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CONTAMINATION & FEED: GE cotton contamination in the USA unlikely to pose feed hazard



                                  PART 1


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TITLE:  EXPERIMENTAL COTTON UNLIKELY TO POSE FEED HAZARD

SOURCE: The Associated Press, USA

AUTHOR: Sam Hananel

URL:    http://www.google.com/hostednews/ap/article/ALeqM5hC7U_BFHfE7fQmWoybmUPfeAeS_gD94RI6F80

DATE:   04.12.2008

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EXPERIMENTAL COTTON UNLIKELY TO POSE FEED HAZARD

WASHINGTON (AP) ? An unauthorized strain of genetically modified cotton was accidentally mixed in with other harvested cotton in Texas last month, but government officials on Wednesday played down any safety concerns.

About a quarter ton of the experimental cotton seed engineered to contain a protein that produces a pesticide was combined with about 60 tons of commercial cotton growing nearby, said Eric Flamm, a senior adviser at the Food and Drug Administration.

The mixture, grown near Lamesa in West Texas, about 300 miles west of Fort Worth, was then stored along with 20,000 tons of commercial cotton seed in a warehouse. Nearly half the crop was processed into cottonseed oil and cotton meal to use as animal feed before officials at Monsanto Co., which grows the experimental cotton on a test plot, realized the mistake.

Monsanto officials notified the government of the error on Nov. 10.

?We?re talking about a very small amount, but nevertheless, a material that contains a pesticidal substance and has not been authorized for food or feed use,? Flamm said on a conference call with reporters.

Flamm said most of the contaminated crop that was processed into animal feed had already been consumed at cattle feed lots. Two truckloads of the crop were delivered to Mexico, and U.S. officials have notified that country.

The FDA, Environmental Protection Agency and Agriculture Department are investigating to determine what enforcement action is warranted against Monsanto.

Monsanto spokesman Lee Quarles said the crop was mistakenly harvested on Oct. 31, and the company learned about it eight days later when field researchers went to check on it and discovered it was not there. It is grown in a research plot adjacent to other cotton and separated by border rows.

?We?ve taken responsibility for this release and we?re actively working to resolve it in a manner that?s satisfactory with the USDA and other agencies,? Quarles said.

Quarles said the protein has been determined to pose no threat to humans and approved for use in corn, but not yet in cotton.

But one food safety group said the case shows the need for stricter government regulation over experimental crops.

?This incident and a string of others that have come to light over the past two years show that the USDA is fundamentally incapable of protecting our food,? said Karen Perry Stillerman, a food analyst at the Union of Concerned Scientists.



                                  PART 2

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TITLE:  FDA, EPA AND USDA CONCLUDE THAT ACCIDENTAL RELEASE OF GENETICALLY ENGINEERED COTTON POSES NO SAFETY RISK TO HUMANS OR ANIMALS

SOURCE: Food and Drug Administration, USA

AUTHOR: Press Release

URL:    http://www.fda.gov/bbs/topics/NEWS/2008/NEW01920.html

DATE:   03.12.2008

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FDA, EPA AND USDA CONCLUDE THAT ACCIDENTAL RELEASE OF GENETICALLY ENGINEERED COTTON POSES NO SAFETY RISK TO HUMANS OR ANIMALS

The U.S. government announced today that there is no food or feed safety concern from an incident in which a small portion of an unauthorized genetically engineered (GE) cotton variety was harvested along with commercially available GE cotton.

The U.S. Department of Health and Human Services? Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture?s (USDA) Animal and Plant Health Inspection Service (APHIS) are working together following notification by the Monsanto Company that a small amount--less than an acre--of an unauthorized GE cotton variety was harvested along with 54 acres of a commercially available GE cotton variety. This unauthorized GE cotton variety produces a pesticide that is a plant-incorporated protectant (PIP) nearly identical to a registered product already in a marketed corn variety. EPA and FDA have concluded that there are no food or feed safety concerns related to this incident. Also, if animals had consumed meal made from the unauthorized GE cotton variety, there would be no residues in the meat, milk or eggs. Additionally, USDA has determined that the unauthorized GE cotton poses no plant pest concerns.

According to Monsanto, an estimated 60 tons of cottonseed was harvested, of which less than 0.5 percent was from the unauthorized GE cotton variety. Government policies for handling low-level presence (LLP) of unauthorized materials are applicable to incidents in which unauthorized materials become inadvertently mixed with commercial grain or seed. FDA, EPA and USDA are working together to investigate the matter.

The U.S. government is investigating whether a small amount of meal from the unauthorized GE cotton variety may have been inadvertently released into the animal feed supply. It is important to note that it has not been determined whether unauthorized cottonseed meal actually entered the feed supply. The processor is holding potentially affected material (both processed and unprocessed) pending further investigation.

Based on additional data provided by Monsanto on the protein produced in the GE cotton--a variant of Cry 1A 105 that acts as a pesticide against cotton insect pests--EPA has concluded that there would be no risk to animals consuming small amounts of feed from the unauthorized cotton, nor to humans from consuming meat or milk from these animals. While EPA has concluded that consuming small amounts of the cottonseed poses no food or animal feed safety risks, under that Agency?s LLP policy, the presence of this material in food or feed would be illegal.

FDA, USDA and EPA are the three government entities primarily responsible for regulatory oversight of GE crop plants and their products. Their responsibilities are complementary. FDA has jurisdiction over food and feed uses of all foods from plants. USDA has jurisdiction over the introduction into the environment of GE plants which may be plant pests. EPA regulates pesticides produced by GE plants such as the pesticidal protein produced by the cotton in this case. These pesticides are called PIPs.



                                  PART 3

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TITLE:  GOVERNMENT AGENCIES ANNOUNCE THAT GENETICALLY ENGINEERED COTTONSEED HAS CONTAMINATED FOOD SYSTEM

SOURCE: Union of Concerned Scientists, USA

AUTHOR: Press Release

URL:    http://www.ucsusa.org/news/press_release/GE-contamination-as-USDA-weakens-rules-0166.html

DATE:   03.12.2008

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GOVERNMENT AGENCIES ANNOUNCE THAT GENETICALLY ENGINEERED COTTONSEED HAS CONTAMINATED FOOD SYSTEM

Contamination Occurs as USDA Finalizes Weaker Biotechnology Rules

WASHINGTON?The U.S. Department of Agriculture (USDA), Food and Drug Administration, and the Environmental Protection Agency announced today that an experimental variety of genetically engineered cottonseed developed by Monsanto has entered the U.S. food system illegally. According to the agencies, Monsanto harvested the unapproved cottonseed in error and allowed it to mix with approved animal feed that food animals have already eaten. (For the agencies? press release go to: http://www.aphis.usda.gov/newsroom/content/2008/12/ifruit.shtml).

This discovery occurs just as the USDA works to finalize rules that would substantially weaken biotechnology oversight before the Bush administration leaves office. The Union of Concerned Scientists (UCS) recently submitted comments on the proposed rules, lambasting the USDA?s rulemaking as ?a serious abdication of its responsibility? to regulate agricultural biotechnology and ensure genetically engineered crops are produced and used safely. The proposed rule was published in October and the public comment period ended on November 24.

The proposed rule has several major defects, including:

 * The USDA has limited the rule?s scope, ensuring that it would cover fewer genetically engineered products over time and leave the department in the dark about biotechnology industry activities.

 * The proposed rule would allow potentially dangerous genetically engineered crops to escape regulation.

 * The proposed rule would allow the industry to use a nonregulatory petition process to remove genetically engineered organisms from the agency?s legal jurisdiction.

 * The USDA would not protect the food supply from pharmaceutical and industrial crops (pharma crops). Unlike current regulations, the proposed rule would no longer treat pharma crops as a high-risk category of products and instead would allow the department to place them in low-risk categories subject to less stringent controls. UCS is recommending that the USDA abandon its proposed pharma-crop oversight and ban the outdoor production of pharma food crops.

In addition to the rule?s substantive defects, the USDA has followed an irregular rulemaking process that makes a mockery of the National Environmental Policy Act (NEPA). To meet NEPA requirements, the USDA should have issued a final environmental impact statement (EIS) at the same time it issued the proposed rule. The purpose of the final EIS is to analyze the environmental impacts of regulatory options and respond to the scientific and legal comments received on the draft EIS, which the USDA published last year. Instead, the department plans to publish a final EIS at the same time it issues the final rule.

Like many other rules favoring industry over the public interest, the USDA is rushing the rule to completion before the Bush administration leaves office, depriving the incoming Obama administration of the opportunity to put its stamp on the direction of biotechnology regulation.

UCS recommends that the USDA comply with NEPA even though such a move would extend the rulemaking process beyond the end of the Bush administration. Even if the department elects not to follow that process, UCS recommends that the USDA wait to finalize the rule until after January 20. Given that the proposed rule represents a significant weakening of biotechnology regulation, the Obama administration should have an opportunity to review it. If the final rule is in effect when the Obama administration takes office, UCS recommends that the new administration make revocation, revision and strengthening a top priority.

For USDA?s proposed rule, go to: http://www.aphis.usda.gov/brs/fedregister/BRS_20081009.pdf

For UCS?s comments on the proposed rule, go to: http://www.ucsusa.org/assets/documents/food_and_agriculture/UCS-comments-APHIS-rule-FINAL-11-24-08.pdf


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