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OpEdNews Op Eds    H2'ed 9/6/18

How Many Innocent and Unsuspecting People in 2019 Will Die Because of the FDA's Revolving Doors?

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Both documents are part of a regulatory framework developed since the 1980s under the Reagan and Bush Administrations to ensure the public's safety and development of the fledgling biotechnology industry "without overly burdensome regulation."

This "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,

(3) GM products are on a continuum with existing products and, therefore, existing statutes are sufficient to review the products."

These tenets were initially presented 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.

The 1992 guidance 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.

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.

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."

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 so-called "science-based approach" called Hazard analysis and critical control points (HACCP) to raising safety standards for meat and poultry production over the protests from industry, which food safety advocates have called "a truly heroic accomplishment".

In February, 1994 anti-biotechnology activist Jeremy Rifkin charged that Taylor had a conflict of interest with respect to the approval of rBST (recombinant Bovine somatotropin). The FDA replied that Taylor had recused himself from all but the final stages of the review.

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."

It 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."

Monsanto, 1996 - 2000

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

In 1999, a lawsuit (Alliance For Bio-Integrity v. Shalala, and a GAO report, as well, 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. (I don't believe any of those sanguine conclusions, not for two seconds!)

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