[Ed. Note: On Friday, February 21, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School) co-sponsored a conference at HLS called “New Directions for Food Safety: The Food Safety Modernization Act and Beyond.” This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]
By Ching-Fu Lin
On February 21, a group of scholars gathered at HLS to discuss new directions for food safety and challenges to the implementation of the 2011 Food Safety Modernization Act (FSMA). The conference featured a keynote speech delivered by Peter Barton Hutt, who is commonly recognized as the food and drug law expert in this country.
Hutt is a senior counsel at the Washington, D.C. law firm Covington & Burling. He also served as chief counsel for the Food and Drug Administration (FDA) from 1971 to 1975. Hutt has taught a full course at HLS on food and drug law for over 20 years and has co-authored an influential casebook in this area.
Bringing in his expertise in the historical development of food law, Hutt began with what he called “still the best statute” from the English experience in 1266. At around that time, the English Parliament codified some early regulatory statutes (assizes) that prohibited the sale of any “corrupted wine” or of any meat, fish, bread, or water that was “not wholesome for Man’s body.” These laws continued to (with amendments and supplements) be of reference power in England until 1884. As articulated by Hutt, it would be sufficient for the FDA to do what it needs to do even when we take the core principle “not wholesome for Man’s body” and get rid of the entire rest of the food law.
Hutt then turned to another landmark development in the history of food law. In 1820, Frederick Accum, a German chemist working in England, published Treatise on Adulteration of Food and Culinary Poisons. The treatise had an immediate impact worldwide and triggered the modern development of food regulatory statutes in the United States and Europe. Indeed, the languages used in such statutes (such as prohibitions against adulteration) are reflected in the design of the 1906 and 1938 legislations in the United States.
Having given several interesting and absorbing historical nodes on the development of food law, Hutt pointed to the legislations that have formed the architecture of government regulation of food: The first national statute, the Federal Food and Drugs Act of 1906, as well as the organic statute, the 1938 Food, Drug, and Cosmetic Act (FD&C Act). The 1938 FD&C Act has been the core statute that the FDA administers and enforces, and has been amended more than a hundred times. According to Hutt, however, from 1938 to present, all the FDA focused on was done through “regulation and enforcement of those regulations,” since there was no new statutory authority conferred by Congress over more than 70 years.
The evolution of federal food law has come to a new front end with FSMA being signed into law by President Obama in 2011. This “poorly drafted and poorly conceived” statute, according to Hutt, was coupled together by Congress in a hurry. Hutt walked the audience through the new mandates for FDA, from hazard analysis and risk-based preventive controls, good manufacturing practices, mandatory recall authority, and produce safety standards, to protection against intentional adulteration, foreign supplier verification programs, and accreditation of third-party auditors and certification bodies. Combined with the authority it already has, the FDA is now “the single most powerful government agency in the United States.” The enormous breadth and depth of FSMA gives an impression that it was “written like a regulation, not like a statute,” and Hutt pointed to the fact that the 1938 FD&C Act covers all food with merely 4 out of 19 pages, while FSMA devotes 88 pages solely to food safety. The burden on the FDA is massive and demanding, especially when it has to go through notice-and-comment rulemaking processes, Department of Health and Human Services (HHS), and Office of Management and Budget (OMB) with all types of impact and regulatory analyses.
Finally, Hutt asked “[w]hether the statute was necessary or even desirable?” Based on his analysis, the FSMA was “not necessary and not desirable.” As explained by Hutt, it was not necessary because none of those regulations couldn’t have been written after the milestone case United States v. Nova Scotia Food Products Corp., 568 F.2d 240 (2nd Cir. 1977). The 2nd Circuit in the Nova Scotiadecision interpreted the FDA authority in a broad manner:
“The public interest will not permit invalidation simply on the basis of a lack of delegated statutory authority in this case. A gap in public health protection should not be created in the absence of a compelling reading based upon the utter absence of any statutory authority, even read expansively. Here we find no congressional history on the specific issue involved, and hence no impediment to the broader reading based on general purpose. We believe, nevertheless, that it would be in the public interest for Congress to consider in the light of existing knowledge, a legislative scheme for administrative regulation of the processing of food where hazard from micro-organisms in food in its natural state may require affirmative procedures of sterilization…”
Hutt emphasized that thousands of warning letters, hundreds of seizures, and lots of criminal prosecutions have been based on the Nova Scotia decision. Given the enormous authority given to the FDA by the decision, the agency could have done what FSMA now requires at a reasonable pace with much greater participation with the regulated industry and much greater understanding of the industry which in fact now must comply.
After having reviewed aspects of government regulation of food from ancient times to present with thrilling quality, Hutt offered his vision of the implementation of FSMA and the future of food law. “This is going to be a serious problem of FDA completing everything it is supposed to do and then industry completing everything that it is supposed to do.” Hutt predicts FSMA’s implementation “is not going to be done quickly. It will be lucky if in ten years we make real progress, and it can easily be 20 or 25. That requires that the FDA understand the complexity of what they are requiring and its impact on the regulated industry.” The picture Hutt painted in his historical scholarship and epitomized in this keynote speech, has indeed informed the day’s panel discussions of future problems.