NEW REPORT SAYS FDA PLAN TO APPROVE SALE OF FOOD FROM ANIMAL CLONES IS BASED ON WISHFUL THINKING, NOT SCIENCE

Center for Food Safety Reveals that Milk and Meat from Clones is Untested and May Pose Health Risks to Consumers

Washington, DC (March 21, 2007) - The Center for Food Safety today issued a report critical of the Food and Drug Administration’s recent risk assessment on animal clones. The Center's review reveals that the risk assessment (which claims to show the safety of cloned food) relies almost entirely on unsupported assumptions and is based "more on faith than science." The Center is calling on FDA to issue a mandatory ban on the use of clones in food production until long-term studies demonstrate the safety of these foods and the vitally important ethical and animal welfare issues in cloning are resolved.
The Center's report "Not Ready for Prime Time: FDA's Flawed Approach to Assessing the Safety of Food from Animal Clones", was released today during a public comment period on FDA's planned approval of food from animal clones that is slated to close on April 2. The Center and numerous other organizations have requested an extension of the comment period to give Americans adequate time to review the Agency's findings and make their views heard.


The FDA says that food from clones is safe, and while they claim this view is supported by strong science, the Center for Food Safety Report actually shows that FDA found virtually no scientific studies to support the commercial release of these experimental foods. For example:



* FDA found no peer-reviewed studies on meat from cloned cows or on milk or meat from the offspring of cow clones.
* FDA found no peer-reviewed studies on meat from cloned pigs or their offspring.
* FDA found no peer-reviewed studies on meat or milk from cloned goats or their offspring.
* FDA found just three peer-reviewed studies on milk from cloned cows; all three studies showed differences in milk from clones that should have prompted further research.



"FDA's flawed approach falls far short of providing the kind of rigorous scientific assessment that Americans deserve before these experimental animals are allowed into the food supply," said Andrew Kimbrell, Executive Director of the Center.



The report further finds that the FDA's risk assessment is based on flawed assumptions and misrepresented findings. A summary of the report, which is attached, shows that:



1. Despite FDA's claim that there is “no difference” between food from clones and their progeny and food from naturally-bred animals, most of the studies they reviewed found troubling abnormalities and defects in animal clones which could pose food safety risks.


2. Evidence from the Agency's own report and from other scientists shows that cloning does not produce identical "twins" and that cloning therefore may not be useful in breeding. In fact, studies have found that clones from the same parent differ significantly from each other and from their parent animal. A recent scientific study concluded that scientists and breeders agree that cloning may not be useful for livestock production.

3. The FDA review contradicts itself, first claiming that genetically defective clones will pose no risk to the food supply because the sick animals will be detected and removed, but then admitting that some sick and defective clones may in fact end up as food.


4. FDA says the defects seen in clones also occur in natural reproduction, differing only by degree in clones, but the Agency also finds several defects in clones that are rarely or never seen in normal animals. For example, one common abnormality in clones that can result in stillbirth or early death - or death of the mother – occurs in normal cows only once in 7,500 instances, while it may occur in up to 42% of cloned cows.

5. While the FDA claims that improvement in cloning technology is resulting in better success rates for clones, a 2005 scientific review found that success rates in cloning remain less than 5%.
6. FDA asserts that the offspring of clones - not clones themselves - will be used for food and that genetic defects in clones are “corrected” in the offspring. But - as the Center finds, the National Academy of Sciences has questioned the validity of this assumption. Even more troubling, FDA downplays or omits from their assessment studies finding that some genetic defects in clones have been reproduced in clones' offspring.


7. FDA has stated that it will not require labels on food from animal clones. But a 2004 National Academy of Sciences study noted that a national system to identify and track food from animal clones "must be implemented" before cloned foods are marketed.



View the Executive Summary (PDF)


View the full report, Not Ready For Prime Time: FDA's Flawed Approach To Assessing The Safety Of Food From Animal Clones (PDF)


In the News:
Reuters - Group Blasts FDA Plan To Allow Food From Clones

Federal Judge Orders First-Ever Moratorium On Sale Of Genetically Altered Seed

USDA approval of genetically engineered alfalfa is vacated, seed sales halted

San Francisco, CA, March 12, 2007 - A Federal judge ruled today that the U.S. Department of Agriculture's (USDA's) 2005 approval of genetically engineered (GE) alfalfa is vacated and ordered an immediate halt to sales of the GE seed. The ruling follows a hearing last week in the case brought by the Center for Food Safety (CFS) against the U.S. Department of Agriculture (USDA) for approving GE alfalfa without conducting the required Environmental Impact Statement.

"We are pleased that the judge called for halt to sales of this
potentially damaging crop," said Will Rostov, a Senior Attorney for CFS. "Roundup Ready alfalfa poses threats to farmers, to our export markets, and to the environment. We expect the USDA to abide by the law and give these harmful effects of the crop full consideration."

The preliminary injunction ordered (PDF) by Judge Charles Breyer in the Federal Northern District of California today follows his ruling last month finding that USDA violated national environmental laws by approving GE alfafa without a full Environmental Impact Statement. Monsanto and Forage Genetics, the developers of the GE alfalfa seed, argued against the injunction. But while Monsanto and its allies claimed that delaying the sale or planting of their GE seed would harm farmers, the judge found otherwise. "Disappointment in the delay to their switch to Roundup Ready alfalfa is not an interest which outweighs the potential environmental harm…" posed by the GE crop, he wrote.

Today's decision is consistent with Judge Breyer's ruling of February 13th, in which Judge Breyer found that the USDA failed to address concerns that Roundup Ready alfalfa will contaminate conventional and organic alfalfa. The ruling noted that "…for those farmers who choose to grow non-genetically engineered alfalfa, the possibility that their crops will be infected with the engineered gene is tantamount to the elimination of all alfalfa; they cannot grow their chosen crop." Commenting on the agency’s refusal to assess this risk and others, the judge noted that "Nothing in NEPA, the relevant regulations, or the caselaw support such a cavalier response."

Judge Breyer will hold a hearing and is expected to decide whether to impose a permanent injunction in late April.

The Center for Food Safety represented itself and the following co-plaintiffs in the suit: Western Organization of Resource Councils, National Family Farm Coalition, Sierra Club, Beyond Pesticides, Cornucopia Institute, Dakota Resource Council, Trask Family Seeds, and Geertson Seed Farms.

In the Headlines

Several readers have requested that we include the news headlines in the main posts so that they will go out on the feed, rather than the sidebar of the blog. You wanted it...you got it. Enjoy!

USDA, you got some 'splainin to do. Casting more doubt on the agency's oversight, another variety of rice in Arkansas has been contaminated by a genetically engineered variety. The recent contamination, found in a popular non-GE variety called Clearfield (CL 131), is thought to be from an unapproved GE line. USDA is barring planting of all CL 131 seed until they figure out where the unidentified genes came from, and whether or not is has been approved for the commercial market. Facing seed shortages due to last year's contamination of another popular rice variety, Cheniere, growers in Arkansas are now facing a potential severe seed shortage. Clearfield 131 and Cheniere together represent 39% of the South’s certified seed supply, so the latest incident is raising serious concerns about the availability of sufficient amounts of uncontaminated seed as planting season nears.

Patents are for toasters. This story from the Memphis Commercial Appeal features CFS' own Science Policy Analyst, Bill Freese. The U.S. Patent and Trademark Office has rejected a key patent in Monsanto's Roundup Ready technology, possibly stripping Monsanto of its power to profit from licensing deals. The patent is one of four that the nonprofit Public Patent Foundation asked the patent office to review last fall, alleging that the patents were granted to Monsanto without merit. It's unclear what will happen with the other three patents under review, but we'll keep you posted.

LA Times hosts cloned dinner "taste test." As the LA Times reported Sunday:

"six intrepid diners agreed to participate in cloned beef's debut on the culinary scene in a private dinner convened by The Times. Several prospective diners declined the invitation. Eric Schlosser, author of "Fast Food Nation" and self-described omnivore, said: "I'd rather eat my running shoes than eat meat from a cloned animal." Spago chef Lee Hefter, who recently opened the Beverly Hills steakhouse Cut, agreed to host this dinner before abruptly changing his mind. "I don't want people to think that I would ever use it," he said. "I don't want to condone cloned beef. I don't want to eat it. I don't want it in my kitchen."

The Times' pretentious party to "taste the future of food" was ultimately held at the Tony Campanile restaurant. I don't know about you, but personally, I don't care whether or not you can taste the difference. Beef from cattle infected with Mad Cow disease doesn’t taste any different either. The concerns about cloned animals go far beyond whether or not my cloned steak will be as tasty as its conventional counterpart with my desired wine pairing. Perhaps all that "Bandol red" interfered with the "intrepid" diners' mental capacity to have a science or ethics discussion comparable to one that could be held by any high school debate club - or was it the Daphne Malvasia prosecco-style sparkling wine from Medici Ermete? Me, I'll take running shoes (and wine I can pronounce) with Schlosser any day, thank you very much.

Monsanto in the Middle. According to this story from NutraIngredients USA, Monsanto is filing a motion to intervene in a case recently won by CFS, calling on USDA to conduct a full environmental impact statement on Monsanto’s RoundUp Ready alfalfa. Monsanto said it decided to intervene "in order to give farmers the choice to use the technology." I've heard they also have several bridges for sale if you're interested.

Total Recall. DairyQueen has a great post over at the Ethicurean, "Why USDA & FDA Should Change Recall Protocols," addressing the paucity of information given to consumers when contaminated food is recalled, California's attempt to remedy the situation, and the possibility of USDA following California's lead. Where does the FDA stand? In the way.

Side note: In case you're unfamiliar with the Ethicurean, and you're thinking this is bound to be a dry read full of gross-me-out statistics, I give you this: "Why doesn’t the USDA come up with catchy names for its bacterial strains, a' la the Department of Defense? 0157:H7 could be known as Operation Gut Storm, for example." Genius.

This is Your Food on Drugs

The Washington Post published two interesting stories over the weekend concerning drug use and production in the food supply. In the first installment of "what the heck are they thinking?" FDA says it may soon approve a new drug for use in cattle, despite warnings against such approval by the American Medical Association, FDA's own scientists, and a myriad of health, consumer and food safety groups. The drug is part of a class of antibiotics that are very important to treating serious human illness, and scientists and health professionals warn that its introduction into the food supply would probably speed the emergence of microbes resistant to that important class of antibiotics, as has happened with other drugs. But FDA, in it's apparent unwavering adherence to the rules, claims it can't reject the drug on these concerns due to restrictive language in something called "Guidance #152." Anyone seen the movie Brazil? "Guidance #152?" It doesn't even have a dash or a stroke. It can't possibly be important enough to override the agency's clear directive to protect public health...wait. What's that clunking noise in the ceiling? (Update: Rick Weiss has a Q&A on the article in the WashPost HERE)

Meanwhile, the second Wash Post article has USDA backing the commercial production of a controversial variety of rice genetically engineered to produce pharmaceutical proteins. The rice, created by California-based Ventria BioScience, is set to be grown and processed in Kansas (where they don't grow rice commercially), after the company was chased out of other states, including Monsanto's stomping grounds, Missouri, and Ventria's home-state California. Ventria has developed three varieties of rice, each engineered with a different human gene to produce one of three human proteins. Two of them -- lactoferrin and lysozyme -- are bacteria-fighting compounds found in breast milk and saliva. The third makes serum albumin, a blood protein used in medical therapies.

Sounds yummy, doesn't it? But not to worry, USDA says everything will be fine. Never mind that unapproved GE "pharm" crops have contaminated conventional crops in the past; or that two strains of conventional rice have now been found to be contaminated with three different genetically engineered varieties; or that pesky StarLink corn incident. USDA's track record isn't exactly spotless, and was further tarnished by two recent court judgements that CFS won against the agency for not following environmental regulations on approving GE bentgrass and GE alfalfa, but I'm sure they'll do a better job this time. In case you are not convinced, USDA is accepting public comments on the plan until March 30th. You can submit comments online at www.regulations.gov, Docket No. APHIS-2007-0006.