Michael R. Taylor is an American lawyer who has played leadership roles in the US Food and Drug Administration, agrochemical company Monsanto, and law firm King & Spalding. He currently co-chairs the board of STOP Foodborne Illness, a non-profit that supports victims of serious illness and their families in efforts to strengthen food safety culture and practices in government and industry.Stop Foodborne Illness Website, “Board Bio on Michael R. Taylor” (https://stopfoodborneillness.org/our-team-2/).
Early career and law practice Taylor received a B.A. degree in political science from Davidson College in 1971 and served on active duty in the US Army as an officer in the Military Police Corps from 1971 to 1973, stationed at the Presidio in San Francisco. He received a J.D. degree from the University of Virginia in 1976 and was employed as a staff attorney at the FDA from 1976 to 1980, where he worked on enforcement litigation, medical device regulations, food safety and food labeling. He served during 1980 as executive assistant to the FDA Commissioner Dr. Jere Goyan.Wells, Della Wager, The First Hundred Years: A Centennial History of King & Spalding (Atlanta: King & Spalding, 1985) at 260.
From 1981 to 1991 Taylor worked in private law practice at King & Spalding.Wells, Della Wager, The First Hundred Years: A Centennial History of King & Spalding (Atlanta: King & Spalding, 1985) at 260. He established and led the firm's food and drug practice and became the firm's first food and drug partner in 1984.Ibid. at 307. During this period, Mr. Taylor wrote and spoke frequently on topics related to FDA and its regulatory programs, including risk management,Taylor, Michael, "Interpreting the Safety Standard: A Collaborative Model," 3 Journal of the American College of Toxicology 103-114 (June 1984); Taylor, Michael, "The Role of Law in Risk Management: A Framework for Managing Uncertainty," 4 Fundamental and Applied Toxicology S408 S417 (1984). the application of risk assessment to food safety decisions,Rodricks and Taylor, "Application of Risk Assessment to Food Safety Decision Making," 3 Regulatory Toxicology and Pharmacology 275 307 (1983). federal preemption,Taylor, Michael, "Federal Preemption and Food and Drug Regulation: The Practical, Modem Meaning of an Ancient Doctrine," 38 Food Drug Cosmetic Law Journal 306 317 (1983). drug approvals,Wisser, Scott and Taylor, Michael, "Does the FDA Drug Approval Plan Overstep the Agency's Mandate?," The National Law Journal (January 16, 1984) at 26. color additiveTaylor, "History of Cosmetic Color Additive Regulation: Creative Maneuvering by FDA Bodes Well for the Future," 37 Food Drug Cosmetic Law Journal 152 162 (1982). and medical device regulation,Taylor, Michael, "Device Notification and the '3R's' What Congress Sought and Where It Went Wrong," a paper presented at the Food and Drug Law Institute Medical Device Update '85, Washington, D.C., June 19, 1985. and the need to maintain FDA funding for consumer protection.Taylor, Michael, "Why Weaken the FDA?” The Washington Post, December 21, 1982, at A20 In some of his early writings, Mr. Taylor addressed the Delaney Clause, a part of a 1958 federal law that prohibits any carcinogenic chemical from being added to food that is processed. In the 1970's and 80's, FDA scientists had developed scientific risk assessments on the basis of which they could conclude that, under certain circumstances, very low human exposure to chemicals found to cause cancer in animals nevertheless could be found safe under the "reasonable certainty of no harm" safety standard for food additives.FDA, “Policy for Regulating Carcinogenic Chemicals in Food and Color Additives (the Constituents Policy),” 47 Fed. Reg. 14464 (April 2, 1982); see also 21 CFR Part 500, Subpart E – Regulation of Carcinogenic Compounds Used in Food-Producing Animals. Some commentators argued that FDA should interpret the Delaney Clause as allowing FDA to approve food additives based on a de minimis risk legal interpretation.Pape, Stuart and Taylor, Michael, "Congress, Not FDA, Should Rewrite Delaney Clause," Legal Times of Washington, May 25, 1981, at 34.
In 1981, Taylor argued in Legal Times of Washington that it was the role of Congress, not FDA, to decide if there should be a de minimis interpretation of the Delaney Clause.Ibid. In 1986, after FDA had established a de minimis risk interpretation for color additives he made a presentation at the Brookings Institution, subsequently published,Taylor M.R., “The De Minimis Interpretation of the Delaney Clause: Legal and Policy Rationale,” International Journal of Toxicology, Vol 7: 529-537 (July/August 1988). explaining the legal and policy rationale for FDA's interpretation and urging that FDA take a cautious, science-based approach to its implementation with protection of public health as its overriding concern. From 1986 to 1987, Taylor served on a National Academy of Sciences Committee that studied the application of the Delaney Clause in pesticide regulation and participated in a Keystone Center dialogue on pesticide regulation,Board on Agriculture/National Research Council, Regulating Pesticides in Food – The Delaney Paradox (Washington, D.C.: National Academy Press, 1987). which contributed to legislation that strengthened safety standards for residues of carcinogenic pesticides in food.EPA, “Summary of the Food Quality Protection Act” (https://www.epa.gov/laws-regulations/summary-food-quality-protection-act).
Government Service at FDA and USDA, 1991 - 1996
US Food and Drug Administration, 1991-1994 On July 17, 1991, Michael Taylor left King & Spalding to return to the FDA in the newly created post of Deputy Commissioner for Policy established by FDA Commissioner David A. Kessler. In this position, Taylor led FDA's new Office of Policy and, on behalf of the commissioner, oversaw development of policy and regulations in all FDA program areas, including food, drugs, and medical devices.
A major focus area for FDA during this period was implementation of the Nutrition Labeling and Education Act of 1990, which overhauled food labeling in the United States by mandating nutrition labeling on all food packages (now the ubiquitous "Nutrition Facts" panel), and regulating health claims, nutrient content claims, and claims such as "healthy" and "light".The Nutrition Labeling and Education Act of 1990 (NLEA) (Public Law 101-535). As Deputy Commissioner for Policy, Taylor oversaw the extensive policy development and rulemaking process needed to implement NLEA.Kessler, David A., A Question of Intent (New York: Public Affairs, 2001) at 55. He was also FDA's point person in contentious negotiations over the content of the rules with the U.S. Department of Agriculture and the White House due to food industry and USDA opposition to many provisions of the rules, especially regarding FDA's proposal to clearly disclose the fat content of foods in relation to calories per serving.Ibid. at 56-59. This culminated in an Oval Office meeting in December 1992, with then-lame duck President George H. W. Bush, HHS Secretary Lou Sullivan, USDA Secretary Ed Madigan, Vice President Dan Quayle and Chief of Staff James Baker in which Taylor advised the president that the administration had run out of time to legally change FDA's preferred policy. The White House sided with FDA and cleared the regulations.Ibid. 67-71. Among the other FDA initiatives Taylor led were the streamlining and enhanced management of the FDA regulations process, a comprehensive review of FDA's international activities, promulgation of regulations implementing the Safe Medical Devices Act of 1990, and development of new seafood safety regulations. He also oversaw development of FDA policies on such matters as human tissue transplantation,Taylor, Michael, "Issues in Human Tissue Regulation," a presentation at the American Association of Tissue Banks 17th Annual Meeting, San Diego, California, August 24, 1992. food biotechnology (discussed below), dietary supplement safety,Wingert, Pat and Kantrowitz, Barbara, “An Industry Unmonitored,” Newsweek, June 7, 1993 at 52. and off-label use of drugs and company-supported continuing medical education.Taylor, Michael, "Drug Regulation, Off-Label Uses, and CME Reconciling Competing Values," a presentation at the FDLI Update on Drug Advertising and Promotion, Arlington, Virginia, February 26, 1992.
In the 1993 transition to the administration of President Bill Clinton, Kessler and Taylor were retained in their FDA positions despite having been political appointees of the Bush administration.Ibid. at 73-74.
United States Department of Agriculture, 1994-1996 In late 1992 and early 1993, an outbreak of foodborne illness caused by E. coli-contaminated hamburger sold at the Jack in the Box fast food chain on the US West Coast killed four children and seriously injured over 700 other people.Wikipedia, “1993 Jack in the Box E.coli Outbreak” (https://en.wikipedia.org/wiki/1993_Jack_in_the_Box_E._coli_outbreak This event triggered calls for reform of USDA's meat safety program, which at the time inspected every beef carcass for visible defects but did not hold slaughterhouses or ground beef processing establishments responsible for preventing contamination with dangerous bacteria, such as the highly pathogenic E. coli O157:H7 implicated in the Jack in the Box outbreak. At that time, USDA did not consider such bacteria to be adulterants and thus unlawful in raw meat because consumers were expected to cook the food properly.Pence, Gregory, The Ethics of Food: A Reader for the 21st Century (Lanham, MD: Rowman & Littlefield Publishers, Inc., 2002) at 249 et seq.
In August 1994, Taylor was appointed by USDA Secretary Mike Espy to be administrator of the Food Safety and Inspection Service (FSIS), with a charge to lead reform in the meat and poultry inspection program. On September 29, 1994, in a speech before a meeting of the American Meat Institute, Taylor outlined his reform agenda to meat industry leaders, which included overhauling the FSIS program to establish legal accountability for industry to prevent contamination of meat and poultry with dangerous bacteria, including E.coli O157:H7.Taylor, Michael, “Change and Opportunity: Harnessing Innovation to Improve the Safety of the Food Supply” (speech delivered to the American Meat Institute National Convention, September 29, 1994) https://www.foodsafetynews.com/AMI%20Speech%20September%201994.pdf As a first step toward that accountability, Taylor informed the industry audience that henceforth FSIS would consider raw ground beef containing any amount of that pathogen to be adulterated, unlawful for sale, and thus subject to recall. He also announced that FSIS would begin testing for E. coli O157:H7 in raw ground beef. One author later called this "perhaps the single most important change in USDA history."Pence, Gregory, The Ethics of Food: A Reader for the 21st Century (Lanham, MD: Rowman & Littlefield Publishers, Inc., 2002) at 256. The meat industry filed a federal lawsuit challenging Taylor's new policy; the court rejected the industry challenge and upheld the policy.Texas Food Industry et al. v. Mike Espy et al., 870 F. Supp. 143 (W.D. Tex. 1994). "And with that the world changed," according to another commentator. "This seemingly simple change – calling E. coli O157:H7 an adulterant – has over the last 20 years saved countless children from kidney failure and death."Marler, Bill, “Publisher’s Platform: Mike Taylor and the Myth of Monsanto’s Man,” Food Safety News (March 25, 2013) (https://www.foodsafetynews.com/2013/03/publishers-platform-mike-taylor-and-the-myth-of-monsantos-man/