Agricultural Biotechnology
Geoffrey S. Becker

Since the first genetically engineered (GE) crop varieties became commercially available in the mid-1990s, U.S. farmers have been rapidly adopting agricultural biotechnology, mainly to control weeds and/or insects, according to USDA. As adoption spreads, the policy debate over costs and benefits has intensified -- particularly in some foreign markets, where U.S. agricultural exporters have encountered barriers to crops and foods that may contain GE material.

Policy Issues

Many farmers seek lower production costs, higher yields, and new market opportunities through use of GE crop varieties. However, introduction of the technology also has been controversial. Concerns were heightened in 2000 when a Bt variety of corn (Starlink) not approved for human food use was detected in taco shells. In 2002, GE corn plants being test-grown in Nebraska for pharmaceutical use (for ProdiGene, Inc.) were inadvertently mixed with some 500,000 bushels of soybeans, which subsequently were destroyed to keep them out of the food supply.

Still, U.S. agricultural interests note that many GE varieties already approved for commercialization have been deemed safe by regulatory officials and the scientific community. The U.S. policy approach to GE food safety focuses on product, not the process by which it was produced (see Federal Regulatory Role, below). That is, if a food produced through biotechnology is substantially equivalent to one produced by more conventional means, that food is subject to no additional (or no different) requirements after commercialization.

This approach contrasts with that of major trading partners like the European Union (EU), Japan, South Korea, China, Australia, and New Zealand, for example, which have been establishing separate mandatory labeling and/or traceability requirements for products containing genetically modified ingredients. These differing regulatory approaches have hindered U.S. exports and heightened trade tensions. (See Biotechnology and Agricultural Trade in the CRS Trade Briefing Book.)

EU-U.S. Dispute. On May 13, 2003, the United States, Canada, and Argentina initiated a case before the World Trade Organization (WTO) against the EU's de facto five-year moratorium on approving new products of agricultural biotechnology. U.S. agricultural interests contend that not only has the moratorium blocked their exports to the EU, but also fueled unwarranted concerns about the safety of agricultural biotechnology throughout the world. On August 7, 2003, the United States asked the WTO to establish formally. The WTO named a dispute settlement panel on March 4, 2004, to hear the case. Meanwhile, in late April, the EU Council of Ministers failed to approve a variety of biotech corn, so the European Commission (the EU executive body) said it would do so by mid-June. However, whether individual EU states will comply remains uncertain.

The U.S.-led WTO case does not involve the EU's new labeling and traceability regulations (which were adopted in July 2003 and took effect on April 18, 2004) to require most food, feed, and processed products from genetically modified organisms (GMOs) to be labeled (meat and livestock products are exempt), even if they no longer contain detectable traces of GM material. U.S. agricultural interests argue that, even if the GMO approval moratorium is lifted, the new labeling and traceability rules are themselves unworkable and unnecessary, and can mislead consumers by wrongly inferring that GM-derived products are inherently different than non-GM foods or pose safety concerns. (See European Union Moratorium on Biotech Crops in this briefing book.)

Other public policy issues include:

• Whether current U.S. regulation and oversight of biotechnology are adequate, particularly as newer biotechnology applications -- such as plant-based pharmaceutical and industrial products -- are being developed;

• The prospects for agricultural biotechnology to improve (according to proponents) or undermine (according to opponents) food security in developing countries and elsewhere in the world;

• The impacts of GE crops on the environment and biodiversity, and on food safety and consumer acceptance, including the controversial issue of whether GE products should be traced and labeled;

• The extent to which a few large companies are gaining control over GE seed varieties -- and how that might affect their cost and availability, the agricultural research agenda, patent ownership rights, and so forth; and

• Economic impacts on U.S. farmers and the agricultural production system.

Adoption of Bioengineered Crops

Approximately 167 million acres of various GE crops were planted worldwide in 2003, 63% of them in the United States, according to International Service for the Acquisition of Agri-biotech Applications, a generally pro-biotechnology group. In the United States, GE crops mainly are aimed at more efficient pest control. They include herbicide tolerant (HT) crops (e.g., "Roundup Ready" soybeans) engineered to tolerate herbicides that would otherwise kill them along with the targeted weeds; and insect-resistant crops that effectively have the pesticide inserted into the plants themselves to control insect pests for the life of the crop.

U.S. Adoption of Major Bioengineered Crops, 1996 and 2004*

(percent of total U.S. acreage)

	Soybeans	Upland Cotton	Corn
1996	7	17	4
2004	86	76	46
Source: Various USDA sources, including NASS. Crop Production (supplement): Acreage, various issues, and ERS web-published data. *2004 data are projected plantings.

Federal Regulatory Role

The basic federal guidance for regulating biotechnology products is the Coordinated Framework for Regulation of Biotechnology (51 Fed. Reg. 23302) published in 1986 by the White House Office of Science and Technology Policy. A key principle is that genetically engineered products should continue to be regulated according to their characteristics -- not according to their method of production. The framework maintains that new biotechnology products are regulated under existing federal statutory authorities. The three main agencies and their roles are:

• The Food and Drug Administration, which regulates food and animal feed additives, including those derived from biotechnology, primarily to ensure that they pose no human health risks.

• The Environmental Protection Agency, which approves the use of all pesticides, including those genetically engineered into plants.

• USDA's Animal and Plant Health Inspection Service (APHIS), which regulates the importation, movement, and field testing of plant GE products.

(USDA announced in the January 22, 2004, Federal Register that it intends to "update and strengthen" its biotechnology regulation, starting with an APHIS environmental impact statement evaluating the current rules.)

In Congress

In the 107th Congress, lawmakers included both in the 2002 farm law (P.L. 107-171) and in trade promotion legislation (P.L. 107-210), provisions aimed at supporting use of GE farm products, including new programs to challenge foreign barriers to U.S. exports of such products, and to educate the public on GE-based foods. In the 108th Congress, the conference report to accompany the consolidated appropriations act for FY2004 (H.Rept. 108-401; P.L. 108-199) notes that $3.3 million is provided to USDA for "cross-cutting trade negotiations and biotechnology resources." After the U.S. action against the EU case was filed, both the Senate and House passed, by unanimous consent, resolutions in support (S.Res. 154 and H.Res. 252, respectively).

Pending bills by Representative Smith (H.R. 2447, H.R. 3472) would create an interagency task force to promote the benefits of agricultural biotechnology. A series of bills (H.R. 2916, H.R. 2917, H.R. 2918, H.R. 2919, H.R. 2920, H.R. 2921) by Representative Kucinich would prescribe a variety of legislative changes intended to mandate labeling of GE-based foods; broaden FDA oversight; protect producers from potential legal and environmental risks from agricultural biotechnology; prohibit unapproved U.S. exports of GE plants and animals; and tighten rules for producing and handling GE pharmaceutical and industrial crops, among other things.

Hearings on issues related to agricultural biotechnology were held by the House Agriculture Committee on March 26, 2003, by the panel's Conservation, Credit, Rural Development, and Research Subcommittee on June 17, 2003.

CRS Products

CRS Issue Brief IB10131, Agricultural Biotechnology: Overview and Selected Issues.

CRS Report RS21556, Agricultural Biotechnology: The U.S.-EU Dispute.

CRS Report RL31970, U.S. Agricultural Biotechnology in Global Markets: An Introduction.

CRS Report RS21418(pdf), Regulation of Plant-Based Pharmaceuticals.

CRS Report RL30198(pdf), Food Biotechnology in the United States: Science, Regulation, and Issues.

CRS Contact: Geoffrey S. Becker (7-7287)

Page last updated May 3, 2004.

Return to CRS Briefing Books. | Return to CRS Agriculture Policy Briefing Book.