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Two Food Safety Modernization Act Draft Guidance Documents Issued by FDA for Farmers, Food Processors

The FDA recently released two new draft guidance documents to help farmers and food processors comply with the Food Safety Modernization Act (FSMA) and some of the FDA’s implementing rules. One of the guidance documents is designed to help farmers understand the range of steps they can take to comply with the Produce Safety Rule. The other is intended to help processors understand the relevant provisions of the Preventive Controls Rule for fresh-cut produce.

According to a statement by Dr. Scott Gottlieb, FDA commissioner, the 152-page draft guidance for farmers, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry,” gives examples to illustrate how the Produce Safety Rule might be implemented on different kinds of produce farms to meet compliance standards. Not every scenario is covered in the draft guidance, and the FDA states that farmers can always use an alternate approach as long as they satisfy the requirements of the rule. The draft guidance can still be used, however, as a guide to help farmers evaluate their own on-farm practices.

The second draft guidance document, “Guide to Minimize Food Safety Hazards of Fresh-cut Produce,” discusses how fresh-cut produce processors may comply with the new requirements for current good manufacturing practices (cGMP) and for hazard analysis and risk-based preventive controls. Fresh-cut fruits and vegetables are those that have been physically altered (e.g., chopped, diced, peeled, shredded, sliced, etc.) after being harvested without additional processing, such as cooking, that could kill potentially dangerous bacteria.

The FDA is accepting comments on the draft guidance documents until April 22, 2019, after which it will begin work on the final versions of the guidances.

As always, the FDA’s guidance documents do not establish legally enforceable responsibilities, but rather describe the FDA’s current thinking on a topic.

© 2021 BARNES & THORNBURG LLPNational Law Review, Volume VIII, Number 302
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About this Author

Lynn C. Tyler FDA Compliance Attorney Barnes & Thornburg
Partner

Lynn Tyler helps innovative companies secure and preserve their market position and competitive advantage. He advises on FDA compliance, helps protect clients with patent infringement and validity opinions, helps and enforce intellectual property rights — which often must be asserted against imitators who seek to reap where they have not sown.

An accomplished advocate, Lynn litigates and represents clients involved in virtually all stages of the dispute resolution process, including pre-litigation counseling, alternative dispute resolution, formal and informal...

317-231-7392
Robert R. Stead, Barnes Thornburg Law Firm, Grand Rapids, Corporate and Tax Law Attorney
Partner

Robert R. Stead is a partner in the Grand Rapids, Michigan, office of Barnes & Thornburg LLP. Mr. Stead focuses his practice on corporate acquisition and financing transactions and related corporate and partnership tax matters. Applying his deep tax background and education, Mr. Stead represents buyers and sellers in merger, acquisition and disposition transactions. He also advises start-up companies as well as established businesses interested in pursuing capital sources from the private equity market. His experience includes raising capital for a number of diverse...

616-742-3995
William Wales litigation lawyer Barnes Thornburg
Partner

Commercial counselor and litigator, esteemed adviser, former Fortune 500 in-house counsel, and agriculture industry veteran Bill Wales represents a global clientele in commercial transactions, including mergers and acquisitions, corporate compliance issues, IP and licensing matters, and complex product liability and commercial litigation matters.

As co-chair of the Agriculture and Food practice group, Bill represents agribusinesses and agtech clients throughout the country and around the world, from across the U.S. to Europe, South America and beyond.

Bill previously served...

317-231-7493
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