Tuesday, December 15, 2009

Monsanto's aggressive seed business tactics revealed in confidential contracts

AP IMPACT: Monsanto seed business role revealed
By CHRISTOPHER LEONARD, AP AGRIBUSINESS WRITER
Associated Press, December 14 2009
http://www.seattlepi.com/business/1310ap_us_seed_giant.html

ST. LOUIS -- Confidential contracts detailing Monsanto Co.'s business practices reveal how the world's biggest seed developer is squeezing competitors, controlling smaller seed companies and protecting its dominance over the multibillion-dollar market for genetically altered crops, an Associated Press investigation has found.

With Monsanto's patented genes being inserted into roughly 95 percent of all soybeans and 80 percent of all corn grown in the U.S., the company also is using its wide reach to control the ability of new biotech firms to get wide distribution for their products, according to a review of several Monsanto licensing agreements and dozens of interviews with seed industry participants, agriculture and legal experts.

Declining competition in the seed business could lead to price hikes that ripple out to every family's dinner table. That's because the corn flakes you had for breakfast, soda you drank at lunch and beef stew you ate for dinner likely were produced from crops grown with Monsanto's patented genes.

Monsanto's methods are spelled out in a series of confidential commercial licensing agreements obtained by the AP. The contracts, as long as 30 pages, include basic terms for the selling of engineered crops resistant to Monsanto's Roundup herbicide, along with shorter supplementary agreements that address new Monsanto traits or other contract amendments.

The company has used the agreements to spread its technology - giving some 200 smaller companies the right to insert Monsanto's genes in their separate strains of corn and soybean plants. But, the AP found, access to Monsanto's genes comes at a cost, and with plenty of strings attached.

For example, one contract provision bans independent companies from breeding plants that contain both Monsanto's genes and the genes of any of its competitors, unless Monsanto gives prior written permission - giving Monsanto the ability to effectively lock out competitors from inserting their patented traits into the vast share of U.S. crops that already contain Monsanto's genes.

Monsanto's business strategies and licensing agreements are being investigated by the U.S. Department of Justice and at least two state attorneys general, who are trying to determine if the practices violate U.S. antitrust laws. The practices also are at the heart of civil antitrust suits filed against Monsanto by its competitors, including a 2004 suit filed by Syngenta AG that was settled with an agreement and ongoing litigation filed this summer by DuPont in response to a Monsanto lawsuit.

The suburban St. Louis-based agricultural giant said it's done nothing wrong.

"We do not believe there is any merit to allegations about our licensing agreement or the terms within," said Monsanto spokesman Lee Quarles. He said he couldn't comment on many specific provisions of the agreements because they are confidential and the subject of ongoing litigation.

"Our approach to licensing (with) many companies is pro-competitive and has enabled literally hundreds of seed companies, including all of our major direct competitors, to offer thousands of new seed products to farmers," he said.

The benefit of Monsanto's technology for farmers has been undeniable, but some of its major competitors and smaller seed firms claim the company is using strong-arm tactics to further its control.

"We now believe that Monsanto has control over as much as 90 percent of (seed genetics). This level of control is almost unbelievable," said Neil Harl, agricultural economist at Iowa State University who has studied the seed industry for decades. "The upshot of that is that it's tightening Monsanto's control, and makes it possible for them to increase their prices long term. And we've seen this happening the last five years, and the end is not in sight."

At issue is how much power one company can have over seeds, the foundation of the world's food supply. Without stiff competition, Monsanto could raise its seed prices at will, which in turn could raise the cost of everything from animal feed to wheat bread and cookies.

The price of seeds is already rising. Monsanto increased some corn seed prices last year by 25 percent, with an additional 7 percent hike planned for corn seeds in 2010. Monsanto brand soybean seeds climbed 28 percent last year and will be flat or up 6 percent in 2010, said company spokeswoman Kelli Powers.

Monsanto's broad use of licensing agreements has made its biotech traits among the most widely and rapidly adopted technologies in farming history. These days, when farmers buy bags of seed with obscure brand names like AgVenture or M-Pride Genetics, they are paying for Monsanto's licensed products.

One of the numerous provisions in the licensing agreements is a ban on mixing genes - or "stacking" in industry lingo - that enhance Monsanto's power.

One contract provision likely helped Monsanto buy 24 independent seed companies throughout the Farm Belt over the last few years: that corn seed agreement says that if a smaller company changes ownership, its inventory with Monsanto's traits "shall be destroyed immediately."

Another provision from contracts earlier this decade- regarding rebates - also help explain Monsanto's rapid growth as it rolled out new products.

One contract gave an independent seed company deep discounts if the company ensured that Monsanto's products would make up 70 percent of its total corn seed inventory. In its 2004 lawsuit, Syngenta called the discounts part of Monsanto's "scorched earth campaign" to keep Syngenta's new traits out of the market.

Quarles said the discounts were used to entice seed companies to carry Monsanto products when the technology was new and farmers hadn't yet used it. Now that the products are widespread, Monsanto has discontinued the discounts, he said.

The Monsanto contracts reviewed by the AP prohibit seed companies from discussing terms, and Monsanto has the right to cancel deals and wipe out the inventory of a business if the confidentiality clauses are violated.

Thomas Terral, chief executive officer of Terral Seed in Louisiana, said he recently rejected a Monsanto contract because it put too many restrictions on his business. But Terral refused to provide the unsigned contract to AP or even discuss its contents because he was afraid Monsanto would retaliate and cancel the rest of his agreements.

"I would be so tied up in what I was able to do that basically I would have no value to anybody else," he said. "The only person I would have value to is Monsanto, and I would continue to pay them millions in fees."

Independent seed company owners could drop their contracts with Monsanto and return to selling conventional seed, but they say it could be financially ruinous. Monsanto's Roundup Ready gene has become the industry standard over the last decade, and small companies fear losing customers if they drop it. It also can take years of breeding and investment to mix Monsanto's genes into a seed company's product line, so dropping the genes can be costly.

Monsanto acknowledged that U.S. Department of Justice lawyers are seeking documents and interviewing company employees about its marketing practices. The DOJ wouldn't comment.

A spokesman for Iowa Attorney General Tom Miller said the office is examining possible antitrust violations. Additionally, two sources familiar with an investigation in Texas said state Attorney General Greg Abbott's office is considering the same issues. States have the authority to enforce federal antitrust law, and attorneys general are often involved in such cases.

Monsanto chairman and chief executive officer Hugh Grant told investment analysts during a conference call this fall that the price increases are justified by the productivity boost farmers get from the company's seeds. Farmers and seed company owners agree that Monsanto's technology has boosted yields and profits, saving farmers time they once spent weeding and money they once spent on pesticides.

But recent price hikes have still been tough to swallow on the farm.

"It's just like I got hit with bad weather and got a poor yield. It just means I've got less in the bottom line," said Markus Reinke, a corn and soybean farmer near Concordia, Mo. who took over his family's farm in 1965. "They can charge because they can do it, and get away with it. And us farmers just complain, and shake our heads and go along with it."

Any Justice Department case against Monsanto could break new ground in balancing a company's right to control its patented products while protecting competitors' right to free and open competition, said Kevin Arquit, former director of the Federal Trade Commission competition bureau and now a antitrust attorney with Simpson Thacher & Bartlett LLP in New York.

"These are very interesting issues, and not just for the companies, but for the Justice Department," Arquit said. "They're in an area where there is uncertainty in the law and there are consumer welfare implications and government policy implications for whatever the result is."

Other seed companies have followed Monsanto's lead by including restrictive clauses in their licensing agreements, but their products only penetrate smaller segments of the U.S. seed market. Monsanto's Roundup Ready gene, on the other hand, is in such a wide array of crops that its licensing agreements can have a massive effect on the rules of the marketplace.

Monsanto was only a niche player in the seed business just 12 years ago. It rose to the top thanks to innovation by its scientists and aggressive use of patent law by its attorneys.

First came the science, when Monsanto in 1996 introduced the world's first commercial strain of genetically engineered soybeans. The Roundup Ready plants were resistant to the herbicide, allowing farmers to spray Roundup whenever they wanted rather than wait until the soybeans had grown enough to withstand the chemical.

The company soon released other genetically altered crops, such as corn plants that produced a natural pesticide to ward off bugs. While Monsanto had blockbuster products, it didn't yet have a big foothold in a seed industry made up of hundreds of companies that supplied farmers.

That's where the legal innovations came in, as Monsanto became among the first to widely patent its genes and gain the right to strictly control how they were used. That control let it spread its technology through licensing agreements, while shaping the marketplace around them.

Back in the 1970s, public universities developed new traits for corn and soybean seeds that made them grow hardy and resist pests. Small seed companies got the traits cheaply and could blend them to breed superior crops without restriction. But the agreements give Monsanto control over mixing multiple biotech traits into crops.

The restrictions even apply to taxpayer-funded researchers.

Roger Boerma, a research professor at the University of Georgia, is developing specialized strains of soybeans that grow well in southeastern states, but his current research is tangled up in such restrictions from Monsanto and its competitors.

"It's made one level of our life incredibly challenging and difficult," Boerma said.

The rules also can restrict research. Boerma halted research on a line of new soybean plants that contain a trait from a Monsanto competitor when he learned that the trait was ineffective unless it could be mixed with Monsanto's Roundup Ready gene.

Boerma said he hasn't considered asking Monsanto's permission to mix its traits with the competitor's trait.

"I think the co-mingling of their trait technology with another company's trait technology would likely be a serious problem for them," he said.

Quarles pointed out that Monsanto has signed agreements with several companies allowing them to stack their traits with Monsanto's. After Syngenta settled its lawsuit, for example, the companies struck a broad cross-licensing accord.

At the same time, Monsanto's patent rights give it the authority to say how independent companies use its traits, Quarles said.

"Please also keep in mind that, as the (intellectual property developer), it is our right to determine who will obtain rights to our technology and for what purpose," he said.

Monsanto's provision requiring companies to destroy seeds containing Monsanto's traits if a competitor buys them prohibited DuPont or other big firms from bidding against Monsanto when it snapped up two dozen smaller seed companies over the last five years, said David Boies, a lawyer representing DuPont who previously was a prosecutor on the federal antitrust case against Microsoft Corp.

Competitive bids from companies like DuPont could have made it far more expensive for Monsanto to bring the smaller companies into its fold. But that contract provision prevented bidding wars, according to DuPont.

"If the independent seed company is losing their license and has to destroy their seeds, they're not going to have anything, in effect, to sell," Boies said. "It requires them to destroy things - destroy things they paid for - if they go competitive. That's exactly the kind of restriction on competitive choice that the antitrust laws outlaw."

Quarles said some of the Monsanto contracts let companies sell their inventory for a period of time, rather than be required to destroy it. Seed companies also don't have to pay royalty fees on the bags of seed they destroyed.

"Simply put, it was designed to facilitate early adoption of the technology," he said.

Some independent seed company owners say they feel increasingly pinched as Monsanto cements its leadership in the industry.

"They have the capital, they have the resources, they own lots of companies, and buying more. We're small town, they're Wall Street," said Bill Cook, co-owner of M-Pride Genetics seed company in Garden City, Mo., who also declined to discuss or provide the agreements. "It's very difficult to compete in this environment against companies like Monsanto."

Farm Groups File Brief Against Biotech Alfalfa Ban

Several farm and trade groups, including the American Farm Bureau Federation, the National Corn Growers Association and the American Seed Trade Association, have filed a joint friend-of-the-court brief to the US Supreme Court in support of a petition seeking review of case related to biotech alfalfa. "Lower courts failed to adequately consider the mountains of evidence that prove biotech alfalfa is safe, and thus those courts abandoned a well-established legal principle when they banned the planting of the crop," according to the brief. "If the courts do not respect those established legal standards, the ability to bring future innovations, especially biotech crops, to the marketplace is in real jeopardy." The brief further noted that the ruling "could begin a wave of anti-biotechnology injunctions."
Visit http://www.fb.org/index.php?fuseaction=newsroom.newsfocus&year=2009&file=nr1208.html for the original story.

Friday, December 11, 2009

Three approved GMOs found unsafe

NOTE: The new paper is available here: http://www.biolsci.org/v05p0706.htm
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Three Major GMOs Approved for Food and Feed Found Unsafe
(Int J Biol Sci 2009; 5(7), 706-726)
CRIIGEN press release, 11 December 2009
Caen, 14 December 2009: In what is being described as the first ever and  most comprehensive study of three major GMOs about assessing the effects on  mammalian health, researchers from CRIIGEN and Universities of Caen and Rouen have highlighted a number of new sex and often dose dependent side effects linked with their consumption. Their study of the 90-day feeding trials data of insecticide producing Mon 810, Mon 863 and Roundup herbicide absorbing NK 603 varieties of GM maize clearly underlines adverse impacts on kidneys and liver,  the dietary detoxifying organs, as well as different levels of damages to heart, adrenal glands, spleen and haematopoietic system. Ironically, the confidential raw data of Monsanto about feeding trials on rats that these researchers have analyzed allowed the international authorization of these three commercialized  GMOs in different parts of the world.
 
Although different levels of adverse impact on vital organs were noticed between the three GMOs, the research, done by J. Spiroux de Vendomois, F. Roullier, D. Cellier and G.E. Seralini and published in the International Journal of Biological Sciences, shows specific effects associated with consumption of each GMO, differentiated by sex and dose. Their research follows in the wake of European Governments obtaining the raw data related to feeding of rats for 90  days and making it publically available for scrutiny and counter-evaluation.
 
The researchers have concluded that all the 3 GMOs that they have studied contain novel pesticide residues that will be present in food and feed and may pose grave health risks to those consuming them. They have, therefore, called for immediate prohibition on the import and cultivation of these GMOs and have strongly recommended additional long-term (up to 2 years) and multi-generational    animal feeding studies on at least three species to provide true scientifically valid data on the acute and chronic toxic effects of GM crops, feed and  foods.

CRIIGEN denounces in particular the past opinions of EFSA, AFSSA and CGB, committees of European and French Food Safety Authorities, and others who spoke on the lack of risks on the tests which were conducted just for 90 days on rats to assess the safety of these three GM varieties of maize. While criticizing their failure to examine the detailed statistics, CRIIGEN also emphasizes the conflict of interest and incompetence of these committees to counter expertise this publication as they have already voted positively on the same tests ignoring the side effects.

Contact:
Prof. Gilles-Eric SERALINI, criigen@unicaen.frThis e-mail address is being protected from spambots. You need JavaScript enabled to view it ; tel. +33 2 31 56 56 84, or +33 6 70 80 20 87.

Citation: de Vendomois JS, Roullier F, Cellier D, Seralini GE. A  Comparison of the Effects of Three GM Corn Varieties on Mammalian Health. Int J  Biol Sci 2009; 5:706-726. Available from http://www.biolsci.org/v05p0706.htm

Sunday, November 29, 2009

Food bill frightens farmers

Proposed legislation holds small growers to difficult standards

By ERIN MILLS
The East Oregonian

Small farmers and local food activists are up in arms about the Food Safety Modernization Act, the U.S. Senate's plan to improve food safety.

The bill, S510, is a rewrite of the nation's food safety rules. It would expand federal regulation of food production facilities, including small farms.

One point of contention for small farmers is the bill's requirement that all food production facilities, no matter how small, register with the federal government and complete a hazard analysis.

"It will mean that small producers that sell direct to consumers will have to go through the same regulations as Smith Foods," said Andrea Malmberg, the director of Oregon Rural Action, a group that supports local foods. "It's a one-size-fits-all regulatory mechanism for food facilities."

The food safety overhaul comes in the wake of national food scares, such as the peanut-related salmonella outbreak last spring that killed nine people. But the tainted products came from large processing facilities, Malmberg said, not small producers.

Gus Wahner, a Stanfield farmer, grows vegetables for markets in Pendleton and Hermiston. He said the bill's regulations might make it impossible for him to do business. It's not just the hazard plan, he said, it's also new Food and Drug Administration guidelines on how to grow crops.

The bill declares that the FDA will establish "science-based minimum standards for the safe production and harvesting of...raw agricultural commodities."

To satisfy those standards, the FDA may require growers to prove they are monitoring insect and wildlife activity in their fields, among other rules.

Under the Senate bill, growers will also be subject to more federal inspections, something which Wahner said he could not afford. He said he already opted out of the state's organic certification program because it required too much time and paperwork.

"They want to put all these regulations on you, but they don't have any idea how much it's going to cost," Wahner said.

Wahner said he was unsure about all the implications of the bill, a concern that was echoed by others in the local foods community. The bill makes reference to a number of new regulations of food "facilities," for example, but doesn't describe what a facility is.

Karen Wagner, the Pendleton Farmer's Market board president, said the bill's rules could have a chilling effect on growers. The profit margins on small and organic operations are thin enough as it is, she said.

"And (the rules) don't address the issues at hand - why people are getting sick," she said.
Much of the bill's regulations concern traceability - the need to know where contaminated food came from. But if a person gets sick from food bought at the farmer's market, she said, traceability is not as issue.

"You go to that farmer and say, 'You made me sick,' and you go to public health and they are shut down," she said.

Wagner pointed out that when people got sick from tainted spinach, it was difficult to trace the source because the produce came from hundreds of different farms and was packaged at a distant location.

"In essence, the extra paperwork does not protect the public," she said. "What protects the public is safe handling of our food."

Julie Edwards, communications director for Sen. Jeff Merkley (D-Ore.) said the bill addresses the problem of food-related illnesses and has provisions to protect small growers from undue regulation.

"It's important to keep in mind why it was needed," she said.

Every year, she pointed out, there are millions of cases of food-borne illnesses. Last year, there were 325,000 hospitalizations and 5,000 deaths from tainted food. And it's not just a public health issue, she said - growers suffer when a food item becomes untouchable in the marketplace.

Merkley was among those who insisted the bill direct the FDA to be flexible for small farmers, she said. For example, one potential rule for large growers could be to have handwashing stations in the field. That requirement is obviously unnecessary when your field is right next to your house, she said.

"As long as their business is direct to consumer, they will benefit from that flexibility," she said.

Edwards said having growers keep a hazard plan was a simple process of keeping a list of guidelines. The FDA would help growers with that process, she added.

After the bill unanimously passed the Senate Health, Education, Labor and Pensions committee, the National Sustainable Agriculture Coalition issued a letter to senators that praised changes in the bill related to organic and small-scale farming. However, it wrote, the bill still has problems.

"The chief flaw relates to the very basic issue of how many farms are presumed to be regulated under the terms of the bill, at what cost, and with what incremental gain to food safety, if any," the NSAC wrote.

Many small-foods activists are happier with the House's food safety bill, the Food Safety Enhancement Act of 2009, which it passed in July.

The House bill exempts some farms that sell food directly to consumers from registration as "facilities" and small farms from traceability requirements.

Janet Marie, the manager of the La Grande Farmer's Market, is among those who have been raising awareness about the two bills for the past several months. She praised Senator Merkley for his additions to the Senate bill, but said he didn't go quite far enough. She would like to see an amendment that exempts small growers from many of the bills requirements, including the hazard plan, she said.

"It's kind of a tiny point in a big bill, but we think it's extremely important for direct market farmers," she said.

Friday, November 27, 2009

China gives safety approval to GMO rice - Reuters

* China approves pest-resistant Bt strain as safe

* Large scale production could start in 2-3 years

* Approval follows phytase corn clearance last week

* Corn, rice approvals are first for grains in China (Adds background, detail, quote)

By Niu Shuping and Tom Miles

BEIJING, Nov 27 (Reuters) - China, the world's largest rice producer and consumer, has approved a locally-developed strain of genetically-modified rice, paving the way for large-scale production in 2 to 3 years, Chinese scientists said on Friday.

The Ministry of Agriculture's Biosafety Committee has issued biosafety certificates to Bt rice, a pest-resistant genetically modified strain, two committee members told Reuters.

Along with GM phytase corn approval announced last week, this is China's first two approvals for grains, although it already permits GM papaya, cotton and tomatoes.

But the strains still need to undergo registration and production trials before commercial production can begin in restricted areas, which may take 2-3 years, the scientists said.

The scientists declined to be identified as the Chinese government has not officially published the information. Officials at the Agricultural Ministry's biosafety office declined to comment.

China is the world's top producer of rice, growing 59.5 million tonnes in the 12 months to October, but it exports only around 50,000 tonnes a month as most is consumed domestically. Exports of GM rice would be likely to face tough scrutiny abroad.

The European Union's executive body, the European Commission, said in July that China needed to tighten export controls on rice products, such as baby food, because shipments might contain traces of the Bt-63 strain, which is not authorised in the EU.

While China is not yet growing GM rice commercially, there are numerous field trials going on around the country.

Bt rice, developed by Huazhong Agricultural University, would help reduce the use of pesticide by 80 percent while raising yields by as much as 8 percent, said Huang Jikun, the chief scientist with the Chinese Academy of Sciences.

"We believe more genetically-modified technology will be used in agriculture production in future to increase production and reduce inputs," said Huang.

Phytase corn, developed by the Chinese Academy of Agricultural Science, will help animals such as pigs digest more of the phosphorus in corn, enhancing growth and reducing environmental phosphorus pollution via animal waste and fertiliser runoff.

Wednesday, November 25, 2009

Are We Being Needlessly Hysterical About Food Safety?

Despite all the media hype, there's little to actually suggest we're facing a major food safety crisis. 

By David E. Gumpert, Chelsea Green Publishing. Posted November 25, 2009.

There have been all kinds of scary headlines and stories about food safety problems. The most recent was a front-page story in the New York Times a few weeks ago about a young dance instructor who wound up paralyzed from the waist down after a bout of illness from E.coli O157:H7 contained in a hamburger she ate. The story led to so much public upset that Agriculture Secretary Tom Vilsack was prompted to issue a statement saying the case was "unacceptable and tragic."

Shortly after that, victims of foodborne illness were received by Obama administration officials at the White House for a high-profile photo session.

Besides health care reform, new food safety legislation moving through Congress (passed by the House, about to be voted on by the Senate) is billed as the most urgent consumer proposal in the Congress. It’s supposed to reduce the scary headlines about contaminated peanut butter, pistachios, ground beef, spinach, and other foods that have embarrassed the public health establishment over the last three years.

Unlike health care reform, food safety legislation, which is designed to give the U.S. Food and Drug Administration more power to monitor food producers and institute recalls, is heavily supported by an array of consumer organizations and health industry professionals, not to mention bureaucrats and legislators. President Obama has indicated he’s ready to sign whatever Congress passes.

But in all the handwringing, there’s been very little data presented by public health officials to document that we have a worsening problem with foodborne illness. Indeed, when you review the testimony provided by the FDA and other experts to the House in connection with the legislation that passed there over the summer (HR 2749), no one even tried to make a statistical case that we have a worsening problem with foodborne illness. The best you’ll find is FDA food safety adviser Michael R. Taylor, saying, "Every year, millions of our friends and neighbors in the United States suffer from foodborne illness, hundreds of thousands are hospitalized, and thousands die."

The reason FDA experts haven’t provided more convincing data is that it doesn’t exist. Indeed, if you examine the data on foodborne illness, you find a different sort of crisis—a crisis of credibility, based on ineffective and incomplete data gathering and investigation. And some of what is there actually shows declines in rates of foodborne illness.

The bastion of data on foodborne illness is the U.S. Centers for Disease Control and Prevention, and the data it pushes the public to consider as most relevant is a study scientists conducted more than ten years ago, and published in 1999. The study estimates that 76 million Americans are sickened by foodborne illness each year, with 325,000 hospitalizations and 5,000 deaths. (That’s the data the FDA’s Michael Taylor was quoting from.)

Three things are most notable about this data. First, it is old. Not only is the paper containing its findings more than ten years old, but the data it draws on goes back to as far as 1948.

Second, it is based entirely on what can only be termed wild estimates of the real situation. The number of reported illnesses are miniscule in comparison with the 76 million estimate. Even allowing for the multiplier effect -- the likelihood that for every reported illness, there may be between ten and forty times that number not reported -- the numbers don’t obviously add up to the millions projected by the CDC. Consider that in 2007, the CDC reported a total 21,183 cases of foodborne illness, based on reports from states and localities around the country. Multiplying that by 40, you still only get 847,000 illnesses, a far cry from 76 million.

Not only that, but the 2007 data of reported illnesses is down 15% from the 25,035 reported in 2001. The Center for Science and the Public Interest, a nonprofit organization that also monitors foodborne illnesses, reported last year that it counted 168,000 illnesses over the 17-year period 1990-2006. That averages out to fewer than 10,000 per year.

The problem here isn’t that the CDC is manipulating the data, but rather that the data is incomplete. Public health officials will tell you that states categorize illnesses differently, and vary widely in their aggressiveness in seeking out information. The Center for Science and the Public Interest in its 2008 report on foodborne illness, reported that "nearly half of all states do not follow national standards for tracking disease outbreaks. Those gaps are particularly troubling given the numerous recent large outbreaks."

So what’s behind the hysteria on foodborne illness? Clearly, part of it has to do with the dramatic cases being reported of individuals who have suffered serious long-term repercussions. While the vast majority of foodborne illnesses involve mild gastrointestinal problems that last just a few days, the serious cases obviously capture public attention, and stir up nervousness, as well they should. They are tragic.

But there’s another factor at work here as well: a drive to broadly expand the powers of the FDA. As one example, it will have the power under the House legislation recently passed to require highly detailed written food plans from all food producers, including the smallest makers of artisan cheese and meats. The owner of a two-person California maker of specialty cheeses, fruits, and nuts, told me that creating such a plan would require about 100 hours of upfront work, and then two hours a day to be kept up to date. Failure to comply could result in a fine of $10,000 per infraction per day, this for a business doing less than $100,000 of annual revenues.

In addition, the FDA could inspect the records of all food producers at will, instead of the current requirement of having strong reason to believe a problem exists, or obtaining a search warrant. It will also be able to quarantine large areas of the country if it believes a serious source of pathogens exist, and shut down all food shipping in the process. And it will obtain substantial additional budget for inspection personnel.

Before requiring such an infringement on individual rights, and added costs for doing business, it would seem that the FDA should at the least put together data showing the nature of the foodborne-illness problem at hand, and to what extent its new powers will solve the problem. It could be that more targeted changes, costing less in funding for new personnel and foregone rights, could be quite effective in reducing foodborne illnesses.

Wednesday, November 18, 2009

Help for Organic Farmers Added to S. 510

Monday the Senate Health, Education, Labor, and Pensions (HELP) Committee released Chairman Tom Harkin's (D-IA) draft markup of the pending S. 510, the FDA Food Safety Modernization Act, which contained new provisions to protect organic and sustainable farmers.

tomatoes-farmer-featured.jpgSenators Jeff Merkley (D-OR), Al Franken (D-MN), Bernie Sanders (D-VT), Sherrod Brown (D-OH), and Michael Bennet (D-CO) sent a letter to Chairman Harkin last week urging the inclusion of provisions to help organic farms and sustainable agriculture comply with the new legislation.

"Specifically, we request that the Chairman's mark include language to streamline food safety guidelines and regulations governing organic and sustainable farms," said the senators in the letter to Harkin.

The letter, which noted that organic food sales have been growing between 15 and 21 percent annually, cited concerns over whether the legislation might unintentionally burden the small and sustainable agriculture sector.

"We are concerned that following enactment of S. 510, organic farms and sustainable agriculture will be subject to two potentially conflicting or duplicative sets of regulations issued by the two agencies," the HELP committee said in its letter. "In order to avoid potential regulatory conflicts or duplication, we urge you to include language...to require the FDA and USDA to work together in developing food safety regulations."

"We believe that a cohesive set of regulations will help ensure the viability or organic and sustainable food producers, while also increasing the safety of the foods these producers bring to market," the letter added.

Harkin listened to the concerns and adopted the suggested provisions.

"The FDA Food Safety Modernization Act of 2009 will strengthen the FDA's ability to protect the nation's food supply by enacting comprehensive reforms that will improve capacity to detect and respond to contamination outbreaks, provide food safety training for small farmers and food processors and enact strong preventative measures for food imports," said Senator Merkley's office in a statement responding to the Chairman's markup draft, released on Monday.

"Oregon farmers, schools and restaurant owners have forged strong partnerships to provide locally grown, sustainable food for our families," said Merkley. "We should work to strengthen those relationships while enacting policies to make sure that the food parents are packing in school lunches and putting on the dinner table is safe to eat."