Guidance on the NIH Plan to Transition from the use of USDA Class B Dogs to Other Legal Sources

Notice Number: NOT-OD-11-055

Update: The following update relating to this announcement has been issued:

  • December 17, 2013 - See Notice NOT-OD-14-034. Notice Regarding NIH Plan to Transition from Use of USDA Class B Dogs to Other Legal Sources.
  • February 8, 2012 - See Notice NOT-OD-12-049. Notice Regarding NIH plan to Transition from use of USDA Class B Cats to Other Legal Sources.

Key Dates
Release Date: March 18, 2011

Issued by
National Institutes of Health (NIH)

Purpose

The National Institutes of Health is implementing a plan to phase out the allowance of using funds to obtain dogs for NIH-supported research from USDA Class B vendors and limit funds to obtaining dogs used for research to other legal sources1. This transition plan is in accordance with the recommendations of the Institute for Laboratory Animal Research (ILAR) report Scientific and Humane Issues in the Use of Random Source Dogs and Cats in Research (2009) http://dels.nas.edu/Report/Scientific-Humane-Issues/12641

BACKGROUND

Many medical advances that enhance the lives of both humans and animals originate from animal studies. The types of animals used in research are chosen for their biological similarity to humans in areas such as anatomy, physiology, and genetics. This research can lead to insights into how to prevent, treat, and cure human diseases. Often the treatments developed for humans can also be used to improve the health of animals.

All animals used in federally funded research are protected by laws, regulations, and policies to ensure the smallest possible number of subjects and the greatest commitment to their comfort. Fulfilling these protections is a collaborative effort between NIH, federally supported scientific investigators, and research institutions. The majority of dogs used in biomedical research are either purpose-bred for research by USDA Class A vendors, or bred and raised in privately owned research colonies. Some research dogs, however, commonly referred to as random source dogs, are procured from USDA licensed Class B dealers. These dealers acquire dogs from random sources such as individual owners, small hobby breeders, dog pounds and animal shelters.

The public and Congress have expressed concern about the humane treatment of animals acquired for use in biomedical research, particularly that of random source dogs. In FY2008, the NIH Appropriations language asked the NIH to seek an independent review by a nationally recognized panel of experts of the use of Class B dogs in federally supported research to determine how frequently such animals are used in NIH research and to propose recommendations outlining the parameters of such use, if determined to be necessary. (Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill, 2008 (S. 1710) Referenced in the Consolidated Appropriations Act 2008, P.L. 110-61 signed 12/26/2007.)

The scope and timeline for the requested report were discussed with the National Academy of Sciences (NAS) in early 2008 and an award was made to conduct the study in June 2008. In May 2009 representatives from the NAS met with NIH staff and delivered the study report Scientific and Humane Issues in the Use of Random Source Dogs and Cats in Research. The report made a number of recommendations and concluded that it is desirable to assure continued access to animals with random source characteristics, e.g., large, mature, tractable, and socialized. However, this access can be accomplished with existing alternative mechanisms other than through USDA Class B dealers and can be assured with additional effort.

TRANSITION

To facilitate the transition from USDA Class B to other legal sources of dogs, NIH is implementing an aggressive acquisition plan to develop a USDA licensed commercial Class A vendor to breed dogs possessing the same characteristics as those previously acquired from USDA Class B dealers, namely large, mature, socialized out-bred hounds or mongrels. Under this pilot project, a limited number of dogs with these characteristics will be acquired and made available at no charge to NIH supported investigators with a demonstrated scientific need. A limited number of animals will be available in Fiscal Year 2011, as part of the 3-5 year pilot project, allowing for the potential need to expand breeding colonies and the forecasted time necessary to breed, wean, socialize and raise animals to a size and age required for selected research purposes. NIH Program Officers will be contacting grantees over the next 48 months regarding participation in the pilot project. Initially, dogs will be made available to test the maturation and socialization programs for these animals, as well as consistency with phenotypic characteristics sought in previously procured USDA Class B animals. During this transition period, NIH will closely monitor the pilot project to ensure that scientifically appropriate animals in adequate numbers will ultimately be available for NIH-supported researchers.

NIH strongly encourages awardees that use or are considering acquisition of dogs from USDA Class B dealers for use in NIH supported research to begin identifying and acquiring dogs from other legal sources. It is anticipated that no later than 2015, NIH will fully implement a new policy prohibiting the procurement of dogs from USDA Class B dealers using NIH grant funds.

IMPLEMENTATION

A successful pilot project will allow NIH to fully implement the recommendation of the Institute for Laboratory Animal Research report Scientific and Humane Issues in the Use of Random Source Dogs and Cats in Research (2009) that:

Although random source dogs represent a very small percentage of animals used in biomedical research, this small number is not commensurate with their potential value, and it is desirable to assure continued access to animals with random source qualities. This access can be accomplished with existing alternative mechanisms other than Class B dealers and can be assured with additional effort.

The precise implementation date of a new policy prohibiting the procurement of dogs from USDA Class B dealers using NIH grant funds will be determined following the pilot and announced in the NIH Guide. The policy will limit the use of grant funds to research only utilizing dogs from USDA Class A dealers, or approved legal sources other than USDA Class B dealers.

Inquiries

General inquires about this change may be directed to:

Margaret Snyder, Ph.D.
Office of Extramural Research
National Institutes of Health
6705 Rockledge Drive, Suite 5040
Bethesda, MD 20892
Phone: (301) 402-1058
E-mail; snyderm@mail.nih.gov

1Other legal sources include Class A vendors, privately owned colonies (e.g. NCI-supported intra-institutional existing colonies, or colonies established by donations from breeders or owners because of genetic defects such as bleeding disorders) or client owned animals (e.g. animals participating in vertinary clinical trials.)