Oversight Needed For Biotech Crops

The Agriculture Department's system for overseeing field trials of genetically engineered (GE) crops is in disarray, says a report from the USDA's Office of Inspector General (OIG). The deficiencies in the department's inspections and regulation of these crops could lead to serious harm to health or the environment, the report says.

The Animal & Plant Health Inspection Service (APHIS), the USDA agency that regulates biotech field trials, contends, however, that improvements are under way. APHIS officials say they have already taken steps to implement 23 of the 28 recommendations in the report. But they disagree with a number of the key recommendations and do not plan to implement them.

OIG audited biotech crop field trials conducted between May 2003 and April 2005. In the process, it visited 91 test sites in 22 states and examined written records. It found a total of 13 violations of APHIS's rules at 11 of the sites.

APHIS "lacks basic information about the field test sites it approves and is responsible for monitoring, including where and how the crops are being grown and what becomes of them at the end of the field test," the report concludes. Although the report did not find any specific instances of environmental harm, it repeatedly noted the potential for harm.

Specifically, the audit found that regulators did not usually find violations of their own rules, did not conduct many of the required inspections, did not usually send notices of violations when problems were found, and did not ensure that biotech plants and seeds were destroyed at the end of the trials. In many cases, regulators had no record of the precise locations of field trials. APHIS cannot effectively monitor compliance with field test requirements without knowledge of test site locations, the report states.

The inspector general was particularly concerned about field trials of nonedible biotech crops designed for production of pharmaceutical or industrial chemicals. In 2003, APHIS promised to conduct five inspections of field trials of each pharmaceutical or industrial chemical crop trial during the growing season and two postharvest inspections. Few of these inspections were actually done, the report says. In two cases, pharmaceutical crops were stored for a full year after harvest in a location that was not even reported to USDA.

The Biotechnology Industry Organization (BIO) says APHIS's oversight of field trials is adequate. "This report is so long in the making and so frozen in time that it was obsolete before it came out," says BIO spokeswoman Lisa Dry.

Sean Darragh, BIO's executive vice president for food and agriculture, concurs. "The OIG report serves only as a historical snapshot of an earlier regulatory system that is not reflective of the current agency that oversees agricultural biotechnology."

In contrast, Susan P. Prolman, the Washington, D.C., representative for the Food & Environment Program at the Union of Concerned Scientists, says the changes that APHIS has already made and has promised to make are not sufficient. The executive summary of the report is explicit in pointing out current deficiencies, she explains. For example, the inspector general says APHIS does not require written copies of field trial protocols. The agency allows the applicants to self-certify that they meet performance standards. This practice is not acceptable, the report points out.

"The inspector general's report shows USDA is not particularly vigilant about oversight of field trials," says Gregory Jaffe, director of biotechnology projects at the Center for Science in the Public Interest. "USDA doesn't seem to have a good handle on what industry is doing."

Field trials are a rapidly growing phenomenon in the U.S. In 1994, more than 8,700 acres were planted with field trial crops; by 2004, applicants proposed to plant more than 67,000 acres with trial crops.

Some of the basic problems the inspector general found concern regulations and internal organization at APHIS. For example, the agency has not updated its regulations to reflect the Plant Protection Act of 2000. Also, coordination between the two APHIS offices responsible for inspection, Biotechnology Regulatory Services (BRS) and Plant Protection & Quarantine (PPQ), is insufficient. PPQ does not complete all the inspections BRS requests.

Another basic problem is that APHIS does not specify when a GE crop should be destroyed after a field test. Sometimes harvested trial crops lie in fields for months, available to wildlife and exposed to wind, and thus to movement beyond the designated test area. Also, edible GE crops that the Food & Drug Administration has not yet approved for human consumption are often grown where they can easily be picked and eaten by anyone walking near the field.

congressional action, not simply a change in rules, would be required to correct another problem. APHIS currently has no authority to require a company to provide proof of financial responsibility before a field test. So if a pharmaceutical crop accidentally contaminates a large volume of corn that is to be sold for food or feed, for example, and the applicant has limited financial resources, USDA would have to pay to find and destroy the contaminated crop.

APHIS is taking steps to remedy some of these problems. It will require that the Global Positioning System (GPS) coordinates of the trial site be reported within 28 days after planting. It is trying to better coordinate the operations of BRS and PPQ so inspections will be completed on time. It has also designed a single system to track inspections and field test reports. And it has asked the USDA secretary to seek legislative authority to require that applicants provide proof of financial responsibility before conducting field trials.

APHIS says it does not agree, however, that applicants should have to submit written scientific protocols for conducting field trials. Nor does it agree that it is necessary to broadly restrict public access to field trials of edible crops. And APHIS does not believe it should develop a risk-based system for selecting field trial sites to inspect.

OIG strongly objects to APHIS's stance on written protocols. "By not obtaining copies of the protocols, APHIS is relinquishing its regulatory responsibility in favor of self-certification by the notification applicants-namely, the applicants merely certify in their notification applications that they will meet the performance standards," the report says. The written protocols are also important for performing inspections, it continues. The inspector general also argues that unapproved crops grown in field trials should not be available to passersby.

Regulation requires APHIS to reach decisions on all the inspector general's recommendations within six months of issuance of the report.