USDA - APHIS - Biotechnology

Biotechnology Regulatory Services

Office of the Inspector General (OIG) Report
Frequently Asked Questions

The U.S. Department of Agriculture's (USDA) Office of Inspector General (OIG) reviewed Biotechnology Regulatory Services (BRS) internal management controls and regulation of genetically engineered (GE) crops. On Dec. 22, 2005, OIG made their findings publicly available.

APHIS worked closely with OIG throughout the review process, and values the opportunity provided by the audit to obtain guidance and recommendations to enhance their program. Many of these recommendations have provided the program with sound ideas which, in combination with BRS' scientific expertise and knowledge of biotechnology, are being turned into workable solutions.

The following document answers frequently asked questions related to the OIG report.

When did OIG conduct its review of BRS?

In April 2003, OIG officially began a review of the activities of USDA's Animal and Plant Health Inspection Service (APHIS) from 2001 to 2003. Although APHIS has regulated GE organisms since 1986, BRS was only established in August 2002 to enable APHIS to take a more comprehensive approach toward regulating biotechnology, keep pace with rapidly evolving technology, and promote greater understanding of our regulatory functions. OIG issued an audit report on its findings in December 2005.

What is BRS' response to the recommendations in the OIG report?

The findings and recommendations in the OIG report reaffirm APHIS’ decision to create BRS and devote greater resources toward regulating biotechnology. Most of the recommendations in the report are in line with changes that BRS has already enforced, is currently undertaking, or plans to implement.

BRS' risk-based regulations are consistent with the principles recognized by the National Academy of Sciences for the safe introduction of GE organisms, and even our critics acknowledge that no demonstrable negative environmental impacts have arisen from the thousands of field tests that have been planted under APHIS' authorization. BRS acknowledges the need to update its regulations and practices to meet the broader regulatory authority bestowed on it with the passage of the Plant Protection Act (PPA) in April 2002 and to better position itself to meet the challenges that will be posed by the next generation of biotechnology products.

The process was initiated in January 2004 with the publication of a Notice of Intent to prepare an Environmental Impact Statement (EIS). BRS plans to publish a draft EIS in 2006, providing clarity and direction on potential new regulations. A proposed rule will likely follow the draft EIS sometime in 2007. It's important to emphasize that revising the regulations is a huge undertaking that cannot be done quickly. Getting input from stakeholders, the scientific community and the public at large is critical to producing regulations that are protective, credible and functional.

What steps has BRS taken to address the recommendation that BRS document all scientific reviews for the approval of field test applications?

BRS concurs with the recommendation from OIG to document the scientific process and criteria used for approving applications, as well as the need for supervisory review of the process.

In 2005, APHIS drafted six Standard Operating Procedures that document, describe, and direct the scientific review process. These documents cover the processing of petitions for deregulation of GE products; the review process of permits, including permits with pharmaceutical and industrial applications; procedures for the review and approval of training programs for individuals conducting field tests of GE plants engineered to produce pharmaceutical and industrial compounds; and the process for posting information on the Internet. APHIS' staff is also currently formulating plans for increased documentation and supervisory review of the field test approval process.

What location information does BRS require in field test applications, and what is BRS' policy on GPS coordinates?

BRS always knows the area, which includes the state, county, and local address, for all field tests. GPS coordinates are also required for all field tests of GE plants engineered to produce pharmaceutical and industrial compounds. While BRS sees great utility in receiving GPS coordinates for all field tests, determining exact site locations prior to planting with any accuracy is difficult. The requirement to submit GPS coordinates before planting for all field tests would result in a large volume of inaccurate information. In January 2005, APHIS issued a memorandum that requested notification holders to voluntarily submit GPS coordinates to identify field test locations after planting occurs.

What written field test protocols does BRS require from field test applicants?

Written field test protocols must be submitted for all field tests conducted under permits. Permits for field tests are required for GE plants that could pose an elevated plant pest risk. These protocols describe how the field test will be carried out, including specific measures to minimize the risk of harm to other organisms, and are reviewed prior to the approval of the permits. Additional conditions may be imposed by APHIS and the State where the field test is to take place to ensure adequate safety precautions are met.

In 2005, APHIS made written protocols mandatory for all field tests, including those performed under notifications. The notification process is a streamlined process used only for those GE plants that are low risk and do not pose a significant plant pest risk. While these protocols are not routinely reviewed before acknowledging the notification, the notification holder must supply the protocols upon request if APHIS reviewers have questions. All notification field trials are subject to inspection to ensure compliance with APHIS regulations, and the written protocols are used by inspectors when the field test sites are chosen for inspection. In the future, ePermits, a USDA-wide initiative, will allow the written protocols to be electronically linked to each notification.

To qualify for the notification process, applicants must agree to design protocols that meet the performance standards set forth by APHIS. APHIS created these performance standards to ensure the safe confinement of regulated materials, so that neither the regulated article nor its offspring is released into, or persists in, the environment, while allowing notification holders some flexibility with their protocol design. APHIS has issued detailed guidance to assist applicants with meeting these performance standards.

Does BRS require proof of financial responsibility before approving field test applications?

BRS does not have the regulatory authority to require permit applicants, based on the level of risk, to provide financial responsibility in the event of an unauthorized release. In addition, it would be very difficult, if not impossible, to gauge the level of financial risk from field testing GE plants. Often, risks are not safety-related, but are related to perceptions of risk and other market considerations. This requirement, if implemented, might also be a significant impediment to participation in technology development by small businesses and academic researchers.

The Plant Protection Act of 2000 currently authorizes fines up to $500,000 for noncompliance incidents, as well as remediation costs. APHIS has successfully invoked this authority in the past, with all noncompliance issues being corrected and paid for by the involved parties.

As this is a complex issue that would have major implications for the way that research is regulated and developed in this country, BRS sought additional guidance from Mike Johanns, Secretary of Agriculture on this issue. In March 2006, Secretary Johanns recommended that BRS continue with its current approach and not pursue the legal authority to establish a new system requiring proof of financial responsibility.

Does APHIS plan to create or strengthen field test requirements to prevent the release of regulated GE materials?

APHIS already has stringent requirements in place to prevent the release of GE materials into the environment. Permit and notification holders must adhere to certain conditions to ensure that the regulated GE organism does not damage agriculture or the environment. These conditions include stringent confinement measures, such as isolation distances, to prevent pollen flow; clean equipment and containers, in good working order, to prevent cross-contamination; and labeling of all regulated articles to prevent accidental use or incorporation with other crops. At the end of all field tests, developers must destroy or properly dispose of any viable plant material and ensure that no regulated articles persist in the environment. In the event that a regulated GE organism does become intermingled with unregulated food or feed, Government agencies have the authority to seize the food or feed and require its destruction, thereby preventing it from entering the food supply. BRS' compliance unit performs inspections of field test sites to ensure that developers are adhering to these requirements.

This approach to regulation has enabled the safe field testing of more than 10,000 GE crops since 1986, and BRS plans to build on this success. BRS will revise policies and procedures as necessary based on the most current scientific knowledge available.

How do BRS and APHIS' Plant Protection and Quarantine (PPQ) work together to ensure the safe field testing of GE crops?

APHIS has regulated field tests, importations, and the interstate movement of GE organisms since 1987. This important function was originally an element of the PPQ program. In recognition of the need to address the complexity of biotechnology, APHIS created BRS in 2002 to provide a higher degree of focus on the regulation of GE organisms. BRS and PPQ are natural partners in protecting American agriculture, with BRS regulating GE organisms and PPQ assisting with inspections. BRS and PPQ coordinate on issues, such as training of inspectors and maintain close contact through regular telephone conferences. A Memorandum of Understanding (MOU) formalizes the partnership of BRS and PPQ and fully clarifies the specific roles and responsibilities of BRS and PPQ regarding the selection and inspection of non-pharmaceutical and non-industrial permits.

How does APHIS document inspections and ensure appropriate follow-up of any noncompliance issues?

In February 2005, BRS' compliance and inspection branch implemented an interim tracking system and procedures for initiating, numbering, tracking, completing, and receiving written follow-up reports for every inspection. Every inspection and inspection result is fully accounted for in this system. Each requested inspection has an identification number and expected completion date that allows the compliance branch to track and follow up regularly with PPQ to ensure all inspections are accounted for. This includes any inspections that are canceled because the applicant decided not to plant.

BRS also implemented requirements for the reporting and follow-up of all noted noncompliance incidents. Inspectors are required to complete reports for all inspection assignments, and compliance officers must review these reports and follow-up with appropriate correspondence or enforcement actions when noncompliance incidents are reported.

How does APHIS regulate the final disposition of GE pharmaceutical and industrial crop harvests?

It is part of BRS' policy to inspect field tests of GE plants engineered to produce pharmaceutical and industrial compounds in order to ensure that GE materials are disposed of in accordance with our regulations. BRS requires applicants to disclose when they plan to dispose of GE pharmaceutical and industrial harvests so we can verify that disposal is done properly. BRS receives pre-harvest reports for these regulated articles, and inspectors are present at harvest to ensure that final procedures are performed as described in the permit conditions for harvest, destruction, or removal of the crop to a contained facility. Written standards require information on the amount, location, and actual disposition of GE pharmaceutical and industrial harvests, including destruction, shipment to another location, or replanting.