Public Affairs
European Animal Welfare Changes Could Affect US

APS-sponsored AAAS Mass Media Fellowship 

APS Comments on the NIH Public Access Proposal 

European Animal Welfare Changes Could Affect US

New animal welfare standards under discussion in Europe could affect researchers throughout the world, including in the US. The new proposals would require significant changes in animal husbandry. Critics object to them because there is a lack of scientific data showing a need for these measures.

This issues will be discussed at IUPS 2005 in a symposium on “Transnational impacts of animal welfare regulations” sponsored by the APS Animal Care and Experimentation Committee. The symposium will take place on Sunday, April 3 from 3:15 to 5:15 pm in Room 29C of the San Diego Convention Center and will be chaired by ACE Committee Chair Kevin Kregel. 

The Symposium’s featured speaker will be Anne-Dominque Degryse, the Director of Animal Husbandry at the Pierre Fabre Research Center in France and Past President of European Society of Laboratory Animal Veterinarians. Degryse will discuss “New European Animal Welfare Standards: Potential Impact and Concerns.”

The Council of Europe (COE) is developing revisions to the animal welfare standards that are recommended practices for its 45 member nations. The changes under consideration include increasing the minimum recommended cage size for a singly housed 21 kg. dog to 8 sq. meters, or approximately 72 sq. feet. The ILAR Guide for the Care and Use of Laboratory Animals currently requires a minimum cage size of 12 sq. feet for a singly housed 21 kg dog. 
In addition to mandating larger cage sizes, the draft revisions would require laboratory animals to be housed in enriched environments that permit the expression of normal behaviors. Animals would have to be housed in compatible social groups, and enhanced mechanical systems may also be required. Some lab animal veterinarians in Europe and the US are concerned because some of these proposals are not based upon studies demonstrating that these proposed modifications will in fact promote animal welfare.

If eventually adopted, the changes could affect scientists in a variety of ways. First, however, the COE working groups must finalize the proposed changes and present them to the COE’s 45 member nations. Even if the COE ratifies the changes, the proposals would be advisory rather than mandatory. However, the recommendations would then be brought to the 15 nation European Union. The EU is expected to adopt the proposals, at which point they would have to be incorporated into the laws of those countries.

New animal welfare standards in Europe will have the most immediate effect on those who conduct research there, particularly in industry. David Brooks of GlaxoSmithKline Pharma-ceuticals will discuss International Animal Welfare Standards and the Pharmaceutical Industry. New standards will also have an impact on academic researchers in EU nations and on their collaborators in other nations. Pontus Persson of Humboldt Univer-sity’s Johannes Mueller Institute of Physiology in Berlin will provide a view from the bench and discuss the future of international collaborations.

The changes could also affect researchers in the US and other nations who submit papers to journals published in countries where the revised standards are in effect. Just as the APS journals require that animal research protocols be carried out in accordance with the provision of the ILAR Guide, journals in other nations often have similar requirements. It is already the case that certain research that is acceptable to IACUCs in the US is rejected by journals in other countries because it violates their national animal welfare standards. The proposed European animal welfare requirements could exacerbate this problem by increasing the gap between European and American animal welfare requirements. 

The final symposium speaker will be J.R. Haywood of Michigan State University, who will provide some perspective on the complexities of animal welfare regulation in the US and elsewhere.
APS members are encouraged to attend the ACE symposium on Trans-national Impacts of Animal Welfare Regulation on Sunday, April 3, 2005 from 3:15-5:15 pm in Room 29C of the San Diego Convention Center. 

APS-sponsored AAAS Mass Media Fellowship 

This 10-week summer 2005 fellowship allows graduate and postdoctoral students the chance to:
· Use their academic training in the sciences to research, write and report today's headlines.
· Improve public understanding of science while developing the ability to communicate science to general audiences.
· Observe and participate in the process by which events and ideas become news.
· Work with professional journalists in the newsroom of a newspaper, television or radio station, magazine or internet media organization. 

Interested? If so, apply for the APS-sponsored AAAS Mass Media Science and Engineering Fellowship. Application Deadline: January 15, 2005. 

Applicants for the APS-sponsored fellowship must be currently enrolled as a graduate or postdoctoral student of physiology or a related discipline. Fellowships for students in other scientific and engineering disciplines are available through AAAS. 

Find out more information at http://www.the-aps.org/awards/student.htm#AAAS or by contacting Stacy Brooks (sbrooks@the-aps.org; 301-634-7253). 

APS Comments on the NIH Public Access Proposal 

The APS supports the principle of public access to science but believes that the NIH plan is not the right approach. The APS submitted a detailed analysis of public policy shortcomings and legal defects of the proposal. The legal analysis incorporated into the APS comment was jointly commissioned by the APS and the American Association of Immunologists (AAI).

The APS has concluded that the NIH proposal will do little to enhance public access to biomedical research while causing disproportionate harm to not-for-profit societies that publish high-quality journals containing a significant amount of NIH-funded research. This cohort includes many publishers who already provide some form of free public access. 
The APS recommends that instead of this proposal, the NIH should enhance the existing MedLine/PubMed web site so that it is possible to search the full text of articles on journals’ own websites. These searches would yield links to finished articles on those websites rather than access to manuscripts. A number of publishers have already expressed interest in this approach, which would lead to the development of a comprehensive search engine that would do for biomedical research what search engines such as Google and Yahoo do for the web as a whole. This approach has a number of advantages to all parties. For NIH, this arrangement would make it possible to search the text of all biomedical research articles and not just the 10% that are based on NIH-funded research. Journals, and especially high-quality journals that publish a significant proportion of NIH-funded research, would still be able to determine their own access policies based upon cost recovery requirements. Finally, and perhaps most importantly of all, instead of access to manuscripts, this would make it possible to locate the final copy-edited version of articles presented in context with links to related materials such as commentaries and corrections.

This policy section of the APS comment will address a series of questions about the NIH proposal. These include:
  • Should NIH operate a manuscript repository? 
  • Should NIH mandate public access after 6 months? 
  • Are the costs of the proposal warranted? 
    The legal analysis commissioned by APS and AAI addresses a variety of defects in the NIH proposal, which are summarized below:
  • NIH’s plan would infringe on the copyright interests of (a) federal grantees who author copyrighted articles based upon NIH-sponsored research, and (b) publishers of professional journals that have accepted those articles for publication and to whom copyright interests have been conveyed. These copyright interests are well-established under federal law and NIH has no authority to alter them on its own. Consequently, NIH must, as a general matter, obtain permission from those authors who have retained a copyright interest and the publishers in order to distribute and/or display accepted manuscripts of the articles to the general public. 
  • The plan is fatally flawed as it fails to recognize the need to obtain copyright permission from authors and/or publishers to distribute or display manuscript copies to the public.  Suggestions that such permission may be excused by resort to the “fair use” defense or NIH’s “federal purpose” license in the manuscripts are without merit. In addition, as to grantees under the Small Business Innovation Research program, NIH has no authority even to seek such permission without approval of the U.S. Small Business Administration. 
  • The plan threatens to undercut the Bayh-Dole Act by interfering with technology transfer.  NIH has recognized in Congressional testimony that scientific publications are an important component of technology transfer for NIH-sponsored research, and weakening that technology transfer component would represent poor public policy.  NIH’s plan also undermines the principle of the Bayh-Dole Act that the private sector is the preferable vehicle to move federally-funded research results to the public and the marketplace. 
  • Because NIH is subject to the Freedom of Information Act and intends to place the accepted manuscripts into an NIH database, manuscripts submitted to NIH likely constitute “printed publications” under U.S. patent laws.  Consequently, the date such a draft manuscript is submitted to NIH would trigger the running of the one-year time period for filing a U.S. patent application covering research disclosed in the manuscript, and patent applications filed after that date in foreign countries that do not provide a grace period similar to US law will be time-barred. This is a change from current practice, which relies on the date of journal publication, and risks significant adverse consequences for researchers and NIH. 
  • The NIH plan constitutes a legislative rule-making under the Administrative Procedure Act.  However, NIH lacks the authority to adopt this plan because it is without legislative rule-making power, and in any event cannot adopt a plan that is at variance with a controlling DHHS regulation.  Even if NIH could undertake legislative rule-making, formal notice and a public comment opportunity are required.  The current notice is legally inadequate for legislative rule-making because it fails to provide sufficient details of the plan or the data upon which NIH has relied to afford the public a meaningful comment opportunity. 
  • Because the Regulatory Flexibility Act applies to NIH’s plan, NIH cannot proceed unless it undertakes the regulatory flexibility analyses required under the Act.  Moreover, the Associations, as small entities under the Act, would be entitled to judicial review of NIH’s compliance (or non-compliance) with the Act. 
  • The Paperwork Reduction Act applies to NIH’s plan.  NIH is required by law to comply with that Act, and failing to do so, NIH cannot enforce any penalty on NIH grantees who decline to submit manuscripts as required by NIH’s plan. 
  • OMB Circular A-76 applies to NIH’s plan.  NIH cannot implement its plan unless the agency performs a cost-comparison study and determines that its plan to have NIH distribute NIH-sponsored research results using accepted manuscripts is less expensive for the federal government than the present system of scientific publishing.  
  • Because NIH’s plan would interfere with constitutionally protected rights, NIH would need to satisfy analytical and reporting requirements to OMB as to potential obligations imposed by the Just Compensation Clause of the Fifth Amendment.  Additionally, while DHHS could, conceivably, change its grant regulation on grantee copyright ownership to authorize NIH’s plan, such a change would require OMB approval for a deviation from OMB’s uniform grant rules. 

The APS therefore recommends that NIH withdraw this proposal and work cooperatively with publishers to determine how best to promote reasonable and sustainable policies to improve public access to science.

A copy of the APS comments is available as a pdf file at http://www.the-aps.org/news/aps.pdf. 

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