United States: Flurry Of EPA Action Continues As TSCA Deadlines Approach

Facing stiff deadlines imposed by the 2016 amendments to the Toxic Substances Control Act (TSCA), EPA has exhibited unusual discipline in implementing the statute's many new requirements. One of the most recent actions of note was the imposition of a suite of new user fees that will provide funding to the Agency to offset its costs for exercising its expanded duties.1 With 2018 coming to an end, EPA will soon be facing another set of impending deadlines during 2019, including a December 2019 deadline to finalize the risk evaluations for the first ten chemical substances to undergo risk evaluations under the amended TSCA.2 Accordingly, EPA released its first draft risk evaluation of one of these substances in November 2018. The Agency also has begun preparations to begin the process for prioritizing another set of chemical substances to undergo risk evaluations. Furthermore, EPA has been working diligently to clear a backlog of premanufacture notices (PMNs) for new chemicals entering US commerce, which has resulted in a substantial number of significant new use rules (SNURs) being proposed in the second half of 2018.

EPA Seeks Public Comment on the First Draft Risk Evaluation Under the Amended TSCA

EPA has issued the first of the Agency's long-awaited draft risk evaluations under the amended TSCA. The 2016 amendments require the Agency to prioritize and evaluate the risks of a minimum number of chemical substances in accordance with statutory deadlines. Substances that are designated as "high priority" must undergo a risk evaluation, which will inform EPA decisions about which substances will be regulated under Section 6 of the amended law to mitigate risks to human health and the environment. EPA published its draft risk evaluation of Pigment Violet 29 on November 15, 2018. The draft risk evaluation concludes that Pigment Violet 29 does not present an unreasonable risk to human health or the environment under the conditions of use evaluated.3 EPA's publication of the draft risk evaluation initiated a 60-day comment period for the draft. Interested parties must submit comments no later than January 14, 2019.4

EPA's draft risk evaluation for Pigment Violet 29 provides interesting insight into how the Agency is developing risk evaluations for the first ten chemical substances. In particular, the draft makes clear that the Agency has been willing to narrow the scope of the risk evaluation in response to comments it receives during the "scoping" and problem formulation stages.5 In the scoping document for Pigment Violet 29, EPA initially included import of Pigment Violet 29 and the use of Pigment Violet 29 in materials including solar cells and polyester fibers as conditions of use that would be examined during the risk evaluation process. However, EPA excluded those uses in the draft risk evaluation because the Agency was unable to confirm that these were "actually conditions of use."6

The scope of the risk evaluations was the subject of numerous public comments received on EPA's problem formulation statements for many of the first ten chemical substances targeted for risk evaluation.7 Parties who had hoped to persuade EPA to narrow the scope of certain risk evaluations based on comments it received regarding the problem formulation statements will be heartened upon seeing EPA's approach in the draft risk evaluation for Pigment Violet 29. However, interested parties should be aware that EPA's approach to determining the scope of a risk evaluation is currently the subject of litigation in the Ninth Circuit. Safer Chemicals, Healthy Families and other non-governmental organizations (NGOs) filed a lawsuit in August 2017 challenging numerous facets of EPA's Risk Evaluation rule, including EPA's determination that it has discretion to exclude conditions of use from the scope of a risk evaluation.8 It is unclear when a decision is expected from the Ninth Circuit. However, a finding for the petitioners could have a significant impact on EPA's approach to conducting risk evaluations under the amended TSCA.9

Also of interest in the draft risk evaluation for Pigment Violet 29 is EPA's consideration of the regulation of Pigment Violet 29 in other contexts. For example, EPA relied on study reports developed by the European Chemicals Agency to make a "preliminary determination of hazard" for Pigment Violet 29.10 Additionally, EPA noted in the draft risk evaluation that the Canadian Ecological Risk Classification for Pigment Violet 29 determined that Pigment Violet 29 "did not meet the criteria... for further evaluation,"11 and similarly that Pigment Violet 29 is "not classified as a hazard" on the European Union's Classification and Labeling list.12 EPA's consideration of the classification and regulation of Pigment Violet 29—and its ultimate finding that Pigment Violet 29 does not present an unreasonable risk to human health or the environment (in line with findings made in other countries and regions)—are an encouraging sign that EPA may align its assessment (and perhaps regulation) of chemical substances with other respected authorities, to the extent that it is able to do so while fulfilling its obligations under TSCA.

EPA's approach to conducting risk evaluations for the first ten chemical substances will become increasingly clear as the Agency continues to release additional drafts later in 2018 and early 2019. EPA made clear in the draft risk evaluation for Pigment Violet 29 that, if a party does not believe that comments it submitted regarding the problem formulation statement for Pigment Violent 29 are adequately addressed by the draft risk evaluation, the party may resubmit its past comments to the docket for the draft risk evaluation and must do so if the party wishes the Agency to consider these comments further. Therefore, interested parties should keep an eye on the Federal Register for the release of additional draft risk evaluations of interest to them, and should be prepared to submit new comments or to resubmit prior comments to the extent that EPA has not adequately addressed the comments in the draft risk evaluation. Additionally, although EPA is providing a 60-day comment period for the draft risk evaluation for Pigment Violet 29, and appears intent on doing so for others, the statute only requires EPA to provide a 30-day comment period. Thus, it is possible, the window provided for public comments on other draft risk evaluations could be narrower.13

Prioritization of Additional Sets of Substances for Review Soon to be Underway

EPA has signaled it will soon commence the formal prioritization process to identify the next group of "high priority" chemical substances to undergo a risk evaluation. The 2016 amendments to TSCA require that by December 22, 2019, the Agency must have at least 20 high priority chemical substances undergoing risk evaluation; and must have designated at least 20 chemical substances as "low-priority" substances. EPA must designate at least one new high priority chemical substance whenever it completes a risk evaluation.

In 2017, EPA issued final regulations establishing the "framework" (process) under which the Agency will conduct both its prioritization and risk evaluation processes. Because the law requires that the prioritization process for any given substance must be completed in accordance with a 9- to 12-month public process, EPA has entertained various strategies for "pre-prioritization," a queue of chemicals to be designated as either "high" or "low" priority. Thus, EPA recently released a "whitepaper" on pre-prioritization described as "A Working Approach for Identifying Potential Candidate Chemicals for Prioritization."14 The Agency also opened dockets to which the public may submit information on 73 specific "Work Plan" chemical substances that are under consideration for prioritization.15 For completeness, EPA opened a "general" docket to which the public may submit suggestions for specific chemical substances (and categories of chemicals) not on the Work Plan that could be considered for prioritization.16

The Agency is certain to be consulting these dockets and reviewing the information received in the near term to ensure it has adequately involved the public and created a process that reflects the level of transparency required by the 2016 amendments. Entities that manufacture, process, or simply use any of the more than 70 chemical substances for which these dockets have been opened are well advised to monitor submissions closely, and to provide information they think might be important for the Agency to consider even before the formal prioritization process has begun.

EPA SNUR Activity Continues

Since August 2018, EPA has published Significant New Use Rules for more than 350 chemical substances.17 SNURs define as "significant new uses" certain practices for manufacturing and processing a chemical substance that an entity must report to EPA at least 90 days before engaging in that activity. These SNURs have been issued as part of an effort to address a backlog at the Agency of new chemical substances that had been undergoing review under Section 5 of TSCA. Of these, all but 13 SNURs relate to substances for which EPA previously issued a TSCA Section 5(e) Consent Order. Initially, the batches of SNURs being issued were for substances that also were subject to TSCA Section 5(e) Consent Orders. These SNURs were issued as direct final rules (and would ordinarily go into effect on a date specified in the Federal Register notice unless adverse comments were received by the Agency). This year, to date, EPA has received adverse comments on 230 SNURs published initially as direct final rules, and consequently has had to withdraw each of these SNURs.18 EPA must consider the various comments that it has received and respond to these comments in the final SNURs. Notably, on November 15, 2018, after receiving adverse comments on many of its direct final SNURs, EPA issued proposed (rather than direct final) SNURs for 66 chemical substances subject to TSCA Section 5(e) Consent Orders—seemingly abandoning its previous approach of issuing SNURs for substances covered by TSCA Section 5(e) Consent Orders via direct final rule.19

The manner in which EPA issued SNURs for 13 chemical substances not covered by TSCA Section 5(e) Consent Orders is also noteworthy.20 EPA made determinations under TSCA Section 5 that these 13 chemical substances are "not likely to present an unreasonable risk" under the conditions of use described in the PMNs.21 Pursuant to TSCA, when reviewing a notification for a new chemical substance, EPA is required to consider both intended conditions of use (i.e., those described in the premanufacture notice) and reasonably foreseen conditions of use.22 In the course of reviewing the PMNs for these 13 substances, EPA was able to make a determination that the intended conditions of use are not likely to present an unreasonable risk to human health or the environment.23 EPA could not reach a similar conclusion for reasonably foreseen uses that were not described in the PMN. Therefore, the Agency decided to issue a SNUR to address its potential concerns about risks to human health or the environment from such reasonably foreseen uses.24 Thus, EPA's determination that these 13 chemical substances are "not likely to present an unreasonable risk" is based on the premise that the SNURs will require notification to EPA of any significant new uses (including such reasonably foreseen uses) of these chemical substances. This approach is likely to generate controversy given that certain members of the environmental NGO community have argued that EPA is required to prohibit or limit reasonably foreseeable conditions of use that present possible concerns using Section 5(e) or 5(f) Orders.

Conclusions

As EPA continues to strive to meet critical deadlines under the amended statute, and to implement the law in a manner reflecting the current Administration's deregulatory perspective, the Agency's actions require both careful scrutiny and active participation by interested parties. Entities having a commercial interest in the continued use of chemical substances that will be undergoing EPA review should take advantage of these opportunities to inform and educate Agency staff at a time when it can be most influential to do so.

*Camille Heyboer also contributed to this Advisory.

Footnotes

1 Fees for the Administration of the Toxic Substances Control Act, 83 Fed. Reg. 52,694 (Oct. 17, 2018) (codified at 40 C.F.R. pt. 700).

2 15 U.S.C. § 2605(b)(4)(G). The Agency may extend the deadline for a risk evaluation for not more than six months.

3 EPA, DRAFT-EPA Document No. 740R18015, Draft Risk Evaluation for C.I. Pigment Violet 29 (Anthra{2,1,9-def:6,5,10-d'e'f'}diisoquinoline- 1,3,8,10(2H,9H)-tetrone) 5 (2018) (hereinafter "Draft Risk Evaluation for C.I. Pigment Violet 29").

4 Draft TSCA Risk Evaluation for Colour Index (C.I.) Pigment Violet 29 (PV29); Notice of Availability, 83 Fed. Reg. 57,473 (Nov. 15, 2018).

5 Draft Risk Evaluation for C.I. Pigment Violet 29 at 11.

6 Id.

7 See, e.g., Environmental Defense Fund, Comments on Ten Scopes under the Toxic Substances Control Act (Sept. 19, 2017) (arguing that the scopes of the problem formulation statements for the first ten chemical substances are not sufficiently "robust" to comply with TSCA); Arkema Inc., Comments to Inform EPA's Rulemaking on the Problem Formulations for the Risk Evaluations for Certain of the First Ten Chemical Substances under the Lautenberg Chemical Safety Act (LCSA) (Sept. 18, 2017) (requesting that EPA remove use in the closed system manufacture of fluorinated gases from the scope of the risk evaluations for methylene chloride and trichloroethylene).

8 Opening Brief of Petitioners at 16, Safer Chemicals, Healthy Families v. EPA, No. 17-72260 (Apr. 16, 2018); see also Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act, 82 Fed. Reg. 33,726, 33,729-30 (July 20, 2017).

9 For additional information about the challenge to EPA's Risk Evaluation rule, please see our June 2018 and October 2018 editions of The Chemical Compound.

10 Draft Risk Evaluation for C.I. Pigment Violet 29 at 5.

11 Id. at 10.

12 Id. at 37.

13 15 U.S.C. § 2605(b)(4)(H).

14 A Working Approach for Identifying Potential Candidate Chemicals for Prioritization, US Envtl. Protection Agency (Sept. 27, 2018).

15 TSCA requires that at least 50% of the chemicals undergoing risk evaluation must come from the Agency's 2014 Update to the TSCA Work Plan (6(b)(2)(B)).

16 Submitting Information on TSCA Work Plan Chemicals to Inform Prioritization and Risk Evaluation, US Envtl. Protection Agency (last updated Sept. 27, 2018).

17 Significant New Use Rules on Certain Chemical Substances, 83 Fed. Reg. 37,702 (Aug. 1, 2018); Significant New Use Rules on Certain Chemical Substances, 83 Fed. Reg. 40,986 (Aug. 17, 2018); Significant New Use Rules for Certain Chemical Substances, 83 Fed. Reg. 43,538 (Aug. 27, 2018); Significant New Use Rules on Certain Chemical Substances, 83 Fed. Reg. 43,527 (Aug. 27, 2018); Significant New Use Rules on Certain Chemical Substances, 83 Fed. Reg. 47,004 (Sept. 17, 2018); Significant New Use Rules on 13 Chemical Substances, 83 Fed. Reg. 49,806 (Oct. 3, 2018); Significant New Use Rules on Certain Chemical Substances, 83 Fed. Reg. 50,838 (Oct. 10, 2018); Significant New Use Rules on Certain Chemical Substances, 83 Fed. Reg. 52,179 (Oct. 16, 2018); Significant New Use Rules on Certain Chemical Substances, 83 Fed. Reg. 57,634 (Nov. 15, 2018).

18 Significant New Use Rules on Certain Chemical Substances; Withdrawal, 83 Fed. Reg. 48,546 (Sept. 26, 2018); Significant New Use Rules; Withdrawal, 83 Fed. Reg. 51,360 (Oct. 11, 2018); Significant New Use Rules; Withdrawal, 83 Fed. Reg. 54,031 (Oct. 26, 2018); Significant New Use Rules; Withdrawal, 83 Fed. Reg. 54,032 (Oct. 26, 2018); Significant New Use Rules; Withdrawal, 83 Fed. Reg. 57,689 (Nov. 16, 2018).

19 Significant New Use Rules on Certain Chemical Substances, 83 Fed. Reg. 57,634.

20 Significant New Use Rules on Certain Chemical Substances, 83 Fed. Reg. 52,179.

21 Chemicals Determined Not Likely to Present an Unreasonable Risk Following Pre-Manufacture Notification Review, EPA (last updated Nov. 8, 2018).

22 15 U.S.C. § 2602(4).

23 See, e.g., EPA, TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-16-0581 (Oct. 9, 2018).

24 Id.

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