Toxic Substances Control Act (TSCA) Reform – First Major Environmental Legislation in 30 Years!
On May 12, 2016, The U.S. House of Representatives passed a bipartisan House-Senate agreement of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LSCA) by a margin of 403 to 12. President Obama signed the Act into law on June 22, 2016. The purpose of LSCA is ultimately to reform, strengthen and improve the Toxic Substances Control Act (TSCA) of 1976. The new law increases the USEPA’s authority to review and regulate chemicals and mandates that the USEPA update its current inventory of existing chemicals and create a risk evaluation process — all within six months.
Previously under TSCA, there was no requirement to review the safety of existing chemicals and 62,000 chemicals were ‘grandfathered’ in and presumed safe. Under the reformed law, safety reviews are mandated for all chemicals in active commerce and assigned concrete deadlines specified for each step of the process. USEPA is required to focus on highest priority chemicals for full risk-based safety assessments. Aggressive and judicially enforceable deadlines are also now required for USEPA decisions.
The USEPA will now have enhanced authority to require additional health and safety testing of both existing and new chemicals. Formerly, additional testing requirements could only be enforced through formal rulemaking, a lengthy process in which the USEPA must first demonstrate potential risk or high exposure. Under the reformed law, the USEPA has empowered to issue testing orders without evidence of risk or high exposure. The USEPA is provided a full range of options to address the risks of substances, including labeling requirements, use restrictions, phase-outs and other actions.
New chemicals will now be required to assign a safety finding before entering the market. Chemical manufacturers will submit a Premanufacture Notice (PMN), which will include information on anticipated uses, chemical identification, anticipated by-products, disposal, available health or environmental effects, and anticipated exposure. The USEPA will review this information to make a ruling of “Pass”, “Limit”, “Restrict” or “Stop”.
Another key change is that LSCA reforms TSCA’s burdensome cost-benefit safety standard. Under TSCA, a finding of “unreasonable risk” required a cost-benefit analysis, which prevented the USEPA from banning asbestos. LSCA replaces this cost-benefit standard with a purely health-based safety standard and explicitly prohibits USEPA from considering cost and other non-risk factors in making safety determinations.
The reformed law also aims to promote sharing of chemical information. Companies will now be limited in their abilities to claim information as confidential. Confidentiality claims must be fully justified and re-substantiated every 10 years. Additionally, state, health and environmental professionals will be granted access to confidential information, as needed, to successfully do their jobs.
Several additional provisions are included to improve TSCA. Members of industry are now allowed to request the USEPA conduct a safety assessment on a specific chemical. Other provisions aim to promote cooperation between state and federal regulators in order to strengthen national chemical regulation while maintaining strong interstate commerce. Additionally, TSCA previously did not include any special considerations for specific populations. Now LSCA explicitly calls for the protection of specific vulnerable populations, including children and pregnant women.
The enactment of the LCSA into law is truly a historic milestone. After years of negotiation, the 40-year old Toxic Substances Control Act is now overhauled and reformed, establishing a high standard for chemical regulation and protection of human health and environmental safety. Attention now shifts to implementation and USEPA has already released a first-year implementation plan, available here. As this unfolds, the impact on industry stakeholders and regulators will surely be felt. Waterborne will continue to stay on the pulse of the changes to the regulatory landscape and assist our clients through implementation and beyond.
For questions about our TSCA capabilities, contact Gregg Hancock at firstname.lastname@example.org.