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Better Science

X. WHAT NEEDS TO BE DONE

Academia - Government - Industry - Consumers

Simple procedural changes by regulatory organizations and industry that do not require any new validated tests could drastically and immediately reduce the number of animals used in safety testing as well as promote greater reliance on humane alternatives. These would include the following:

  • Minimize testing done for notification purposes (e.g., new batches of approved substances).

  • Place an emphasis on alternatives-focused, step-wise or tier-testing rather than simplistic adherence to check-box or six-pack protocols.

  • Mandate the inclusion of structure-activity relationships, in vitro methods and mathematical models whenever available.

  • Prohibit tests that are irrelevant to the use of the product

  • Switch the scientific basis of toxicity testing from correlative to mechanistically-based methods.

  • Facilitate dialogue between the scientific, toxicological and industry communities, with mandatory requirements for data sharing.

  • Promote greater international harmonization of both testing requirements and data acceptance. There is no need for each country to repeat the validation and regulatory decisions of another.

  • Fully analyze pubic and private databases for information on existing chemicals to enhance computerized testing programs and to determine if significant "gaps" actually exist.

  • Support the creation and enforcement of legal requirements for immediate regulatory acceptance and academic/industry use of validated alternatives.

  • NIH and other research support agencies and organizations should give higher approval review scores to protocols based on the development and/or use of alternative methods. Regulatory agencies should proactively support use and submission of in vitro versus in vivo data.

  • The United States needs effective inter-agency dialogue and coordination to centralize and promote alternative method development and validation, regardless of individual agency regulatory mandates.

  • Human tissues are still not available in sufficient amounts to meet the needs of basic researchers and toxicity testing. A nation-wide system of donor promotion and storage facilities is needed.

There is still a need for more collaboration between and financial support from academia, industry and regulatory agencies to proactively support the identification, fast-track development, validation, acceptance and use of new alternative methods. This would include increased funding for high quality validation studies and provisions of adequate resources and specialized laboratories to design and manage those projects. Initially there should be priority funding for key target areas such as HPV, ED and basic research involving pain and distress to the animals.

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Other NEAVS Fact Sheets:
Benefits of Non-Animal Tests | Xenotransplants | Animal Welfare Act | Limitations of Animal Tests | Non-Animal Product Safety Test Alternatives

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Three rats in cage.

In the United States, the Animal Welfare Act (AWA) and Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals are the two main regulations governing the use of animals in laboratories.

However
, even with the supposed "protections" afforded by the AWA and PHS Policy, millions of animals suffer and die in unnecessary, counterproductive research.

AWA and PHS regulations for animals in labs are limited in their scope and fraught with loopholes that continue to allow for both physical and psychological cruelty and suffering.