Difference between revisions of "Michael Taylor"

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In July 2009 US President [[Barack Obama]] appointed former [[Monsanto]] lobbyist [[Michael Taylor]] as a senior adviser to the US FDA ([[Food and Drug Administration]]).
 
In July 2009 US President [[Barack Obama]] appointed former [[Monsanto]] lobbyist [[Michael Taylor]] as a senior adviser to the US FDA ([[Food and Drug Administration]]).
  
==The "substantial equivalence" spin==
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=="Substantial equivalence" spin==
  
Taylor is the creator of the US FDA's doctrine of substantial equivalence, which was published in  a 1992 Federal Register notice for which he was responsible. Substantial equivalence provides the basis for the non-regulation of GMOs. It assumes that a GM food is the same as its non-GM counterpart and therefore requires no special testing. It is a lawyer's and spin doctor's concept (Taylor is a lawyer and a lobbyist), with no scientific basis. As such, it has come under repeated criticism from scientists independent of the industry.<ref>[http://www.psrast.org/subeqow.htm Inadequate safety assessment of GE foods], Physicians and Scientists for Responsible Application of Science and Technology (PSRAST) website, accessed 8 July 2009</ref> Where detailed testing has been done, GM foods have been found to be different from their non-GM equivalents and to have different biological effects.<ref>Food Safety — Contaminants and Toxins. Unpublished study reviewed in J.P.F. D’Mello, CABI Publishing, 2003; Genetically modified soya leads to the decrease of weight and high mortality rate of rat pups of the first generation. Ermakova I.V. EcosInform, 1: 4-9, 2006; Fine structural analysis of pancreatic acinar cell nuclei from mice fed on GM soybean. Malatesta M. et al. Eur J Histochem., 47: 385-388, 2003; Ultrastructural morphometrical and immunocytochemical analyses of hepatocyte nuclei from mice fed on genetically modified soybean. Malatesta M et al. Cell Struct Funct., 27: 173-180, 2002; Ultrastructural analysis of testes from mice fed on genetically modified soybean. Vecchio L. et al. Eur J Histochem., 48: 448-454, 2004; Transgenic expression of bean alpha-amylase inhibitor in peas results in altered structure and immunogenicity. Prescott V.E. et al. J Agric Food Chem., 53: 9023-9030, 2005; Biotechnology Consultation Note to the File BNF No 00077. Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, 4 September 2002; Effects of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine. Ewen S.W. and Pusztai A. The Lancet, 354: 1353-1354, 1999; New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. Séralini, G.-E. et al. Arch. Environ Contam Toxicol., 52: 596-602, 2007; A three generation study with genetically modified Bt corn in rats: Biochemical and histopathological investigation. Kilic A and Akay MT. Food and Chemical Toxicology, 46: 1164-1170, 2008; Intestinal and Peripheral Immune Response to MON810 Maize Ingestion in Weaning and Old Mice. Finamore A et al. J. Agric. Food Chem., 56: 11533-11539, 2008; Biological effects of transgenic maize NK603xMON810 fed in long term reproduction studies in mice. Velimirov A et al. Bundesministerium für Gesundheit, Familie und Jugend Report, Forschungsberichte der Sektion IV Band 3/2008, Austria, 2008; A long-term study on female mice fed on a genetically modified soybean: effects on liver ageing. Malatesta M. et al. Histochem Cell Biol., 130: 967-977, 2008; Genetically modified soya bean in rabbit feeding: detection of DNA fragments and evaluation of metabolic effects by enzymatic analysis. R. Tudisco et al. Animal Science, 82: 193-199, 2006; Fate of genetically modified maize DNA in the oral cavity and rumen of sheep. Duggan P.S. et al. Br J Nutr., 89: 159-166, 2003; A three-year longitudinal study on the effects of a diet containing genetically modified Bt176 maize on the health status and performance of sheep. Trabalza-Marinucci M. et al. Livestock Science, 113: 178-190, 2008.</ref>  
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Many commentators see Taylor as the creator of the US FDA's doctrine of substantial equivalence, which was published in  a 1992 Federal Register notice for which he was responsible. Substantial equivalence provides the basis for the non-regulation of GMOs. It assumes that a GM food is the same as its non-GM counterpart and therefore requires no special testing. It is a lawyer's and spin doctor's concept (Taylor is a lawyer and a lobbyist), with no scientific basis. As such, it has come under repeated criticism from scientists independent of the industry.<ref>[http://www.psrast.org/subeqow.htm Inadequate safety assessment of GE foods], Physicians and Scientists for Responsible Application of Science and Technology (PSRAST) website, accessed 8 July 2009</ref> Where detailed testing has been done, GM foods have been found to be different from their non-GM equivalents and to have different biological effects.<ref>Food Safety — Contaminants and Toxins. Unpublished study reviewed in J.P.F. D’Mello, CABI Publishing, 2003; Genetically modified soya leads to the decrease of weight and high mortality rate of rat pups of the first generation. Ermakova I.V. EcosInform, 1: 4-9, 2006; Fine structural analysis of pancreatic acinar cell nuclei from mice fed on GM soybean. Malatesta M. et al. Eur J Histochem., 47: 385-388, 2003; Ultrastructural morphometrical and immunocytochemical analyses of hepatocyte nuclei from mice fed on genetically modified soybean. Malatesta M et al. Cell Struct Funct., 27: 173-180, 2002; Ultrastructural analysis of testes from mice fed on genetically modified soybean. Vecchio L. et al. Eur J Histochem., 48: 448-454, 2004; Transgenic expression of bean alpha-amylase inhibitor in peas results in altered structure and immunogenicity. Prescott V.E. et al. J Agric Food Chem., 53: 9023-9030, 2005; Biotechnology Consultation Note to the File BNF No 00077. Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, 4 September 2002; Effects of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine. Ewen S.W. and Pusztai A. The Lancet, 354: 1353-1354, 1999; New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. Séralini, G.-E. et al. Arch. Environ Contam Toxicol., 52: 596-602, 2007; A three generation study with genetically modified Bt corn in rats: Biochemical and histopathological investigation. Kilic A and Akay MT. Food and Chemical Toxicology, 46: 1164-1170, 2008; Intestinal and Peripheral Immune Response to MON810 Maize Ingestion in Weaning and Old Mice. Finamore A et al. J. Agric. Food Chem., 56: 11533-11539, 2008; Biological effects of transgenic maize NK603xMON810 fed in long term reproduction studies in mice. Velimirov A et al. Bundesministerium für Gesundheit, Familie und Jugend Report, Forschungsberichte der Sektion IV Band 3/2008, Austria, 2008; A long-term study on female mice fed on a genetically modified soybean: effects on liver ageing. Malatesta M. et al. Histochem Cell Biol., 130: 967-977, 2008; Genetically modified soya bean in rabbit feeding: detection of DNA fragments and evaluation of metabolic effects by enzymatic analysis. R. Tudisco et al. Animal Science, 82: 193-199, 2006; Fate of genetically modified maize DNA in the oral cavity and rumen of sheep. Duggan P.S. et al. Br J Nutr., 89: 159-166, 2003; A three-year longitudinal study on the effects of a diet containing genetically modified Bt176 maize on the health status and performance of sheep. Trabalza-Marinucci M. et al. Livestock Science, 113: 178-190, 2008.</ref>  
  
 
The Royal Society of Canada described substantial equivalence as “scientifically unjustifiable and inconsistent with precautionary regulation of the technology.”<ref>Quoted by Jeffrey M. Smith in [http://www.wellbeingjournal.com/index.php?option=com_content&task=view&id=85 FDA-Sanctioned Genetically Engineered Foods], WellBeing Journal, 2009, accessed 8 July 2009</ref>
 
The Royal Society of Canada described substantial equivalence as “scientifically unjustifiable and inconsistent with precautionary regulation of the technology.”<ref>Quoted by Jeffrey M. Smith in [http://www.wellbeingjournal.com/index.php?option=com_content&task=view&id=85 FDA-Sanctioned Genetically Engineered Foods], WellBeing Journal, 2009, accessed 8 July 2009</ref>

Revision as of 09:42, 10 July 2009

In July 2009 US President Barack Obama appointed former Monsanto lobbyist Michael Taylor as a senior adviser to the US FDA (Food and Drug Administration).

"Substantial equivalence" spin

Many commentators see Taylor as the creator of the US FDA's doctrine of substantial equivalence, which was published in a 1992 Federal Register notice for which he was responsible. Substantial equivalence provides the basis for the non-regulation of GMOs. It assumes that a GM food is the same as its non-GM counterpart and therefore requires no special testing. It is a lawyer's and spin doctor's concept (Taylor is a lawyer and a lobbyist), with no scientific basis. As such, it has come under repeated criticism from scientists independent of the industry.[1] Where detailed testing has been done, GM foods have been found to be different from their non-GM equivalents and to have different biological effects.[2]

The Royal Society of Canada described substantial equivalence as “scientifically unjustifiable and inconsistent with precautionary regulation of the technology.”[3]

Substantial equivalence is viewed by the UN Food and Agriculture Organization, World Health Organisation and Codex Alimentarius differently from the FDA. These bodies, unlike the FDA, emphasize that safety assessment of GMOs must be focused on establishing the safety of the differences in the new product such that the safety of the food can be established.

In 2001 the European Union (EU) abandoned the doctrine of substantial equivalence, opting for more stringent scientific risk assessment. As a result of this doctrine, the FDA has never substantiated the material facts of GM foods and food safety, such as testing their safety. The FDA has always asserted as a result of this policy that validated testing methods are not currently available.

History

The following is a summarized history of Taylor's career by blogger Jill Richardson, writing in the Daily Kos.[4]

Taylor previously worked at the USDA from 1976-1981 as a staff lawyer. He left government to work at King & Spaulding, a law firm representing Monsanto.

He returned to government - this time to the FDA - for a stint as Deputy Commissioner for Policy from 1991-1994. According to Marion Nestle in Food Politics:

[At the FDA] he was part of the team that issued the agency's decidedly industry-friendly policy on food biotechnology and that approved the use of Monsanto's genetically engineered growth hormone in dairy cows. His questionable role in these decisions led to an investigation by the federal General Accounting Office, which eventually exonerated him of all conflict-of-interest charges.

In 1994, he moved over to the USDA's Food Safety & Inspection Service to serve as Administrator until 1996. Then it was back to King & Spaulding for a little bit, and - in 1998 - over to Monsanto, where he was a senior lobbyist (Vice President for Public Policy).

Most recently, beginning in 2000, he was a fellow for Resources for The Future, serving as Research Professor Of Health Policy at George Washington University.[5] Until this week, that is. Resources for Our Future is quite corporate funded, with members of its Board of Directors from BP, Chevron, and DuPont [and Rio Tinto, American Electric Power Company, Warburg Pincus, and the Ford Foundation - SpinProfiles ed.].[6]

And now he's back at the FDA.

Comment

The following is Tom Philpott's commentary on the appointment of Taylor, in GRIST.[7]

Monsanto's man Taylor returns to FDA in food-czar role

by Tom Philpott

GRIST, 8 July 2009

In a Tuesday afternoon press release, the FDA announced that Michael Taylor, a former Monsanto executive, had joined the agency as “senior advisor to the commissioner.” If the title is vague, the portfolio (pasted from the press release) is substantial — a kind of food czar of the Food and Drug Administration:

  • Assess current food program challenges and opportunities
  • Identify capacity needs and regulatory priorities
  • Develop plans for allocating fiscal year 2010 resources
  • Develop the FDA’s budget request for fiscal year 2011
  • Plan implementation of new food safety legislation

Taylor's new position isn't his first in government. He's a veteran apparatchik who has made an art of the role-swapping dance between the food industry and the agencies that regulate it. (The FDA's press release highlights his government service while delicately omitting his Monsanto dal[l]iances.) In her 2002 book Food Politics, the nutritionist and food-industry critic Marion Nestle describes him like this (quote courtesy of La Vida Locavore):

Mr. Taylor is a lawyer who began his revolving door adventures as counsel to FDA. He then moved to King & Spalding, a private-sector law firm representing Monsanto, a leading agricultural biotechnology company. In 1991 he returned to the FDA as Deputy Commissioner for Policy, where he was part of the team that issued the agency’s decidedly industry-friendly policy on food biotechnology and that approved the use of Monsanto’s genetically engineered growth hormone in dairy cows. His questionable role in these decisions led to an investigation by the federal General Accounting Office, which eventually exonerated him of all conflict-of-interest charges. In 1994, Mr. Taylor moved to USDA to become administrator of its Food Safety and Inspection Service ... After another stint in private legal practice with King & Spalding, Mr. Taylor again joined Monsanto as Vice President for Public Policy in 1998.

"Vice president for public policy" means, of course, chief lobbyist. Monsanto had hired him to keep his former colleagues at USDA and FDA, as well as Congress folk, up to date on the wonders of patent-protected seed biotechnology.

"Since 2000," the FDA press release informs us, "Taylor has worked in academic and research settings on the challenges facing the nation's food safety system and ways to address them."

Watchdog in flack's clothing?

And somewhere along the away, according to his erstwhile critic Nestle, Taylor had a moment like Saul's on the road to Damascus: the one-time company man suddenly became a valorous industry watchdog. In a surprising blog post Tuesday, Nestle declared Taylor "a good pick" for the FDA. "I say this in full knowledge of his history," Nestle wrote. Here's her rationale:

Watch what happened when he moved to USDA in 1994 as head of its Food Safety and Inspection Service (FSIS). Just six weeks after taking the job, Mr. Taylor gave his first public speech to an annual convention of the American Meat Institute. There, he announced that USDA would now be driven by public health goals as much or more than by productivity concerns. The USDA would soon require science-based HACCP systems in every meat and poultry plant, would be testing raw ground beef, and would require contaminated meat to be destroyed or reprocessed. And because E. coli O157.H7 is infectious at very low doses, the USDA would consider any level of contamination of ground beef with these bacteria to be unsafe, adulterated, and subject to enforcement action. Whew. This took real courage.

Nestle goes on to report that Taylor, after serving a stint as Monsanto’s chief lobbyist, became a kind of food-safety intellectual, issuing wise papers on how the regulators should oversee food companies. She points us to an "excellent report" [PDF] co-written by Taylor, released this year.

That paper must be read carefully: Given Taylor’s new status, it—along with new guidelines released by the White House Food Safety Working on Tuesday—will likely serve as a kind of blueprint for the Obama FDA food oversight.

Two things jump out immediately from Taylor's paper. First, it amounts to a forceful push to shift much more of the burden for funding food-safety operations to the state and local level. Its very title is "An Agenda for Strengthening State and Local Roles in the Nation's Food Safety System." The paper promotes a "Joint Funding Responsibility" between federal and local/state agencies.

Why is this a problem? For one, state and local budgets are parched dry, drained by the most severe economic downturn since the Depression. Is, say, California now going to fund a robust food-safety platform—with IOUs, perhaps?

Moreover, we've seen the sort of federal-state partnership Taylor promotes in action—and there have been spectacular failures. Remember the great peanut-butter calamity of 2008-'09, the one that killed at least seven people and sickened hundreds? In that case, the FDA had farmed out inspections of the ofending factory to Georgia authorities, who dutifully documented atrocious sanitary lapses even as tainted product got distributed nationwide.

The other immediate problem with Taylor’s blueprint relates to scale. A sane food-safety policy would do two things: 1) rein in the gigantic companies that routinely endanger millions with a single lapse at a single plant—say, a gigantic beef company that can send out 420,000 pounds of E. coli-tainted beef from a day’s processing; and 2) do so in a way that doesn’t harm the thousands of small-scale, community-oriented operations rising up in new alternative food systems.

Again and again, we’ve seen regulations designed to rein in big players actually consolidate their market power by wiping out small players. As a recent Food & Water Watch report showed, regulations that make sense for industrial slaughterhouses can spell the end for community- and regional-scale ones. The Taylor report only addresses this critical point once in its 80 pages: "Due regard should be given to making the traceback requirement feasible for small businesses." Clearly, the small-scale producer issue isn’t a priority for Monsanto’s man at FDA.

A technocrat's tinkering

With the widely respected Marion Nestle throwing her support behind the Taylor pick, I went looking for other perspectives. I asked Patty Lovera, assistant director of Food & Water Watch, for her take. FWW has been actively working to promote a scale-appropriate food-safety regime that checks Big Food without crushing small producers.

Lovera does not share Nestle's enthusiasm. "Taylor basically promotes a risk-based approach, and we don’t think that’s adequate," she told me. Lovera explained that in a risk-based approach, regulators focus limited resources on areas of the food system that pose the most risk. Sounds logical, she said, but it's proven difficult to predict where risk factors really lie. I asked her if the peanut-butter debacle was a good example. Who would have foreseen multiple deaths from a factory that produces peanut paste for processed food manufacturers? She concurred. She added that the USDA's FSIS program, which oversees meat safety, has largely failed in a 10-year effort to identify the riskiest parts of the meat-production process.

Then there's the emphasis on what Nestle praised in her blog post as "science-based HACCP systems." HACCP stands for "hazard analysis and critical control point." In an HACCP system, you identify the points in a process that pose the most risk and "fix" the problem.

"That approach is really geared to techno fixes," Lovera told me — stuff like ammonia washes, irradiation, etc. These procedures don't seek to, say, keep salmonella-tainted peanut butter out of cookies, but rather to make salmonella-exposed cookies safe to eat. Moreover, the HACCP approach "hasn't proven friendly to small producers," she adds. To see the Obama FDA appear to embrace it, she told me, "makes us cringe." In the end, the food safety system doesn't just need to tinker with the use of scarce resources, leveraged by increasing the burden on states and localities. It needs to devote more resources to actual inspections.

As for Taylor, here's my take: Despite massive marketing budgets, the food industry has become widely distrusted over the last several years, with high-profile outbreaks a major reason. "Consumers are increasingly wary of the safety of food purchased at grocery stores," declares a recent study. "And their confidence in—and trust of—food retailers, manufacturers and grocers is declining."

The industry knows it needs an improved safety system; technocrats like Taylor can deliver a marginally improved food safety system while preserving profit margins and market share.

Perhaps the FDA's new food czar can save some lives—I hope he does. It’s abominable when people die from eating pre-fab peanut butter cookie or salad from a bag. Taylor’s tinkerings could well reduce such disasters.

But what we really need is a food safety system that takes the shit out of industrial meat and the salmonella out of peanut butter, without dumping on small producers. And I don’t think Taylor will deliver that — or even try.

Affiliations

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Notes

  1. Inadequate safety assessment of GE foods, Physicians and Scientists for Responsible Application of Science and Technology (PSRAST) website, accessed 8 July 2009
  2. Food Safety — Contaminants and Toxins. Unpublished study reviewed in J.P.F. D’Mello, CABI Publishing, 2003; Genetically modified soya leads to the decrease of weight and high mortality rate of rat pups of the first generation. Ermakova I.V. EcosInform, 1: 4-9, 2006; Fine structural analysis of pancreatic acinar cell nuclei from mice fed on GM soybean. Malatesta M. et al. Eur J Histochem., 47: 385-388, 2003; Ultrastructural morphometrical and immunocytochemical analyses of hepatocyte nuclei from mice fed on genetically modified soybean. Malatesta M et al. Cell Struct Funct., 27: 173-180, 2002; Ultrastructural analysis of testes from mice fed on genetically modified soybean. Vecchio L. et al. Eur J Histochem., 48: 448-454, 2004; Transgenic expression of bean alpha-amylase inhibitor in peas results in altered structure and immunogenicity. Prescott V.E. et al. J Agric Food Chem., 53: 9023-9030, 2005; Biotechnology Consultation Note to the File BNF No 00077. Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, 4 September 2002; Effects of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine. Ewen S.W. and Pusztai A. The Lancet, 354: 1353-1354, 1999; New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. Séralini, G.-E. et al. Arch. Environ Contam Toxicol., 52: 596-602, 2007; A three generation study with genetically modified Bt corn in rats: Biochemical and histopathological investigation. Kilic A and Akay MT. Food and Chemical Toxicology, 46: 1164-1170, 2008; Intestinal and Peripheral Immune Response to MON810 Maize Ingestion in Weaning and Old Mice. Finamore A et al. J. Agric. Food Chem., 56: 11533-11539, 2008; Biological effects of transgenic maize NK603xMON810 fed in long term reproduction studies in mice. Velimirov A et al. Bundesministerium für Gesundheit, Familie und Jugend Report, Forschungsberichte der Sektion IV Band 3/2008, Austria, 2008; A long-term study on female mice fed on a genetically modified soybean: effects on liver ageing. Malatesta M. et al. Histochem Cell Biol., 130: 967-977, 2008; Genetically modified soya bean in rabbit feeding: detection of DNA fragments and evaluation of metabolic effects by enzymatic analysis. R. Tudisco et al. Animal Science, 82: 193-199, 2006; Fate of genetically modified maize DNA in the oral cavity and rumen of sheep. Duggan P.S. et al. Br J Nutr., 89: 159-166, 2003; A three-year longitudinal study on the effects of a diet containing genetically modified Bt176 maize on the health status and performance of sheep. Trabalza-Marinucci M. et al. Livestock Science, 113: 178-190, 2008.
  3. Quoted by Jeffrey M. Smith in FDA-Sanctioned Genetically Engineered Foods, WellBeing Journal, 2009, accessed 8 July 2009
  4. Jill Richardson, Obama White House Appoints Former Monsanto Lobbyist to FDA, Daily Kos, 8 July 2009, accessed 8 July 2009
  5. University Fellows, Resources for the Future website, accessed 8 July 2009
  6. Board of Directors, Resources for the Future website, accessed 8 July 2009
  7. Tom Philpott, [ http://www.grist.org/article/2009-07-08-monsanto-FDA-taylor/ Monsanto's man Taylor returns to FDA in food-czar role], GRIST, 8 July 2009, accessed 8 July 2009