The F.D.A. in Crisis: It Needs More Money and Talent

Editorial
New York Times
February 3, 2008

The Food and Drug Administration is supposed to be Americans' main line of defense against tainted food, drugs, medical devices and other products - in a world abounding with tainted goods. So it was especially chilling last week to hear the agency's former chief counsel, Peter Barton Hutt, tell a Congressional panel that the F.D.A. was "barely hanging on by its fingertips."

That warning was supported by several equally grim authoritative reports and other expert testimony that made clear that the agency does not have enough money or enough skilled scientists to do its job.

In a hearing before a House Energy and Commerce subcommittee, members of the agency's own scientific advisory board outlined the F.D.A.'s many weaknesses. It lacks scientists who understand rapidly emerging technologies - including genomics and nanotechnology - relevant to product safety. The agency is further hobbled by a high turnover rate of scientists, a decrepit information technology system, a weak organizational structure, and a shrinking inspection force.

The Government Accountability Office, meanwhile, warns that at a time when imports are pouring in from all over the globe, the agency does not have enough staff or adequate computer systems to conduct timely inspections of foreign plants that make drugs, medical devices and food products. That is especially worrisome in China, the source of so many dangerous goods. At its current pace, the agency would take 13 years to inspect every foreign drug plant exporting to the United States, 27 years to check every foreign medical device plant and 1,900 years to inspect every foreign food plant.

The reason for the agency's woes is simple. Congress has repeatedly piled new burdens on the F.D.A. - more than 100 statutes have added new responsibilities over the past 20 years - without providing enough money and personnel to carry out the tasks. To make things worse, the increasing complexity of modern medical products and the flood of food and drug ingredients from abroad have overwhelmed the agency's ability to keep up.

User fees from industry have helped the F.D.A. review applications to market new drugs and medical devices in this country, but the agency's underlying scientific core is eroding. The two units that regulate food are in "a state of crisis," according to the science board, and dietary supplements and cosmetics get short shrift.

The near unanimity about the agency's weaknesses - among Congressional Democrats and Republicans, industry and consumer groups, and authoritative independent analysts - is striking. But hand wringing is not enough. The F.D.A. desperately needs an infusion of money and talent. To make up for decades of neglect, Mr. Hutt proposes that its appropriation be doubled and its staff increased by 50 percent over the next two years.

'Simultaneous Release' with Other Countries No Longer a Condition

By Scott A. Yates
Capital Press
February 6, 2008

WASHINGTON, D.C. - The Joint Biotech Committee of U.S. Wheat Associates and the National Association of Wheat Growers on Tuesday revealed an industry eager to get back in the biotech game.

Committee members from the two wheat organizations, in Washington, D.C., for their annual meet, said they would even support the release of a genetically modified wheat trait in the U.S. before it is introduced in Australia or Canada.

In the past, a unilateral release was viewed as a major hurdle because of the perceived marketing advantage a non-genetically modified wheat supplier might have in a market like Japan, where the technology is viewed with suspicion.

Although the biotech committee would prefer a "simultaneous release," it is no longer a condition. Al Slogen, a North Dakota wheat grower who serves on the biotech panel, said the condition has been a burden weighing down tech providers' ability to move forward.

"We can't have anchors that tell the tech industry 'here we go again'," he said.

Sherman Reese, former president of NAWG and an Oregon wheat commissioner, agreed. Speaking from the audience, he said it's time to see what's possible, rather than being hamstrung out of fear of consequences.

"My take is there is not a lot of concern about biotech wheat. The concern is that there is wheat at all," he said.

The current mood is a far cry from the conflicted attitude that existed when Monsanto was trying to get the industry behind the release of Roundup Ready wheat at the turn of the century. Back then, U.S. Wheat Associates warned of markets being lost and backed up its claim with surveys of buyers who said they would cease buying all U.S. wheat if a genetically modified wheat trait were commercialized.

Monsanto ultimately shelved its Roundup Ready wheat technology and shut down its wheat research four years ago. Since then, wheat acreage has continued to lose ground against soybeans and corn, crops that saw single-gene genetically modified traits introduced in 1996. Stacked traits involving multiple genes are now being planted.

Syngenta has put a fusarium-resistant biotech trait through field trials, but it has not started the commercialization process.

BASF is said to be in the midst of developing a drought-tolerant biotech variety, but an invitation for company officials to meet with the biotech committee was politely rejected. An e-mail explained the research is in a very early phase and "we are not in the position to talk about target markets and business potential at the moment."

Michael Doane, who served as Monsanto's point man during its Roundup Ready wheat push, sat in on the biotech committee's meeting. Although he has a different assignment within the company now, the chairman of the biotech committee, Joe Kejr, asked for his input.

"It's worthwhile to consider what the technification of other crops will do to wheat over the next eight to 12 years. Drought tolerance, nitrogen use efficiency, better yield - these things are all going to come in other crops," Doane said, adding the wheat industry needs to send a signal that the crop is open for investment. "That is the most important thing you can do now."

Several members of the biotech committee plan to visit BASF and Bayer headquarters in North Carolina in the next couple of months to talk with top executives. Although the message of cooperation is also being communicated to Monsanto, there was no discussion at the biotech committee of revisiting Roundup Ready wheat.

The North American Millers Association, which has expressed concern over genetically modified organisms in the past, feels comfortable with the direction growers are taking.

Betsy Faga, president of the North American Millers Association, said millers, bakers and food manufacturers all recognize what is happening to prices and supplies and what it means.

"I don't think anybody has the feeling that producers are over here and we're back over here," she said.

Vince Peterson, vice president of overseas operations for U.S. Wheat Associates, said current high prices have given his organization a particular opportunity to get the biotech message out to customers.

"We do have their attention. This is a good time to talk about it," he said, adding that in every meeting the organization attends, the need for biotechnology to be in farmers' toolbox is incorporated into supply anddemand and price outlook presentations.

First Documented Case of Pest Resistance to Biotech Cotton

By Mari N. Jensen
University of Arizona
February 7, 2008

UA entomologists have reported on the discovery of Bt-resistant bollworms in Mississippi and Arkansas.

A pest insect known as bollworm is the first to evolve resistance in the field to plants modified to produce an insecticide called Bt, according to a new research report by University of Arizona entomologists.

Bt-resistant populations of bollworm, Helicoverpa zea, were found in more than a dozen crop fields in Mississippi and Arkansas between 2003 and 2006.

"What we're seeing is evolution in action," said lead researcher Bruce Tabashnik, professor and head of the UA entomology department and an expert in insect resistance to insecticides. "This is the first documented case of field-evolved resistance to a Bt crop."

Bt crops are so named because they have been genetically altered to produce Bt toxins, which kill some insects. The toxins are produced in nature by the widespread bacterium Bacillus thuringiensis, hence the abbreviation Bt.

The bollworm resistance to Bt cotton was discovered when a team of UA entomologists analyzed published data from monitoring studies of six major caterpillar pests of Bt crops in Australia, China, Spain and the U.S. The data documenting bollworm resistance were first collected seven years after Bt cotton was introduced in 1996.

"Resistance is a decrease in pest susceptibility that can be measured over human experience," Tabashnik said. "When you use an insecticide to control a pest, some populations eventually evolve resistance."

The researchers write in their report that Bt cotton and Bt corn have been grown on more than 162 million hectares (400 million acres) worldwide since 1996, "generating one of the largest selections for insect resistance ever known."

Even so, the researchers found that most caterpillar pests of cotton and corn remained susceptible to Bt crops.

"The resistance occurred in one particular pest in one part of the U.S.," Tabashnik said. "The other major pests attacking Bt crops have not evolved resistance. And even most bollworm populations have not evolved resistance."

The field outcomes refute some experts' worst-case scenarios that predicted pests would become resistant to Bt crops in as few as three years, he said.

"The only other case of field-evolved resistance to Bt toxins involves resistance to Bt sprays," Tabashnik said. He added that such sprays have been used for decades, but now represent a small proportion of the Bt used against crop pests.

The bollworm is a major cotton pest in the southeastern U.S. and Texas, but not in Arizona. The major caterpillar pest of cotton in Arizona is a different species known as pink bollworm, Pectinophora gossypiella, which has remained susceptible to the Bt toxin in biotech cotton.

Tabashnik and his colleagues' article, "Insect resistance to Bt crops: evidence versus theory," will be published in the February issue of Nature Biotechnology. His co-authors are Aaron J. Gassmann, a former UA postdoctoral fellow and now an assistant professor at Iowa State University; David W. Crowder, a UA doctoral student; and Yves Carrière, a UA professor of entomology. Tabashnik and Carrière are members of the UA's BIO5 Institute.

The U.S. Department of Agriculture funded the research.

"Our research shows that in Arizona, Bt cotton reduces use of broad-spectrum insecticides and increases yield," said Carrière. Such insecticides kill both pest insects and beneficial insects.

To delay resistance, non-Bt crops are planted near Bt crops to provide "refuges" for susceptible pests. Because resistant insects are rare, the only mates they are likely to encounter would be susceptible insects from the refuges. The hybrid offspring of such a mating generally would be susceptible to the toxin. In most pests, offspring are resistant to Bt toxins only if both parents are resistant.

In bollworm, however, hybrid offspring produced by matings between susceptible and resistant moths are resistant. Such a dominant inheritance of resistance was predicted to make resistance evolve faster.

The UA researchers found that bollworm resistance evolved fastest in the states with the lowest abundance of refuges.

The field outcomes documented by the global monitoring data fit the predictions of the theory underlying the refuge strategy, Tabashnik said.

Although first-generation biotech cotton contained only one Bt toxin, called Cry1Ac, a new variety contains both Cry1Ac and a second Bt toxin, Cry2Ab. The combination overcomes pests that are resistant to just one toxin.

The next steps, Tabashnik said, include conducting research to understand inheritance of resistance to Cry2Ab and developing designer toxins to kill pests resistant to Cry1Ac.

Team Finds Tough Bollworms

By Alan Fischer
Tucson Citizen
February 8, 2008

With new weapons ready to fire, a University of Arizona research team has discovered a cotton pest that developed a resistance to previously successful crop protection.

The team led by Bruce Tabashnik discovered that a species of bollworm has evolved a resistance to a toxin that has protected genetically modified cotton crops for 12 years.

Growers need not worry yet as the researchers also helped develop a modified version of the toxin to handle future resistances developed by pests.

UA researchers also tested the effectiveness of a second generation of Bt toxin called Cry2Ab that is being used with the earlier toxin to control resistant pests.

Helicoverpa zea - or H. zea - bollworms studied in more than a dozen sites in Mississippi and Arkansas were found resistant to Cry1Ac, the first generation of Bt toxin introduced to cotton in 1996, said Tabashnik, professor and head of UA's entomology department.

The team's research findings were published Thursday in Nature Biotechnology, he said.

Contributing to the project were Aaron Gassmann, post doctoral fellow in entomology; David Crowder, entomology doctorate student; and Yves Carrière, a professor of entomology.

Bt cotton crops were genetically altered to produce Bacillus thuringiensis - Bt - toxins, which kill some insects without the need for additional insecticides, he said.

The H. zea bollworms were inherently less susceptible to the Bt toxin than the pink bollworms more commonly found in Arizona that pose a bigger threat to cotton crops here, he said.

"Our conditions here are such that the pink bollworm is a major pest and H. zea is a minor pest," said Tabashnik, who led the research project and was lead author of the paper.

"In the Southeastern United States, it's paradise for the H. zea bollworms. They do really well there," he said. "They are a major threat to cotton there."

Cry1Ac remains an effective control agent for Arizona's pink bollworms, he said.

In addition, hundreds of millions of sterilized pink bollworms are being dropped on fields here to try to prevent pink bollworms from reproducing.

"We've got pink bollworm on the ropes here," he said. "That is very different from the situation in the Southeast, where the H. zea bollworm has withstood and survived the first round of Bt crops almost unscathed, and the second generation of Bt crops with two toxins is now in the fray against the bollworm."

It took seven years from the launch of Bt cotton for researchers to first document that H. zea began to develop field resistance to Bt toxin longer than the three years predicted by worst-case scenario computer modeling, Tabashnik said.

As evolution marches on and crop pests continue to develop resistances to man's efforts to keep them at bay, researchers toil to keep a full quiver of weapons available to growers.

In addition to Cry2Ab, a third-generation vegetative insecticide protein toxin called Vip3 is waiting in the wings and will likely be commercialized soon to take care of any insects that develop resistance to the two previously used toxins, Tabashnik said.

A team of UA and Mexico researchers engineered and tested a modified version of Cry1Ac called Cry1AcMod that is more potent against resistant insects, Tabashnik said. This product is not in use but could be ready for future resistances pests develop.

"In principle any toxin could be modified to be effective against an insect that has developed a resistance," he said.

But researchers must remain vigilant as nature marches forward, he said.

"No single approach is a panacea for controlling insects," Tabashnik said. "They are the champions of adaptability."

California State Assembly Approves GMO Bill

California Farmer
February 8, 2008

AB 541, which could become California's first state law protecting farmers from the hazards of genetically engineered crops, passed out of the full Assembly on January 29 with a vote of 49-12. It has the support of the California Farm Bureau as well as California Certified Organic Farmers, Community Alliance with Family Farmers, the National Farmers Union and many food safety and environmental organizations.

Introduced by Assembly Member Jared Huffman (6th AD) early in 2007, the bill was held over in the Agriculture Committee in April. Since then, AB 541 has been scaled back to address two provisions related to farmer protections.

AB 541 will enact protections for California farmers against frivolous lawsuits that intimidate and harass those who have not been able to prevent the inevitable \u2013 the drift of genetically engineered pollen or seed. It will level the playing field for farmers accused by agricultural biotechnology companies and other patent holders of contract violations, and discourage the practice of biotech companies sampling crops without explicit permission from farmers and prosecuting based on unverifiable testing results.

Specifically, the newly amended bill would provide for:

"I am very pleased that the stakeholders on this issue have found a way to address one of the issues related to genetic contamination of crops," says Assembly Member Huffman. "While there is still work to do on other issues concerning genetically engineered food, AB 541 would be an important step in establishing basic protections for California's farmers."

The original bill included several other elements, including the establishment of the country's first system of notification for the locations of GE crops; the confinement of experimental pharmaceutical-producing crops to greenhouses to protect the food system from contamination; and, legislative clarity that the GE crop manufacturer is liable in the event of contamination, and not farmers.

"While AB 541 as currently amended represents only a small piece of what our stakeholders identify as issues to be addressed, we think this represents a move in the right direction," says Renata Brillinger, director of the Genetic Engineering Policy Project, the 13-member coalition of organic and conventional farmers, food industry, environmental, and faith organizations sponsoring AB 541.

The bill will now move to the Senate for consideration.

top of page