`[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Notices]
[Pages 5809-5812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01103]


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 Notices
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
 appearing in this section.
 
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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 
https://www.fsis.usda.gov/policy/fsis-guidelines.

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: https://www.fsis.usda.gov/policy/fsis-guidelines. Although 
comments on this guideline will no longer be accepted through 
www.regulations.gov, 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:
     Carcass washing with or without an antimicrobial;
     Spray chilling carcasses, parts, trimmings, byproducts, 
bones, or other edible parts with or without an antimicrobial;
     Water or ice chilling with or without an antimicrobial;
     Post-chill spraying with or without an antimicrobial; and
     Application of any aqueous antimicrobial or processing 
aid.
    FSIS further clarifies that the following processes are not subject 
to 9 CFR 441.10:
     Scalding or flushing gastrointestinal organs to remove 
digestive tract contents;
     Flushing beef heads to remove digestive tract contents; 
and
     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: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register .
    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: https://www.fsis.usda.gov/subscribe. 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 https://www.usda.gov/forms/electronic-forms, 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: [email protected].
    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`