Is FDA Exceeding FSMA Inspection Authority?
August 21, 2019
The Department of Control Strikes Again
October 9, 2019
By Pete Kennedy, Esq.
The International Association of Food Protection (IAFP) held its annual meeting in Louisville July 21-24 at the Kentucky International Convention Center. Over 3,800 food safety professionals from industry, federal and state regulatory agencies and academia (students and faculty) attended this year’s meeting.1
Food safety continues to be a growth industry. In spite of the Food Safety Modernization Act (FSMA) and various food safety measures undertaken by the United States Department of Agriculture (USDA), foodborne illness outbreaks in the U.S. have not declined much, if at all. One of the sessions at the meeting was titled “Why Are We Still Having Food Safety Failures If We All Have Food Safety Systems?”2 Globalization and a deterioration of quality in the industrial food system remain as drivers of the food safety industry. Recently, USDA issued a proposed rule to allow the import of poultry slaughtered in China.
The IAFP meeting is a huge networking event with a friendly and collegial atmosphere for attendees. Food safety troubles represent a substantial business opportunity and enable IAFP to serve as an incubator for the development of food legislation, like FSMA, which advances the financial position of each of the groups attending IAFP. The way this works is that the industrial food companies cause the food safety problems, Congress increases the budget of the U.S. Food and Drug Administration (FDA) and USDA to deal with these problems, then part of that budget increase goes to academia for grants to come up with solutions for the problems and another part goes to state agencies in grants to do the Fed’s bidding (e.g., state inspections to enforce the new federal laws); further, the newly legislated requirements give labs and other firms involved in food safety more revenues, and the industrial food companies get one-size-fits-all food safety regulations that increase their market share when their smaller competitors cannot afford the cost of compliance.
One sector that is not a part of the food safety trail of revenue is the local food system. Regulators, industry and academia have done some great work dealing with problems in the industrial food system but they have never acknowledged how a stronger local food system can improve overall food safety. So the question is: if the small farmers and artisans making up the local food system don’t have a place at the table, are they on the ‘menu’ for the players in the food safety industry? For now, it looks like local food producers still have ways of staying off the ‘menu’ but the food safety industry is monitoring them, possibly considering ways to get them more under the industrial food regulatory umbrella.
During a roundtable session at IAFP titled “Cottage Foods — Harmonizing Food Safety Practices for a Growing Entrepreneurial Industry”3, regulators on the panel expressed some frustration at the lack of uniform regulation for cottage foods in the U.S. but none of them indicated that legislation to make state cottage food laws the same would have any traction.
There was also a panel for the topic, “Has the Time Come for the Complete Adoption of the Food Code?”4 The Food Code is a set of onerous model regulations that FDA develops to govern retail sales of food to the consumer. All states have adopted at least some portion of the Food Code but full adoption would mean the repeal of laws in states such as Wyoming, Maine, Utah, and North Dakota that currently allow unregulated sales from producer direct to consumer of foods needing time and temperature control (e.g., dairy and foods with dairy as an ingredient). Again, no one on the panel for this presentation stated there was a legitimate chance that this kind of legislation would pass.
The most alarming news at the conference was the disclosure by an FDA official regarding the agency’s inspections of food facilities for compliance with Current Good Manufacturing Practices (GMPs) which are one-size-fits-all regulations governing plant construction and design, sanitation, and warehousing and distribution. Producers with less than $1 million in sales per year come under the Tester-Hagen qualified exemption and are to be exempt from FSMA requirements for a food safety plan and, arguably, from the GMPs. Nonetheless, assumed as part of its duties under FSMA, FDA has been conducting GMP inspections of these exempt facilities anyway. A reading of the relevant FSMA statute indicates that FDA doesn’t have the authority to require compliance with GMPs by firms under Tester-Hagen. The typical FDA inspection for GMP compliance can last 2-½ to 3 days. [see “Is FDA Exceeding FSMA Inspection Authority”]
FSMA provides an absolute exemption from the food safety plan requirement for those producers who derive over half of their sales revenues from direct-to-consumer transactions. Most small farmers and local artisans fit this description, but expanding their sales to restaurants and retail stores is a step many of them need to take to increase business. The unauthorized FDA inspections for GMPs make that a more difficult road to travel if their direct-to-consumer sales fall below half of their total revenue.
A growing local food system can make the food safety regulators’ jobs easier. At the IAFP meeting, a high-ranking FDA official acknowledged that the “Achilles heel” of the food safety system is the lack of traceability for industrial food, an admission that isn’t surprising given the international food trade and the long complex supply chains that result. Nothing is more traceable than locally-produced and -consumed food. Deregulating local food producers and increasing their numbers is the path to fewer foodborne illness outbreaks and safer, more nutritious food.
Instead of FDA inspectors and state regulators spending a few days on the premises of small producers, they could invest their time more productively by inspecting imports. One speaker at the meeting displayed a graph showing that from 2009-2016 the greatest number of foodborne illness outbreaks were caused by seafood (25%) followed by produce (15%).5 It is estimated that 90% of the seafood consumed in the U.S. is imported6; a 2018 article citing USDA data on produce for 2016 estimated that 53% of fresh fruits and 31% of fresh vegetables are imported7.
Over 8 years after passage, FSMA is now close to being fully operational. A food law attorney speaking at the meeting observed that FDA was getting more strict on its interpretation of the FSMA requirements. The attorney also noted that FDA inspectors are called “investigators”, meaning that their purpose is primarily to find problems in a food facility they inspect rather than working with the facility to assure compliance with the law. The unstated goal of FSMA has always been to consolidate the food supply.
With the way the law now stands, the key for local producers to survive FSMA over the long-term is to educate the public on how the most safe, nutritious food is found in the local food system. It is the best way to stay clear of a regulatory scheme that can put producers providing nutrient-dense food out of business. More retail outlets will be adopting requirements similar to those in FSMA for producers wanting to sell to them.
The Weston A. Price Foundation (WAPF) has started a campaign to encourage its members to spend at least 50% of their food dollar purchasing raw dairy, meat, poultry, eggs, and produce direct from local farmers and artisans. For improved public health and the viability of producers in the local food system, buying more food directly from local producers is a critical step for consumers to take.
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1. International Association of Food Protection, “Annual Meeting”. Statement: “The IAFP Annual Meeting is attended by more than 3,800 of the top industry, academic and governmental food safety professionals from six continents.” Accessed 6 Sep 2019 at https://www.foodprotection.org/annualmeeting/
2. Prince, G., S. Crowley, and N. Anderson. S11: Why Are We Still Having Food Safety Failures If We All Have Food Safety Systems? Annual Meeting of the International Association for Food Protection. Louisville, KY. Symposia. July 22, 2019
3. Andress, E., E. Ceylon, E. Edmunds, J. Eifert, S. Giovinazzi, and A. Snyder. Cottage Foods: Harmonizing Food Safety Practices for a Growing Entrepreneurial Industry. Annual Meeting of the International Association for Food Protection. Kentucky International Convention Center, Louisville, KY. Roundtable RT15. July 23, 2019
4. Bryant, V. D. Detwiler, J. Horn, G. Lewis, and A.M. McNamara. Has the Time Come for Complete Adoption of the Food Code?, Annual Meeting of the International Association for Food Protection. Kentucky International Convention Center, Louisville, KY. Roundtable RT16. July 23, 2019.
5. Sayler. A. “FDA’s FSMA Enforcement Impact on Non-U.S. Food Manufacturers – Examples: Food Retailer: Examples, Case Studies and Recommendations”, Tracking FSMA Quantitative and Qualitative Impacts on the Food Industry Under Full FDA Enforcement – Stats, Trends, Challenges and Lessons Learned. Annual Meeting of the International Association for Food Protection. Kentucky International Convention Center, Louisville, KY. Symposia S1, 4th Presentation, Slide #4, “CDC Foods Causing Foodborne Illness 2009-2016”. July 22, 2019.
6. NOAA Fisheries, “Fisheries of the United States, 2012: A Statistical Snapshot of 2012 Fish Landings. National Oceanic and Atmospheric Administration”, 2013, p. 4. Accessed at https://www.st.nmfs.noaa.gov/Assets/commercial/fus/fus12/FUS_2012_factsheet.pdf
7. Karp, D. “Most of America’s Fruit Is Now Imported. Is That a Bad Thing?” New York Times online, 13 March 2018. Accessed at https://www.nytimes.com/2018/03/13/dining/fruit-vegetables-imports.html
Last updated 11/21/2019
