The following is a speech given by Organic Consumers Association political director Alexis Baden-Mayer at a protest demanding the resignation of Michael Taylor, former Monsanto lawyer, current Obama Food Safety Czar. For a video of the action, please click here. For more photos, please click here. TAKE ACTION: Sign the petition telling Obama to cease FDA ties to Monsanto.
Michael Taylor must resign.
It is a terrible scam on the American people that the man responsible for one of the biggest food safety loopholes in the history of Food & Drug Administration regulation is our so-called Food Safety Czar.
Michael Taylor, a lawyer who lobbied regulators on behalf of Monsanto before and after working as a regulator at the FDA, is responsible for the legal fiction -- and the official US regulatory policy -- that, if genetically engineered food is substantially equivalent to normal food in composition, there is no need to safety test or label it. This is the loophole that has prevented regulators and government scientists from investigating the truth about the harms of genetic engineering. This loophole has made it impossible for government regulators to reject new GMOs, and it that has made sure consumers don't know what they're eating. Today, even with almost all processed foods containing genetically engineered ingredients (made from corn, soy, cotton, canola, alfalfa, or sugar beets, or milk, meat or eggs from animals given GMO feed or growth hormones), only one quarter of the public believes that they've ever eaten GMOs.
Michael Taylor created this loophole to force the first genetically modified organism (GMO) into our food supply.
The FDA policy Michael Taylor created to get Monsanto's genetically engineered bovine growth hormone approved -- still the policy for approving GMOs to this day -- allowed Monsanto to escape an independent review of their product's safety. Instead, Monsanto was asked to submit its own data on whether milk made with GMO growth hormone was substantially equivalent in composition to normal milk.
Monsanto had trouble even stepping over this very low hurdle. Monsanto's own data showed that the GMO milk was different. Michael Taylor and FDA scientists who had also worked for Monsanto did their best to suppress the evidence, and the FDA took an official position that the Monsanto milk was similar enough to normal milk to avoid safety testing and labeling. However, the FDA record of Monsanto data to the contrary was preserved and in 2010, a federal appeals court found:
- a compositional difference does exist between milk from untreated cows and conventional milk ... the use of rbST in milk production has been shown to elevate the levels of insulin-like growth factor 1 (IGF-1), a naturally-occurring hormone that in high levels is linked to several types of cancers, among other things. ... rbST use induces an unnatural period of milk production during a cow's "negative energy phase." According to these studies, milk produced during this stage is considered to be low quality due to its increased fat content and its decreased level of proteins. ... milk from treated cows contains higher somatic cell counts, which makes the milk turn sour more quickly and is another indicator of poor milk quality.
Michael Taylor had gone directly from working for Monsanto to, as an FDA regulator, implementing a radical new regulatory framework that clearly benefited his former client. Someone had to cry foul. Luckily, a few members of Congress were paying attention and they called for the Government Accountability Office to conduct an ethics investigation into Michael Taylor's actions at the FDA.
The investigation found that ethics rules had been violated 11 times, but that "there were no conflicting financial interests." The assumption that Michael Taylor wouldn't benefit financially proved to be short-sighted.
During the investigation, the Clinton Administration tried to put down the scandal by transferring Taylor to the USDA. This, incidentally, is the way Michael Taylor got his first real food safety, as opposed to regulatory policy, job. At the FDA he was Deputy Commissioner for Policy, while at the USDA he became Administrator of the Food Safety & Inspection Service, a position he clearly was not qualified for, as a lawyer with no training or experience in public health or science. Nevertheless, with that placement, he began to be referred to, however erroneously, as "a nationally recognized food safety expert" and on that basis he was given posts as a research professor in the academic community and placed on several National Academy of Sciences expert committees studying food-related issues.
Just four years after being removed from his post at the FDA in shame, he was back making money at Monsanto as Vice President for Public Policy from 1998 to 2001.
In 2000, a lawsuit filed on behalf of nine university scientists and 12 religious leaders by Steven Druker, the Alliance for Bio-Integrity, and the International Center for Technology Assessment delved deeper into how controversial Michael Taylor's pro-Monsanto policy was with scientists and FDA employees who weren't political appointees. According to a Salon.com report:
- As part of the lawsuit, the FDA was required to turn over to Druker some 44,000 internal documents. These include memos from agency scientists criticizing the FDA's developing policy on GM foods.
- The policy, which was published in the Federal Register in May 1992, is regarded even by the FDA's own scientists as an industry cheat sheet: "The initial intent of the document was to present scientific considerations and to avoid telling industry what tests to run and how to go about doing it," said Louis J. Pribyl, an FDA microbiologist in a February 1992 memo.
- Yet a major part of this policy is a flowchart that effectively tells a company not only what to test in a crop but what results will be needed for the product to be considered safe. By including the flowcharts and telling the companies what to test and what results to get to meet safety standards and by listing all the tests and the answers, Pribyl felt that the FDA made it possible for companies to tailor their tests to get the results they would need. ...
- ... in previously undisclosed FDA memos, at least 10 of the 17 scientists who took part in shaping the Federal Register document along with other FDA researchers invited to comment -- including head scientists from the agency's Division of Food Chemistry and Toxicology, Center for Veterinary Medicine, Biological and Organic Chemistry Section -- cast serious doubts on the scientific evidence for this assumption.
- As Linda Kahl, an FDA compliance officer, noted in a memo dated Jan. 8, 1992, the FDA's approach to writing the policy was the equivalent of "putting a square peg in a round hole -- are we asking the scientific experts to generate the basis for this policy statement in the absence of any data? It is an exercise in hypotheses forced on individuals whose jobs and training ordinarily deal with facts."
- Even the FDA official with approval authority over the policy, Biotechnology Coordinator James Maryanski, raised questions about the agency's assumptions. In a letter to a Canadian government official dated Oct. 23, 1991, Maryanski acknowledged that there was no scientific consensus about the safety of GM foods. He also admitted that the potential for genetic engineering to introduce new compounds into foods that could trigger allergic reactions "is particularly difficult to predict."
The FDA is not regulating GE foods at all.
The FDA's politically appointed bureaucrats did not follow the
advice and warnings of the agency's scientific staff about GE foods
but disregarded them.
- There is currently significant disagreement among scientific experts about the safety of GE foods.
- Further, the judge avoided the issue of whether adequate safety testing has been done and failed to make a determination that GE foods have been demonstrated to be safe -- even though such a determination is legally required in order for these foods to be on the market.
- Despite the above findings, the judge upheld the FDA's policy on narrow, technical grounds. As plaintiffs, our burden was to demonstrate that the FDA administrators had abused their discretion by acting arbitrarily and capriciously in adopting the presumption that GE foods are generally recognized as safe (GRAS). This was the key issue: whether the administrators had acted arbitrarily in presuming that GE foods are GRAS, not whether these foods actually are. Ultimately, the judge held that there was some rational basis for the FDA's presumption and that its policy could therefore be upheld.
Monsanto's milk may cause obesity and premature puberty in very young girls:
According to Pediatrics:
- the accelerated growth of obese children results from the increased bioavailability of IgF-1. Low growth hormone concentrations can probably be explained by a suppressive effect of free IgF-1 at the level of the pituitary-hypothalamus. Obesity in females leads to an early onset of puberty.
- before milk can be eliminated as an environmental determinant in human puberty, much more needs to be known about the potential for its various growth factors to cross the gut wall and interact with human receptor sites. While rBGH itself does not find its way into cow's milk, cows so treated do produce higher levels of insulin-like growth factor-1 (IGF-1). Identical in structure to human IGF-1, bovine IGF-1 does enter milk. Its ability to cross the human gut and enter circulation, however, is an unresolved question. If IGF-1 exists only as free protein in the whey fraction of milk, it should be fully digested in the human gut. Controversial evidence, however, shows that some IGF-1 may bind to casein (the curds in milk out of which cheese is made), and thereby escape digestion and enter the bloodstream. In this way, dairy consumption could potentially elevate IGF-1 levels in humans (Oransky, 2007). However, variability in IGF-1 levels among individuals is considerable, and no one knows what percent of that variability is accounted for by IGF-1 increases in rBGH-treated cows.
- The need to understand more about the influence of milk on IGF-1 levels is underscored by new studies that have documented regulatory interactions between IGF-1 and estrogens. More specifically, neuroendocrinologists have found evidence for cross-talk between IGF-1 receptors and estrogen receptor sites in the brain. Indeed, IGF-1 appears to be a key part of the mechanism for estradiol signaling and is required for the priming actions of estradiol on signaling and is required for the priming actions of estradiol on the HPG axis (Etgen, 2006; Mendez, 2006; Scharfman, 2006). And, as described above, emerging evidence suggests that IGF-1 all by itself plays a role in regulating pubertal onset; certainly GnRH neurons express receptors for IGF-1 (Daftary and Gore, 2005).
- The continued discovery of new mechanisms for sex hormone regulation gives reason for precaution about exposure to excess levels of animal hormones and growth hormones.
The excessive use of antibiotics causes two related problems, an increase in deadly pathogens like E. coli and a decrease in the effectiveness in antibiotics typically used to treat such infections. According to the National Institute of Allergies and Infectious Diseases:
- Approximately 2 million patients in the United States acquire an infection as a result of receiving health care in a hospital, and overall 70 percent of the bacteria causing such infections are resistant to at least one of the drugs most commonly used to treat these infections.
Faced with this massive, but reversible, public health crisis, the FDA has done absolutely nothing.
Last year, the Natural Resources Defense Council, Center for Science in the Public Interest (CSPI), Food Animal Concerns Trust (FACT), Public Citizen, and Union of Concerned Scientists (UCS) filed a lawsuit to force the Food and Drug Administration to act. The suit was successful and they issued this statement announcing last month's federal court ruling:
- "For over 35 years, FDA has sat idly on the sidelines largely letting the livestock industry police itself," said Avinash Kar, NRDC health attorney. "In that time, the overuse of antibiotics in healthy animals has skyrocketed -- contributing to the rise of antibiotic-resistant bacteria that endanger human health. Today, we take a long overdue step toward ensuring that we preserve these life-saving medicines for those who need them most -- people.
- "These drugs are intended to cure disease, not fatten pigs and chickens," Kar said.
In 1977, FDA concluded that feeding animals low doses of certain antibiotics used in human medicine, namely, penicillin and tetracyclines, could promote antibiotic-resistant bacteria capable of infecting people. Despite this conclusion and laws requiring that the agency move on its findings, FDA failed to take action on penicillin and tetracyclines to protect human health for the last 35 years.
- The court decision noted, "In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown."
- "This health threat has been hiding in the margins for four decades.
The rise of superbugs that we see now was predicted by FDA in the 70's,"
said NRDC attorney Jen Sorenson. "Thanks to the Court's order, drug
manufacturers will finally have to do what FDA should have made them do
35 years ago: prove that their drugs are safe for human health, or take
them off the market."
The ruling compels FDA to take action on its own safety findings by withdrawing approval for most non-therapeutic uses of penicillin and tetracyclines in animal feed, unless the industry can prove in public hearings that those drug uses are safe. The ruling also makes clear that future nonbinding guidance from FDA will not excuse the Agency from its obligation to hold hearings on whether to withdraw approval for antibiotics covered by the decision. ...
The Court noted the issue in its decision: "Research has shown that the use of antibiotics in livestock leads to the development of antibiotic-resistant bacteria that can be -- and has been -- transferred from animals to humans through direct contact, environmental exposure, and the consumption and handling of contaminated meat and poultry products."
"Judge Katz's decision is an important advance toward our goal of preserving the effectiveness of medically important antibiotics and not squandering them with reckless overuse on animal farms," said CSPI executive director Michael F. Jacobson. "Improving conditions for chickens, hogs, and cattle would help obviate the reason these drugs have been so over-administered in the first place."
In recent years, the American Academy of Pediatrics, the American Medical Association, the Infectious Diseases Society of America, the Centers for Disease Control and Prevention, the Institute of Medicine of the National Academy of Sciences, the United States Department of Agriculture (USDA), the World Health Organization and many other groups have identified the routine use of low-dose antibiotics for livestock growth promotion as a significant contributor to the rapid proliferation of antibiotic-resistant bacteria in both animals and humans.
"After decades of delay, the FDA will finally have to address this long-standing threat to the public," said Richard Wood, executive director for FACT. "This is a great victory for public health and a great chance to make American farms move in a more healthy direction."
Factory farms use 80 percent of the antibiotics in this country. That means factory farms produce 80% of the profits the pharmaceutical industry makes on antibiotics sales. Trust the antibiotics companies to give up their biggest revenue stream? Companies like Pfizer? Yeah, right.
Taylor's plan is clearly intended to fail. Not only is it bad policy, in the wake of the NRDC lawsuit, it's illegal. The ruling made clear that nonbinding guidance from FDA would not excuse the Agency from its obligation to hold hearings on whether to withdraw approval for antibiotics covered by the decision. Taylor's plan is a nonbinding guidance document. Taylor's illegal action is a cynical delay tactic, designed to protect the corporations while forcing the public interest groups to go back to court to win real FDA compliance.
President Obama, you're running for reelection. When you ran the first time, you made sure that the 90% of Americans who support labels on genetically engineered food knew you were on their side. It's hard for those of us who know you broke your campaign promise to give you a pass, but we can't imagine you wouldn't be ready to pander to such a large majority of voters a second time around. You can't seriously be thinking about keeping someone like Michael Taylor in your administration as we get closer to November, can you?
President Obama, you must drop Michael Taylor!