Senator Lautenberg Introduces Bill To Overhaul The Toxic Substances Control Act Of 1976 (TSCA)
Yesterday, Sen. Frank R. Lautenberg (D-NJ) introduced S. 3209, the Safe Chemicals Act of 2010 (S. 3209 or The Safe Chemicals Act) to reform and modernize TSCA. Sen. Lautenberg's legislation builds upon the Kid-Safe Chemicals Act of 2008. The Safe Chemicals Act includes provisions that contain concepts similar to those utilized by the European Union's legislation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), but does not contain some of the more structured mandates of the EU legislation.
One of the most significant provisions in the Safe Chemicals Act is that manufacturers must demonstrate existing and new chemicals meet the safety standard of "reasonable certainty of no harm." The bill defines this standard as "a negligible risk of any adverse effect on the general population or a vulnerable population" from aggregate and cumulative exposure to a chemical or mixture of chemicals. Should EPA determine that a manufacturer has failed to meet that burden the manufacturer cannot make, process, or market the chemical in question. Like REACH, S. 3209 is premised on the idea that industry is best positioned to prove that chemicals in the marketplace are safe versus the government having to prove they are not.
The Safe Chemicals Act also requires chemical manufacturers to develop and submit data sets that include information on the characteristics, hazards, use, and exposure of chemicals. Based on this information, EPA is granted broad authority to require testing and/or the submission of chemical samples that it deems necessary. Based on the data collected EPA would be required to develop and prioritize a list of at least 300 chemicals based on risk relative to other chemical substances, presence, use, production volume, toxicity, persistence, bioaccumulation, or other risk-indicative properties. EPA would be required to expedite action on chemicals that clearly pose the highest risk to human health or the environment.
To better inform the public a new publicly accessible, online database containing information on chemicals would be established. The database will contain information submitted to EPA from both public and private entities, as well as related EPA findings. Notably, manufacturers claiming that data submitted to EPA constitutes confidential business information must do so in writing, include a justification for each claim of confidentiality, and certify that such information is not publicly available. Confidential information can be shared with state, tribal, and municipal governments provided that the recipient governments take appropriate measures to maintain confidentiality.
Last, Sen. Lautenberg's bill also requires EPA to establish a green chemistry program that will create incentives for manufacturers to develop safer alternatives to existing chemicals. Unlike REACH, which requires manufacturers to analyze possible substitutes for chemicals of high concern and to prepare substitution plans in the event that there are suitable alternatives, Sen. Lautenberg's bill establishes incentives to evaluate safer alternatives versus mandates.
Sen. Lautenberg's bill will have far-reaching impacts on chemical manufacturers. By shifting the burden to manufacturers to prove the safety of chemicals in commerce and by establishing data development and submission requirements, manufacturers will incur added cost burdens in complying with the reformed TSCA. Moreover, there is sure to be confusion and ambiguity regarding what will constitute "a reasonable certainty of no harm." The safety standard language mirrors changes made under the Food Quality Protection Act of 1996, which revised how EPA reviews pesticide chemical tolerances or maximum residue levels. Unlike pesticides, however, which have a directed focus and use, applying this nebulous standard to chemicals used in literally thousands of different use applications and as many different purposes may prove a difficult challenge.
The reform measures proposed in Sen. Lautenberg's bill also will undoubtedly impact downstream users of chemical products. As is the case with REACH, Sen. Lautenberg's bill gives the government the authority to require not just manufacturers, but also downstream users and persons who dispose of chemicals, to maintain and report records relating to chemicals that may assist in making safety determinations.
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