This quarterly newsletter provides updates on litigation, regulatory, legislative, and other notable developments involving chemicals of concern to business. Our present focus is on substances which are the subject of regulatory activity or scrutiny by various government agencies and potential litigants. This includes emerging contaminants, such as perfluorinated chemicals (PFCs), hexavalent chromium, trichloroethylene (TCE), 1,2,3-Trichloropropane (TCP), and 1,4-dioxane, as well as substances identified by the Environmental Protection Agency (EPA or the Agency) under the 2016 amendments to the Toxic Substances Control Act (TSCA) for prioritization, risk evaluation, or regulation. We hope you find this publication informative, and we welcome your feedback on chemicals of interest to your organization.
This special edition of the newsletter covers TSCA developments since our last issue.
EPA Progress on TSCA Risk Evaluations for First 10 Chemicals: Eight Draft Evaluations, Six SACC Reports, Two Test Orders
Since our last edition, EPA published a draft risk evaluation for trichloroethylene (TCE),1 bringing its total number of draft risk evaluations to eight of the initial 10 substances being evaluated. The amended TSCA requires the first 10 risk evaluations of existing chemical substances to be finalized by June 2020 (barring any announced extensions).
The TCE draft risk evaluation preliminarily determined, based on an evaluation of 54 conditions of use, that there was unreasonable risk associated with dermal and inhalation exposure for workers, occupational non-users, consumers, and bystanders. The risk evaluation preliminarily found no unreasonable risk to the environment and no unreasonable risk from consumer use of pepper spray. Comments on the risk evaluation are due by April 27, 2020. On March 24–27, 2020, the TSCA Science Advisory Committee on Chemicals (SACC) will hold a virtual public meeting.
The two chemicals for which EPA has not yet issued draft risk evaluations are asbestos and perchloroethylene. At a conference in Washington, DC in early February, EPA Assistant Administrator Alex Dunn said the Agency would probably issue the draft risk evaluation for asbestos in two parts,2 with an initial draft evaluation focusing on ongoing uses already identified by EPA and a supplemental evaluation considering "legacy uses" (and disposal of legacy products), as required by a Ninth Circuit decision that found EPA improperly excluded such uses from the conditions of use required to considered in a risk evaluation.3
The comment period for one previously released draft risk evaluation (carbon tetrachloride) remains open, with comments due by March 27, 2020.4 The TSCA SACC held a meeting on carbon tetrachloride on February 25–26, 2020.
Also since our last edition, EPA released the TSCA SACC final peer review reports on previously issued draft risk evaluations for two substances: methylene chloride (released on March 4, 2020)5 and N-Methylpyrrolidone (NMP) (released on March 9, 2020).6
- The peer review report on methylene chloride said the draft risk evaluation's consideration of environmental fates and exposures was "far more complete" than in previously released risk evaluations for other chemicals. The report also noted, however, that because the draft risk evaluation for methylene chloride examined only releases from point sources to water, exposures to workers/bystanders in workplaces, and exposures to methylene chloride during use of consumer products—and not other environmental releases and general population exposures, which EPA determined are covered under other non-TSCA statutes—the evaluation conveys "a partial picture of risks." The report suggested that the evaluation include "[a] short summary of methylene chloride's regulatory status under EPA, [the Occupational Safety and Health Administration], and [Food and Drug Administration]" to "help readers understand the TSCA-focused conceptual model for methylene chloride and provide a more complete understanding of the limits of this risk evaluation." The report also identified other SACC concerns, including that "some of EPA's exposure concentrations and assumptions are likely to underestimate actual exposures."
- The peer review report on NMP said the draft risk evaluation did not clearly support the conclusion of no unreasonable risk for aquatic organisms. The report indicated that many TSCA SACC members expressed concern that considering environmental releases to water alone provided "an inadequate picture of risk from this chemical." The report also called the absence of discussion of transformation products a "major omission." Regarding human exposures, and dermal exposure in particular, the report said "the greatest concern was assumptions on the protection afforded by glove use." The SACC found that the information presented supported the conclusion that inhalation and dermal exposures to NMP pose an unreasonable risk of developmental and reproductive effects for occupational users in certain conditions of use, but SACC members could not agree on whether the information supported the conclusion that NMP exposure does not present an unreasonable risk for occupational non-users. The report said lack of exposure data for occupational non-users was a major issue.
Another development related to EPA's ongoing risk evaluations was the Agency's issuance of TSCA Section 4 test orders to require two manufacturers of pigment violet 29 (PV29)—another of the first 10 chemicals—to provide information on worker exposure and solubility.7 The SACC peer review report identified the absence of such information as a shortcoming in the PV29 draft risk evaluation.
In addition, the National Academies of Sciences is proceeding with a peer review of EPA's Application of Systematic Review in TSCA Risk Evaluations, an internal guidance document published by EPA in 2018 to guide the Agency's application of systematic review in the development of its first 10 risk evaluations.8 The TSCA Science Advisory Committee on Chemicals "strongly encouraged" EPA to obtain such a review "as soon as practical."9 In its announcement of the peer review, EPA said NAS would convene a public meeting and issue a final report by June 2020.10 A NAS ad hoc committee held an initial meeting on February 28, 2020 to hear information from EPA about its approach to systematic review under TSCA. In its closed session, the committee discussed its statement of task, its approach to the task, information presented during the open session, and committee assignments and project schedule. A second meeting is scheduled for April 13¬–14, 2020.11
EPA Modified Proposal for LCPFAC Significant New Use Rules to Remove Exemption for Article Importers
On March 3, 2020, EPA published a supplemental notice modifying the Agency's 2015 proposed Significant New Use Rule (SNUR) for certain Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate Chemicals.12 The 2015 proposal would have amended the existing LCPFAC SNUR by removing the exemption for importers of articles containing any of the SNUR chemicals, requiring at least 90 days notice prior to beginning importation of any article containing one of the listed substances. The supplemental proposal would require the 90-day notice prior to import only for manufactured articles that contain a surface coating containing one of the identified LCPFAC substances. The modification is intended to tie the reporting requirements to certain conditions (i.e., presence in a surface coating) that EPA suggests are indicative of potential for exposures to the LCPFAC substances. EPA presumes this change will satisfy the 2016 TSCA amendments' new statutory standard for requiring notification for articles under SNURs. The 2016 amendments to Section 5(a) of TSCA authorize EPA to require significant new use notification for the import or processing of a chemical substance as part of an article or category of articles only after EPA makes an affirmative finding in a "SNUR" that the reasonable potential for exposure to the chemical substance through the article or category of articles subject to the rule justifies notification."13 In the preamble of the supplemental proposal, EPA cites studies that the Agency says show that when added to the surface coating of an article, LCPFAC substances can be released over time. The supplemental proposal indicates that coatings include materials such as paints, varnishes, sealants, adhesives, inks, maskants, and temporary protective coatings. The preamble to the proposal also provides a non-exhaustive list of articles that could potentially have LCPFACs as part of a surface coating, including furniture, medical garments, safety equipment, outdoor apparel or equipment, automobile components, aerospace components, electronics, heavy machinery, and household appliances. EPA intends to exclude from the final significant new uses any "confirmed ongoing activities" for these chemicals presumably based on comments received on the 2015 version of the proposal. Ongoing uses will not require submission of a SNUN.
The National Defense Authorization Act of Fiscal Year 2020 (NDAA) (S. 1790) requires EPA to finalize the 2015 proposed SNUR by June 22, 2020. The comment period on the supplemental notice is open through April 17, 2020.
EPA Amended Chemical Data Reporting Rule and Extended Reporting Period Through November 30
On March 17, 2020, EPA Assistant Administrator Dunn signed final rules amending Chemical Data Reporting (CDR) requirements and extending the deadline for 2020 reports to November 30, 2020.14 The rules had not been published in the Federal Register as of March 23. EPA is also making non-regulatory changes to the CDR reporting process, including replacement of the pre-formatted Form U with a customized report generated using information entered through an updated e-CDRweb tool. The changes to CDR requirements include modifications associated with confidentiality claims to conform to the 2016 TSCA amendments, including updates to substantiation requirements and identification of data elements that cannot be claimed as confidential (e.g., data elements concerning general information about how a substance is used or processed). Other changes include a revised approach to reporting for co-manufactured chemicals; addition of data elements, including the NAICS code for the site of manufacture; use of Organisation for Economic Co-operation and Development's (OECD) functional use and product and article use codes; requirements for secondary submitters of joint submissions; modification of parent company reporting requirements; and addition of a voluntary data element identifying the percent total production volume of a chemical substance that is a byproduct. The amendments also provide for two new exemptions related to byproducts, one for certain byproduct substances produced and recycled on-site by Portland cement manufacturers and manufacturers using the Kraft pulping process, and the second for byproducts manufactured in certain equipment via processes that are not integral to the production process. In its press release, EPA indicated that it would finalize a separate amendment to update the size standards for small manufacturers for reporting and recordkeeping requirements and that the extended timeframe for CDR reports would allow compliance with this separate rule.
EPA said it would host a webinar on March 31, 2020 to discuss the amended CDR requirements and to introduce the updated e-CDRweb reporting tool.
EPA Mulls Over TSCA Fee Policy While Extending Time for Parties to "Self-Identify" as Manufacturers of High-Priority Substances
On March 9, 2020, EPA announced that it would extend by two months the comment period for its notice regarding the availability of preliminary lists of manufacturers and importers identified as subject to the fee to defray EPA's costs of conducting risk evaluations for the first 20 High-Priority Substances.15 EPA indicated that "many implementation impracticalities" had been brought to its attention and that it was "actively seeking ways to address" the impracticalities and "to reduce concerns by affected entities." The fees rule promulgated by EPA in October 2018 set a $1.35 million fee for each risk evaluation. Manufacturers and importers of the High-Priority Substances are required to pay the fee, which may be shared among entities subject to the requirement. In a January 27, 2020 Federal Register notice, EPA announced that the obligation to contribute to the fee extends to importers of articles containing the substance and manufacturers of the substance as a byproduct or impurity. During the comment period—which was originally scheduled to end on March 27, 2020 but will now extend until May 27—manufacturers (including importers) are expected to "self-identify" if they have been left off the preliminary list but are a manufacturer or importer of the High-Priority Substance. Manufacturers that fail to self-identify may be subject to penalties. In its March 9 email, EPA said it would be providing more guidance on reporting requirements and expectations during the extended comment period. See our January 21 Advisory for more discussion of the risk evaluation fee and the obligation of importers of articles containing High-Priority Substances to pay the fee.16
EPA Announced Availability of TSCA Inventory Update
On March 11, 2020, EPA announced that the biannual update to the TSCA Inventory had been posted on the EPA website.17 EPA said the Inventory included 81 new chemicals. The total number of chemicals in the Inventory is 86,405, of which 41,484 are active in US commerce.
EPA Made Two Microorganism Strains Eligible for Exemption from Notice Requirement
On March 10, 2020, EPA published a final rule adding two strains of microorganisms to the list of recipient microorganisms eligible for exemption from TSCA's requirements for Microbial Commercial Activity Notices.18 EPA determined that certain strains of the two microorganisms will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism provided that certain criteria for the introduced genetic material and the physical containment conditions are met. The two strains are Trichoderma reesei (T. reesei) strain QM6a and its derivatives and Bacillus amyloliquefaciens (B. amyloliquefaciens) subspecies (subsp.) amyloliquefaciens. The final rule made certain changes in response to comments from the Biotechnology Industry Organization and the Enzyme Technical Association on a 2012 proposed rule.
Additional Substantiation Required by November 2 for CBI Claims for the Identity of Chemicals
On March 6, 2020, EPA published its final rule on "Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory."19 The final rule adds two additional questions on "reverse engineering" that manufacturers and processors must answer to substantiate specific chemical identity confidential business information (CBI) claims:
- Does this particular chemical substance leave the site of manufacture (including import) or processing in any form, e.g., as a product, effluent, or emission? If yes, please explain what measures have been taken, if any, to guard against the discovery of its identity.
- If the chemical substance leaves the site in a form that is available to the public or your competitors, can the chemical identity be readily discovered by analysis of the substance (e.g., product, effluent, or emission), in light of existing technologies and any costs, difficulties, or limitations associated with such technologies? Please explain why or why not.
The addition of the new questions was required as a result of litigation challenging EPA's rule for designating chemical substances as "active" or "inactive" on the TSCA Inventory.20 In addition to requiring answers to these questions to maintain a CBI claims, the CBI regulation establishes the timeframe in which manufacturers and processors must submit substantiation and sets forth the process by which EPA will review CBI claims for specific chemical identities that were asserted by manufacturers and processors during the one-time retrospective reporting of active substances. Within 180 days of the May 5, 2020 effective date (November 2, 2020), any manufacturer or processor who sought to maintain a CBI claim for specific chemical identity in an Notice of Activity (NOA) Form A (filed during the one-time reporting period under the TSCA "active/inactive" reporting rule) must submit the applicable substantiations, including answers to the two new questions. (EPA increased the amount of time from the 90 days in the proposed rule.) EPA noted that the substantiation deadline applies to (1) manufacturers and processors newly substantiating their claims; (2) manufacturers and processors who voluntarily substantiated during the one-time reporting period and who only need to respond to the two additional substantiation questions; and (3) manufacturers and processors who substantiated their claims in another submission within the last five years and who need only submit information identifying that prior substantiation. In addition, manufacturers and processors who already submitted an NOA Form B that asserted and substantiated a CBI claim for specific chemical identify must submit responses to the two additional questions by June 4, 2020. Failure to submit substantiation will result in a denial of the claim; the denial will be a reviewable final agency action. The statutory target completion date for EPA to finish its reviews of the claims is February 19, 2024. Starting in 2021 and until its review is completed, EPA will post at the beginning of each year annual goals for reviews and report on the number of reviews completed in the prior year.
EPA Finalized Designation of Low-Priority Substances
In the February 26, 2020 issue of the Federal Register, EPA published notice of its final designation of the following 20 chemical substances as Low-Priority Substances for which risk evaluations are not warranted at this time:21
|1-Butanol, 3-methoxy-, 1-acetate, CAS RN 4435-53-4 1-Butanol, 3-methoxy-, 1-acetate, CAS RN 4435-53-4||1-Butanol, 3-methoxy-, 1-acetate, CAS RN 4435-53-4 1-Butanol, 3-methoxy-, 1-acetate, CAS RN 4435-53-4|
|D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)-, CAS RN 31138-65-5 D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)-, CAS RN 31138-65-5||D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)-, CAS RN 31138-65-5 D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)-, CAS RN 31138-65-5|
|D-Gluconic acid, CAS RN 526-95-4 D-Gluconic acid, CAS RN 526-95-4||D-Gluconic acid, CAS RN 526-95-4 D-Gluconic acid, CAS RN 526-95-4|
|D-Gluconic acid, calcium salt (2:1), CAS RN 299-28-5 D-Gluconic acid, calcium salt (2:1), CAS RN 299-28-5||D-Gluconic acid, calcium salt (2:1), CAS RN 299-28-5 D-Gluconic acid, calcium salt (2:1), CAS RN 299-28-5|
|D-Gluconic acid, .delta.-lactone, CAS RN 90-80-2 D-Gluconic acid, .delta.-lactone, CAS RN 90-80-2||D-Gluconic acid, .delta.-lactone, CAS RN 90-80-2 D-Gluconic acid, .delta.-lactone, CAS RN 90-80-2|
|D-Gluconic acid, potassium salt (1:1), CAS RN 299-27-4 D-Gluconic acid, potassium salt (1:1), CAS RN 299-27-4||D-Gluconic acid, potassium salt (1:1), CAS RN 299-27-4 D-Gluconic acid, potassium salt (1:1), CAS RN 299-27-4|
|D-Gluconic acid, sodium salt (1:1), CAS RN 527-07-1 D-Gluconic acid, sodium salt (1:1), CAS RN 527-07-1||D-Gluconic acid, sodium salt (1:1), CAS RN 527-07-1 D-Gluconic acid, sodium salt (1:1), CAS RN 527-07-1|
|Decanedioic acid, 1,10-dibutyl ester, CAS RN 109-43-3 Decanedioic acid, 1,10-dibutyl ester, CAS RN 109-43-3||Decanedioic acid, 1,10-dibutyl ester, CAS RN 109-43-3 Decanedioic acid, 1,10-dibutyl ester, CAS RN 109-43-3|
|1-Docosanol, CAS RN 661-19-8 1-Docosanol, CAS RN 661-19-8||1-Docosanol, CAS RN 661-19-8 1-Docosanol, CAS RN 661-19-8|
|1-Eicosanol, CAS RN 629-96-9 1-Eicosanol, CAS RN 629-96-9||1-Eicosanol, CAS RN 629-96-9 1-Eicosanol, CAS RN 629-96-9|
The designations are final agency actions subject to judicial review and do not trigger any required action by manufacturers, importers or processors.
Plaintiffs Filed Lawsuit Challenging Transparency of TSCA New Chemicals Program
Five environmental groups, led by Environmental Defense Fund, filed a lawsuit against EPA on March 18, 2020 in federal district court alleging that the Agency operates the TSCA new chemicals program "as a black box, thwarting the ability of the public to be informed and to provide input."22 The plaintiffs assert that EPA violated Sections 5 and 14 of TSCA by failing to publish or make available to the public certain categories of information, including complete notices of receipt of Premanufacture Notifications (PMNs) and the PMNs themselves, correspondence related to PMNs, health and safety studies, safety data sheets, substantiation information for CBI claims, and information claimed by manufacturers as confidential where exemptions to disclosure allegedly were "clearly inapplicable." The complaint includes 9 tables identifying PMNs and applications for test marketing exemptions for which the plaintiffs allege EPA did not fully comply with TSCA's requirements for disclosure.
2. Maria Hegstad, EPA Will 'Probably' Review Asbestos In Two Parts After Appellate Ruling, InsideEPA.com (Feb. 6, 2020.
4. 85 Fed. Reg. 4658 (Jan. 27, 2020); EPA, Draft Risk Evaluation for Carbon Tetrachloride (Methane, Tetrachloro-) CASRN: 56-23-5, EPA Doc. No. EPA-740-R1-8014 (Jan. 2020).
5. TSCA Science Advisory Comm. on Chems., Meeting Minutes and Final Report, No. 2020-01, Peer Review for EPA Draft Risk Evaluation for Methylene Chloride, December 3-4, 2019 TSCA Science Advisory Committee on Chemicals Meeting (Mar. 2, 2020).
6. TSCA Science Advisory Comm. on Chems., Meeting Minutes and Final Report, No. 2020-02, Peer Review for EPA Draft Risk Evaluation for N-Methylpyrrolidone (NMP), December 5 – 6, 2019 TSCA Science Advisory Committee on Chemicals Meeting(Mar. 5, 2020).
7. See Maria Hegstad, EPA Issues First TSCA Test Orders To Companies Since Statute's Reform, InsideEPA.com (Mar. 3, 2020) (subscription required); Pat Rizzuto, Industrial Dye Maker Handed EPA's First Chemical Data Order, Bloomberg Env't (Mar. 2, 2020, 5:10 PM) (subscription required).
8. EPA, Application of Systematic Review in TSCA Risk Evaluations, EPA Doc. No. 740-P1-8001 (May 2018).
9. See TSCA Science Advisory Comm. on Chems., Meeting Minutes and Final Report, No. 2019-01, A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding: Peer Review for EPA Draft Risk Evaluation of C.I. Pigment Violet 29, June 18-21, 2019, at 25.
10. Press Release, EPA, EPA Initiates Peer Review of TSCA Systematic Review Approach (Dec. 13, 2019), https://www.epa.gov/chemicals-under-tsca/epa-initiates-peer-review-tsca-systematic-review-approach.
11. See Review of EPA's TSCA Systematic Review Guidance Document, Nat'l Acads. Sci. Eng'g Med. (last visited Mar. 16, 2020).
12. 85 Fed. Reg. 12479 (Mar. 3, 2020).
14. News Release, EPA, EPA Continues to Deliver on Commitments under Amended TSCA (Mar. 17, 2020).
16. Lawrence E. Culleen, Importer Beware: You Might Be Asked to Pay EPA to Evaluate a Chemical You Don't Manufacture (Jan. 21, 2020).
17. See How to Access the TSCA Inventory, EPA (last updated Mar. 11, 2020).
18. 85 Fed. Reg. 13760 (Mar. 10, 2020).
19. 85 Fed. Reg. 13062 (Mar. 6, 2020).
21. 85 Fed. Reg. 11069 (Feb. 26, 2020).
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