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The Honolulu Advertiser
Posted on: Saturday, September 2, 2006

Biotech crops can be safe, improve health

By Kevin Kelly

Your recent article, "Modified Growers Take a Hit" (Aug. 15), reported that the U.S. District Court found the U.S. Department of Agriculture needed to conduct environmental studies before it issued permits for biopharmaceutical crop testing in Hawai'i.

The court's opinion is important because it underscores the need for government to do environmental reviews before issuing permits. Although the USDA did not comply with all federal laws regarding the permits issued for Hawai'i between 2001-2003, people in Hawai'i should understand that those permits expired and currently no biopharmaceutical crop testing is being conducted in Hawai'i.

Furthermore, under current procedures, the federal government is conducting all required environmental reviews before such work can go forward.

For these reasons, the hysterical claims by the anti-biotech community are a cynical attempt to frighten and misinform people. The companies that obtained the permits that were considered in this case fully complied with the permitting process in place at that time.

Yes, the court ruled correctly that there were procedural violations dating back to 2001-2003, but it did not find that the issuance of any of the permits resulted in any harm to human health, safety or the environment.

More to the point, in late 2002, the USDA's Animal and Plant Health Inspection Service established the Biotechnology Regulatory Service to address and correct concerns such as those raised in the lawsuit. This is confirmed in the government's Nov. 5, 2005, update to a USDA audit that was initiated in 2003 and released earlier this year.

The update includes a long list of upgrades, such as formation of the BRS within USDA, and significant improvements to the regulatory system in the areas of organizational structure, compliance, inspection, enforcement, documentation and transparency. The upgrades are described as Exhibit A of the report, which can be found at http://www.usda.gov/oig/web docs/50601-08-TE.pdf.

Opponents of crop biotechnology conveniently overlook the government's update as they misuse the old USDA audit in an effort to further their cause.

The BRS today coordinates and regulates the field-testing, movement and importation of genetically engineered organisms that are known to be or could be plant pests. It issues various types of permits for each of these activities, and its compliance and enforcement program (http:// www.aphis.usda.gov/brs/com pliance.html) inspects, audits, and oversees activities under the permit process. BRS also evaluates petitions for deregulation to ensure that products being considered for removal from regulation do not pose a threat to U.S. agricultural or environmental health.

As a result, the regulatory requirements and oversight of biotech crops are extremely stringent, and it is more so for biopharmaceutical crops.

Companies working in this field continue to meet all federal and state regulations as they seek to develop low-cost therapeutic proteins that can be used to combat life-threatening illnesses such as such as heart disease, diabetes, cystic fibrosis and cancer.

A good example comes from a Canadian company SemBioSys Genetics, which last month announced the development of a variety of safflower that produces insulin at commercially viable levels. This breakthrough has the potential to make insulin affordable for anyone with diabetes — a disease that is widespread in Hawai'i.

The prospects for savings are excellent because safflower-produced insulin saves about 70 percent of capital costs that otherwise would be needed to build traditional pharmaceutical manufacturing facilities. What's more, it is estimated that the world's current demand for insulin could be met with only 16,000 acres of planted crop.

In another example, Ventria Bioscience, of Sacramento, developed a new plant variety that may eradicate diarrhea as the number two infectious killer of children under the age of 5 in developing countries—if we don't let misinformation and fear mongering interfere with education and dialogue about biotechnology.

The achievement was possible by producing two breast milk proteins in a genetically modified crop. Adding the proteins to Ventria's Oral Rehydration Solution reduced the duration and recurrence of diarrhea by 30 percent. Since acute diarrhea causes the death of 2 million children every year, the hope is that this improvement will be widely added to oral hydration solutions, which are consumed by at least half of the world's children.

With regulatory oversight to ensure health and safety and with free market forces in play, it will be only a matter of time before this new insulin and other therapies from plant-based production systems find their way into the marketplace at increasingly competitive prices.

People concerned about the safety of biotech foods will appreciate that biotech crops are the most extensively tested and regulated of all agricultural products. Today, some 31 regulatory agencies in 17 countries plus prominent international scientific authorities in the United States and throughout the world have stated that biotech crops are as safe as conventional crops.

The most telling fact is that during the 10 years biotech crops have been commercially grown, people have consumed more than a trillion servings of food containing biotech ingredients. During this time there has not been one single documented case of an ecosystem being disrupted or a person made ill by these foods — in Hawai'i or anywhere else.

The USDA today has a strong regulatory system designed to keep pace with the continued rapid advances in agricultural biotechnology. And the innovative coordination provided by the BRS ensures that the system works to protect the environment and improve human health.

With the current strict industry and federal oversight, there is no reason why biopharmaceutical plants should not be grown in the United States, including Hawai'i. This will help ensure that new and affordable pharmaceutical therapies be accessible to people in our state and throughout the world.

Kevin Kelly is a board member and chairman of the Policy Committee for the Hawai'i Science &Technology Council. He wrote this commentary for The Advertiser.