FDA Bootstrapping Its Power under FSMA

By Pete Kennedy, Esq.

Recently the New York Department of Agriculture and Markets (NYDAM) sent what it called a “Milk Control Facility FSMA Survey” to a number of licensed dairy producers in the state, including raw cheesemakers. The survey was mainly concerned with whether the producers were complying with various requirements related to the FDA Food Safety Modernization Act (FSMA) but there was one requirement the survey asked about that was never brought up at all when Congress was deliberating over FSMA–current Good Manufacturing Practices (cGMPs), which FDA could try to use for regulating all commerce other than most meat and poultry that are under the jurisdiction of the United States Department of Agriculture (USDA). This could include all intrastate commerce; under FDA’s interpretation of the law, any local producer– whether a raw milk dairy with a couple of cows or a private homemaking cottage foods operation–would be subject to the cGMP requirement and FDA jurisdiction.

The agency is claiming that authority given it by the Public Health Service Act (PHSA) to regulate communicable diseases gives it the power to impose cGMP requirements. The PHSA provides that “[t]he Surgeon General, with the approval of the Secretary [of Health and Human Services], is authorized to make and enforce such regulations as in his judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. For the purposes of carrying out and enforcing such regulations, the Surgeon General may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in his judgment may be necessary.”¹

A common sense reading of this power would be that FDA could get involved if there was a foodborne illness outbreak confined to one state or if a producer solely in intrastate commerce was found to be manufacturing food under unsanitary conditions but, according to the agency, its power to regulate communicable disease gives it the authority to impose cGMP requirements on all food manufacturers (other than those in the meat and poultry business) for the following: “plants and grounds; sanitary facilities, controls, and operations; equipment and utensils; processes and controls; warehousing and distribution; and natural or avoidable defect levels.”²

The cGMPs are part of a one-size-fits-all regulatory scheme; unlike some of the more onerous FSMA provisions such as the national produce safety standards and the food safety standards (HAPRPC – Hazard Analysis Risk-Based Preventive Controls) in which many smaller producers are exempt from those mandates, there are no exemptions from the cGMP requirements.

FDA has long held that cGMPs apply to food manufacturers in intrastate commerce but the agency’s position fell on deaf ears until after the passage of FSMA. The cGMPs used to have their own section in the Code of Federal Regulations (21 CFR part 110) but, when FDA issued regulations governing the HARPC requirement (21 CFR part 117), it moved the cGMP regulations over to that section as well. FDA wants to make it seem like cGMPs are part of FSMA even though they were never brought up when Congress was considering the food safety legislation in 2009 and 2010.

At this time FDA doesn’t have nearly the resources to enforce the cGMP requirements across the board but that doesn’t have to happen for the agency to create a chilling effect among local food producers; an occasional inspection of or enforcement action against a raw milk producer or cottage food operation will do the trick. The cGMPs potentially threaten to roll back some of the progress made in recent years through legislative and policy changes in the areas of consumer access to raw dairy and cottage foods.

There are ways to protect against the cGMP threat to intrastate business. One way would be for state legislatures to more closely monitor FDA cooperative agreements between state departments of health and agriculture to make sure the state agencies don’t impose these requirements on food producers operating only in intrastate commerce; with FSMA, states will be counted on to carry out much of its enforcement. Another way would be to amend the Federal Food, Drug and Cosmetic Act to make it clear that the cGMP requirements only apply to firms operating in interstate commerce. As it is FSMA is possibly the most draconian piece of food legislation ever passed; FDA needs to be stopped from expanding its power beyond what Congress ever intended.

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¹ United States Code of Laws, 42 USC 264(a). Accessed 2/28/2018 at https://www.law.cornell.edu/uscode/text/42/264

² Federal Register, 78 FR 3651. Section II.B.1 accessed 2/28/2018 at
https://www.federalregister.gov/documents/2013/01/16/2013-00125/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-human