On December 1, 2011, NIH announced that on January 1, 2012 the new 8th edition of the Guide for the Care and Use of Laboratory Animals will go into effect for all animal care and use programs. As of that date, all institutions conducting PHS-supported activities involving animals must use the standards in the 8th edition for all activities covered under their Assurance. Within the next 12 months institutions will also be required to complete at least one semi-annual program review and facilities inspection using the new Guide and to have in place to implement any necessary changes. The plan must be in place by December 31, 2012 even if it takes longer than that to implement the changes.
On February 24, 2011, NIH issued a Federal Register announcement requesting public comments on its adoption of the new Guide and proposed an implementation plan that would have required institutions to complete a semiannual inspection using the new Guide by March 31, 2011. The original 30-day comment period was subsequently extended first to 60 and then to 90 days. Ultimately NIH received about 800 comments that the agency analyzed. A summary of these comments has been posted on the NIH website.
In its analysis of the comments submitted, NIH determined that “a majority of respondents opposed the adoption of the 8th Edition of the Guide.” At the same time, many organizations and individuals who opposed the adoption of the Guide were supportive of some sections but objected to specific issues. NIH’s Office of Laboratory Animal Welfare (OLAW) sought to address these concerns by posting comments affirming its support for performance standards and defending the Guide’s reliance on practice standards developed by experts in the field of laboratory animal care. OLAW also responded to key issues in a series of Position Statements that were published late in the day on December 1. These Position Statements “describe the ways in which OLAW expects institutions to implement the 8th Edition of the Guide.” Topics include:
- Cost “cannot be the overriding factor” in animal welfare issues and compliance with the new Guide
- Performance standards may be used in determining appropriate housing
- Why pharmaceutical-grade chemicals may be required and when non-pharmaceutical grade drugs such as investigational compounds, veterinarian- or pharmacy-compounded drugs, and/ or Schedule I controlled substances can be used to meet scientific and research goals.
- When multiple surgical procedures are acceptable
- Applicability of the Guide to farm animals
There is a 61 day period public comment period on these position statements that will end January 30, 2012. (See web link accompanying each position statement to submit comments.)
On December 1 OLAW also updated 23 FAQs and issued 6 new ones. Of particular interest to researchers are the following updated topics concerning animal use and management:
In addition, OLAW issued new FAQs on the following topics:
Background: OLAW New Guide Implementation
After the pre-publication version of the 8th edition of the Guide for the Care and Use of Laboratory Animals was published in June, 2010, NIH’s Office of Laboratory Animal Welfare (OLAW) announced that it would continue to use the 7th edition until the final version of the Guide was published and an implementation plan was announced.
On February 24, 2011, OLAW proposed a one-year transition period, with assured institutions required to complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012. OLAW asked for comments on this proposal and also asked for comments on the broader question, namely, whether NIH adopt the new Guide as the basis for evaluating the animal care programs of institutions seeking to obtain federal research funding.
OLAW’s request for comments initially allowed a 30-day period for responses. However, that was subsequently extended to 60 and then to 90 days. The comment period closed on May 24, 2011.
On June 9, 2011, OLAW announced that the 7th edition of the Guide would remain in effect pending its review and analysis of the comments. Moreover, upon completion of that review, the comments themselves will be posted online, and OLAW will issue one or more position statements and an updated implementation plan. These documents will also be subject to public comment periods.
APS submitted comments affirming that there were important updates in the new Guide while also taking the position that OLAW should not adopt the new Guide unless it did so in the framework of outcome-oriented performance-based standards. APS argued that if OLAW were to implement certain sections of the Guide without the flexibility inherent in performance standards, the Guide would effectively function as a regulatory document. In that case, it should undergo appropriate regulatory review.