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 |
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 |
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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