February 18, 2020

Document Control Office (7407M)
Office of Pollution Prevention and Toxics (OPPT)

Environmental Protection Agency
1200 Pennsylvania Ave. NW
Washington, DC 20460-0001

Docket ID No.: EPA-HQ-OPPT-2019-0684

Via Regulations.gov submission

RE: Updated Working Approach To Making New Chemical Determinations Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comment


To whom it may concern:

SOCMA appreciates the opportunity to submit comments on the U.S. Environmental Protection Agency’s framework document entitled: “TSCA New Chemical Determinations: A Working Approach for Making Determinations under TSCA Section 5”.[1]

SOCMA is the national trade association representing the specialty and fine chemical industry. Founded in 1921, SOCMA represents a diverse membership of chemical companies who manufacture unique and innovative chemistries used in a wide range of commercial, industrial, and consumer products. SOCMA maintains a strong record of member service through programs that maximize commercial opportunities, enhance regulatory and legal compliance, and promote industry stewardship.

SOCMA members specialize in producing new chemistries to meet customer demands, and the TSCA new chemicals program largely determines their ability to introduce their products into the marketplace. SOCMA thus has a vital interest in the ongoing implementation of the new chemicals program, as the approaches taken by EPA can directly – and negatively – affect the ability of specialty chemical manufacturers to meet customer demands and to operate profitably.

SOCMA offers several recommendations to ensure that reviews of new chemical notices under TSCA Section 5 meet statutory deadlines, adopt appropriate risk assessment approaches, and avoid unnecessary limitations on commercial manufacture.  

In particular, EPA should:

  • Stop issuing SNURs on the basis of “unreasonably foreseen” conditions of use;
  • Recognize that the 2016 TSCA amendments did not require EPA to significantly change how it reviews exemption requests under Section 5(h); and
  • Continue to expedite and improve reviews of premanufacture notices.
I. EPA’s Imposition of SNURs for “Unreasonably Foreseen” Conditions of Use Exceeds its Statutory Authority

The working approach document articulates circumstances in which EPA will utilize Significant New Use Rules (SNURs) in conjunction with determinations on new Pre-Manufacture Notices (PMNs). While SOCMA appreciates the Agency’s documenting the circumstances and timing of its use of SNURs, EPA has gone beyond its legal authority when evaluating the pertinent scope of conditions of use (COU), particularly for SNURs that follow “not likely to present unreasonable risk” determinations.

The working approach document problematically states: “If EPA has determined that the chemical substance under its conditions of use is ‘not likely’ to present an unreasonable risk, EPA may still issue a SNUR that follows the determination. Specifically, where EPA has identified other circumstances that – should they occur in the future, even if not reasonably foreseen – may present risk concerns, EPA may consider identifying those other circumstances as significant new uses.” (emphasis added). This approach essentially confirms that EPA will now be imposing SNURs on COUs that are “unreasonably foreseeable”, i.e., those which remain in the realm of the hypothetical. Evaluating such hypothetical COUs does not align with the amended statute, which states that that EPA must evaluate “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”[2] The same standard of reasonable foreseeability is also embedded in the statutory provision that authorizes SNURs.[3]  COUs which by definition are not reasonably foreseeable are clearly outside the bounds of EPA’s legal mandate.

EPA’s new interpretation of the statute poses severe practical problems for submitters willing to undergo the lengthy and difficult process of getting a PMN approved. Even if a chemical substance is able to successfully navigate the review process, has no known, intended or reasonably foreseen uses that present risk concerns, and consequently receives a “not likely to present an unreasonable risk” determination, it will still face the regulatory burden and delays associated with a SNUR so long as Agency can imagine uses that have no evidence-based relation to the substance. Besides violating the amended statute, this approach substantially limits a new chemical substance’s commercial viability.

II. The Direction of Exemption Request Reviews Needs Improvement

SOCMA is disappointed to see no discussion in the working approach document of Section 5(h) exemption requests, which make up a significant portion of the notices the Agency receives annually, and which are undergoing their own set of difficulties in the new chemicals program. SOCMA has heard from EPA leadership that, in the Agency’s effort to prioritize reduction of the PMN backlog, significantly fewer resources are being devoted to the review of exemptions.  This inhibits a critical mechanism for the introduction of new chemistries into the marketplace.

Often before a manufacturer is prepared to expend significant resources and time on a PMN submission, it will opt to leverage an exemption request (typically a Low Volume Exemption) to evaluate the viability of a new chemistry in the marketplace. Once the new chemistry has an established a customer base and consistent downstream use(s), the company will consider moving forward with a PMN to facilitate expansion of production. The various logistical hurdles for a PMN review (such as the financial costs of the submission, data generation requirements, internal labor costs, and the extended time frame for review) require companies to take an increasingly conservative approach when evaluating whether potential revenues from a product would justify the submission. If a company cannot even get approval from the Agency for an LVE, its pipeline for the development of new chemistries is impeded at its source, which will consequently lead to reduced commercial innovation.

Another important function of exemptions, LVEs in particular, is that they facilitate new product development for specialty chemical manufacturers who may never have the need for a PMN for their products due to the nature of the chemicals they produce. Small quantity, high value, non-commodity chemicals, such as intermediates, are the backbone of many specialty chemical producers. These producers are being severely limited from expanding their business if they cannot get their LVEs approved in a timely and reasonable fashion.

These scenarios are not merely theoretical – they are the reality taking place under the new chemicals program today. SOCMA members consistently report that the timeframe for the review of an exemption can take over six months, and that case managers are insisting on additional data and modifications to production processes, far beyond what had been the norm for such submissions. The Agency is applying significantly more scrutiny to such requests, even though by nature such exemptions are for manufacturing that is extremely limited in volume or for substances that have low release and exposure potential. As SOCMA has emphasized to EPA in prior comments:

  • The statute distinguishes between PMNs and exemption applications – and the only change to Section 5(h) under amended TSCA was to incorporate language regarding potentially exposed or susceptible subpopulations.  EPA thus has no statutory basis to scrutinize exemptions any differently post-2016 on basis of the “sufficient information” or “affirmative determination” language, which Congress only applied to PMNs and SNUNs.
  • Since 1995, EPA’s policy has been to grant an exemption application only if it is able “to affirmatively find” that the granting the application “will not present an unreasonable risk. . . .”[4]  Therefore, exemption request approvals for decades have already met the risk standards that amended TSCA now imposes for PMNs.

SOCMA strongly urges the Agency to resolve these problematic issues that Section 5(h) exemptions are experiencing and ensure that the processes for such applications are expedited and returned to their prior review periods and approval rates. SOCMA also recommends that EPA distinguish exemptions from PMNs and SNUNs in its working approach document and articulate the distinction in the review processes and information requirements for such notices.

III. EPA Must Expedite and Improve the Review Process for New Chemical Notices

SOCMA acknowledges and is grateful for EPA’s ongoing work to resolve the backlog of new chemical notices, improve transparency for submitters, and streamline the review process for submissions. However, SOCMA continues to hear from members that the current program still lacks predictability and transparency. Submitters continue to face the dilemma of being asked by the Agency to suspend the statutory review deadline for their application. Their only choice is to agree to the suspension request or to withdraw their submission entirely. This has also allowed the Agency to avoid refunding applicable fees, since the suspension action is effectively forced on the submitter.

The Agency also continues to utilize an excessively precautionary approach to new chemical reviews. This is causing a variety of difficulties for submitters including requirements for expensive and time-consuming tests, reliance on default assumptions regarding hazard and exposure, and unwillingness to rely upon robust data summaries. And while EPA has noted on frequent occasions to stakeholders that it cannot legally require minimum data sets to conduct reviews, case managers insist on obtaining them in practice. SOCMA members report that EPA case managers often provide no guidance to resolve their specific case (while continuing to request multiple suspensions of the review deadline), leaving submitters unable to expedite review – even when they can readily provide additional information to the Agency or revise their engineering processes and controls to mitigate potential risk concerns.

Altogether, these practices are greatly impeding the introduction and commercialization of new chemicals, and therefore impeding innovation. Companies always face some commercial risk that a new chemistry will not turn an adequate profit when introduced into the market. The uncertainties and delays created by the new chemicals program only increase that risk and lead many companies to forego opportunities to create new substances. Alongside the ongoing bottleneck of exemption requests, it is not surprising then that EPA has begun to observe fewer and fewer PMNs being submitted.

IV. The Working Approach Document’s Acknowledgement of Workplace Exposure Controls is a Positive Development

SOCMA is pleased to see the Agency recognize in the Working Approach document that employers will comply with applicable requirements for engineering controls and personal protective equipment as set by the U.S. Occupational Health and Safety Administration (OSHA) and other relevant authorities. SOCMA is also pleased that EPA recognizes the important role of hazard communication in protecting workers, in that submitter Safety Data Sheets (SDSs) will account for the risks identified in the Agency’s new chemical assessment and incorporate necessary handling practices and protections to prevent occupational exposures by users. Worker protection standards are omnipresent in the chemical manufacturing industry, and companies consistently evaluate what protections are needed to guarantee worker health and safety when manufacturing a new chemical substance. SOCMA appreciates EPA’s acknowledgment that “unless case-specific facts indicate otherwise, EPA believes that a chemical is generally not likely to present unreasonable risks to workers if the use of PPE and/or other exposure controls would mitigate potential risk.”[5]

Conclusion

SOCMA appreciates the opportunity to comment on EPA’s updated working approach for making determinations on new chemical notices under TSCA Section 5. SOCMA strongly urges the agency to return to a screening level risk assessment of new chemical applications and continue to work toward ensuring all PMNs and exemptions complete review by the applicable deadline. SOCMA looks forward to continued involvement and collaboration with EPA on its TSCA implementation efforts in the future.

Respectfully submitted,

Jared Rothstein
Senior Manager, Regulatory Affairs, SOCMA
1400 Crystal Drive, Suite 630
Arlington, VA 22202

[1] 85 FR 99 (January 2, 2020).

[2] 15 U.S.C. § 2602(4).

[3] Id. § 2604(a)(2)(D) (EPA to consider, in determining whether to issue a SNUR, “the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance”).  See also H.R. Rep. 94-1341 (July 14, 1976) at 24 (“only when a new use of a substance may reasonably be expected to have health or environmental importance should it be subjected to the notification requirement.”).

[4] 60 Fed. Reg. 16336, 16337 (March 29, 1995).

[5] “TSCA New Chemical Determinations – A Working Approach for Making Determinations under TSCA Section 5 (Dec. 2019), p. 9.

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