Public Affairs

As originally printed in The Physiologist, 
August 2001, Volume 44, Number 4 
Page 196

House Acts to Extend Moratorium on USDA Rodent, Bird Regulations
NIH Funding Increase Awaits Action
VA-HUD Subcommittee Marks Up Spending Bill
Congressman Nethercutt Introduces Antiterrorism Bill
Stem Cell Debate Heats Up

House Acts to Extend Moratorium on USDA Rodent, Bird Regulations
    On July 11 the House passed its version of the FY 2002 agriculture appropriations bill that included language to extend for another year a moratorium on USDA regulation of rats, mice, and birds. The provision bars the agency from spending funds to change the definition of “animal” used in the Animal Welfare Act regulations. House Agriculture Appropriations Subcommittee Chairman Henry Bonilla (R-TX) included the language to extend the moratorium. Subcommittee member Rep. George Nethercutt, Jr. (R-WA) was instrumental in making certain that the language remained in the bill during floor debate in the House. The Senate Agriculture Appropriations Subcommittee was expected to take up the language July 17. The moratorium will expire on September 30, 2001 unless Congress acts to renew it.
    Last year Sen. Thad Cochran (R-MS), who was then the chairman of the Senate Agriculture Appropriations Subcommittee, added this language in conference to block the USDA from proceeding with an out-of-court settlement agreement that it had reached with the Alternatives Research and Development Foundation (ARDF), a group affiliated with the American Anti-Vivisection Society. With the change of majority in the Senate, Cochran became the senior or ranking Republican member of the Subcommittee, and Sen. Herbert Kohl (D-WI) is the new chairman.
    The ARDF and several individual plaintiffs had sued the USDA in 1999 to force the agency to regulate rats, mice, and birds under the Animal Welfare Act (AWA). The language of the AWA requires the USDA to regulate six specific animal species (dogs, cats, nonhuman primates, guinea pigs, rabbits and hamsters) and gives the Secretary of Agriculture discretion to add regulations for other species of warm blooded animals used in research. The USDA has never sought to regulate rats, mice, and birds, nor has Congress ever instructed the agency to do so. However, animal activists have long wanted to change that policy.
    The current situation began when the ARDF and several individuals petitioned the USDA to regulate rats, mice, and birds, arguing that as commonly used species of laboratory animals they ought to fall under the AWA. (Purpose-bred laboratory rodents account for perhaps 95% of the animals used in research.) The USDA published a Federal Register notice in on January 28, 1999, asking for public comments on the petitioners’ request. The USDA noted that most of the animals in these species that are used in biomedical research are found in institutions that use the National Research Council’s Guide for the Care and Use of Laboratory Animals. The Guide requires that research protocols be given prior ethical review by an Institutional Laboratory Animal Care and Use Committee and that all animal use be appropriate and humane. The USDA also noted that the size of the task was a consideration since its animal welfare enforcement program would be hard-pressed to conduct inspections of a large number of additional animals.
    In its comments, the APS opposed USDA regulation of rats, mice, and birds at major biomedical research institutions as both unnecessary and burdensome. On the one hand, research with these animals at institutions that are federally funded or accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) already conforms to the strictures of the Guide for the Care and Use of Laboratory Animals. The addition of USDA standards under the AWA would not improve the quality of care those animals receive. On the other hand, AWA requirements would significantly add to compliance paperwork and would raise the costs of using these animals in research.
    During the comment period on the Federal Register notice, the ARDF filed suit to compel the USDA to regulate rats, mice, and birds. The first issue that had to be resolved was whether the plaintiffs were entitled to challenge government regulations. Until recently, no individual had ever been granted standing to sue the government under the Animal Welfare Act. That changed with a 1998 ruling by the US District Court of Appeals for the DC Circuit in a case involving a challenge to USDA’s regulations for the environmental enrichment of nonhuman primates. Even though that case was finally decided against the plaintiff on its merits, the precedent was established. 
    In June, 2000, US District Court Judge Ellen S. Huvelle granted one of the individual plaintiffs in the rats, mice, and birds legal standing, meaning that this plaintiff had passed the legal threshold test and would be allowed to sue the USDA over how it was enforcing the AWA with respect to rats, mice, and birds. The National Association for Biomedical Research (NABR) and Johns Hopkins University sought to join the USDA as defendants in the suit to challenge the plaintiff’s standing on appeal. However, the court held this request in abeyance because, rather than continuing to fight the suit, the USDA entered negotiations with the ARDF to settle it. The research community also sought to join the settlement talks and was again excluded. 
    In late September the USDA and ARDF reached an out-of-court settlement in which the USDA promised to “initiate and complete” the rulemaking process with respect to the regulation of rats, mice and birds, and the ARDF agreed to withdraw its suit. Although the USDA insists that the outcome of the rulemaking is not a foregone conclusion, having been excluded from the entire process leading up to the settlement, the research community sought congressional intervention. The University of Mississippi appealed to then-Chairman Cochran for assistance, and he responded by putting language into the USDA’s funding legislation to block the settlement from taking effect. 

NIH Funding Increase Awaits Action
    It is generally expected that Congress will wait until after its August recess to draft fiscal year 2002 spending plans for the NIH. This is because the House and Senate Appropriations Subcommittees that handle this legislation were given insufficient spending authority to provide increases for the priority programs under their jurisdiction, which include the NIH and education initiatives. 
    President Bush requested $23.2 billion for the NIH, an increase of $2.8 billion or 13.4% more than in FY 2001. Although this was a generous recommendation, it is still $500 million below the amount needed to keep the NIH on the path to a five-year doubling. The APS supports the FASEB consensus conference recommendation for a $23.7 billion NIH budget in FY 2002.
    Infusions of spending authority at the last minute have become routine in Washington. However, there is concern on Capitol Hill because early reports indicate that government revenues may be lower than expected as a result of the tax cut and a slowdown in the economy. If the projected budget surplus turns out in fact to be a deficit, it would make it more difficult to provide the additional funds.
    In addition, The Washington Fax reported on July 16 that the $2.8 billion increase was actually only about $2.3 billion because of funds that may be administratively transferred out of the NIIH into other HHS programs. It has been common practice for the Secretary of HHS to transfer up to 1% of funds from one agency to others such as the Agency for Healthcare Research and Quality and the National Center for Health Statistics. That authority is frequently exercised with respect to the NIH because it has the largest budget among the HHS discretionary programs. 
    However, the size of the transfers coming off the top of the NIH budget this year is drawing attention. According to The Washington Fax, some $469 million of the announced $2.8 billion NIH increase may end up in other programs. Because this would exceed the 1% transfer authority, the administration is also asking to increase the allowable amount to 2%. This year funds would be transferred not only for AHRQ and NCHS but also to help support data collection efforts at the Substance Abuse and Mental Health Services Administration and work at the HHS Office of Policy Research. 

VA-HUD Subcommittee Marks Up Spending Bill
    On July 10, the House Appropriations Committee, Subcommittee on Veterans Affairs and Housing and Urban Development (VA-HUD) approved an FY 2002 spending bill that provided the National Science Foundation with a substantial increase over the President’s original budget request.    
    The FY 2002 spending bill increased NSF funding by 9% to $4.8 billion dollars. The President’s budget request had originally proposed only a 1% increase for NSF. The bulk of this money—$3.64 billion—would go to research, with $885 million to be used for education and $135 million to be used for equipment. While this 9% increase is much needed and appreciated, it falls short of the $5.1 billion (15%) increase that FASEB had advocated for in its FY 2002 consensus conference.    
    Although there was good news for the NSF, VA Medical Research received only a small increase. VA Medical and Prosthetics Research would be funded at $360 million or a 2.9% increase over FY 2001. This funding increase falls $35 million short of FASEB’s recommendation of $395 million for FY 2002. The VA-HUD subcommittee also created a new VA appropriation line item for a “Facility Rehabilitation Fund.” Of the $300 million allocated for this line item, $30 million must be spent on research facilities.
    The subcommittee also recommended $685.9 million for the Office of Biological and Physical Research, which is an increase of $325.0 million over the President’s budget request. This recommendation includes an increase of $318.6 million for space station research consisting of a transfer of $283.6 million. The committee instructed NASA to move all funding for space station research to the Office of Biological and Physical Research to help ensure that it be used only for research purposes. The FASEB consensus conference urged NASA to enhance the quality, depth and breadth of its Biology Research Enterprise through the new Office of Biological and Physical Research. It is not clear what the actual biological research budget will be. 

Congressman Nethercutt Introduces Antiterrorism Bill
    A recent wave of attacks on Washington state research facilities has prompted Congressman George Nethercutt (R-WA) to introduce the Agroterrorism Prevention Act of 2001, as a way to deter future acts of violence. Speaking to reporters after introducing the legislation on June 5th, Nethercutt said, “these environmental terror groups are getting more aggressive-much more aggressive-and I think we need a strong response…My greatest fear is that someone is going to get killed.”
    Specifically, the Agroterrorism Prevention Act (APA) expands the Animal Enterprise Protection Act, by making terrorist actions against agricultural research facilities a federal crime. The new legislation provides deterrence by increasing the minimum mandatory sentence for fire bombings and providing prosecutors the discretion to seek the death penalty if such a crime results in someone’s death.
    A major problem facing law enforcement officials is the difficulty of tracking the perpetrators. The two lead animal and environmental terrorist factions, the Animal Liberation Front and the Environmental Liberation Front, work in small factions without a centralized structure. To aid law enforcement officials Congressman Nethercutt’s legislation would establish a National Agroterrorism Incident Clearinghouse. This clearinghouse will help authorities track and monitor violent animal and eco-terrorist groups by collecting and maintaining information on specific incidents; collating and indexing this information for purposes of cross referencing, and providing this information to investigators at a crime scene.
    For universities, a major target of terrorists, the legislation provides help. There would be award grants on a competitive basis to colleges and universities for technical assistance, threat and risk assessments and other activities designed to improve security. Some of these activities include, developing a comprehensive security report for universities, colleges and non-profit organizations which examines the threat posed by animal and plant enterprise terrorism on research activities, education on prevention, facility hardening, and coordination with law enforcement.
    The APA aims at preventing and punishing future acts of harm rendered by animal and environmental rights groups but it is not the only piece of legislation in the 107th Congress dealing with this issue. On May 15, 2001, Congressman Felix Grucci (R-NY) introduced the Hands Off Our Kids Act of 2001. Congressman Grucci’s bill aims to prevent animal and environmental groups from recruiting young adults to participate in violent and illegal activities. The legislation would allow the Attorney General to establish and implement a policy within the Department of Justice to identify organizations that recruit adolescents to participate in violent and illegal activities related to the environment, animal rights or any other matter the Attorney General considers being appropriate. It also would direct the Attorney General to develop a national program within the Office of Juvenile Justice and Delinquency Prevention (OJJDP), which identifies organizations that recruit juveniles to participate in violent and illegal activities. This measure would also authorize the Administrator of OJJDP to award grants to States, and State and Local Educational Agencies, to develop, establish, or conduct programs designed to combat and educate juveniles about these criminal organizations. 

Stem Cell Debate Heats Up
    With a decision by the Bush Administration pending, federal funding of human embryonic stem cell research is taking center stage on the Washington political theater. President George W. Bush has said that a decision could come by mid to late summer, although there is no indication that a resolution is near.
    On June 27, the NIH released a private report to Secretary of Health and Human Services Tommy Thompson based on a literature survey of over 1,200 scientific publications. While the report made no direct determination about the relative benefits of adult stem cells versus embryonic stem cells, it did refer to findings suggesting that adult stem cells may be more limited than cells of embryonic origin. The report said that for human stem cell research to advance to the stage of clinical investigation, a “virtual safety net composed of core set of safeguards is required. . . Whether embryonic stem cells are of embryonic, fetal or adult origin, donor sources are must be carefully screened.” Additional protections advocated in the draft include “proof of concept, toxicity testing and evaluation of proliferative potential in animal models.” In particular, the report suggested human stem cells be transplanted into animal models of human disease and that animal transplantation models be used to help address the question of whether embryonic human stem cells are “more robust and durable” than adult stem cells.
    The controversy here revolves around the use of stem cells derived from human embryos since the embryos themselves must be destroyed in the process. There is a federal ban on embryo research, but the Clinton administration sought to work around it. Although federal funds may not be used to derive stem cells, the Clinton administration had put into place a policy that would allow federal researchers to conduct research with stem cell lines derived by others from “spare” embryos that remain at the end of fertility treatments. The first round of such grants were reviewed this past spring, but there was some apprehension that the Bush administration would refuse to permit the research to go forward.
    Many Democrats and moderate Republicans favor embryonic stem cell research, but a number of unlikely advocates have also come forth, including some politicians who have consistently opposed issues widely seen as relating to abortion. Key among this group of stem cell research supporters has been Senator Orin Hatch (R-UT), one of the Senate’s most pro-life members. “Stem cell research facilitates life,” according to a Hatch statement. “Abortion destroys life; this is about saving lives.” Other anti-abortion Republicans who have added their support for federal funding of embryonic stem cell research include Sens. Strom Thurmond (R-SC), Gordon Smith (R-OR), John McCain (R-AZ), and Representative Randy “Duke” Cunningham (R-CA). Nancy Reagan, wife of former Republican President Ronald Reagan, who now suffers from Alzheimer’s, sent a letter urging President Bush to allow federal funding of this research to proceed.
    While there is a core set of Republicans fighting for this research, there is an equally adamant group who oppose it. House Majority Leader Richard Armey (R-TX), Majority Whip Tom Delay (R-TX), and Republican Conference Chairman J.C. Watts (R-OK) said in a statement, “The federal government cannot morally look the other way with respect to the destruction of human embryos, then accept and pay for extracted stem cells for the purpose of medical research.” 
    Reports from the White House say that President Bush is grappling with this issue both politically and personally. According to aides, Bush has immersed himself in the moral and ethical issues at stake as well as the science. The Washington Post reports that he is “clearly searching for some kind of compromise that not only takes into account the strong political crosscurrents at play, but also fits his own values.” It now appears unlikely that a decision will be made before the end of July as advisers now say they do not expect Bush to make up his mind until his July 23 visit with Pope John Paul II.

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