Wisconsin researchers Hannah Carey (left) and Joseph Kemnitz (right) met with Senator Herbert Kohl (D-Wisc.) during a July 11, 2001 “advocacy day” on Capitol Hill organized by the APS.
Public Affairs
As originally published in The Physiologist
Volume 45, Number 1, February 2002, page 14-19
Rats, Mice and Birds Rule Delayed Further
Activists’ Funding Remains Strong; PCRM, PETA Hide
Fundraising Costs
Congress Finalizes 2002 Budgets
AAHRPP Forming Human Accreditation Site Visit Teams
NIH Issues New Graduate Student Compensation Policy
107th Congress Tackles Domestic Terrorism
Senate Abandons Farm Relief Effort; “Puppy Protection”
Amendment Waits in Wings
Rats, Mice, and Birds Rule Delayed Further
As part of the USDA’s FY 2002 funding legislation the agency got the green light from Congress to begin consideration of whether to extend the Animal Welfare Act (AWA) regulations to rats, mice, and birds. The bill contains language permitting the USDA to begin the rulemaking process, but prohibits it from finalizing changes before the fiscal year ends on September 30, 2002.
This lifts the prohibition against such rulemaking that was included in last year’s USDA funding bill. Congress forbade the USDA from spending funds during FY 2001 on efforts to change the regulatory definition of “animal.” This blocked implementation of an out-of-court settlement of a lawsuit brought against the USDA by the Alternatives Research and Development Foundation (ARDF). The ARDF sued in 1999 to compel the USDA to extend its AWA regulations to rats, mice, and birds.
The issue is whether the wording of the AWA statute requires the USDA to issue regulations that cover rats, mice, and birds used in research, education, and testing. The statute, as amended by Congress in 1970, defines animal within the scope of the AWA as “any live or dead dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster, rabbit or other such warm-blooded animal, as the Secretary may determine is being used, or is intended for use, for research, testing, experimentation” and for other specified purposes. However, ever since implementing regulations for the 1970 amendments were adopted, the USDA has administratively excluded rats and mice bred for research as well as birds. (Wild-caught rats and mice used in research are covered by the regulations.)
The ARDF and several individuals petitioned the USDA in 1998 to end the exclusion. The petitioners argued that excluding these species was arbitrary and capricious, an abuse of agency discretion, and not in accordance with the law. These terms reflect the legal arguments commonly used in seeking to overturn federal agency actions. The ARDF’s co-petitioners included the head of an in vitro testing company, an ethicist, and two professors of biology and pharmacology who have developed alternative teaching and in vitro testing methods. The petitioners argued that the lack of USDA regulation of these species means that researchers are not required to consider alternatives to their use, and that this has caused damage to the petitioners’ financial and professional interests.
The USDA published the ARDF petition in the Federal Register on January 28, 1999, and asked for public comments. The USDA requested comments on several questions. These included whether the definition of animal should be revised to include laboratory rats, laboratory mice, and birds, or any of the three; whether the USDA’s Animal Care unit should regulate the care provided to these species “in all circumstances covered by the AWA or in certain circumstances, such as use in research only”; how many rats, mice, and birds might the USDA be asked to regulate if the change in the definition was made; and what should be the USDA’s enforcement priorities if the regulation of rats, mice and birds were added to its workload.
Dissatisfied with the agency’s failure to take more decisive action, the ARDF filed suit in March 1999, seeking to compel the USDA to regulate laboratory-bred rats and mice as well as birds. The Humane Society of the United States and the Animal Legal Defense Fund had brought a similar suit against the USDA in 1990. That case resulted in an initial ruling in favor of the plaintiffs in 1992, that was overturned on appeal in 1994 because the higher court found that none of the plaintiffs met the legal tests necessary to give them standing to challenge USDA enforcement of the AWA. However, while the 1999 ARDF suit was underway in the courts, a decision was handed down in a separate challenge to AWA regulations in which an individual plaintiff was granted standing to sue.
In June 2000, Judge Ellen Huvelle of the US District Court for the District of Columbia issued a ruling in favor of the ARDF in the suit. The National Association for Biomedical Research (NABR) sought to join the suit on behalf of research community interests in the case during the appeal phase. However, rather than appealing, the USDA began negotiating with the ARDF for an out-of-court settlement. NABR and others then sought to participate in the settlement talks, but these requests were denied. An out-of-court settlement was reached on September 25, 2000, and on October 6, Judge Huvelle agreed to dismiss the suit. According to the USDA Animal Care home page, the terms of the settlement agreement require the USDA to “initiat[e] and complet[e], in a reasonable time, a rulemaking on the regulation of rats, mice, and birds under the AWA.” The notice goes on to say, “Beyond this condition, final results and timeframes are not specified.” The settlement agreement also requires the USDA to make periodic reports to the plaintiffs’ attorneys on its progress.
It was this rulemaking that was put on hold during FY 2001. With the FY 2002 funding legislation in place, it is anticipated that USDA will proceed with the rulemaking process. Researchers should be prepared on short notice to respond to a request for comments on extending AWA regulations to rats, mice, and birds. In response to the USDA’s 1999 request for comments, the APS expressed concern that at major research institutions, USDA regulation of rats, mice, and birds duplicates the existing oversight protection provided by the PHS Policy on Humane Care and Use of Animals and voluntary accreditation through the Association for the Assessment and Accreditation of Laboratory Animal Care, International. AWA regulations would add no benefit in terms of improving animal welfare and would at the same time be administratively burdensome and costly for both the USDA and research facilities to implement.
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Wisconsin researchers Hannah Carey (left) and Joseph Kemnitz (right) met with Senator Herbert Kohl (D-Wisc.) during a July 11, 2001 “advocacy day” on Capitol Hill organized by the APS. |
Activists’ Funding Remains Strong;
PCRM, PETA Hide Fundraising Costs
Two prominent animal activists set up a foundation in 1993 to undertake fundraising on their organizations’ behalf. Physicians Committee for Responsible Medicine (PCRM) founder Neal Barnard and People for the Ethical Treatment of Animals (PETA) President Ingrid Newkirk comprise a controlling interest of the board of the Foundation for the Support of Animal Protection (FSAP).
The existence of this foundation was one of the most striking revelations in the 12th annual “Who Gets the Money?” feature published in
Animal People in November 2001. Using information from IRS financial disclosure statements of the three organizations,
Animal People concluded “the major purpose of [FSAP] appears to be to enable PETA and PCRM to evade public recognition of their relationship and the real extent of their direct mail expenditures.”
Animal People is an independent monthly publication that covers animal advocacy and protection activities. It regularly reports on extravagant salaries, inappropriate uses of funds, and excessive fundraising costs by activist organizations. The annual “Who Gets the Money?” investigative report is compiled from financial data that nonprofit organizations must file annually with the IRS. The current edition covers 148 “animal protection charities” operating in the US and abroad along with eight “opposition” groups, such as Americans for Medical Progress (AMP) and the National Association for Biomedical Research (NABR). Information comes mainly from IRS Form 990 filings for the year 2000.
In addition to disclosing the existence of FSAP, Animal People documented the continuing success of self-appointed animal advocacy organizations in amassing financial support for their activities. Some groups that oppose the use of animals in research receive donations through the Combined Federal Campaign or local United Way organizations. For more information, see “Are You Giving Money to Undermine Medical Research?”
(The Physiologist: Vol. 44, No. 6, December 2001, p. 414.) This article is also available on line at
http://www.the-aps.org/pub_affairs/leg_act_cntr/news/money.htm.
The Animal People report is intended to assist donors sympathetic to animal-oriented causes to determine the financial strength of these organizations’ programs; how much of their resources are being used for fundraising and other overhead costs; and whether they are accumulating assets or providing services with the funds they receive. In assessing the proportion of budget utilized for overhead costs,
Animal People uses a benchmark developed by the now-defunct National Charities Information Bureau (NCIB). The NCIB recommended that charities spend at least 60% of their budgets on programs excluding direct mail appeals. According to
Animal People, “This standard is stricter—and more indicative of priorities—than IRS rules, which allow charities to call some direct mail costs ‘program service’ under the heading of ‘public education.’” The accompanying table shows budget, program expenditures, assets, and overhead claimed as well as
Animal People’s estimation of adjusted overhead percentage that includes the cost of public education mailings that also contained requests for donations.
FSAP was incorporated in 1993. Its sole purpose, according to its IRS Form 990 is to “Provide support to various charitable, educational, and scientific organizations specified in the Corporation’s Certificate of Incorpo-ration.” These organizations are PETA and four of its subsidiaries, the PCRM, and the Washington Humane Society. The FSAP board consists of three people: the PCRM’s Barnard (President), PETA’s Newkirk (Director), and Nadine Edles (Secretary). Edles’ address as filed with the IRS is the same as the PCRM’s.
Animal People further reports that “in fiscal years 1999 and 2000 combined, FSAP raised $7,454,914 in donations and program service revenue, paying the mortgage on the PETA headquarters and leasing the site to PETA.” The Foundation “apparently did mailings in the names of the beneficiaries” and paid $432,524 to PCRM in 2000. It spent $3,487,585 or 89% of its budget, on fundraising and administration and paid salaries totaling $2,102,216.
The bottom line, according to Animal People is that “If FSAP, PETA, and PCRM were seen as a single fundraising unit, as the existence and activities of FSAP indicates they should be, their spending in 1999 came to $20,391,253; their declared overhead came to $4,053658, 20% of budget; and their overhead if the cost of all direct main containing fundraising appeals were counted as fundraising costs came to $9,633,083: 47% of budget.” In the year 2000, their combined spending was $22,756,984, with declared overhead of $5,778,242 (25% of budget), and the overhead total adjusted to include direct mailings with fundraising appeals came to $9,168,478 or 40.3% of budget.
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Congress Finalizes FY 2002 Budgets
After months of debate and distractions, Congress completed action on fiscal year (FY) 2002 funding for the National Institutes of Health (NIH) on December 20. Funding for the National Science Foundation (NSF), Veterans Research and the National Aeronautics Space
Administration (NASA) was approved in November for the fiscal year that began October 1.
On December 18, House and Senate conferees approved the conference report for the Labor-HHS-Education spending bill, which included funding for NIH. The House approved the measure on December 19, and the Senate followed the next day before Congress adjourned for the year.
Under the agreement, NIH receives a funding increase of $2.99 billion in FY 2002, or 15 percent over its FY 2001 budget. This will bring the total NIH budget to $23.28 billion.
Nevertheless, the agency’s net funding level in FY 2002 decreases due to interagency transfers for administrative and evaluation costs. Under the agreement, $100 million will be transferred to the Global AIDS-Malaria-TB Fund and $297 million will be transferred for studies at other HHS agencies. After these deductions are calculated, the net total for NIH is $22.88 billion, an increase of $2.87 billion or 13.9 percent over FY 2001. An increase of this magnitude is particularly notable given the focus on addressing concerns from the September 11 attacks and the need to pursue the war on terrorism.
The accompanying table outlines appropriations for individual NIH institutions that were provided by the Senate Labor-HHS-Education Sub-committee.
On November 6, 2001, the conferees for the VA/HUD Appropriations Committee approved funding for NSF, as well as the Veterans Medical Re-search programs and NASA. President Bush signed the bill into law on November 26, 2001 (P.L. 107-73) In the end, Congress adopted the $4.8 billion dollar increase for NSF that was approved by the House. This appropriation was an 8.2 percent increase over FY 2001 and a boost of $365 million over last year’s budget and $316 million over President Bush’s request respectively. Included in this are:
While NSF received a substantial increase, VA medical research did not fare quite as well. Veterans Medical and Prosthetic Research was increased by $20 million over FY 2001, bringing FY 2002 funding to $371 million, an increase of 5.6 percent.
For FY 2002, NASA’s overall budget is $14.7 billion, a 3.5 percent increase over FY 2001. The newly created Office of Biological and Physical Research, which now houses many of NASA’s life sciences programs, will be funded at $714 million in FY 2002. The biology research budget within the office is expected to be $172 million.
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AAHRPP Forming Human Accreditation
Site Visit Teams
The Association for the Accreditation of Human Research Protection (AAHRPP) is actively recruiting individuals to participate in site visits to institutions seeking accreditation for their human research protections programs, according to Marjorie Speers, Executive Director of this new organization.
Researchers are encouraged to sign up to become site visitors. Accreditation will have an enormous impact on the conduct of human subject research. It is very much in the interest of the research community to be involved in developing approaches to apply regulations and standards.
According to the Washington Fax, an online daily science policy publication, AAHRPP is seeking institutional review board (IRB) professionals, researchers familiar with federal regulations, research deans and administrators, public representatives and others involved in human research protection programs to comprise its site visit team.
AAHRPP was incorporated in April 2001 and published a draft set of accreditation standards for comment on October 15, 2001. Initial site visits were scheduled for December 2001 to evaluate human research protections in NIH’s intramural research program. Comments on the draft standards along with information gained from the test visits will be used in formulating the final standards. According to Speers, AAHRPP expects to continue piloting its site visitor procedure by examining Clemson University in South Carolina; Summa Health System in Akron, Ohio and “one or two more” institutions to be determined later. Once the pilot site visits are completed, Speers predicted, “it’s very possible that by the end of next year, we will be able to announce our first accredited institutions.”
The site visit process is the second step toward AAHRPP’s accreditation. The first step is for institutions to undertake a self-assessment of their existing human research protection measures using the standards laid out by AAHRPP. It then submits its program description with an application. After the site visit is completed, AAHRPP representatives will put together a report for its council on accreditation. The council will then recommend to AAHRPP’s board of directors one of three levels of accreditation: full, provisional or none. This accreditation will be good for three years, but the organization is considering allowing institutions to pay annually so the fee can be built into budgets.
More information about AAHRPP and its activities can be found online at http://www.aahrpp.org.
NIH Issues New Graduate Student Compensation Policy
The National Institutes of Health (NIH) issued a new policy concerning compensation for graduate students supported by NIH research grants and cooperative agreements. The new policy, which will apply to future awards, ties the maximum amount of support for a graduate student on an NIH-funded research grant or cooperative agreement to the stipend level of first-year National Service Award (NRSA) post-doctoral students in effect when the award is made. Compensation includes salary or wages, fringe benefits, and tuition reimbursement.
The current entry-level NRSA stipend is $28,260 but is expected to increase as part of a plan NIH announced in spring 2001 to raise first-year NRSA stipends to $45,000 over the next four to five years. This plan was a response to the August 2000 recommendations of a National Research Council (NRC) report on National Needs for Biomedical and Behavioral Scientists. The NRC report called for significant increases in graduate and post-doctoral student salaries.
NIH’s new graduate student compensation policy was announced in the December 10, 2001 issue of the NIH Guide to Grants and Contracts. It applies to graduate students supported by NIH grants and cooperative agreements but not to students directly supported by NRSA training awards. The policy will apply to all future new and competing awards. According to the notice, NRSA stipend levels are intended to “offset the cost of living during the period of training and are not considered equivalent to salaries or other forms of compensation provided to individuals supported on research grants.” Despite that disclaimer, the NIH goes on to say, “Nevertheless, the entry-level postdoctoral NRSA stipend provides a useful benchmark for an award amount that approximates a reasonable rate of compensation for graduate students.
“In general, graduate student compensation will not be considered reasonable if in excess of the amount paid to the first-year postdoctoral scientists at the same institution performing comparable work,” the NIH cautioned.
107th Congress Tackles Domestic Terrorism
As the 107th congressional session came to an end, legislators were faced with an issue that had not presented itself in the history of the Republic—a foreign terrorist attack on US soil. While the clear priority is to combat terrorism from abroad, a few legislators are also concerned with violent groups with domestic agendas.
On November 2, 2001 several members of Congress sent a letter to environmental groups urging them to reject the actions of eco-terrorist groups. “We are calling on you and your organization to publicly disavow the actions of eco-terrorist organizations like Earth Liberation Front (ELF) and Animal Liberation Front (ALF),” Congressmen Scott McInnis (R-CO), Chairman of the House Sub-committee on Forests and Forest Health, James Hansen (R-UT), Chair-man of the House Resources
Committee and several congressional colleagues wrote. “Eco-terrorist cells like these have exacted a substantial financial and personal toll on scores of individuals and enterprises in all corners of the United States,” they stated.
Groups such as ALF and ELF have been responsible for millions of dollars worth of damage to university labs, research facilities and personal businesses. In fact, the FBI believes that eight out of 12 suspected domestic terrorist incidents in the US in 1999 were caused by the ALF or ELF.
As recently as this October 30, 2001 ELF claimed responsibility for the firebombing of a US Bureau of Land Management wild horse corral in California. According to Congressman McInnis’s letter, ALF has been equally destructive with an attack on a New Mexico biomedical research lab that caused nearly $1 million in damage.
In calling on environmental groups to disavow the actions of the terrorist organizations, McInnis likened the search for domestic terrorist groups to the war that is currently being conducted following the September 11 attack. In a press release accompanying the release of his letter, he urged environmental groups to help in the fight. “In probing the threat of terrorism, it only stands to reason the Congress should probe the threat of eco-terrorism as well,” McInnis said. “It is crucial that key environmental organizations join with us in combating these underground eco-terrorist organizations.”
Representative McInnis also called for a series of hearings this year beginning February 12. He plans to use these hearings to probe the infrastructure of the ALF and ELF. One of the witnesses scheduled to testify is Craig Rosebraugh, who until recently was a spokesman for the ELF. The committee issued a subpoena to Rosebraugh in November 2001 after he refused previous requests to testify voluntarily.
Because Rosebraugh is being compelled to testify, activists are calling for demonstrations in Washington. One activist urged others on an e-mail listserv to “follow your conscience and take…any action necessary to stop the destruction of animals, humans, and the natural environment.”
Other members of Congress have expressed similar concerns about the violent tendencies of some domestic groups. In the first session of the 107th Congress, Congressman George Nethercutt (R-WA) introduced the Agroterrorism Act of 2001—designed to deter domestic terrorism through increased university security funding and stiffer criminal penalties. Similarly, Congressman Felix Grucci (R-NY) introduced the Hands Off Our Kids Act of 2001. This legislation was devised as a measure to prevent groups, such as ALF and ELF, from recruiting unsuspecting young adults from participating in violent and illegal activities.
Senate Abandons Farm Relief Effort;
“Puppy Protection” Amendment Waits in Wings
An amendment to farm relief legislation that could cause problems for research with dogs was introduced in the closing days of the first session of the 107th Congress. The provision, sponsored by Senators Rick Santorum (R-PA) and Richard Durbin (D-IL), was intended to help puppies bred as pets but would also affect dogs bred and used in research. However, prior to adjournment, the Senate was forced to abandon consideration of the farm bill for the time being after Senate Democrats tried three times without success to secure the votes to end a threatened Republican filibuster of the bill. Some observers expect the Senate to make another effort to pass a farm bill in the spring.
The amendment of concern to the research community was based upon Sen. Santorum’s “Puppy Protection Act” (S. 1478). Sen. Santorum introduced this measure earlier last year to improve conditions for puppies bred and raised in so-called “puppy mills.” Although intended to end undesirable practices among breeders who sell to commercial pet stores, the changes called for in the legislation would have unintended negative consequences on dogs raised and used in research.
This legislation would establish precise and rigid “engineering standards” for the breeding and socialization of dogs. These provisions would be based upon the recommendations of “animal welfare and behavior experts” and would override the current system of outcome-oriented performance-based care standards that permit veterinarians trained in laboratory animal medicine to determine how best to ensure the welfare of the dogs under their care. The American Veterinary Medical Association noted in a letter to Senator Santorum that there is “a minimal amount of published, peer-reviewed scientific research available on which engineering standards could be comfortably based.”
The amendment would also establish harsh enforcement sanctions with poorly defined criteria for imposing them. It calls for mandatory license revocation when three violations of the Animal Welfare Act are cited over an eight-year period. However, the amendment does not define the severity of violations that would trigger the “three strikes, you’re out” provision, nor does the AWA itself make such distinctions. In a letter to Senator Santorum, APS President John Hall expressed concern that these new sanctions would cause confusion and lead to increased demand for administrative and judicial review whenever USDA inspectors cited any violation. “This could create a logjam of appeals that may overwhelm the agency’s animal welfare enforcement resources,” Hall wrote.
Having made their concerns known to Senator Santorum, researchers are hopeful that before the Puppy Protection Act is brought to the floor either as freestanding legislation or as an amendment to another bill, the offending provisions will be modified or removed.
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