The use of Laboratory animals is a privilege not a right. Under the ethical and legal standards in the United States, institutions have a duty to ensure the welfare of the animals they use in biomedical research, teaching or testing. In addition all animal studies should be designed to generate results and to minimize time and avoidable animal loss. The federal government and the City of Cambridge have regulations you must comply with in order to use Laboratory Animals.

THE FEDERAL LAW
The Animal Welfare Act (AWA) requires that minimum standards of care and treatment be provided for certain animals bred for commercial sale, used in research, transported commercially, or exhibited to the public. Individuals who operate facilities that use animals in this way must provide their animals with adequate care and treatment in the areas of housing, handling, sanitation, nutrition, water, veterinary care, and protection from extreme weather and temperatures. Although Federal requirements establish acceptable standards, they are not ideal. Regulated businesses are encouraged to exceed the specified minimum standards.

Exemptions
The AWA regulates the care and treatment of warm blooded animals, except those – such as farm animals – used for food, fiber, or other agricultural purposes, rats of the genus Rattus, and Mice of the genus Mus bred for research.

Currently, cold blooded animals, such as snakes and alligators, are exempt from coverage under the Act. Retail pet shops are not covered under the Act unless the shop sells exotic or zoo animals or sells animals to regulated businesses. Animal shelters and pounds are regulated if they sell dogs or cats to dealers. Pets owned by private citizens are not regulated.

The AWA also requires that all individuals or businesses dealing with animals covered under the law be licensed or registered with APHIS.
Excerpted from USDA Animal Care Fact Sheet.

CAMBRIDGE LAW
Cambridge Laboratory Animal Ordinance (CLA) Chapter 6.12 CARE AND USE OF LABORATORY ANIMALS.

In the city of Cambridge Massachusetts, to use any laboratory animal you must register with the Cambridge Commissioner of Laboratory Animals. The ordinance covers all warm blooded animals including mice and rats bred for research.

Section 6.12.040 Guidelines for the care and use of animals.

All experiments on all animals within the City shall be undertaken in conformity with all federal, state and local statutes, ordinances and regulations concerning the welfare of animals including the “Guide for the Care and Use of Animals” of the National Institutes of Health, the “Animal Welfare Act” (7 U.S.C. sections 2131, et seq.), the Health Research Extension Act of 1985, the “Public Health Service Policy on Humane Care and Use of Laboratory Animals,” G.L. c. 140, s. 174D, and 105 CMR 910.000 et seq., all as amended or revised from time to time. (Ord. 1086 (part), 1989: prior code § 11-33).

The ordinance uses the Guide for Care and Use of Lab Animals as its primary regulatory document.

2. When you receive the application fill it out and return it to USDA Animal Care. The USDA has 60 days from receipt of your completed application to perform the first unannounced site visit. You may begin operations once you have received a registration number and you have complied with all the aspects of the AWA. The Act can be read electronically. There is an application and three year renewal fee, which is generally less than $100.00.

3. Enter into an arrangement with a veterinarian with experience in Laboratory Animal Medicine and fill out the Program of Veterinary Care document that was included with the application. This document is NOT sent in to USDA. It is kept on hand for inspection review when the USDA inspector (Veterinary Medical Officers) arrives unannounced at your facility to perform a compliance inspection.

USDA/APHIS/AC
920 Main Campus Drive, Suite 200
Raleigh, NC 27606-5210
(919) 855-7100

Steps to comply with the Cambridge Ordinance;
1. Contact the Commissioner of Laboratory Animals (CLA) to request an application.
The commissioner is part time; so a few phone calls/emails may be necessary.

Julie Medley, DVM
JMedley@challiance.org
Cambridge Public Health Dept
119 Windsor St.
Cambridge MA 02139
(617) 665-3853

2. Fill out Application and return to CLA.

3. Institutional Animal Care Use Commitee (IACUC) must have met and approved and inspected facilities before commissioner will come and inspect. Commissioner will require environmental enrichment for all species and that the Non Scientist is not the same person as the unaffiliated. The two positions must be filled by two individuals.

4. Fee is based on numbers of Animals used.

5. Animal use may not commence until the commissioner has inspected or gives permission. This may take 1-2 months.

Other regulatory requirements that may apply:
If the company is currently receiving any federal funding (SBIR, NIH, NSF, NCI or others), the federal government, by virtue of funding the research, requires the company have an Assurance on file with Office of Lab Animal Welfare (OLAW). The Assurance is only for currently funded research. It is not available proactively. You can not apply unless you have federal funding. If you are applying, you will be notified when the award is granted that you must now apply for an assurance. OLAW uses the Guide for Care and Use of Laboratory Animals as its primary regulatory guideline; therefore rats and mice bred for research are covered under IACUC review.

An “Assurance” is a written, binding commitment an institution submits to a federal agency promising to comply with human subjects or research animal regulations, and stating procedures for achieving compliance. These are required by the National Institutes of Health (NIH) Office of Extramural Research (OER) prior to granting public funding. For more information and to see a sample of an Animal Welfare Assurance, please refer to the Web site of the NIH-OER-Office of Laboratory Animal Welfare (OLAW) and look under “Sample documents for Implementation of PHS Policy.”

CLA: Julie Medley, DVM
Email: JMedley@challiance.org
Phone: (617) 665-3853

Unknown

2) Is there a cost involved and how do you find out how much?

USDA generally less than 100 dollars
CLA Based on number of animals

3) How long should you expect to wait before getting a response?

USDA within one week
CLA is a part time position; return call time may vary

Results of UDSA inspections and annual reports are available on the Web. It is important to be complaint with these regulations to avoid being targeted by animal activists who use these data to select companies.

USDA animal Care

OLAW

Animal Welfare Act

Guide for Care and Use of Lab Animals

Sample IACUC training