By Lisa Seachrist
WASHINGTON ¿ In the wake of a petition to expand the regulatory authority of the U.S. Department of Agriculture (USDA) to mice and rats bred for research, the biomedical research community is attempting to assess the extent to which the department¿s duties will increase.
The National Association for Biomedical Research (NABR) and the Biotechnology Industry Organization (BIO) are surveying their members to provide an accurate assessment to the USDA of how many new facilities will need to be inspected by the Animal and Plant Health Inspection Service (APHIS).
Barbara Rich, executive vice president for NABR, said no one knows the exact number, but ¿APHIS has less than a $10 million budget to conduct all of its current inspections, [and] if the petition were to go into effect they would need a lot more money.¿
The USDA is seeking comment until May 28 on a petition for rule-making that would amend the Animal Welfare Act to include the regulation of birds, and rats and mice bred for laboratory research. The petition was brought by the Alternatives Research and Development Foundation, which is affiliated with the Antivivisection Society. That group has recently filed suit in U.S. District Court to enforce the petition.
Rich pointed out that the use of research animals is regulated under a number of laws, including the Good Laboratory Practices enforced by the FDA and the Environmental Protection Agency, as well as measures in force through the Department of Health and Human Services. In addition, many animal facilities choose to be accredited by the Association for the Assessment of Laboratory Animals.
¿I¿m not going to say that these regulations cover all uses of research animals,¿ Rich said. ¿We are trying to find out from our members what assurances they have in place, and what regulations they fall under for the appropriate use of research animals.¿
Rich pointed out that, while the larger academic research institutions and the larger companies have the specialized facilities in place, smaller companies may not.
¿For most of our members, the change will result in record-keeping and an additional inspection,¿ Rich said. ¿For smaller entities, it may be a physical plant issue, where additional facilities may have to be built. That¿s why it¿s particularly important that we hear from biotechnology companies to get an idea of what the petition could mean for them.¿
Allan Goldhammer, executive director of technical affairs for BIO, said BIO is actively working with NABR to get just that information.
¿BIO is going to be surveying our membership to find the extent to which research with rats and mice occurs,¿ Goldhammer said. ¿With all the genetically engineered rodent disease models, it¿s likely quite a lot. We think there is a significant public interest in seeing this type of work go forward to provide new therapies.¿
Rich said that NABR is concerned with both the potential duplication of effort and the costs to the already under-funded USDA. However, the organization is focusing on generating the most complete picture of the biomedical research community¿s use of these animals.
¿This is the time for people to get involved in this process,¿ Rich said. ¿We really need to hear from all sectors of the community.¿ n