Is FDA Exceeding FSMA Inspection Authority?

By Pete Kennedy, Esq.

FDA has compiled statistics for the first half of 2019 on the number of inspections it and state regulatory agencies under contract to FDA have conducted pursuant to the Food Safety Modernization Act (FSMA).¹ What stands out in the numbers is that by far, the most inspections FDA has conducted has been for compliance with Current Good Manufacturing Practices (GMPs).²

The GMPs are a one-size-fits-all regulatory scheme that includes requirements for plant construction and design, equipment, sanitation, and warehousing and distribution; GMPs are broadly worded and subject to varying interpretations by inspectors. According to an FDA official who spoke at the recent annual meeting of the International Association for Foods Protection (IAFP), some of those inspections for GMP compliance were for firms under the Tester-Hagan exemption that removes the requirement of having a food safety plan (known as HARPC or Hazard Analysis and Risk-based Preventive Controls). The average inspection for the GMP requirements is 3 to 4 days; if the firm has a compliance history with FDA, that inspection could be as long as 7 to 9 days.³ Arguably, FDA has no legal authority under FSMA to conduct GMP inspections of most or all of the Tester-Hagen exempt firms.

Among other requirements, FSMA requires facilities engaged in processing, manufacturing, packing, or holding food to have a written food safety plan showing that the facility

• has identified the potential hazards associated with the food being produced, packed, or held;
• has implemented preventive controls to address the hazards; and
• is monitoring the performance of the preventive controls to ensure that such controls are effective.

This requirement for HARPC is found in 21 CFR 117 Part C.

HARPC for human food has several exemptions from its mandates, one of which is a “qualified exemption for those firms grossing less than one million dollars per year ⁴, an exemption known as Tester-Hagen. In addition, to be eligible for the exemption, the facility must make more than half its sales either directly to consumers or to a restaurant or retail food establishment located either in the same state or within 275 miles of the facility.⁵

To obtain the exemption, facilities must submit a form to FDA that includes one of the following attestations:

• that the facility has a modified food safety plan addressing most of the HARPC requirements [FDA could mandate that the food safety plan include GMPs]; or
• that the facility is “in compliance with state local, county, tribal or other applicable non-Federal food safety law…including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency such as a state department of agriculture, or other evidence of oversight.”⁶

A reading of the federal statute on HARPC, 21 USC 350g, shows how FDA could be exceeding its authority by inspecting those under the Tester-Hagen exemption for the GMP requirements; 21 USC 350g(L)(2)(A) provides that a qualified facility “(A) shall not be subject to the requirements under Subsection (a) through (i) and Subsection (n) in an applicable calendar year….” Subsection (c) covers preventive controls, which is defined in Subsection (o) as:

• “…those risk-based, reasonably appropriate procedures and practices, and processes that a person knowledgable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (b) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include: …(F) Current Good Manufacturing Practices under part 110 of title 21, Code of Federal Regulations (or any successor regulations).”⁷

  NOTE: The Current Good Manufacturing Practices (CGMP) have since been moved to the HARPC section (part 117).

Most, if not nearly all, facilities exempt by Tester-Hagen would obtain the exemption by attesting that their business is subject to some kind of state regulation. Why spend that time and resources drawing up a modified HARPC plan when you can get the exemption by sending FDA a copy of a state license or other proof of state oversight?

The only food business that would not be subject to state regulation would be those selling only direct to consumers; those firms would not have to register as food facilities and, therefore, would not have to be subject to any of the FSMA requirements for HARPC if over half of their gross revenues are from direct-to-consumer sales in which case they would be exempt as a “retail food establishment” under federal regulation.⁸

FDA hasn’t divulged how many facilities with a qualified exemption it has inspected but it looks like it has exceeded its authority if it has inspected any facility that obtained its exemption through an attestation that it was subject to non-federal regulation. To go from being allowed to include GMPs as a part of preventive controls regulations to issuing GMP rules under FSMA that are separate from preventive controls is a big reach. There was never any deliberation by Congress contemplating separate regulation of requirements for CGMPs as part of FSMA.

A food law attorney speaking at the IAFP conference observed that FDA is paying close attention to GMP compliance and has no tolerance for GMP violations. Given the length of GMP inspections, how FDA is interpreting the GMPs more strictly, and the number of enforcement tools the agency has which use to cripple a small business without the economies of scale to comply, it’s recommended that small farmers and local artisans have, if at all possible, over half of their sales as direct-to-consumer to be exempt from the food facility registration requirement. This includes firms currently registered; there is a procedure to cancel registration.⁹

The time to move is now; it looks like FDA’s interpretation of the FSMA requirements will only be getting more strict. The likelihood is that neither Congress or the court will exercise oversight to limit FDA’s inspection authority to what FSMA provides.

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1. Bass, Glenn. US Food and Drug Administration. “FDA’s Perspective and Experience on FDA Enforcement and Inspection.” Symposia S1: 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, 22 July 2019. Speech, Kentucky International Convention Center, Louisville, KY.

2. Ibid. Out of nearly 9,000 FSMA inspections conducted, over 7,500 included assessing GMP compliance as well as HARPC (of which 7,000 were inspections for limited provisions of HARPC). Of the remaining, the FSMA inspections fell into the following categories: Sanitary Transport, Foreign Supplier Verification Program, Produce Safety Standards, HARPC for Animal Food, and GMPs for Animal Food.

3. Ibid.

4. 21 CFR 117.5

5. 21 CFR 117.3, see definition of “qualified end-user”

6. 21 CFR 117.201

7. 21 USC 350g(L)(2)(A)

8. 21 USC 350d, 21 CFR 1.226, 21 CFR 1.227

9. 21 CFR 1.241(c)