Today, the Southern Shrimp Alliance filed comments with the U.S. Food and Drug Administration (FDA) in response to the agency’s new proposed regulations regarding traceability obligations for all shrimp and other select food products, imported and domestic, sold in the U.S. market. These comments requested that the FDA (1) amend the regulations to provide a specific exemption for sales of food directly by fishing vessels to consumers, consistent with the proposed exemption for sales of food directly from farms to consumers; (2) work collaboratively with the NOAA Sea Grant College Program to develop outreach programs for first receivers (unloading docks and fish houses) of seafood to assist in implementing the new requirements; and (3) create a new violation code, a unique ASC ID, and charge code for refusals of entry lines of imported food refused due to a failure to meet these traceability requirements.
In September of last year, the FDA issued proposed regulations imposing new reporting and recordkeeping requirements for foods identified on the agency’s Food Traceability List (85 Fed. Reg. 59,984 (September 23, 2020)) and requested comments on its proposal. Any comments on the proposed regulations are due by no later than February 22, 2021.
The regulations were proposed pursuant to Congress’s direction to the agency in Section 204(d) of the Food Safety Modernization Act (FSMA), a law adopted in 2011. The FSMA required the FDA to publish, within two years of the law’s enactment, a notice of proposed rulemaking to establish recordkeeping requirements for foods designated by the agency as “high-risk.” Following a lawsuit in federal court challenging the speed of the FDA’s promulgation of these regulations, the agency entered into a consent decree before a federal district court that requires, among other things, final regulations to be published by no later than November 7, 2022.
Although virtually all seafood products have been identified by the FDA as “high-risk,” the agency’s regulations, consistent with the FSMA, provide an exemption from these rules for fishing vessels that are not required to register with the FDA under current law. Under existing regulations (21 C.F.R. § 123.3(k)(2)(ii)), fishing vessels on which shrimp are headed and/or frozen “solely to prepare a fish for holding on board a harvest vessel” are not required to register with the FDA. This should mean that commercial shrimp boats are not impacted by the FDA’s new proposed rule.
In its comments, the Southern Shrimp Alliance notes that the FDA’s proposed regulations also include an express exemption from the regulations “with respect to food produced on the farm . . . that is sold directly to a consumer by the owner, operator, or agent in charge of the farm” (21 C.F.R. § 1.1305(b)). The organization requests that the agency adopt an express exemption for food sold directly to consumers from fishing vessels to consumers, mirroring the language used for farms, as such an amendment is appropriate and consistent with the discretion afforded to the FDA by Congress in the FSMA to modify requirements or exempt a facility type from its regulations.
Separately, the Southern Shrimp Alliance noted the obligations imposed by the new regulations upon the first receivers of domestically landed seafood to identify “critical tracking events” (CTEs) and report “key data elements” (KDEs). The organization explained that the first receivers in the domestic seafood supply chain are often small- and medium-sized family-owned and operated unloading docks and fish houses and requested that the FDA work with NOAA’s National Sea Grant College Program to provide technical assistance to these businesses, as they continue to confront ever-increasing and expanding federal government regulations.
The Southern Shrimp Alliance also emphasized that rules imposed on the domestic seafood industry must be equally applied, and enforced, on imported seafood that is offered for sale in the U.S. market. Existing foreign shrimp supply chains demonstrate the inability of exporters to trace shipments of shrimp to the United States back to the point of harvest. The organization encouraged the FDA to adopt a unique violation code, ASC ID, and charge code for entry lines of imported food refused because of a failure to comply with the traceability requirements once they become effective. Adoption of these codes will allow the public to monitor the FDA’s enforcement of its rules with regard to imported food products.
The Southern Shrimp Alliance encourages members of the shrimp industry to familiarize themselves with the FDA’s proposed new requirements. Video recordings of the FDA’s three public meetings regarding these new proposed regulations are accessible here: https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meetings-discuss-fsma-proposed-rule-requirements-additional-traceability-records-certain. The third, and final, public meeting provides the most in-depth information on the impact of these new rules on the seafood supply chain and may be viewed here: https://www.youtube.com/watch?v=4ir400l1PQc. Comments to the FDA on the agency’s proposed regulations imposing new traceability requirements are due no later than February 22, 2021 and instructions as to how to submit comments are set forth in the agency’s Federal Register notices.
Read the Southern Shrimp Alliance’s February 11, 2021 comments to the U.S. Food and Drug Administration here: https://www.shrimpalliance.com/wp-content/uploads/2021/02/SSA-Comments-on-FDA-Traceability-Rule.pdf
Read the September 23, 2020 Federal Register notice from the U.S. Food and Drug Administration with the new proposed regulations here: https://www.shrimpalliance.com/wp-content/uploads/2021/02/Federal-Register-Notice-Requirements-for-Additional-Traceability.pdf
Read the December 18, 2020 Federal Register notice from the U.S. Food and Drug Administration extending the comment deadline to February 22, 2021 here: https://www.shrimpalliance.com/wp-content/uploads/2021/02/Federal-Register-Notice-Extending-Deadline-for-Comments.pdf