Public Affairs

As originally published in The Physiologist
Volume 45, Number 4, August 2002, page 223-227

“IACUC 101” at EB 02; EB 03 Follow-on Planned 
President Proposes Homeland Security Department
Bioterror Protection Bill Signed
Germany Writes Protection for Animals Into its Constitution
Congressional Appropriations Season Heats Up
NSF Doubling Effort Gets Boost
Senate Avoids Cloning Vote

“IACUC 101” at EB 02; EB 03 Follow-on Planned

Some 60 scientists participated in a four-hour symposium on the workings of the Institutional Animal Care and Use Committee (IACUC) that was offered as part of Experimental Biology 2002. “Everything You Ever Wanted to Know About the IACUC But Were Afraid to Ask” was organized by the APS Animal Care and Experimentation Committee (ACE) with support from the NIH Office of Laboratory Animal Welfare (OLAW). The session was co-sponsored by the American Society for Pharmacology and Experimental Therapeutics, American Society for Nutritional Sciences, American Association of Immunologists, American Association of Anatomists, and the Federation of American Societies for Experimental Biology.
A similar program entitled “IACUC 101 for Scientists” is planned for EB 2003 in San Diego. That symposium will take place on Friday, April 18, 2003, from 1-5 pm. Further information and a registration form will be included in the EB 2003 Call for Papers.

“Everything You Ever Wanted to Know About the IACUC” was moderated by ACE Committee Chairman John Stallone. It was adapted from the popular “IACUC 101” series and offered working scientists an overview of the IACUC process. The program also included several opportunities to pose questions to representatives from OLAW, USDA’s Animal and Plant Health Inspection Service (APHIS)-Animal Care, and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International. An electronic version of this article with links to these organizations and other materials related to this symposium are available on the APS website at http://www.the-aps.org/pub_affairs/IACUC.

Monte Matthews, who is the Director of the Office of Veterinary Services and Animal Care at the University of Oregon, described the evolution of the US laboratory animal welfare system and the role played by the IACUC. The post-World War II origins of animal welfare oversight go back to 1950. The US had begun increasing its investment in biomedical research after World War II, and in 1950, five Chicago-area veterinarians at research facilities began discussing ways to enhance science by improving the care provided to laboratory animals. By 1953 this group was publishing proceedings of its discussions and incorporated itself as the Animal Care Panel (ACP). 

In 1952, the National Academy of Sciences established the Institute of Laboratory Animal Resources (ILAR). Both ILAR and the ACP were addressing animal welfare issues 15 years before there were any federal oversight laws. The ACP appointed an Animal Facilities Certification Committee that developed into the independent accrediting body now known as AAALAC. In 1963, the ACP sought NIH funding to develop a Guide for Laboratory Animal Facilities and Care, which evolved into the Guide for the Care and Use of Laboratory Animals (Guide), a document periodically updated by ILAR and published by the National Research Council. The Animal Care Panel itself continued to grow and in 1967 was reconstituted as the American Association for Laboratory Animal Care (AALAS). 

Matthews explained that the 1966 Laboratory Animal Welfare Act (later known as the Animal Welfare Act) established the first federal animal care standards. It set a handful of minimum standards that applied to the areas where dogs and cats intended for research were housed. It also required facilities to maintain records on the dogs and cats they purchased. The legislation came about after a 1966 Life magazine article, “Concentration Camps for Dogs,” that described how dealers treated animals that were to be sold to research. 

The Animal Welfare Act was amended in 1970, 1976, 1985, and 1990, gradually expanding the number of animal species covered and the breadth of welfare requirements. The 1970 amendments changed the name of the law and extended USDA regulation beyond cats and dogs to include non-human primates, rabbits, guinea pigs, and hamsters. The 1970 amendments also granted the USDA discretion to regulate other species of warm-blooded vertebrates used in research. (One area of continuing controversy has been whether this provision permitted or required the USDA to regulate laboratory rats and mice, as well as birds. That controversy has been resolved for now with the approval of the 2002 farm aid bill, which amends the AWA to exclude these species.)
 
The 1985 AWA amendments made sweeping changes to the regulations, requiring facilities that use covered species to designate an institutional official and to establish an IACUC to conduct program oversight and review all proposed research, educational, or testing activities. 

Matthews recounted the history of a parallel system of oversight for the care and use of laboratory animals that developed within the Public Health Service (PHS). The PHS is part of the Department of Health and Human Services and serves as the parent organization to such agencies as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). In 1971, the NIH formalized a policy requiring humane treatment of animals based upon the requirements of the Guide. This policy was formally adopted by the PHS as a whole in 1973 and was subsequently revised in 1979. In 1985, Congress adopted legislation reauthorizing NIH programs known as the Health Research Extension Act. This legislation included a provision making the PHS Policy on Humane Care and Use of Laboratory Animals part of the framework of laws governing the NIH and required henceforth that all PHS-funded research involving vertebrate animal species be conducted according to the PHS Policy. The elements of the PHS Policy largely paralleled the AWA in requiring the appointment of an institutional official and the establishment of an IACUC, although the composition and mandates of the IACUC differed somewhat from that specified by the AWA. 

In many ways, 1985 was a watershed because it was also the year that the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training were adopted. These nine principles apply to all federally funded activities involving animals.

Molly Greene of the University of Texas Health Science Center at San Antonio (UTHSCSA) discussed the function and responsibilities of the IACUC. Greene has been with UTHSCSA since 1986 and currently serves as the Director of the Department of Academic Support. Her talk described key components of effective animal care and use programs. She emphasized that an effective program complies with federal, state and local laws and regulations, can assure the public of quality animal care, minimizes the burden on research teams, and facilitates scientific research. 

Greene detailed the responsibilities of the various “team members,” including the Institutional Official, IACUC members, IACUC staff, attending veterinarian, and researchers, staff, and students. Greene said that the membership of an IACUC should represent the research and teaching strengths of the institution. 
The ultimate purpose of IACUC review is to protect the continued use of animals in research. Sometimes, however, issues arise between investigators and the IACUC, and it is important to handle them in ways to minimize conflict. For example, Greene recommended that when the IACUC asks an investigator to modify a protocol prior to its approval, it should cite the pertinent section of regulation or policy in its response to the investigator. Greene provided a handout on Protocol Review Process Requirements listing the responsibilities of the IACUC under the AWA and the PHS Policy and identifying the sections of regulation or policy containing the various requirements. This document is available electronically on the APS web site at http://www.the-aps.org/pub_affairs/IACUC. 

Greene recommended that the IACUC take responsibility for compliance issues so that the veterinarian and animal care staff can focus on animal care and facilitating research. She referred participants to the statement on Adequate Veterinary Care on the website of the American College of Laboratory Animal Medicine (http://www.aclam.org).

Stallone reviewed the basics of protocol review requirements as required under the AWA, PHS Policy, and US Government Principles. He provided a series of issues to be addressed, IACUC approval criteria and questions that should be answered to the IACUC’s satisfaction before a protocol is approved. He provided two handouts developed by Greene to assist IACUCs. The first was a side-by-side comparison of the respective Protocol Review Content Requirements of the AWA regulations, PHS Policy, the Guide, and the US Government Principles. The second was a model Protocol Review Checklist Greene designed to help IACUCs make certain that the protocol has addressed all relevant issues satisfactorily. (These documents are also available on the APS website at the URL indicated above.)

The question-and-answer sessions between talks covered a wide range of topics. One questioner wanted to know how to determine when significant and unexpected animal loss has occurred that should be reported to OLAW or USDA. OLAW Director Nelson Garnett, DVM, explained that although it is difficult to give detailed guidance, it is generally expected that institutions with PHS Assurances will report cases where an approved activity has to be suspended or when there has been an instance of serious non-compliance with the PHS Policy or a deviation from the NRC Guide that result in the preventable deaths of animals.

Training requirements were also discussed. Garnett noted that training should be oriented toward the activities an individual engages in. The requirement for training specifies that training must be available but does not prescribe its frequency or intensity. Richard Van Sluyters, OD, PhD, a Professor of Optometry and IACUC Chair from the University of California, Berkeley, who was representing AAALAC, noted that investigators at his institution are asked to take a training refresher course at least every five years. This requirement is typically fulfilled through periodic seminars given to each department by the attending veterinarian. Jodie Kulpa, DVM, of the APHIS Animal Care staff at USDA recommended that training should be offered in a variety of lectures, workshops, hands-on clinics and online courses tailored to areas where researchers want and need further information. The website http://www.iacuc.org was recommended as a resource because it provides a list of training programs and model policies.

The panel was asked whether there are ethical standards in place for research involving animal exercise. At the moment, the only standard regarding exercise is the AWA requirement that dogs be provided with opportunities to exercise. AAALAC’s Van Sluyters indicated that it is important for scientists involved in specific types of research to provide written guidelines that IACUCs can use when reviewing protocols. Garnett said that OLAW is interested in supporting the development of such guidelines, as is the National Academy of Sciences, possibly in the form of an ILAR committee report similar to the Guide. 

Another question that provoked a lively interchange involved protocols for animal models that cause pain and distress. The questioner was concerned about instances in which the attending veterinarian has decided to euthanize an animal without notifying the investigator so the data were lost and the animal’s life was wasted. Andrea Barnes, DVM, of the APHIS Animal Care staff commented that the issue may be one of specifying a humane end point for the experiment, and pilot studies may be needed to refine or define that end point. Barnes pointed out that the animal study proposal serves as a contract between the principal investigator and the animal care staff so it is important to indicate what are the end points for each group of animals and to spell out whether the investigator is to be notified before animals are euthanized. Van Sluyters noted that veterinarians have an obligation to euthanize animals that are suffering so provisions should also be made about how to proceed if the lab personnel are unavailable. Greene underscored the need for the IACUC to ensure that these procedures have been established before animal use begins. 

President Proposes Homeland Security Department

President Bush has proposed the creation of a cabinet level Department of Homeland Security to improve the nation’s ability to defend itself against terrorist threats. The new agency would bring together nearly 170,000 federal employees and $37.5 billion in domestic security programs from various government agencies. The four primary missions of the new department would be chemical, biological, radiological, and nuclear countermeasures; information analysis and infrastructure protection; border and transportation security; and emergency preparedness and response. Some of the changes proposed under this massive reorganization would affect agencies that fund and oversee biomedical research.

“The President’s most important job is to protect and defend the American people,” the White House said in a statement explaining the proposal. “America needs a single, unified homeland security structure that will improve protection against today’s threats and be flexible enough to help meet the unknown threats of the future.” The details of the sweeping proposal were closely guarded until President Bush announced it in a June 6 televised address. The plan had been developed by a handful of trusted advisors who worked in secrecy. Implementing legislation to create the Department of Homeland Security was submitted to Congress on June 18, and President Bush asked Congress to expedite its passage so that the new agency would be in place by the anniversary of the September 11 attacks. 

In the areas of civilian biodefense research and public health response, the plan calls for transferring some 300 government workers and $4 billion to the new department. Some concerns have arisen about how the new department will affect on-going infectious disease research. Analysts believe that $1.7 billion of the biodefense research and civilian response budget will be drawn from funds the administration originally proposed for bioterrorism research activities at the National Institute for Allergy and Infectious Diseases. In addition, the section of the proposed legislation that deals with chemical, biological, radiological and nuclear countermeasures includes the following language:

“With respect to any responsibilities carried out through the Department of Health and Human Services under this subsection, the Secretary [of Homeland Security], in consultation with the Secretary of Health and Human Services, shall have the authority to establish the research and development program, including the setting of priorities.”

FASEB President Bob Rich pointed to two troubling aspects of this plan in a June 24 letter to House Energy and Commerce Committee Chairman W.J. “Billy” Tauzin. While “supporting the efforts of the Congress and the Administration to provide adequately for homeland defense against future acts of terrorism,” Rich expressed concern about the efficacy of taking a “top down” approach to research on potential infectious agents of bioterrorism. “The risk is that a ‘top down’ approach to research might preclude the discovery and development of new understandings of infectious agents,” Rich wrote. 

Rich also questioned the proposal to transfer major elements of the HHS research and public health portfolio to the new department, which would then provide funds for the NIH and CDC to carry out the designated tasks. “Funding transfers are likely to be accompanied by a re-allocation of and redistribution according to different research priorities,” Rich wrote. “If there is no reallocation, such interagency transfers are pointless and will only add transaction costs and delay to performing the research.” Rich concluded by noting that FASEB members “share [the] belief that enhanced federal coordination and oversight is essential to protect all Americans from bioterrorism, but we are concerned that the proposed structural research changes, however well-meaning, might well be counter-productive.” 

The Department of Homeland Security could also affect biomedical research through the proposed transfer of the USDA’s Animal and Plant Health Inspection Service (APHIS) to the proposed Security Division of Border and Transportation Security. The transfer is intended to improve the effectiveness of APHIS efforts to safeguard US agriculture from exotic invasive pests and diseases. However, it is unclear what impact the transfer would have on other aspects of APHIS operations, including its responsibility to enforce the Animal Welfare Act regulations. 

Bioterror Protection Bill Signed

On June 12 President Bush signed into law a $4.6 billion bioterrorism bill (Public Law 107-188). The law authorizes funds to purchase stockpiles of vaccines and antibiotics, mandates increased protection of the food supply, and authorizes grants to the states for emergency preparedness against bioterror attacks. The legislation had virtually unanimous support in Congress. The conference report passed the House by a vote of 425-1 and passed the Senate by a vote of 98-0.

The measure requires the Department of Health and Human Services (DHHS) to develop a list of biological agents or toxins that pose a threat to public health and safety, and to update the list every two years. Individuals who handle these materials must register with the Secretary of HHS. DHHS must submit these names to the Attorney General for background checks and keep a database of registered persons and materials. 

Funds were also authorized for the Centers for Disease Control and Prevention to upgrade its scientific equipment and laboratories and for DHHS to award grants to health professions schools and programs to relieve shortages of health professionals needed to prepare for bioterrorism or other public health emergencies.
The new law also provides new penalties for causing the disruption of or physical damage to animal research and agricultural facilities. It also makes conspiring to commit “animal enterprise terrorism” a criminal offense. The law establishes penalties for actions that result in economic damages, serious bodily injury, and death. Crimes that cause economic damages of up to $10,000 are subject to fines and/or a prison term of up to 6 months. Actions that cause economic damages of $10,000 or more are subject to fines and/or a prison term of up to three years. In both instances, those convicted of the crimes may be required to pay restitution for the damage caused. Crimes against animal enterprises that result in serious bodily injury may be punished with fines and/or a prison term of 20 years, and crimes that result in a death may be punished by fines and/or imprisonment for life. 

Germany Writes Protection for Animals Into its Constitution

Germany has included protection of animals as an element in its Basic Law or constitution. The lower house of parliament approved the measure on May 17, with 543 lawmakers supporting it, 19 lawmakers voting against it, and 15 abstaining. The upper house of parliament followed suit on June 21.

Switzerland passed a similar amendment in 1992, allowing animals to be recognized before the law as beings rather than things.

The German constitutional amendment followed a decade of debate and will require federal courts in that nation to weigh animal protection against other considerations, such as scientific and religious freedom. Until this year, conservative legislators opposed the amendment on the grounds that it might damage German research. However, opinion shifted sharply after Germany’s highest court dismissed a court challenge to Muslim slaughter practices. Muslim law requires butchers to slaughter animals without first stunning them. By contrast, German animal welfare laws are based on the belief that it is more humane to stun animals prior to slaughter. The court refused to intervene in this case because freedom of religion was enshrined in the Basic Law, while protection for animals was not.

The amendment added the words “and animals” to a clause in the Basic Law that obliges the state to respect and protect the dignity of “life.” This passage was previously interpreted as referring only to human life. The amended language now reads, “The state takes responsibility for protecting the natural foundations of life and animals in the interest of future generations.”

Some scientists are concerned about the implications of this language for their work. The BBC reported that one German organization called the Society for Health and Research said that the amendment would create legal insecurity in research and education because it opens the door to court challenges of animal research as well as moves by the government to restrict certain research. 

Consumer Affairs Minister Renate Kunast, a member of the pro-environmentalist Green party that backed the language, insisted that it would not place animals above humans. “People remain the most important,” she said after the lower house voted to approve the amendment. However, questions remain concerning how the courts will interpret the language and how perceived conflicts between the interests of humans and animals will be resolved. Kunast was also quoted commenting, “Work is not stopping. It is just beginning.” 

Congressional Appropriations Season Heats Up

Congress is lagging behind schedule to finish the 13 spending bills that fund the federal government. Further delays are expected as the issue of Homeland Security takes center stage as the top priority for Congress.
To date, the House has passed two FY 2003 spending bills and four other House bills are scheduled for full committee action by the middle of July. However, the bills that fund most biomedical research, such as the Labor HHS and VA-HUD appropriations bills, likely will not come up before the August recess. These bills, particularly the Labor HHS, are large, involve numerous controversial issues and take time to pass.
In the Senate, Senate Appropriations Chairman Robert Byrd (D-WV) indicated that he intends to move all 13 annual appropriations bills through his committee before the August recess. Currently only two bills, FY 2003 Interior and Military Construction, have made it out. 
However, Senate Republicans are threatening to hold up appropriations bills. Senate Majority Leader Trent Lott (R-MS) said he would protest bills that far exceed President Bush’s budget request by loading them down with amendments. 

NSF Doubling Effort Gets Boost

The effort to put the National Science Foundation’s (NSF) budget on a five-year doubling path is gaining momentum in the 107th Congress. 

On May 3, 2002, leadership from the House Science Committee, including Chairman Sherwood Beohlert (R-NY), Ranking Member Ralph Hall (D-TX) and physicist Vernon Ehlers (R-MI) circulated a “Dear Colleague” letter asking House members to show support for a $5.5 billion appropriation for the NSF in FY 2003. This would be a $720 million increase over the agency’s FY 2002 level and $479 million more than the Bush administration’s request. This effort fueled the movement to pass authorization legislation.

On June 6, 2002, advocates for doubling the NSF’s budget achieved a victory when the House of Representatives overwhelmingly (397-25) voted to pass H.R. 4664 the “Investing in America’s Future Act.” The bill now moves to the Senate for consideration.

This legislation, which will reauthorize NSF programs, calls for doubling the NSF’s budget over five years with a series of 15% increases. The first step would be a funding level of $5.5 billion for fiscal year (FY) 2003. While authorizing legislation does not actually fund federal agencies, it does provide strong justification for particular funding levels for a program. 

During the House floor debate on the bill, Representative Ehlers noted that “National Science Foundation funding has fallen behind that of other major federal research agencies, and we are not third among nations in our spending of basic research.” Representative Connie Morella (R-MD) echoed Representative Ehlers’ remarks: “If we expect the technological advances we have achieved in recent years to continue, we must fund the underpinning science and engineering more robustly. In addition, we must provide adequate resources to produce the next generation of scientists and engineers. As the premier supporter of the overall scientific enterprise, the NSF has the ability to balance the research and education dollars needed to achieve both of these goals.” 

Senate Avoids Cloning Vote

In early June, a major Senate floor debate on all forms of cloning legislation was averted. Cloning opponent Senator Sam Brownback (R-KS) declined an offer by Senate Majority Leader Thomas Daschle (D-SD) to have his legislation brought to the Senate floor for a vote.

Late last year, Senator Daschle offered Senator Brownback a chance to bring his bill to the floor for a vote later in the year in exchange for not trying to attach it to the FY 2002 Labor Health and Human Services, Education and Related Agencies appropriations bill. Under Senator Daschle’s offer there would be three full days of debate on various pieces of cloning legislation, including Senator Brownback’s legislation.

In early June, Senator Brown-back rejected this offer. He felt that under the agreement his legislation would be put in a position to fail while cloning proponents Senators Arlen Specter (R-PA) and Diane Feinstein’s (D-CA) legislation would pass. Senators Specter and Fein-stein’s legislation bans reproductive cloning but not the use of cloning techniques for research and to develop therapies.

Senator Daschle indicated that the agreement he arranged was his final attempt to debate the issue on the Senate floor: “It is up to others to decide how to pursue [cloning legislation]. I don’t have time to keep coming back to this issue.”

Brownback has not given up on trying to ban all forms of cloning. Late in the evening of June 13, he attempted to offer an amendment to an unrelated bioterrorism insurance bill. His amendment would have blocked the issuance of patents for cloned human beings or the technology to produce them. This effort failed after the Senate voted to remove all amendments that had nothing to do with bioterrorism insurance from the bill.
Subsequently Senator Brownback indicated he would no longer try to persuade the US Senate to pass a bill outlawing all human cloning. Instead, he says he will work to win congressional approval for a two-year moratorium on such work.

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