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Thursday, September 30, 2010

Biotechnology in Animal Agriculture: Status and Current Issues


Tadlock Cowan
Analyst in Natural Resources and Rural Development

Animal agriculture is being transformed by rapid advances in biotechnology—a term that encompasses a variety of technologies, including genetic engineering (GE), genetic modification, transgenics, recombinant DNA techniques, and cloning, among others. Producers are interested in the application of biotechnology to improve productivity, consistency, and quality; to introduce new food, fiber, and medical products; and to protect the environment. Potential human health applications of transgenic animals include producing biopharmaceuticals and generating organs, tissues, and cells for xenotransplantation. Criticisms of such applications involve issues ranging from food safety and social resistance to potential negative impacts on animal welfare and on ecosystems. Questions also have arisen about the adequacy of the current regulatory structure to assess and manage any risks created by these technologies.

On January 15, 2009, the U.S. Food and Drug Administration (FDA) released final guidance on how it is to regulate GE animals and products. FDA is to do so under its existing statutory authority and regulations. Generally, GE-derived foods, for example, are to be regulated like non- GE foods; if their composition does not differ from their conventional counterparts, they will not have to be labeled. Nonetheless, developers of GE animals and of GE-derived products must gain FDA pre-market approval.

On February 6, 2009, the FDA announced the first approval of a drug from a GE animal. The drug is a human anti-clotting agent produced in the milk of transgenic goats. The FDA is currently considering approval of the first genetically modified animal for human consumption, having declared in August 2010 that a GE salmon is safe to eat and poses no threat to the environment.

Although animal biotechnology involves many techniques other than cloning, this latter technology has attracted widespread attention. A final risk assessment and industry guidance on the safety of meat and milk from cloned cattle, pigs, and goats and their offspring were released January 15, 2008, by FDA. The documents generally echoed the FDA’s December 28, 2006, draft risk assessment, which found that such products are as safe to eat as those of conventionally bred animals. The FDA also concluded that cloning poses the same risks to animal health as those found in animals created through other assisted reproductive technologies—although the frequency of such problems is higher in cloning. (Scientists stress that cloning is an assisted reproduction technique that does not involve any transfer or alteration of genes through GE.) The agency said it was no longer asking industry to refrain voluntarily from marketing the products of cloned animals and their offspring, although the U.S. Department of Agriculture (USDA) did ask that it be continued for products from clones (but not from the offspring of clones).

Bills on animal cloning introduced in the 110
th Congress would have required all food from cloned animals or their offspring to be labeled, and prohibited food from cloned animals from being labeled as organic. These and other bills on cloning or other regulation of animal biotechnology could be offered in the 111th Congress.


Date of Report: September 10, 2010
Number of Pages: 25
Order Number: RL33334
Price: $29.95

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Wednesday, September 29, 2010

Deregulating Genetically Engineered Alfalfa and Sugar Beets: Legal and Administrative Responses

Tadlock Cowan
Analyst in Natural Resources and Rural Development

Kristina Alexander
Legislative Attorney


Monsanto Corporation, the developer of herbicide-tolerant varieties of genetically engineered (GE) alfalfa and sugar beet (marketed under the name of Roundup Ready alfalfa and Roundup Ready sugar beet), petitioned USDA’s Animal and Plant Health Inspection Service (APHIS) for deregulation of the items. Deregulation of GE plants is the final step in the commercialization process. Monsanto filed a petition for deregulation of its GE alfalfa in 2004, and for sugar beet in 2005.

As part of the deregulation process, APHIS conducts an environmental review under the National Environmental Policy Act (NEPA) to determine whether any significant environmental impacts will result from deregulating the item. APHIS conducted a limited review, known as an environmental assessment (EA), of the GE plants to assess the impacts of growing them on a commercial scale. For both GE alfalfa and sugar beets, APHIS issued a “finding of no significant impacts” (FONSI), in June 2005 and March 2005, respectively.

Lawsuits subsequently challenged the adequacy of the EAs as the basis of the FONSI. The courts agreed that APHIS should have prepared an environmental impact statement (EIS) for both deregulation decisions. An EIS is a more comprehensive review than the EA completed by APHIS. APHIS was directed by the court to complete an EIS on the effects of deregulating both of the GE varieties.

The court in the GE alfalfa case halted planting of the genetically modified seed after May 3, 2007, and nullified the deregulation. The injunction was appealed to the U.S. Supreme Court, which held that the injunction was too broad and that the court should have considered partial deregulation. The Supreme Court did not discuss the appropriateness of the environmental review.

The court in the GE sugar beet case did not formally prohibit planting sugar beet, but it voided APHIS’s deregulation decision in August 2010. This decision undoes the five-year-old approval of GE sugar beet, from which nearly half of U.S. sugar is derived. APHIS announced on September 1, 2010, that the agency is currently evaluating a request to partially deregulate GE sugar beets, which would permit planting and harvesting sugar beets under certain restrictions. APHIS is also issuing permits authorizing seedling production that would not allow flowering. A suit seeking an injunction against growing the seedlings was filed on September 9, 2010.

APHIS anticipates that the draft EIS for sugar beet will be publicly available May 2011, and the final EIS in May 2012. A draft EIS for alfalfa was released to the public on December 14, 2009. The final EIS is scheduled for publication in fall 2010, when APHIS also will announce its decision on deregulating the GE alfalfa.

The cases of GE alfalfa and sugar beet highlight continuing policy questions about the adequacy of APHIS’s deregulation protocol, particularly regarding the environmental review process. In their suits against APHIS, plaintiff lawyers cited, among other analytical inadequacies, the EAs’ failure to assess the impact on non-GE alfalfa growers (particularly those who export to Japan, Korea, and Taiwan) and on producers of commercial table beet and chard seeds (species that can cross-pollinate with GE sugar beet). APHIS currently is in the process of issuing a final rule on its revision of regulations regarding the importation, interstate movement, and environmental release of GE organisms.



Date of Report: September 10, 2010
Number of Pages: 17
Order Number: R41395
Price: $29.95

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Monday, September 27, 2010

The Endangered Species Act (ESA) in the111th Congress: Conflicting Values and Difficult Choices


Eugene H. Buck
Specialist in Natural Resources Policy

M. Lynne Corn
Specialist in Natural Resources Policy

Pervaze A. Sheikh
Specialist in Natural Resources Policy

Robert Meltz
Legislative Attorney

Kristina Alexander
Legislative Attorney


The Endangered Species Act (ESA; P.L. 93-205, 16 U.S.C. §§ 1531-1543) has been one of the more contentious environmental laws. This may stem from its strict substantive provisions, which can affect the use of both federal and nonfederal lands and resources. Under ESA, species of plants and animals (both vertebrate and invertebrate) can be listed as endangered or threatened according to assessments of their risk of extinction. Once a species is listed, powerful legal tools are available to aid its recovery and protect its habitat. ESA may also be controversial because dwindling species are usually harbingers of broader ecosystem decline. The most common cause of species listing is habitat loss. ESA is considered a primary driver of large-scale ecosystem restoration issues.

The 111
th Congress has considered whether to revoke ESA regulations promulgated in the waning days of the Bush Administration that would alter when federal agency consultation is required. In addition, legislation related to global climate change includes provisions that would allocate funds to the U.S. Fish and Wildlife Service’s endangered species program and/or to related funds to assist species adaptation to climate change. Other major issues concerning ESA in recent years have included the role of science in decision-making, critical habitat (CH) designation, protection by and incentives for property owners, and appropriate protection of listed species, among others.

The authorization for spending under ESA expired on October 1, 1992. The prohibitions and requirements of ESA remain in force, even in the absence of an authorization, and funds have been appropriated to implement the administrative provisions of ESA in each subsequent fiscal year. Proposals to reauthorize and extensively amend ESA were last considered in the 109
th Congress, but none was enacted. No legislative proposals were introduced in the 110th Congress to reauthorize the ESA.

In the first session of the 111
th Congress, P.L. 111-8 contained language authorizing the Secretary of the Interior to withdraw or reissue (1) revisions to the ESA Section 7 consultation regulations promulgated by the Bush Administration and (2) a December 2008 special rule that outlined protections afforded polar bears. In addition, P.L. 111-11 included provisions (1) authorizing the implementation of the San Joaquin River Restoration Settlement, providing for the reintroduction of Chinook salmon, and (2) amending P.L. 106-392 to extend the authorizations for the Upper Colorado and San Juan River Basin endangered fish recovery programs through FY2023. P.L. 111-88 appropriated about $281 million for U.S. Fish and Wildlife Service endangered species and related programs for FY2010.

This report discusses oversight issues and legislation introduced in the 111
th Congress to address ESA implementation and management of endangered and threatened species.


Date of Report: September 16, 2010
Number of Pages: 29
Order Number: R40185
Price: $29.95

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The Animal Welfare Act: Background and Selected Legislation


Tadlock Cowan
Analyst in Natural Resources and Rural Development

In 1966, Congress passed the Laboratory Animal Welfare Act (P.L. 89-54) to prevent pets from being stolen for sale to research laboratories, and to regulate the humane care and handling of dogs, cats, and other laboratory animals. The law was amended in 1970 (P.L. 91-579), changing the name to the Animal Welfare Act (AWA). Congress periodically has amended the act to strengthen enforcement, expand coverage to more animals and activities, or curtail practices viewed as cruel, among other things. A 1976 amendment added Section 26 to the AWA, making illegal several activities that contributed to animal fighting. Farm animals are not covered by the AWA, which is administered by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service.

In the 110
th Congress, the Animal Fighting Prohibition Enforcement Act of 2007 (H.R. 137; P.L. 110-22) was enacted. The bill amended Section 26 of the AWA to strengthen provisions against animal fighting. The AWA was amended again in 2008 when provisions were included in the 2008 farm bill (P.L. 110-246). These provisions ban the importation of puppies under six months of age for resale, tighten prohibitions on dog and other animal fighting activities, and increase penalties for violation of the act.

Other AWA bills introduced in the 110
th Congress included the Pet Safety and Protection Act (H.R. 1280/S. 714) to restrict where research facilities could obtain their dogs and cats; Haley’s Act (H.R. 1947) to make it unlawful for animal exhibitors and dealers (but not accredited zoos) to allow direct contact between the public and big cats such as lions and tigers; the Animal Protection and Accountability Improvement Act (H.R. 2193), to prohibit the use of animals in marketing medical devices and products; and the Puppy Uniform Protection and Safety Act (H.R. 6949/S. 3519), to require an AWA license from USDA of dog breeders who raise more than 50 dogs in a 12-month period and sell directly to the public.

In the 111
th Congress, two of the bills were reintroduced: the Pet Safety and Protection Act (H.R. 3907/S. 1834); and the Puppy Uniform Protection and Safety Act (H.R. 5434/S. 3424).


Date of Report: September 9, 2010
Number of Pages: 11
Order Number: RS22493
Price: $29.95

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Humane Treatment of Farm Animals: Overview and Issues

Tadlock Cowan
Analyst in Natural Resources and Rural Development

Animal protection activists in the United States have long sought legislation to modify or curtail some practices considered by U.S. agriculture to be acceptable or even necessary to animal health. Members of Congress over the years have offered various bills that would affect animal care on the farm, during transport, or at slaughter; several proposals have been introduced in the 111th Congress. Members of the House and Senate Agriculture Committees generally have expressed a preference for voluntary rather than regulatory approaches to humane care. Meanwhile, animal activists have won initiatives in several states to impose some care requirements on animal producers.


Date of Report: September 13, 2010
Number of Pages: 8
Order Number: RS21978
Price: $19.95

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