On June 22, 2023, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) for three flame retardants, tris(2-chloroethyl) phosphate (TCEP), 4,4′-(1-methylethylidene)bis[2,6-dibromophenol], also known as “tetrabromobisphenol A” (TBBPA), and triphenyl phosphate (TPP), which are all undergoing risk evaluations under the Toxic Substances Control Act. 88 Fed. Reg. 40728. EPA states that the proposed significant new uses are manufacture (including import) or processing for any use, “with the exception that the conditions of use [(COU)] the Agency expects to consider within the scope of the TSCA section 6 risk evaluations are not proposed as significant new uses.” Persons subject to the SNURs would be required to notify EPA at least 90 days before commencing any manufacturing (including import) or processing of the chemical substance for a significant new use. Once EPA receives a notification, EPA must review and make an affirmative determination on the notification, and take such action as is required by any such determination before the manufacture (including import) or processing for the significant new use can commence. Comments are due August 7, 2023. EPA states in its June 21, 2023, press release that it “is particularly interested in comments on uses that should or should not be included in the SNUR.” According to EPA, this information will help guide its approach to assessing these chemicals and protecting human health and the environment.
Rationale and Objectives of the Proposed Rule
Rationale
EPA states that it has identified the potential for adverse environmental and health effects from the COUs of TCEP, TBBPA, and TPP based on data and information sources already described in the proposed designation of TCEP, TBBPA, and TPP as high-priority substances for TSCA Section 6 risk evaluation and the final scopes of the risk evaluations for TCEP, TBBPA, and TPP. According to the proposed rule, EPA will evaluate risk under TSCA Section 6 from the COUs of TCEP, TBBPA, and TPP.
EPA states that based on an extensive review of reasonably available information, it proposes to determine that significant new uses of TCEP, TBBPA, and TPP are manufacture (including import) or processing for any use, with the exception that the COUs EPA expects to consider within the scope of the TSCA Section 6 risk evaluations are not proposed as significant new uses. The COUs that EPA identified for the TSCA Section 6 risk evaluations include all manufacture, processing, and use that the information available to EPA demonstrates to be ongoing in the United States. The proposed significant new uses include manufacture and processing for uses that have ceased; manufacture and processing for uses that have not yet ceased but for which all manufacture and processing has ceased; and manufacture and processing for uses for which EPA has no information demonstrating that the use has previously commenced in the United States. EPA notes that it has identified certain uses of TCEP, TBBPA, and TPP that have ceased, as well as industrial, commercial, or consumer COUs that are ongoing but for which manufacturing (including import) or processing have ceased. In the absence of a SNUR, the manufacturing (including importing) or processing of TCEP, TBBPA, and TPP for the significant new uses proposed in the SNURs “could begin at any time, without prior notice to EPA under section 5 and without providing EPA an opportunity to review and address potential risks associated with the new use.” EPA states that it is concerned that commencement of manufacturing (including importing) or processing TCEP, TBBPA, and TPP for the proposed significant new uses could significantly increase the volume of manufacturing (including importing) and processing of these chemicals, as well as the magnitude and duration of exposure to humans and the environment over that which would otherwise exist currently, particularly to the potentially exposed or susceptible subpopulations identified by EPA in the final scopes for risk evaluation or during risk evaluation. Given the concerns associated with the COUs, “EPA believes that notification and EPA’s required review are warranted for these chemicals prior to the commencement of a significant new use.”
Objectives
EPA states that it wants to achieve the following objectives with regard to the significant new use(s) designated in the proposed SNURs:
- EPA would receive notice of any person’s intent to manufacture (including import) or process the chemical substances for the described significant new use before that activity begins;
- EPA would have an opportunity to review and evaluate data submitted in a significant new use notice (SNUN) before the notice submitter begins manufacturing (including importing) or processing the chemical substances for the described significant new use; and
- EPA would be able either to determine that the significant new use is not likely to present an unreasonable risk of injury or to take such regulatory action as is associated with any other determination under TSCA Section 5, before the manufacture or processing for the significant new use could commence.
Applicability of General Provisions to the Proposed SNURs
EPA notes that general provisions for SNURs appear in 40 C.F.R. Part 721, Subpart A. These provisions describe persons subject to SNURs, recordkeeping requirements, and exemptions to reporting requirements. Provisions relating to user fees appear at 40 C.F.R. Part 700. Pursuant to 40 C.F.R. Section 721.1(c), persons subject to SNURs must comply with the same requirements and EPA regulatory procedures as submitters of premanufacture notices (PMN) under TSCA Section 5(a)(1)(A). EPA states that in particular, these requirements include the information submission requirements of TSCA Sections 5(b) and 5(d)(1), the exemptions authorized by TSCA Sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 C.F.R. Part 720.
Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination under TSCA Section 5 before the manufacture (including import) or processing for the significant new use can commence. If EPA determines that the significant new use of the chemical substance is not likely to present an unreasonable risk, EPA is required under TSCA Section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA’s finding.
Applicability of General Exemptions to the Proposed SNURs
EPA states that the general exemptions from SNUR notice requirements that are described in 40 C.F.R. Section 721.45 would apply to these proposed SNURs. EPA requests public comment on the alternative of making inapplicable the article exemption at 40 C.F.R. Section 721.45(f). Under this alternative, the import and processing of articles containing TCEP, TBBPA, and TPP would not be exempt from significant new use notification requirements. According to EPA, as it collects and reviews information about the importing or processing of TCEP, TBBPA, and TPP as part of articles and the potential exposure to these chemical substances through articles, it may consider whether to make inapplicable the articles exemption at 40 C.F.R. Section 721.45(f). EPA also seeks comment on the potential impact of making inapplicable the articles exemption on firms that plan to import or process articles containing TCEP, TBBPA, and TPP, “because, while not required by the proposed SNUR, these parties may take additional steps to determine whether TCEP, TBBPA, and TPP are part of the articles that they are considering for importing or processing.”
Applicability of the Proposed SNURs to Uses Occurring before the Effective Date of the Final Rule
EPA states that any use that it determines, in the final rule, was ongoing as of the date of publication of this proposal and did not cease prior to issuance of the final rule will not be designated as a significant new use in the final rule.
EPA notes that as discussed in its April 24, 1990, Federal Register notice (55 Fed. Reg. 17376), it “has decided that the intent of the TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of the proposed rule rather than as of the effective date of the final rule.” According to EPA, the objective of its approach “is to ensure that a person cannot defeat a SNUR by initiating a significant new use after publication of the proposed rule but before the effective date of the final rule.” EPA distinguishes uses arising after the publication of the proposed rule from uses that are identified in the final rule as having been ongoing on the date of publication of the proposed rule. The former would be new uses, the latter ongoing uses, “except that uses that are identified as ongoing as of the publication of the proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule.”
Any person who begins commercial manufacturing (including importing) or processing of the chemical substances for a use that is designated as a significant new use in the final SNUR would have to cease any such activity upon the effective date of the final SNUR. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until all TSCA prerequisites for the commencement of manufacture or processing have been satisfied.
Important Information about SNUN Submissions
SNUN Submissions
EPA states that according to 40 C.F.R. Section 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 C.F.R. Section 720.50.
EPA recommends that SNUN submitters consult with the Agency if, for instance, the chemical substance is also subject to a rule, order, or consent agreement under TSCA Section 4. EPA states that prior to submitting a SNUN, submitters should consider what information may be useful in evaluating a SNUN. Discussions with EPA prior to submission “can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance.”
Development and Submission of Information with the SNUN
EPA states that it recognizes that TSCA Section 5 does not usually require developing new information (e.g., generating test data) before submission of a SNUN. EPA notes that there is an exception: if a person is otherwise required to submit information for a chemical substance subject to the SNUR pursuant to a rule, TSCA order, or consent agreement under TSCA Section 4, then TSCA Section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.
In the absence of a TSCA Section 4 test rule, order, or consent agreement covering the chemical substance, persons are required to submit only information in their possession or control and to describe any other information known to or reasonably ascertainable by them. EPA states that as a general matter, it recommends that SNUN submitters include information that would permit a reasoned evaluation of risks posed by the chemical substance during its manufacture (including import), processing, distribution in commerce, use, or disposal. EPA notes that it “encourages persons to consult with the Agency before submitting a SNUN.” As part of this optional pre-notice consultation, EPA would discuss specific information it believes may be useful in evaluating a significant new use.
According to the proposed rule, submitting a SNUN that does not include information sufficient to permit a reasoned evaluation “may increase the likelihood that EPA will either respond with a determination that the information available to the Agency is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant new use or, alternatively, that in the absence of sufficient information, the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance may present an unreasonable risk of injury.”
EPA “strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection.” EPA notes that furthermore, pursuant to TSCA Section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation on the use of alternative test methods and strategies (New Approach Methodologies (NAM)), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA Section 4(h).
According to EPA, the potentially useful information listed in the proposed rule may not be the only means of addressing the potential risks of the chemical substance. EPA states that submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA Sections 5(e) or 5(f), however. EPA recommends that potential SNUN submitters contact EPA “early enough so that they will be able to conduct the appropriate tests.”
EPA states that SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information on the following:
- Human exposure and environmental release that may result from the significant new use of the chemical substance; and
- Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
Commentary
EPA’s proposed SNUR provides further insight on the direction that EPA plans to take on chemical substances it identifies as high-priority substances under TSCA Section 6. As we previously commented (see our commentaries dated April 7, 2023, on chrysotile asbestos and April 25, 2023, on methylene chloride), EPA’s proposed risk management rules on chrysotile asbestos and methylene chloride telegraph EPA’s intent to prohibit most industrial and commercial uses, require workplace chemical protection plans (WCPP) with occupational exposure limits (OEL) that are, thus far, significantly lower than existing OELs, and propose time-limited exemptions under TSCA Section 6(g) for specific COUs (e.g., national security and critical infrastructure). EPA’s latest action supports that it will begin using its SNUR authority under TSCA Section 5 to prohibit those COUs that are no longer ongoing for existing chemical substances that are undergoing risk evaluation. We agree with this approach. By prohibiting COUs that are not ongoing, EPA both protects against the risks that may arise from those COUs and limits the COUs that must be evaluated in the scope of the risk evaluation. We caution interested parties, however, to consider the importance of this action and the potential legal requirements that it imposes or may impose, as discussed below.
Exporters and importers of the subject chemical substances should be mindful of the pending requirements of EPA’s proposal. For example, under 40 C.F.R. Section 721.20, entities that export or intend to export these substances will be required to comply with the export notification provisions under TSCA Section 12(b) and the implementing regulations under 40 C.F.R. Part 707, Subpart D, based on EPA’s mere proposal of the rule on or after June 24, 2023. It is also critically important that stakeholders consider EPA’s request for public comment on the option of making the article exemption at 40 C.F.R. Section 721.45(f) inapplicable. While this may be reassuring at some level — banning the import of articles that may contain any of the applicable flame retardants — it is also the case that importers have had no obligation to identify whether any is present in an article. As a result, many article importers do not know if the imported article is present, intentionally or otherwise. It would be impossible for article importers to know and comment on the presence or absence of these flame retardants in the 30-day comment window. EPA has no reason to suspect that those flame retardants are absent in imported articles or to conclude that the import of flame-retardant-containing articles is not ongoing. In B&C’s view, EPA must address articles in the scope of its Section 6 risk evaluation, not in a Section 5 SNUR rulemaking. If the SNUR is promulgated with a ban on import of articles containing these flame retardants, importers will be in a position of potentially and unknowingly being in violation of the SNUR.
B&C was a bit perplexed by EPA’s statement that SNUN submitters on these chemical substances should provide “Information on risks posed by the chemical substances compared to risks posed by potential substitutes.” We mention this because EPA will undoubtedly issue WCPP requirements for the subject chemical substances in its proposed risk management rule. On other chemical substances (e.g., methylene chloride), EPA has determined that compliance will “as a matter of risk management policy … eliminate any unreasonable risk of injury to health.” If a SNUN can demonstrate that the uses proposed do not present an unreasonable risk, that is sufficient to meet the statutory requirement for EPA to allow the new use to proceed with the restrictions of an order and/or the eventual Section 6(a) rule. It is also unlikely that a SNUN submitter will have sufficient information about its competitor’s practices to be able to provide a meaningful risk assessment. After all, unlike EPA, a competitor has no legal authority to compel a competitor to provide hazard, release, and exposure information. Therefore, we question EPA’s authority for providing uncharacterized risks of potential substitutes in SNUN submissions.
B&C encourages interested parties to review and comment, as appropriate, on EPA’s proposed SNUR. This proposal may be focused on chemistries that are not part of an entity’s portfolio. It does, however, provide insight on the direction that EPA plans for regulating chemical substances identified as high-priority substances and undergoing risk evaluation under TSCA Section 6. It is especially important to comment on EPA’s request for comment on its proposal to void the article exemption for the SNUR substances and EPA’s proposal to require a comparative risk assessment between the SNUR substance and alternatives.