What the Toxic Substances Control Act Overhaul Means to Manufacturers
The U.S. Senate passed the long-pending bill (S. 697) to overhaul the Toxic Substances Control Act, which will bolster the government’s power to regulate a wide variety of chemicals. The practical effect of the Frank R. Lautenberg Chemical Safety for the 21st Century Act will be to shift the burden and cost of evaluating and regulating chemicals to manufacturers, along with imposing new user fees, while also allowing U.S. EPA to consider—without regard to cost—the health and safety impact of chemicals. The bill will now need to be reconciled with the U.S. House of Representatives’ bill passed in June (the Toxic Substances Control Act Modernization Act).
The bill would amend the Toxic Substances Control Act (TSCA) for the first time in forty years, to ensure that only human and environmental health are considered in assessing the safety of chemicals, and replace TSCA’s current standard which requires a cost-benefit balancing during safety review. EPA’s oversight of chemicals manufactured, sold or distributed in the U.S. would be greatly expanded, as would the processes by which chemicals may be approved. As some examples, the modernized version of TSCA would allow EPA to:
- Identify individuals and groups relevant to assessing the safety of a chemical, including risks to relevant populations and ensuring their protection.
- Review the safety of all chemicals in active commerce, as compared to the grandfathering-in of chemicals in use without also conducting a safety review.
- Establish a priority ranking of all active chemicals, with high-priority chemicals undergoing full safety assessment and safety determinations. For any chemical that does not meet the safety standard, EPA must impose restrictions sufficient for the chemical to meet the safety standard; where restrictions cannot ensure the safety standard will be met, the EPA must ban or phase out the chemical. To the extent sufficient information exists, EPA may conclude a chemical is likely to meet the safety standard, and is therefore a “low priority” chemical.
- In identifying high priority chemicals, give preference to chemicals that are persistent and bioaccumulative, and those that are known human carcinogens and have high acute and chronic toxicity. EPA’s criteria must account for recommendations of the Governor of a State, hazard and exposure potential, and storage near a significant source of drinking water.
Notably, the bill would allow EPA to issue an order requiring testing, rather than having to promulgate a rule, where rulemaking was often a multi-year process. Testing authority applies to both new and existing chemicals, and in limited instances may also be applicable to the prioritization process.
The revisions will place substantial new burdens on manufacturers, including requirements that they:
- Identify all chemicals they are currently manufacturing or processing.
- Pay fees to fund the review of new and existing chemicals to defray a portion of the costs of implementation of the program (fees are capped at 25% of relevant EPA program costs, with companies to pay 100% of the costs of safety assessments they request).
Several provisions of the bill would also alter the process for review of new chemicals and the handling of Confidential Business Information in ways that will impact manufacturers as well. When reviewing new chemicals, EPA would now be required to make an affirmative safety finding that a chemical is likely to meet the safety standard as a condition of market entry. But the amendments maintain TSCA’s current 90-day review period for new chemicals and shortens that period when EPA makes a positive safety determination. The amendments would also require EPA to review past CBI claims for active chemicals on the TSCA Inventory, and that certain CBI claims be substantiated when made. For the first time, CBI is to be shared with state governments, health and environmental professionals and first responders, subject to adequate protections and nondisclosure agreements.
Full TSCA modernization will certainly take place in 2016. In the meantime, we will watch carefully and await the results of the House and Senate bill reconciliation process.