they have been using
subtraction to calculate differences in moisture percentages, rather
than the amount of retained water as a percentage of the product
weight. FSIS published this guideline to help members of industry
ensure that they are not underreporting retained water in the future.
Comment: One organization representing the poultry industry noted
that, in the revised guideline, FSIS distinguishes between the
calculation of moisture percentage for products with water added
incidentally due to processing and for products with solutions,
including water, added purposefully to change the nature of the
product.
Response: When adding an aqueous solution as an ingredient, the
weight of the added solution is known. However, with retained water,
the amount that is added is an unknown. Therefore, the formulas to
calculate added solutions as ingredients versus retained water are
different. The guideline makes clear that it only applies to the
retained water regulations and does not apply to the added solution
regulations. If the product has added solutions, then that product must
be labeled in accordance with 9 CFR 317.2(e)(2) for meat and 9 CFR
381.117(h) for poultry.
Comment: A member of the meat industry stated that if the
establishment's data supports that the product has no retained water
(<=0.49 percent), then it is not required to have a retained water
label statement. The commenter said that it would be more useful for
this information to be provided early in the guideline when outlining
the scope of the document instead of almost halfway through as a note.
Response: FSIS made the requested change. The Agency clarified when
protocols are not needed earlier in the guideline.
Comment: During a RWP review, a member of the poultry industry
requested that FSIS change the format of its moisture content formula
for dry basis to match the format of the wet basis formula.
Response: FSIS made the requested change to improve readability.
Validation of New Retained Water Formulas
Comment: One organization representing the meat industry stated
that studies should be conducted to validate that the calculations
provided in the revised guideline will produce the same retained water
percentage as the traditional wet weight method used under existing
Agency guidance. The commenter stated that the revised guideline should
be withdrawn to allow for such validation studies to be conducted. The
commenter offered to partner with FSIS to conduct the studies and
provide additional training and support to industry depending on the
results.
Response: FSIS disagrees that the guidance requires additional
validation by FSIS. The guidance explains basic math. The math doesn't
change through repetitions of side-by-side comparisons. FSIS provided
the side-by-side comparison in the Appendix of the guideline that
clearly demonstrates that subtraction grossly underrepresents the
percentage of retained water in a product when compared to the
uncontested formula used to calculate retained water from product
weights. The formula provided in the guideline demonstrates that it
provides the same retained water percentage as when using product
weights. However, FSIS encourages any additional industry validation of
guidance or support that would facilitate accurate labeling.
Comment: One commenter stated that, prior to implementing the
revised guideline on water retention, FSIS should engage with consumers
to fully understand how they interpret retained water statements and
what those statements mean to end users.
Response: Current retained water regulations went through
rulemaking and provided opportunity for consumer comment. As explained
above, the guideline explains basic math. FSIS requested comments on
the updated guideline and met with industry groups after it announced
the updated guideline. The clarifications provided in the revised
guideline will ensure that establishments label their products with
accurate, supportable retained water statements.
Sample Size Calculation Disparity in Revised Guideline
Comment: One organization representing the poultry industry stated
that, when it used the sample size calculator provided on page 10 of
the revised guideline, the organization produced a different sample
size than reported in the guideline. Specifically, the commenter stated
that, in the provided examples with a 6% mean water retention and a
standard deviation of 3.1 percent, the calculator indicates that
establishments would need a sample size of 105, as compared to the 40
samples reported in the revised guideline.
Response: FSIS acknowledges that the revised guideline did not
include sufficient information regarding the provided calculator for
establishments to enter the values and replicate the tool. The Agency
updated the revised guideline to clarify the examples.
Deadline To Submit Revised RWPs to FSIS and Compliance Date for
Labeling Changes
Comment: A few organizations representing the meat and poultry
industry stated that the Agency's announced September 30, 2024,
deadline for establishments to submit to FSIS for approval any revised
RWPs did not provide them enough time to develop and submit revised
RWPs.
Three organizations representing the meat and poultry industry also
stated that the Agency's announced April 1, 2025, timeline for
companies to make label changes in response to the revised guideline is
inadequate. The commenters stated that, at a minimum, FSIS should
follow the Agency's uniform compliance date for labeling, under which
companies would have until January 1, 2026, to make any necessary label
changes.
Response: FSIS announced in the August 30, 2024, Constituent Update
that the Agency has extended the deadlines. The deadline for
establishments to submit retained water protocols to the Agency has
been moved to March 3, 2025. OFO will start reviewing RWPs on October
1, 2025. Meanwhile, the deadline for establishments to make any
labeling changes will be the Uniform Compliance Date, which is January
1, 2026.
Trade Considerations
Comment: One organization representing the poultry industry stated
that the revised guideline could impact trade and the ability of
domestic producers to export poultry products from the United States.
Response: Some countries restrict how much retained water certain
products can retain. However, the changes in this guideline do not
affect foreign countries' regulations. FSIS is
[[Page 5812]]
providing clarification based on arithmetic errors commonly encountered
in protocol reviews. In addition, the formula FSIS uses for retained
water using product weights matches that of other countries, including
Canada and countries in the European Union.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this notice
online through the FSIS web page located at: <a href="https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register">https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register</a> .
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, and other types of information
that could affect or would be of interest to our constituents and
stakeholders. The Constituent Update is available on the FSIS web page.
In addition, FSIS offers an email subscription service which provides
automatic and customized access to selected food safety news and
information. This service is available at: <a href="https://www.fsis.usda.gov/subscribe">https://www.fsis.usda.gov/subscribe</a>. Options range from recalls to export information,
regulations, directives, and notices. Customers can add or delete
subscriptions themselves and have the option to password-protect their
accounts.
USDA Non-Discrimination Statement
In accordance with Federal civil rights law and USDA civil rights
regulations and policies, USDA, its Mission Areas, agencies, staff
offices, employees, and institutions participating in or administering
USDA programs are prohibited from discriminating based on race, color,
national origin, religion, sex, gender identity (including gender
expression), sexual orientation, disability, age, marital status,
family/parental status, income derived from a public assistance
program, political beliefs, or reprisal or retaliation for prior civil
rights activity, in any program or activity conducted or funded by USDA
(not all bases apply to all programs). Remedies and complaint filing
deadlines vary by program or incident.
Program information may be made available in languages other than
English. Persons with disabilities who require alternative means of
communication to obtain program information (e.g., Braille, large
print, audiotape, American Sign Language) should contact the
responsible Mission Area, agency, or staff office; the USDA TARGET
Center at (202) 720-2600 (voice and TTY); or the Federal Relay Service
at (800) 877-8339.
To file a program discrimination complaint, a complainant should
complete a Form AD-3027, USDA Program Discrimination Complaint Form,
which can be obtained online at <a href="https://www.usda.gov/forms/electronic-forms">https://www.usda.gov/forms/electronic-forms</a>, from any USDA office, by calling (866) 632-9992, or by writing a
letter addressed to USDA. The letter must contain the complainant's
name, address, telephone number, and a written description of the
alleged discriminatory action in sufficient detail to inform the
Assistant Secretary for Civil Rights (ASCR) about the nature and date
of an alleged civil rights violation. The completed AD-3027 form or
letter must be submitted to USDA by:
(1) Mail: U.S. Department of Agriculture, Office of the Assistant
Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC
20250-9410; or
(2) Fax: (833) 256-1665 or (202) 690-7442; or
(3) Email: <a href="/cdn-cgi/l/email-protection#0575776a627764682b6c6b71646e6045707661642b626a73"><span class="__cf_email__" data-cfemail="a6d6d4c9c1d4c7cb88cfc8d2c7cdc3e6d3d5c2c788c1c9d0">[email protected]</span></a>.
USDA is an equal opportunity provider, employer, and lender.
Done, at Washington, DC
Denise Eblen,
Administrator.
[FR Doc. 2025-01103 Filed 1-16-25; 8:45 am]
BILLING CODE 3410-DM-P
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