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In order for the European Union to fulfil its commitments to reduce animal experiments by 50 per cent, promote the development and validation of non-animal methods and avoid duplicate chemical-testing in the implementation of its new chemicals policy, the EU must commit to the following actions:
1. Evaluate human and environmental exposure to existing chemicals and publish these findings for public comment. Although many industrial chemicals have toxic properties, it is only when the public or environment is actually exposed to these chemicals that their use can become dangerous. Therefore, only chemicals with significant human or environmental exposure should be considered candidates for testing regardless of the volume in which they are produced.
2. Require data-sharing among companies and countries to ensure that all existing chemical toxicity information (particularly in the hands of chemical companies) is made available. One approach that has proved to be very successful is to establish an amnesty period for chemical companies to share previously withheld chemical information. Legislative measures may also be appropriate.
3. Fully analyse data submissions, in consultation with government regulators worldwide, and thoroughly characterise the actual extent of any knowledge gap for existing chemicals. This information should be published on the Internet, and public comment should be accepted for at least one year. All public comments that are received should be published, and the Commission should commit to re-evaluating proposed test plans on the basis of public comments.
4. Take immediate regulatory action to:
1. Prevent human or environmental exposure to any chemical that does not break down in the environment (persistent) or can become concentrated in the food chain (bio-accumulative). Every effort should be made to phase these chemicals out of production;
2. Actively restrict the release of industrial chemicals into the environment; and
3. Reward industry efforts to use the least hazardous chemicals available (principle of substitution).
5. Prioritise chemicals for further testing based on:
1. The actual risk they pose to human health or the environment (per Recommendation 1);
2. A thorough review, characterisation and documentation of information gaps (per Recommendation 3); and
3. Coordinated discussions with other countries to ensure that duplicate testing does not occur.
6. Require that similar chemicals be tested as a group rather than
individually. Grouping chemicals into categories for testing is common in other countries and vastly reduces both the financial and the animal welfare costs associated with a large-scale chemical-testing programme.
7. Publish a list of all chemicals being considered for further testing and the tests being proposed for each (per Recommendation 5) and accept public comment for at least six months following the publication of each chemical test plan. All public comments that are received should be published, and the Commission should commit to re-evaluating proposed test plans on the basis of public comments.
8. Proactively support the fast-track development, validation and incorporation of non-animal methods in lieu of animal tests in the EU chemicals policy by:
1. Establishing, in consultation with the European Centre for the Validation of Alternative Methods (ECVAM), an aggressive and targeted strategy and timetable for the validation of new non-animal test methods. This timetable should be written into the EU chemicals policy and strictly enforced;
2. Vastly increasing the funding made available to those such as ECVAM to permit the successful implementation of this strategy;
3. Harmonising the international validation and regulatory acceptance process for non-animal test methods to maximise the use of alternatives and avoid the unnecessary duplication of validation efforts;
4. Conducting the chemical-testing using a battery of in vitro screening tests performed according to a stepwise strategy (e.g., cytotoxicity, genetic toxicity and structure-activity relationship analysis), followed by further in vitro tests as a result of the European Commissions new, coordinated validation initiative; and
5. Committing, when a complete risk assessment cannot be performed using available non-animal methods, to delay further testing until new non-animal methods have been validated and accepted.
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