Proposed GE regulations are inadequate

November 24, 2008

Regulatory Analysis and Development
PPD, APHIS, Station 3A-0.38
4700 River Road, Unit 118
Riverdale, MD 20737-1238

Re: Docket # APHIS-2008-0023, Importation, Interstate Movement, and Release into the Environment of Certain Genetically Engineered Organisms


As a grocery retailer with more than $135 million in annual sales, I’m writing on behalf of our 45,000 members/owners to say we appreciate the United States Department of Agriculture’s (USDA) stated intent “to respond to emerging trends in biotechnology” and to “improve regulatory processes (for genetically engineered organisms) so they’re more transparent to stakeholders and the public.” We believe, however, that the proposed changes actually would create a less transparent system with less accountability that makes our farmers, the food industry as a whole, and consumers more vulnerable than ever to potential dangers in our food supply.

It is wholly unacceptable that Sec. III E (2) would amend current regulations so that “a low level presence of GE plant materials in seeds or grains” would not necessarily trigger remedial action. “Case by case” determinations of what is or isn’t actionable are not sufficient since research increasingly shows that even current, commonly commercialized crops pose health risks (discussed later in this letter) to consumers or livestock. Zero contamination should be the standard and regulations must be rewritten for that to be the goal to strive for and achieve.

In Sec. III B (3), instead of saying industry only has “to effectively minimize the risks that may be associated with the environmental release of (plant made pharmaceutical and industrial, a.k.a. PMPI) GE plants,” the rules should be rewritten to say “industry must set zero contamination as a standard to strive for and achieve.” Sec. B (5) should be redrafted from “make it unlikely that the permitted activity will result in the introduction and dissemination …” to “ensure that the permitted activity will not result in the introduction and dissemination …”

Sec. III B 5 “Permit Conditions” also must add a requirement that permit applicants must post bond and carry liability insurance as an additional “performance standard.” It is not acceptable that farmers, the food industry, and consumers bear the risks and costs of unwanted contamination caused by private industry. Just like other professionals, the biotech industry must be required as a condition of the permit process to accept the risks of its practices, especially when others may be harmed.

Section 340.7 (e) (iv) (2) “Compliance, enforcement, and remedial action” also should include a mandatory measure requiring developers to post bond and carry liability insurance. The proposed regulations outline only “possible consequences” of “failure to comply” with the regulations; they do not but should stipulate mandatory bond and adequate insurance to cover costs from any unwanted contamination of other nearby crops. Liability must not be shifted to taxpayers or the food industry.

As a member of the food industry, we are acutely aware that in 2002, ProdiGene failed to keep pharmaceutical corn out of warehoused soybeans enroute to become infant formula and veggie burgers; USDA fined Prodigene and ordered 500,000 bushels of contaminated soy to be destroyed, but because ProdiGene didn’t have the capital to remediate violations, it got a low-interest loan from USDA (i.e., taxpayers) to pay up. Years later, USDA still granted Prodigene permits to conduct experimental biopharmaceutical and chemical crop trials. Section 340.7 should stipulate mandatory denials of future permits to such companies.

In Sec. IV A, research clearly contradicts the statement “We have not seen evidence suggesting that these types (PMPI) of organisms present unique or uncontrollable risks, or risks higher than those that may be associated with many other uses for GE plants.” That is demonstrably untrue and it’s difficult not to conclude that USDA simply is not looking at the evidence.

It’s known that a growth and development factor produced by Amgen in cell cultures was discontinued in human trials when some patients’ immune systems attacked both the drug and their own natural growth factor. In another case, use of a recombinant hormone that stimulates red blood cell production was linked to 160 cases of aplasia, where red cell production virtually shut down.

Such immune reactions were a surprise — to the industry and regulators. Dr. Burt Adelman, head of research and development at Biogen, reportedly said, “The conventional wisdom had been that this was a theoretical risk … nobody saw it coming.” He is quoted as calling the immune reactions “stunning.”

The point is that the human immune system can detect differences that science today cannot discern. These differences can provoke a range of immune system reactions, including poorly understood autoimmune disorders. Lactoferrin and lysozyme — two compounds produced by PMPI GE barley grown in experimental Washington state fields — are reportedly linked specifically to ulcerative colitis, Crohn’s disease, vasculitis, lupus and rheumatoid arthritis.

Scientists from the Center for Food Safety and Consumers Union also note that pharmaceutical lactoferrin expressed by PMPI GE rice shares significant similarities with two known human allergens that cause gonorrhea, meningitis, whooping cough, legionnaire’s disease, stomach ulcers and certain stomach cancers.

Particularly worrisome is Section 340.2 outlining procedures for permits, saying permit applicants must provide information on the “intended uses of the GE organism.” The trouble is that there’s no required examination of the actual properties, so some unintended effects may escape regulation altogether.

For instance, because aprotinin corn was sold as a research chemical it escaped formal regulation. So even while it was being produced by GE corn and tobacco in open fields, conventional aprotonin (a blood clotting agent) was under FDA review for increasing the risk of life-threatening reactions, including kidney failure, heart attack and stroke (New England Journal of Medicine, Jan 26, 2006). Research hasn’t been done on whether ingestion, inhalation or skin contact from open field aprotonin corn would cause similar harm. Meanwhile, two other generic drugs are safer and cost one-tenth as much.

Studies also show that avidin-corn, which kills pests in storage, has been grown in open fields since 1993 and its developer has been allowed to market this avidin for years as a research chemical — even though avidin poses threats to health such as a vitamin B (biotin) deficiency that can cause birth defects, retarded growth and impaired immunity. (Journal of Nutrition 113 pp 2316-22, Journal of Nature 123 pp 2101-08, American Journal of Clinical Nutrition 67 pp 431-437).

Corn-grown trypsin, a digestive enzyme, also has been grown in open air fields and marketed, even though it can cause allergies, is a skin, eye and respiratory irritant, and may be a mutagen (Institute of Science in Society, May 2004).

These above considerations illustrate why provisions of Sec. III A.2, deleting the list of organisms which are or contain “plant pests,” would make the public more vulnerable. The list of plant pests codified under Sec. 340.2 covered almost all the genetic traits that companies use to modify crops. Under the proposed policy deleting this list, the USDA effectively would remove regulatory measures necessary for identifying many potential public health risks in or from the food supply. Removing the list would place many GE crops outside the bounds of regulation.

The proposed regulations also would continue to allow the very companies developing GM crops to submit just the summaries of their testing data, and would not require the data to be available for public scrutiny. This is not transparent, poses a conflict of interest, and could encourage developers to design studies that favor the desired outcome.

Recently, a study published in the Archives of Environmental Contamination and Toxicology reports that even Monsanto’s non-PMPI GE corn (MON 863) — authorized already for human and animal consumption in the U.S. — is toxic to the liver and kidneys of lab animals in feeding trials. Higher triglycerides and reduced excretion of phosphorus and sodium reportedly indicate hormonal disruptions. Since humans can be exposed at comparable levels, lead researcher Professor Gilles-Eric Seralini says no one can say this GE corn is safe or healthy.

A preliminary study from the Russian National Academy of Sciences recently found that more than half the offspring of mother rats fed GE soy died within three weeks (compared to 9 percent from mothers fed natural soy). The Center for Sustainable Agriculture reports that more than 10,000 sheep died within days after grazing on GE cotton plants expressing the Bt toxin — also already commercialized.

Only one human GM feeding study ever has been published and it showed foreign genes inserted into GE food crops can transfer into the DNA of human gut bacteria. This means that long after we stop eating GM corn chips, for instance, our intestines might continue to manufacture the “Bt” pesticide the GM corn plants are engineered to produce.

Surely the GE corn, soy and cotton should qualify as “noxious weeds” defined under Sec. III (3) G — that is, any plant that can “directly or indirectly injure or cause damage to … livestock, the public health …”

USDA’s dismissive attitude of such evidence is particularly troubling given that Sec. IV A would institutionalize further gene flow between PMPI and food grade crops. The proposed regulations say gene flow “can be minimized or substantially prevented” with genetic and phenotypic characteristics that “discourage survivability” of the PMPI plant away from the intended site. There is no evidence that the intended purpose of PMPI plants can be contained or controlled outside of controlled, closed vat systems in a laboratory setting.

In numerous places in Sections I, II, and III, APHIS says it wishes “to continue to ensure a high level of environmental protection,” that “the current program has been effective in ensuring the safe environmental release” of GMOs, that the proposed permitting procedure “can continue to effectively minimize the risks that may be associated with the environmental release” of GE plants, and that the proposed changes will continue to support “coexistence” in the U.S. agriculture These assumptions are demonstrably less than totally accurate.

The federal court system has confirmed that USDA’s current procedures have failed to abide by federal environmental law, for instance, in approving GE alfalfa — that GE alfalfa is a threat to farmers’ livelihoods and the environment since farmers who want to grow non-GE alfalfa cannot because GE traits contaminate their fields, effectively eliminating all other alfalfa. The federal courts also have confirmed that GE creeping bentgrass contaminated native grasses more than 12 miles away, including plants in a national grassland, despite USDA’s judgment that it would not. Contamination of food grade rice by experimental GE rice expressing human genes for experimental pharmaceuticals is a third example of inadequate regulations.

Even the USDA’s own auditor, the Office of the Inspector General (OIG), has sharply criticized current regulations, finding that USDA has failed to inspect pharmaceutical GE crop fields as promised, and to document inspections properly. If companies and the USDA have been so lax with small plots of crops, it’s hard to imagine how they might manage the larger-scale productions that the proposed changes suggest.

It is difficult to avoid concluding that the USDA sympathizes with an industry view, voiced in 2002 by biotech consultant Don Westfall to the Toronto Star, that “The hope of the industry is that over time the market is so flooded that there’s nothing you can do about it, you just sort of surrender.”

Using self-pollinating crops or varieties that flower separately doesn’t mean they can’t contaminate other crops. Soybeans are self-pollinating yet GE traits have been found in at least 50 percent and as much as 83 percent of the traditional non-GE soybean seeds bought by farmers.

Monsanto and Novartis admitted years ago that it’s practically impossible to prevent genetically modified pollen from spreading to where it’s not wanted. (Reuters, “Spanish shippers say hard to segregate GM foods,” David Brough, June 14, 1999)

Again, ProdiGene’s failure in 2002 to keep its pharmaceutical corn out of warehoused soybeans enroute to become infant formula and veggie burgers is just one example. In 2005, Syngenta admitted to selling farmers hundreds of tons of corn engineered with a gene conveying antibiotic resistance from 2001 to 2004, even though it wasn’t approved for human consumption. Syngenta won’t say where in the U.S. the corn was grown, only that it covered 37,000 acres in four states. In 2006, Bayer CropScience learned that its experimental GE rice was contaminating the food chain, including baby food. Bayer didn’t notify the government until July 31 and then government waited another 18 days before informing the public.

Deliberate theft complicates the risks. Chris Webster of Pfizer Inc. reportedly said at an industry conference, “You may have tens, hundreds or even thousands of acres growing these plants and what’s really to prevent strange people coming in and taking them away and growing them somewhere else?… We’ve seen it on the vaccine side,” he is quoted as saying, “where modified live seeds have wandered off and have appeared in other products.” (“Plant-Derived Biologics Meeting” transcript, April 5 & 6, 2000., p. 77)

USDA would better serve our food security and the food industry — including grocers, such as PCC Natural Markets — by adopting the following measures as the basis of the regulatory framework:

  1. GE crops producing pharmaceutical and industrial chemicals should not be allowed in open-air fields. Developers of such crops should follow the lead of Dow AgroScience, which has received approval of a plant-made drug — a vaccine for chickens produced by tobacco cell cultures in a contained steel tank. Controlled laboratory conditions are a proven way to generate pharmaceuticals, without the risk of untested drugs in our food.

    More than 100 genetically engineered pharmaceuticals produced through traditional, controlled and contained cell cultures or fermentation vats already are helping people in need, although unexpected problems have arisen with these compounds as well. Growing pharmaceuticals and industrial chemicals in food crops is not necessary.
  2. All GE food crop permit applications should trigger mandatory reviews by the Food and Drug Administration (FDA). Sec.IV A “Required Analyses” should be rewritten to acknowledge not only that FDA has “authority” over the food safety aspects but that FDA must be involved in all permit application reviews from the start and must review the actual crop properties, not just their intended use. USDA should not be the agency to “evaluate whether there are any signs that the environmental release … could present risks to the public health.” Since USDA acknowledges FDA’s authority over food safety, it should be FDA’s role to determine potential health risks.
  3. USDA must allocate much more than the current pittance to risk assessment. APHIS rarely conducts an environmental assessment for PMPI plants. The few risk assessments that have been done led to cancellations of the permits. This is significant.

    What little safety data we have comes from corporations seeking approval to market their products and when a company conducts or pays for the research, the results tend to echo what the company wants to hear. Scientists say the studies often are not well designed or peer reviewed and the data is low quality. Experts report that the experiments designed to look for harmful side effects typically include only three or four samples per test. This is analogous to including only three or four people per treatment when looking for side effects of a drug. No one would trust such a weak study when considering approval of a new drug.
  4. The proposed regulations still assume that it’s acceptable for developers of genetically modified organisms (GMOs) to provide — voluntarily, no less — mere summaries of their data to demonstrate safety. A truly transparent system would require all the data be made available from the start not only to USDA but also to independent public health and environmental experts, and the food industry.

    It also is not acceptable for USDA to approve any permit applications to grow GE crops outdoors without a formal environmental impact statement IEIS). An EIS requirement — supported by federal court rulings — must be written into the regulations, into Sections III B (1), III B (5), and 340.2.
  5. Full environmental EIS on all proposed GE food crop permit applications — before approval.
  6. No state or local laws or regulations should be preempted by the federal rules.

Overall, farmers, retailers, processors and consumers will be more vulnerable than ever in the proposed regulatory framework. As drafted, these regulations would accommodate — virtually unquestioned — the experimentations of private industry.

Any potential profits still would be privatized while the risks and costs of contamination from GE crops grown outdoors are externalized to the food industry, consumers and taxpayers.

The proposed changes are wholly inadequate by starting from a disproven assumption that whatever the biotechnology industry wants to do is good for the common welfare and our food security.

On behalf of our 45,000 member households/consumer owners, our 1,000 employees, and the health of our business as a whole, I urge you to reject them and begin the process of requiring mandatory safety tests, risk assessments, EIS, and liability insurance to tighten these woefully inadequate standards.


Trudy Bialic
Director, Public Affairs
PCC Natural Markets
Seattle, Wash.

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Letter to the USDA to oppose the deregulation of genetically modified (GM) papaya trees on the U.S. mainland.

No need for Roundup Ready GE alfalfa

Letter to the USDA detailing the flawed assumptions, judgments and conclusions of its draft Environmental Impact Statement (EIS).