Legislation & Regulation In The United States of America

In the US, the Animal Welfare Act 1966 sets out the minimum standards of care and treatment for animals used in research, across the country. This was first enacted in 1966, and also includes regulations on other animal uses and practices, such as the pet trade. It is enforced by the US Department of Agriculture, through the Animal Care Programme of the Animal and Plant Health Inspection Service.

In terms of animals protected under the Animal Welfare Act, birds, rats (of the genus Rattus) and mice (of the genus Mus) are explicitly excluded. There is also no mention of fish, amphibians and reptiles, meaning that none of these species are protected either. The exclusion of these species, particularly birds, rats and mice, is a major limitation of the Act, as they are the most commonly used species within research in the US – estimated to be around 90% of all animals used.

In terms of regulation, the Animal Welfare Act sets out:

• Minimum standards of veterinary care and animal husbandry
• Requirements for licensing of research procedures, but not individuals
• Requirements for the provision of anesthesia and pain relieving medication
• Requirements for facilities to provide dogs with opportunities for exercise
• Requirements to promote the psychological well-being of primates
• Forbiddance of unnecessary duplication of experiments
• Requirements for the establishment of Institutional Animal Care and Use Committees to oversee the use of animals

In 2015, the Humane Cosmetics Act was introduced to phase out cosmetic animal testing and the sale of cosmetics that have been tested on animals.

Canada 

The Canadian Council on Animal Care (CCAC) is an independent body that oversees animals use in scientific research throughout Canada. As an organisation, they have established requirements for institutions to follow, under the Guide to the Care and Use of Experimental Animals. This was most recently revised in April 2020. These guidelines provide details on:

• Animal facilities and housing
• Behavioural requirements and welfare or each species
• Transportation
• Breeding
• Health and safety
• Controls of animal pain and anaesthetic
• Euthanasia
• 3R’s
• Animal Care Committees and Research Ethics Boards

The use of animals in research in Canada is regulated on a Provincial basis, rather than nationally, with each province having their own animal welfare laws. Out of the 10 provinces in Canada, 8 of them have incorporated the CCAC guide into their own legislation, meaning that despite the guide not being legally binding on it’s own, the guidelines it has set out now must be followed in:

• Alberta, under the Animal Protection Act 2000
• Manitoba, under the Animal Care Act 1998
• Newfoundland and Labrador, under the Animal Health and Protection Act 2012
• Nova Scotia, under the Animal Protection Act 2018
• Prince Edward Island, under the Animal Health and Protection Act 1988
• Quebec, under the Animal Health Protection Act and Animal Welfare and Safety Act
• Saskatchewan, under the Animal Protection Act 1999
• Ontario, under the Animals for Research Act 1990 – the only province to have an act specific to animal use in research.

Brazil 

In Brazil, the Brazilian National Council for the Control of Animal Experimentation (CONCEA) is the legal authority responsible for regulating the use of animals in research. CONCEA was set up in 2008, and issued Law No. 11794, Brazilian Federal Law on Animal Experimentation, in the same year. This piece of legislation details responsibilities such as licensing, what animals are protected, classification of procedures, ethical review bodies, penalties for non-compliance, etc. Law No. 11794 was enacted in 2009 by federal Decree No. 6899 of 2009. CONCEA also produce a range of species specific guidance documents that provide comprehensive detail on housing and husbandry requirements.

Ethical reviews are conducted on a national scale by CONCEA, and institutionally through Ethics Committees on the Use of Animals (CEUA). These involve accrediting institutes for animal use, reviewing projects prior to taking place and throughout, maintaining records of animal use, and monitoring for alternatives

In 2012 Brazil set up the Brazilian Centre for Validation of Alternative Methods (BraCVAM) and The National Network of Alternative Methods (RENAMA). BraCVAM is a partnership between the National Institute of Health Quality Control (INCQS/Fiocruz) and the National Health Surveillance Agency (ANVISA). Two years later BraCVAM recommended 17 validated alternative methods published by the OECD that were accepted by the CONCEA after hearing the Brazilian regulatory agencies. In July 2015, the ANVISA Executive Board decided that all alternative methods recognised by CONCEA will be immediately accepted by ANVISA.