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The Honolulu Advertiser
Posted on: Sunday, February 19, 2006

COMMENTARY
Biotech upgrades put safety first

By Richard Klemm

Genetically engineered papayas ripen at the Kamiya Farm in La'ie. The U.S. Department of Agriculture has beefed up its regulation of biotechnology, the author says, although critics overlook this fact.

AP LIBRARY PHOTO | Jan. 10, 2006

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Opponents of crop biotechnology are misusing parts of a U.S. Department of Agriculture report to further their cause, based on an audit conducted over three years ago.

The report found that regulatory controls and oversight of field tests were not as rigorous and effective as they needed to be. This was true when the audit was conducted but it is not true today. The USDA made changes to correct the situation.

Unfortunately, the report was released only recently, and critics unfairly overlook the Nov. 5, 2005, update contained in the report. The update, "Attachment A," includes a long list of upgrades the USDA made after the initial audit was completed in April 2003. These include:

  • The formation of the Biotechnology Regulatory Service within the USDA.

  • Significant improvements to the regulatory system in organization, compliance, inspection, enforcement, documentation and transparency.

    In a recent public statement, the USDA said, " ... the BRS was established in 2002 to enable the agency to take a more comprehensive approach toward regulating biotechnology, keep pace with rapidly evolving technology and promote greater understanding of regulatory functions."

    Yet critics overlook these upgrades, many of which address key things they want changed. The upgrades are described in detail in the report: www.usda.gov/oig/web docs /50601-08-TE.pdf.

    ONLINE INFORMATION

    As the update shows, the USDA established the Biotechnology Regulatory Service four years ago — just four months after the initial USDA audit was completed — which reflects well on the USDA's responsiveness.

    "Through all of our revisions, safety has always remained paramount. BRS keeps detailed records on the location of field tests and conducts thorough safety evaluations according to an established science-based system," the BRS letter noted.

    The BRS has done this by regulating the industry to ensure safety through strong compliance and enforcement procedures. To instill confidence in their regulatory process, a Web site and extensive communications with key stakeholders now make it transparent to the public — addressing a key concern of agriculture biotechnology opponents. Web site visitors can view what changes have been proposed and what updates are occurring.

    The BRS uses the best-available science to guide decision-making and ensure safety. And, since 2004, has brought all its compliance/inspection activities within one branch to strengthen its oversight. Furthermore, the BRS is providing international leadership to help ensure that international biotech standards are science based, that international regulatory capacity building is supported and that the international implications of policy and regulatory decisions are considered.

    SAFETY ENFORCEMENT

    Today, the BRS regulates the field testing, interstate movement and import of genetically engineered organisms though a rigorous and comprehensive permit and notification process. It assesses the agricultural and environmental safety of genetically engineered organisms and evaluates petitions for the USDA to deregulate specific genetically engineered organisms. They do this only after testing by the appropriate authorities confirms the organisms pose no threat to the environment and are safe to eat.

    These steps assure BRS regulations govern the safe introduction of crop biotech products into the environment. They also provide transparency of the regulatory compliance and inspection process.

    And the inspection/compliance program has teeth. USDA's Investigative Enforcement Service investigates alleged violations of any federal laws and regulations related to its Animal and Plant Health Inspection Service. The enforcement service gathers information and evidence to build a case; it may also refer serious cases to the Department of Justice for possible prosecution under the Plant Protection Act of 2000.

    There is increased collaboration between USDA's Compliance unit and the enforcement service when necessary. And when the case is closed, results are posted on the Web to ensure transparency.

    This provides a strong framework to ensure the safe and contained introduction of new genetically modified plants into open fields — with significant safeguards to prevent the accidental release of any such material.

    Consider the record: Since 2003, 100 percent of pharmaceutical and industrial permit sites have been inspected, and the frequency increased.

    GLOBAL POSITIONING

    The Hawai'i Agricultural Research Center had an open field test of a biotech variety of sugar cane that produced a small amount of a pharmaceutical protein, and the site was inspected seven times over the 10-month period that the test was conducted. There was one inspection before planting, three during the growing season, one upon harvest and two inspections after the harvest to verify compliance with permit requirements for planting and post-harvest procedures.

    The BRS also has improved the quality and coordination of inspections through the use of global positioning systems to document the precise geographic location of test plots. Improvements also result from regional coordination of assignments and biotech-specific training and certification for inspectors.

    Readers should be wary of sources that provide misleading information or portray only half of the story. Reports of the USDA agricultural biotech audit are incomplete without mentioning the upgrades listed in the report itself — many of which I have summarized here.

    Today more than ever, the USDA is well equipped to protect America's agricultural and natural resources by ensuring the safe development of genetically engineered organisms using a science-based regulatory framework.

    In addition, as the BRS notes in its letter, it has scheduled an environmental impact statement to be published later this year. This report will provide the basis for new regulations for BRS to ensure that genetically engineered organisms are just as safe for agriculture and the environment as traditional varieties.

    Rick Klemm is executive director of the Hawaiian Alliance for Responsible Technology and Science. He wrote this commentary for The Advertiser.