Saturday, November 5, 2011

Food Chemical Safety Relies on Self-policing


According to the Pew Health Group, safety decisions regarding a third of the more than 10,000 chemicals and additives that can be put in food were made by food manufacturers and a trade association without any formal review by the U.S. Food and Drug Administration. The findings were published Wednesday Comprehensive Reviews in Food Science and Food Safety, a peer-reviewed journal.

"Congress established our food additive regulatory program more than 50 years ago, and it does not stand up well to scrutiny based on today's standards of science and public transparency," said Tom Neltner, Food Additives Project director in the Pew Health Group.

The shift away from public involvement in FDA's safety decisions led to an influx of food chemicals for the agency to review -- requests for approval doubled, according to the analysis.

"While the shift to a new regulatory process-one in which companies make safety decisions and ask FDA to confirm them-has sped up agency review, it has also bypassed the public," Neltner said in a release. "Subjecting safety decisions to comment from competitors, academic scientists, public interest groups, and the general public can result in stronger protections for consumers. In an age of growing demand for government transparency, there is virtually no meaningful opportunity for participation in decisions about large classes of substances added to the food supply."

Congress' Food Additives Amendment of 1958 created a structure that has "limited FDA's ability to effectively regulate substances added to food," according to Pew. The group points to two tenets of the law:

- It allows manufacturers to determine that the use of an additive is "generally recognized as safe" (GRAS), and then use that substance without notifying the FDA. As a result, the agency is unaware of many substances that may be added to food and lacks the ability to ensure that safety decisions were properly made.

- It does not require that manufacturers inform the FDA when health reports suggest new hazards associated with additives already used in food. Therefore, the agency has no access to unpublished reports and must expend limited resources sifting through published information to identify potential problems and set priorities.

The report is the beginning of a broader effort to assess FDA's regulatory system for ensuring chemicals added to food are safe. Future articles will examine scientific analysis and law and provide case studies that illustrate weaknesses in the system, which will ultimately lead to policy recommendations, according to Pew.

The non-profit is already highly engaged on food and agriculture issues, including industrial farming, school lunch, and food safety reform. 

Saturday, September 3, 2011

GM Biotech Revenues Increase in U.S.

Biodesic 2011 Bioeconomy Update reports that "within the United States, more than 50% of cropland is now planted in genetically modified (GM) seed resulting in 2010 revenues of nearly $110 billion." Biodesic is an engineering, design and consulting firm based in Seattle, Washington.

For 2010, total revenues from GM products including those of biologics and industrial biotechnology exceeded $300 billion or the equivalent of more than 2% of Gross Domestic Product (GDP). The report further notes that "revenues from GM crops are growing rapidly and are substantially larger than generally reported."

GM corn, soy, and cotton earned $100 billion in U.S. farm scale revenues in 2010. GM sugar beets contributed over $1.5 billion while GM papaya, canola, and other crops gave another billion dollars. "Continued increases in GM crop acreage in the next few years will certainly raise the total, with revenues from GM alfalfa contributing $1-2 billion dollars next year," the report added.

The full report can be downloaded at http://www.biodesic.com/library/Biodesic_2011_Bioeconomy_Update.pdf

Monday, August 22, 2011

Asian Honey, Banned in Europe, Is Flooding U.S. Grocery Shelves


Honey Laundering

Asian Honey, Banned in Europe, Is Flooding U.S. Grocery Shelves

FDA has the laws needed to keep adulterated honey off store shelves but does little, honey industry says.

A third or more of all the honey consumed in the U.S. is likely to have been smuggled in from China and may be tainted with illegal antibiotics and heavy metals.  A Food Safety News investigation has documented that millions of pounds of honey banned as unsafe in dozens of countries are being imported and sold here in record quantities. 

And the flow of Chinese honey continues despite assurances from the Food and Drug Administration and other federal officials that the hundreds of millions of pounds reaching store shelves were authentic and safe following the widespread arrests and convictions of major smugglers over the last two years.
Thumbnail image for honeycomb406.jpgExperts interviewed by Food Safety News say some of the largest and most long-established U.S. honey packers are knowingly buying mislabeled, transshipped or possibly altered honey so they can sell it cheaper than those companies who demand safety, quality and rigorously inspected honey. 

"It's no secret that the honey smuggling is being driven by money, the desire to save a couple of pennies a pound," said Richard Adee, who is the Washington Legislative Chairman of the American Honey Producers Association. 

"These big packers are still using imported honey of uncertain safety that they know is illegal because they know their chances of getting caught are slim," Adee said.

Food safety investigators from the European Union barred all shipments of honey from India because of the presence of lead and illegal animal antibiotics.  Further, they found an even larger amount of honey apparently had been concocted without the help of bees, made from artificial sweeteners and then extensively filtered to remove any proof of contaminants or adulteration or indications of precisely where the honey actually originated.

An examination of international and government shipping tallies, customs documents and interviews with some of North America's top honey importers and brokers documented the rampant honey laundering and that a record amount of the Chinese honey was being purchased by major U.S. packers.

Food Safety News contacted Suebee Co-Op, the nation's oldest and largest honey packer and seller, for a response to these allegations and to learn where it gets its honey. The co-op did not respond to repeated calls and emails for comment. Calls and emails to other major honey sellers also were unreturned. 

EU Won't Accept Honey from India

Much of this questionable honey was officially banned beginning June 2010 by the 27 countries of the European Union and others. But on this side of the ocean, the FDA checks few of the thousands of shipments arriving through 22 American ports each year. 

According to FDA data, between January and June, just 24 honey shipments were stopped from entering the country. The agency declined to say how many loads are inspected and by whom. 

However, during that same period, the U.S. Department of Agriculture reported that almost 43 million pounds of honey entered the U.S. Of that, the Department of Commerce said 37.7 million pounds came from India, the same honey that is banned in the EU because it contained animal medicine and lead and lacked the proper paperwork to prove it didn't come from China.

"There are still millions of pounds of transshipped Chinese honey coming in the U.S. and it's all coming now from India and Vietnam and everybody in the industry knows that," said Elise Gagnon, president of Odem International, a worldwide trading house that specializes in bulk raw honey. 

The FDA says it has regulations prohibiting foods banned in other countries from entering the U.S. However, the agency said last month that it "would not know about honey that has been banned from other countries ..."

Adee called the FDA's response "absurd." He said the European ban against Indian honey is far from a secret.

"Why are we the dumping ground of the world for something that's banned in all these other countries?" asked Adee, who, with 80,000 bee colonies in five states, is the country's largest honey producer.

"We're supposed to have the world's safest food supply but we're letting in boatloads of this adulterated honey that all these other countries know is contaminated and FDA does nothing."

The food safety agency said it's doing the best it can with existing resources and will do more when the newly passed Food Safety Modernization Act is up and running.

Where Is Our Honey Coming From?

honeypot350.jpgThe U.S. consumes about 400 million pounds of honey a year - about 1.3 pounds a person. About 35 percent is consumed in homes, restaurants and institutions. The remaining 65 percent is bought by industry for use in cereals, baked goods, sauces, beverages and hundreds of different processed foods.

However, the USDA says U.S. beekeepers can only supply about a 48 percent of what's needed here.  The remaining 52 percent comes from 41 other countries.   

Import Genius, a private shipping intelligence service, searched its databases of all U.S. Customs import data for Food Safety News and provided a telling breakdown: 

- The U.S. imported 208 million pounds of honey over the past 18 months.

- About 48 million pounds came from trusted and usually reliable suppliers in Argentina, Brazil, Canada, Uruguay and Mexico.

- Almost 60 percent of what was imported - 123 million pounds - came from Asian countries - traditional laundering points for Chinese honey. This included 45 million pounds from India alone.

"This should be a red flag to FDA and the federal investigators. India doesn't have anywhere near the capacity - enough bees - to produce 45 million pounds of honey. It has to come from China," said Adee, who also is a past president of the American Honey Producers Association.

Why Is Chinese Honey Considered Dangerous? 

Chinese honeymakers began using various illegal methods to conceal the origin of their honey beginning in about 2001. That's when the U.S. Commerce Department imposed a stiff tariff - as much as $1.20 a pound -- on Chinese honey to dissuade that country from dumping its dirt-cheap product on the American market and forcing hundreds of U.S. beekeepers out of the business.

About the same time, Chinese beekeepers saw a bacterial epidemic of foulbrood disease race through their hives at wildfire speed, killing tens of millions of bees. They fought the disease with several Indian-made animal antibiotics, including chloramphenicol. Medical researchers found that children given chloramphenicol as an antibiotic are susceptible to DNA damage and carcinogenicity. Soon after, the FDA banned its presence in food.
"We need imported honey in this country.  But, what we don't need is circumvented honey, honey that is mislabeled as to country of origin, honey that is contaminated with antibiotics or heavy metal," said Ronald Phipps, co-chairman of the International Committee for Promotion of Honey and Health and head of the major honey brokerage firm CPNA International. 

Heavy Metal Contamination
The Chinese have many state-of-the-art processing plants but their beekeepers don't have the sophistication to match. There are tens of thousands of tiny operators spread from the Yangtze River and coastal Guangdong and Changbai to deep inland Qinghai province.  The lead contamination in some honey has been attributed to these mom-and-pop vendors who use small, unlined, lead-soldered drums to collect and store the honey before it is collected by the brokers for processing.

The amount of chloramphenicol found in honey is miniscule. Nevertheless, public health experts say it can cause a severe, even fatal reaction -- aplastic anemia -- in about one out of 30,000 people. 

European health authorities found lead in honey bought from India in early 2010. A year later, the Indian Export Inspection Council tested 362 samples of honey being exported and reported finding lead and at least two antibiotics in almost 23 percent of the test samples. 

The discovery of lead in the honey presents a more serious health threat.

"The presence of heavy metals is a totally different story, because heavy metals are accumulative, they are absorbed by organs and are retained. This is especially hazardous for children," Phipps said.  

All the bans, health concerns and criticism of Indian honey hasn't slowed the country's shipping of honey to the U.S. and elsewhere. In February, India's beekeepers and its government agricultural experts said that because of weather and disease in some colonies, India's honey crop would be late and reduced by up to 40 percent. 

Yet two months later, on April 15 in Ludhiana, officials of Kashmir Apiaries Exports and Little Bee Group, India's largest honey exporters, posed for newspaper photographers in front of "two full honey trains" carrying 180 20-foot cargo carriers with a record 8.8 million pounds of honey headed for the export ports.  

"They're clearly transshipping honey from China and I can't believe that they are so brazen about it to put it right on the front page of a newspaper," honey producer Adee said.

Data received by FSN from an international broker in India on Friday showed that within the last month 16 shipments - more than 688,000 pounds - of honey went from the Chinese port of Nansha in Guangzhou China to Little Bee Honey in India.  The U.S. gurus of international shipping documents - Import Genius - scanned its database and found that just last week six shipments of the honey went from Little Bee to the port of Los Angeles. The honey had the same identification numbers of the honey shipped from China.

Government investigators in the U.S. and Europe and customs brokers in India told FSN that previous successful criminal investigations had proven that the Chinese honey suppliers and their brokers are masterful at falsifying shipping documents.

Each of the shipments - whether from China or India - bore an identical FDA inspection number. However, FDA's Division of Import Operations did not respond to requests for information on how and where it issued that FDA number. 

Food Safety News left several messages for the Little Bee Group to discuss the source of their honey and how they were breaking records when the rest of India's honey producers were months behind schedule. None of the phone messages or emails were returned.

Other major Indian honey exporters insist that India gets no honey from China. However, Liu Peng-fei and Li Hai-yan of the prestigious Chinese Academy of Agricultural Sciences disagree. In a scientific study of the impact the global financial crisis is having on China's honey industry, the apiculture scientists wrote that to avoid the "punitive import tariffs" Chinese enterprises "had to export to the United States via India or Malaysia in order to avoid high tariffs..."

Why Hasn't Smuggling Stopped?

The massive honey laundering scams that plagued the U.S. for more than a decade - the transshipment of Chinese honey to a second country before being reshipped to the U.S. -- were presumably given a deathblow over the past two years.

During that period, Justice Department lawyers and Department of Homeland Security and FDA investigators launched a series of indictments and arrests of 23 German, Chinese, Taiwanese and American corporate officials and their nine international companies. 

They were charged with conspiracy to smuggle more than $70 million worth of Chinese honey into the U.S. by falsely declaring that the honey originated from countries other than China. That allowed them to avoid paying stiff anti-dumping charges imposed on China.

It was an impressive series of complex busts spanning three continents, and instant fodder for a great whodunit novel. But, according to some of North America's largest producers and importers of honey, the arrests bombed as a deterrent.  

"There are still millions of pounds of transshipped Chinese honey coming into the U.S.A. and it's all coming now from India and Vietnam. Everybody in the industry knows that," said Odem International's Gagnon.

How Do They Get Away With It?

When it comes to honey laundering, the crooks are always trying to stay one step ahead of the criminal investigators.

honeybarrels-inside.jpg
For example, when customs agents discovered that China usually shipped its honey in blue steel drums, the exporters quickly painted the drums green. 

It took investigators a while to learn that often -- while the drums were in port or en route at sea -- the Chinese shuffled drum labels and phony paperwork showing country of origin as places that didn't have an onerous anti-dumping tariff. The Russian Honey Federation blew the whistle on the Chinese relabeling millions of pounds as coming from Russia. 

After that scam became known, the felons then shipped Chinese honey to countries like Vietnam, Indonesia, Malaysia and even Australia. There the honey was repacked, authentic local documents were issued and the honey was shipped on to the U.S. or elsewhere. 

Another favorite con among Chinese brokers was to mix sugar water, malt sweeteners, corn or rice syrup, jaggery, barley malt sweetener or other additives with a bit of actual honey. In recent years, many shippers have eliminated the honey completely and just use thickened, colored, natural or chemical sweeteners labeled as honey.

However, sophisticated analysis that will match the pollen in honey to flowers from a specific geographic region is available at just two or three laboratories around the world.  There are also simpler, less expensive tests to detect the telltale presence of commercial sweeteners and other adulterants that are more readily available.

A laboratory in Bremen, Germany, founded a half century ago by German beekeepers, can accurately scan honey samples for flower pollen.   There is only one expert in the U.S. known to analyze pollen in honey to determine where it was actually grown and that would be at the Palygnology Laboratory at Texas A&M.  The lab was created and is run by Vaughn Bryant, a forensic palynologist and Professor of Anthropology.

Melissopalynology, or pollen analysis, has been used for years by geologists seeking evidence of ancient coastal areas - often sites of major oil deposits. Scientists tracing the origins of the Shroud of Turin have identified 61 different pollens on the cloth that could only have come from around Jerusalem. 

Forensic scientists have used pollen identification to help solve murder, rapes, kidnapping and at least one espionage case. Now, at least in the labs in Texas and Germany, melissopalynologists use pollen to determine - with great accuracy - the geographic area where the bees foraged for the nectar. 

"If they find, for example, pollen from flowers that grow in northern latitudes - like China - but it's found in honey ostensibly produced in tropical countries - like India, Vietnam, Malaysia and the like - you know something's rotten or illegal," said CPNA International's Phipps, who also produces a quarterly, international intelligence report that monitors the country-by-country supply of honey and everyone's exports.

To avoid detection by concerned purchasers or criminal investigators, some Chinese producers in state-of-the-art processing plants pump the alleged honey, heated and under high pressure, through elaborate ceramic filters. This ultra-filtration removes or conceals all floral fingerprints and indicators of added sweeteners or contaminants.

"The Chinese have refined methods of masking their contaminated product by ultra-filtration so their honey seems perfect. But it's not honey anymore. There's no color.  There's no flavor. There's nothing.  So you take this perfect product, which could be confused with honey, and you blend it with real Indian honey," Gagnon said.

"Everyone avoids tariffs because government agents cannot test to prove it's from China."

honeytesting-inside.jpgThe FDA says it has sent a letter to industry stating that the agency does not consider ultra-filtered honey to be honey. 

"We have not halted any importation of honey because we have yet to detect ultra-filtered honey.  If we do detect ultra-filtered honey we will refuse entry," said FDA press officer Tamara Ward.

"FDA is just not looking" was the answer that most honey brokers offeredThey added that the FDA doesn't want to find it because then the agency would have to test for it, something it is incapable of doing in its existing laboratories. 

Honey experts worry that new technologies will make detection of adulterants even more difficult. 
At June's conference of the Institute of Food Technologists in New Orleans, there were hundreds of Chinese vendors working in small clusters beneath bright red banners. They offered for sale almost any spice, food-processing substance or additives a food processor might want and promises of concocting anything else they could dream of. "All FDA approved," they emphasized to potential clients. 

One salesman quickly jerked back his business card when a reporter pulled out a tape recorder to capture the man's promises offering a "nanoparticle sweetener for honey that cannot be detected."

Does the FDA Care?

The U.S. Departments of Customs and Border Patrol and Immigration and Customs Enforcement have dollar and cents issues to worry about because hundreds of millions of dollars in unpaid taxes and anti-dumping tariffs on Chinese imports are circumvented by the honey laundering. 

"These honey crimes are not a Republican or Democratic, Liberal or Conservative issue.  The country is being ripped off of millions and millions," Phipps said.

Recent news releases by the border patrol and the FDA say they have developed an anti-smuggling strategy to identify and prevent smuggled foods from entering the United States and posing a threat to national security and consumer safety.

But at the field level, investigators with the two agencies and an agent with ICE's Commercial Fraud Unit said the cooperation is more on paper then in practice and that the FDA continues to be the weak link. They say the FDA either doesn't have the resources to properly do the job or is unwilling to commit them.
ICE and the border patrol can and do go after the honey launderers by enforcing the anti-dumping and tariff violation laws. But protecting consumers from dangerous honey, identifying it as adulterated and therefore illegal for importation, falls to the FDA. And many of its enforcement colleagues say the food safety agency doesn't see this as a priority.

A Justice Department lawyer told Food Safety News that the FDA has all the legal authority and obligation it needs to halt the importation of tainted honey. He cited two sections of the agency's regulations defining when food products are considered "adulterated." 

The regulations say: "Food is adulterated if it bears or contains a poisonous or deleterious substance which may render it injurious to health" and "damage or inferiority has been concealed."

Those two factors pretty much sum up the health concerns that many have with the smuggled honey. But the honey industry and Congress can't get the FDA to even come up with a legal definition of what honey is.

Eight years ago, America's beekeepers and some honey packers petitioned FDA to issue an official definition of honey. Their concern was how to determine whether honey is bogus if there is no official standard to measure it against. The FDA did nothing. 

Last Nov. 15, senators asked the food safety agency for the same thing. Again, nothing.

On Aug. 10, two members of the Senate Committee on Appropriations tried once more.

Sens. Kirsten Gillibrand (D-NY) and John Hoeven (R-ND) urged the FDA Commissioner Margaret Hamburg to issue the official definition.

Calling the lack of regulations "a food safety concern," Gillibrand said a national standard of identity for honey is needed "to prevent unscrupulous importers from flooding the market with misbranded honey products..."

An investigator in FDA's import section explained the agency's refusal to develop an official definition to FSN. "If we had an official description of honey then FDA would have to inspect everything we're importing to ensure it's legal. That's the last thing we want to do," he said, but would not allow his name to be used because he wasn't authorized to make public statements. 

How Do You Stop The Illegal Flow?

Gagnon and four other major players in the honey industry have formed a voluntary group called True Source Honey.  They hope it will eventually expand into an international, industry-wide program to certify the origin and quality of honey. 

"We need an origin traceability program, a professional audit of both the exporters and the packers so those buying and selling honey can ensure its authenticity and quality," said Gagnon, who is the group's vice chairman.
Meanwhile, it's rumored that the feds are increasing their surveillance of the large U.S. importers and not too soon, Adee and others say. 

Adee likens the honey laundering to a huge auto chop shop, where the police occasionally arrest the low-level car thieves but others pop up to continue supplying the criminal operation, which authorities never go after.

"That's what's happening here," Adee explained. "ICE and the other investigators have arrested a handful of the middle men, the brokers who supply the honey packers, but haven't gone after the big operators buying the phony foreign honey."
Adee and others interviewed by Food Safety News say there are 12 major honey packers in the U.S. and four or five that are involved with the bulk of illegal trade.
 
"We know who they are," he said. "Everyone in the industry knows. If these packers are allowed to continue buying this possibly tainted but clearly illegal smuggled honey, the importers will always find a way to get it to them."

Saturday, August 20, 2011

Monsanto rolls out GMO sweet corn

 NOTE:  This press release was issued by "The Packer," a fresh produce industry publication for industrial food crops.


Vegetable seed giant Monsanto Co. is entering the genetically modified sweet corn market earlier than expected, but how soon consumers will get over their fear of GMOs remains to be seen.

Creve Coeur, Mo.-based Monsanto will sell GMO sweet corn for plantings this fall, said Danielle Stuart, a company spokeswoman. Originally, rollout of the product was slated for 2012.

The seed, to be sold under Monsanto’s Seminis Performance Series label, protects against European corn borers, corn earworms, fall army worms and corn rootworm larvae and is resistant to Roundup weed control herbicides, Stuart said.

Boise, Idaho-based Rogers Brand Vegetable Seeds, a division of Basel, Switzerland-based Syngenta International AG, introduced its Attribute brand GMO sweet corn seed in 1998.

Even after 13 years, however, consumer resistance to GMO sweet corn remains high, grower-shippers say.

E. Miedema & Sons, Byron Center, Mich., uses GMO seed on about 100 of its 700 sweet corn acres, said Dave Miedema, the company’s president.

GMO seed provides good disease and pest protection, Miedema said, but consumer resistance has checked category growth.

“It definitely has a place, but you always have to be careful,” he said. “Certain customers won’t accept it.”

GMO sweet corn has been the victim of propaganda, not legitimate criticism, Miedema said.

“It’s just PR,” he said. “It’s silly. It’s just people’s perceptions.”

Miedema said consumers’ attitudes toward GMOs haven’t changed much in recent years.

Those attitudes will likely change, but it hasn’t happened yet, said John Gill, owner of Hurley, N.Y.-based Gill Corn Farms Inc.

Because of consumer resistance, Gill Corn Farms doesn’t grow any GMO sweet corn.

People already eat plenty of GMO foods, including grains and chicken, Gill said. That’s one of the reasons he thinks they’ll eventually come around on sweet corn and other produce commodities.

GMO foods are not only safe, Gill said. They’re also environmentally friendly, since they require fewer pesticides.

Thursday, August 11, 2011

China: 2,000 Arrested in Food Safety Crackdown

China's latest food safety crackdown, which focused on the rampant use of illegal and often dangerous food additives, resulted in 2,000 arrests and 4,900 business shut downs, official state media announced last week.

Since April, authorities have inspected nearly 6 million food or additive manufacturers and catering businesses, according to an update issued by the Food Safety Commission, which operates under the State Council. The campaign is the latest in a series of initiatives aimed at quelling widespread distrust of food production in China.

In May, Chinese authorities announced they resolved more than 1,000 severe food safety cases so far in 2011, including hundreds of arrests.

In a country with an enormous food sector, and limited transparency, it's difficult to assess the overall impact of the waves of enforcement, but the campaigns have certainly not kept food safety from the headlines.

In the past few months alone, hundreds have been seriously sickened by clenbuterol-tainted pork, over a dozen noodle makers were ordered to stop production because they were using ink, industrial dyes and paraffin wax as ingredients, and 16 tons of pork were pulled from the marketplace for containing sodium borate, a chemical that seemingly transforms cheap pork into darker, higher-value "beef."

Chinese officials also arrested 12 people for involvement in a 40-ton bean sprout debacle, in which farmers were using sodium nitrite (a known carcinogen), urea, antibiotics and a plant hormone called 6-benzaledenine to make the sprouts grow faster and look shinier.

In recent weeks, seemingly fantastic exploding watermelons and glow-in-the-dark pork scandals have garnered international media attention as well, further complicating China's effort to boost consumer confidence.

According to the latest update, police have investigated 1,200 criminal cases concerning "the illegal adding of non-edible materials in food" and destroyed key elements of black market food production.

The statement said government agencies across the country will "continue the fight against irregularities to safeguard food" and severely punish violators.

by Helena Bottemiller | Aug 09, 2011

With Debt Deal, Food Safety Funding Uncertain

The debt deal struck by leaders in Washington last week has food policy insiders worried about the future of food safety funding at both the U.S. Department of Agriculture and the Food and Drug Administration.

The deal -- liked by virtually no one, but praised for saving the country from default -- raised the debt ceiling through 2012 in exchange for between $2.1 and 2.4 trillion in savings over the next 10 years, including $917 billion in savings by capping discretionary spending, which includes public health agencies.

Future budget cuts, though significant, will "protect core investments," according to the Obama administration, but it is hard to see a budgetary scenario in which FDA and USDA, and the Centers for Disease Control and Prevention, are able to expand their capacity or invest in additional initiatives. Appropriators in the House and Senate have tough decisions ahead as they work to trim almost a trillion dollars from a wide variety of programs.

The spending limits come right as FDA is working to implement an ambitious food safety overhaul, mandated by the FDA Food Safety Modernization Act that President Obama signed into law in January.

"I don't see [FDA] going above flat line at best ... which is effectively a cut," says food safety consultant David Acheson, who served as associate commissioner of foods at FDA under the Bush administration. "FDA will likely stay on track with the [Food Safety Modernization Act] rule writing, but enforcement will be compromised as will the inspection mandates."

The Alliance for a Stronger FDA, a group of consumer and industry interests that lobbies for building the agency's capacity to regulate food and drugs in the 21st century, says it's "impossible to say" where exactly FDA or other agencies stand before the appropriations subcommittees weigh in, but the agency would likely fare better than under the House-passed agriculture appropriations bill. The House measure called for $285 million in cuts to the agency for fiscal year 2012, an 11 percent cut, $87 million of the reduction would come from food safety.

The Alliance is continuing to actively lobby for a budget increase at FDA and is planning an ad campaign targeting Capitol Hill publications in September.

"We have been active in presenting the Senate with reasons why FDA needs an increased level of funding in FY 12," writes Steven Grossman, deputy executive director for the Alliance. "We have been working to show the House that a higher FDA number from the Senate would be justified and should be accepted."

"FDA's responsibilities are not going to shrink just because federal spending is being reduced. We hope Congress sees, as we do, that FDA is not optional," added Grossman. "It is part of what society needs to function."

How the debt deal will impact USDA programs, including the Food Safety and Inspection Service, is also not entirely clear. Though the deal stipulates what cannot be cut -- food stamps and direct payments, for example, are protected through at least 2013 -- discretionary cuts will still apply.

"We're not sure how they're going to allocate these discretionary cuts, but clearly, you know, the department's going to get their share, and they've been cut so much already that it's going to have an impact," Rep. Collin Peterson (D-MN), ranking member of the House Agriculture Committee, told Farmpolicy.com in an interview last week.

Agriculture Secretary Vilsack told an audience of food protection professionals in Milwaukee he would work to keep food safety a priority at USDA.

"There are a lot of things we'd like to do, but one of the things we must do, and I will tell you that food safety is one of those things that ... is a must do," said Vilsack at the International Association of Food Protection conference last week, citing the tough budget landscape ahead. "We'll be looking at ways in which we can, even in a constrained resource environment, do a better job."

The House agriculture appropriations bill, passed in June, calls for a $35 million cut, a less than 4 percent cut for meat, poultry, and processed egg inspection. The Senate has not acted on FDA and USDA budgets for FY 2012 yet.

As for the more structural spending cuts under the debt deal, a so-called super committee made up of six Democrats and six Republicans will ultimately outline the toughest reductions -- entitlement reform, tax reform and revenue are all on the table, though what combination of these will be tenable is not clear. The panel must develop a plan to reduce approximately $1.5 trillion in deficit reduction over ten years and report back by Nov. 23.

If the committee fails to find cuts, or Congress refuses to adopt them, an enforcement mechanism will trigger spending reductions beginning in 2013 - split 50/50 between domestic and defense spending, according to the White House outline of the agreement.

Enforcement protects Social Security, Medicare beneficiaries, and low-income programs from any cuts, but the triggers could have significant impacts on other domestic programs, including food safety and other public health functions. 

Sunday, July 17, 2011

National Leafy Greens Marketing Agreement Threatens Small Growers

"Big Ag" is at it Again
The most powerful “Big Ag” players in the leafy green industry are pushing the National Leafy Greens Marketing Agreement (NLGMA).   The sellers, processors, and distributors that sign on to the rule will require that the farmers they purchase from comply with its standards. The rule adds a second and conflicting layer of food safety standards and audits on top of FDA food safety rules.
This confusing and duplicative rule could effectively shut small and mid-sized farmers out
of the leafy greens market
.  Tell the USDA's Agricultural Marketing Service (AMS) to withdraw their unnecessary and confusing rule.

Add your comments to USDA using the link below and then click on the submit button.  Use the following talking points to help compose your comment.  It is best, however, if you use your own words.

1.    The Agricultural Marketing Service is NOT a food safety agency and it should leave food safety regulation to the Food and Drug Administration.   AMS staff is made up of economists and marketing specialists who convene industry to reach agreement on orderly marketing of produce.  They are NOT food safety scientists.

2.    The governance structure for this agreement is dominated by processors and distributers and provides only token representation for farmers and consumers.  The standards developed under this rule are likely to be driven by the most powerful voices and the largest players in the leafy greens market to the detriment of small and mid-sized farmers and processors.

3.    Consumers expect food safety standards to apply to all produce, not just those subject to a marketing agreement.  Food safety should not be used to gain a competitive advantage in the market place.

4.    If a final rule is issued it should include those provisions in the Food Safety Modernization Act (FSMA) that provide food safety alternative compliance measures for small and mid-sized producers and processors.   Food safety must be achieved without obstructing the growing interest and investments in producing for local and regional food systems.  Broad access to these growing markets is vital to rural economic recovery, public health and nutritional well-being.


Please submit your comments here:
http://salsa.wiredforchange.com/o/5735/p/dia/action3/common/public/?action_KEY=4109

Catchy Propaganda

Chinese and Swahili Versions of Mandy and Fanny Cartoon Book on Biotech

The novel educational cartoon featuring two characters, "Mandy" and "Fanny" impersonating biotech maize and biotech cotton, is now finding its way to China and East Africa through Mandarin and Swahili versions.

The 60-page educational cartoon publication features a lively dialogue between Mandy (biotech maize) and Fanny (biotech cotton). Eye-catching frames present factual messages about biotech crops as contributors to sustainable agriculture. The educational cartoon publication aims to demystify misconceptions/notions that biotech crops are harmful to human beings and their environment.
Dr. Clive James, Founder and Chairman of ISAAA commented that "Sharing knowledge with young people about the new technologies of the 21st century, such as biotech crops, is vital, because they will be the decision-makers of tomorrow. The educational cartoon illustrations will enhance the understanding of children and young people about the utility and safety of biotech crops, which represent an essential element in a global strategy that will contribute to food security and the alleviation of poverty in developing countries."

Follow "Mandy & Fanny" on http://www.facebook.com/mandyandfanny and log on to http://www.chinabic.org and http://www.isaaa.org/india for more information about the cartoon and illustrations, selected images and a print copy of the cartoon publication "Mandy & Fanny: The Future of Sustainable Agriculture". For a print copy of the Chinese version contact China BIC at zhangt@mail.las.ac.cn and zhanghx@mail.las.ac.cn. The Chinese, English, and Swahili versions of Mandy & Fanny are available at http://www.isaaa.org/resources/publications/mandy_and_fanny/default.asp

Thursday, July 14, 2011

Fight for FDA Funding Turns to Senate

As the U.S. Food and Drug Administration works to meet deadlines and implement an ambitious new food safety law, the agency's budget for the next fiscal year remains highly uncertain. The House recently approved a $285 million cut to FDA, $87 million of which would come from the agency's food safety program. Now, food safety advocates are turning their focus to the Senate to make the case for a strong budget, or at the very least, no budget cuts.

The Senate has been slow to begin the appropriations process as Democrat and Republican leadership and the president work to strike a broad deficit-cutting deal as part of a plan to raise the debt ceiling, which the U.S. government is projected to be in danger of reaching August 2.

"No one had much insight into what the Senate will do next on appropriations, nor was their great optimism that any agency or program will do well," says Steven Grossman, deputy executive director of Alliance for a Stronger FDA, referring to recent meetings with staff. The Alliance -- a coalition of consumer and industry interests advocating for FDA funding -- is stepping up lobbying efforts on agency's behalf.

"We received positive feedback on the Alliance's fundamental position: programs that are the necessities of a stable functional society must be funded regardless of the overall budget situation," wrote Grossman, on the Alliance's blog last week. "When Congress makes those judgments, FDA should (properly) be seen in the same company as national defense and air traffic controllers ... rather than with other programs."

But Grossman, and others in the food safety community, are not taking the steep cuts the House cleared lightly.

"The threat from the House position is still under-appreciated. Many offices did not understand that the House FY 12 position on FDA funding (a $285 million cut) is larger than the cut we faced in FY 11 in the House-passed HR 1 (a $242 million cut)," explains Grossman.

Michael Taylor, deputy commissioner for foods at FDA, has stressed on numerous occasions that the agency will need resources to enforce the new FDA Food Safety Modernization Act signed by president Obama in January.

"While we build on a strong foundation and we have a base of resources that we can do a lot with, you can't build a new house without new financing," said Taylor at a recent meeting of food and drug officials in Plano, Texas. "You can't pretend that all the new programs and systems that this law calls for can be achieved without new resources."

The Alliance has been working to especially highlight FDA's critical role in ensuring the safety of imported food. Among the group's talking points is pointing out that a decade ago, 6 million shipments of FDA-regulated goods came in through U.S. ports, this year that number is 24 million shipments.

"Along with our points about safe foods and more/better medications, the safety/quality issues raised by imports captured attention, interest and sympathy," adds Grossman.

A debt ceiling agreement between party leaders is expected to jump start the appropriations process in the Senate --i f leaders can agree on general domestic spending levels for the next few years, then Senate committees will have ballpark figures to work with for each appropriations bill.

Because the House agriculture appropriations bill, which covers FDA and the U.S. Department of Agriculture, has already been completed, it could be one of the earlier bills taken up by the Senate, but the timeline remains up in the air. 

Monday, July 11, 2011

Biotech Country Facts and Trends

Biotech Country Facts and Trends are one- to two-page summaries that highlight the commercialization of biotech crops in the developing countries. Data on biotech crop commercialization (hectarage and adoption), approvals and planting, benefits and future prospects in each country are presented in a brief and easily understandable manner. The contents are all based on the annual ISAAA Brief on the Global Report of Commercialized Biotech/GM Crops, authored by Clive James.

Sunday, July 10, 2011

Genetically modified food labels don't sit well in U.S.

Activists rejoiced last week when a hard-fought battle over international standards for labeling genetically modified food came to an end — finally — after decades of debate.

But the agreement, which many say opens the door for labels to be placed on such foods, will probably have little effect on food labels in the U.S. for the foreseeable future. 
 
And that could be a good thing, some scientists said.

"The public gets bogged down on whether [crops are] genetically engineered or not. We think that's a distraction," said Pamela Ronald, a professor of plant pathology at UC Davis. "The consumer needs to know: Is it safe to eat?"

Delegates to the so-called Codex Alimentarius Commission, a body created in 1963 by the United Nations to set voluntary standards for food safety and handling, have been arguing over labels for genetically engineered food for the better part of 20 years.

Concerned that the biotech food is not adequately tested and could be unsafe for people or the environment, some countries, particularly ones in Europe, have pushed for mandatory labeling. Others, including the U.S., have argued that such labels are misleading because the genetically modified products that are on the market have been thoroughly tested and deemed safe.

Requiring that genetically engineered foods be labeled as such would be unfair, said Nathan Field, director of biotechnology and economic analysis at the National Corn Growers Assn. in St. Louis, echoing the feelings of many in the food production industry.

"There is no nutritional content difference between the products," he said. Genetic engineering "doesn't affect the environment or food or feed quality in any way. If there's no evidence they're different, there shouldn't be a label."

But some consumer advocates argue that chronic effects of eating genetically engineered foods could go undetected by what they see as lax oversight.

"Consumers have a legitimate right to be skeptical, given the imperfections of our safety system," said Doug Gurian-Sherman, a senior scientist at the food and environment program at the Union of Concerned Scientists in Washington, D.C.

On Tuesday in Geneva, Codex delegates agreed on guidance that had been cobbled together to give each side of the debate a little bit of what they wanted.

The document declared on the one hand that "different approaches regarding labeling of foods derived from modern biotechnology are used" around the world. And, in what was probably a concession to the U.S., it also declared that it "is not intended to suggest or imply that foods derived from modern biotechnology are necessarily different from other foods." The document then pointed to 10 existing Codex standards that countries should comply with in food labeling.

Though this might seem like a very modest achievement after 20 years of consideration, it broke up a logjam and — simply by laying out some ground rules — legitimized the practice of labeling genetically modified foods.

"This is a major victory and milestone for consumer rights," said Jean Halloran, director of food policy initiatives for the Consumers Union, a consumer advocacy organization in Yonkers, N.Y.

Still, the agreement fell short of what many activists, including Halloran, wanted because it didn't call for mandatory labeling. Countries are free to do what they want.

In some Latin American and African countries — "battlegrounds" where consumer groups are fighting for labeling laws, Halloran said — that might very well mean new labeling policies. But the Codex decision is highly unlikely to affect practices in places like the U.S. and Canada, where many genetically engineered crops are grown and products are consumed. In the U.S., more than 70% of processed foods contain genetically engineered or biotech ingredients.

Labeling here is voluntary; what labeling exists is mostly used to declare that a food has no genetically modified ingredients. Products labeled organic, for instance, fall into this category.

The official acknowledgement that genetically modified foods can be labeled does at least mean that countries that label such foods shouldn't have to worry about sparking trade disputes, Halloran said. "It seems to us a major step forward."

In Europe, where modified foods are labeled, the European Union Parliament is taking steps to go much further: It voted last week on draft legislation to give countries greater authority to ban such crops altogether.

While critics of genetically modified foods said they believed oversight in the U.S. is too lax, many scientists say that ample studies have demonstrated the items are safe.

"People have been eating products from genetically modified crops for almost 15 years," said UCLA molecular biologist Bob Goldberg, who helped develop a genetically engineered canola plant that is widely planted in Canada and produces more oil than conventional canola. "They've been more tested than any food product you can imagine, without even a sneeze."

Ronald of UC Davis, who is married to an organic farmer and whose lab has genetically engineered rice for resistance to diseases and flooding, wonders why more consumers don't worry about unintended consequences arising from conventionally bred crops. One type of celery, for example, was conventionally bred to resist insects. But it caused allergic reactions in farmworkers during the harvest.

"Everything we eat has been genetically improved by some method," she said. When crops are altered by genetic engineering, she added, the process is regulated. Conventional breeding methods are not.

"The most important aspect isn't how the seed is developed — but can it be used to increase food security, reduce insecticide use, foster good soil and improve the lives of farmers and communities?" she said. "I would like to see barcode labeling where you see, 'This conventionally bred cotton shirt was grown using insecticides. This genetically engineered cotton shirt was not.' But I don't see us getting that information."

eryn.brown@latimes.com

Thursday, July 7, 2011

FDA issues anti-smuggling strategy and draft guidance on new dietary ingredients

For Immediate Release: July 5, 2011
Media Inquiries: Doug Karas, 301-796-2805, douglas.karas@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

 Agency meets critical milestones in Food Safety Modernization Act
The U.S. Food and Drug Administration today announced that it has completed two tasks required by the new Food Safety Modernization Act (FSMA). FDA has issued an anti-smuggling strategy, and issued draft guidance clarifying agency expectations on new dietary ingredients.

The FDA issued an anti-smuggling strategy developed by the Department of Health and Human Services (HHS) in coordination with the Department of Homeland Security (DHS) that will help to identify and prevent smuggled foods from entering the United States and posing a threat to national security and consumer safety.

“The Food Safety Modernization Act requires the agency to build a new food safety system,” said Deputy Commissioner for Foods Michael R. Taylor. “This new system, overall, will better leverage the resources of federal agencies and it will make industry an important partner in safeguarding the health of U.S. consumers.”

FDA will work with U.S. Customs and Border Protection (CBP) in DHS to review historical data and better identify products, firms, and countries of origin to establish food smuggling targeting criteria. The FDA and CBP also will share information on import shipments and conduct joint examinations, when appropriate, to identify shipments that may contain smuggled food. When possible, the agencies will work together to publicize food smuggling enforcement actions to deter others from attempting similar acts.

“Safeguarding the American public from unsafe or potentially harmful imported goods is a priority for U.S. Customs and Border Protection,” said CBP Commissioner Alan D. Bersin. “CBP and FDA are working closer than ever to identify and prevent smuggled foods from entering the country, as well as streamline the flow of legitimate products.”

The FDA also issued draft guidance clarifying agency expectations on new dietary ingredients for industry which is an important preventive control to ensure that consumers are not exposed to unnecessary public health risks from new ingredients with unknown safety profiles.

Dietary supplement manufacturers are required to notify the FDA in advance when they intend to add a new dietary ingredient to their products, except in certain situations when the ingredient has been part of the food supply and has not been chemically altered for use in supplements. The notifications must identify the new dietary ingredient and be accompanied by evidence on its safety. The draft guidance is intended to inform and assist manufacturers, distributors, and others in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient is necessary and in preparing premarket safety notifications.

FSMA requires FDA to undertake many actions in strict time frames, in order to build a new food safety system based on prevention. FSMA required the FDA to complete both tasks on or before July 3, 2011, or within 180 days of the signing of FSMA into law.

FDA has created a special website to inform the public about the various aspects of FSMA implementation.  Among other developments related to FSMA implementation, the FDA also announced that the agency’s authority to suspend the registration of food facilities to prevent the import and export into the United States, or other intrastate or interstate distribution of food became effective on July 3, 2011.

The FDA expects individuals responsible for registered food facilities to take steps to produce safe products. If those efforts fail, the facility should file a food report with FDA, voluntarily recall affected products, and take action to keep products from reaching consumers.

FDA may suspend the registration of a facility in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

Additionally, the rule, issued in May, has gone into effect that allows the FDA to administratively detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed, to ensure they are kept out of the marketplace. Under this rule, these products will not be sold or distributed while the agency determines whether an enforcement action such as seizure or federal injunction against distribution of the product, is warranted.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

For more information:
• Federal Register Notice for New Dietary Ingredient Notifications and Related Issues
• Federal Register Notice for Interim Final Rule on Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption

• FDA Food Safety Modernization Act (FSMA)

Sunday, July 3, 2011

China Ratifies 7 GM Crops

China has issued biological safety certificates to seven GM crops including cotton and papaya. Aside from GM cotton, other GM crops have been planted in small-scales in China such as delayed-ripening tomatoes, phytase corn, pest-resistant rice, and disease-resistant peppers.

China's national agricultural GM biosafety evaluation authority ratified imports of genetically modified cotton, soybean, corn, and rape. China only allows imported cotton to be used for planting, and the other three imports can only be used as materials for processing. Most GM imports of China come from the U. S., Canada, Brazil, and Argentina.

Read the original article at http://english.cri.cn/6909/2011/06/28/189s645259.htm.

USDA Announces Decision to Deregulate Genetically Engineered Corn Seed

The USDA in its Federal Register recently issued a non-regulated status to Pioneer Hi-Bred International's GM corn event DP32138-2. The line has been genetically engineered to produce male-sterile/female inbred plants to generate non-transgenic hybrid corn. The decision is based on evaluation data and on the comments received from the public in response to public solicitations on the environmental assessment and plant pest risk assessment. Documents on the written determination and findings of no significant impact are now available to the public.

See http://www.aphis.usda.gov/newsroom/2011/06/engineered_corn_seed.shtml for complete details

Sunday, June 26, 2011

Taylor Talks FSMA Implementation, Funding

Taylor Optimistic on FSMA Implementation, Funding

Food and Drug Administration "food safety czar" Michael Taylor expressed cautious optimism Monday that FDA can resolve what has become a primary concern: a huge new regulatory mandate coupled with the threat of no resources for implementation.

Taylor told an audience of state and local food and drug officials that while the funding to implement the newly enacted FDA Food Safety Modernization Act -- a sweeping new responsibility for FDA -- remains uncertain, the agency remains optimistic that "at the end of the day, it won't be so dire."

As he has several times in outreach speeches to the food policy community, Taylor pointed out that FDA has a "a huge workload." And even though public health officials are working hard, the agency will likely not meet all of its deadlines. On top of the back log, FDA has no idea what its budget will be for fiscal year 2012. An agriculture appropriations bill that cleared the House last week would cut food safety programs $87 million below fiscal year 2011.

Under FSMA, the agency has to craft standards for produce safety and preventive controls, establish a risk-based inspection program, conduct a traceability pilot, and the list goes on.

"This is part of the empathy-inducing aspect of the law, because it is, in fact, a huge work load. But one that we readily embrace," said Taylor in his remarks at the opening session of Association of Food and Drug Officials conference in Plano, Texas.

"There's a lot of work going on. People are energized," added Taylor, emphasizing, again, that it is "impossible to meet all the deadlines."

"The reality of our resources and the processes of getting rules cleared...it's physically impossible to do all of them," he said. The FDA is working to prioritize these issues and push through "the most essential building blocks" first.

All of these initiatives, of course, depend on resources.

"[The resource challenge] is a serious one," said Taylor. "We have been given really a whole new job...been given a mandate to build a whole new system of food safety oversight."

"While we build on a strong foundation and we have a base of resources that we can do a lot with, you can't build a new house without new financing," he said. "You can't pretend that all the new programs and systems that this law calls for can be achieved without new resources."

Without more funding, FDA can still create regulations, though rulemaking could be delayed, according to Taylor, but it remains to be seen whether the agency will be able to build the capacity to enforce them.

"I think we all know that words on the page don't make food safer," said Taylor. "What do you do to make those come to life? What investments do we have to make to make those regulations come to life so they can have the effect we want them to have on strengthening food safety?"

Taylor pointed to the need for real investments in science and research as well as state and local capacity as critical elements of the new system.

"Again, you can't do this without the resources. The current budget situation does paint a challenging picture," said Taylor, noting that a patchwork of continuing resolutions to keep the government funded -- as we saw in 2011 -- makes it nearly impossible to plan ahead.

"When Congress gives us our budget over half way through the fiscal year it's very difficult to use that money in as orderly a way as possible. You cant use that money to hire the experts you need because the hiring process is such that you wont get them hired until the end of the fiscal year." All of this compounds the resource issue.

"We just have to work together to figure this out," said Taylor. "We can make good, efficient use of whatever we've got, but figuring out a way to get a more predictable flow of resources is crucial for all of us."

Thursday, June 16, 2011

House Moves to Ban GE Salmon, Ag Debates Continue

The House of Representatives continued debate yesterday on an agriculture appropriations bill that affects key food safety programs. The bill still contains significant cuts to the U.S. Food and Drug Administration and the U.S. Department of Agriculture's Food Safety and Inspection Service, but has yet to be adopted by the lower chamber.

Lawmakers spent the better part of Tuesday and Wednesday debating a series of amendments affecting a wide variety of programs--from federal nutrition to conservation to food safety.

Late Wednesday, the House approved an amendment by Congressman Don Young (R-AK) that would bar the FDA from spending money to approve an application for controversial genetically-engineered (GE) salmon. If the agency were to approve the GE fish--which grow rapidly, reducing cost of production--it would be the first GE animal approved for human consumption.

The measure passed the Republican-controlled House by voice vote.

AquaBounty, the company that developed the salmon technology, insists the salmon pose no threat to human health and will be kept out of wild salmon populations; but consumer groups and much of the seafood industry remain staunchly opposed to the idea.

The modified fish, formally known as AquaAdvantage salmon, are essentially Atlantic salmon with an inserted growth gene from a Chinook salmon and an antifreeze gene from an ocean pout. They grow twice as fast as typical Atlantic salmon and require approximately 10 percent less feed to achieve the same weight.

Lawmakers from salmon states--who often call GE salmon "alien fish," "frankenfish" or "monsters"-- have been fighting for months to pass legislation to block FDA's expected approval of the fish.

"Frankenfish threatens our wild stocks, their habitat, our food safety, and would bring economic harm to Alaska's wild salmon fishermen," said Senator Begich (D-AK) in February, when a similar measure was introduced in the upper chamber, adding that he believes the modified fish are "risky, unprecedented and unnecessary."

AquaBounty argues that its Salmon would complement, not harm, existing wild fisheries.

"The availability of AquAdvantage Salmon can help meet demand for a safe and sustainable food by providing a US-grown farmed Atlantic salmon, without stressing the valuable and finite Alaskan fisheries, preserving their markets," the company has stated.

However, members of Congress from several key salmon states, on both sides of the aisle, have now signed onto bills to block the salmon. The Senate has not yet voted on the matter.

The House is expected to continue debate on the agriculture appropriations and to vote on the spending bill this week.  

Thursday, June 9, 2011

China Genetically Modifying Cows To Produce Human Breast Milk

Updated: Wednesday, 08 Jun 2011, 7:54 AM EDT
Published : Wednesday, 08 Jun 2011, 7:54 AM EDT
BY NEWSCORE

BEIJING - Chinese scientists have genetically modified dairy cows to produce human breast milk, and hope to be selling it in supermarkets within three years.

The milk produced by the transgenic cows is identical to the human variety, with the same immune-boosting and antibacterial qualities as breast milk, scientists at China's Agricultural University in Beijing said.

The transgenic herd of 300 was bred by inserting human genes into cloned cow embryos which were then implanted into surrogate cows. The technology used was similar to that used to produce Dolly the sheep, the first mammal to be cloned by scientists, in Scotland.

The milk is still undergoing safety tests, but with government permission it will be sold to consumers as a more nutritious dairy drink than cow's milk.

Workers at the university's dairy farm have already tasted the milk -- and said it is sweeter and stronger than the bovine variety, according to Sky News .

"It's good," said worker Jiang Yao. "It's better for you because it's genetically modified."
The scientists have also produced animals that are resistant to mad cow disease, as well as beef cattle that are genetically modified to produce more nutritious meat.

The director of the research project, Professor Li Ning, said Western concerns about the ethics of genetic modification are misplaced.

"There are 1.5 billion people in the world who don't get enough to eat," he said. "It's our duty to develop science and technology, not to hold it back. We need to feed people first, before we consider ideals and convictions."

Tuesday, June 7, 2011

Bill to Accelerate Biotech Approvals in U.S.

Representative Stephen Fincher, a congressman from Tennessee, USA, introduced a legislation to speed up the process of approval for biotech crops. Fincher, who is also a farmer, called the bill as 'Expediting Agriculture Through Science (EATS) Act'. The legislation would allow Animal Plant and Health Inspection Service (APHIS) to have 180 days "to approve or deny a petition for non-regulated status, with an additional 60 days if needed to ensure the safety of the environment and compliance is met before deeming the petition approved."

Fincher emphasized the need for a more efficient approval process to keep the U.S. farmers leaders in biotech crop production.


The original news is available at http://brownfieldagnews.com/2011/05/31/bill-would-accelerate-biotech-approvals/.

Tuesday, May 10, 2011

The problem with GM nutritionally enhanced plants - study

Perspective: The Problem with Nutritionally Enhanced Plants
David R. Schubert
Cellular Neurobiology Laboratory, The Salk Institute for Biological Studies, La Jolla, California
JOURNAL OF MEDICINAL FOOD
J Med Food 11 (4) 2008, 000–000
http://www.liebertonline.com/doi/abs/10.1089/jmf.2008.0094

ABSTRACT Among the next generation of genetically modified (GM) plants are those that are engineered to produce elevated levels of nutritional molecules such as vitamins, omega-3 fatty acids, and amino acids. Based upon the U.S. current regulatory scheme, the plants and their products may enter our food supply without any required safety testing. The potential risks of this type of GM plant are discussed in the context of human health, and it is argued that there should be very careful safety testing of plants designed to produce biologically active molecules before they are commercially grown and consumed. This will require a mandatory, scientifically rigorous review process.

CONCLUSIONS
The above paragraphs summarize published data that clearly show the following: (1) Compounds structurally related to a common small molecule can have a lethal effect when present as even a minor contaminant in a food supplement. (2) The GM enhancement of a metabolic pathway by the overexpression of genes for that pathway can have unpredictable consequences in the form of synthesizing a toxin. (3) Finally, in the case of golden rice, it is argued that biologically active compounds derived from aberrant plant carotenoid synthesis could have profound effects on human development. Similar arguments can be made for NEP-derived fatty acids that are directly incorporated into brain lipids and about NEPs overproducing vitamin E. Aberrant fatty acid composition of brain lipids is implicated in Alzheimer's disease, and vitamin E has a role similar to RA in mammalian development. The excess consumption of a nutrient can also have negative effects. For example, a clinical trial with vitamin E supplementation showed that a relatively small dose increased the risk of heart failure, and smokers who supplemented their diet with -carotene had an increased risk of lung cancer. Therefore, there is a potential for nutrient toxicity in NEPs because upper tolerable levels of many nutrients are not well established and are likely to vary between individuals and lifestyles.

The information presented here shows that not only the potential harm of the product should be considered for risk assessment, but the GM process itself. The data clearly invalidate the argument that "the regulatory trigger for risk assessment should be based upon the physical features of the product rather than the process by which the product was generated." While it is true that traditional breeding methods can give rise to potentially hazardous products, the most recent assessment of GM food safety by the National Research Council stated that GM "has a higher probability of producing unanticipated changes than some genetic modification methods", but it curiously concludes by stating that the risk of GM technology is no greater than conventional breeding methods. There are, in fact, no data comparing the food safety profiles of GM versus conventional breeding, and the ubiquitous argument that since there is no evidence that GM products make people sick, they are safe (see, for example, McHughen and Smyth, Bradford et al., and Miller et al.) is both illogical and false. There are, again, simply no data or even valid assays to support this contention. Without proper epidemiological studies, most types of harm will not be detected, and no such studies have been conducted. The necessity of labeling all GM products and particularly NEPs is therefore critical if there is any hope of monitoring adverse health consequences due to their consumption. For example, it would have been impossible to identify the source of the toxic tryptophan supplement if the product were not traceable through labeling.

It follows that before NEPs producing biologically active molecules such as beta -carotene, omega-3 fatty acids, or vitamin E are introduced into the food chain, great care must be taken to do rigorous, multigenerational animal safety assessments with the hope of identifying risks to health (for methods, see, for example, the 2007 publication by the National Toxicology Program and Pusztai and Bardocz). In addition, the products must be labeled and traceable, and the unpredictable and unintended metabolic changes that may occur in NEPs require the thorough testing of the entire edible portion of the plant, not just the designated product as is almost always done by biotech companies. To date there is essentially no multigenerational animal safety testing published for GM plants and no required labeling in the United States for any GM product. In an excellent review of our current GM regulatory process, Mandel concluded that for second-generation GM products, like NEPs, "it is necessary to establish a comprehensive, efficient and scientifically rigorous regulatory system." As discussed herein there are very valid scientific concerns to support this conclusion.

Thursday, April 21, 2011

USDA Decision on Deregulation of GM Plums

Scientists in West Virginia have planted purple-black HoneySweet plums, which are one of the two transgenic fruit trees approved by the US Department of Agriculture (USDA). This genetically engineered (GE) fruit has been developed by the scientists of USDA to fight the emerging, invasive plum pox virus, which has infected 100 million trees in Europe and surfaced in Pennsylvania, Michigan, and New York during the past 12 years.

"We couldn't find a gene for plum pox resistance in any plums, so we turned to genetic engineering," says Ralph Scorza, a horticulturist and lead scientist at the USDA's Appalachian Fruit Research Station. "We've had test-field plantings in Europe since 1996 and the U.S. since 1995, and we've never had a single tree infected."


HoneySweet plums have been in the GM approval pipeline for eight years and will clear final regulatory hurdles this year. Scorza said that he does not expect farmers to plant the GE plum since plum pox can still be managed. But when the pathogen causes outbreaks in the U.S., especially in California which is the largest producer of prunes, HoneySweet will be of great help to producers.
For more details, read http://audubonmagazine.org/features1103/biotech.html.

Sunday, April 17, 2011

Seed saving, seed banks, Monsanto and Gates

Seed Saving and Seed Banks
By Andrew Kimbrell, Executive Director
Center For Food Safety
http://www.centerforfoodsafety.org/campaign/save-our-seeds/seed-saving-and-seed-banks/

My first experience with the perils of large scale seed banks was the scandal that erupted over the Fort Collins collection in the mid 1980s.  Journalists had published stories dramatically detailing the grossly negligent manner in which deposits to the seed bank were treated.  Numerous seed deposits were spilling out onto the floors of the facility, the facility was woefully understaffed, there was no testing of the seed and a virtually complete failure of required regeneration - in short a seed saving disaster. A legal petition by my organization to rectify the decision seemed to get the United States Department of Agriculture’s (USDA) attention. But when no real action resulted we litigated. I was a very active member of that legal team. As such I reviewed much of the material in the case that documented USDA’s complete disregard for the safety and integrity of the seeds under its care. This litigation ultimately forced a settlement where USDA agreed to do an Environmental Impact Statement (EIS) pursuant to the National Environmental Policy Act (NEPA) and conditions at the seed bank improved somewhat.

Since that first experience I learned that bigger is definitely not better or safer when it comes to seed saving. As noted elsewhere on this site, the Center for Food Safety (CFS) strongly advocates for in situ protection of plant diversity, and when ex situ seed saving is required it should reside at the most local and ecologically appropriate level. This has been one of the bases for CFS’ longstanding concerns about the Svalbard Global Seed Vault. Not surprisingly these fears have recently been justified. In December 2010 NordGen, the entity overseeing Svalbard, fired its Director Jessica Kathle.  Some at NordGen believed that she was a “scapegoat” for the seed bank’s well known problems including continuing deficits, significant understaffing, and failure to do routine tests on the deposited seed to determine viability. (http://dagendresen.wordpress.com/about/Dot.) Sadly it seems like the Fort Collins fiasco redux.

There is however yet another important concern about Svalbard.    The Global Crop Diversity Trust (GCDT), which supports the operational costs of Svalbard, has received almost $30 million dollars in support from the Bill and Melinda Gates Foundation. (Global Diversity Trust, “Funding Status 1-1-2011.” http://www.croptrust.org/main/funds.php) This is by far the largest support of any non-governmental entity.  As is well known, the Gates Foundation has very close working ties to Monsanto. The Gates Foundation invested $23 million in Monsanto in 2010 to help the company through some financial woes, and has been a determined supporter of spreading Monsanto’s genetically engineered crops throughout the developing world. In 2006 the Gates Foundation hired Rob Horsch, a former Monsanto Vice President and a key scientist involved in the creation of the company’s Round Up Ready crops in the 1980s, as their Senior Program Officer for their International Agriculture Development Program. This Monsanto connection to Svalbard is very troubling as the corporation owns almost a quarter of all the world’s commercial seeds and is the world’s leader in the genetic engineering of crops and the patenting of plant genetics (including plant genes, cells and seeds). Monsanto has also had a decade long history of persecuting and prosecuting thousands of farmers for saving seeds.

Svalbard’s ties to the Gates Foundation and Monsanto are not the only issue. Only two private corporations have donated to the GCDT.    Dupont/Pioneer Seeds has donated $1 million as has Syngenta. (Global Diversity Trust, “Funding Status 1-1-2011.” http://www.croptrust.org/main/funds.php)Together these two companies own another 25% of the world’s commercial seeds and are also among the leaders in agriculture biotechnology and in patenting of plant genetics. So a major question looms. Why this interest by these biotech companies and their surrogates in paying the operational costs of Svalbard? These companies have no record of altruistic concern for the integrity and diversity of seeds and have in fact been destroying that diversity through genetic engineering and patenting for decades. The most obvious hypothesis is that these corporations see in Svalbard an opportunity to gain further control of the world’s plant genetics — being able to utilize the seed bank as a resource for germplasm that can be used for creating patentable hybrid or genetically engineered seed varieties.

To test that hypothesis I requested that the CFS legal team investigate the deposit agreements at Svalbard. The point of this analysis was to see if in some way the contract between Svalbard and depositors created an advantage for these corporations in their efforts to control and patent seed genetics. As the legal memorandum reveals, the answer to the question is “yes.” The Svalbard agreement does provide corporations seeking to patent plant genetics additional advantages in their efforts.

Determining this, however, turned out to be no easy task.  As the following legal memorandum indicates, the Svalbard deposit agreement is extremely complicated, opaque, at times downright misleading and involves difficult questions and interpretations of international law.  The very complexity of this deposit agreement is another major red flag with Svalbard. Numerous seed banks only require a simple Memorandum of Understanding (MOU) with depositors. This allows for informed consent by the depositors. By contrast, there is little chance that some seed banks and collections, especially those that are local, smaller scale and/or from developing countries, have the legal expertise, or funding to hire attorneys to decipher the myriad complications of the Svalbard contract.  Meanwhile the GCDT, and its supporting biotech companies and their surrogates, are advertising how they are spending millions of dollars trying to acquire local and smaller seed collections from developing countries for Svalbard.  As noted, these local collectors have little chance to understand, much less give informed consent, to what can happen to their deposits. As will be discussed in the Memorandum, this informed consent problem, and the issue of corporate patenting of the genetics of the seeds deposited in Svalbard, can only be resolved through major revisions in the Agreement.

CFS will continue to monitor both the operational and legal aspects of the Svalbard Global Seed Vault and provide on this website new material and analysis on an ongoing basis.

View CFS Legal Memorandum
http://www.centerforfoodsafety.org/wp-content/uploads/2011/04/Legal-Memorandum.FINAL_.pdf

For an alarming example of the damage that the usurping of local seed saving by Svalbard advocates can cause, and for a trenchant critique of Svalbard, please see a recent speech given by Kent Whealy at Wes Jackson’s Land Institute on what happened to the Seed Savers Exchange which he founded and tended for more than three decades.

Kent Whealy Speech
http://www.centerforfoodsafety.org/wp-content/uploads/2010/11/Land-Inst-Svalbard-portion.pdf

Kent Whealy Response
http://www.centerforfoodsafety.org/wp-content/uploads/2010/11/Response-Final.pdf

Sunday, April 3, 2011

Genetically modified cows produce ‘human’ milk

By Richard Gray
Telegraph UK
 
Sientists have successfully introduced human genes into 300 dairy cows to produce milk with the same properties as human breast milk. Human milk contains high quantities of key nutrients that can help to boost the immune system of babies and reduce the risk of infections.
The scientists behind the research believe milk from herds of genetically modified cows could provide an alternative to human breast milk and formula milk for babies, which is often criticised as being an inferior substitute.

They hope genetically modified dairy products from herds of similar cows could be sold in supermarkets. The research has the backing of a major biotechnology company.
The work is likely to inflame opposition to GM foods. Critics of the technology and animal welfare groups reacted angrily to the research, questioning the safety of milk from genetically modified animals and its effect on the cattle’s health.

But Professor Ning Li, the scientist who led the research and director of the State Key Laboratories for AgroBiotechnology at the China Agricultural University insisted that the GM milk would be as safe to drink as milk from ordinary dairy cows.

He said: “The milk tastes stronger than normal milk
.
“We aim to commercialize some research in this area in coming three years. For the “human-like milk”, 10 years or maybe more time will be required to finally pour this enhanced milk into the consumer’s cup.”

China is now leading the way in research on genetically modified food and the rules on the technology are more relaxed than those in place in Europe.

The researchers used cloning technology to introduce human genes into the DNA of Holstein dairy cows before the genetically modified embryos were implanted into surrogate cows.

Writing in the scientific peer-reviewed journal Public Library of Science One, the researchers said they were able to create cows that produced milk containing a human protein called lysozyme.

Lysozyme is an antimicrobial protein naturally found in large quantities in human breast milk. It helps to protect infants from bacterial infections during their early days of life.

They created cows that produce another protein from human milk called lactoferrin, which helps to boost the numbers of immune cells in babies. A third human milk protein called alpha-lactalbumin was also produced by the cows.

The scientists also revealed at an exhibition at the China Agricultural University that they have boosted milk fat content by around 20 per cent and have also changed the levels of milk solids, making it closer to the composition of human milk as well as having the same immune-boosting properties.

Professor Li and his colleagues, who have been working with the Beijing GenProtein Biotechnology Company, said their work has shown it was possible to “humanise” cows milk.
In all, the scientists said they have produced a herd of around 300 cows that are able to produce human-like milk.

The transgenic animals are physically identical to ordinary cows.
Writing in the journal, Professor Li said: “Our study describes transgenic cattle whose milk offers the similar nutritional benefits as human milk.

“The modified bovine milk is a possible substitute for human milk. It fulfilled the conception of humanising the bovine milk.”

Speaking to The Sunday Telegraph, he added the “human-like milk” would provide “much higher nutritional content”. He said they had managed to produce three generations of GM cows but for commercial production there would need to be large numbers of cows produced.

He said: “Human milk contains the ‘just right’ proportions of protein, carbohydrates, fats, minerals, and vitamins for an infant’s optimal growth and development.

“As our daily food, the cow’s milk provided us the basic source of nutrition. But the digestion and absorption problems made it not the perfect food for human being.”

The researchers also insist having antimicrobial proteins in the cows milk can also be good for the animals by helping to reduce infections of their udders.

Genetically modified food has become a highly controversial subject and currently they can only be sold in the UK and Europe if they have passed extensive safety testing.

The consumer response to GM food has also been highly negative, resulting in many supermarkets seeking to source products that are GM free.

Campaigners claim GM technology poses a threat to the environment as genes from modified plants can get into wild plant populations and weeds, while they also believe there are doubts about the safety of such foods.

Scientists insist genetically modified foods are unlikely to pose a threat to food safety and in the United States consumers have been eating genetically modified foods for more decades.

However, during two experiments by the Chinese researchers, which resulted in 42 transgenic calves being born, just 26 of the animals survived after ten died shortly after birth, most with gastrointestinal disease, and a further six died within six months of birth.

Researchers accept that the cloning technology used in genetic modification can affect the development and survival of cloned animals, although the reason why is not well understood.

A spokesman for the Royal Society for the Protection of Animals said the organisation was “extremely concerned” about how the GM cows had been produced.

She said: “Offspring of cloned animals often suffer health and welfare problems, so this would be a grave concern.

“Why do we need this milk – what is it giving us that we haven’t already got.”

Helen Wallace, director of biotechnology monitoring group GeneWatch UK, said: “We have major concerns about this research to genetically modify cows with human genes.

“There are major welfare issues with genetically modified animals as you get high numbers of still births.

“There is a question about whether milk from these cows is going to be safe from humans and it is really hard to tell that unless you do large clinical trials like you would a drug, so there will be uncertainty about whether it could be harmful to some people.

“Ethically there are issues about mass producing animals in this way.”

Professor Keith Campbell, a biologist at the University of Nottingham works with transgenic animals, said: “Genetically modified animals and plants are not going to be harmful unless you deliberately put in a gene that is going to be poisonous. Why would anyone do that in a food?

“Genetically modified food, if done correctly, can provide huge benefit for consumers in terms of producing better products.”