[Federal Register Volume 89, Number 63 (Monday, April 1, 2024)]
[Rules and Regulations]
[Pages 22331-22333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06837]



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 Rules and Regulations
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
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  Federal Register / Vol. 89, No. 63 / Monday, April 1, 2024 / Rules 
and Regulations  

[[Page 22331]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 441

[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 and request for comments.

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SUMMARY: FSIS is announcing the availability of a 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, and the proper labeling of these products. FSIS is also 
announcing when the Agency will start verifying that establishments are 
correctly calculating retained water in applicable product. The 
guideline clarifies the methods an establishment may use to collect and 
use data to determine the amount of retained water in a product covered 
by its retained water protocol (RWP). In addition, it provides specific 
information on protocol development, process control, and air-chilled 
product claims.

DATES: Submit comments on or before May 31, 2024.
    Establishments will have until September 30, 2024, to submit their 
revised protocols to the Risk Management and Innovations Staff (RMIS) 
via askFSIS for review. Establishments will have until April 1, 2025, 
to make any necessary label changes.
    Unless the Agency receives substantive comments that warrant 
further review, RMIS will stop reviewing RWPs April 1, 2025. After that 
date, the RWPs will be reviewed by inspection program personnel (IPP).

ADDRESSES: A downloadable version of the guideline is available at 
https://www.fsis.usda.gov/policy/fsis-guidelines.
    FSIS invites interested persons to submit comments on this 
guideline. Comments may be submitted by one of the following methods:
    Federal eRulemaking Portal: This website provides the ability to 
type short comments directly into the comment field on the web page or 
attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
    Mail: Send to Docket Clerk, U.S. Department of Agriculture, Food 
Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 
3758, Washington, DC 20250-3700.
    Hand- or courier-delivered submittals: Deliver to 1400 Independence 
Avenue SW, Jamie L. Whitten Building, Room 350-E, Washington, DC 20250-
3700.
    Instructions: All items submitted by mail or electronic mail must 
include the agency name and docket number FSIS-2022-0014. Comments made 
in response to the docket will be made available for public inspection 
and posted without change, including any personal information, to 
https://www.regulations.gov.
    Docket: For access to background documents or comments received, 
call (202) 205-0495 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Washington, DC 20250.

FOR FURTHER INFORMATION CONTACT: Rachel A. Edelstein, Assistant 
Administrator, Office of Policy and Program Development, FSIS; 
Telephone: (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On January 9, 2001, FSIS published 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. On December 2, 2015, 
FSIS amended its retained water regulations to include fish of the 
order Siluriformes and products derived from these fish (80 FR 75590). 
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 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 2005, FSIS issued the 
``Compliance Guidelines for Retained Water'' to assist establishments 
in developing and carrying out their RWPs.
    The revised guideline represents the Agency's current thinking on 
retained water requirements and includes new updates based on the 
latest scientific information. FSIS is encouraging establishments that 
have been using the previous version of the guideline to update their 
protocols with the recommendations in the new guideline in order to 
ensure their data are reproducible and statistically verifiable.
    FSIS will update the guideline, as necessary, as new information 
become available.

Revised Guideline

    Recently, RMIS conducted a review of older RWPs and found that 
establishments were not correctly applying formulae 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). The post-
evisceration moisture percentage reflects the dry weight and the 
natural water weight of the carcass. The pre-pack moisture percentage 
reflects the dry weight, the natural water weight (the amount of water 
that is in the bird naturally, prior to any aqueous applications), and 
the retained water weight.
    Therefore, FSIS is making available a revised version of its 2005 
guideline for

[[Page 22332]]

retained water to clarify for inspected establishments the ways that 
they can collect and use data to determine the amount of retained water 
in the products covered by their RWPs. The updated guideline includes 
better explanations of the measurement formulae used in determining 
retained water percentages. It provides the mathematical formulae for 
calculating retained water using the weight of the carcasses, the 
mathematical formulae for calculating the moisture percentages, and the 
mathematical formulae for calculating retained water using moisture 
percentages.
    The guidance also explains that establishments should have large 
enough sample sizes to ensure that they are getting accurate results. 
In addition, the guidance expands on what constitutes acceptable 
analysis and conclusions of the retained water data for labeling 
purposes, to include demonstrating that a given package in a lot 
retains no more water than what is declared on the label, within a 20% 
margin of error.
    The guideline recommends that establishments verify the retained 
water in their products at a frequency that ensures they are 
maintaining process control of the retained water in their systems, 
i.e., that the retained water percentages do not exceed the labeling 
declarations over time. The guideline also provides information needed 
for retained water testing methods to be applied, such as the number of 
carcasses tested, the carcass type (e.g., specific poultry carcass 
type), weight of carcass at each point tested, time period tested, the 
number of sample sets tested, and the frequency of how often retained 
water is verified for labeling purposes.
    The updated guideline explains what 9 CFR 441.10 requires an 
establishment to do when developing a new or revising an existing RWP. 
For example, an establishment is required to state specifically the 
type of product (e.g., carcass or giblets) to which the data apply. The 
guideline recommends that a flow chart of the establishment's process 
be included in the RWP.
    FSIS has removed the regulatory pathogen reduction performance 
standards for Salmonella (9 CFR 310.25(b) and 9 CFR 381.94(b)) that are 
no longer in the regulations. The guideline recommends providing 
temperature reduction throughout the process. It also recommends 
including information on all antimicrobial treatments, not just the 
chiller, when describing special features of the chilling system. In 
addition, the guidance provides recommendations on water retention when 
using dips or sprays as interventions applied to beef trim, pork cuts, 
or poultry parts.
    FSIS removed references to variables affecting retained water that 
occur pre-evisceration, such as scalding temperatures. FSIS also 
removed outdated information concerning testing various chiller 
settings.

RWP Review Process

    In accordance with 9 CFR 441.10(c)(2), establishments must notify 
FSIS as soon as they have new or revised RWPs available for review by 
the Agency. Currently, establishments submit new and revised RWPs to 
RMIS, in the Agency's Office of Policy and Program Development, for 
review.
    Establishments will have until September 30, 2024, to submit their 
revised protocols to RMIS. All meat and poultry establishments using 
incorrect formulae must submit revised protocols to RMIS (for single-
ingredient products in which water was applied, whether that be a dip 
or a spray), if their processes result in retained water. 
Establishments need a system to show whether the products retain water. 
If RMIS finds a problem with the methodology, the establishments will 
need to address the noncompliance with the methodology immediately, so 
that they have enough time to collect new samples to determine the 
amount of retained water and adjust their labeling prior to April 1, 
2025. Establishments may continue selling product while they fix the 
methodology in their RWPs and determine the amount of retained water.

Labeling

    As stated above, the guidance provides information on analyzing the 
retained water data for labeling determinations.
    It also covers the retained water labeling of giblets, products 
intended for export (like dark-meat chicken parts), marinated products, 
products that are subject to religious or dietary exemptions, and 
products sold at retail-service counters.
    FSIS is providing establishments with additional time to correct 
the information. By April 1, 2025, establishments must have accurate, 
supportable retained water statements on their labels. If the 
statements are found to be inaccurate, IPP will issue noncompliance 
reports and tag product. FSIS chose April 1, 2025, as that should give 
establishments enough time to submit their protocols to FSIS, for FSIS 
to review the protocols, and for establishments to revise the 
information, if needed.

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

[[Page 22333]]

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.

Paul Kiecker,
Administrator.
[FR Doc. 2024-06837 Filed 3-29-24; 8:45 am]
BILLING CODE 3410-DM-P