1. First note that these subcommittees did not call any environmental, consumer
or organic groups to testify. It was simply a vehicle to get their pro-GE views
into the record and set EPA up to weaken the Plant Pesticide Rule.
2. Rep Ewing says "We must be sure that regulatory excess does not suffocate
biotech." As if.
3. EPA's Aidala said that EPA would be willing to adopt language proposed by
industry scientists - "plant-expressed protectants" instead of "plant
pesticides" for both the crops and their Rule. So much for the much-touted
government principle of "transparency". This is clearly a way to hide from
the public what EPA is doing.
4. EPA is going to put out a formal notice to change the name of the Rule.
Perhaps we should come up with our own term and make it stick, like Terminator
did. How about Frankenfood Rule, or Pesticidal Foods Rule. In any event we
should comment en masse about this trick to euphemize and obscure the fact that
"foods" like Bt corn are genetically engineered.
5. Rep Brown said that EPA has "misnamed the plant pesticides as a way to
preserve EPA's jurisdiction." Aidala denies it. But it's true. The name
reflects the legitimate authority EPA has under FIFRA to regulate the
pesticides which are engineered into plants.
6. If anyone wants the reference for the "Coordinated Framework of
Biotechnology" published under the Reagan administration, it is Federal
Register Vol 50 No. 220 page 47174, Nov 14, 1985.
It should be noted that the Coordinated Framework, which divvied up
different GE products to different federal agencies, did not assign plants
engineered to produce industrial chemicals like plastics to anyone. Hence,
to this day they are not regulated. It didn't ensure that products which
might produce both health and environmental effects would get review for
both. Thus USDA reviews certain plants for weediness, but not for human
7. The paragraph in which EPA's Aidala grovels, beginning: "WE (emphasis mine)
have more market penetration..."is a pathetic demonstration of how far
environmental protection and public service have sunk.
8. Note that Dr. Kelman said members of CAST reached a "scientific"consensus
that regulation should ignore how GE crops are
made. It would appear that this consensus is based more on a concern for
grant funding than it is on the accumulating data which strongly indicates that
rDNA techniques introduce uncertainty into both the characteristics and
behavior of GEOs.
9. EPA's Aidala stated that EPA's approach to regulation of biotech is "process
neutral", but that is inaccurate. EPA has repeatedly stated that it considers
biopesticides including Bt corn to be "safer" pesticides than conventional
chemicals. These are placed on fast track for regulatory approval.
--- March 25, 1999 Pesticide Toxic Chemical News
House Ag subcommittees question EPA's authority to regulate biotech plants as pesticides
by Kathleen Hart
Members of congress reviewing the Environmental Protection Agency's proposed Plant Pesticide Regulation this week called into question the agency's authority to regulate as pesticides plants that have been genetically engineered to resist insect pests.
During a March 24 hearing, Rep. Thomas Ewing (R-Ill), chairman of the House Agriculture subcommittee on Risk Management, Research and Specialty Crops, asked EPA to re-open the comment period on the five-year-old proposed rule and conduct a cost-benefit analysis of the regulatory burden to the agricultural biotechnology industry. "We must be sure that regulatory excess does not suffocate"the biotech industry, he said.
James Aidala, EPA associate assistant administrator for Prevention, Pesticides and Toxic Substances, did not immediately agree to re-open the comment period, but said the agency would consider the need to do so. He said the agency would like to have the rule finished by the end of the year. In the past few months, the agency has been "making progress toward reaching a consensus"with industry groups over the kinds of plants and biopesticides that would be immediately exempt from regulation under the proposed rule.
EPA's use of the phrase "plant pesticides" to describe plants genetically engineered to express traits that enhance resistance to pests has long rankled many scientists and members of the food industry. Aidala said EPA would be willing to adopt language proposed by industry scientists - "plant-expressed protectants" - instead of "plant pesticides" to describe both the rule and the biotech products covered under the rule.
Industry representatives and scientists agreed to the new terminology at a March 16 meeting sponsored by the Council for Agricultural Science and Technology (CAST), Arthur Kelman, speaking on behalf of CAST, said at the hearing. Aidala said EPA would put out a notice to formally change the name of the rule to the plant-expressed protectants regulation.
Ewing and other congressmen pressed Aidala to justify EPA's authority to regulate biotech plants. Aidala responded that the "plain language" of the Federal Insecticide, Fungicide and Rodenticide Act clearly give the agency jurisdiction over plants intended for use as pesticides. "FIFRA section 2 defines 'pesticide' to include any substance or mixture of substances indented for preventing, destroying, repelling or mitigating and pest," Aidala said.
Rep. George Brown (D-Calif.), who described himself as generally friendly toward EPA policies, also raised questions about the fundamental basis for the agency's regulation of plants and plant substances as "pesticides" under the FIFRA. "I'm concerned that what we have here is a semantic problem," said Brown. "Scientific communities seem to think you've misnamed these plant protectants to preserve your jurisdiction."
Ewing argued that by regulating biotech plants that resist pests in the same way as chemical pesticides are regulated "we could be creating a new Delaney Clause here, where you've taken that wording out of context." Aidala responded that the agency had "no intention of doing that." But he acknowledged the definition of pesticides, passed in 1947, is broad.
Ewing at one point suggested that it would have been better for Congress to have created a new law to deal with regulation of biotechnology products, rather than "expanding" the definition of pesticides as EPA has. Aidala noted that many countries, including those in the European Union, that have approached biotechnology by writing entirely new laws, have run into difficulties.
In fact, Congress made a conscious decision in the 1980s not to regulate the products of agricultural biotechnology, because the current laws seemed broad enough to cover them, Brown noted. In 1986 the Reagan administration published the "Coordinated Framework of Biotechnology," that allowed federal agencies to promulgate new regulations under existing laws, as necessary to handle novel products. The framework anticipated that pesticides made through techniques of biotechnology would be regulated by EPA, plant pests would be regulated by the U.S. Department of Agriculture, and foods derived from novel plant varieties by the Food and Drug Administration. The largest commercial biotech plants regulated as pesticides by EPA to date include crops genetically engineered to express the toxin <I>Bacillus thuringiensis</I> - Bt-corn, Bt-cotton, Bt-potatoes and others.
"We have more market penetration and are getting ahead of the game compared to a lot of other countries," Aidala said. "Those plant pesticides that have been registered have been enthusiastically embraced by growers, and have been a boon for the biotechnology industry. Since their production in 1995, the adoption of these products has increased significantly each year. Sales were estimated to reach the $9 million mark for 1998 and are predicted to reach $20 million in 1999."
The 15-member EU has been slow to approve genetically engineered plants, and some member nations have separately banned genetically modified (GM) crops which had gained EU approval. Responding to consumer objections to GM crops, several major grocery store chains in the United Kingdom and France have pledged to stock non-GM foods and have sought suppliers of conventional corn and soybeans for their products. Despite the strong opposition to genetically engineered crops in Europe - and problems U.S. growers face finding markets for their biotech corn and soybeans, none of the House Ag members at the hearing questioned the exuberance of the biotech industry over the future of the technology for American agriculture.
Rep Bob Goodlatte (R-VA.), chairman of the Agriculture subcommittee on Department Operations, Oversight, Nutrition and Forestry, suggested that EPA's approach to regulation will slow down the development of new pest-resistant crops. "In Washington, no good deed goes unpunished," he said. "We're creating a $50 solution to what might be a $5 problem."
Aidala said EPA believes biotechnology is a "win-win" technology that "holds tremendous promise. "However, he said the broad acceptance of GM food in the United States - in contrast to the widespread skepticism about GM food in the EU - is based on consumer confidence in the regulatory agencies in this country.
Gene transfers from animals, other plants need review.
To maintain public trust - and protect public health and the environment - EPA needs to continue to review plants genetically engineered for novel pest-resistance traits, particularly when those traits result in the introduction of genes from animals, bacteria and other plants, Aidala told the subcommittees.
Genes transferred from one kind of potato to another, for instance, would require no review under the proposed rule. But genes transferred from a potato plant to spinach, would trigger a review, because of potential health risks. Potato leaves contain a compound which causes birth defects in people, he explained. No one eats potato leaves, so it is not a health problem. But if that trait were to be transferred to spinach, the leaves of which people do eat, a potential health problem could arise.
Kelman said members of CAST reached a scientific consensus that the guiding principle in regulation has to be the outcome, not in the way in which the breeding was done. Pest-resistant plants produced by genetic engineering "are, in general, indistinguishable in behavior and appearance from plants bred by conventional methods, "he said. "However, the latter types of plants are exempted from the EPA regulations although they may be highly resistant and may in fact have several pesticidal compounds that can be identified."
Aidala repeatedly stated that EPA's approach to regulation is "process neutral". Under EPA's 1994 proposed rule, exemptions from agency review are based only on the characteristics of the plant and "the probability of exposure to unknown toxicological profiles, "he said.
Kelman said CAST members believe a review by EPA is warranted when genetic modifications "involve substances with known or suspected potential pesticidal effects "or substances "otherwise of a character to be considered pesticides, such that, when extracted from a producer organism and tested <I>in vitro</I> or in the environment in some purified or semipurified form, "they act as pesticides. Examples include: pyrethrum, neem, rotenone, nicotine, scorpion toxin, spider venom, and crystalline Bt endotoxin."
In addition to Aidala and Kelman, the two House Agriculture subcommittees heard testimony from Joseph Panetta, vice president, Mycogen Corp., speaking on behalf of the American Crop Protection Association and the Biotechnology Industry Organization, and James Cook, professor of plant pathology at Washington State University, Pullman, on behalf of the Institute for Food Technology.
The subcommittees did not call any representative of environmental, consumer or organic grower groups to testify.
Subject: more on that Congressional hearing Date: Fri, 2 Apr 1999 19:17:44 -0700
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