Congressional Letter to Vilsack

June 23, 2010

Dear Secretary Vilsack:

We have serious concerns regarding the Draft Environmental Impact Statement (DEIS) for genetically engineered (GE) alfalfa. We have concluded that USDA's preliminary finding of "No Significant Impact" cannot be justified and we call on you to correct the serious deficiencies in the DEIS and to deny the request for deregulated GE alfalfa.

In the DEIS, USDA- APHIS concludes that contamination of non-GE alfalfa is highly unlikely, and if it does occur, the impacts would be inconsequential. That conclusion is based on the fact that the alfalfa is typically harvested prior to maturity, negating the potential of cross-pollination and contamination. Even if harvest occurs after maturity, APHIS contends that the required isolation distances will insure that the contamination is contained. These conclusions are not supported by the evidence or the science.

The DEIS acknowledges that gene flow contamination will likely occur and goes on to elaborate on the conditions which increase that possibility: proximity of fields, pest management strategies, feral alfalfa corridors, movement of honey bees and overstocking of pollinators. The DEIS further acknowledges that honey bees, the primary pollinators of alfalfa, travel distances far in excess of the required isolation distances. While APHIS maintains that contamination is unlikely, they contradict their own conclusion by determining that glyphosate tolerant alfalfa deregulation will lead to a shift to larger farms as alfalfa producers seek more land to avoid contamination.

During the two years that GE alfalfa was permitted to be grown commercially, approximately 200,000 acres of Roundup Ready alfalfa were planted - amounting to less than 1% of the total alfalfa acres in the U.S. Cal/West Seeds, a major alfalfa seed exporter, reported that 12% of 200+ lots and all 6 of its research lots had tested positive for GE alfalfa in 2008 and that preliminary data indicated that 30% of 10 seed stock lots had tested positive in 2009. Additionally, Dairyland Seed Company, a major alfalfa seed producer and exporter, reported contamination of 11-16 sites at distances of up to 1 ½ miles - far beyond the recommended 900 foot isolation distances.

We believe that GE contamination will occur and it will result in significant economic harm to both the alfalfa seed and forage export markets and to the organic dairy industry. APHIS has ignored the potential economic harm, concluding that GE sensitivity was too speculative while blaming farmers and the organic industry for its failure to provide evidence of consumer resistance and consequent economic loss.

There is nothing speculative regarding the loss of foreign alfalfa seed and forage markets. According to the Foreign Agriculture Service at USDA, the alfalfa forage exports in 2007 amounted to $159 million to GE sensitive markets in Japan, Korea and Taiwan. Saudi Arabia, the largest importer of alfalfa seed, banned the import and/or use of GE seeds in 2004. Saudi Arabia imported $38 million of U.S. alfalfa seeds in 2007. Based on those figures, alfalfa producers could lose at least $197 million annually in alfalfa seed and forage exports as a result of GE alfalfa deregulation.

Today, U.S. exports of biotech corn and soybeans, as well as other agriculture products that contain or may have been contaminated with biotech ingredients continue to face a wide array of trade barriers. Several U.S. trading partners have employed restrictive measures or imposed bans on some U.S. agricultural products over health and environmental safety concerns related to biotechnology.

We believe that organic dairy producers will also suffer significant economic losses as a result of GE alfalfa deregulation. APHIS contends that organic certification is process-based and contamination would not impact certification. This conclusion is contradicted by organic industry leaders. The CROPP Cooperative processes and markets organic dairy and meat products for 941 producers in 28 states under the "Organic Valley" brand, which in 2007 had annual sales of $333 million and a growth rate of 38% between 2005-2007. George Siemans, CROPP Cooperative CEO, has stated that if GE alfalfa results in the contamination of certified organic alfalfa stands or seed stock, it will devastate the organic farmers who market their milk as organic. Albert Straus of the Straus Family Creamery in Marshall California has stated that contamination of alfalfa forage would result in the widespread loss of organic and non-GE certifications and have a devastating impact on organic dairy producers and their ability to acquire organic forage. Organic feed is already expensive and in short supply in this country, if organic alfalfa becomes contaminated by GE alfalfa, it would greatly compound the feed shortage and increase the operating costs for organic dairy farms. This comes just as organic dairy producers are proving that they can be competitive with conventional production and are finding ways to further reduce their operating costs.

Consumers today respect and rely on what the USDA certified organic seal represents, which includes no GE contamination. If the USDA organic seal no longer represents a GE-free product, the integrity of the entire organic industry in this country will be compromised and consumers may no longer choose organic products. The organic dairy industry is now at approximately $1.4 billion in sales and according to USDA's 2008 Organic Production Survey, farm sales of organic fluid milk were $750 million. If farmers are unable to source adequate organic feed, they will not be able to produce organic milk.

The DEIS analysis fails to consider the need for GE alfalfa. Herbicides are used on only 7% of the alfalfa acreage in the country as "companion crops" in alfalfa fields are commonly utilized by dairy and beef producers for weed control and nutritional balance in livestock diets. The potential development of herbicide tolerance is minimized and dismissed. We believe that other significant environmental impacts are overlooked, ignored or minimized in the DEIS analysis. Neither impact was given any significance by APHIS, and should be reconsidered.

USDA has taken an impermissibly narrow view of its regulatory authority. The National Environmental Policy Act (NEPA) and the Plant Protection Act (PPA) provide a robust regulatory framework that ensures the protection of the environment and the vital economic interests of U.S. farmers. NEPA requires a hard look at the environmental consequences of federal actions and mandates that all reasonably foreseeable environmental impacts be addressed. The PPA grants you with broad authority to protect the agriculture, environment and economy of the U.S.

Congress enacted legislation in the 2008 Farm Bill to provide the USDA Secretary with added authority to ensure that GE contamination was minimized or prevented after rice producers lost an estimated $1.25 billion as a result of a contamination event. The USDA has failed to adopt regulations implementing these statutory mandates. APHIS cannot run away from its regulatory responsibilities to protect farmers from environmental and economic harm that are the direct result of GE contamination in the promotion of agricultural biotechnologies.

We believe that the broad regulatory authority available to you has been ignored, in order to justify deregulation of a biotech crop that has limited utility to anyone except the manufacturer. You have spoken often about USDA having a role to help all farmers, both conventional and organic, and how organic agriculture helps to support local and regional food systems. How you respond to this DEIS, the first of its kind involving agricultural biotech and a perennial crop, and the 200,000 comments that USDA has received will demonstrate whether you truly want to do everything you can to support all farmers. USDA must do a better job to help organic operators coexist with those who chose other farming alternatives.

We request that you fully review the facts, law, and science in this case and take the "no action" alternative to maintain the regulated status for GE alfalfa. As the 200,000 comments indicate, there is significant concern that the risks to alfalfa producers and U.S. agriculture are too great and benefits too few to allow deregulation.

Sincerely,

PATRICK LEAHY
United States Senator

PETER DEFAZIO
Member of Congress

Senator Russell D. Feingold (WI), Senator Bernard Sanders (VT), Senator Ron Wyden (OR), Senator Jon Tester (MT), Senator Sherrod Brown (OH), Rep. Michael A. Arcuri (NY-24), Rep. Tammy Baldwin (WI-2), Rep. Earl Blumenauer (OR-3), Rep. Steve Cohen (TN-9), Rep. Danny K. Davis (IL-7), Rep. Susan A. Davis (CA-53), Rep. Rosa L. DeLauro (CT-3), Rep. Norman D. Dicks (WA-6), Rep. Lloyd Doggett (TX-25), Rep. Keith Ellison (MN-5), Rep. Anna G. Eshoo (CA-14), Rep. Sam Farr (CA-17), Rep. Bob Filner (CA-51), Rep. Barney Frank (MA-4), Rep. Raúl M. Grijalva (AZ-7), Rep. John J. Hall (NY-19), Rep. Martin Heinrich (NM-1), Rep. Maurice D. Hinchey (NY-22), Rep. Rush D. Holt (NJ-12), Rep. Jay Inslee (WA-1), Rep. Steve Israel (NY-2), Rep. Ron Kind (WI-3), Rep. Dennis J. Kucinich (OH-10), Rep. Rick Larsen (WA-2), Rep. Barbara Lee (CA-9), Rep. Christopher John Lee (NY-26), Rep. Nita M. Lowey (NY-18), Rep. Carolyn B. Maloney (NY-14), Rep. Jim McDermott (WA-7), Rep. James P. McGovern (MA-3), Rep. Michael H. Michaud (ME-2), Rep. George Miller (CA-7), Rep. Gwen Moore (WI-4), Rep. James P. Moran (VA-8), Rep. Jerrold Nadler (NY-8), Rep. David R. Obey (WI-7), Rep. John W. Olver (MA-1), Rep. Chellie Pingree (ME-1), Rep. Jared Polis (CO-2), Rep. Nick J. Rahall II (WV-3), Rep. Steven R. Rothman (NJ-9), Rep. Louise McIntosh Slaughter (NY-28), Rep. Jackie Speier (CA-12), Rep. Betty Sutton (OH-13), Rep. Mike Thompson (CA-1), Rep. John F. Tierney (MA-6), Rep. Peter Welch (VT-At Large), Rep. Lynn C. Woolsey (CA-6), Rep. David Wu (OR-1)

Genetically Altered Salmon Get Closer to the Table

By Andrew Pollack
NY Times
June 25, 2010

The Food and Drug Administration is seriously considering whether to approve the first genetically engineered animal that people would eat - salmon that can grow at twice the normal rate.

The developer of the salmon has been trying to get approval for a decade. But the company now seems to have submitted most or all of the data the F.D.A. needs to analyze whether the salmon are safe to eat, nutritionally equivalent to other salmon and safe for the environment, according to government and biotechnology industry officials. A public meeting to discuss the salmon may be held as early as this fall.

Some consumer and environmental groups are likely to raise objections to approval. Even within the F.D.A., there has been a debate about whether the salmon should be labeled as genetically engineered (genetically engineered crops are not labeled).

The salmon's approval would help open a path for companies and academic scientists developing other genetically engineered animals, like cattle resistant to mad cow disease or pigs that could supply healthier bacon. Next in line behind the salmon for possible approval would probably be the "enviropig," developed at a Canadian university, which has less phosphorus pollution in its manure.

The salmon was developed by a company called AquaBounty Technologies and would be raised in fish farms. It is an Atlantic salmon that contains a growth hormone gene from a Chinook salmon as well as a genetic on-switch from the ocean pout, a distant relative of the salmon.

Normally, salmon do not make growth hormone in cold weather. But the pout's on-switch keeps production of the hormone going year round. The result is salmon that can grow to market size in 16 to 18 months instead of three years, though the company says the modified salmon will not end up any bigger than a conventional fish.

"You don't get salmon the size of the Hindenburg," said Ronald L. Stotish, the chief executive of AquaBounty. "You can get to those target weights in a shorter time."

AquaBounty, which is based in Waltham, Mass., and publicly traded in London, said last week that the F.D.A. had signed off on five of the seven sets of data required to demonstrate that the fish was safe for consumption and for the environment. It said it demonstrated, for instance, that the inserted gene did not change through multiple generations and that the genetic engineering did not harm the animals.

"Perhaps in the next few months, we expect to see a final approval," Mr. Stotish said.

But the company has been overly optimistic before.

He said it would take two or three years after approval for the salmon to reach supermarkets.

The F.D.A. confirmed it was reviewing the salmon but, because of confidentiality rules, would not comment further.

Under a policy announced in 2008, the F.D.A. is regulating genetically engineered animals as if they were veterinary drugs and using the rules for those drugs. And applications for approval of new drugs must be kept confidential by the agency.

Critics say the drug evaluation process does not allow full assessment of the possible environmental impacts of genetically altered animals and also blocks public input.

"There is no opportunity for anyone from the outside to see the data or criticize it," said Margaret Mellon, director of the food and environment program at the Union of Concerned Scientists. When consumer groups were invited to discuss biotechnology policy with top F.D.A. officials last month, Ms. Mellon said she warned the officials that approval of the salmon would generate "a firestorm of negative response."

How consumers will react is not entirely clear. Some public opinion surveys have shown that Americans are more wary about genetically engineered animals than about the genetically engineered crops now used in a huge number of foods. But other polls suggest that many Americans would accept the animals if they offered environmental or nutritional benefits.

Mr. Stotish said the benefit of the fast-growing salmon would be to help supply the world's food needs using fewer resources.

Government officials and industry executives say the F.D.A. is moving cautiously on the salmon. "It's going to be a P. R. issue," said one government official, who spoke on the condition of anonymity because he was not authorized to speak about the issue.

Some of these government officials and executives said that F.D.A. officials had discussed internally whether the salmon could be labeled to give consumers the choice of avoiding them.

The government has in the past opposed mandatory labeling of foods from genetically engineered crops and animals merely because genetic engineering was used. Foods must be labeled, it says, only if they are different in their nutritional properties or other characteristics.

It would seem difficult for the government to change that policy. And experts say the administration may not have the legal authority to do so.

One possibility could be voluntary labeling by those who sell the fish.

Dr. Joshua M. Sharfstein, the principal deputy commissioner of the F.D.A., said in a statement: "Labeling is one of many issues involved with the review of genetically engineered animals for use in food. As has been publicly reported, the AquAdvantage Salmon is under review by the agency, and as we move forward, we will share information with the public."

Mr. Stotish of AquaBounty said his company was not against voluntary labeling, but the matter was not in its hands because it would only be selling fish eggs to fish farms, not grown salmon to the supermarket.

He said the company had submitted data to the F.D.A. showing that its salmon was indistinguishable from nonengineered Atlantic salmon in terms of taste, color, vitamins, minerals, fatty acids, proteins and other nutrients.

"Our fish is identical in every measurable way to the traditional food Atlantic salmon," Mr. Stotish said. "If there's no material difference, then it would be misleading to require labeling."

Virtually all Atlantic salmon now comes from fish farms, not the wild.

The F.D.A. must also decide on the environmental risks from the salmon. Some experts have speculated that fast-growing fish could out-compete wild fish for food or mates.

Mr. Stotish said the salmon would be grown only in inland tanks or other contained facilities, not in ocean pens where they might escape into the wild. And the fish would all be female and sterile, making it impossible for them to mate.

The F.D.A. is expected to hold a public meeting of an advisory committee before deciding whether to approve the salmon. Typically at such advisory committee meetings, much of the data in support of the drug application is made public and there is some time allotted for public comment.

But Gregory Jaffe, biotechnology project director of the Center for Science in the Public Interest, said such meetings often do not give the public enough time to analyze the data.

Monsanto Soybean Claims Probed by West Virginia

By Jack Kaskey
Bloomberg
June 25,, 2010

Monsanto Co., the world's biggest seed company, is being investigated by West Virginia over possibly misleading growers who were promised improved yields from its new Roundup Ready 2 Yield soybean seeds.

"My office is concerned that West Virginia farmers are paying much higher prices for soybeans with the Roundup Ready 2 trait when the yields do not live up to the claims and do not justify the increased prices," West Virginia Attorney General Darrell V. McGraw wrote in a letter dated June 24 and posted on his website.

Monsanto last year began shifting growers to the new seeds by promising a 7 percent to 11 percent bigger harvest compared with the original Roundup Ready soybean seeds, which lose patent protection in 2014. Iowa State University, Pennsylvania State University, a farmer group and investment researcher OTR Global found the latest seeds failed to boost yields as promised, McGraw said in the letter.

The St. Louis-based company may have engaged in unfair or deceptive acts under West Virginia law and be subject to penalties, McGraw wrote. He invited the company to meet before the state possibly begins litigation.

Monsanto has data demonstrating the improved performance, it said in an e-mailed statement. Roundup Ready 2 soybeans increase yields on average by 3.6 bushels, more than 7 percent, according to 40,000 comparisons the company conducted between 2007 and 2009, it said.

Purchase Decisions

The attorney general's letter "is based on a misunderstanding of our national marketing materials," Monsanto said. "Growers measure the performance of these products on their farm and make their purchase decisions based on what's right for them."

Monsanto fell 74 cents, or 1.5 percent, to $48.27 as of 4:15 p.m. in New York Stock Exchange composite trading. The shares fell 41 percent this year.

Roundup Ready 2 soybeans were planted on 1.5 million acres last year and cost growers $74 an acre, 42 percent more than the older product. West Virginia growers bought enough of the new seeds to plant fewer than 50 acres in 2009, Monsanto spokesman Lee Quarles said. Sales this year aren't yet available, he said.

West Virginia grew about 18,000 acres of the nation's 77.5 million acres of soybeans last year, making it the smallest soybean-growing state tracked by the U.S. Department of Agriculture.

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