As part of its implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Public Law 114-182E reforming the Toxic Substances Control Act ("TSCA"), EPA recently published two proposed rules, including a proposed rule that would govern the process for active/inactive designations and a proposed rule that would establish the procedure for prioritizing chemicals for risk evaluation. Notably, although EPA has released a pre-publication of a third rule – proposing the process for performing a risk evaluation – that proposal appears to have been caught up in the Administration transition and has not yet been published in the Federal Register.
Active/Inactive Notification Requirements
On January 13, 2017, EPA published a proposed rule entitled, "TSCA Inventory Notification (Active-Inactive) Requirements," 82 Fed. Reg. 4255 (Jan. 13, 2017) ("Active/Inactive Proposal"). EPA states that the proposal "would enable [it] to fulfill a statutory obligation to designate chemical substances on the TSCA Inventory as active or inactive in U.S. commerce." This designation is intended to assist EPA in prioritizing chemical substances for risk evaluations.
The Active/Inactive Proposal would require persons who manufactured chemical substances on the TSCA Inventory for nonexempt commercial purposes between June 21, 2006 and June 21, 2016 to submit a retrospective notification to EPA. This notification would need to include the chemical identity, type of commercial activity, date rage for when the manufacturing occurred, and whether the manufacturer intends to maintain an existing claim for protection against disclosure of chemical identity as confidential business information ("CBI").
Once a notice is submitted, EPA would designate the substance as "active" on the TSCA Inventory. Processors would have the option, but not the obligation, to request that a substance be identified as "active" if no manufacturer requests the designation. Finally, if no one requests that an existing CBI claim be maintained as part of a notification for a given substance, EPA will transfer that substance from the confidential portion of the TSCA Inventory to the public portion.
Once a substance is designated as "inactive," the proposal also would require manufacturers and processors to notify EPA before they manufacture or process that substance for non-exempt commercial purposes. Once EPA receives a notice, it would change the chemical substance's designation on the TSCA Inventory from inactive to active. Manufacturers and processors would be required to submit the notice no more than 30 days prior to the chemical substance's actual manufacturing or processing. Notably, the manufacture or processing of a chemical substance that is designated as inactive would be considered a violation of TSCA. As a result, it is important that manufacturers and processors ensure that notifications are submitted for their current products.
Under TSCA as reformed, EPA is under a statutory deadline to finalize this rule by June 22, 2017, with the deadline for manufacturers to submit notifications no more than 180 days later.
This proposal can be accessed here. Comments are due on March 14, 2017.
Prioritizing Chemicals for Review
On January 17, 2017, EPA published a proposed rule to establish a four-part process for prioritizing chemicals for review under TSCA, as reformed ("Prioritization Proposal"). Under the revised statute, EPA is required to establish a risk-based screening process and criteria to designate chemicals as High- or Low-Priority Substances. This process would include pre-prioritization, initiation, proposed designation, and final designation.
The Prioritization Proposal articulates a process that will screen a candidate chemical primarily against criteria drawn from the Agency's TSCA Work Plan, which includes nine metrics such as the chemical substance's hazard and exposure potential, persistence and bioaccumulation, the conditions of use, the volume manufactured and processed, susceptible subpopulations, and a "catch-all" provision granting EPA added flexibility. If the Agency determines a chemical qualifies under these criteria, it will formally initiate the prioritization process, providing two opportunities for public comment (only one comment period is required by the revised statute). EPA specifically notes that for chemical substances with insufficient information to conduct a risk evaluation, the Agency plans to "pursue a significant amount of data gathering before initiating prioritization." EPA also indicates that in the face of "scientific uncertainty," the Agency will "weigh in favor of a High Priority Substance designation."
While EPA is required under the revised statute to focus on substances identified in the Agency's Workplan in determining High-Priority chemicals, EPA indicates in the proposal that it believes the Safer Chemicals Ingredients List to be a "good starting point" for identifying Low Priority Substance candidates.
This prioritization process does not apply to the first ten chemical substances that EPA identified in November 2016, which will automatically go through the risk evaluation process: 1,4 dioxane; 1-bromopropane; asbestos; carbon tetrachloride; cyclic aliphatic bromide cluster; methylene chloride (MC); n-methylpyrrolidone (NMP); pigment violet 29; trichloroethylene (TCE) and tetrachloroethylene (PERC).
This proposal can be accessed here. Comments are due on March 18, 2017.
Risk Evaluation Requirements
On January 13, 2017, EPA also released a pre-publication version of a proposed rule that would establish the process for conducting risk evaluations for High Priority Substances (in addition to the ten substances that EPA has already identified). Although much of the proposal is intended to implement the statutory language, EPA does provide additional specifics with regard to the process for and scope of the risk evaluation.
Under TSCA, as revised, EPA is required to issue a final scoping document within six months of initiating a risk evaluation. EPA proposes to add the requirement to first issue a draft scoping document for public comment, and to prohibit commenters from providing additional comment regarding the scope of the risk evaluation after that initial comment period is over. Part of the scoping process will include defining the "known, intended, and reasonably foreseen" conditions of use, which will guide the risk evaluation.
Notably, EPA proposes not to define key aspects of the risk evaluation, including what constitutes an "unreasonable risk" that would justify regulating a chemical substance, the "weight of the scientific evidence" used to determine whether a chemical substance presents an "unreasonable risk," and "best available science," which the Agency is required to evaluate in determining whether the "weight of the scientific evidence" indicates that a chemical substance presents an "unreasonable risk." EPA asks for comment on whether definitions for these terms should be codified.
The proposed rule also includes a process for manufacturer-initiated risk evaluations, for which the Agency proposes to allow a public comment period for others to provide relevant information that may inform the risk evaluation.
EPA plans to apply this process to the first ten chemical substances to be evaluated from the TSCA Work Plan as well as chemicals that are identified as High Priority as a result of the prioritization process discussed above.
Although the Priebus Memo – delaying the effective date of rules that had been published in the Federal Register and requiring the Office of the Federal Register to return rules to agencies that had not yet been published – may not directly apply to this proposed rule, it appears that it has been held up at least temporarily during the transition to the new Administration. Although it is unclear whether it will be revised prior to being re-submitted to the Office of Federal Register for publication, whether and how to define many of the relevant terms, including "best available science" and "weight of the science," could be seen as an opportunity by the incoming Administration to influence EPA decision-making as it implements TSCA reform.
A copy of the pre-publication of the risk evaluation process proposal can be found here.
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