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Constituent Update
Friday, August 30 2024

Constituent Update - August 30, 2024

FSIS Announces Availability of Guideline on Substantiating Animal-Raising or Environment-Related Labeling Claims

FSIS is announcing the availability of an updated guideline that makes recommendations to strengthen the documentation that supports animal-raising and environment-related claims on meat or poultry product labeling. The Guideline on Substantiating Animal-Raising or Environment-Related Labeling Claims includes revisions informed by sampling data, petitions, public comments to those petitions and feedback received from a wide range of stakeholders. FSIS last updated its guideline on these claims in 2019.

Animal-raising claims, such as “Raised Without Antibiotics,” “Grass-Fed” and “Free-Range,” and environment-related claims, such as “Raised using Regenerative Agriculture Practices” and “Climate-Friendly,” are voluntary marketing claims that highlight certain aspects of how the source animals for meat and poultry products are raised or how the producer maintains or improves the land or otherwise implements environmentally sustainable practices. The documentation submitted by companies to support these claims is reviewed by FSIS and the claims can only be included on the labels of meat and poultry products sold to consumers after they are approved by the agency.

In the updated guideline, FSIS strongly encourages the use of third-party certification to substantiate animal-raising or environment-related claims. Third-party certification of animal-raising or environment-related claims helps ensure that such claims are truthful and not misleading by having an independent organization verify that their standards are being met on the farm for the raising of animals and for environmental stewardship. The revised guideline also emphasizes more robust documentation for environment-related and animal-raising claims.

Additionally, the updated guideline recommends that establishments using “negative” antibiotic claims (e.g., “Raised Without Antibiotics” or “No Antibiotics Ever”) implement routine sampling and testing programs to detect antibiotic use in animals prior to slaughter or obtain third-party certification that includes testing.

In light of concerns about negative antibiotic claims, FSIS announced last year that the agency would be conducting a study in partnership with USDA’s Agricultural Research Service (ARS) to assess the veracity of these claims. FSIS collected liver and kidney samples from 196 eligible cattle at 84 slaughter establishments in 34 states, and ARS analyzed the samples using a method that targeted more than 180 veterinary drugs including various major classes of antibiotics. The study found antibiotic residues in approximately 20% of samples tested from the “Raised Without Antibiotics” market. 

The action FSIS is taking through the publishing of this guidance today addresses these concerning findings and makes clear that FSIS will take enforcement action against any establishments found to be making false or misleading negative antibiotic claims. Additionally, FSIS has informed the establishments with positive results from the ARS-FSIS study and advised them to conduct a root cause analysis and implement corrective actions. FSIS has also advised these establishments to determine how antibiotics were introduced into the animal and to take appropriate measures to ensure that future products are not misbranded. Further information on the study can be found in the Federal Register Notice announcing the availability of the updated guideline. 

FSIS and ARS will be publishing a peer-reviewed paper with complete results from the study in the near future. The study findings underscore the need for more rigorous substantiation of such claims. These sampling results may lead to additional testing by the agency. FSIS has the authority to collect samples any time it believes a product is mislabeled with any claim covered by the guidance. Moreover, FSIS may consider future additional actions, including random sampling and rulemaking, to further strengthen the substantiation of animal-raising and environment-related claims.

For more information, please view the Federal Register notice. The updated guideline will be open for public comment for 60 days after publishing in the Federal Register.

FSIS to Host September Webinars on Salmonella Framework Proposal

As announced in the August 16, 2024, Constituent Update, FSIS is hosting two webinars to share information about the science behind its Salmonella Framework for Raw Poultry Products proposed rule and determination to reduce Salmonella illnesses linked to raw poultry products. The webinars will be held on September 9, from 10 a.m. to 12:30 p.m. E.T. and September 10, from 10 a.m. to 12 p.m. E.T. The webinars will address topics such as findings from the NACMCF Subcommittee Report on Enhancing Salmonella Control in Poultry Products; the Salmonella Risk Profile, and the Salmonella in Poultry Risk Assessments; Statistical Process Control and the FSIS Proposed Lower Capability Process Index Statistical Measurement Model; and the FSIS Poultry Exploratory Sampling Program Report. Different topics will be covered each day, and the presentations will be recorded.

FSIS invites interested stakeholders, including public health partners, industry representatives, consumer groups, and other members of the public, to join the webinars to learn more about the scientific support documents and related resources referenced in the proposed Salmonella framework. The proposal was published on August 7, 2024, in the Federal Register. Participants will have an opportunity to ask clarifying questions or technical questions about the information shared during the webinar. There will be no opportunity to give or submit formal public comment during the webinars.

Comments may be submitted online via the federal eRulemaking portal, available at www.regulations.gov; by mail sent to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Washington, DC 20250-3700, or by hand or courier delivery to 1400 Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, Washington, DC 20250-3700. All items submitted by mail or electronic mail must include the agency name and docket number FSIS-2023-0028.

The webinars’ agenda is posted on the FSIS Events & Meetings page. To join the webinars, go to:

September 9
10 a.m.-12:30 p.m. ET: Scientific Support for FSIS’ Salmonella Framework Webinar - Part 1
Microsoft Teams
Join the meeting now
Dial in by phone
+12026500123, 638814788#
Phone conference ID: 638 814 788#

September 10
10 a.m.-12:00 p.m. ET: Scientific Support for FSIS’ Salmonella Framework Webinar - Part 2
Microsoft Teams
Join the meeting now
Dial in by phone
+1 202-650-0123, 943457901#
Phone conference ID: 943 457 901#

FSIS to Implement New Screening Method for Chemical Residue Testing

FSIS is implementing a new screening method that combines the current veterinary drug and pesticide analyses into a single method workflow. 

Currently, FSIS conducts residue screening analysis for veterinary drugs with “Screening and Confirmation of Animal Drug Residues by UHPLC-MS/MS” (CLG-MRM3) and pesticides with “Screening for Pesticides by LC-MS/MS and GC-MS/MS” (CLG-PST5). For samples arriving on or after September 30, 2024, the FSIS laboratory system intends to implement the new screening method to combine both the veterinary drug and pesticide analyses in muscle for several slaughter classes (beef, pork, poultry, goat, and sheep), as well as Siluriformes (catfish) muscle, and liquid egg products. The method maximizes laboratory efficiency by conducting these analyses into a single workflow. The method is entitled “Multi-Residue Screening of Veterinary Drug and Pesticides Residues by Ultra-High Performance Liquid Chromatography with Tandem Mass Spectrometry (UHPLC-MS/MS)” (CLG-MEGA1.0).

The method benefits include:

  • Screening of 188 veterinary drugs and pesticide residues simultaneously in a single analysis:
    • 107 veterinary drugs from FSIS’ multi-residue method (CLG-MRM3)
    • 74 pesticides from FSIS’ pesticide method (CLG-PST5)
    • 7 new pesticide residues with established tolerances were added to expand FSIS’ capabilities for pesticide analysis
  • Utilization of multiple instrument platforms to improve robustness and flexibility with UPLC-MS/MS analysis, making the method more versatile than previous methods
  • Aligning screening detection limits with chemical residue tolerances updated since previous methods were developed
  • Decreasing time to result for chemical residue screening analysis by approximately one business day

The CLG-MEGA1.0 method represents the first phase in which FSIS laboratories are improving efficiency of chemical residue analysis for veterinary drugs and pesticides.  A second phase will expand this method further to incorporate a more efficient analysis of the remaining gas chromatographic (GC) amenable pesticides and is anticipated to occur later in FY2025. FSIS will continue to analyze GC amenable pesticides with CLG-PST5 until the second phase is completed and implemented.

New Dates for Submitting Revised Retained Water Protocols to FSIS and Making Necessary Labeling Changes

On April 1, 2024, FSIS published the Revised Guideline for Controlling Retained Water.  FSIS announced a deadline of April 1, 2025, for establishments to make any necessary product label changes in response to policy clarified in the revised retained water guideline (89 FR 22331). 

During the 60-day comment period, members of industry requested an extension of the agency’s April 1, 2025, deadline for establishments to make label changes. 

In addition, after the guideline was published, members of industry requested an extension on the September 30, 2024, deadline for establishments to submit to FSIS any revised retained water protocols developed in response to the revised guideline. 

To provide members of industry with sufficient time to revise their retained water protocols and update their labels, FSIS has extended the following deadlines:

  1. Establishments are to submit their revised retained water protocols to the Risk Management and Innovations Staff by March 3, 2025.
  2. The Office of Field Operations will start verifying establishments meet regulatory requirements on October 1, 2025.
  3. Establishments will have until January 1, 2026, to make any labeling changes.

Upcoming Events

Available for Public Comment

FSIS seeks public comments on proposed rules and notices, which are viewable on the FSIS Federal Register & Rulemaking webpage. FSIS is currently seeking comments on the following:

Policy Update

FSIS notices and directives on public health and regulatory issues are available on the FSIS Policy webpage. The following policy update was recently issued:

FSIS Notice 28-24 - Availability of Updated FSIS Guideline on Substantiating Animal-Raising or Environment-Related Labeling Claims

FSIS Directive 4451.5 - FSIS Outreach, Recruitment, and Non-Monetary Recognition Programs - Revision 1

Export Requirements Update

The Library of Export Requirements has been updated for products for the following:

  • Philippines
  • Chile
  • Dominican Republic
  • Ecuador
  • Guatemala
  • Solomon Islands
  • El Salvador
  • Honduras
  • St. Lucia
  • Turks & Caicos Islands
  • Kuwait
  • Curacao
  • Tunisia
  • India
  • Colombia
  • Costa Rica
  • Mexico
  • Singapore
  • Korea
  • Jamaica
  • North Macedonia
  • Canada
  • Cuba
  • Vietnam
  • Uzbekistan
  • Azerbaijan
  • French Polynesia (Tahiti)
  • Ukraine

Complete information can be found at the FSIS Import & Export Library.

Last Updated: Aug 30, 2024