Hello,

As you may have heard, the EPA has now released its "Plant Introduced Protectant Rule" and will accept public comment within the next 30 days.

Please, please, read it and comment, and ask others to do so as well.

Information about the Rule, as well as the Rule itself can be found through:

http://www.epa.gov/scipoly/new.htm

A lot has happened since this Rule was proposed - seven long years ago: the public has started to become aware that much of their food is GE; over 500,000 signatures demanding labeling of GE food were delivered to the President, Congressionals, EPA, FDA and USDA; there have been grass roots protests about the effects of GE crops on farm communities, the disadvantaged, and consumer rights; numerous polls have shown that Americans want GE food labeled; the EPA Science Advisory Panel has confirmed that Bt will quickly become obsolete, that the organic farming sector will suffer and that there is no way to be sure a novel protein will not be allergenic when introduced into the food supply. The public sent USDA over 300,000 comments making it clear they want GE crops excluded from organic foods. There have been numerous reports of environmental problems (Monarch toxicity, leakage of Bt into the soil, uptake of transgenes by gut bacteria in bees, genetic contamination of non-GE crops) which indicate that EPA's risk analysis is largely post hoc admission of adverse impacts; American farmers have lost a large chunk of their foreign markets, and the StarLink fiasco exposed the fact that EPA's Rube Goldberg "regulation" of GE plant pesticides has in effect transferred federal regulatory responsibilities to the registrant and that, once released a GE crop spreads uncontrolled through the food supply with no hope of recall.

If this agency were to carry out its responsibilities to offer the public a meaningful opportunity to comment, the whole Rule would have to be reopened for comment. As is, this Rule is promulgated - made final - with several exceptions to which comment is still permitted. That violates the intent if not the provisions of the Administrative Procedures Act

Secondly, the version released by the Bush/Whitman EPA, is likely similar to that briefly released by the Clinton/Browner EPA in January, and if so, that means there is a significant change from when the Rule was last seen in 1994: back then the "plant pesticide" under the law was defined as all the insecticidal transgenic proteins and all the transgenes necessary for their production. Now, the definition of "plant introduced protectant" is limited to the transgenic protein with insecticial activity. This is a clever way to prevent the biotech industry from any future StarLink type liabilities: current assays for protein are much less sensitive than those for genes. Lots of foods which could be shown to contain transgenes would not be considered to contain or be derived from a GE crop because - voila! - the transgenes are not "the pesticide". If such a Rule had been in place when FOE identified StarLink genes in the taco shells, there would have been, legally, no contamination, there would have been no embargo of Starlink, and Aventis would not have had to shell out millions to keep StarLink out of the American food supply.

It is critical that scientists register their thoughts about EPA's assumption that there is enough evidence to demonstrate that transgenes and non-pesticidal transgenic proteins in GE crops present no human health or environmental risks. It is also critical that comment be made about the alleged pesticide reduction and crop yield "benefits" of GE crops. EPA uses these "benefits" to discount the known and potential adverse effects.

Comments on toxicity assessment of GE crops are in order. To establish tolerances in/on food, EPA tests toxicity of transgenic proteins with only a single rodent acute feeding test, done at high doses. If no toxicity is found at high doses, EPA assumes that there can be no chronic toxicity at low doses in the food supply, despite known examples of exceptions for other proteins, and innumerable examples with conventional chemical pesticides. Despite authority to require chronic feeding studies, EPA has used this single assay to pronounce the protein "non-toxic" and grant exemptions for the requirement for a tolerance for the transgenic insecticidal protein in GE crops. This means any amount of the transgenic protein is allowed in the crop (likely manufacturers cannot control trangenic protein levels). Curiously, EPA does not consider potential allergenicity in its dietary tolerance analysis, even though allergenic reactions from novel dietary proteins cannot be ruled out. If it did consider allergenicity, it would have to either identify a safe level (a tolerance), or deny the registration. As the Science Advisory Panel just told EPA, there is no way to identify a safe level of a potential dietary allergen. Thus trangenic proteins are declared "non-toxic" and GE crops can be registered.

The 1996 Food Quality Protection Act specifically requires EPA to set tolerances to pesticides in/on crops with childrens' sensitivities in mind. The method required is to reduce the tolerance set for adults by a factor of 10 unless there are data to the contrary. Despite this legal requirement, despite the fact that children are known to be sensitive to allergenicity, and despite the fact that there is no way to identify a safe level of potential allergen, EPA allows any amount of transgenic protein in GE crops when it grants an exemption from the requirement for a tolerance. Apparently EPA has had to find a way around the FQPA requirements in order to grant these registrations.

The real kicker is that this Rule is not enforceable!

With conventional pesticides, farmers - the end users - read legally enforceable instructions in the label on the can of pesticide. If they fail to follow the instructions, EPA and through delegation, state agencies, can and do take legal action against them. This makes sure that the pesticides are used as intended, and a whole framework of applicator instruction, inspectors and state and federal legal teams keep this system working. All of that is thrown out with "plant introduced protectants." Here, farmers get no legally enforceable label, the manufacturer is supposed to make sure they get an "instruction sheet". It is the manufacturer - in New Jersey or Missouri or Michigan which holds the enforceable label. if a farmer in Iowa fails to follow instructions, no state or local EPA office can take action against them (not surprisingly, neither EPA nor states' labs have any way to even identify GE crops). What happens is the manufacturer is supposed to enforce "grower agreements". So, Monsanto or DuPont of Dow is supposed to go out into the Iowa and Illinois and Florida and Ohio fields and check to make sure farmers are following the instructions - planting their Bt refugia, for example. As StarLink demonstrated so clearly, this system was broken from the start. It's a built-in conflict of interest for the registrant, to whom federal regulatory responsibilities have been transferred. When there is a problem, EPA is supposed to enforce against the registrant. We shall see further how well this system works when we see what type of penalties are levied against Aventis for their failure to hand out and enforce "grower agreements" designed to keep StarLink out of the human food supply.

There is more: comments are actually solicited on exemptions to the Rule. Take a look.