Bayer CropScience is changing from a producer of crop protection products to a biotechnology and seed breeding group. CEO Helmut Schramm announced that the company will increase its research and development allocation to enable genetic engineering and breeding efforts.
Biotech research will account for 50 percent of its total research activities. Over 850 million € is expected to be spent on biotech research.
The company will strengthen its presence in Brazil, Russia, India and China. The acceptance of biotech in Europe, according to Schramm is only "a matter of time."
See the original article in German at http://www.agrarheute.com/bayer-cropscience.
Friday, March 16, 2012
EU JRC Notification for Limited Environmental Release of GM Potatoes
The European Commission JRC published one summary notification for the limited environmental release of genetically modified potato with resistance to Phytophthora infestans, the causal pathogen of late blight disease. The environmental release will be conducted to quantify the impact of GM potato cultivation on bacterial, fungal, nematode and earthworm diversity in the soil, compared to a conventional potato system; identify integrated pest management (IPM) strategies and components which could be positively or negatively affected by the adoption of GM late blight resistant potato; and to educate various stakeholders on the issues and concerns that the public has on GM crop cultivation in Ireland.
The study will be conducted in June 2012 to December 2016 in Oak Park, Co. Carlow, Ireland by the Teagasc Company, Ireland.
See the notification at http://gmoinfo.jrc.ec.europa.eu/gmp_report.aspx?CurNot=B/IE/12/01.
The study will be conducted in June 2012 to December 2016 in Oak Park, Co. Carlow, Ireland by the Teagasc Company, Ireland.
See the notification at http://gmoinfo.jrc.ec.europa.eu/gmp_report.aspx?CurNot=B/IE/12/01.
Monday, March 5, 2012
Produce Farming on the Brink
by Daniel B. Cohen | Mar 05, 2012
Our process of framing and regulating produce food safety is upside down and backwards.
Human pathogens constantly flow from urban environments and animal production into farm environments, contaminating water and soil, and finding a home in wildlife. Then we ask farmers to deliver pathogen-free fruits and vegetables.
Produce is increasingly sold as centrally processed fresh-cut products, diced fruits and cut salads in wholesale and retail packages, facilitating cross-contamination without a kill step. Then it is shipped in closed plastic containers that can allow pathogen maintenance and growth, with use-by dates of about three weeks from harvest. A cold chain for processing and delivery, that prevents E. coli O157:H7, for example, from multiplying allows Listeria to survive or thrive.
On farm, two of the greatest hazards have nothing to do with actually growing the crop. Washing, cooling and storage -- on-farm handling, and providing sanitary conditions for employees that do not lead to human-to-produce contamination. On farm regulation focuses on field practices.
Farmers are asked to cut down trees and shrubs, which provide habitat for birds; to fence off fields and water sources, which might attract deer and other large species; to bury poisoned bait stations around the perimeters of their field, to prevent squirrels, mice, shrews and other rodents from entering their fields; to remove the low-growing filter strips next to streams, which actually prevent fertilizer run-off and some pathogens from entering the streams, because they also attract wildlife.
They are supposed to have management practices that prevent flies and other insects, snails and other invertebrates, frogs and other amphibians, from carrying human pathogens onto their fields. All have been shown to be potential carriers. Since farm food safety is focused on growing operations, sources that provide human pathogens to contaminate the fauna of a farm ecosystem are not regulated.
I use produce outbreaks where there have been outbreak investigation reports as case studies that provide some, limited, evidence. They may or may not support this thesis. They provide a window into how produce safety is being framed and understood.
In this article two of the 2011 outbreaks are covered: the Jensen Farm Listeria-cantaloupe outbreak and the Jaquith Farms O157:H7 strawberry outbreak. The implications for food safety policy are covered on the national and then small-farm scales.
*****
Using the normal rules of thumb that make sense of food safety, there should never have been a Jensen Farms lLsteria cantaloupe outbreak. We may be in a changed world.
The FDA environmental assessment Report (1) states:
"This is the first listeriosis outbreak associated with a whole fruit or vegetable raw agri- cultural commodity. Listeria monocytogenes contamination has historically been associ- ated with ready-to-eat and processed food products, such as deli meat, unpasteurized cheese, raw milk, fresh-cut fruit, and fresh-cut vegetables, and is typically thought of as an environmental contaminant of food plants. Known reservoirs for Listeria monocytogenes include ruminant animals (e.g., cattle, goats, and deer), decaying vegetation, and cold, wet, and difficult to clean environments."
Fresh-cut fruits and fresh-cut vegetables are recent food additions to the list. The usual combination of concern is Salmonella and cantaloupes, not Listeria,
With 33 deaths out of 146 reported cases, the Listeria-cantaloupe outbreak was one of the worst foodborne outbreaks in over 80 years. The death rate is close to 25 percent.
In many outbreak investigation reports I have read, "absence of evidence" in a processing facility is taken to be "evidence of absence," even when it was documented that management had spent up to a week sanitizing their plant post-outbreak and pre-inspection.
In the Jensen Farms case, the equipment design and facility design prevented sanitation, both before the outbreak and before the investigation. Outbreak strains were found within the packing facility and cold storage. It was a rare case of presence of evidence, and some equipment had to actually be cut out and replaced in order to be sanitized to show no Listeria.
When the FDA looked for a source of contamination on-farm, they took the more usual approach.
"All environmental samples collected in the growing fields were negative for Listeria monocytogenes."
Despite this:
"FDA has determined that the growing environment cannot be eliminated as a potential
contributor in the introduction of Listeria monocytogenes contamination..."
That is true, as far as it goes, but it is also true of pretty much every farm in the country, given the ubiquity of ruminants and of Listeria in the environment. It does not do much to explain the origins or root cause of this unique case (2).
Many observers, including Bill Marler, have characterized the on-farm handling as gross negligence; and condemned the lack of prevention by food safety auditors. Jensen Farms had passed its audits for safety. Its papers were in order.
Now Jensen Farms appeared to me to be a large or very large operation responsible for a national outbreak centered on Colorado and Texas. Based on the recalled canta-Jim loupes alone, it looked like it probably was one of the 5,600 largest farms in the country with farm gate sales of over $5 million.
Jim Prevor had outstanding coverage of the outbreak in his Perishable Pundit articles but with a very different perspective (3):
"If Wal-Mart really put food safety first, it would have never bought cantaloupes from this small producer, which produced in a six-week season what California ships in a day."
A small farm with local production, and small farms are not safe? We do not seem to be talking about the same outbreak. When I asked him about this, it turned out we were using the same words with different meanings from different contexts (4).
Prevor's context is the national produce market, dominated by the largest buyers and their major produce suppliers. The vocabulary of the buyers is different than farmers, and perhaps most of their customers. "Local" can be defined as "within a 7 hour drive" by Whole Foods. "Small" in this world of the top strata within the top 5,600 farmers (the number is for all crops, not just produce) includes Jensen Farms. He estimated that maybe 10 of the very large melon farms in the U.S. had the money, size and motivation for a particular kind of food-safety processing equipment.
His main point was that the largest buyers do not make food safety their first priority in buying decisions, when one looks at how they actually operate. For example, if they can label produce as "local," in their terms, this can have top priority. Buying from a "small" farm like Jensen Farms may meet a marketing decision for "local" produce, despite there being major farms with better food safety capacity. Therefore "safe versus local" as a choice. He was using the words as industry terms; to people outside the industry, they read differently.
Prevor then makes a critical observation: that how major produce buyers are actually rewarded determines the effectiveness of food safety commitments. He wrote an interesting analysis of overall food safety issues, including changing liability so that food safety is not unrewarded (5). On a national policy level his approach and mine have many points in common. Trying to use common language:
The food system as a whole should be evaluated by a hazard analysis. The worst hazards overall should have the highest priority for being dealt with.
To really have an effective outbreak, one has to have a way to spread and multiply the pathogens; incidental contamination won't do the job.
Any centralized source for contaminating produce, which spreads, multiplies, and preserves pathogens is more dangerous than any incidental source. Handling and processing can be major centralized sources in handling, and fresh-cut is a special hazard in part because it is food processing without a kill step.
Widespread hazards from the farm environment also can create broadly contaminated produce, for example from contaminated surface water or ground water or flooding.
Within farming operations, handling operations, packing and cold storage as in Jensen Farms, might be the highest priority after water quality and direct exposure to feces. Texas may be the state that has gotten this right, with a new law focused on on-farm handling (and processing).
Incentives for individual decision makers also can determine over-all food safety. Company incentives for major buyers are also a critical control point for food safety. Business expansion and growth with increased contracted deliveries can be a hazard for two reasons: newly acquired equipment can be a hazard, and pressure to deliver can lead to pressure on safety standards (6).
However, right now, we are quite distant from this approach.
On October 06, 2006, as the spinach outbreak was ending, the FDA put out one of the bluntest statements issued by a bureaucracy, saying to the lettuce and spinach industry that enough was enough, clean up your act or we will do it for you; and inadvertently creating the category of "leafy greens" (7).
In my view, what happened next was a tactically brilliant takeover by the major processors and handlers of the produce safety issue, starting with the California LGMA. It left farmers under the control of processors, who somehow left out the food safety issues of handling and processing operations.
The fundamental flaw in this approach is that in the absence of an effective kill step, for fresh-cut in particular, they basically have to sterilize the farm environment instead, which is impossible. It can be an ecological, social and strategic disaster. [For detailed discussions of the impact on farm environments see the Wild Farm Alliance website (8).]
This "processor-favoring" approach dominates all discussions of food safety on farms.
A cold-hearted analysis of sprouts as a commodity, that takes food safety as the first priority, is that they should be cooked. A cold-hearted analysis of fresh-cut as a commodity is that it is a food safety failure. We could go back to local production consumed within a few days of harvest for salad greens; local food service doing their own cutting for "fresh-cut" fruits and vegetables. This eliminates the pathogen increase time from farm to retail to consumption, and other factors. As commodities, both sprouts and fresh-cut lack kill steps and provide humid sealed environments in plastic containers for pathogen maintenance and increase.
Food safety, looked at cold-heartedly, is not the top priority when fresh-cut processing is analyzed. Other factors, including market share, value-added, and consumer convenience are priorities. Priorities have to be balanced, perhaps. It is not a justification for displacing all food safety concerns onto farms.
That still leaves the whole produce outbreaks.
It's curious. No one studies the effectiveness of small farms at achieving food safety. I once heard an FDA hearing commissioner explain to an audience of mainly large processors and grower-shippers: "what you call a spinach harvester, I call a pathogen inoculator." Harvesting on small farms is completely different, but which techniques are better or worse for food safety in comparison?
Can small farms really have a better safety record, and if so why; due to which practices?
The 2011 E. coli O157:H7 outbreak in Oregon involving Jaquith Strawberry Farm, initially thought to be a small grower, looks like a fairly large producer, distributing through multiple channels. One of them, Ron Spada Farms, was reported to have recalled 4,800 flats still in inventory after the outbreak trace-back. Other strawberries went to roadside stands, farm stands and farmers markets as if they were self-produced (9).
This can make "knowing your farmer" problematic. The farmer wasn't small, and the people who looked like small farmers weren't farmers, or had not grown the crop. Consumers may have had the illusion they were buying from a small local farmers in many parts of Oregon. Only the epidemiological trace-back found the common source.
There was no complete outbreak investigation report, but the outbreak strain was found in deer feces in the actual sole-farm's strawberry production field. If there is a widespread pathogen contamination of deer, it did not affect multiple producers.
UC Davis field studies showed that O157:H7 in deer in California was quite rare, challenging the frequently made association with some California outbreaks. Oregon might be different.
There are many actual small strawberry producers in Oregon. They all managed to avoid causing outbreaks. There also are very large producers (super-farms) including Driscoll's, which appears to have an outstanding food safety record, who also grew and sold strawberries safely.
It looks like this outbreak could have been due to negligence, probably at harvest, on one "medium" sized farm; that ordinary precautions might have been enough to prevent contamination even with the presence of E. coli O157:H7 in local deer.
Is there a statistical distribution of food safety by farm size? We know that the pressure of growth can be a major hazard point, throughout the produce outbreak record. Food safety can slip under the pressure to meet increased sales.
Actual incentives are not just a hazard point for the largest national produce buyers; they can compromise safety priorities for individuals or operations anywhere in the supply chain.
This outbreak involved multiple illnesses and one death. It was a relatively local, perhaps "regional" and "limited" outbreak. That is cold or no comfort to the family of the person who died or to those who became ill.
One can imagine a consensus on a set of national priorities focused on fixing the worst hazards first, an FDA that puts more emphasis on causal analysis of outbreaks as Michael Taylor has called for, and co-management of food safety and the preservation of habitats and the farm environment, as both the California LGMA and the Wild Farm Alliance have called for. Overall food safety would be greatly improved.
That is not where we are, right now.
What can I say to a small organic farmer who asked me about the impact of the three major outbreaks in 2011, and the oncoming regulations under the Food Safety Modernization Act (FSMA)?
By acreage, she and her husband are small farmers under any U.S. definition, owning and farming 20 acres. By farm gate sales they are in the top 20 percent of U.S. farmers.
Something like this:
Most of the work being done on food safety is not for their benefit and the regulatory schemes in process may be mostly harmful, imposing burdens without improving overall food safety because it avoids dealing with major hazards in the overall system of food production.
Regulators have a compulsive belief in the efficacy of complex paperwork, almost for its own sake. It could be called faith-based paperwork. The same money could be spent on solving problems, but they assume the solutions are all known.
In contrast, they should try and align their ordinary commercial records with food safety, an approach also favored by some major food safety consultants for the largest firms.
They need to know how to approach a recall, and be able to trace-up deliveries quickly.
Regulation will be based on the largest farms, even when these have been the source of multiple recalls or even outbreaks. Systemic failures such as the Listeria-cantaloupe case will not lead to new systemic approaches.
Expect to pay for third-party audits that lack meaning; and Extension services, which might have been helpful in actually solving safety problems, have been cut in half.
Reduce known hazards. There may be some crops, and some ways of growing and harvesting crops, that have to be dropped. Look carefully at washing, handling and packing.
Make food safety an over-riding contingency of sale in delivery contracts. Make food safety a part of any plan to grow production and sales, from the start. Consider increasing liability insurance and buying business interruption insurance.
Improved safety, and meeting all imposed regulations, provides no legal protections. In- cidental contamination beyond farmer control still comes under strict liability.
They can improve their odds.
I can guess that the ethical standards they use in all their approaches to farming do have a beneficial impact on food safety as well, for their size of farm, because they frame their own personal incentives, and oppose temptations to cut safety to meet a dellivery.
"Don't screw up." Know the common important hazards and have a systematic plan to control their risks.
You are always,farming on the brink of disaster.
(1) Environmental Assessment: Factors Potentially Contributing to the Contamination of Fresh Whole Cantaloupe Implicated in a Multi-State Outbreak of Listeriosis
October 19, 2011
(2) A lot of specific information is missing from the report that could be useful in analyzing the outbreak and preventing future outbreaks. Jensen Farms used equipment that could not be cleaned, that came from a non-cantaloupe use (supposedly for potatoes). Was the previous operation contaminated with the outbreak strains? Similarly, a truck was used to bring culls to a cattle operation as feed and could have been a contaminant source for the cleaning and packing facility. Were outbreak strains found in the cattle operation? A neighboring field was reported to have received municipal sewage sludge, of unreported treatment, and Listeria bacteria are resistant to degradation in sludge. It would be important to know if the outbreak strains were found in the neighboring field.
I read " All environmental samples collected in the growing fields were negative..." in a lawyerly fashion, and wonder why environmental samples collected in the larger environment were not reported on.
For a comprehensive review of Listeria and food safety and Listeria in the agricultural environment see, for example: Listeria, Listeriosis, and Food Safety, Third Edition
Edited by: Elliot T. Ryser, Michigan State University, East Lansing, USA; Elmer H. Marth, University of Wisconsin, Madison, USA March 27, 2007 CRC Press
(3) Perishable Pundit: The Cantaloupe Crisis: The Truth That Dare Not Speak Its Name: The Priority Can Be Safe Or The Priority Can Be Local, But It Cannot Be Both , October 4, 2011
(6) For example, that is my reading of the outbreak reports for two major cases: Odwalla juice, and Dole spinach, as well as others.
See "Next Steps" section.
(9) Deer Confirmed as Source of Strawberry Outbreak August 18, 2011, Food Safety News
------------------------
Daniel B. Cohen is the owner of Maccabee Seed Co., an agricultural research-and-development and consulting company in Davis, CA. See also "Sizing Food Safety Regulations to Fit the Farm" and "An Outbreak Like Germany's Could Happen Here"
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 HarmBy 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 naïve 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
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.
Largest Corporate Dairy, Biotech Firm and USDA Accused of
Conspiring to Corrupt Rulemaking and Pollute Organics
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."
Wednesday, January 4, 2012
GM Soybean Receives USDA Deregulation
MON 87705, a genetically modified soybean traded as Monsanto's Vistive®Gold oybeans has received deregulation approval by the US Department of Agriculture (USDA). The GM soybean produces soybean oil with increased levels of monounsaturated fat while significantly lowering saturated fat.
"With the availability of Vistive®Gold soybeans, farmers will soon be able to deliver an economical and sustainable source of nutritionally improved soybean oil to consumers and food companies," said Joe Cornelius, Monsanto global technology lead for food quality traits.
This USDA deregulation completes the regulatory processes in the United States, that would allow field testing and seed production within the United States, under strict stewardship guidelines until Monsanto has obtained the necessary regulatory approvals in the key soybean export markets. The Food and Drug Administration completed the consultation process in January 2011. The trait has also been approved for use in Canada.
See the news release at http://monsanto.mediaroom.com/vistive-gold-usda-deregulation The Registry can be viewed at http://www.gpo.gov/fdsys/pkg/FR-2011-12-16/pdf/2011-32323.pdf
"With the availability of Vistive®Gold soybeans, farmers will soon be able to deliver an economical and sustainable source of nutritionally improved soybean oil to consumers and food companies," said Joe Cornelius, Monsanto global technology lead for food quality traits.
This USDA deregulation completes the regulatory processes in the United States, that would allow field testing and seed production within the United States, under strict stewardship guidelines until Monsanto has obtained the necessary regulatory approvals in the key soybean export markets. The Food and Drug Administration completed the consultation process in January 2011. The trait has also been approved for use in Canada.
See the news release at http://monsanto.mediaroom.com/vistive-gold-usda-deregulation The Registry can be viewed at http://www.gpo.gov/fdsys/pkg/FR-2011-12-16/pdf/2011-32323.pdf
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