107th Congress

Agriculture Appropriations Act, Fiscal Year 2003

H.R. 5263/S. 2801, House Report 107-623, and Senate Report 107-223

Background

The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2003 has a number of provisions related to the National Institutes of Health (NIH), and there is one item in House Report 107-623 that would enlist NIH's participation in expanded research on ephedrine alkaloids. The report would require the Food and Drug Administration (FDA) to review its practices on allergenicity, develop a comprehensive and consistent policy for evaluating new foods and ingredients for potential allergenicity, including the types of tests that would be appropriate for evaluating different ingredients, and acquire input from NIH and other relevant agencies. Also addressed is the comprehensive review of the scientific data on ephedra products raised by adverse event reports (AERs). Both the House and Senate Appropriations Committees addressed the U.S. Department of Health and Human Services' (DHHS) "one voice" initiative but did not support the transfer of FDA public and legislative affairs activities to DHHS. Similar language for NIH is contained in the fiscal year (FY) 2003 Senate Labor, Health and Human Services (HHS), and Education appropriations bill.

In July 2002, the House and Senate Appropriations Committees approved versions of the FY 2003 Agriculture Appropriations bill that would have provided about $74.3 billion. In both cases, the Committee members put off controversial issues remaining from debate on the new farm bill. Ultimately, only 2 of the 13 regular FY 2003 appropriations bills (U.S. Department of Defense and Military Construction) were enacted before the 107th Congress adjourned, neither of which affected NIH funding. NIH and other agencies such as the U.S. Department of Agriculture (USDA) and FDA have been provided with funding for FY 2003 through a series of continuing resolutions, the fifth and most recent of which provides funding through January 11, 2003, at the current rate of spending for FY 2002.

Provisions of the Legislation/Impact on NIH

Legislative provisions of particular interest to NIH include:

House Report 107-623

• Proposed New User Fees: The budget request assumes the establishment of new user fees for animal welfare inspections.
• Environment and Animal Waste Research: The Committee supports the need for additional research to find methods to reduce or eliminate the risks to the environment and human health caused by animal waste. The Committee provides an increase of $1.25 million in FY 2003 to support this research. The Committee also provides an increase of $750,000 over FY 2002 for farm and watershed research and monitoring of manure nutrients, pathogens, and emissions.
• Animal Welfare Information Center: The Animal Welfare Information Center (AWIC) is a key component of the Agricultural Research Services' (ARS) integrated information services program, which enhances access to information about animal welfare. AWIC assists researchers and others responsible for the care of laboratory animals by providing important information to enable them to comply with the humane standards established under the Animal Welfare Act. The Committee provides an increase of $80,000 in FY 2003 to support animal welfare activities. The AWIC would be held to FY 2002 levels.
• Barley Foods and Health: The Committee recognizes the need to investigate the benefits of barley foods to human health. The Committee provides an increase of $60,000 in FY 2003 for investigation and documentation of the benefits of barley foods to human health.
• Animal Genetics: The Committee supports the research program on biotechnology and genetics in cattle jointly carried out by ARS, the University of Connecticut, and the University of Illinois. This program uses advanced research technologies to improve the efficiency of cloning and establish cell lines from elite cows and bulls for cloning. The Committee provides an increase of $400,000 in FY 2003 to expand these studies.
• West Nile Virus: The Committee recognizes the continuing threat of mosquito-borne West Nile Virus to humans and domestic animals. A $350,000 increase is provided in FY 2003 for expanded cooperative research with the Connecticut State Agricultural Experiment Station to develop methods of efficiently controlling mosquitoes, evaluate antiviral drugs to cure infected humans, and determine if the virus is mutating to more virulent forms.
• National Research Initiative: The Committee recommends that grants made available through the National Research Initiative (NRI) include genetically modified agriculture products (GMAP) research grants. Such grants should be made for the purpose of evaluating the risks and benefits to humans of genetically modified plant and animal products.
• Dietary Supplements: The Committee commends the FDA for having signed in September 2000 a 2-year contract with the Institute of Medicine (IOM) of the National Academies to develop a framework for evaluating the safety of dietary supplements and apply it to six dietary supplements. The Committee encourages the FDA to continue this contract into FY 2003 and, if possible, to increase the number of dietary supplements to be evaluated by the IOM.
• Food Allergies: The Committee is concerned about the incidence of food allergies and notes that scientists and the public are increasingly concerned about the possibility of new food ingredients causing allergic reactions. While FDA encourages careful evaluation of new proteins in genetically engineered foods, it has given less scrutiny to other food ingredients such as whole new foods, including kiwifruit and mycoprotein (processed fungus). The Committee requests that FDA, with input from NIH and other agencies it believes appropriate, review its practices on allergenicity and develop a comprehensive and consistent policy for evaluating new foods and ingredients for potential allergenicity, including the types of tests that would be appropriate for evaluating different ingredients.
• Ephedra Products: The Committee commends FDA for its recent statement that AERs regarding dietary supplements containing ephedrine alkaloids do not alone provide a scientific basis for assessing the safety of these products. The Committee also agrees that the DHHS-sponsored comprehensive review of the scientific data is the appropriate response to possible concerns raised by AERs. The Committee further understands that NIH will use the review to guide an expanded research effort on ephedrine alkaloids and that FDA will be guided by the review in regulatory discussions on ephedra products. The Committee urges that following the publication of this review, a dialog take place between FDA and industry to discuss any necessary actions or decisions regarding ephedra products, including development of a standard label of warnings and contraindications.
• Vaccine Review: The Committee is aware that clinical testing of vaccines, including candidate HIV vaccines, requires careful review and oversight by the Center for Biologics Evaluation and Review (CBER) and notes that there is particular urgency for expediting clinical trials for HIV vaccines, as well as vaccines for other serious illnesses, without compromising safety. The Committee urges the agency to develop a feasibility plan for a Fast Track program to facilitate the awarding of Investigational New Drug status to new vaccine candidates. The Committee directs FDA to report on progress toward implementing this program by March 1, 2003.
• DHHS "One Voice" Initiative: The Committee notes that the recommended funding level includes $7,317,000 for FDA public and legislative affairs activities, and states that "the Committee does not support the transfer of these functions to the Department of Health and Human Services, as proposed in the budget request." The recommended funding level includes a total of $8.3 million for costs associated with establishing the Unified Financial Management System (UFMS), a DHHS initiative, including costs for FDA to maintain and improve its legacy systems. The Committee recommendation fully funds the request.

Senate Report 107-223

• Biomedical Materials: Increased research is needed to carry out studies on tobacco and other plants as a medium to produce vaccines and other biomedical products for the prevention of many human and animal diseases. The Committee provides an increase of $425,000 from the FY 2002 level for expanded ARS cooperative research with the Biotechnology Foundation.
• Biotechnology Research: Biotechnology research has allowed for sequencing and mapping the genes of crops and livestock, marking genes for added precision in the breeding of improved plants and animals, and identifying gene products through proteomics technology. The Committee provides an increase of $1.5 million from the FY 2002 level to ARS to support cooperative research in genomics and bioinformatics and the use of biophotonics for the imaging of animal physiological processes at the cellular level.
• Chronic Wasting Disease: In order to reduce livestock losses and improve efficiency of production, it is important to eradicate transmissible spongiform encephalopathy (TSE) in domestic animals. Scrapie in sheep and goats, bovine spongiform encephalopathy, and chronic wasting disease (CWD) in deer and elk are classes of TSEs found in ruminant animals and are fatal diseases that can affect both animals and humans. The Committee provides an increase of $1 million from the FY 2002 funding level to the Animal Disease Laboratory in Pullman, WA, and the National Animal Disease Laboratory in Ames, IA, for urgent research on CWD.
• Livestock Genome Sequencing: The Committee provides an increase of $300,000 in FY 2003 to the U.S. Meat Animal Research Center for expanded genomics research to identify the genes that influence disease resistance, reproduction, nutrition, and other economically important traits in livestock. This research is to be performed in collaboration with the University of Illinois.
• Microbial Genomics: The Committee recognizes the importance and significance of the joint microbial genomics initiative between the ARS Animal Disease Research Unit in Pullman, WA, and the ARS Tick Research Unit in Kerrville, TX, and continues the FY 2002 level of funding.
• Animal Care: The Animal and Plant Health Inspection Service within USDA conducts regulatory activities that ensure the humane care and treatment of animals and horses as required by the Animal Welfare and Horse Protection Acts. These activities include inspecting certain establishments that handle animals intended for research, exhibition, and as pets, and monitoring certain horse shows. The inspection service also performs other regulatory activities, including the development of standards for the licensing and testing of veterinary biologicals to ensure their safety and effectiveness, diagnostic activities to support the control and eradication programs in other functional components, applied research to reduce economic damage from vertebrate animals, the development of new pest and animal damage control methods and tools, and regulatory oversight of genetically engineered products.
• DHHS "One Voice" Initiative: The Committee does not recommend a decrease of $7,317,000 in budget authority to consolidate the FDA Office of Public Affairs and the FDA Office of Legislation into the DHHS Office of the Secretary. However, the Committee does support the Secretary's efforts to streamline and coordinate the activities of DHHS agencies to ensure the ability of DHHS to provide clear, consistent messages to Congress and the American public. The Committee also does not recommend an increase in budget authority of $5.2 million for the DHHS UFMS. These funds were provided through a reprogramming of FY 2002 funds and are no longer necessary as an increase in FY 2003.
• Dietary Supplements: The Committee believes that the potential for dietary supplements to have positive health benefits has been realized in many cases. However, it is essential that FDA continue its efforts to ensure their safety and fully enforce the prohibition of false, misleading, or unsubstantiated claims regarding dietary supplements implemented in the Dietary Supplement and Health Education Act of 1994. The budget request includes total funding of $5.6 million for the Center for Food Safety and Applied Nutrition Adverse Events Reporting System (CAERS), of which approximately $1.5 million is for dietary supplements. The Committee provides an increase of $2 million for CAERS, bringing total funding to $7.6 million. These funds are to be used to ensure prompt identification of and response to adverse health events related to foods, including dietary supplements. FDA has indicated that the ability to identify and analyze specific components in ingredients, including botanical ingredients, is an essential component of research and regulatory programs directed at ensuring the safety and effectiveness of dietary supplements. The Committee provides $2 million in new budget authority for FY 2003 to continue the review of botanicals in dietary supplements. This work is being carried out by FDA in collaboration with the National Center for Natural Products Research.

Status and Outlook

The House Appropriations Committee approved H.R. 5263 (House Report 107-623) on July 11, 2002. The Senate Appropriations Committee approved S. 2801 (Senate Report 107-223) on July 25. Senator Byron L. Dorgan (D-ND) promised to offer a floor amendment to the Agriculture Appropriations bill that would allow U.S. banks to finance food sales to Cuba. This amendment is strongly opposed by the Administration and House Republicans. Until issues such as this are resolved, programs funded under the annual appropriations bill are left to operate at FY 2002 levels until January 11, 2003, under a stopgap spending law (Public Law 107-294).

For information on other FY 2003 appropriations legislation, see the following articles entitled:

• "21st Century Department of Justice Appropriations Authorization Act"
• "Department of Defense Appropriations, Fiscal Year 2003"
• "Appropriations for the National Institutes of Health, Fiscal Year 2003"
• "Treasury and General Government Appropriations Act, Fiscal Year 2003"