Michael R. Taylor

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For other people named Michael Taylor, see Michael Taylor (disambiguation).
For the museum director, see Michael R. Taylor (museum director). For the basketball player Michael Rene Taylor, see Mike Taylor (basketball).
Michael R. Taylor
Michael R. Taylor in 2009
NationalityAmerican
Occupation(s)Deputy Commissioner for Foods, Food and Drug Administration

Michael R. Taylor is an American lawyer who has played leadership roles on public health and food safety in government, academia, and the private sector, with a major focus on modernizing the U.S. food safety system to prevent foodborne illness. From 2010 to 2016, he was the Deputy Commissioner for Foods and Veterinary Medicine at the United States Food and Drug Administration (FDA) and currently co-chairs the board of Stop Foodborne Illness, a non-profit that supports victims of serious illness victims and their families in efforts to strengthen food safety culture and practices in government and industry.[1]


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 1971-1973, 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 1976-1980, 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.[2][3]

From 1981-1991 Taylor worked in private law practice at King & Spalding.[4] He established and led the firm's food and drug practice and became the firm’s first food and drug partner in 1984.[5] During this period, Mr. Taylor wrote and spoke frequently on topics related to FDA and its regulatory programs, including risk management,[6] the application of risk assessment to food safety decisions,[7] federal preemption,[8] drug approvals,[9] color additive[10] and medical device regulation,[11] and the need to maintain FDA funding for consumer protection.[12] 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.[13] 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.[14]

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.[15] In 1986, after FDA had established a de minimis risk interpretation for color additives he made a presentation at the Brookings Institution, subsequently published,[16] 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 1986-87, 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,[17] which contributed to legislation that strengthened safety standards for residues of carcinogenic pesticides in food.[18]

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.”[19] As Deputy Commissioner for Policy, Taylor oversaw the extensive policy development and rulemaking process needed to implement NLEA. 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. 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. 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, food biotechnology (discussed below), dietary supplement safety, and off-label use of drugs and company-supported continuing medical education .

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.

1992, he signed a guidance that milk from cows treated with BGH did not have to be labeled as such.[20][21] His name is not on the FDA's May 1992 guidance on genetically modified (GM) plant foods,[22] but he is said to have been a co-author.[20] Both documents are part of a regulatory framework developed since the mid-1980s under the Reagan and Bush Administrations to ensure the public's safety and development of the fledgling biotechnology industry without overly burdensome regulation.[23] The guidance had three tenets: "(1) U.S. policy would focus on the product of GM techniques, not the process itself, (2) only regulation grounded in verifiable scientific risks would be tolerated, and (3) GM products are on a continuum with existing products and, therefore, existing statutes are sufficient to review the products."[23] These tenets were first described in the 'Coordinated Framework for Regulation of Biotechnology', published by the President's Domestic Policy Council Working Group on Biotechnology through the Office of Science and Technology Policy in 1986.[24] The 1992 guidance, for example, treats "transferred genetic material and the intended expression product or products" in food derived from GM crops as food additives subject to existing food additive regulation, under which that material may be considered either generally recognized as safe (GRAS) or not GRAS, initially at the producer's determination.[22] If the food additive is not GRAS, the producer is required to submit data proving that the food additive does not "adulterate" the food - in other words, that the additive is not injurious to health.[22] With respect to GM food, the FDA retained its ability to take enforcement action any food it found to be "adulterated", which would make its producer "subject to the full range of enforcement measures under the act, including seizure, injunction, and criminal prosecution of those who fail to meet their statutory duty."[22]

United States Department of Agriculture, 1994-1996

Between 1994 and 1996 Taylor moved to the United States Department of Agriculture (USDA), where he was Administrator of the Food Safety & Inspection Service. During that term he implemented a science-based approach called Hazard analysis and critical control points (HACCP) to raising safety standards for meat and poultry production[25] over the protests from industry, which food safety advocates have called "a truly heroic accomplishment".[20][26]

In February, 1994 anti-biotechnology activist Jeremy Rifkin charged that Taylor had a conflict of interest with respect to the approval of rBST.[27] The FDA replied that Taylor had recused himself from all but the final stages of the review.[27] The Washington Post reported that: "On March 15, FDA Commissioner David A. Kessler sent Rifkin a four-page letter stating that 'none of the activities of Mr. Taylor cited in your petition were in violation of any applicable law or regulation, or were otherwise inappropriate.... I believe that Mr. Taylor's behavior adhered to all applicable ethical standards.' Kessler said that Taylor had not been 'intimately' involved in Monsanto's efforts to obtain approval, as Rifkin charged, and that he was involved in the FDA's bST policy only in the final stages of review. Kessler attached a nine-page memo by FDA ethics official Jack M. Kress supporting that position. Upon arriving at the FDA in the summer of 1991, Taylor recused himself for one year from taking part in any agency action dealing directly with Monsanto or any other King and Spalding clients."[27] It also reported that "Some longtime agency critics found the charges against Taylor misplaced, like Sidney Wolfe, a physician who heads the Public Citizen Health Research Group and has filed complaints with the FDA about revolving-door ethics issues concerning other officials."[27]

Monsanto, 1996 - 2000

Between 1996 and 2000, after briefly returning to King & Spalding, Taylor worked for Monsanto as a Vice President for Public Policy.[28]

In 1999, a lawsuit (Alliance For Bio-Integrity v. Shalala[29][30]) and GAO report revealed considerable disagreement within the FDA concerning decisions about biotechnology products made during Taylor's tenure. The lawsuit and report also said that Taylor had recused himself from matters related to Monsanto's BGH and had "never sought to influence the thrust or content" of the agency's policies on Monsanto's products.[20][31]

Center for Risk Management, 2000 - 2009

In June 2000, he joined the think tank Resources for the Future (RFF) in the position of Senior Fellow and Director of RFF's Center for Risk Management,[32] where he published two documents on U.S. aid for African agriculture, both of which were funded by the Rockefeller Foundation. During this time he was also a Director at 'Resolve', a nonprofit environmental and public health mediation and dispute resolution organization, and was an adjunct professor of law at Georgetown University Law Center.[32]

During this time, Taylor made strong arguments for a more rigorous and unified approach to food safety, in which he argued for:

  • "A single agency accountable for providing consistent and coordinated oversight of food safety, from farm to table.
  • Institution of Pathogen Reduction: HACCP, with performance standards verified by pathogen testing, at every step of food production.
  • Recall authority, access to records, and penalties for lapses in safety procedures.
  • Standards for imported foods equivalent to those for domestic foods.
  • Food safety to take precedence over commercial considerations in trade disputes."[20][33]

Taylor has been a professor at the University of Maryland's School of Medicine. In 2007, he became a Research Professor of Health Policy at the George Washington University School of Public Health and Health Services.[20]

FDA, 2009 - 2016

Taylor in 2013

On July 7, 2009, Taylor returned to government as Senior Advisor to the FDA Commissioner.[34] On January 13, 2010, he was appointed to another newly created post at the FDA, Deputy Commissioner for Foods.[35] On March 8, 2016, Taylor notified friends and colleagues that he would be departing the FDA as of June 1, 2016.[36]

In everyday culture

Taylor is featured in the documentaries

References

  1. ^ Stop Foodborne Illness Website, “Board Bio on Michael R. Taylor” (https://stopfoodborneillness.org/about- us/people/).
  2. ^ Stop Foodborne Illness Website, “Board Bio on Michael R. Taylor” (https://stopfoodborneillness.org/about-us/people/).
  3. ^ Wells, Della Wager, The First Hundred Years: A Centennial History of King & Spalding (Atlanta: King & Spalding, 1985) at 260.
  4. ^ Wells, Della Wager, The First Hundred Years: A Centennial History of King & Spalding (Atlanta: King & Spalding, 1985) at 260.
  5. ^ Ibid. at 307.
  6. ^ 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).
  7. ^ Rodricks and Taylor, "Application of Risk Assessment to Food Safety Decision Making," 3 Regulatory Toxicology and Pharmacology 275 307 (1983).
  8. ^ 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).
  9. ^ 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.
  10. ^ Taylor, "History of Cosmetic Color Additive Regulation: Creative Maneuvering by FDA Bodes Well for the Future," 37 Food Drug Cosmetic Law Journal 152 162 (1982).
  11. ^ 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.
  12. ^ Taylor, Michael, "Why Weaken the FDA?” The Washington Post, December 21, 1982, at A20
  13. ^ 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.
  14. ^ Pape, Stuart and Taylor, Michael, "Congress, Not FDA, Should Rewrite Delaney Clause," Legal Times of Washington, May 25, 1981, at 34.
  15. ^ Ibid.
  16. ^ 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).
  17. ^ Board on Agriculture/National Research Council, Regulating Pesticides in Food – The Delaney Paradox (Washington, D.C.: National Academy Press, 1987).
  18. ^ EPA, “Summary of the Food Quality Protection Act” (https://www.epa.gov/laws-regulations/summary-food-quality-protection-act).
  19. ^ The Nutrition Labeling and Education Act of 1990 (NLEA) (Public Law 101-535).
  20. ^ a b c d e f Marion Nestle Michael Taylor appointed to FDA: A good choice! Food Politics (Blog) 7 July 2009
  21. ^ Federal Register Labeling Notice Archived September 21, 2012, at the Wayback Machine
  22. ^ a b c d FDA. FDA Guidance to Industry for Foods Derived from New Plant Varieties Federal Register. Volume 57 - 1992. Friday, May 29, 1992. Note. Taylor's name does not appear in this document, Maryansky's does.
  23. ^ a b Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture, Boston College Law Review 733 Volume 4, Issue 3 Number 3 (5-1-2003) 56 pages
  24. ^ Coordinated Framework United States Regulatory Agencies Unified Biotechnology Website decommissioned per 27 March 2013 Archived August 19, 2012, at the Wayback Machine
  25. ^ Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems Federal Register Meat Production
  26. ^ NY Times profile 2010
  27. ^ a b c d Washington Post article 1994
  28. ^ Michael R. Taylor, Named Deputy Commissioner for Foods at FDA marlerblog.com, January 2010
  29. ^ FDA report of decision
  30. ^ "Alliance report on lawsuit". Archived from the original on 2013-01-25. Retrieved 2012-09-23.
  31. ^ Marion Nestle. Safe Food: Bacteria, Biotechnology, and Bioterrorism (California Studies in Food and Culture) ISBN 0520242238, p=205
  32. ^ a b Bio as Director of Resolve
  33. ^ Michael R. Taylor and Stephanie D. David. Stronger Partnerships for Safer Food: An Agenda for Strengthening State and Local Roles in the Nation’s Food Safety System
  34. ^ Noted Food Safety Expert Michael R. Taylor Named Advisor to FDA Commissioner Archived January 13, 2017, at Archive-It
  35. ^ Meet Michael R. Taylor, J.D., Deputy Commissioner for Foods Archived 2012-01-26 at the Wayback Machine
  36. ^ Dan Flynn (March 9, 2016). "FDA's Mike Taylor departing agency — totally on his own terms". Food Safety News. Retrieved November 5, 2018.
  37. ^ The World according to Monsanto from Google Video Archived May 26, 2008, at the Wayback Machine

External links

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