U.S. to mull changes to oversight of biotech crops (14/7/2007)

1.U.S. to mull changes to oversight of GM crops
2.Comments from L. Val Giddings

For the draft Environmental Impact Statement (EIS) see http://www.aphis.usda.gov/newsroom/content/2007/07/content/printable/complet e_eis.pdf

For the USDA press release see http://www.aphis.usda.gov/newsroom/content/2007/07/drafteis.shtml

And for an USDA fact sheet with background see http://www.aphis.usda.gov/publications/biotechnology/content/printable_version/fs_programmatic_eis.pdf.

NOTE: The comments in item 2 come from a former Vice President of BIO, as well as President of PrometheusAB "Advanced Expertise in US and Global Biotechnology", and were posted on the pro-GM AgBioView list.


1.U.S. to mull changes to oversight of biotech crops
Christopher Doering Reuters, July 12 2007

WASHINGTON - U.S. oversight of genetically modified crops, which critics charge is insufficient, may be overhauled following a series of proposed changes released on Thursday by the Agriculture Department.

Cindy Smith, associate administrator with USDA's Animal and Plant Health Inspection Service, said any revisions it makes to its existing framework would be "the first comprehensive review of our regulatory structure" for genetically engineered crops.

One change USDA is considering would abandon the existing two-tiered permit system in favor of a multilevel one.

The new system would provide more stringent review for plants with which USDA is less familiar, or those that may pose an increased risk, such as plants that produce substances not intended for food use. Those engineered for herbicide tolerance or insect resistance would be less complicated.

The proposed changes would "expand our regulatory oversight while at the same time minimizing our regulatory burden for those (genetically engineered) organisms that have been safety field tested for more than 20 years," said Rebecca Bech, an acting deputy administrator at APHIS.

USDA is also considering expanding its oversight to include organisms that have the potential to become noxious weeds. This would increase review of genetically engineered organisms that may damage crops to include plants that pose a broader risk to agriculture, the environment and public health.

The draft environmental impact statement, which evaluates potential revisions to existing regulations, will be open to public comment for 60 days starting on Friday.

The draft, public comments and further scientific information will be used to create a proposed rule. USDA first announced in 2004 it was beginning a review of its biotech regulations.


Consumer groups, environmentalists and organic farmers oppose biotech crops, which they fear could mix with other crops or develop super weeds resistant to herbicides.

Currently, USDA no longer has oversight of a plant once it is deregulated and determined to be safe.

"We're exploring whether a different type of system might be applicable," said John Turner, another biotechnology official at APHIS.

"You might envision a system where certain things would be unconditionally approved ... whereas others might be approved with conditions," he said.

A string of court cases has criticized USDA oversight. In May, U.S. District Judge Charles Breyer upheld a ban on the planting of a genetically modified alfalfa crop variety developed by Monsanto Co. until government studies on its environmental effects were concluded.

The judge found in a preliminary injunction that U.S. regulators had not properly examined the effects of the alfalfa before allowing it to be commercialized.

A separate ruling in February by a District of Columbia judge found "substantial evidence that the field tests may have had the potential to affect significantly the quality of the human environment."


2.USDA/APHIS' Long-Awaited Programmatic EIS on Biotech is Out
- L. Val Giddings, Ph.D., PrometheusAB, Inc.,
[email protected]

The long awaited draft environmental impact statement prepared by APHIS in support of their intention to revise USDA's biotech regulations is now available for public review and comment. The comment period ends on 11 September, 2007. This is a significant development. The proposals in the draft will no doubt fall short of what would satisfy those who think that regulation should be proportional to risk (hazard X exposure) and without regard to process. But even if implemented directly as proposed the changes contemplated in the EIS would bring some benefits -- more flexibility for APHIS in dealing with newer developments, such as multi-year permits for plants modified to produce pharmaceutical or industrial compounds, and a multi-tiered permit system which would (in theory) more closely match the degree of oversight and permit conditions to the level of risk posed by the particular plants subject to the permits. APHIS is also considering expansion of its regulatory oversight in a number of areas as well.

It is certain, however, that activist groups adept at distorting science and fomenting fear for ulterior motives will use the comment period and opportunity to inundate APHIS with demands for much more stringent regulation. It is to be hoped that those who understand these technologies best -- the industrial and academic communities developing new applications of biotechnology for agriculture, the agricultural producers and allied groups who grow biotech improved crops, and their customers in the food manufacturing and retail industries, will provide reasoned and rational input to help guide APHIS in their consideration of the alternatives...


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