POISONER? Michael Taylor FDA

Michael R. Taylor

From Wikipedia, the free encyclopedia: http://en.wikipedia.org/wiki/Michael_R._Taylor

Michael R. Taylor
Michael R. Taylor in 2009
Nationality	American
Occupation	Deputy Commissioner for Foods, Food and Drug Administration

Michael R. Taylor is the Deputy Commissioner for Foods at the United States Food and Drug Administration (FDA).

Contents

• 1 Early career
• 2 USDA
• 3 Later career
• 4 References

Early career

He received a B.A. degree in political science from Davidson College and a law degree from the University of Virginia. In 1976, after passing the bar examination, Taylor became a staff attorney for the FDA, where he was executive assistant to the Commissioner.^[1][2]

In 1981 he went into private practice at King & Spalding, a law firm, one client of which was the biotechnology company Monsanto,^[3] where he established and led the firm's food and drug law practice.^[1][2]

In 1988 he published an article entitled "The De Minimis Interpretation of the Delaney Clause: Legal and Policy Rationale" in the Journal of the American College of Toxicology (now called the International Journal of Toxicology), which he had previously presented in December 1986 at a symposium on Topics in Risk Analysis, sponsored by International Life Sciences Institute Risk Science Institute, Society for Risk Analysis, and Brookings Institution.^[4] The paper was delivered and published during the midst of a debate and litigation over federal agencies' interpretation of the Delaney clause, a part of federal law written in 1958 that on its face, literally prohibits any chemical from being added, in any amount, to food that is processed, if that agent is carcinogenic. As analytical instrumentation increased in power and more and more agents were found to be carcinogenic at very low levels, the agencies had developed a quantitative risk assessment approach to interpreting the Delaney Clause, which stated that if a carcinogen was present at levels less than 1 in 1,000,000 parts, the risk of that carcinogen was "de minimis" and it could be allowed on the market.^[5] In the article, Taylor presented arguments in favor of this approach. Advocates in favor of organic food have criticized Taylor for taking this stance and have attributed the stance not to a good faith effort to reasonably regulate, but to an alleged desire to benefit Monsanto financially.^[6]

On July 17, 1991, Michael Taylor left King & Spalding, returning to the FDA to fill the newly created post of Deputy Commissioner for Policy. During that time, he signed the Federal Register notice stating that milk from cows treated with BGH did not have to be labeled as such.^[1][7] His name is not on the FDA’s 1992 policy statement on genetically engineered plant foods,^[8] but he is said to have been a co-author.^[1] Both of these documents grew out of, and fall within, the regulatory policy framework that was developed starting in the mid-1980s under the Reagan and Bush Administrations to ensure safety of the public and to ensure the continuing development of the fledgling biotechnology industry without overly burdensome regulation.^[9] The policy 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."^[9] 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.^[10] The 1992 policy, 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, initially at the producer's determination.^[8] 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.^[8] 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."^[8]

USDA

Between 1994 and 1996 he 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^[11] over the protests from industry, which has been called by food safety advocates "a truly heroic accomplishment".^[1][12]

Anti-biotechnology activist Jeremy Rifkin made charges in February, 1994 that Taylor had a conflict of interest with respect to the approval of rBST.^[13] The FDA replied with a memo indicating that Taylor had recused himself from all but the final stages of the review.^[13] 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."^[13] It also reported that "Some longtime agency critics found the charges against Taylor misplaced. Sidney Wolfe, a physician who heads the Public Citizen Health Research Group here, has filed complaints with the FDA about revolving-door ethics issues concerning other officials. But he said yesterday that 'It's barking up a silly kind of tree to be going up against Mike Taylor.' Wolfe said that 'as far as we're concerned, he's done a perfectly good job.' Wolfe compared Rifkin's charges to saying that anyone who worked for a drug company and began working for the FDA should not be allowed to say anything about drugs in general -- a stance that Wolfe characterized as 'preposterous.'"^[13]

Later career

Between 1996 and 2000, after briefly returning to King & Spalding, he then went to work for Monsanto as a Vice President for Public Policy.^[14]

In 1999, a lawsuit (Alliance For Bio-Integrity v. Shalala^[15][16]) and GAO report revealed considerable disagreement within the FDA concerning decisions about biotechnology products made during Taylor's tenure there. The lawsuit and report also revealed that Mr. 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.^[1][17]

In June 2000 he joined the think tank Resources for the Future in the position of Senior Fellow and Director of RFF’s Center for Risk Management,^[18] 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.^[18]

During this time, according to Marion Nestle, 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."^[1][19]

Taylor has been a professor at the University of Maryland’s School of Medicine^[20] and in 2007 he became a Research Professor of Health Policy at the George Washington University School of Public Health and Health Services.^[1]

On July 7, 2009, Taylor once again returned to government as Senior Advisor to the FDA Commissioner.^[21] And on January 13, 2010, he was appointed to another newly created post at the FDA, this time as Deputy Commissioner for Foods.^[22]

Taylor is featured in the documentaries The Future of Food and The World According to Monsanto^[23] as a pertinent example of revolving door since he is a lawyer who has spent the last few decades moving between Monsanto and the FDA and USDA.

References

1. Food Politics
2. Woodrow Wilson Center bio
3. Marie-Monique Robin: The World According to Monsanto
4. Taylor MR. The De Minimis Interpretation of the Delaney Clause: Legal and Policy Rationale. International Journal of Toxicology July/August 1988 7: 529-537 [1] subscription required
5. Merrill, Richard A. "Food Safety Regulation: Reforming the Delaney Clause" in Annual Review of Public Health, 1997, 18:313-40.[2] This source includes a useful historical survey of prior food safety regulation.
6. Organic Consumers
7. Federal Register Labeling Notice
8. 1992 FDA Policy Note. Taylor's name does not appear in this document, Maryansky's does.
9. Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture, 44 B.C.L. Rev. 733 (2003)[3]
10. Coordinated Framework
11. Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems Federal Register Meat Production
12. NY Times profile 2010
13. Washington Pos article 1994
14. Michael R. Taylor, Named Deputy Commissioner for Foods at FDA
15. FDA report of decision
16. Alliance report on lawsuit
17. Marion Nestle. Safe Food: Bacteria, Biotechnology, and Bioterrorism (California Studies in Food and Culture) ISBN 0520242238
18. Bio as Director of Resolve
19. 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 [4]
20. http://www.sourcewatch.org/index.php?title=Michael_R._Taylor
21. Noted Food Safety Expert Michael R. Taylor Named Advisor to FDA Commissioner
22. Meet Michael R. Taylor, J.D., Deputy Commissioner for Foods
23. The World according to Monsanto from Google Video