Testing Authority

Additional Testing Authority The original TSCA rule had several provisions for testing of chemical substances or mixtures. Section 4 of the legislation outlined these testing requirements. If a chemical was thought to present an unreasonable risk to health or the environment, but testing was necessary to obtain data to support this claim, then testing was to be required for that chemical. Testing was also required for chemicals or mixtures that would be produced, processed, distributed, etc. in large quantities and that may have a harmful effect on health or the environment. The Frank R. Lautenberg Chemical Safety for the 21^st Century Act has provided the EPA with additional testing authority for certain chemical substances and mixtures. The previous requirements remain in place, but the agency may now:

• Require additional information through testing to perform a risk evaluation or implement a new rule or regulatory requirement, or if a Federal authority requests information under another Federal law.
• Require additional information in order to prioritize a chemical substance, so long as the chemical is designated within 90 days of receiving the information.

If the EPA requires the development of such new information, the agency must release a statement of need. This would include why it was concluded that new information was needed and explain the reason for issuing the request for information rather than promulgating a regulation. The new Act has also added a subsection on tiered testing. When the EPA requires the development of new information, the most basic testing must be done, and then the agency may use the results of that test to determine if more stringent testing should be completed. If the agency already has information that leads them to believe that more advanced testing is needed, they may skip any preliminary testing. Reduction of Testing on Vertebrates Before requesting that testing must be done involving vertebrate animals, the EPA must take into consideration any available information. When requiring the development of information that would involve the use of vertebrates in testing, the agency must publish a statement of need, which should explain the basis for this decision. The agency must also encourage and facilitate scientifically valid alternatives to using vertebrate animals where applicable. In order to promote the development of alternative testing methods, the agency must develop a strategic plan within two years of implementation of the rule, which should include a list of testing methods that do not require the use of vertebrates. As part of this effort, the EPA must facilitate public notice and comment period on the strategic plan developed. Five years after the enactment of this rule, the agency must submit a report to congress describing the progress made in implementing the plan.  The rule also gives EPA the authority to group similar chemicals together, in instances where testing on one chemical would produce valid information on the other chemical. Facilitation of joint testing among industries will be a responsibility for the EPA in order to reduce unnecessary duplication of tests.