Thank you to my colleague, Emilee Mooney Scott, for this post. Emilee is an associate in our Environmental & Utilities Practice Group.
TSCA Framework Rules Promulgated
As we outlined last year, the Toxic Substances Control Act (“TSCA”) was recently updated to provide EPA with much broader authority to regulate “existing” chemical substances (i.e., those that are already in use in commerce). EPA’s review of existing chemical substances under its new TSCA authority will follow these three steps: 1) Prioritization; 2) Risk Evaluation; and 3) Risk Management (as we explained in further detail in December).
On July 20, 2017, EPA issued the final rules on the Prioritization and Risk Evaluation processes. Notably, the final rule specifies that when EPA conducts a risk evaluation, it will not evaluate all possible conditions of use, but will instead focus on the conditions of use that raise the greatest potential for risks. This will conserve agency (and industry) resources by limiting the need for data and analysis on conditions of use that are uncommon or risks that are remote.
Risk Evaluations Underway
The TSCA reform bill also directed EPA to identify a slate of ten substances that would skip the prioritization step and proceed directly to the risk evaluation step. EPA recently published the risk evaluation scope for each of these first ten substances. EPA has opened a docket for each substance, and will accept comments on risk evaluation scopes until September 19, 2017. The table below provides links to the risk evaluation scopes (and any supporting documents), the use and exposure pathways and hazards identified by EPA, and the docket that interested parties may use to leave comments.
|Substance||Use and Exposure Pathways||Hazards||Docket|
|1,4-Dioxane||Used in consumer products. Present in groundwater, ambient air and indoor environments. High reported releases to the environment.||Possible human carcinogen.||EPA-HQ-OPPT-2016-0723|
|1-Bromopropane||Used in consumer products. Present in drinking water, indoor environments, surface water, ambient air, groundwater, soil. Estimated to have high releases to the environment.||Possible human carcinogen.||EPA-HQ-OPPT-2016-0741|
|Asbestos||Used in chlor-alkali production, consumer products, coatings and compounds, plastics, roofing products, and other applications. Also found in certain imported products such as brakes, friction products, gaskets, packing materials and building materials.||Known human carcinogen; Acute and chronic toxicity from inhalation exposures.||EPA-HQ-OPPT-2016-0736|
|Carbon Tetrachloride||Used in commercial/industrial products. Present in biomonitoring, drinking water, indoor environments, surface water, ambient air, groundwater, soil. High reported releases to the environment.||Probable human carcinogen.||EPA-HQ-OPPT-2016-0733|
|Cyclic Aliphatic Bromide Cluster (HBCD)||Flame retardant in extruded polystyrene foam, textiles, and electrical and electronic appliances||Acute aquatic toxicity||EPA-HQ-OPPT-2016-0735|
|Methylene Chloride||Used in consumer products. Present in drinking water, indoor environments, ambient air, groundwater, and soil||Probable human carcinogen||EPA-HQ-OPPT-2016-0742|
|N-Methylpyrrolidone (NMP)||Used in consumer products. Present in drinking water and indoor environments. High reported releases into the environment.||Reproductive toxicity.||EPA-HQ-OPPT-2016-0743|
|Pigment Violet 29||Used in consumer products. Estimated to have moderate releases to the environment.||Aquatic toxicity.||EPA-HQ-OPPT-2016-0725|
|Trichloroethylene (TCE)||Used in consumer products. Present in drinking water, indoor environments, surface water, ambient air, groundwater, and soil.||Probable human carcinogen.||EPA-HQ-OPPT-2016-0737|
|Tetrachloroethylene (perchloroethylene)||Used in consumer products and dry cleaning. Present in biomonitoring, drinking water, indoor environments, ambient air, groundwater, soil. High reported releases to the environment.||Probable human carcinogen.||EPA-HQ-OPPT-2016-0732|
In December 2016 and January 2017 EPA also issued proposed rules that would 1) ban the use of TCE in aerosol degreasing and spot cleaning; 2) ban the use of TCE in vapor degreasing; and 3) ban the use of methylene chloride and NMP in consumer and most commercial coating removal products. These rules have not yet been finalized, and the new administration has repeatedly extended the comment deadlines.
While the proposed TCE rules face an uncertain fate, they do potentially forecast how risk evaluations might proceed. The proposed TCE rules do not include any restrictions on what is presently the most common use of TCE in the United States: as a precursor in refrigerant manufacturing. When TCE is used in refrigerant manufacturing, the use occurs in a closed system with very limited potential for worker exposure or releases to the environment. In other words, when a discrete use of a high-priority substance poses little risk, it may be allowed to continue even in the face of a total ban on other uses. Manufacturers aware of such low-risk uses should take advantage of opportunities for public comment to make sure EPA is aware as well.