Public Affairs
House Proposes 2.6% Increase for NIH; New Grants Would Decrease by 460

USDA Reviews Status of Rats, Mice and Birds Not Bred for Research

Society for Neuroscience Signs onto DC Principles

House Proposes 2.6% Increase for NIH 
New Grants Would Decrease by 460

     NIH would receive an increase of 2.6% in FY 2005 under the proposal approved July 8 by the House Appropriations Subcommittee on Labor-HHS-Education. The $727 million increase in the Labor-HHS-Education proposal for the fiscal year that begins October 1 would bring the NIH budget to $28.5 billion, the level proposed by President Bush. 
     According to the NIH, with a 2.6% increase the agency would have to make significant reductions in its activities. For example, NIH could fund about 460 fewer new and competing grants than in the current fiscal year, or else it would have to reduce grant size below the level needed to keep pace with biomedical inflation. 
     The subcommittee’s recommendation was expected to be ratified the following week by the full House Appropriations Committee. The Senate Appropriations Subcommittee had also originally planned to mark up its bill on July 8, but that timetable has slipped.
      It was recognized from the outset that this would be a difficult funding year for medical research funding. The President’s announced budget priorities were to provide the US military with the funds needed for the wars in Iraq and Afghanistan and to fund programs needed to enhance homeland security. Other domestic spending programs were given a lower priority, and the President, as well as the Republican leadership in Congress, made clear they intended to keep domestic spending tightly in check. 
      Federal funding decisions are made in a two-stage process that begins with Congressional approval of a broad budget plan, followed by the actual appropriations bills. This year the effort to agree on a congressional budget plan dragged on until mid-May, and the final version allowed a total increase of only $3.1 billion for all domestic discretionary programs unrelated to homeland security. This resulted in very low spending “allocations” for the appropriations committees. 
      In this environment the House could do no better than to adopt the President’s budget plan for the NIH. Biomedical research advocates are hopeful that Senate Labor-HHS-Education Appropriations Subcommittee Chairman Arlen Specter (R-PA) will take advantage of the greater legislative flexibility allowed in the Senate and can do better. Specter, a long-time NIH champion, has indicated that he will try to provide additional funds.
     In late June and early July FASEB sought to bolster Congressional support by asking scientists who lived in the districts of key Members of Congress to urge their Representatives to provide the highest possible funding allocation for the NIH. FASEB legislative alerts may be found at http://capwiz.com/faseb/home/. 

USDA Reviews Status of Rats, Mice and Birds Not Bred for Research
     The USDA announced June 4, 2004 that it has revised its regulatory definition of animal to exclude rats, mice, and birds bred for research. This change was mandated in 2002 by the Helms amendment to the Animal Welfare Act (AWA). The agency also announced that it will extend AWA coverage to all other birds and that it is considering whether to develop new regulatory standards for non-purpose-bred rats and mice.
     Researchers who use wild, caught, or other non-purpose bred rats, mice, or birds may wish to provide comments to the USDA on how these changes could affect their work.
     The AWA is the law that requires the USDA to regulate the breeding, transportation and care of warm-blooded animals used in research, teaching, testing, and exhibition. However, there are a number of exceptions. The definition provided in the law lists certain species and activities that are specifically included or excluded from coverage, and the Secretary of Agriculture also has the authority to decide whether to regulate other species. 
Starting in the early 1970s, the USDA used its administrative discretion to exclude rats and mice bred for research from the purview of the AWA. It also excluded all birds. In 1999, the Alternatives Research and Develop-ment Foundation and several other plaintiffs filed suit against the USDA to end these exclusions. However, before the suit went to trial, the USDA reached an out of court settlement in which it agreed to go through a formal rule-making process to determine whether and to what extent the agency should regulate these species. 
     When the USDA-ARDF settlement agreement was announced in October 2000, many in the research community objected. Concerns were expressed that USDA regulations would add unnecessary bureaucratic red tape to the oversight protection that the vast majority of these animals already receive. Congress intervened in 2000 by placing a one-year moratorium on USDA rulemaking to revise the AWA definition of “animal.” In 2002 Congress went further by passing an amendment to the AWA sponsored by Sen. Jesse Helms (R-NC) that changed the definition of animal in the AWA to exclude rats, mice, and birds bred for research. The eventual result of this was the notice that the USDA published in the Federal Register on June 4, 2004, amending the regulatory definition of “animal.” 
     On June 4 the USDA also published an Advance Notice of Proposed Rulemaking (ANPRM) requesting comments on two sets of issues related to revising AWA regulations and standards for birds, rats, and mice. USDA said in the notice that it intends to “extend enforcement of the AWA to birds other than birds bred for use in research” and asked for comments on what standards should be applied. In addition, APHIS asked for comments on whether the agency should develop specific standards for the handling, care, treatment and transportation of non-purpose bred rats and mice. These animals were already covered under the AWA, but their care has been governed by the general standards that apply to warm blooded animals not otherwise covered in one of the species-specific sections of the regulations. 
     USDA acknowledged that oversight mechanisms are already in place for the vast majority of rats, mice, and birds—whether purpose-bred or not—that are used in research. The agency noted in the ANPRM that in addition to the “protections afforded by the standards and regulations” of the AWA, “the vast majority of animals used in biomedical research, including birds, rats, and mice, are provided with oversight by [the] Public Health Service (PHS) of the US Department of Health and Human Services, through voluntary accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), or both.” 
     When Congress changed the AWA definition of animal in 2002, the rationale offered was to avoid burdensome and duplicative regulation of purpose-bred rats and mice. However, USDA remains bound by its settlement agreement with the ARDF. Jerry DePoyster, a Senior Veterinary Medical Officer with the USDA’s Animal and Plant Health Inspection Service (APHIS) confirmed that the June 4 proposals were developed as a result of that agreement even though the proposals now involve only rats, mice, and birds that were not bred for research.
     Researchers who use wild-caught or other non-purpose bred rats, mice, or birds are encouraged to provide comments to the USDA concerning the numbers of animals used, and what standards should be applied concerning their care, handling, transportation, and use. Anecdotal evidence suggests that while relatively few non-purpose-bred rats, mice, and birds are used in research, they come from a wide variety of orders, families, genera, and species. If data can be provided demonstrating that this is the case, it may affect the USDA’s decisions about whether to promulgate species-specific standards.
     The June 4 notice entitled “Regulations and Standards for Birds, Rats, and Mice” is available on the USDA website at http://www.aphis.usda.gov/ac/ under “Federal Register Notices.” The notice includes background information and a list of topics for which comments are sought. Responses may be submitted via postal mail, through a web form or by email. Although the end of the comments period was announced as August 3, 2004, the USDA is expected to grant a 90 day extension of the comment period until approximately November 1, 2004.

Society for Neuroscience Signs onto DC Principles

     In June, the Society for Neuroscience (SfN) became the 52nd non-profit publisher to sign onto the DC Principles for Free Access to Science, a declaration of “free access” publishing principles launched in March and backed by APS, FASEB, the American Academy of Pediatrics, American Cancer Society, and the American Diabetes Association, among other not-for-profit medical and scientific publishers.
     Other recent signatories include the International & American Associations for Dental Research, the American Society of Tropical Medicine and Hygiene, and the Anthropology Review Database.
     “The fact that large societies like SfN are signing on even after the initial announcement in March is proof positive that the scientific community realizes the value of our model,” DC Principles spokesman and APS Executive Director Martin Frank said. “They recognize it is one that is worth speaking out for.” 
At the time of the launch, then-FASEB president Robert D. Wells noted that, “during the past several years scientific journals have been extraordinarily innovative, and as a result access to the research literature is greater today than ever.” 
     The DC Principles outline the commitment of not-for-profit publishers to work in partnership with scholarly communities such as libraries to ensure that these communities are sustained, science is advanced, research meets the highest standards, and patient care is enhanced with accurate and timely information. For more information on the DC Principles, go to http://www.dcprinciples.org. 

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