Food Law Prof Blog

GE Alfalfa ruling upheld

Yesterday the 9th Circuit Court of Appeals upheld the injunction against planting of Roundup Ready alfalfa issued last year in Geertson Seed Farms. 

The Federal District Court for the Northern District of California had entered an injunction prohibiting the planting genetically engineered alfalfa without preparation of a full Environmental Impact Statement.

The Federal Circuit Court of Appeals for the 9th Circuit upheld the injunction noting that there was no abuse of discretion:

There are no issues of law and we therefore review for
abuse of discretion. See Idaho Watersheds Project v. Hahn,
307 F.3d 815, 823 (9th Cir. 2002). We affirm because the district
court did not abuse its discretion in entering the injunction
after holding one hearing on the nature of the violation
of the National Environmental Policy Act of 1969 (“NEPA”),
42 U.S.C. § 4332(C), and two hearings on the scope of
injunctive relief, as well as reviewing extensive documentary
submissions relating to an appropriate remedy. The injunction
is limited in duration to the time necessary to complete the
EIS. The existence of the NEPA violation is not disputed on
appeal.

Center for Food Safety attorney Andrew Kimbrell represented the plaintiffs.  Here is their press release.

The full opinion is available here: Geertson Seed Farms v. Monsanto, No. 07-16458, No. 07-16492, No. 07-16725, D.C. No. CV-06-01075-CRB, Filed 09-02-2008.

20 US Companies Reject Clones

News Release from the Center for Food Safety:

Washington, D.C., September 3, 2008 – The Center for Food Safety and Friends of the Earth today announced that 20 of America’s leading food producers and retailers have stated that they will not use cloned animals in their food.  The companies include Kraft Foods; General Mills; Gerber/Nestle; Campbell Soup Company; Gossner Foods; Smithfield Foods; Ben & Jerry’s; Amy’s Kitchen; California Pizza Kitchen restaurants; Hain Celestial; Cloverland, Oberweis, Prairie, Byrne, Plainview, and Clover-Stornetta Dairies; and grocers PCC Natural Markets, Albertsons, SUPERVALU, and Harris Teeter.  The move by these companies represents a growing industry trend of responding to consumer demand for better food safety, environmental, and animal welfare standards.

“This rejection of food from clones sends a strong message to biotech firms that their products may not find a market,” says Lisa Bunin, PhD, Campaigns Coordinator at the Center for Food Safety.  “American consumers don’t want to eat food from clones or their offspring, and these companies have realistically anticipated low market acceptance for this new and untested technology.”  This sentiment is echoed by General Mills in their letter to the Center which identified “consumer acceptance” as an important consideration with respect to the potential use of ingredients from clones in their products.

Kraft Foods expressed a similar position in a letter stating that although they defer to the conclusions of the FDA on the safety of ingredients from cloned animals, “product safety is not the only factor we consider in our products.  We must also carefully consider additional factors such as consumer benefits and acceptance...and research in the U.S. indicates that consumers are currently not receptive to ingredients from cloned animals.”

In May 2008, the Center for Food Safety began reaching out to companies involved in the production, use, and sale of meat and milk products, regarding their position on the use of food from clones.  In response, three of the top-earning food manufacturing companies indicated that they will not be using ingredients from clones or their offspring. 

Kraft Foods, North America’s second largest food and beverage company, reported revenue of approximately $37.2 billion in 2007, with products such as Cracker Barrel, Cool Whip, Velveeta, Oscar Meyer, and Philadelphia Cream Cheese.  General Mills, another leading American food processing company, with brands that include Pillsbury, Betty Crocker, Totino’s, Yoplait and Haagen-Dazs, reported revenue of approximately $12.4 billion in 2007.  Gerber/Nestle, a top international food manufacturing company and leader in baby food and infant formula production, whose brands include Carnation, Toll House, Lean Cuisine, and Stouffer’s reported approximately $121 billion in revenue in 2007; Bringing their total revenue for 2007 to $170.6 billion.

Ben & Jerry's Social Mission Director, Rob Michalak, told the Center for Food Safety “Cloning presents a host of complex social, economic and animal welfare consequences.  The decision to approve clones for food use was rushed through, under the radar, without a proper, comprehensive review.  As a result, we now need to establish a national registry and tracking framework so that people know where the clones are.”

Ben & Jerry’s, Amy’s Kitchen, Clover-Stornetta, Oberweis Dairy, Prairie Farms Dairy, Plainview Dairy, PCC Natural Markets, and Hain Celestial have gone one step further by stating that they would not use ingredients from clones or their offspring.  The Center for Food Safety, Friends of the Earth, and the American Anti-Vivisection Society are working to obtain more commitments of this kind.

In addition, Friends of the Earth has worked with top U.S. grocers to determine their policy on the use of cloned animals and their offspring in their food, and presented them with over 8,000 signatures from consumers who reject products made from these animals.  To date, Albertsons, SUPERVALU and Harris Teeter have informed Friends of the Earth that they will not sell products from cloned animals.  SUPERVALU, owner of Shaw’s, Cub Foods, Acme Markets, and partial owner of Albertsons, is the second-ranked grocer in the nation, with a reported 2008 revenue of $44 billion.  Albertsons, which operates more than 300 Albertsons supermarkets nationwide, reported over $40 billion in revenues in 2006.  North Carolina-based grocer Harris Teeter reported $3.3 billion in revenues, supplying upwards of 90% of parent company Ruddick’s profits.

“Grocers are recognizing that people do not want to eat food from cloned animals,” said Gillian Madill, Genetic Technologies Campaigner at Friends of the Earth.  “Food safety authorities must also recognize this and – in keeping with their public interest mandate – enact labeling regulations that allow Americans their fundamental right to choose.”

The American Anti-Vivisection Society, Center for Environmental Health, Center for Food Safety, Citizens for Health, Consumer Federation of America, Consumers Union, Farm Sanctuary, Food & Water Watch, Friends of the Earth, Humane Society of the United States, Organic Consumers Association, Union of Concerned Scientists, and Interfaith Center on Cooperate Responsibility have sent FDA over 150,000 letters from their supporters who oppose the unlabeled introduction of cloned animals and their offspring into the US food supply.

Center for Food Safety:  http://www.centerforfoodsafety.org

Friends of the Earth: http://www.foe.org/

Eli Lilly's Elanco buys Posilac (rBGH) from Monsanto

Earlier this week Monsanto announced that it was selling off it's recombinant bovine growth hormone product, Posilac.  Here is the news release from Eli Lilly, whose Elanco acquired Posilac for $300 million plus contingent consideration (whatever that is).  I don't imagine this makes any difference for anything, but it's all over the green/veggie news sites:

GREENFIELD, Ind., Aug 20, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Elanco, a division of Eli Lilly and Company (NYSE: LLY), today announced that Lilly has signed an agreement to acquire the worldwide rights to the dairy cow supplement, Posilac® (sometribove), as well as the product's supporting operations, from Monsanto Company (NYSE: MON).

"Global dairy demand is increasing, outstripping supply, and consumers are seeing rapidly rising prices," said Jeff Simmons, president, Elanco. "With the purchase of Posilac, Elanco can enhance its overall product portfolio and work together with the industry to provide dairy farmers more options and give consumers affordable choices. Critically, we remain focused on the health and care of the cow in working with farmers to increase global milk supply.

"With our rich history and experience in the dairy industry, Elanco is the ideal steward of this vital technology," Simmons said. "Elanco remains committed to using science to address the growing need for safe, affordable food; and to choices for consumers, retailers and producers."

Elanco has exclusively sold sometribove outside of the United States for a decade. . . .

more of the news release

rBGH results in millk with higher than normal levels of Insulin Like Growth Factor (IGF-1), which some believe contributes to breast and other cancers: Cancer Prevention Coalition

Biofortification for China

Interesting article on genetically engineered crops in China -- Biofortification for China: Political Responses to Food Fortification and GM Technology, Interest Groups, and Possible Strategies, by Carl Pray (Rutgers University) and Jikun Huang (Chinese Academy of Sciences), 10(3) AgBioForum 161 (2008).

The article points out that "China was the first country to introduce a transgenic crop for commercial production.  Virus-resistant tobacco was first planted by farmers in 1992. Tomatoes with a long shelf life and resistance to virus, sweet peppers with virus resistance, and color-altered GM petunias were also grown in small amounts starting in the mid-1990s."

Abstract: Despite making enormous strides in reducing poverty, hunger, and malnutrition, China still has large numbers of people who do not consume sufficient micronutrients such as iron, zinc and Vitamin A. To meet this need, government agencies in China are supporting programs in industrial fortification and vitamin supplements. In recent years the government has also supported research on biofortification of major grain crops using both conventional plant breeding and transgenic techniques. The article assesses the potential political barriers to the acceptance of biofortified crops and concludes that biofortification using non-transgenic techniques would probably not face much opposition, while biofortification with transgenic techniques might have a more difficult time. The article then assesses which groups in China are likely to support or oppose biofortification and then proposes some strategies that the government and international agencies might use if they decide to support biofortification.

Pray, C., & Huang, J. (2007). Biofortification for China: Political responses to food fortification and GM technology, interest groups, and possible strategies. AgBioForum, 10(3), 161-169. Available on the World Wide Web: http://www.agbioforum.org.

Article: Litigating the Economic Effects of Biotech Crops

Thomas P. Redick (Global Environmental Ethics Counsel) and A. Bryan Endres (U. Illinois -- Agriculture) have published Litigating the Economic Effects of Biotech Crops, 22 SPG-Nat. Res. & Env't 24 (2008).  The article begins:

The past year has seen groundbreaking litigation in agricultural biotechnology that could make future U.S. federal regulatory approval for biotech crops more difficult to secure and leave clouds of potential liability for those crops that pass the federal approval hurdle. The hottest news in biotech crop regulation and liability is the pending litigation regarding the economic impacts of novel crop varieties approved for use in the United States. This looming threat of economic impact liability raises potential regulatory and commercial barriers to entry. If the final resolution of these cases requires consideration of potential economic impacts in addition to the existing health and environmental reviews conducted prior to regulatory approval, the bar will be raised not just for commercial marketing of biotech crops, but possibly for similar technologies (e.g., nanotechnology and chemicals) that enter the global marketplace and can cause analogous impacts (e.g., food recalls or environmental remediation).

This is primarily a tale of two pending cases--one federal case on appeal in California and another just getting started in St. Louis, Missouri--and the implications of this litigation. Biotech crop litigation also demonstrates how traditional common law tort theories of liability can be commingled with claims based on environmental law and regulation.

Ben and Jerry's v. rBGH

Ben and Jerry’s Ice Cream – famous purveyors of flavored pints such as Chubby Hubby and Chunky Monkey – has launched a national campaign  against state legislative efforts to prohibit the labeling of dairy products for rBGH (Recombinant Bovine Growth Hormone) content.

From the Minneapolis Star Tribune:

"We're very concerned about, from a primary standpoint, the freedom of speech to be able to put what we believe is truthful and appropriate messaging on our packaging," said Rob Michalak, a spokesman for Ben & Jerry's, which has mounted a campaign to get consumers on its side.

The StarTribune article says a newly formed farmers' group,  AFACT -- American Farmers for the Advancement and Conservation of Technology, allegedly backed by Monsanto, is pushing for labeling changes because the hormone-free labels imply that the milk is safer than other milk, when the group argues it is not.

Links to other state efforts to ban rBGH labeling:
Pennsylvania’s revisions to its ban on labeling milk (blogged here)
Indiana legislation providing that dairy products are misbranded if they contain “claims that cannot be confirmed through laboratory analysis.

Thank you to William Mitchell College of Law student Jessica Webster, who prepared this post.

PA won't ban rBGH-free label after all

From a Center for Food Safety press release:

The Pennsylvania Department of Agriculture (PDA) has backed down from a controversial ban on the use of labels on milk products. The agency had issued new rules in October (blogged here), set to go into effect February 1st that would have barred dairy companies or milk producers from labeling their products as from cows not treated with rBGH. PDA argued that a misleading impression might be conveyed by identifying milk as coming from cows not treated with synthetic hormones. Pennsylvania would have been the first state to implement such a labeling ban.

Yesterday the Pennsylvania Department of Agriculture released revised regulations.  The revised regulations, in response to consumer outcry, do not ban the "not treated with rBST" information:   

(B) Permitted Claims. The following claims are permitted:

i. RBST. If the product is represented as, or intended to be represented to consumers as, containing or produced from milk from cows not treated with rBST:

1. “From cows not treated with rBST. No significant difference has been shown between milk derived from rBST-treated and non-rBST-treated cows” or a substantial equivalent. Hereinafter, the first sentence shall be referred to as the “Claim,” and the second sentence shall be referred to as the “Disclaimer.”

a. A substantial equivalent Claim would include, for example: “Produced without the use of rBST” instead of “From cows not treated with rBST.”

b. The phrase “Farmer’s Pledge” may precede any such Claim, provided that what follows clearly articulates a difference in farming practices or dairy herd management methods and does not state or imply a compositional difference between milk from rBST-treated and non-rBST treated cows. An example of a permissible pledge would be “Our farmers pledge not to use rBST.”

c. Wherever used in 7(B), the term rBST shall also include the terms rBGH, artificial bovine growth hormone, artificial growth hormone, synthetic bovine growth hormone, synthetic growth hormone, and their plurals.

Watching for Clones

We're back from a short vacation.  By now it is not news that the Mikulski-Spector amendment to the Farm Bill passed by the Senate last month requires the FDA to wait before approving meat and milk from clones and their progeny. (Read about it at Center for Food Safety.)

And it probably is not news that the Wall Street Journal thinks the FDA may go ahead and approve the sale of clone products any day now.  (Read the Wall Street Journal article.)

I may well become a vegan.  Either way, I can't wait to see what happens.

USDA -- Monsanto GE seed corn deal

From the Dec. 26 Chicago Tribune --

Seed Controversy Sprouts, by Stephen J. Hedges

While the federal government doesn't usually endorse products, the U.S. Department of Agriculture has struck an unusual arrangement with agribusiness giant Monsanto Co. that gives farmers in Illinois, Indiana, Iowa and Minnesota a break on federal crop insurance premiums if they plant Monsanto-brand seed corn this spring.

The arrangement has raised some eyebrows, particularly among organic farm groups that argue the government agency should not be promoting corn that contains an herbicide; the Monsanto brands contain chemicals that kill weeds and insects.

more

Synthetic biology -- manmade life to make bug-made fuel

Last week the Washington Post carried an interesting article on "synthetic" biology: Synthetic DNA on the Brink of Yielding New Life Forms, by Rick Weiss.  Not exactly food, but worth reading.

Excerpt:

. . . Scientists in Maryland have already built the world's first entirely handcrafted chromosome -- a large looping strand of DNA made from scratch in a laboratory, containing all the instructions a microbe needs to live and reproduce.

In the coming year, they hope to transplant it into a cell, where it is expected to "boot itself up," like software downloaded from the Internet, and cajole the waiting cell to do its bidding. And while the first synthetic chromosome is a plagiarized version of a natural one, others that code for life forms that have never existed before are already under construction.

more

Consumers protest PA ruling on milk labels -- want info on rBGH

From a press release from Goodman Media and Consumers Union:

Sixty-Five Consumer, Environmental Groups and Dairies Urge Pennsylvania Governor Rendell to Rescind Ban on Milk Hormone Labeling; Consumers Want to Know About Hormone Use on Dairy Cows

More than 65 dairy farmers, consumer, farm and agricultural, public health, animal protection and environmental organizations, food processors and retailers today wrote to Pennsylvania Governor Edward G. Rendell to protest the recent Pennsylvania Department of Agriculture (PDA) action which would prohibit state farmers from telling consumers that they aren’t using artificial hormones on their dairy cows. A copy of the letter can be found here:

http://www.consumersunion.org/campaigns//notinmyfood/005230indiv.html

In late October, PDA informed 16 dairies that they cannot use certain labels on milk, including “Our farmers’ pledge: no artificial growth hormones,” “From cows not treated with the growth hormone rBST,” and “free of artificial growth hormones.” The ban on using these labels will go into effect on February 1, 2008.

read more

Gary Marchant speaks on The Role and Rule of Law in the Global Development of Food Biotechnology at Oregon State

Gary Marchant (Arizona State) is speaking today on “The Role and Rule of Law in the Global Development of Food Biotechnology,”  as part of the Food for Thought lecture series at Oregon State University.  From the Corvallis Gazette-Times:

Are genetically modified foods safe? Should biotechnology products have special labels? Under what circumstances can nations restrict imports of modified foods? Should genes and modified organisms be patented? These and other difficult questions about biotechnology are ultimately decided by the law. Marchant’s talk will examine the capability of law to decide such issues in a fair, scientifically credible, and socially acceptable manner.

Biotech Wheat?

Reuters article posted on CheckBiotech.org:

Time is right for biotech wheat - U.S. growers

By Carey Gillam

KANSAS CITY, Mo. - The time is right for a renewed push for biotech wheat, leading U.S. wheat industry players said this week, as tight world wheat supplies and high prices underscore strong global demand for the key food crop.  . . . Wheat industry players say they have warned for years that wheat acres were in decline because a lack of technology to deal with troubling weather, weeds and disease. And years of reluctance by wheat buyers to embrace genetically modified wheat has made any immediate help impossible, say technology providers. There are still many hurdles to acceptance of biotech wheat, but industry leaders expressed fresh hope that the current squeeze can generate acceptance for gene technology that could make wheat more profitable for farmers to grow and thus more plentiful. more

LA Times on Biotech foods

The Los Angeles Times science section ran an interesting piece on biotech foods.  There's not really anything new, but it describes the issues pretty well (IMHO):

Biotech foods are still hard to swallow, by Elena Conis

OPPONENTS call them Frankenfoods, man-made aberrations that should be banished from our grocery stores or at least clearly labeled so consumers know what they're eating.

Supporters have long cast genetically modified foods in a different light: as answers to human problems. They would, the dream went, make crops that didn't rot, spoil or succumb to frost. They would boost harvests, feed the hungry and fortify the malnourished.

Several decades later, very few of those goals have been realized. Yet today, largely unbeknownst to most consumers, more than 70% of processed foods on grocery store shelves contain genetically engineered or biotech ingredients.

More

Transgenics Transformed

Scientists are hard at work developing better transgenic technology.  From Innovations Report:

In the October 19, 2007, issue of PLoS-Genetics, a team of academic and commercial researchers show that their "maize mini-chromosomes" (MMC) can introduce an entire "cassette" of novel genes into a plant in a way that is structurally stable and functional. Early results, the study authors say, "suggest that the MMC could be maintained indefinitely."

. . .

The production of transgenic plants, including maize, has historically relied on techniques that integrate DNA fragments into a host chromosome. This can disrupt important native genes or lead to limited or unregulated expression of the added gene.

The new technique inserts a whole mini-chromosome instead of just DNA fragments.

The study itself is posted on the peer-reviewed, online journal, PLoS-Genetics website: Meiotic Transmission of an In Vitro–Assembled Autonomous Maize Minichromosome.

And here is the Innovation Report article, Transgenics Transformed.

National Center for Food and Agriculture Policy report on biotechnology

The National Center for Food and Agriculture Policy website includes its 2006 Update of Impacts on US Agriculture of Biotechnology-Derived Crops Planted in 2005, a quantitative analysis of the use of transgenic crops in the U.S.  The National Center for Food and Agriculture Policy board includes both university and industry representatives.  Projects are designed to illustrate the value of herbicides, the benefits of pesticide use, and the improvement in crop production due to transgenic crops.  Project funding comes from industry and other sources.  From the NCFAP website:

Biotechnology Assessment Program

NCFAP’s Biotechnology Assessment Program encompasses studies that analyze the potential of transgenic plants to improve pest management in the United States. NCFAP plays a unique role in the biotech debate because transgenic plants deliver pest control benefits. NCFAP’s extensive experience assembling and analyzing pesticide use data forms a strong basis for preparing these studies. NCFAP’s projects can best be described as educational in focus because they shape the basis to understand why US farmers have embraced biotechnology and are likely to continue to do so. NCFAP’s intent is to prepare concise, definitive, non-technical summaries of the technology and the reasons that farmers have chosen to plant millions of acres with transgenic plants. 

NCFAP researchers began the Biotechnology Assessment Program before the first transgenic crops were commercialized. In the early 1990s, NCFAP researchers estimated the potential benefits that herbicide tolerant soybeans and cotton would provide once they were commercialized. Following the widespread adoption of genetically-engineered corn, soybeans and cotton plants in the mid-1990s, NCFAP researchers prepared a series of in-depth assessments of the aggregate national impacts through 1999 including changes in yield, production costs, and pesticide use. The Rockefeller Foundation and Biotechnology Industry Organization (BIO) financially supported these efforts.

UK scientists plan to create human-cow embryos

This is not exactly food, but the technology is pretty much the same as the technology for cloning animals that would be used for food.  The following is from a BBC News article by Fergus Walsh:

UK scientists have applied for permission to create embryos by fusing human DNA with cow eggs. . . .The hybrid human-bovine embryos would be used for stem cell research and would not be allowed to develop for more than a few days.

Stem cells are the body's master cells and five-day-old embryos are packed with them - each with the potential to turn into any tissue in the body.

It is this ability which scientists want to harness to treat diseases such as Parkinson's Disease, strokes and Alzheimer's Disease.

To do that, they say they need to have access to thousands of embryos for research.

Short supply

The problem is that human eggs for research are in short supply and to obtain them women have to undergo surgery.

That is why scientists want to use cows' eggs as a substitute.

They would insert human DNA into a cow's egg which has had its genetic material removed, and then create an embryo by the same technique that produced Dolly the Sheep.

The resulting embryo would be 99.9% human; the only bovine element would be DNA outside the nucleus of the cell.

Read the rest of the article

Maybe the  George the singing cow Ben and Jerry'sisn't so far off the mark. 

Other singing cows: PETA anti-leather commercial

ISIS Comments on Genetically Engineered Crop Regulation

The Institute for Science in Society has posted its comments on USDA APHIS's Draft Environmental Impact Statement for proposed changes to regulations on Introduction of Organisms and Products Altered or Produced Through Genetic Engineering. 

APHIS is accepting comments through September 11, 2007. The Call for Comments can be found in the Federal Register Vol. 72, No. 136 for Tuesday, July 17, 2007, Docket No. APHIS-2006-0112. 

Related links:

• USDA-APHIS Fact Sheet
• APHIS Stakeholders Announcement
• Draft EIS (pdf)
• Institute for Science in Society Comments

Biotech Industry Plans New Standards

Reuters story by Carey Gillam via Checkbiotech.org:

U.S. biotech crop companies on Wednesday unveiled a plan for new industry standards at a time when the sector faces unfavorable court rulings and concerns that lax government oversight is allowing contamination of crops used in food and animal feed.

Leaders of the Biotechnology Industry Organization (BIO) and executives with Monsanto Co. and DuPont Co., two biotech crop giants, said they hoped the plan, which includes third-party auditing, will help agricultural players around the world feel confident that biotech crop development is subject to stringent safety standards. . . .

U.S. regulators have encouraged the trend, agreeing with corporate backers who say science shows GMO crops are as safe as conventional crops and essentially identical in nutrition and food traits. But many consumer and environmental groups and governments around the world fear the crops can cause human and animal health problems as well as weed resistance and other environmental problems.

more

New fruit fly gene from "out of nowhere"

Cornell University researchers have discovered a fruit fly gene from 'out of nowhere.' They report that this may change ideas about how new genes are formed.  And here we thought we already knew everything about how genes behave.  From the Cornell Chronicle:

"This is a de novo -- 'out of nowhere' -- gene," said Hsiao-Pei Yang, a senior research associate in Cornell's Department of Molecular Biology and Genetics and senior author of a paper published in the July 6 issue of the online journal PLoS Genetics (Public Library of Science Genetics). "People used to think that new genes were always formed from tinkering with other genes, but with this gene we can find no homologues [genes with a similar structure]. You cannot find any related genes in the fly genome or any species' genome, and that is what is unique."

. . .

The researchers do not yet know how the hydra gene was created, but they speculate that the gene may have developed from a piece of DNA junk called a transposable element (also known as a "jumping gene"), which may have been inserted into the genome by a virus. These transposons are known to copy and insert themselves into DNA sequences. For example, one theory is that when a transposon sits next to a gene and then jumps to a new location, it carries part of the gene sequence it was next to and inserts it in the new location.

Interesting.  Viruses are sometimes used intentionally to "splice" genes:

Viruses can also act as vectors in genetic engineering. Viruses are infectious particles that contain genetic material to which a new gene can be added. The virus can carry the new gene into a recipient cell in the process of infecting that cell. The virus can also be disabled so that while it can carry a new gene into a cell, it cannot redirect the cell's genetic machines to make thousands of copies of itself.

Union of Concerned Scientists, Genetic Engineering Techniques

Genetically Engineering Corn to Self-Destruct

According to an article by Michael Schirber on Checkbiotech Green, Scientists at Michigan State are developing strains of corn that can more efficiently provide biofuel.  The idea is to have the corn make cellulase, an enzyme that breaks down cellulose, in order to make the otherwise unusable parts of the corn plant suitable for ethanol production.  It is possible to make ethanol from cellulose, but it is expensive.

"Converting biomass would add value to the corn residues that are currently not used," said genetic engineer Mariam Sticklen of Michigan State University.Professor Sticklen's engineered corn could help by making its own cellulase and storing it in isolated regions. Fortunately for the plant, the enzymes would only start degrading cellulose when the plant is crushed up and heated.

But breaking down corn leaves and stalks into usable sugars is expensive. To help reduce costs, Sticklen and her colleagues have genetically tailored corn plants to manufacture the necessary enzymes in their own tissues.

This would streamline production and increase the harvest value for farmers. Sticklen's team were issued a patent for their corn in 2006, and currently three undisclosed companies have expressed an interest in licensing it, Sticklen told LiveScience.

Article: Corn stalks engineered to self-degrade into fuel

Genetically Engineered Biofuel

An article by Kevin Bullis on Technologyreview.com reports that "researchers have genetically engineered transgenic corn plants that produce enzymes that can turn their leaves and stems into sugar by breaking down cellulose."  This would make  biofuel production less expensive.  Environmental effects are still uncertain:

[I]n-plant production of enzymes comes with its own challenges.

One of these challenges, according to James McMillan, a principal group manager at the National Renewable Energy Laboratory, in Golden, CO, is ensuring that the transgenic plants don't have negative environmental effects. For example, if plant matter containing these enzymes was left in the field, it could change ecosystems by making sugar more readily available to microorganisms.

Read the article: Cheaper, Cleaner Ethanol from Biotech Corn

EU to debate three new GMO applications

Checkbiotech.org:

BRUSSELS - EU biotech experts will discuss three applications this week to approve new genetically modified (GMO) plants but are unlikely to break the bloc's longstanding deadlock on GMO foods, officials said on Wednesday.

The applications, to authorize two modified maize hybrids and one GMO sugar beet, do not relate to cultivation in Europe.

Experts representing the EU's 25 national governments will discuss and possibly vote on the applications. But they were not expected to reach the required consensus under the EU's weighted voting system either to approve or reject them, officials said.

Cloned genetically engineered cows to produce Insulin in Argentina

Argentina already allows clones.  Argentine scientists say they have produced four genetically modified cloned calves that can produce human insulin in their milk.  This will provide a cheaper source of insulin to treat type-1 diabetics.

From checkbiotech.org:

To produce pharmaceutical products from cow's milk, scientists insert the human gene of interest into an embryo before implanting it into a surrogate mother cow. In this case they used a gene for insulin.

Once milk is obtained from the genetically modified cow, it will be purified and refined to extract the insulin. Similar techniques have already been used to produce human proteins in goats and cows.

Argentina, the world's third-biggest beef exporter, is famous for its sweeping Pampas grazing lands and it is one of a handful of countries to have cloned livestock.

Caruso on "How to Confine the Plants of the Future"

Denise Caruso (hybridvigor.org) published a column in the New York Times this week on the risks and challenges of genetically engineered "pharma" crops.

The plants produce medicinal substances like insulin, anticoagulants and blood substitutes. They produce vaccine proteins for diseases like cholera, as well as antibodies against tooth decay and non-Hodgkin’s lymphoma. Enzymes and other chemicals from the plants can be used for a range of industrial processes.

As in past debates over genetically modified crops, biotech developers say that the benefits outweigh the risks, and that the risks are manageable. Critics question the benefits, and say the risk of a contaminated and potentially toxic food supply is untenable.

Who Saw This Coming? -- Glyphosate Resistant Weeds

This is from the Union of Concerned Scientists Food and Environment news page:

Glyphosate resistance popping up in weeds
A decade after the introduction of crops genetically engineered to tolerate the herbicide glyphosate (Roundup Ready crops), farmers are noticing glyphosate-resistant weeds in their fields. At first, farmers who planted herbicide-tolerant crops were able to kill weeds with a single application of glyphosate. But now, thanks to natural selection, even after repeated applications of glyphosate, herbicide-resistant weeds keep growing. . . .

Read more

Monsanto Again Seeking to Eliminate non-rBST Labels

Evidently consumers have been expressing a preference for milk from cows that have not been treated with rBST, and rBST maker Monsanto has noticed.

Monsanto issued a press release this week announcing a letter campaign to get the FDA to disallow current non-rBST labelling practices:

"The people who signed these letters are dairy producers, industry professionals and consumers from across the country who have expressed concerns about specific labels they find to be false or misleading," said Kevin Holloway, president of Monsanto Dairy Business. "In many cases, they came to Monsanto to find out what could be done about milk marketing tactics that disparage milk and deny farmers a choice in using approved technologies. We believe FDA and FTC are the correct agencies to address the matter with the companies who employ misleading labels or promotions."

The letter to the FDA highlights deceptive milk labels and calls for clear guidance and enforcement by FDA to address labeling that disparages milk from cows supplemented with POSILAC. The letter to the FTC outlines deceptive advertising and milk promotions that mislead consumers and requests FTC begin an investigation into the challenged practices. Specific examples of misleading labels and ads are cited and attached to the letters. Letters and attachments are available at http://www.monsanto.com/posilac/letters.

Monsanto submitted the first set of signed letters on behalf of all who signed them in February and continues to compile additional letters as dairy producers and others sign them.

FDA Extends Comment Period for Cloning Approval

FDA news release:

The U.S. Food and Drug Administration (FDA) today announced an extension  to May 3, 2007, of  the comment period of the notice of availability  that appeared in the Federal Register of January 3, 2007, (72 FR 136).   In the notice, FDA requested comments on the draft risk assessment; the proposed risk management plan; and the draft guidance for industry on animal cloning.  The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

To submit electronic comments on the three documents, visit http://www.fda.gov/dockets/ecomments.  

The Federal Register Notice is located at:  http://www.fda.gov/OHRMS/DOCKETS/98fr/2003n-0573-nec0001.pdf.

Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must be received May 3, 2007, and should include the docket number 2003N-0573.

For more information, visit http://www.fda.gov/cvm/CloneRiskAssessment.htm.  

Roundup Ready Alfalfa is Regulated Again

In response to a March 12 federal district court injunction, USDA/ APHIS announced that Roundup Ready alfalfa is once again a regulated article.  According to APHIS:

The court did not overturn federal conclusions regarding the safety of the crop for food and feed purposes, but rather concluded that APHIS had not adequately documented potential environmental impacts.  A future decision regarding the deregulation of RR alfalfa will be issued only after the completion of an appropriately documented environmental analysis.

The District Court's discussion was a bit more pointed than the APHIS press release suggests, and did seem to question the conclusions:

APHIS’s reasons for concluding that the potential for the transmission of the genetically engineered gene is not significant are not “convincing” and do not demonstrate the “hard look” that NEPA requires. APHIS did not conclude that gene transmission would not occur; indeed, an internal APHIS email acknowledges that “[i]t may be hard to guarantee that seeds or sprouts are GE free.” Instead, it in effect concluded that whatever the likelihood of gene transmission, such impact is not significant because it is the organic and conventional farmers’ responsibility to ensure that such contamination does not occur. It rested its “no significant impact” decision on this conclusion even though it made no inquiry into whether those farmers who do not want to grow genetically engineered alfalfa can, in fact, protect their crops from contamination, especially given the high geographic concentration of seed farms and the fact that alfalfa is pollinated by bees that can travel more than two miles. Neither the EA nor the FONSI identify a single method that an organic farmer can employ to protect his crop from being pollinated by a bee that travels from a nearby genetically engineered seed farm, even assuming the farmer maintains a “buffer zone.”

USDA Clarifies Policy on Low-level Presence of Genetically Engineered Material

USDA APHIS news release:

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service is clarifying the existing approach for handling situations in which regulated genetically engineered (GE) plant material becomes mixed at low levels with commercial seeds and grain.

This policy is not new, but rather a description of how APHIS currently evaluates and responds to these incidents.  In light of continuing international discussions regarding low-level presence (LLP), APHIS is taking this opportunity to formally state our approach. 

European Patents for Conventional Rice?

Interesting article on checkbiotech.org:  Indian farmers against patenting of seeds, by Ashok B. Sharma:

The Munich-based European Patent Office (EPO) has now become the target of attack as it has already granted hundreds of patents on genetically modified (GM) seeds as well as on seeds developed through conventional breeding process.

Further the EPO has on its agenda for according general approval of patent rights over conventional breeding methods and normal plants and animals. EPO’s decision to accord such patent rights flows from the ruling of its Enlarged Board of Appeal which is also set to decide on the validity of a patent on Broccoli (EP 1069819 B1), this year.

“The approval of this patent would mean that in future a mere genetic description of a plant or animal would be sufficient to get a patent right covering the plant or animal as well as methods of their breeding. Thus the use of plants and animals would be controlled by the patent holders,” said Krishan Bir Chaudhary, the executive chairman of India’s largest farmers’ organisation.

Commercial Cloning is Here Now

Viagen, Inc., which offers livestock cloning services, encourages its customers to comply with the voluntary moratorium on meat and milk from cloned animals.  But the moratorium is on using cloned animals for food, not for cloning them in the first place.

Cloning is alive and well, but not yet profitable.  Bloomberg.com has an article on the subject

Cloned Cattle Yield Test-Tube Herds for U.S. Sirloins (Update2)
By Catherine Larkin

March 27 (Bloomberg) -- Mark Walton, head of the world's largest animal cloning company, sees his biotechnology lab in Austin, Texas, as the next frontier in food production.

Nine months ago, scientists at Walton's closely held ViaGen Inc. extracted genetic information from customers' prized cattle and transferred the DNA into bovine eggs to make embryos. Now, 75 miles away at the 300-acre Hillman Ranch in the town of Cameron, surrogate mother cows, carrying the embryos, are giving birth to calves that are clones of the clients' finest cattle.

Not Ready For Prime Time: CFS Report Criticizes FDA's Risk Analysis on Clones

The public comment period for the FDA's proposed approval of meat and milk from cloned animals ends April 2.  A report by the Center for Food Safety concludes that the FDA approval process is flawed:

http://www.centerforfoodsafety.org/pubs/NotReadyForPrimeTime_ExecSummary.pdf. 

Our analysis finds that FDA’s conclusion of safety is based upon scant data from few peer-reviewed studies. Furthermore, the Agency’s assessment of the data is slanted, information is selectively reported to fit predetermined conclusions, and FDA fails to consider possible side-effects of cloning that independent scientists, including the National Academy of Sciences (NAS), say should be considered in a regulatory review. Also troubling is our finding that FDA’s assessment relies heavily on unpublished data from two cloning companies who have a financial interest in FDA approval, and on studies that make use of this same data.

Our review of FDA’s risk assessment finds that for direct studies of meat or milk, the agency based its “safety” finding on the following:

• FDA found no peer-reviewed studies on meat from cloned cattle 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.

Essay on Labeling of Clones

Rebecca Spector of the Center for Food Safety has published a thoughtful essay on labeling of cloned meat products.  The essay appears in GEN Genetic Engineering and biotechnology News.  It begins:

Since a sheep named Dolly made headlines in 1997, a public debate has swirled around the issues and implications of her very existence. Much of that discourse has shed more heat than light on the issue of cloning, with the result being that the public is confused, feels misled, and has become increasingly concerned about what’s in their food. While this discussion is unavoidable, one might argue that it needs to be based less on emotion and more on better information.

Link to article

California Rice Industry Moratorium on Transgenic Rice

Because of discoveries in recent months that transgenic rice traits have been discovered in non-GMO rice, the California rice industry is self-imposing a moratorium on engineered rice.  From the California Rice Commission press release:

The California Rice Commission voted [Wednesday (3/14)] to support a moratorium “on the field testing of all genetically modified (GM) rice cultivars in the State of California for the 2007 crop, and for future crops, until such time as research protocol and safeguards are acceptable to the California Rice Commission."

It is the position of the industry that a moratorium on GM field testing in California would allow for an opportunity to evaluate federal regulations that safeguard the rice industry.

Direct link to the press release.

More on pharma rice with human genes

A Chicago Tribune blog post by Julie Deardorff looks at genetically engineered rice using human genes.  The controversy surrounds growing such "pharma" crops outdoors, where the engineered genetic material could spread to non-engineered crops.

Table of Genetically Engineered Foods

The website of the Union of Concerned Scientists includes an interesting table of Genetically Engineered Food and Feed Allowed on the Market.  The table provides not only the product and the date allowed on the market, but also the sources of the new genes, whether bacteria, virus, or some other plant.

The table does not contain any plants with genes from human sources (although such crops have been planted) because they are not grown for food.  The UCS website also includes a crop by crop list of genetically engineered crops approved for planting, including GE crops grown for pharmaceutical or industrial purposes (rather than for food).  Rice has been genetically engineered with human genes to produce bacteria-fighting compounds present in breast milk and saliva, which are useful in treating diarrhea and dehydration.  Plantings have been approved in California, North Carolina, and Hawaii according to the UCS online database.

DuPont to Open Plant Biotech Research Center in India

According to a DuPont press release, the company will open the first major plant biotech research center outside the US.  The company cites strong global demand for agricultural products and an ability to get to market faster as the reasons for an overseas biotech center.

"DuPont today has major plant biotech research centers in Delaware, Iowa and California, along with 90 plant genetics research centers around the globe. Plant biotech scientists at the DuPont Knowledge Center will develop biotech traits and technologies that will be incorporated into multiple crops for markets around the world. The trait discovery work conducted on site will help create advanced seed products to meet the growing global demand for increased food production, improved animal feed products and expanding energy needs."

While I have focused mostly on domestic food law issues, I now find myself wondering how the regulatory climate in India differs from the regulatory climate in the US.  Are the advantages of an overseas lab just geographical? Or are the rules for field testing and approval different as well?  (Now there's a nice independent research topic for someone!)

Pioneer Hi-Bred wins Patent Infringement Suit on GE soybeans

DuPont subsidiary Pioneer Hi-Bred has won a patent infringement suit regarding its genetically engineered soybean markers.  From the Pioneer Hi-Bred press release:

The United States District Court for the Southern District of Iowa in Des Moines issued a consent judgment holding that Pioneer patents 5,491,081; 6,162,967; and 6,538,175 were valid and had been infringed by GAAB. The patents are for the process that uses molecular markers to select soybean varieties resistant to soybean cyst nematode (SCN). . . .

Soybean cyst nematode is responsible for $870 million in annual losses to growers in North America. To help growers combat this pest, Pioneer has developed high-yielding SCN-resistant varieties in its product lineup through the use of molecular markers.