Monday, February 27, 2012

Fed Court dismisses OSGATA vs Monsanto; enables genetic contamination of organics

Judge Sides With Monsanto

Ridicules Farmers’ Right to Grow Food Without Fear, Contamination and Economic Harm

By Organic Seed Growers and Trade Association

On February 24, Judge Naomi Buchwald handed down her ruling on a motion to dismiss in the case of Organic Seed Growers and Trade Assn et al v. Monsanto after hearing oral argument on January 31st in Federal District Court in Manhattan.  Her ruling to dismiss the case brought against Monsanto on behalf of organic farmers, seed growers and agricultural organizations representing farmers and citizens was met with great disappointment by the plaintiffs.

Plaintiff lead attorney Daniel Ravicher said, “While I have great respect for Judge Buchwald, her decision to deny farmers the right to seek legal protection from one of the world’s foremost patent bullies is gravely disappointing.  Her belief that farmers are acting unreasonable when they stop growing certain crops to avoid being sued by Monsanto for patent infringement should their crops become contaminated maligns the intelligence and integrity of those farmers.  Her failure to address the purpose of the Declaratory Judgment Act and her characterization of binding Supreme Court precedent that supports the farmers’ standing as ‘wholly inapposite’ constitute legal error.  In sum, her opinion is flawed on both the facts and the law.  Thankfully, the plaintiffs have the right to appeal to the Court of Appeals, which will review the matter without deference to her findings.”

Monsanto’s history of aggressive investigations and lawsuits brought against farmers in America have been a source of concern for organic and non-GMO farmers since Monsanto’s first lawsuit brought against a farmer in the mid-90′s.  Since then, 144 farmers have had lawsuits brought against them by Monsanto for alleged violations of  their patented seed technology.  Monsanto has brought charges against more than 700 additional farmers who have settled out-of-court rather than face Monsanto’s belligerent litigious actions. Many of these farmers claim to not have had the intention to grow or save seeds that contain Monsanto’s patented genes. Seed drift and pollen drift from genetically engineered crops often contaminate neighboring fields. If Monsanto’s seed technology is found on a farmer’s land without contract they can be found liable for patent infringement.

“Family farmers need the protection of the court,” said Maine organic seed farmer Jim Gerritsen, President of lead plaintiff OSGATA.  ”We reject as na├»ve and undefendable the judge’s assertion that Monsanto’s vague public relations ‘commitment’ should be ‘a source of comfort’ to plaintiffs. The truth is we are under threat and we do not believe Monsanto.  The truth is that American farmers and the American people do not believe Monsanto. Family farmers deserve our day in court and this flawed ruling will not deter us from continuing to seek justice.”

The plaintiffs brought this suit against Monsanto to seek judicial protection from such lawsuits and challenge the validity of Monsanto’s patents on seeds.

“As a citizen and property owner, I find the Order by the Federal Court to be obsequious to Monsanto,” said plaintiff organic farmer Bryce Stephens of Kansas.  ”The careless, inattentive, thoughtless and negligent advertisement Monsanto has published on their website to not exercise its patent rights for inadvertent trace contamination belies the fact that their policy is in reality a presumptuous admission of contamination by their vaunted product on my property, plants, seeds and animals.”

“Seeds are the memory of life,” said Isaura Anduluz of plaintiff Cuatro Puertas and the Arid Crop Seed Cache in New Mexico.  ”If planted and saved annually, cross pollination ensures the seeds continue to adapt. In the Southwest, selection over many, many generations has resulted in native drought tolerant corn.  Now that a patented drought tolerant corn has been released how do we protect our seeds from contamination and our right to farm?”

A copy of Judge Buchwalds ruling is located here

About OSGATA: The Organic Seed Growers and Trade Association is a not-for-profit agricultural organization made up of organic farmers, seed growers, seed businesses and supporters. OSGATA is committed to developing and protecting organic seed and it’s growers in order to ensure the organic community has access to excellent quality organic seed free of contaminants and adapted to the diverse needs of local organic agriculture. www.osgata.org

Monday, February 6, 2012

Dean Foods, Biotech, USDA Conspiring to Pollute Organics

By Cornucopia
Largest Corporate Dairy, Biotech Firm and USDA Accused of
Conspiring to Corrupt Rulemaking and Pollute Organics
Watchdog Requests Federal Investigation, Files Ethics Charges
WASHINGTON, DC: The Cornucopia Institute, an organic industry research and watchdog organization, announced it has formally requested the USDA’s Office of Inspector General (OIG) to investigate corruption at its National Organic Program resulting in the use of illegal synthetics in organic food and then allowing powerful corporations to “game the system” for approval “after the fact.”
The controversy surrounds products developed by Martek Biosciences Corporation. Martek, part of a $12 billion Dutch-based conglomerate, recently petitioned for approval of its genetically modified soil fungus and algae as nutritional supplements in organic food.
Martek’s formulated oils are processed with synthetic petrochemical solvents in a blend containing a myriad of other synthetic chemicals. Supplements derived from these oils, commonly marketed as DHA and ARA, are being added to milk, infant formula and other organic foods by such companies as Dean Foods (Horizon), Abbott Laboratories (Similac) and Nurture, Inc. (Happy Baby).
“This is a long-standing controversy that the USDA seems to think is just going to go away,” said Mark A. Kastel, Codirector of the Wisconsin-based Cornucopia Institute
After a formal legal complaint by Cornucopia, and an investigative story by the Washington Post, the USDA announced in April 2010 that it had “inappropriately” allowed Martek oils to be included in organic foods.
The scandal contributed to the removal of the previous director of the National Organic Program (NOP), who overruled her staff’s decision finding Martek supplements were illegal in organics—after she met with a prominent Washington lobbyist, William J. Friedman.
The former NOP director’s decision was reversed in April 2010. But instead of immediately ordering the removal of these unapproved synthetics from organic food, the Obama/Vilsack administration at the USDA delayed enforcement by 18 months in an apparent effort to permit corporate lobbyists to properly petition for review and possibly legal inclusion in organic food.
“It’s unacceptable that these materials are still in organic food and that corporations think they can manipulate the system and get away with it,” said Kastel. “It’s even worse because, according to our research and reports at the FDA, some babies have become ill after consuming Martek supplements in infant formula.”
In December, the National Organic Standards Board (NOSB), the expert panel set up by Congress to advise the USDA Secretary on organic matters, narrowly approved the Martek petitions for their patented versions of DHA and ARA. “All hell broke loose at the meeting in Savannah as the controversy grew extremely heated,” Kastel noted.
In their complaint to the OIG, Cornucopia alleges that Martek misrepresented their novel, synthetic product and manipulated the vote by the NOSB.
“Martek oils, marketed under the Life’sDHA™ brand and included in organic infant formula, milk and baby food, are processed with petrochemical solvents like hexane or isopropyl alcohol, both of which are explicitly banned in organic production,” stated Charlotte Vallaeys, Director of Farm and Food Policy at Cornucopia.
Although Martek told the board that they would discontinue the use of the controversial neurotoxic solvent n-hexane for DHA/ARA processing, they did not disclose what other synthetic solvents would be substituted. Federal organic standards prohibit the use of all synthetic/petrochemical solvents, including isopropyl alcohol, which is currently used to extract DHA algal oil for use in products such as Horizon milk.
Martek again brought in William “Jay” Friedman, with the powerful Washington law firm of Covington and Burling, to lead their approval process. Friedman appeared to deliberately mislead NOSB members into believing that the powdered form of Martek’s DHA oil was not covered in the petition. This particular product formulation uses microencapsulation (banned in organics) and includes a number of additional synthetic materials that have never been reviewed or approved for use in organics.
When asked by NOSB Board chairperson, Tracy Miedema, “Are we approving dried powder or just oil?” Friedman stated on the record, “I can answer that. That’s not the petitioned material.”
Friedman’s statement was inconsistent with Martek’s formal petition to the NOSB, which states that “the petitioned material is unchanged from that which was authorized previously,” referring to the USDA’s earlier corrupted authorization of all Martek’s products, including the powdered form.
“Mr. Friedman’s statement thus appears patently false in an apparent attempt to intentionally mislead the NOSB. This apparent subterfuge led, in turn, to the NOSB’s failure to review other aspects of these materials which would have disqualified them, under law, for inclusion in organic food,” Cornucopia’s Kastel said.
In addition to the letter to the OIG, Cornucopia has requested the D.C. Bar conduct a formal ethics investigation of Mr. Friedman’s conduct.
“The dog and pony show put on by Martek and their largest customer, Dean Foods, was without precedent in the organic industry,” said Alexis Baden-Mayer, Political Director of the Organic Consumers Association, who was present in Savannah.
The only scientists who testified at the meeting on the DHA issue were all on Martek’s payroll, and focused on research showing benefits of consuming naturally occurring omega-3 fatty acids (such as those found in fish and breast milk), while ignoring the preponderance of published peer-reviewed research that shows that these health benefits are not gained from consuming Martek’s novel, manufactured DHA additive.
The written statements of leading scientists in this field, who did not attend the meeting but whose findings were presented to the Board members, including assertions that this field of research is “driven to a large extent by enthusiasm and vested interest,” were overpowered by the handful of corporate-sponsored scientists with a blatant financial interest in the outcome of the vote.
Dean Foods, Martek’s largest customer, brought in a well-known web-pediatrician, Dr. Alan Greene, who has acted as a public relations agent endorsing Horizon brand organic milk with the added Martek DHA oils.
Although Dr. Greene represented himself as a “consultant,” simply answering questions for Dean Foods, and stated he had previously worked for two other organic companies, but failed to disclose his multiple conflicts of interest in commenting on the benefits of Martek’s manufactured DHA supplements.
Greene has also accepted compensation from Mead Johnson, the largest conventional infant formula manufacturer, to promote Martek’s DHA oil in their products, and even has his own product line of nutritional supplements that include Martek DHA, marketed by Twinlabs with his name and photograph on the product package.
“It is unconscionable that a physician, who accepted money from a big drug company to promote synthetic DHA—which many believes promotes the use of baby formula at the expense of the nutrients in breast feeding—failed to disclose such a gross conflict of interest when he testified before the governmental body on certified ‘organic’ standards,” said Lisa Graves, Executive Director of the Center for Media and Democracy/PRWatch, which helps expose corporate PR tactics.
Greene’s role on behalf of Dean Foods and Martek was to directly dispute the preponderance of scientific literature, including two meta-analyses, that discredits Martek’s claims that their supplements promote cognitive development in infants and children.
Cornucopia’s complaint to the OIG also included evidence documenting that three corporate-backed members of the NOSB, who voted in favor of this petition, had undeclared conflicts of interest.
Two of the board members work for Earthbound Farms, a giant produce distributor that also compensated Dr. Greene during 2011. A third member of the NOSB board works for General Mills which partnered with Martek, starting in 2009, on the technology to microencapsulate their DHA and ARA oils.
Cornucopia said that these board members should have considered recusing themselves from voting on this issue because of the apparent conflicts of interest. One of the members was the prime champion of the Martek petition during board deliberations.
Adding fuel to the controversy, the Federal Trade Commission (FTC) just announced the end of its investigation into Dean Foods’ advertising campaign for Horizon DHA supplemented milk, forcing the dairy giant to alter claims in its advertising concerning “brain development or function, cognitive development or function, intelligence, learning abilities in children over the age of two.” This action resulted from a complaint filed by The Cornucopia Institute based on its research of the fraudulent and misleading health claims.
“While they did not fine Dean, or its WhiteWave division, for its misrepresentations in Horizon marketing, we are pleased that the FTC has taken this action to protect children and prevent the defrauding of their parents,” said Vallaeys.
Although the FDA has dismissed complaints about the safety of Martek products in infant formula, reports persist from parents and healthcare providers of infants who experience serious gastrointestinal symptoms from consuming Martek’s DHA and ARA oils in infant formula, raising serious public health questions about the marketing of these products.
The Cornucopia Institute has sent a formal briefing paper on these matters to all members of the National Organic Standards Board.
Cornucopia contends that the board did not fulfill its legal responsibilities of due diligence, and instead solely accepted unsubstantiated statements by Martek that their products were not genetically engineered and were not “synthetic.”
“We are asking the NOSB to reopen their deliberations and consider rescinding their approval of Martek nutritional oils,” Kastel added. “If the board fails to act now, protecting the integrity of organics, it risks changing the working definition of the organic seal and degrading its value in the eyes of consumers.”
MORE:
Stakeholders in the organic community who would like to send an formal message to the National Organic Standards Board, expressing their support for reevaluating the Martek materials, can do so by accessing an action alert distributed by The Cornucopia Institute.
The Organic Consumers Association, a Minnesota-based organization, is calling on the USDA to immediately remove the powdered form of Martek’s oils from all organic products, including infant formula and baby cereals. OCA believes that Martek’s lobbyist, Friedman, realized that the powdered form would never be approved by the NOSB, and that he, through his oral testimony, effectively changed the petition to exclude the powdered DHA oil.
“Let me play devil’s advocate here. If Friedman wasn’t being dishonest, it means that the powdered form was not recommended for approval by the NOSB and thus should be immediately removed from baby food and infant formula,” says Alexis Baden-Mayer, Political Director of the Organic Consumers Association.
Consumers wishing to reap the health benefits of omega-3 fatty acids can find these naturally occurring nutrients in a variety of foods, including leafy green vegetables, fish, flax, walnuts, milk and meat from grass-fed animals, and pastured eggs.
Research suggests that increasing the amount of omega-3s in the diet by supplements, such as fish oil, will not confer health benefits unless the consumption of omega-6-rich foods, especially corn and corn-based foods such as grain-fed meat and milk, is simultaneously decreased.
An online guide to avoiding foods with Martek’s genetically mutated DHA oils will be available soon on the Cornucopia website: www.cornucopia.org. A list of organic food brands that currently contain Martek DHA algal oil is already available.
After this controversy became prominent in the media, a number of companies that included Martek’s DHA in organic foods in the past have removed these controversial ingredients. These brands include ZenSoy organic soymilk, Plum Organics baby foods, and NuGo organic nutrition bars.

Thursday, February 2, 2012

The Food Safety Modernization Act - One Year Later

Progress, missed deadlines as FDA works to implement new law

Just over a year ago, President Obama used 15 pens to sign the FDA Food Safety Modernization Act (FSMA) into law. The most sweeping update to U.S. food safety law in more than 70 years, FSMA is a huge undertaking for the U.S. Food and Drug Administration, and, not surprisingly, the agency is already behind on some major deadlines in its efforts to implement it.

As of January 4, exactly one year from the time the law was enacted, the agency was supposed to have initiated the rulemaking process for science-based produce safety standards and finished rules for a foreign supplier verification program.  So far, FDA has not released these two critical rules -- though it is rumored they may be released in February.

The FDA was also supposed to have published updated good agricultural practices (GAPs) for fresh produce, a guidance on protecting against the intentional adulteration of food (i.e. bioterrorism), and a National Agriculture and Food Defense Strategy, which, under the law, must be revised and updated every four years.

The agency was also supposed to have have published a guidance to help schools and childcare programs mitigate allergy risks, designated what falls into the "high-risk foods" category (which will face more strict recordkeeping requirements) and have created five Integrated Food Safety Centers of Excellence at health departments.

Michael Taylor, Deputy Commissioner for Foods at FDA, had warned that the agency would not meet all of the deadlines in the new law.

"This law has 50 major deliverables: regulation, guidances for industry, over a dozen reports to Congress, all due over the next two or three years, with timelines that are pretty strict," said Taylor, during a policy Q&A session in Washington, D.C. last spring. "I've conceded publicly that it is physically impossible to get all of those deliverables to the finish line [within the deadlines]... so we are prioritizing."

Though the one-year deadline has come and gone for some key elements of the new law, food safety advocates, who, along with industry, lobbied for FSMA, seem to be pleased with the agency's progress on implementation. 

Consumer and public health groups are urging FDA to release the rules that are past due --  the Safe Food Coalition recently asked the Obama administration to release the rules "in a timely manner" -- but they are also quick to point out that FDA has made great strides in the past year.    

"We've been very happy with FDA's approach to proposal development," said Sandra Eskin, director of the food safety campaign at the Pew Charitable Trusts, adding that she believes the agency has done a good job of engaging a wide variety of stakeholders in the process. "These are complicated proposals ... it's understandable that it will take some time."

Caroline Smith DeWaal, the head of food safety at the Center for Science in the Public Interest, reiterated that while advocacy groups are urging FDA to release the rules so the rulemaking process can get started, they are also happy with the progress that's been made.  

Since FSMA was enacted, the agency has met a number of deadlines, according to its one year progress report.

For example, FDA met its foreign inspection mandate, of 600 facility inspections, for the year -- this number is supposed to double each year for five years. There are nearly 200,000 foreign food facilities registered with the FDA to import into the United States.

The agency made its recall website more consumer-friendly, updated a food safety guidance for the seafood industry, and launched two traceability pilots with the Institute of Food Technologists.

The agency's one year progress report also noted that the agency defined "high risk" and "non high risk" for fiscal year 2011 and between FDA and its contracts with states, 20,000 food facility inspections were conducted. There are more than 140,000 registered food facilities in the United States. 

"At this rate the Agency will most assuredly meet the domestic food inspection frequency mandates defined in FSMA," the agency said in its report, issued in early January. "In addition, FDA is developing new risk-based approaches to domestic inspection to maximize public health benefit."

Though FDA reported a lengthy list of accomplishments for FSMA's first year (see full list here), the agency has a long way to go, with the most critical elements -- like the produce safety rule, which some predict could be more than 125 pages, and the preventative control requirements for food and animal feed facilities -- still to come.

"Although it can feel frustrating to wait on an overstuffed federal agency to provide more details about how it will soon dramatically enhance its regulatory authority - I do not find it to be too frustrating", said Ben England, Founder and CEO of FDAImports.com.  "[T]hese are very complicated guidances and regulations FDA is expected to issue. It is better that it take longer and perhaps get it right."

David Acheson, who served as associate commissioner for foods at FDA and now consults the food industry at Leavitt Partners, agreed that the delay was understandable, but suggested that the agency provide a "tentative time line" for going forward.

"FDA has done a great job so far and it is not unexpected that the deadlines would slip on these major proposed rules," said Acheson. "Getting them written, approved by HHS and then through [the Office of Management and Budget] is a lot to do and my understanding is that the current hold up is at OMB. I think it would have been appropriate for FDA to announce that fact and let the world know what the adjusted tentative time line is looking like. After all, a lot of folks are waiting to read and begin to act on the new proposed requirements."

According to an FDA spokesman, the agency doesn't yet have a "specific timeframe for issuing these rules," but they are "making significant progress."