Source: USDA, 9/2/21 The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) published today 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.“This ANPR is an important step forward in ensuring the appropriate labeling of meat and poultry products made using animal cell culture technology,” said USDA Deputy Under Secretary for Food Safety Sandra Eskin. “We want to hear from stakeholders and will consider their comments as we work on a proposed regulation for labeling these products.” On March 7, 2019, USDA
and FDA announced a formal agreement to jointly oversee the production of human
food products made using animal cell culture technology and derived from the
cells of livestock and poultry 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. Other than new labeling
regulations concerning this product, FSIS does not intend to issue any other
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. FSIS already has received thousands of 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, however, needs specific types of comments and information that will inform the process of developing labeling regulations for meat and poultry products made using animal cell culture technology. The ANPR is requesting
comment on specific topics to be considered during rulemaking related to
statutory and regulatory requirements for the labeling of these meat and
poultry products: consumer expectations about the labeling of these products,
especially in light of 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. The ANPR also discusses
how FSIS will generally evaluate labels for these products if they are
submitted before the agency completes rulemaking. There is a 60-day period
for comment on the ANPR. To view the ANPR and information
on how to comment or submit information, visit the FSIS website at www.fsis.usda.gov/policy/federal-register-rulemaking/federal-register-rules.
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