Thursday, November 9, 2017

Agricultural Law Weekly Review—November 9, 2017

Written by M. Sean High—Staff Attorney
The following information is an update of recent local, state, national, and international legal developments relevant to agriculture:
FSMA: FDA Issues Guidance Giving More Time to “Co-Manufactures”  
On November 3, 2017, the U.S. Food and Drug Administration (FDA)  announced guidance intended to provide certain “co-manufactures” of food with more time to meet FDA Food Safety Modernization Act (FSMA) supplier approval and verification requirements.  Under FSMA, regulations for the Preventive Controls for Human Foods, the Preventive Controls for Animal Food, and the Foreign Supplier Verification Programs each require a supply-chain program for certain raw materials and other ingredients.  According to FDA, the purpose of the guidance is to assist those involved in co-manufacturing agreements which involve a second party manufacturing or processing food for a brand owner.  FDA stated that under the guidance, the agency “does not intend to take enforcement action for two years against a co-manufacturer that is not in compliance with certain supply-chain program requirements related to supplier approval and supplier verification.”

Biotechnology: USDA Withdraws Proposed Revisions to Biotechnology Regulations
On November 6, 2017, the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service announced a withdrawal of a proposed rule intended to revise the agency’s biotechnology regulations.  According to USDA, following the withdrawing of the proposed rule, the agency will explore policy alternatives and “re-engage with stakeholders to determine the most effective, science-based approach for regulating the products of modern biotechnology while protecting plant health.” Regarding the decision to re-examine the biotechnology regulations, USDA Secretary Sonny Perdue asserted a need for a balanced regulatory process that does not restricting innovation. The Secretary stated that biotechnology “is evolving every day” and as a result, there is a need for “regulations and policies that are flexible and adaptable to these innovations to ensure food security for the growing population.”

Menu Labeling: FDA Issues Draft Menu Labeling Guidance
In November 2017, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance document entitled: Menu Labeling: Supplemental Guidance for Industry.  Accordingly, the document: (1) addresses concerns that have been raised by stakeholders regarding implementation of the menu labeling requirements; (2) clarifies additional options for complying with the menu labeling requirements; and (3) identifies places where FDA intends to be more flexible in its approach.  The document contains nonbinding recommendations and is intended for comment purposes only.  Comment on the document is scheduled to end 60 days after publication in the Federal Register.

International Trade: U.S. Department of Commerce Announces Duty on Softwood Lumber from Canada
On November 2, 2017, the U.S. Department of Commerce announced a final determination regarding the antidumping and countervailing duty investigations of softwood lumber imports from Canada.  According to the Commerce Department, Canadian exporters have been selling softwood lumber in the United States at prices between 3.2% and 8.89% below fair market value.  Additionally, The Commerce Department stated that Canada has been unfairly subsidizing Canadian softwood producers at rates between 3.34% and 18.19%.  As a result, the Commerce Department announced that U.S. Customs and Border Protection will be instructed to collect cash deposits from importers of Canadian softwood lumber at amounts based on the final rates.  

Antibiotics: WHO Calls for End of Antibiotic Use in Healthy Animals
On November 7, 2017, the World Health Organization (WHO) announced recommendations designed to limit antibiotic use in healthy animals.  According to WHO, the over-use of antibiotics in healthy animals has become a contributor to the increased threat of antibiotic resistance.  As a result, WHO recommends that healthy animals should not receive antibiotics for growth promotion.  Additionally, WHO recommends that antibiotic use in healthy animal be limited to the prevention of disease where there has been a diagnosis “in other animals in the same flock, herd, or fish population.” WHO stated that instead of antibiotics, producers should consider improved “hygiene, better use of vaccination, and changes in animal housing and husbandry practices.”

Pennsylvania Actions and Notices
Department of Agriculture

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