ACA Submits Comments on TSCA Rulemakings to EPA
March 28, 2017 •
Over the last few weeks, ACA has submitted several sets of comments to the U.S. Environmental Protection Agency (EPA) addressing the agency’s proposed rules under the recently amended Toxic Substances Control Act (TSCA).
The Frank R. Lautenberg Chemical Safety for the 21st Century Act, signed into law on June 22, 2016, mandates the agency to restrict chemicals already in commerce that pose unreasonable risks to public health and the environment. Since January, EPA has released multiple proposed regulations that will impact how EPA evaluates chemicals used in the coatings industry. ACA has been actively developing coatings industry positions and comments on these important rulemakings. As these rules are finalized, ACA will provide compliance materials for the industry.
Inventory Reset Proposed Rule
On March 14, ACA submitted comments to EPA on the agency’s proposed rule that will establish a process to designate substances on the TSCA Inventory as “active” or “inactive,” also known as the TSCA Inventory Reset. Once the TSCA Inventory has been “reset,” no one would be permitted to manufacture or process an inactive chemical substance without first submitting a notification to EPA within 30 days of manufacturing or processing the substance.
Under the statute, EPA is obligated to first designate chemicals reported under the 2016 Chemical Data Reporting rule (CDR) as an interim list of active substances. Per the proposal, manufacturers and processors of chemical substances listed on the non-confidential portion of the TSCA inventory would not have to tell the agency that they made a chemical if they or another manufacturer had already done so by providing the EPA information required under the 2012 or 2016 Chemical Data Reporting rules. The Chemical Data Reporting rules required companies that produced certain volumes of a chemical (generally 25,000 pounds or more) submit to the EPA information such as the identity of the chemical they make, the volume made or imported, how the chemical was used, and the extent to which workers were exposed to it.
ACA comments supported agency’s proposal to utilize 2012 and 2016 CDR Data to formulate an interim list of active substances. However, ACA comments underscored the need for clarification of reporting requirements for importation of new substances. ACA is concerned that there are situations where manufacturers and processors are working with reportable chemicals where the reporting requirements are unclear. ACA proffered that there could be situations where chemical substances already on the inventory designated as inactive will be imported for use in manufacturing after the final date of the rule. ACA believes that these chemicals should be reported as active. This can be accomplished either by making Notice of Activity (NOA) Form B immediately available on the final date of the rule, or by modifying the reporting procedures for NOA Form A.
Moreover, ACA urged EPA to provide an opportunity to modify or correct notifications where a good faith effort is demonstrated. Particularly because there is no de minimus threshold for notification under the Inventory Reset, it is possible that these “minor use, minor volume” chemical ingredients will be inadvertently overlooked in the information gathering stage.
“The complexity of identifying all these reportable chemicals is compounded when many of the notifications will be designated Confidential Business Information (CBI) co-submissions and 4 submitters will be required to consider acquisitions/merger activity over the last 10 years,” stated ACA comments. “Consequently, we believe that EPA is vastly underestimating the complexity of this request, and thus should allow for companies to make corrections for up to one year after the submittal deadline.”
ACA also stressed that the proposal should have greater protections for CBI. ACA noted that chemical substances designated as CBI and filed by Pre-Manufacture Notice (PMN) but not produced in the 10-years prior to TSCA reform will automatically lose their confidentiality. “It is problematic that there is currently no mechanism to address this. Materials on the 2012 CDR and the anticipated 2016 CDR will be interim active chemicals not subject to reporting unless they are on the confidential inventory. Even if reported in the CDR, materials on the confidential inventory will require reporting with confidentiality assertion and substantiation.” ACA urged EPA to specify a mechanism to protect the confidentiality of materials not in production during the “look-back period.”
Prioritization Proposed Rule
On March 20, ACA submitted to EPA on the agency’s Jan. 16 proposed rule to establish a process and criteria for identifying high-priority and low-priority chemicals for evaluation. A chemical designated as “High-Priority” must undergo evaluation. Chemicals designated as “Low-Priority” are not required to undergo further evaluation.
The TSCA amendments require that the prioritization process will last between nine months and one year. Once the prioritization process has been triggered, there is no authority to stop this process or pause this timeline. Consequently, EPA intends to gather a complete set of data prior to the pre-prioritization stage, before any deadline is triggered. Section 702.7(e) describes the general methodology. ACA noted that this section does not provide for any transparency in this process. While the proposal indicates that EPA will be working initially on the list of candidates from the 2014 Update of the TSCA Work Plan for Chemical Assessments, there is no notification requirement for stakeholders. ACA is concerned that the screening process may lead to a pool of chemicals that EPA plans to seek information on without any deadline or action plan, and asked EPA to provide clarification on the screening process and scope.
In its comments, ACA also urged EPA to focus solely on intentional uses of chemical substances during the prioritization process. ACA noted that when chemicals are not intentionally added and are only present as residuals in trace amounts, accurate concentration data of such substances in finished formulated products is often not available. Coatings formulators rely on information provided by their raw material suppliers to disclose whether the chemical in question is present in their products. Because the levels are so low, the substance’s identity may not be disclosed, or the concentration may not be disclosed on the Safety Data Sheet (“SDS”).
“Alternatively, if disclosed, the concentration stated may represent theoretical maximums, based on manufacturing process or other limits, rather than actual concentrations. Residual levels and byproducts are typically present at trace levels, with very little potential exposure to human health and the environment. There is no need for the agency to consider these unintentional uses when making Prioritization determinations.” ACA suggested that EPA use the Globally Harmonized System (GHS) reporting thresholds as the de minimus value for consideration of a “use” for this purpose.
ACA requested that EPA work to ensure that the public understands that “High Priority” does not equal high risk. To make that abundantly clear, ACA proffered the inclusion of a single statement that the High Priority designation merely indicates that EPA will be conducting a risk evaluation on a chemical. Any determination of risk associated with a chemical would only be made after a Risk Evaluation has been completed. ACA believes that this clarification in the rule is critical.
EPA Designation of Ten Chemical Substances for Initial Risk Evaluations
On March 15, ACA submitted comments on the EPA proposed rule announcing the first 10 chemicals it will evaluate under the recently amended TSCA, including 1,4-dioxane; Pigment Violet 29; Methylene Chloride, N-Methyl pyrrolidone (NMP), Trichloroethylene (TCE); and Perchloroethylene. EPA will conduct risk evaluations on these chemicals by December 19, 2019, and could impose restrictions on the use of these compounds or bans.
In general, ACA provided comments on the intentional use of several of these compounds — for example NMP and Pigment 29) — as well as commenting that many of these compounds are only present at trace or residual levels, e.g., 1,4-dioxane.
ACA will remain engaged in the development and implementation of regulations under the amended TSCA, working on behalf of its members.