The Institute of Science in Society

ScienceISIS Press Releasese 22/12/04 http://www.i-sis.org.uk

The US Food and Drug Administration (FDA) published a proposal on 24 November 2004 to allow experimental GM crops grown on "test" sites to legally enter the food chain. The proposal is open for comment until 24 January 2005.

The FDA proposal came in response to a 2002 Bush administration initiative in the wake of widespread contamination of US food supplies and exports in 2000 with unauthorised Starlink GM corn, which continued to be detected in the US grain supply and in food shipments to Bolivia, Japan and South Korea as recently as autumn 2003.

FDA Commissioner Lester Crawford described the proposed policy as "a high priority for the Administration and the industry, to enhance public confidence, avoid product recalls, and provide an international model" for similar policies around the world.

The new policy sets out loose "safety assessment" guidelines under which a company may voluntarily consult with the FDA to have its experimental GM crop material deemed "acceptable" as a food contaminant. The "safety assessment" consists of paperwork and two inadequate tests that the FDA estimates will take companies just 20 hours to complete; and does not include animal feeding trials or tests for unintended effects caused by genetic modification. This would then give biotech companies the legal cover to allow their experimental GM crops to enter the US food supply. The US biotechnology and grain industries are already calling on the US government to "vigorously promote global adoption" of this policy.

It is already virtually impossible to test for the presence of experimental GM food crops in foods imported from or processed in the US, because over two-thirds of US field trials of experimental GM crops involve one or more genes classified as confidential which therefore cannot be detected.

Bill Freese, research analyst with Friends of the Earth (US) said, "FDA’s new proposal has nothing to do with food safety, it’s designed to provide biotech companies with legal cover for contaminating the food supply with experimental biotech traits. Such contamination has happened in the past and has cost biotech companies more than $1billion." Aside from Starlink, another experimental GM corn containing a pharmaceutical sprouted in a field of soya one year after the trial crop had been harvested. ProdiGene, the makers of the GM corn, paid out millions of dollars in damages and a $250 000 fine, although the product never reached the food chain.

Adrian Bebb of Friends of the Earth Europe added: "Because of the secrecy behind experiments in the United States, no one - not food companies, not even governments - will be able to test food products or food imports for contamination because they won’t know what to test for. This will leave consumers worldwide exposed to new risks from genetically modified foods."

Those experiments that are known to the public include crops with radically altered nutritional content for use as animal feed or anti-fungal compounds that resemble food allergens. Others include crops engineered to be resistant to chemical herbicides, produce their own insecticides or have sterile pollen or seeds. The FDA is also considering a similar proposal to allow residues from experimental pharmaceutical crops to enter the food chain. (See Ban Plant-based Transgenic Pharmaceuticals www.i- sis.org.uk/Banpharmcrops.php).

Juan Lopez from Friends of the Earth International said: "The Bush Administration, with the active support of the biotechnology industry, is about to force their untested genetically modified experiments into the world’s food supply. This proposal should be ringing alarm bells in every consumer, every food company and every food agency of the planet."

In line with the same policy proposal, Prof. Joe Cummins at the University of Western Ontario points out, "USDA [US Department of Agriculture], which regulates organic certification, has proclaimed that organic food crops polluted with modified genes from wind-borne pollen released from neighbouring farms will still be certified as organic food." (See "GM sugar beet gone sour", ISIS report, 9 December 2005, http://www.i- sis.org.uk/GMSBGS.php).

More information at Friends of the Earth International Action Alert: http ://www.foei.org/cyberaction/fda.html

Submit your comments by 24 January 2005.

Through the FDA website (Docket ID"2004D-03692) at

www.accessdata.fda.gov/scripts/oc/docke ts/comments/commentsmain.cfm?EC_DOCUMENT
_ID=543&SUBTYP=N EXT&CID=&AGENCY=FDA

Or send written comments, referencing Docket ID2004D-0369 to FDA Commissioner

Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD20852, USA

Sources

FDA release of the policy was announced at:
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01327.html

FDA’s draft policy is available at:
http://www .cfsan.fda.gov/~dms/bioprgui.htm.

FOE Press release. Anger over US plans to allow GM contamination on food, Nov 23 http://www.foe.co.uk/resour ce/press_releases/anger_over_us_plans_to_all_23112004.html

Bad seeds, Crop Choice News 24 Aug. 2004 http://www.cropchoice.com/leadstry39e0- 2.html?recid=2720

FoE briefing paper: www.foei.org/publications/pdfs/contamination.pdf