USDA Revises Policies

The United States Department of Agriculture (USDA) has revised three Animal Welfare Act (AWA) policies relating to Institutional Animal Care and Use Committees (IACUC); licensing and registration of facilities; and submission of annual reports.

Policy#15: has been revised to specify the qualifications of IACUC members. Whereas IACUC members previously were required to have "access" to training, the policy now says that research facilities are required to ensure that members are provided training and instruction to ensure that they are qualified to assess the facilities animal programs and procedures, as well as the facility itself.

Policy #10: has been revised to state that any facility conducting genetic engineering which results in a live (whole) animal species should be regulated as a research facility, provided that the species is covered under the AWA. Such facilities would have to be registered with USDA and be under IACUC oversight. However, the USDA adds that the act of cloning does not require a facility to be licensed or registered with the USDA. A facility that clones animals for AWA-regulated purposes will be considered to be a breeder and must be licensed by the USDA as a dealer. The USDA will review cloning companies on a case-by-case basis to determine whether or not they require licensure or registration.

Policy #17: Under the Animal Welfare Act, research facilities are required to submit an annual report on animals used for research, testing, and/or teaching purposes. Policy 17 – “Annual Report for Research Facilities” – has been revised to emphasize the need to provide data that is “true, correct and complete.” New information on the distribution of annual report form packages, clarification to instructions for completing the APHIS forms, and description of the optional online procedure for submitting reports, is also provided.

The AWEN Group maintains a comprehensive and customizable array of training programs for animal care and use, including IACUC training, and can assist in the preparation of all USDA documentation. To discuss the specific needs of your institution, contact AWEN at info@theawengroup.com or 888.770.2936.

City of Boston Tightens Biosafety Rules for Research

In September 2006, the Boston Public Health Commission published new biosafety rules for oversight of research. Under the regulations, institutions doing work at Biosafety Levels 3 and 4 must obtain a permit from the Commission; set up a biosafety committee that includes two outside community members; and submit regular reports on research and safety procedures. In addition, laboratories in Boston must hold public meetings to disclose ongoing research.

Institutions that fail to comply with the new rules could face fines of $1,000 per day/per violation and a suspension of the research.

The AWEN Group offers biosafety management and support services, as well as a customizable array of training programs for institutional biosafety, including IBC training, and can assist in the preparation of documentation. To discuss the specific needs of your institution, contact AWEN at info@theawengroup.com or 888.770.2936.

NIH-USDA-FDA Release New Joint Memo of Understanding

NIH, USDA, and FDA have participated under a Memorandum of Understanding (MOU) Concerning Laboratory Animal Welfare for much of the past two decades. Each agency, operating under its own authority, has specific responsibilities for fostering proper animal care and welfare. This agreement sets forth a framework for reciprocal cooperation intended to enhance agency effectiveness while avoiding duplication of efforts in achieving required standards for the care and use of laboratory animals. A new MOU, outlining each agency's responsibilities and shared concerns, was released March 1, 2006.

Internal USDA Audit Report Uncovers Compliance Concerns

In September 2005, the Office of the Inspector General (OIG) of the U.S. Department of Agriculture (USDA) published an audit report on enforcement of the Animal Welfare Act (AWA). The report addresses the inspection and enforcement activities of the USDA's Animal Plant and Health Inspection Service (APHIS), which is responsible for responsible for monitoring animal research facilities for compliance with the AWA.

The OIG report uncovered problems with the agency's enforcement of the Animal Welfare Act (AWA), prompting USDA to recommend several corrective actions. Specifically, the audit found concerns relating to oversight of research facilities, for example, a finding that APHIS has been lax in enforcing sanctions of AWA violators. The auditors also found under-reporting of the numbers of animals used on the part of licensed institutions. The document faults the oversight of Institutional Animal Care and Use Committees (IACUCs) for not effectively monitoring mandated activities. The report says IACUCS are not adequately following up on deficiencies, in part because of high turnover and inadequate training among panel members.

Based on the audit, the USDA has made recommendations to clarify enforcement policy; review cases of "declined" enforcement; eliminate the discounts on fines when facilities agree to settle out of court and increase fines overall, along with calculating fines according to number of animals affected. The USDA also plans to revise the Research Facility Inspection Guide to require Veterinary Medical Officers (inspectors) to verify the actual number of animals used in research institutions.

The AWEN Group can conduct program reviews and provide program support and training for animal care and use, including IACUC support and training. To discuss the specific needs of your institution, contact AWEN at info@theawengroup.com or 888.770.2936.