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Association for Research in Otolaryngology

Animal Research Committee


To inform members of changes or proposed changes to federal regulations and policies pertaining to the use of animals in research

 2004 Changes or Proposed Changes

  • NIH Revises Rules of Conflict of Interest of Grant Peer Reviewers
  • FDA Announces New Rates for Animal Drug Application Fees
  • Court Dismisses Suit to Force USDA to Issue New NHP Regulations
  • USDA Amends Rules on Blood and Tissue Collection at Slaughtering and Rendering Establishments
  • HHS Creates New Advisory Board to Improve Biosecurity in 'Dual Use' Research
  • USDA to Regulate the Transportation of Animals on Foreign Air Carriers
  • Pet Safety and Protection Act of 2004 Introduced in U.S. Senate
  • FDA Issues Notice on New Rates for Animal Drug Product, Establishment, and Sponsor Fees
  • NIH Panel on Conflicts of Interest Releases Report
  • Senate Judiciary Committee Held Hearing on "ANIMAL RIGHTS: ACTIVISM VS. CRIMINALITY"
  • Ecoterrorism Prevention Act of 2004 Introduced in U.S. House of Representatives
  • USDA Issues Final Rule on the Definition of Animal
  • USDA Solicits Comments on Animal Welfare Regulations and Standards for Birds, Rats and Mice
  • NIH Notice Issued Regarding Submission of Animal Welfare Documents to OLAW
  • USDA issues notice of a request for extension of approval to collect information from foreign air carriers transporting animals and solicits comments regarding this activity
  • USDA Issues Final Rule for amending the Animal Welfare Act regulations regarding inspection, licensing and procurement of animals
  • USDA extends the comment period for its proposed rulemaking regarding the regulation and standards for birds, rats and mice
  • Terrorism Against Animal-Use Entities Prohibition Improvement Act of 2004 Introduced in U.S. House of Representative
  • FDA Announces Rates for Animal Drug User Fees and Payment Procedures for Fiscal Year 2005
  • UK to Develop a National Center on Alternative Methods
  • Austria Adopts New Animal Laws
  • NIOSH Publishes Occupational Safety and Health Resources
  • AAALAC International Restructures Its Executive Office

     

  • NIH Revises Rules of Conflict of Interest of Grant Peer Reviewers

    The National Institutes of Health (NIH) issued a final rule on January 5th, 2004, effective February 4th, 2004, that revises 42 CFR Part 52h, the regulations governing scientific peer review of research grant applications, research and development contract projects, and project proposals. The revised regulation clarifies the review criteria and revises conflict of interest requirements of reviewers. [DHHS NIH. Final Rule. Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects. Federal Register 69(2), 272-278 (5 January 2004)]

  • FDA Announces New Rates for Animal Drug Application Fees

    The US Food and Drug Administration (FDA) Center for Veterinary Medicine announced the following rates for animal drug application fees for fiscal year (FY) 2004 (1 September 2003 to 30 September 2004) and payment procedures for those fees: $61,000 for an animal drug application and $30,500 for a supplemental animal drug application for which safety or effectiveness data are required. The Federal Food, Drug, and Cosmetic Act, as amended by the Animal Drug User Fee Act of 2003, Public Law 108-130, authorizes FDA to collect user fees for certain animal drug applications, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. President Bush signed Public Law 108-199, appropriating FY 2004 animal drug user fee revenues, on 23 January. [FDA Center for Veterinary Medicine. FDA announces animal drug user fee rates for FY04. (18 February 2004). http://www.fda.gov/cvm/index/updates/feesup.htm; DHHS FDA. Notice. Establishment of Animal Drug User Fee Rates for Applications for Fiscal Year 2004 and Payment Procedures. Federal Register 69(32):7646-7649.]

  • Court Dismisses Suit to Force USDA to Issue New NHP Regulations

    On March 2nd, 2004, the US District Court in Northern California dismissed a lawsuit filed by the Animal Legal Defense Fund (ALDF) and the Animal Welfare Institute (AWI) to force the US Department of Agriculture (USDA) to issue new Animal Welfare Act regulations to promote the psychological well being of nonhuman primates (NHP) by addressing physical environment, social grouping, enclosures, and other issues. US District Court Judge Phyllis Hamilton agreed with the USDA and the National Association for Biomedical Research (NABR) when she ruled that the case lacked merit. Judge Hamilton dismissed the case with prejudice, meaning that the suit cannot be filed again in the United States. [National Association for Biomedical Research. News Alert. Court agrees with NABR, dismisses primate case filed by ALDF and AWI. (2 March 2003)]

  • USDA Amends Rules on Blood and Tissue Collection at Slaughtering and Rendering Establishments

    Effective March 4th, 2004, the USDA amended its regulations governing interstate transportation of animals to establish requirements for the collection of blood and tissue samples from livestock (horses, cattle, bison, captive cervids, sheep and goats, swine, and other farm-raised animals) and poultry at slaughtering and rendering establishments when it is necessary for disease surveillance. The amended rule specifies individuals transporting livestock and poultry across state lines can only deliver them to slaughtering or rendering facilities that have been approved by the Animal and Plant Health Inspection Service (USDA APHIS). USDA APHIS will only approve establishments that provide the type of space and facilities specified by the regulations to safely collect blood and tissue samples for disease testing. This amended rule is meant to 'to improve surveillance programs for animal diseases, to contribute to the eventual control or eradication of such diseases, and to assist in certifying the status of the United States or its regions with regard to freedom from specific animal diseases.' [USDA APHIS. Final rule. Blood and tissue collection at slaughtering and rendering establishments. Federal Register 69(43), 10137-10151 (4 March 2004)]

  • HHS Creates New Advisory Board to Improve Biosecurity in 'Dual Use' Research

    On March 4th, 2004 US Department of Health and Human Services (HHS) Secretary Tommy G. Thompson announced the creation of the National Science Advisory Board for Biosecurity (NSABB) to improve biosecurity measures related to so-called 'dual use' research - legitimate biological research that could be misused to threaten public health or national security. The HHS Secretary, with input from directors of other federal departments and agencies, will appoint board members, including up to 25 voting members with specialties ranging from bioethics, to law enforcement, to veterinary medicine. The NSABB will also include nonvoting members representing at least 15 federal departments and agencies. The NSABB will be managed by NIH and will be expected to advise the Secretary of HHS, the director of NIH, and the heads of federal departments and agencies that conduct or support 'dual use' biomedical research on the following issues:

    • strategies for local and federal biosecurity oversight for all federally funded or supported life sciences research;
    • development of guidelines for biosecurity oversight of life sciences research and [provision of] ongoing evaluation and modification of these guidelines as needed;
    • strategies to work with journal editors and other stakeholders to ensure the development of guidelines for the publication, public presentation and public communication of potentially sensitive life sciences research;
    • development of guidelines for mandatory programs for education and training in biosecurity issues for all life scientists and laboratory workers at federally funded institutions; and
    • development of a code of conduct for life scientists and laboratory workers that can be adopted by federal agencies as well as professional organizations and institutions engaged in the performance of life sciences research domestically and internationally."

    HHS will extend its biosecurity policies internationally on a voluntary and cooperative basis through existing international scientific and health organizations, and other relevant international organizations. [http://www.biosecurityboard.gov/; US Department of Health and Human Services. News Release. HHS will lead government-wide effort to enhance biosecurity in "dual use" research. (4 March 2004). http://www.hhs.gov/news/press/2004pres/20040304.html]

  • USDA to Regulate the Transportation of Animals on Foreign Air Carriers

    The U.S. Department of Agriculture (USDA) reconfirmed the effective date (7 April 2004) in their determination to regulate the transportation of animals on foreign air carriers and responded to comments received since the period for their request for comments ended (9 December 2003). [USDA APHIS. Determination to regulate; confirmation of effective date. Animal Welfare; Transportation of Animals on Foreign Air Carriers. Federal Register 69(66):17899-17901 (6 April 2004)]

  • Pet Safety and Protection Act of 2004 Introduced in U.S. Senate

    On April 26th, 2004, Senator Daniel Akaka (D-Hawaii) introduced the "Pet Safety and Protection Act of 2004," S. 2346, which contains provisions to amend the Animal Welfare Act. S. 2346 currently has no co-sponsors and has been referred to the Senate Committee on Agriculture, Nutrition, and Forestry. Contributing to the stricter regulation of Class B animal vendors, S 2346 would:

    • Ban research facilities from obtaining dogs or cats from dealers who do not breed and raise the animals themselves;
    • Require animal pounds to be registered by the USDA in order to provide animals for research;
    • Prohibit private shelters from voluntarily choosing to make animals available for research;
    • Permit individuals to donate dogs or cats to research facilities only if they breed and raise, and own them for more than one year; and,
    • Assess $1,000 fines for each violation of the above items.

    [S 2346. Pet Safety and Protection Act of 2004. 108th Congress, 2nd Session. (26 April 2004)]

  • FDA Issues Notice on New Rates for Animal Drug Product, Establishment, and Sponsor Fees

    The US Food and Drug Administration (FDA) announced fee rates and payment procedures for animal drug product, establishment and sponsor fees for fiscal year 2004. The Federal Food, Drug, and Cosmetic Act, as amended by the Animal Drug User Fee Act of 2003, Public Law 108-130, authorizes FDA to collect user fees for certain animal drug applications, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. President Bush signed Public Law 108-199, appropriating FY 2004 animal drug user fee revenues, on 23 January. [DHHS FDA. Notice. Establishment of Animal Drug User Fee Rates and Payment Procedures for Product, Establishment, and Sponsor Fees for Fiscal Year 2004. Federal Register 69(81):22846-22849 (27 April 2004)]

  • NIH Panel on Conflicts of Interest Releases Report

    The National Institutes of Health (NIH) Blue Ribbon Panel on Conflicts of Interest, chaired by Bruce Alberts and Norman Augustine, presented its final report to the Advisory Committee to the Director (ACD) on May 6th, 2004. NIH Director Elias Zerhouni, M.D. established the Panel as part of the agency's inquiry into its own conflict of interest policies after concerns were raised in the media and Congress that some NIH employees had financial relationships with industry that could affect their work as government employees and that represented potential or actual conflicts of interest. The report contains 18 recommendations for correcting identified concerns and addressing key policy issues. During the ACD's deliberations, the Panel clarified and amplified several of its points and responded to concerns and questions raised by ACD members and submitted its revised and final report on June 22nd, 2004. [http://www.nih.gov/about/ethics_COI_panelreport.pdf]

  • Senate Judiciary Committee Held Hearing on "ANIMAL RIGHTS: ACTIVISM VS. CRIMINALITY"

    The hearing on "Animal Rights: Activism vs. Criminality" scheduled by the U.S. Senate Committee on the Judiciary was held May 18th, 2004 and was presided over by Committee Chairman Orrin G. Hatch (R-UT). Strong testimony was presented on the subject of animal rights extremism. At the outset of the hearing before the full committee, Chairman Hatch stated his concern that some fringe activists have moved beyond protected speech and reasonable protest - rights cherished by all - and are engaging in criminal conduct. While vowing not to violate rights that we collectively hold dear, Chairman Hatch added, "… where political activism breaches peaceful protest and dives headfirst into criminal conduct, we can, should and will use very mechanism available to prosecute the individuals responsible." He concluded, "Our task here today is to help identify and show the line that distinguishes lawful expression and protest from criminal behavior." Witnesses including leaders of a restaurant company, a biotechnology firm, and a university biomedical research center describing the nature and consequences of animal extremists' attacks offered compelling personal accounts. Law enforcement officials discussed the threat posed currently by animal rights extremists, the efforts of the Federal Bureau of Investigation (FBI) and its other federal, state and local law enforcement partners to address that threat and some of the difficulties being faced. John E. Lewis, the FBI's Deputy Assistant Director for Counterterrorism, stated: "The Animal Liberation Front ... is our highest domestic terrorism investigative priority." Mr. Lewis detailed animal rights activists' use of "improvised explosive devices" and "threats of more, larger bombings and even potential assassinations of researchers, corporate officers and employees." At present, more than 34 FBI field offices have over 190 pending investigations associated with Animal Liberation Front/Earth Liberation Front (ALF/ELF) activities. Mr. Lewis listed the successful prosecutions to date, but also outlined the inadequacies of existing statutes to deal with these cases. McGregor W. Scott, United States Attorney for the Eastern District of California echoed Mr. Lewis using California cases in which he has been involved. A letter read by Senator Hatch from the Center for Consumer Freedom included the following statements: "A disturbing current of violence runs beneath the surface of 'mainstream' animal rights groups in the United States … And some of these tax-exempt charities are providing 'material support or resources' to groups and individuals whose activities fit the U.S. Criminal Code's definition of 'domestic terrorism'." For example, People for the Ethical Treatment of Animals (PETA) has donated over $150,000 to criminal activists - including the terrorist Earth Liberation Front (ELF), and individuals jailed for arson, burglary, and attempted murder. Until last year, the Humane Society of the United States (HSUS) was quietly funding the operation of an Internet service, which distributed official "communiqués" from the Animal Liberation Front claiming responsibility for criminal activities. At the "Animal Rights 2003" national conference, Physicians Committee for Responsible Medicine (PCRM) spokesman Jerry Vlasak publicly advocated the murder of doctors who use animals in their research, saying: "I don't think you'd have to kill - assassinate - too many ... I think for 5 lives, 10 lives, 15 human lives, we could save a million, 2 million, 10 million non-human lives." The Center for Consumer Freedom has urged the government to remove the tax exempt status benefiting these organizations [http://judiciary.senate.gov/hearing.cfm?id=1196]

  • Ecoterrorism Prevention Act of 2004 Introduced in U.S. House of Representatives

    On May 20th, 2004, HR 4454, the "Ecoterrorism Prevention Act of 2004" was introduced by Rep George R. Nethercutt, Jr. (R-WA) and was referred to the House Committee on the Judiciary and the Committees on Ways and Means and Science. HR 4454 would "amend title 18, United States Code, to protect and promote the public safety and interstate commerce by establishing Federal criminal penalties and civil remedies for certain violent, threatening, obstructive, and destructive conduct that is intended to injure, intimidate, or interfere with plant or animal enterprises, and for other purposes." [HR 4454. Ecoterrorism Prevention Act of 2004 (Introduced in House). 108th Congress, 2nd Session. (20 May 2004); http://thomas.loc.gov/cgi-bin/bdquery/z?d108:h.r.04454:]

  • USDA Issues Final Rule on the Definition of Animal

    On June 4th, 2004, the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) amended the Animal Welfare Act (AWA) Regulations with a final rule on its definition of animal. This action brings the regulations in line with a legislative provision included the Farm Security and Rural Investment Act of 2002 (P.L. 107-171), signed into law on May 13, 2002, which amended the definition of animal to specifically exclude rats of the genus Rattus and mice of the genus Mus that had been bred for use in research, and all birds - not exclusively those bred for use in research. The final rule, effective June 5th, 2004, narrows the scope of the exclusion for birds to only those bred for use in research. Thus, for the first time, regulations will cover birds not bred for research. In Sec. 1.1 the definition of 'animal' is revised as follows: "Animal means any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warmblooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes: birds, rats of the genus Rattus, and mice of the genus Mus bred for use in research, and horses not used for research purposes, and other farm animals, such as, but not limited to livestock or poultry, used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. With respect to a dog, the term means all dogs, including those used for hunting, security, or breeding purposes." [USDA APHIS. Final rule. Animal Welfare; Definition of Animal. Federal Register 69(108):31513-31514 (4 June 2004).]

  • USDA Solicits Comments on Animal Welfare Regulations and Standards for Birds, Rats and Mice

    As a result of the final rule (4 June 2004) issued by the USDA on its definition of 'animal', the USDA also published an advance notice of proposed rulemaking on June 4th, 2004 soliciting comments from the public to aid in the development of regulations and standards for birds not specifically bred for use in research, as well as for the humane handling, care, treatment, and transportation of rats and mice not bred for use in research. The comment period ends on August 3rd, 2004. [USDA APHIS. Advance notice of proposed rulemaking and request for comments. Animal welfare; regulations and standards for birds, rats, and mice. Federal Register 69(108), 31537-31541 (4 June 2004).]

  • NIH Notice Issued Regarding Submission of Animal Welfare Documents to OLAW

    The Office of Extramural Research (OER) issued a notice to inform NIH awardee institutions holding Animal Welfare Assurances in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals of changes related to two required documents. Since 1989, the Office of Laboratory Animal Welfare (OLAW) has approved most assurances for a period of five years, and under the new provisions, they will now approve Animal Welfare Assurances for periods of up to four years. In addition, OLAW now strongly encourages awardee institutions to use the calendar year (1/1 to 12/31) for the reporting period of annual reports to promote consistent reporting periods. Consequently, annual reports, which are due by the last day of the month immediately following the end of the institution's reporting period, will be due January 31st, unless alternate arrangements have been made with OLAW by submitting a letter or email to OLAW by January 31st, 2005, indicating the institution's preferred reporting period. [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-052.html]

  • USDA issues notice of a request for extension of approval to collect information from foreign air carriers transporting animals and solicits comments regarding this activity

    On July 8th, 2004, the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) issued a notice of a request for extension of approval to collect information from foreign air carriers for an additional 3 years from the Office of Management and Budget (OMB) and solicited comments regarding the value of APHIS' information collection from foreign air carriers involved in animal transportation. The USDA is requiring foreign air carriers to comply with the transportation standards that domestic carriers must comply with and maintain records pertaining to animal transport. Comments concerning information collection may be submitted until September 7th, 2004. [USDA APHIS. Notice of Request for Extension of Approval of an Information Collection; Federal Register 69(130):41226-41227 (8 July 2004).]

  • USDA Issues Final Rule for amending the Animal Welfare Act regulations regarding inspection, licensing and procurement of animals

    On July 14th, 2004, the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) published the final rule effective 8/13/04 revising and clarifying the exemptions from the licensing requirements, the procedures for applying for licenses and renewals, and the restrictions upon the acquisition of dogs, cats, and other animals. [USDA APHIS. Final Rule: Animal Welfare; Inspection, Licensing, and Procurement of Animals. Federal Register 69(134):42089-42102]

  • USDA extends the comment period for its proposed rulemaking regarding the regulation and standards for birds, rats and mice

    On July 21st, 2004, the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) extended the comment period for its proposed rulemaking regarding the regulation and standards for birds, rats and mice not specifically excluded from coverage under the Animal Welfare Act (AWA) to November 1st, 2004. The extension is designed to allow interested parties additional time to prepare and submit comments regarding changes to AWA regulations applying to the humane handling, care, treatment, and transportation of birds, rats and mice not specifically bred for research. [USDA APHIS. Proposed Rule. Animal Welfare; Regulations and Standards for Birds, Rats, and Mice; Federal Register 69(139):43538-43539]

  • Terrorism Against Animal-Use Entities Prohibition Improvement Act of 2004 Introduced in U.S. House of Representative

    Representative Sam Graves introduced H.R. 4883, the "Terrorism Against Animal-Use Entities Prohibition Improvement Act of 2004" in the House of Representatives on July 21st, 2004 to amend title 18 of the U.S. Code. The bill contains provisions that amend the Animal Enterprise Protection Act by including economic disruption of an animal enterprise as an offense. It also increases fines and prison terms for certain offenses. The bill was introduced with no co-sponsors and has been referred to the House Committee on the Judiciary. [HR 4883, 108th Congress, 2nd Session; (21 July 2004); http://thomas.loc.gov/cgi-bin/bdquery/z?d108:h.r.04883:]

  • FDA Announces Rates for Animal Drug User Fees and Payment Procedures for Fiscal Year 2005

    The US Food and Drug Administration (FDA) announced rates for animal drug user fees for fiscal year (FY) 2005 and payment procedures for those fees. Rates increased substantially compared to the rates for 2004. The Federal Food, Drug, and Cosmetic Act, as amended by the Animal Drug User Fee Act of 2003, Public Law 108-130, authorizes FDA to collect user fees for certain animal drug applications, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. [DHHS FDA. Notice. Establishment of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2005. Federal Register 69(147):46147-46151 (2 August 2004).]

  • UK to Develop a National Center on Alternative Methods

    Lord Sainsbury, Parliamentary Under-Secretary of State for Science and Innovation for the UK's Department of Trade and Industry, reported that his office would soon announce plans for developing a national center for replacement, reduction, and refinement of animal experiments. This follows the October 2003 plan of the British Parliament to devote resources to alternative methods. It remains to be determined whether the new center will be free standing or be a part of an existing organization. [Adam, D. Centre to cut down on animal research. The Guardian (26 February 2004); http://www.guardian.co.uk/uk_news/story/0,,1156322,00.html]

  • Austria Adopts New Animal Laws

    Austria has approved "far-reaching" legislation affecting the treatment of animals according to the Associated Press. The new law, which takes effect in January, prohibits the use of chains, choke collars or "invisible fences" for dogs, as well as chicken caging called "batteries", cropping dogs' ears and tails and the use of lions, tigers and other wild animals in circuses. Austria's four political parties are said to have reached a compromise requiring anesthesia during traditional Kosher and Halaal (Muslim) animal slaughter, instead of banning those practices. [http://msnbc.msn.com/id/5077350]

  • NIOSH Publishes Occupational Safety and Health Resources

    The National Institute for Occupational Safety and Health (NIOSH) recently released a manual and a companion site on its web page to advise employers on methods used to assess and measure the effectiveness of steps they have taken to prevent work-related injuries and illnesses. These materials may be important for animal care personnel because injuries similar to those described in these resources may occur in laboratory animal facilities. The manual, DHHS (NIOSH) Publication No. 2004-135, was developed by the Intervention Effectiveness Team under the National Occupational Research Agenda (NORA) and was formed by representatives from NIOSH, industry, labor, and academia. The web page www.cdc.gov/niosh/docs/2004-135/ provides the text of the manual in an interactive format. [NIOSH. Guidance for Assessing Safety, Health Fixes is Offered by NIOSH Through Web Site, Manual. (15 March 2004). http://www.cdc.gov/niosh/updates/upd-03-15-04.html]

  • AAALAC International Restructures Its Executive Office

    The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) has reorganized its Council on Accreditation into North American and European Sections. The European Section of the Council on Accreditation, which will be based in AAALAC's Brussels' office will conduct site visits to European organizations applying for or renewing their accreditation. AAALAC Senior Director Kathryn A. Bayne, MS, PhD, DVM will relocate to Hawaii to assume the duties of Director of Pacific Rim Activities and Associate Director for Accreditation. The North American Section, which will continue to operate out of AAALAC's Executive Office in Rockville, MD, will conduct site visits in the United States, Canada, and other international locations. [AAALAC International. AAALAC International forms European and North American Sections of the Council on Accreditation. (8 March 2004). http://www.aaalac.org/pr030804.htm]

     

 

 


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