Aug 3, 2017

EPA to Publish Three Final Rules under TSCA

On June 22, the U.S. Environmental Protection Agency (EPA) made three final rules available on its website, pending official publication. The rules guide the agency's path for assessing and regulating chemicals in commerce under the amended Toxic Substances Control Act (TSCA). EPA's issuance of final rules for 'Prioritization," "Risk Evaluation," and "Inventory Reset," 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 since their proposal in January 2017. ACA is currently working to provide compliance materials for the industry.  Since the June 22 pre-publication, EPA officially published the prioritization and risk evaluation rules in the Federal Register on July 20.  The inventory reset rule is expected to be officially published soon.

In addition, EPA released its TSCA Risk Evaluation Guidance, outlining the expectations for draft risk evaluations provided by interested parties, and articulating the approach EPA will apply in risk evaluations conducted under the risk evaluation process rule under TSCA Section 6. EPA also published scoping documents that will shape evaluations of the first 10 chemicals for initial risk evaluation: asbestos; pigment violet 29; 1,4-dioxane; cyclic aliphatic bromides cluster; carbon tetrachloride; 1-bromopropane; methylene chloride; n-methylpyrrolidone; trichloroethylene; and tetrachloroethylene.

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.

The following outlines the rule's evolution from proposal to finalization, with ACA's comments and the rule's final most salient changes summarized.

Inventory Reset Rule

This rule establishes 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 prior to manufacturing or processing the substance, provided that notification cannot be more than 90 days prior to the expected date of manufacture or processing.

Under TSCA, Sec. 8(b)(6), EPA is obligated to designate chemicals reported under the 2016 Chemical Data Reporting rule (CDR) as an interim list of active substances. In response to public comment, EPA expanded the interim list to include chemicals reported pursuant to the 2012 CDR rule, in addition to the 2016 CDR rule as required by statute.  In effect, manufacturers and processors of chemical substances listed on either the non-confidential or 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 reported information required under the 2012 or 2016 CDR rules. In the final rule, EPA determined that this exemption applies regardless of listing as confidential or non-confidential. The CDR 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.  EPA issues the CDR rule every four years.  With inclusion of chemicals reported during the 2012 and 2016 CDR reporting period in the interim list of active substances, the list now covers substance reported for the last two CDR reporting periods, instead of just the most recent period as instructed in TSCA Section 8(b)(6).

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