Constituent Update - September 3, 2021
FSIS Seeks Comments on the Labeling of Meat and Poultry Products Derived from Animal Cells
On September 2, 2021, FSIS announced an advance notice of proposed rulemaking (ANPR) to solicit comments and information regarding the labeling of meat and poultry products made using cultured cells derived from animals under FSIS jurisdiction. FSIS will use these comments to inform future regulatory requirements for the labeling of such food products.
In 2019 USDA and the Food and Drug Administration (FDA) announced a formal agreement to jointly oversee the production of human food products made using animal cell culture technology to ensure that such products brought to market are safe, unadulterated and truthfully labeled. Under the agreement, FDA will oversee cell collection, growth, and differentiation of cells. FDA will transfer oversight at the cell harvest stage to FSIS. FSIS will then oversee the cell harvest, processing, packaging, and labeling of products. FDA and FSIS also agreed to develop joint principles for the labeling of products made using cell culture technology under their respective labeling jurisdictions. Seafood, other than Siluriformes fish, falls under FDA’s jurisdiction, whereas meat, including Siluriformes fish, and poultry are under FSIS’ jurisdiction.
FSIS has received numerous comments on the topic in response to a 2018 joint public meeting with FDA and regarding two petitions for rulemaking (from the United States Cattlemen's Association and Harvard Law School Animal Law and Policy Clinic). The Agency now seeks additional comments on specific topics that will inform rulemaking related to statutory and regulatory requirements for the labeling of these meat and poultry products. Topics include consumer expectations about the labeling of these products, especially considering the nutritional composition and organoleptic qualities (taste, color, odor, or texture) of the products; names for these products that would be neither false nor misleading; economic data; and any consumer research related to labeling nomenclature for products made using animal cell culture technology. Should any labels be submitted before the Agency completes its rulemaking, FSIS acknowledges in the ANPR how they would be generally evaluated.
Other than labeling regulations for this product, FSIS does not intend to issue any new food safety regulations for the cell-cultured food products under its jurisdiction. Current FSIS regulations requiring sanitation and Hazard Analysis and Critical Control Point (HACCP) systems are immediately applicable and sufficient to ensure the safety of products cultured from the cells of livestock and poultry.
There is a 60-day period for comment on the ANPR. To view the ANPR and information on how to comment or submit information, please visit the FSIS website.
Listening Sessions for Improvements to CIS Program
FSIS is seeking recommendations for improvements to its Cooperative Interstate Shipment (CIS) Program. Join the National Association of State Departments of Agriculture and the National Sustainable Agriculture Coalition for a listening session with FSIS on the CIS program on September 16, 2021 at 4:00 p.m. ET. In the Consolidated Appropriations Act, 2021 (Public Law 116-260), Sec. 764(e)(2) charges FSIS with submitting a report on the CIS Program, describing any recommendations, developed in consultation with all States, for possible improvements to the cooperative interstate shipment program.
FSIS is interested in feedback from state Departments of Agriculture, small processors that use or would like to use the CIS program, and other relevant experts’ thoughts on the following:
- If your state’s Meat and Poultry Inspection (MPI) program is currently participating in the CIS program, please identify the specific benefits your state and its inspected establishments experience from the CIS program and recommendations for potential improvements to the program that would enhance those specific benefits.
- For all states and processors, including those who are not currently participating in the CIS program, please provide a detailed description of your recommendations that include:
- The underlying need for the recommendations
- The potential improvement(s) the program would achieve from implementing the proposed recommendations
- The stakeholders who would benefit from the potential improvement
- Any known existing constraints to implementing the recommendations
Proposed recommendations need not be limited to those that can be implemented under the current laws, regulations, and Agency policy. Stakeholders may also submit written recommendations to CISProgram@usda.gov by September 17, 2021.
Register in advance for the listening session here. After registering, you will receive a confirmation email containing information about joining the meeting.
Upcoming FSIS Webinars on Labeling
FSIS will host two labeling webinars this month.
The first webinar will cover generic labeling and will be held on September 14, 2021 at 1:00 p.m., ET. The webinar will provide an overview of the generic labeling regulations, including changes to prior label approval requirements for egg products. Additional information about generic labeling can be found in the FSIS Compliance Guideline for Label Approval.
To access the generic labeling webinar on Webex, please click here and follow the on-screen instructions. Use the following information when logging in: Meeting Number: 888-844-9904 Code: 2956126. For questions, please contact Gianfranco Santaliz-Rogers at (301) 504-0878 or email@example.com.
The second webinar will take place on September 21, 2021 at 1:00 p.m., ET to discuss claims related to animal raising, including the absence of non-genetically modified ingredients or animal feed on labels. The intent is to help industry understand the requirements and streamline the label submission process. The webinar will provide an overview on documentation needed to support animal raising claims made on meat or poultry products as discussed in the Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims for Label Submissions.
The animal raising claims webinar will also provide updated guidelines for factual statements concerning the non-use of bioengineered or genetically modified ingredients on labels of meat, poultry, and egg products addressed in the Labeling Guideline on Statements That Bioengineered or Genetically Modified Ingredients or Animal Feed Were Not Used in Meat, Poultry, or Egg Products.
To access the animal raising claims webinar on Webex, please click here and follow the on-screen instructions. Use the following information when logging in: Meeting Number: 888-844-9904 Code: 2956126. For questions, please contact Gianfranco Santaliz-Rogers at (301) 504-0878 or firstname.lastname@example.org.
Recordings of the webinars, along with presentation slides, will be posted on the FSIS Events & Meetings webpage for those who cannot attend. Additional guidelines on labeling and other topics are available here.
FSIS Posts Quarterly U.S. National Residue Sampling Report
The quarterly U.S. National Residue Sampling report is available for fiscal year (FY) 2021 third quarter (Q3). The report covers domestic (scheduled and inspector-generated) and import sampling programs. Quarterly chemical residue reports are available on the FSIS website here.
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 36-21 - Continued In-Field Study to Test the Cloth Sample Collection Method For Beef Manufacturing Trimmings
Export Requirements Update
The Library of Export Requirements has been updated for products for the following:
- Sri Lanka
- St. Kitts and Nevis
- United Arab Emirates
- Cayman Islands
Complete information can be found at the FSIS Import & Export Library.