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Recent FDA Guidance on FSMA Produce Safety Rule and Preventive Controls Rule

Updated: Nov 11, 2020

By Nicole Cook

Image is a close up of apples on the tree. Image by Edwin Remsberg.

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If you’ve been following this blog for news about updates about the Food Safety Modernization Act (FSMA), then yout know that the Food and Drug Administration (FDA) has been busy over the past year issuing new guidance on its FSMA’s Produce Safety and Preventive Controls rules. Regulatory agencies, like the FDA, issue “Guidance” and “Fact Sheets” to answer specific questions or provide clarification to the industries they regulate about how the agency interprets its own rules and regulations. Below is a brief summary of the FDA’s latest statements about how the agency interprets parts of its Produce Safety and Preventive Controls rules. And if you haven’t been following along, you can search this blog for “FSMA” to see all the information we’ve provided since the FDA started issuing its regulations in 2015 to keep Maryland’s producers and processors aware of the most sweeping reform of our country’s food safety laws in more than 70 years.

FDA’s Newest Guidance

In March, the FDA published guidance explaining how to determine the number of full-time equivalent employees a farm has. The guidance, Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507, 83 FR 12,143, was very important because knowing whether your farm qualifies as a “small business” under the Produce Safety and Preventive Controls rules determines whether the rule(s) apply to your farm. You can read more about the FDA’s guidance about how to determine whether a business qualifies as a small business under FSMA by reading this post.

In May, the FDA issued guidance intended to assist small entities with understanding the August 2016 extended compliance dates and the FDA’s decision in January 2018 not to enforce compliance in order to give farmers more time to come into compliance. For more information about the FDA’s Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide, 83 FR 22,193, see my post.

That same month, the FDA issued guidance to help farms determine whether they are exempt from having to register their farm with the FDA under the Preventive Controls for Human Food (“Preventive Controls”) rule. The guidance, Registration of Food Facilities: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide, 83 FR 24,479, explains new facility registration requirements for small facilities.

In August, the FDA published guidance on registration requirements for domestic and foreign facilities that “manufacture, process, pack, or hold food for human or animal consumption.” Among other things, the new guidance, Questions and Answers Regarding Food Facility Registration (Seventh Edition) (“Food Facility Registration”), 83 FR 42,024, clarifies that farms do not have to register with the FDA if they are placing lables directly on raw agricultural commodities (RACs) or boxes containing RACs. If a farm doesn’t have to register, it is exempt from complying with the Preventive Control rule. Remember, however, that although a farm may qualify as exempt from the Preventive Controls rule, some of the activities performed could fall under the rule, so understanding the details is important. Read this post for more information about what activities are and are not exempt from registration under the Preventive Controls rule.

Unfortunately, the draft Food Facility Registration guidance document inaccurately stated that an owner of a shared-use facility is required to either confirm that each food-producing business is registered with FDA or register the entire facility. The language in the draft guidance also caused confusion because it inferred the owner could force all food business tenants, regardless of their exemption status, to register. The final Food Facility Registration guidance document did not directly address this issue, but FDA has addressed it in a new Supplemental Questions and Answers Regarding Food Facility Registration: Draft Guidance for Industry (“supplemental draft guidance”), 83 FR 42,062. The supplemental draft guidance clarifies who should register in situations involving more than 1 registration (e.g., lessor and 1 or more lessees). The FDA accepted public comments on the supplemental draft guidance through October 19, 2018, so, because under the Administrative Procedures Act, the agency must publish its responses to the comments, we will see additional clarification issued by the FDA on this point.

In September, the FDA published Guidance for Industry: Determination of Status as a Qualified Facility meant to clarify which facilities qualify under FSMA as “very small businesses” or “qualifying facilities.” See this previous post for the definitions of “very small businesses” and “qualifying facilities.” The guidance explains how to determine whether your facility meets the definition of “qualified facility.” A qualified facility is exempted from the hazard analysis and risk-based preventive control requirements, and is only subject to modified requirements. Basically, to qualify as a “very small business,” if the facility does less than $1 million in annual business or they sell a majority of their products by annual dollar volume direct to end users (for example, a fruit grower that sells her produce at a roadside stand) and does less than $500,000 in annual sales. The guidance also explains how a facility should submit the forms required under the rule to show the farm’s status as a qualified facility.

This month, the FDA put out a pair of documents aimed at helping produce growers and processors comply with food safety rules. The recommendations address employee training, equipment cleaning and guidelines to determine when produce has been contaminated by a wild animal or flooding and therefore shouldn’t be harvested. The Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Freshcut Produce covers things like what is “fresh-cut produce” (it’s any fresh fruit or vegetable or combination thereof that has been physically altered from its whole state after being harvested from the field, for example by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing, without additional processing such as blanching or cooking) and explains that fresh-cut produce may or may not undergo a wash or other treatment before being packaged for use by the consumer or a retail food establishment. It also explains that fresh-cut produce can be a single commodity or two or more mixed in the same package, such as coleslaw or fruit salads, and sometimes called “ready to use,” “pre-cut,” or “value added” produce. And, it tells us that fresh-cut produce does not include produce that has been processed by freezing, cooking, canning, or packing in a juice, syrup, or dressing.

The Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption is intended to help covered farms comply with the requirements of the Produce Safety rule by providing a broad range of recommendations on how to meet the requirements for most subparts of the rule. It also outlines how to determine whether produce or farms may be eligible for exemptions from certain requirements or from the rule entirely.

The FDA is seeking comments on the most recent draft guidance. Click on the links above to learn how you can submit comments to the FDA on the draft guidance.

Remember, the FDA’s guidance is not binding. It merely describes the agency’s current thinking on a topic. Seek legal advice from an attorney if you have any questions about whether or how FSMA affects your farm.

Stay Tuned

In conjunction with issuing guidance, FDA Commissioner Scott Gottlieb sent a letter to the heads of state departments of agriculture letting them know that the FDA is reconsidering its definition of the term “farm” as part of the implementation of the Produce Safety Rule. In his letter, Gottlieb noted that various stakeholders, including the farming community, have expressed concerns about “whether and when packing houses, terminal markets, and other entities conducting farm-related activities are required to comply with the preventive controls or produce rules,” and that the FDA agrees that there is a need for additional clarification, so it is “actively working on proposing a draft rule .. that would make changes to general provisions related to the registration of food facilities rule — including edits to the farm definition.” The FDA expects to issue the proposed draft rule in 2019. In the meantime, as I explained in this post, the FDA announced in January that it intended to exercise enforcement discretion for certain facilities, such as some that pack and hold raw produce, that are subject to preventive controls provisions because they are not considered farms. Gottlieb’s letter confirmed that the FDA intends to exercise enforcement discretion until it has completed its rulemaking to address this issue.

Gottlieb also said the FDA is working on water agricultural water standards, safe use of biological soil amendments of animal origin (raw manure), produce growing practices and “parity” in the safety of domestic and foreign-grown food. Keep an eye on this blog and the food safety page of the ALEI website for future updates, including my upcoming post explaining the FDA and USDA agreement recognizing USDA’s Harmonized Good Agricultural Practices (H-GAPs) Program as aligned with the Produce Safety Rule.

Get More Info.: Nov. 7th FSMA Grower Produce Safety Rule Training and On-Farm Readiness Reviews

If you still need to attend a Produce Safety Grower’s Training to get the certificate required to comply with the Produce Safety rule, the Maryland Department of Agriculture (MDA), the University of Maryland Extension and ALEI are offering a one-day training on November 7, 2018, at the Eastern Shore Hospital Center in Cambridge, MD. The cost is $25, which covers training materials, food and the training certificate. You can register for the training here.

And remember that farms that have completed the training and have their certificates can make request to have MDA perform an On Farm Readiness Review visit to help assess how prepared farms are to comply with the Produce Safety Rule.The review is voluntary and is purely for the purpose of helping producers make sure they’re reading to pass inspections once those get underway next year.You can find out more by contacting Deanna Baldwin at 410-841-5769.

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