TSCA Reform – What to Expect in 2016
Operating at warp speed for a federal agency, on June 29, 2016, the Environmental Protection Agency (U.S. EPA) released its First Year Implementation Plan to comply with the deadlines established by The Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Lautenberg Act), signed by President Obama on June 22nd. The Lautenberg Act significantly revises the Toxic Substances Control Act of 1977 (TSCA), a law regulating the approval and use of chemicals in commerce that is known to many industries currently preparing the TSCA Form U reports that are due by September 30, 2016. In light of U.S. EPA’s issuance of a plan to implement the statute, we provide the following highlights to watch for as the agency implements TSCA reform under the Lautenberg Act.
Inventory Reset. U.S. EPA currently maintains a sprawling inventory of chemicals available in commerce (the TSCA Inventory). The Lautenberg Act will require a “reset” of that inventory. No later than June 2017, U.S. EPA must enact a rule requiring manufacturers and processors to report to the Agency all chemicals they have manufactured or processed during the previous ten years.
According to the Agency’s Implementation Plan, the proposed rule is expected to be published in mid-December 2016. Potentially impacted industries should be prepared to review and comment on the rule. Of note, the inventory reset process has the potential to extend to persons or companies “processing” a chemical, which is defined to include preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce as part of an article containing the chemical substance or mixture. Thus, impacts from the Inventory Reset process have the potential to be far-reaching.
- Prioritization of Chemical Substances for Risk Evaluations. The Lautenberg Act allows U.S. EPA to review chemicals more easily and, furthermore, requires U.S. EPA to conduct risk evaluations of chemical substances currently allowed for sale in commerce, prioritizing those with higher potential for injury to health or the environment. No later than June 2017, U.S. EPA will be required to enact final regulations outlining a risk-based screening process that must contain criteria to designate chemicals as either “high priority” or “low priority” for conducting these risk evaluations. Any chemical designated as “high priority” must undergo a risk evaluation that will serve as the basis for determining applicable prohibitions or restrictions on that chemical substance. A “high priority” designation is required if EPA finds the chemical may present an “unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to a potentially exposed or susceptible subpopulation…” and cannot include consideration of costs or other non-risk factors.
According to the U.S. EPA’s First Year Implementation Plan, the Agency expects to publish a proposed rule outlining the prioritization and risk evaluation processes by December 2016. Again, potentially impacted businesses may wish to review and comment on these proposals later this year.
Miscellaneous changes. Other items noted in the First Year Implementation Plan are U.S. EPA’s goals to complete significant new use chemical reviews (under Section 5) as well as ongoing reviews of chemicals currently in commerce (Section 6). Of note, U.S. EPA is currently reviewing two commonly-used chemicals—trichloroethylene, a degreaser, and methylene chloride, a paint stripper—and may restrict their future use for these purposes as a result of these ongoing reviews.
For more information, or assistance in understanding the Lautenberg Act, please contact any of the following: Peter A. Tomasi (414) firstname.lastname@example.org, Lauren Grahovac Harpke at (414) email@example.com, or your Quarles & Brady attorney.