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NewsRegulatoryFDA

FDA, New York Sign Domestic Mutual Reliance Partnership Agreement

FDA logo full

Credit: U.S. Food and Drug Administration (FDA)

February 20, 2023

On February 15, 2023, the U.S. Food and Drug Administration (FDA) signed a domestic mutual reliance partnership agreement with the New York Department of Agriculture and Markets (NYSAGM) at the National Association of State Departments of Agriculture (NASDA) 2023 Winter Policy conference. Domestic mutual reliance enables FDA and states with comparable regulatory systems to rely on and leverage each other’s work to ensure food safety. 

Via the Port of New York in New York City, the state regularly imports products from across the world. Additionally, the wide variety of international specialty stores and diverse products grown, distributed, and manufactured in New York amplifies the need for the focused regulatory oversight by New York that complements the work of FDA. New York also evaluates imported products in retail stores, regularly testing for heavy metals such as lead.

Lab findings are often the foundation of enforcement and investigative activities. In 2018, to increase the use of state laboratory results, FDA and New York created a domestic mutual reliance pilot program, which enabled FDA to take regulatory action on a variety of imported products and increased efficiency for state and local governments. Enhancing New York laboratory capabilities and acceptance of state lab data is one of the main components of the newly signed partnership agreement.

Domestic mutual reliance has also helped New York bolster food safety by streamlining many important processes regarding incident response. For example, collaboration between agencies allowed for quick and efficient communication regarding spice mix with dangerously high levels of lead that entered through the port of New York and was discovered in Michigan. An FDA Emergency Response Coordinator was able to call upon the NYSAGM Rapid Response Team to immediately embargo the product while FDA ran tests and lab analyses. The product has such high levels of lead that protective equipment was recommended be used when handling it. A large, multi-state recall of the spice mix was issued.

Anticipated next steps under the partnership agreement include closer coordination around operational functions and heightened focus on inspections conducted by a state that are not a part of the contract with FDA and conducted under a state’s authority. New York performs thousands of state-authorized food safety inspections each year throughout the entire food supply chain. Cooperation with FDA through the partnership agreement will allow inspectors to apply a unified, systematic approach to conducting inspections, further reducing the regulatory burden on New York regulators, FDA, and stakeholders in the supply chain.

In addition to New York, FDA has established domestic mutual reliance partnership agreements with seven other states: California, Florida, Iowa, Minnesota, Utah, Virginia, and Wisconsin. The agency has also entered developmental and specialized partnership agreements with Alaska, Hawaii, and Rhode Island. The agreements will enhance existing relationships with states and other government counterparts, working towards a nationally integrated food safety system in the U.S. as envisioned in FDA’s Food Safety Modernization Act (FSMA), Partnership for Food Protection, and New Era of Smarter Food Safety blueprint.

KEYWORDS: domestic mutual reliance FDA New York

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