United States: Important Deadline For Businesses That Make Or Use 10 Chemicals Under Scrutiny At EPA

Stakeholders have until August 16, 2018 to comment on "problem formulation documents" issued by the US Environmental Protection Agency for the first 10 chemical substances for which EPA is conducting risk evaluations under the 2016 amendments to the Toxic Substances Control Act (TSCA).1 This is an important opportunity for entities that import, manufacture, process, or use any of the 10 substances to provide information to EPA that could influence the contours of the Agency's risk evaluations. EPA's risk evaluations will determine, under the terms of the nation's central chemical control law, whether the Agency must issue regulations that could restrict or even ban use of the chemicals under review. A table summarizing the key features of the problem formulation documents can be found at the end of this advisory.

Background

During June 2018, EPA issued for public comment 10 problem formulation documents which will define the scope of risk evaluations EPA must conduct under the recent TSCA amendments. If EPA concludes in the context of a risk evaluation that one or more conditions of use of a chemical substance presents an unreasonable risks to human health and the environment, the Agency is required to propose new regulations to limit or prohibit such use. The risk evaluation process and the rulemaking procedures EPA must follow under the 2016 TSCA amendments require the Agency for the first time to meet deadlines established by the new provisions.

EPA designated the 10 chemical substances currently under review in December 2016.2 In June 2017, EPA published the initial "scope" documents for the risk evaluations being conducted for these chemical substances. The Agency released problem 10 formulation documents which refine the initial scope documents and identify with greater specificity the conditions of use, exposure and release pathways, and the "susceptible" sub-populations EPA is evaluating.

Importers and manufacturers of the 10 substances, and their customers who are processors and users of products that contain these substances, should be aware of related developments that could significantly affect EPA's risk evaluation process for the substances under review. The most consequential include:

  • The ongoing debate over "conditions of use" and
  • EPA's previously proposed rules for methylene chloride, NMP, and TCE.

The Debate over "Conditions of Use"

Since the 2016 TSCA amendments were enacted, there has been significant debate over what "conditions of use" EPA must evaluate. During the Obama Administration, the Agency planned to consider all known, intended, and reasonably foreseen activities associated with the chemical substances.3 Following the change in Administrations, EPA changed its perspective.4 Citing its discretion under TSCA § 6(b)(4)(D) in the problem formulation documents, the Agency has excluded certain conditions of use from the risk evaluations, including certain "legacy uses" (i.e., discontinued uses), associated disposal practices, and those conditions of use covered by other federal regulatory programs, such as the Resource Conservation and Recovery Act (RCRA).

Several environmental groups are challenging EPA in the Ninth Circuit over its interpretation of the statute and EPA's authority to narrow the scope of the risk evaluations.5&]] If the environmental groups prevail, EPA could be required to evaluate more conditions of use of the first 10 chemical substances than EPA intends to at this time, which could affect Agency resources, and its ability to meet certain statutory deadlines.

Separate Proposed Rules Regarding Methylene Chloride, NMP, and TCE

Three of the chemical substances undergoing risk evaluation also are the subject of three rules proposed by EPA on the eve of the 2017 presidential inauguration. These proposed rules would ban or restrict certain specific uses of trichloroethylene (TCE), methylene chloride, and N-methylpyrrolidone (NMP). Given the change in Administrations, the future of these proposed rules has been uncertain. The problem formulation documents provide some insight.

Methylene Chloride Rule Likely to Be Finalized

In the problem formulation document for methylene chloride, EPA announced its intent to finalize the proposed rule pertinent to paint stripper uses. If promulgated, the proposed rule would prohibit the manufacture (including importation), processing, and distribution of methylene chloride for consumer use and use by small business contractors in paint and coating removal products. In an effort to expedite the final rulemaking process, EPA has announced it will not reevaluate its 2014 assessment of methylene chloride for consumer and commercial paint removal uses, and such uses will be excluded from the ongoing risk evaluation for other uses of methylene chloride.

TCE and NMP Rules' Future is Uncertain

The Agency had proposed banning or significantly restricting certain uses of TCE, including use in commercial vapor degreasing, as an aerosol degreaser, and for spot cleaning in dry cleaning facilities, and uses of NMP in commercial paint and coating removal uses. Unlike its approach to methylene chloride, EPA announced in the problem formulation documents that it will reevaluate potential risks from these and other uses of TCE and NMP under the process set forth in the Agency's risk evaluation procedural rule. These reevaluations could require another 18 or more months to complete; EPA is not likely to be able to move forward with final TCE or NMP rulemakings in the near term.

Conclusion

Manufacturers, importers, processors, users, and distributors of the 10 chemical substances currently under review should consider taking part in the comment process for the problem formulation documents. Commenters can provide EPA with important information that could shape the Agency's risk evaluations. Such submissions could include data and information not in EPA's possession which pertain to exposures and releases under the conditions of use identified by EPA. In the absence of such information, EPA is likely to rely on modeling and other proxies for such data when estimating exposures and releases in the context of completing its risk evaluations.

Comments are due for the problem formulation documents by August 16, 2018.

Table: Summary of the Problem Formulation Documents

The table below provides a brief summary of the conditions of use and exposure pathways described in EPA's problem formulation documents for each of the 10 chemical substances undergoing TSCA risk evaluations. For more details, please refer to EPA's web-pages which provide access to each chemical substance's problem formulation document and the Agency's rulemaking docket.

Chemical Substance
Conditions of Use*
Exposure Pathways
 

Asbestos**

Will include various industrial and commercial uses, including asbestos diaphragms, sheet gaskets, and oilfield brake blocks.

Will analyze inhalation exposure pathways to workers and consumers, environmental releases to water, and pathways exposing aquatic species via contaminated surface water.

Will exclude legacy (i.e., discontinued) uses, including certain adhesives, sealants, roof and non-roof coatings, and building materials.
Will not further analyze the following pathways because the Agency considers them to either be low-risk or covered by other regulatory schemes: oral and dermal exposure to workers and consumers, exposures to asbestos fibers by sediment-dwelling organisms, land application of biosolids, ambient air, drinking water, ambient water, and disposal.

1-Bromopropane (1-BP) Will include 1-BP's manufacture, processing (such as processing as a reactant), distribution, and recycling.

Will analyze inhalation exposure pathways to workers, consumers, and bystanders.

Will exclude agricultural non-pesticidal industrial/commercial/consumer use and the consumer use in: adhesives, engine degreasing, and brake cleaning products.
Will not further analyze most dermal and oral exposure pathways to workers and consumers because they are not considered significant routes of exposure.

Will not further analyze
environmental pathways relating to inhalation exposures to ecological terrestrial species; water; biosolids, sediment, and soil; and disposal. EPA concludes there is a lack of evidence that 1-BP has a lasting impact on aquatic systems and concludes 1-BP is subject to regulation under other statutes, including RCRA.

Carbon Tetrachloride

Will include carbon tetrachloride's manufacture, processing, distribution, and disposal, ranging from its domestic manufacture including its manufacturing of agricultural products.

Will analyze inhalation and dermal exposure pathways to workers.
Will exclude carbon tetrachloride's incorporation into an article, and industrial/commercial/consumer uses in commercially available aerosol and non-aerosol adhesives/sealants, paints/coatings, and cleaning/degreasing solvent products.

Will not further analyze any exposure pathways from environmental releases and waste streams associated with industrial and commercial activities because carbon tetrachloride is covered by regulatory schemes under other federal statutes, including the CWA, CAA, and RCRA.

1,4-Dioxane

Will include 1,4-dioxane's manufacture, processing, distribution in commerce, industrial use, commercial use, and disposal, including processing as a reactant and laboratory chemicals.

Will analyze inhalation and dermal exposure pathways to workers.
Will exclude fuels and fuel additives.
Will not further analyze any exposure pathways from environmental releases associated with industrial and commercial activities because those pathways are covered by other federal regulatory schemes.

Cyclic Aliphatic Bromides Cluster
(HBCD)

Will include HBCD importation; incorporation into formulation, mixture, or reaction product; incorporation into articles; disposal; recycling; and the industrial, commercial, and consumer use of expanded polystyrene (EPS) and extruded polystyrene (XPS) in construction materials.

Will analyze dermal, oral, and inhalation exposure pathways to workers and the general population, air emissions, releases to surface water and sediment, and biosolid application to soil from wastewater.
Will exclude domestic manufacture of HBCD, EPS resin, and XPS Masterbatch; uses (and legacy uses) in High Impact Polystyrene, textiles, adhesives, the automotive sector, and electronics; and other consumer uses.

Will not further analyze drinking water and disposal pathways because these pathways are either addressed by other regulatory schemes or do not present high enough of a risk to warrant further analysis.

Methylene Chloride**
Will include methylene chloride's manufacture; processing; disposal; and industrial, commercial, and consumer uses, such as in solvents for cleaning/degreasing and paints/coatings.

Will analyze dermal and inhalation exposure pathways to workers, consumers, and bystanders, and exposure to aquatic species via surface water.
Will exclude extraction solvents in agricultural chemical manufacturing and food processing; and most commercial and consumer paint and coating removers.
Will not further analyze oral exposure pathways to consumers and bystanders because the Agency concluded there would not be significant exposure via this route.

Will not further analyze ambient air, drinking water, ambient water, and disposal pathways because methylene chloride is covered by other federal regulatory schemes.

N-Methylpyrrolidone
(NMP)**

Will include NMP's manufacture; uses in electronics, petroleum products, pharmaceuticals, polymers, and other specialty chemicals; and NMP's applications in paints, coatings, and adhesives.

Will analyze dermal and inhalation exposure pathways to workers, consumers, and bystanders, and oral exposure pathways to consumers and bystanders.

No activities identified in scope document will be excluded.
Will not further analyze any exposure pathways from environmental releases and waste streams associated with industrial and commercial use because these pathways do not pose a significant risk or are covered by programs under other federal environmental statutes.

Perchloroethylene

Will include perchloroethylene's manufacture; disposal; and use in the production of fluorinated compounds, dry cleaning, and vapor degreasing.

Will analyze dermal and inhalation exposure pathways to workers, consumers, and bystanders, and exposures to aquatic organisms via contaminated surface water.

No activities identified in scope document will be excluded.

Will not further analyze oral exposure to consumers; and ambient air, drinking water, ambient water, biosolids, and disposal pathways because they are covered by other federal regulatory schemes.

Pigment Violet 29

Will include Pigment Violet 29's manufacture; disposal; and uses in plastic and rubber products, paints/coatings, and merchant ink.

No activities identified in scope document will be excluded.

Will not further analyze any exposure pathways to workers or consumers, nor any environmental release or waste pathways because of the low risk of exposure and because these pathways are covered by other federal regulatory schemes.

Trichloroethylene (TCE)**

Will include TCE's manufacture; disposal; and use in solvents for cleaning and degreasing, lubricants and greases, adhesives and sealants, and more.

Will analyze dermal and inhalation exposure pathways to workers, consumers, and bystanders, and exposures to aquatic species via contaminated surface water.

Will exclude paints and coatings for consumer use.
Will not further analyze oral exposure pathways to consumers; land application of biosolids; exposure to terrestrial organisms; ambient air; drinking water; ambient water; and disposal, sediment, and soil pathways because these pathways are managed by other federal regulatory schemes or do not pose unreasonable risks.


* The listed conditions of use represent a synopsis of the uses to be included and excluded for EPA's risk evaluation. For the full description, please refer to the substances' respective problem formulation documents.

** These chemical substances are the subject of other EPA rulemakings, which are described in detail above.

footnoes

1 Problem Formulations for Risk Evaluations To Be Conducted Under Toxic Substances Control Act, and General Guiding Principles To Apply Systematic Review in TSCA Risk Evaluations; Notice of Availability, 83 Fed. Reg. 26,998 (June 11, 2018).

2 Designation of Ten Chemical Substances for Initial Risk Evaluations Under the Toxic Substances Control Act, 81 Fed. Reg. 91,927 (Dec. 19, 2016).

3 Proposed Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act. 82 Fed. Reg. 7562 (Jan. 19, 2017).

4 Final Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act. 82 Fed. Reg. 33,726, 33,728 (July 20, 2017) (codified at 40 C.F.R. § 702)

5 TSCA Case Resources, EDF.

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