Biotechnology:

Agriculture's Regulatory System Needs Clarification

RCED-86-59: Published: Mar 25, 1986. Publicly Released: Mar 25, 1986.

Additional Materials:

Contact:

Brian P. Crowley
(202) 512-9450
contact@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

In response to a congressional request, GAO reviewed the Department of Agriculture's (USDA): (1) programs and activities relating to biotechnology; (2) decisionmaking concerning the release of genetically engineered organisms into the environment; and (3) relationship with other federal agencies involved in biotechnology.

GAO found that: (1) USDA has not formulated a well-defined regulatory structure to approve requests for the deliberate release of genetically engineered organisms into the environment; (2) oversight of biotechnology programs is handled by agencies within USDA that have other responsibilities and were established before the emergence of new biotechnologies; (3) the USDA Agriculture Recombinant DNA Research Committee (ARRC) lacks the authority and direction to effectively act as the focal point for biotechnology matters; and (4) USDA has not communicated to Congress and the public the benefits and risks of biotechnology, as well as its plans to minimize those risks. GAO also found that USDA has been hesitant to develop a well-defined regulatory structure because: (1) it does not want to impose cumbersome regulations that might stifle growth; (2) the Office of Science and Technology Policy (OSTP) has been examining biotechnology regulation and coordinating the actions of many federal agencies; and (3) several lawsuits filed by opponents of biotechnology have created some anxiety. USDA has recently set up a general framework for biotechnology regulation, but it still needs to establish: (1) detailed procedures concerning responsibility for a wide range of research and product development; (2) ARRC authority and duties; and (3) improved communications with Congress and the public for more informed discussion and a lessening of fears.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: The USDA biotechnology regulatory structure has been formalized and better defined since the issuance of the GAO report in March 1986. Changes that were made appear consistent with and responsive to this recommendation.

    Recommendation: The Secretary of Agriculture should direct the Assistant Secretaries for Marketing and Inspection Services and Science and Education to work together to develop a formalized, well-defined regulatory structure over biotechnology, particularly with regard to deliberate releases of genetically engineered organisms into the environment. Such a structure should be sufficiently detailed to minimize questions about who in USDA is responsible for decisions in particular areas and flexible enough to encompass the wide range of biotechnological research and product development expected. It could, if deemed appropriate, incorporate a fully developed National Biological Impact Assessment Program and recombinant deoxyribonucleic acid guidelines geared specifically toward agriculture. Further, it should clearly identify the regulatory procedures for handling requests to license biotechnology products and approve the deliberate release of genetically engineered organisms into the environment.

    Agency Affected: Department of Agriculture

  2. Status: Closed - Implemented

    Comments: A number of different organizational bodies were recently established at USDA to oversee and handle biotechnology matters. The organizational structure in USDA over biotechnology, as now constituted, is consistent with and responsive to this recommendation.

    Recommendation: The Secretary of Agriculture should direct the Assistant Secretaries for Marketing and Inspection Services and Science and Education to work together to provide the USDA coordinating committee, currently ARRC, with the authority, prestige, and sense of direction it needs to effectively act as the USDA focal point for biotechnology. The committee should have the power to resolve differences that may arise with regard to biotechnology within USDA and to act on behalf of USDA in resolving differences between USDA and other federal agencies, such as the National Institutes of Health, Environmental Protection Agency, or Food and Drug Administration. The committee should be constituted as it is now with representatives from various agencies within and outside USDA. The various representatives should be able and willing to commit high priority to their committee responsibilities.

    Agency Affected: Department of Agriculture

  3. Status: Closed - Implemented

    Comments: USDA considered this recommendation to be sound. It identified a number of means by which it plans to improve communication of its views concerning biotechnology.

    Recommendation: The Secretary of Agriculture should look for, and take advantage of, opportunities to improve and increase the communication of USDA views on biotechnology, both in terms of the benefits to be derived and the risks that must be considered and managed. In this regard, the Secretary should consider a variety of approaches for doing this, including brochures, newsletters, public conferences and debates, and a Yearbook of Agriculture devoted to biotechnology. The purpose of all such communication should be to foster a more open, frank, and informed discussion about USDA views on biotechnology and how USDA will address the related risks.

    Agency Affected: Department of Agriculture

 

Explore the full database of GAO's Open Recommendations »

Jun 9, 2016

May 26, 2016

May 19, 2016

Apr 14, 2016

Jan 14, 2016

Jan 8, 2016

Jul 9, 2015

Jun 18, 2015

May 26, 2015

May 20, 2015

Looking for more? Browse all our products here