The FDA's Latest Outrage, No Limits on Bt Toxin in Food

The FDA's latest outrage is the August 6, 2008 proposed rule to eliminate safety limits for the Bt toxin found in genetically engineered foods.  To provide insect resistance for crops, the Bt gene from a bacteria called Bacillus thuringiensisis is placed into the corn plant, a common method used in genetic engineering (GMO food, genetically modified organism). (1)

The problem with eliminating safety limits is that genetically modified Starlink Corn with the Bt gene for protein Cry9C may cause allergic reactions in animals and humans.  

Left Image: Bt Protein Cry9C spores courtesy of wikipedia.

In fact, the Starlink Bt Corn by Aventis was banned from human consumption because of safety concerns, and Aventis paid 9 million dollars to settle a class action law suit claiming negligence in causing health problems.  Aventis paid another 110 million dollars to farmers for being a "public nuisance" and causing genetic pollution of the seed crop.(2)  Bt modified Starlink corn has been banned from human consumption in the US because of safety issues.
 
Dr Cummins has reported that current research shows evidence that ingestion of Bacillus thuringirnsis (Bt) toxin will damage the small bowel (the ileum), will trigger an immune response, and that synthetic Bt cry toxin genes have not been proven to be equivalent to the natural bacterial gene used in the safety studies.(3)  During Testimony to the EPA,  Dr. Michael Hansen was also concerned that Bt protein Cry9C provokes allergic reactions in humans.(6)  Luca Bucchini and Lynn R. Goldman have expressed concern in their article about allergenicity of the Bt Protein.(7) Others have summarized the evidence that Bt protein is potentially harmful to humans (4)(5)

An October 2007 White Paper from the EPA, US Environmental Protection Agency, discusses  Scientific Considerations Regarding Allergenicity of the StarLink Cry9c Protein, and the potential risks associated with human exposure, as well as the events leading to the banning of Starlink Corn from human consumption.

Stop this Outrage Now, You have the right to Know, Ban GMO Foods

This is a clear example of the FDA NOT Protecting the American Public ! Instead they are serving their corporate masters.

Call, write or email your congressman and the FDA to demand that limits be placed on the amount of Bt Toxin in the food supply. Send your objection before October 6, 2008, to the FDA, in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

Currently GMO foods require no labeling or safety testing.  This is an outrage.  Demand that all Genetically Modified GMO Foods be BANNED from the US until appropriate safety testing and labeling regulations are adopted.

To read more see the previous more complete article:

Genetically Modified GMO Food, the Great Scandal by Jeffrey Dach MD

Jeffrey Dach MD
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Hollywood Fl 33021
954-983-1443
www.jeffreydach.com
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References and Links

(1) http://edocket.access.gpo.gov/2008/pdf/E8-17931.pdf

Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 174
[EPA–HQ–OPP–2007–0830; FRL–8374–2]
Bacillus thuringiensis Vip3Aa Proteins in Corn and Cotton; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus thuringiensis Vip3Aa proteins in or on corn; corn, field; corn, sweet; corn, pop; and cotton, undelinted seed; cotton, refined oil; cotton, meal; cotton, hay; cotton, hulls; cotton, forage; and cotton, gin byproducts, when applied or used as
plant-incorporated protectants. DATES: This regulation is effective August 6, 2008. Objections and requests  for hearings must be received on or before October 6, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

(2) http://www.usatoday.com/tech/news/techpolicy/business/2004-08-23-starlink-snafu_x.htm
USA Today News Posted 8/23/2004. StarLink corn settlement also to include interest
By Kevin O'Hanlon, Associated Press LINCOLN, Neb. — Farmers nationwide will be paid interest on the $110 million settlement with makers and distributors of genetically altered corn that was mistakenly introduced into the food supply.  A 9 million dollar setlement was given to people with health problems from Starlink corn.

Harmful Effects on Humans Ingesting  Bt modified Foods

(3) http://www.biotech-info.net/bt_cummins.html
Comments on the human health impact of Bacillus thuringiensis toxin gene product in genetically modified crops" EPA Review Docket Number OPP-00678B
Professor Joe Cummins Professor Emeritus of Genetics University of Western Ontario

(4) http://www.seedsofdeception.com/utility/showArticle/?objectID=1264
Genetically Engineered Foods May Cause Rising Food Allergies (Part Two)
Part 2: Genetically Engineered Corn By Jeffrey M. Smith

(5) http://www.twnside.org.sg/title/service6.htm
Third World Network report on the StarLink scandal. In the US, genetically engineered StarLink corn which has not been approved for human consumption was found in food products. This has caused a major controversy and 44 Americans have so far claimed that they have suffered allergic reactions from consuming StarLink corn products.

(6) http://www.mindfully.org/GE/StarLink-Hansen-Testimony-EPA.htm
Dr. Michael Hansen's Testimony to the EPA Comments on the Assessment of Scientific Information Concerning StarLink Corn (Cry9C Bt Corn Plant-Pesticide)
EPA Docket Number OPP-00688
Michael Hansen, Ph.D. Consumer Policy Institute/Consumer Union 28nov00
Consumers Union thanks the EPA for the opportunity to comment on Aventis' petition for a temporary exemption from the requirement of a tolerance for the genetically engineered plant-pesticide materials (Cry9C protein and the genetic material necessary for the production of this protein) in StarLink. Although Aventis has narrowed the scope of their petition from asking for an exemption covering both the Cry9C DNA and Cry 9C protein in all food commodities to one asking for an exemption only for food products made from StarLink corn, and only for a limited time of four years, we firmly believe that the EPA should not grant Aventis petition, for both scientific and legal reasons.

(7) http://www.ehponline.org/members/2002/110p5-13bucchini/bucchini-full.html
Starlink Corn: A Risk Analysis
Luca Bucchini and Lynn R. Goldman
Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA

Allergenicity. The biochemical characteristics of Cry9c created challenges for the U.S. EPA in applying allergenicity assessment principles that had been used to support the safety of other pesticidal proteins. Consequently, there was a rapid evolution in the nature of the experimental evidence that the U.S. EPA and Aventis employed in the effort to evaluate the potential for allergenicity. The original submission (22) relied on stability studies and sequence analysis. These data did not rule out the possibility of allergenicity of Cry9c. The in vitro digestibility study showed that Cry9c is stable for 4 hr when exposed to pepsin digestion at pH 2.0. Cry9c is also stable to trypsin because, as noted above, it has been modified for increased proteolytic resistance. The protein was also found heat stable for 10 min at 90°C. Therefore, it was concluded that Cry9c was likely to survive processing and digestion and, as a consequence, to have the potential to interact with the immune system. The sequence analysis did not show any homology with known allergens. However, on the basis of its relative stability, the U.S. EPA restricted Cry9c to animal-feed use (23). Later, it was recognized that Cry9c may be glycosylated in plants; many believe that glycosylation is a feature of many food allergens (50) and that glycosyl groups contribute substantially to allergen binding (51,52). Retrospectively, the equivalence of trypsinized microbially produced Cry9c to the plant product seems to have been questionable; in fact, bacterially produced recombinant allergens sometimes cannot be validated, and eukaryotic systems may have to be used for their production instead, at least for aeroallergens (53).

(8) http://www.epa.gov/pesticides/biopesticides/pips/star-link-white-paper.pdf
US Environmental Protection Agency Office of Pesticide Programs
(Draft White Paper) Concerning Dietary Exposure To Cry9c Protein Produced By Starlink® Corn And The Potential Risks Associated With Such Exposure. October 16, 2007, Scientific Considerations Regarding Allergenicity for the Initial StarLink® Decision