Exciting and expected news announced from the White House this week: The Frank R. Lautenberg Chemical Safety for the 21st Century Act, which provides for common-sense amendments to the Toxic Substances Control Act (TSCA), was signed into law by President Barack Obama after bipartisan support in both houses of Congress.
Typically a divisive area of law, the law revamps TSCA and finally gives the Environmental Protection Agency (EPA) the authority it needs to effectively regulate the chemical industry of the 21st century. The law contains a number of important amendments that should help modernize the industry. Under the law, the EPA has a number of new obligations that will present both opportunities and challenges for industry.
Under the law, chemicals being used in commerce and new chemicals to be introduced will receive much more scrutiny by the EPA. When TSCA was first enacted, approximately 62,000 chemicals were grandfathered-in, meaning they did not go through any type of risk assessment and were allowed to remain in commerce. The Act now mandates the EPA to review the risk of chemicals currently being used in commerce and the EPA may issue an order requiring testing for both new and existing chemicals. The EPA must differentiate between high and low priority chemicals for evaluation, and risk evaluation procedures must be established though notice-and-comment rulemaking. Under the old regime, a new chemical had to be shown to pose an unreasonable risk before the EPA could request more information from the manufacturer. Even when a chemical may have been shown to pose an unreasonable risk, the procedure for evaluating the risk utilized a cost-benefit balancing standard. Under the new law, the EPA has the authority to request more information on any new chemical. In addition, only human and environmental impacts are relevant to risk assessments; cost may be considered in determining how to regulate, but not whether to regulate.
Previously, the operative mechanism of TSCA required manufacturers to give EPA notice prior to manufacture (pre-manufacture notice [PMN]) of a new chemical. Unless the EPA went through testing and found that the chemical posed an unreasonable risk, the chemical could be manufactured and distributed in commerce. Because manufacturers only had to submit the PMN 90 days prior to manufacture – EPA rarely had enough time to complete a proper risk assessment. The EPA must now affirm the safety of a new chemical before it may enter commerce.
Other important provisions of the Act are the inventory reset rule and changes to confidential business information (CBI) claims. The inventory reset is something that manufacturers will want to pay attention to and understand. The current inventory lists over 84,000 chemicals, most of which are not even in commerce, yet the EPA doesn’t know exactly which chemicals are active or inactive (no longer in commerce). The reset requires the EPA to distinguish between active and inactive chemicals, allowing the agency to focus on chemicals that are still in commerce and therefore pose the most risk to the public. Manufacturers will want to make sure their chemicals are reported to the agency so that they may be put on the ‘active’ list and allowed to remain in commerce. Companies that violate this requirement may face large fines. The rule also requires manufacturers to report all of the chemicals they have manufactured in the previous ten years.
Under TSCA, CBI claim review was not required, meaning that manufacturers simply had to make a claim to be protected. CBI information would only be disclosed to state and local governments if the manufacturer authorized the disclosure. Now, the EPA must review all CBI claims for chemicals maintained on the active inventory list, and those claims will expire after 10 years. Additionally, under certain circumstances, state and health professionals will be given access to information that is otherwise CBI-protected. Furthermore, manufacturers must substantiate the basis for claiming that a chemical identity should be kept confidential.
In short, industry and government alike are touting the TSCA Amendments as a considerable upgrade and positive reform of TSCA. While the bipartisan support is evidence of compromise and improvement, some experts believe that the mandates required by the Act are too large of a job for the resource-limited EPA. Time will tell whether the EPA is able to meet its new regulatory obligations on this important area of law.