Agricultural Biotechnology: Background, Regulation, and Policy Issues

Tadlock Cowan
Analyst in Natural Resources and Rural Development

Biotechnology, as used in this report, refers primarily to the use of recombinant DNA techniques to genetically modify or bioengineer plants and animals. Most crops developed through recombinant DNA technology have been engineered to be tolerant of various herbicides or to be pest resistant through having a pesticide genetically engineered into the plant organism. U.S. soybean, cotton, and corn farmers have rapidly adopted genetically engineered (GE) varieties of these crops since their commercialization in the mid-1990s. Over the last dozen years, GE varieties in the United States have increased from 3.6 million planted acres to 171.7 million acres in 2012. Worldwide, 28 countries planted GE crops on approximately 420.8 million acres in 2012. GE varieties now dominate soybean, cotton, and corn production in the United States, and they continue to expand rapidly in other countries. They are regulated under three federal agencies, the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).

Ongoing concerns include ownership concentration in the global seed industry, plant patenting and licensing contracts, the impacts of GE crops on the environment (e.g., pest and weed resistance), whether GE foods should be labeled, their potential contamination of conventionally raised and organic plants, and issues of liability. Underlying these issues are concerns about the adequacy of regulation and oversight of GE organisms, particularly as newer applications (e.g., biopharmaceuticals, multiple GE traits in single organisms, GE trees, GE insects) emerge that did not exist when the current regulatory regime was established in 1986. The FDA is currently considering approval of the first GE animal for human consumption, a salmon genetically engineered to grow faster than conventional salmon. Global trade issues involving GE organisms are a long-standing issue, and will be particularly salient in upcoming U.S.-EU trade discussions.

Regulatory non-compliance incidents most pointedly raise concerns about the adequacy of existing U.S. regulatory structures. About 16 major events have occurred since 1995. A more recent concern has been the adequacy of USDA Animal and Plant Health Inspection Service’s (APHIS) environmental assessments (EAs) for deregulating GE plants. In 2006, a U.S. district court held that USDA’s EA for a variety of GE alfalfa was inadequate for issuing a finding of no significant impact, and ordered APHIS to complete an environmental impact statement (EIS). The final EIS was published in December 2010, and USDA fully deregulated GE alfalfa. A similar case involved APHIS’s decision in 2005 to deregulate GE sugar beets on the basis of its EA. In February 2011, APHIS announced that the agency would partially deregulate GE sugar beet until the EIS was completed. In July 2012, GE sugar beets were completely deregulated following publication in June of the final EIS.

In the 113th Congress, three GE-related bills have been reintroduced: the Seed Availability and Competition Act (H.R. 193); a bill to require labeling of GE fish (H.R. 584/S. 248); and a bill (S. 246) to prohibit interstate and foreign sales of GE salmon. On March 24, 2013, a Senate budget resolution also approved an amendment favoring mandatory labeling of GE fish. The Senate Continuing Resolution (H.R. 933, Section 735) enacted on March 26, 2013, requires USDA to issue permits to growers to plant and market a GE plant even though a court may have vacated the deregulation decision and ordered further review, as happened with GE alfalfa and sugar beets. Similar language was included in the House-passed FY2013 agriculture appropriation bill (H.R. 5973, Section 733). The 2012 House farm bill (H.R. 6083) contained provisions that would have significantly modified current regulations for GE plants under the Plant Protection Act. Another provision in that bill directs USDA to develop a national policy for low-level presence of . GE material in crops and commodities for food and processing. The Senate farm bill did not contain these provisions. Farm bill action is pending in the 113th Congress and could be a vehicle for further legislation affecting biotechnology.


Date of Report: April 3, 2013
Number of Pages: 52
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Agricultural Export and Import Programs

A selected collection of Congressional Research Service studies expanded by Penny Hill Press through content selection and hyperlink activation.


Date of Report: April 8, 2013
Number of Pages: 88
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Hemp as an Agricultural Commodity

Renée Johnson
Specialist in Agricultural Policy

Industrial hemp is a variety of Cannabis sativa and is of the same plant species as marijuana. However, hemp is genetically different and distinguished by its use and chemical makeup. Hemp has long been cultivated for non-drug use in the production of industrial and other goods. Some estimate that the global market for hemp consists of more than 25,000 products. It can be grown as a fiber, seed, or other dual-purpose crop. Hemp fibers are used in a wide range of products, including fabrics and textiles, yarns and raw or processed spun fibers, paper, carpeting, home furnishings, construction and insulation materials, auto parts, and composites. The interior stalk (hurd) is used in various applications such as animal bedding, raw material inputs, low-quality papers, and composites. Hemp seed and oilcake are used in a range of foods and beverages, and can be an alternative food protein source. Oil from the crushed hemp seed is an ingredient in a range of body-care products and also nutritional supplements. Hemp seed is also used for industrial oils, cosmetics and personal care, and pharmaceuticals, among other composites.

Precise data are not available on the size of the U.S. market for hemp-based products. Current industry estimates report that U.S. retail sales of all hemp-based products may exceed $300 million per year. Because there is no commercial industrial hemp production in the United States, the U.S. market is largely dependent on imports, both as finished hemp-containing products and as ingredients for use in further processing. Under the current U.S. drug policy, all cannabis varieties, including hemp, are considered Schedule I controlled substances under the Controlled Substances Act (CSA, 21 U.S.C. §§801 et seq.; Title 21 CFR Part 1308.11). As such, while there are legitimate industrial uses, these are controlled and regulated by the U.S. Drug Enforcement Administration (DEA). Strictly speaking, the CSA does not make growing hemp illegal; rather, it places strict controls on its production and enforces standards governing the security conditions under which the crop must be grown, making it illegal to grow without a DEA permit. Currently, cannabis varieties may be legitimately grown for research purposes only. Among the concerns over changing current policies is how to allow for hemp production without undermining the agency’s drug enforcement efforts and regulation of the production and distribution of marijuana.

In the early 1990s a sustained resurgence of interest in allowing commercial cultivation of industrial hemp began in the United States. Several states have conducted economic or market studies, and have initiated or passed legislation to expand state-level resources and production. Several states have legalized the cultivation and research of industrial hemp, including Colorado, Hawaii, Kentucky, Maine, Maryland, Montana, North Dakota, Oregon, Vermont, Washington, and West Virginia. However, because federal law still prohibits cultivation, a grower still must get permission from the DEA in order to grow hemp, or face the possibility of federal charges or property confiscation, despite having a state-issued permit.

The Industrial Hemp Farming Act was first introduced in the 109th Congress by former Representative Ron Paul. In the 113th Congress, the Industrial Hemp Farming Act of 2013 (H.R. 525; S. 359) would amend Section 102 of the Controlled Substances Act (21 U.S.C. 802(16)) to specify that the term “marijuana” does not include industrial hemp, which the bill would define based on its content of delta-9 tetrahydrocannabinol (THC), marijuana’s primary psychoactive chemical. Such a change could remove low-THC hemp from being covered by the CSA as a controlled substance and subject to DEA regulation, thus allowing for industrial hemp to be grown and processed under some state laws.


Date of Report: March 21, 2013
Number of Pages: 28
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Agricultural Biotechnology: Risk Analysis Research in the Federal Government

This book presents a summary of work done by the AGRA task group beginning in 2004. The first phase was identification of the agricultural biotechnology research needs by the relevant regulatory agencies, followed by a portfolio analysis covering research supported by all of the participating Federal agencies. This report presents a “snapshot” of the directed biotechnology risk analysis research supported by Federal funding for this specific time period. In the time since the portfolio analysis was completed, the Federal agencies participating in AGRA have used the outcomes to address risk analysis issues.

Date of Report: March 20, 2013
Number of Pages: 27
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USDA’s “GIPSA Rule” on Livestock and Poultry Marketing Practices

Joel L. Greene
Analyst in Agricultural Policy

The 2008 farm bill (P.L. 110-246) included new provisions that amended the P&S Act to give poultry and swine growers the right to cancel contracts, to require that poultry processors clearly disclose to growers additional required capital investments, to set the choice of law and venue in contract disputes, and to give poultry and swine growers the right to decline an arbitration clause that requires arbitration to resolve contract disputes. The farm bill required USDA to propose rules to implement these provisions.

On June 22, 2010, the U.S. Department of Agriculture’s (USDA’s) Grain Inspection, Packers and Stockyards Administration (GIPSA) published a proposed rule to implement regulations on livestock and poultry marketing practices as mandated by the 2008 farm bill. The proposed rule, commonly referred to as the “GIPSA rule,” added new regulations to clarify conduct that violates the Packers and Stockyards Act of 1921 (P&S Act). The P&S Act regulations are used by USDA to ensure fair competition in livestock and poultry markets.

In what some saw as a major change from current practice, GIPSA proposed that a violation of the P&S Act does not require a finding of “harm or likely harm to competition.” The proposed rule set criteria for “unfair, discriminatory, and deceptive practices” and “undue or unreasonable preference or advantages” that violate the P&S Act. The proposed rule also included arbitration provisions to ensure that contract growers have a meaningful opportunity to participate in arbitration and the right to decline arbitration.

According to proponents of the proposed rule implementing the farm bill provisions, the rule brought fairness to contracts and reshaped interactions between producers and large meat packers and poultry processors. Opponents argued that the proposed rule went far beyond the intent of Congress in the 2008 farm bill, and that the rule altered business practices to the detriment of producers, consumers, and the industries.

USDA issued a final rule on December 9, 2011, which went into effect on February 7, 2012. The final rule, a significant modification of the proposed rule, included four provisions that address, respectively, suspension of the delivery of birds, additional capital investments, remedy of breach of contract, and arbitration.

Before USDA finalized the GIPSA rule in December, Congress passed in November 2011 the FY2012 appropriations bill (P.L. 112-55), which included Section 721 prohibiting USDA from finalizing the most contentious parts of the rule. The language from the FY2012 appropriations bill was continued into FY2013 as part of the temporary continuing resolution (P.L. 112-175), which provided funding through March 27, 2013, and was continued for the rest of the fiscal year by the year-long continuing resolution (P.L. 113-6). In addition, three provisions finalized by USDA in December 2011 were rescinded.

Repeal of the GIPSA rule may also become part of the omnibus farm bill debate in the 113th Congress. In the 112th Congress, the House-reported farm bill, H.R. 6083, included a provision—Section 12105—that repealed the final GIPSA rule and prohibited USDA from implementing a similar rule. .


Date of Report: March 29, 2013
Number of Pages: 40
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