Document ID: EPA-HQ-OPPT-2017-0560-0059
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2019-10-28T04:00Z

Public Comments on Proposed Significant New Use Rule (17-4) and EPA Responses  -  Public Docket EPA-HQ-OPPT-2017-0560
EPA received public comments from four entities on the proposed rule. The Agency's responses are described below. In addition, EPA received two anonymous comments. They were general in nature and did not pertain to the proposed rule; therefore, no response is required.
Withdrawal of Two Proposed SNURs:  P-16-455 and P-16-503
One commenter, as well as subsequent EPA review of the proposed batch SNUR, noted that two of the proposed SNURs already appear in 40 CFR part 721 from earlier SNUR rules. The SNUR for P-16-455 was erroneously proposed as part of this current rule as 40 CFR 721.11121 and will not be finalized, because it is already regulated under the final SNUR found at 40 CFR 721.11017. The SNUR for P-16-503 was erroneously proposed as part of this current rule as 40 CFR 721.11122 and will not be finalized, because it is already regulated under the final SNUR found at 40 CFR 721.11018. 
Ad Hoc Testing Policy Change
Comment:  One commenter noted that EPA has instituted an ad hoc testing policy change without acknowledging it has done so and without meeting TSCA's requirements. With these proposed SNURs, the commenter continues, EPA has implemented a significant departure from past policy and practice by ceasing to include any testing requirements or identifying any recommended testing. Instead, the commenter states, each chemical-specific description in Unit IV. of the direct final rule only identifies "potentially useful information" that EPA indicates is only being "provided for informational purposes;" EPA has not defined what it means for information to be only potentially useful and why EPA does not identify the information as useful or necessary. EPA provides no explanation for why it no longer identifies testing as "recommended testing," as it previously did, and instead only describes the associated information as "potentially useful."
Response:  The comment pertains to the preambles of each SNUR, which are not requirements for testing. EPA has modified language in its regulatory documents to ensure consistency with TSCA section 4(h) requirements to reduce testing on vertebrates to the extent practicable. Section 5(e) Orders will now contain a statement of need that explains the basis for any decision that requires the use of vertebrate animals. In addition, EPA is modifying language in its legal documents describing test requirements to reflect a preference for tiered testing and use of non-vertebrate testing strategies and using that information to inform whether higher tiered testing (including testing of vertebrates) is necessary. EPA is modifying language in its SNURs to generally describe the information EPA believes would help characterize chemical properties, fate and/or the potential human health and environmental effects, rather than list specific recommended tests. EPA is encouraging companies to consult with the Agency on the potential for use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs) to generate data to inform risk assessment. EPA encourages dialogue with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h).
Consistency Between SNURs and Orders
Comment:  One commenter noted that for a number of chemical substances covered by the proposed rule, the corresponding Orders prohibit distribution of the substance until it has been completely cured, while the proposed SNURs do not contain a corresponding notification requirement applicable to a company that intends to distribute the uncured substance. The commenter concludes that the final SNURs must do so.
Response:  For P-16-342, P-16-406, and P-16-407, the Orders do not prohibit distribution of the substances until they are completely reacted (cured). The Orders allow distribution under certain conditions. The terms of the Orders including the distribution requirements are exempted for these PMNs when they have been fully reacted (cured). The final SNURs for these substances will contain the same exemption. Manufacturers and processors distributing chemicals in commerce subject to SNURs are subject to the notification requirements found in 40 CFR part 721.5(a)(2).
Generic Chemical Names Must Comply with the Requirements of TSCA and EPA's Guidance
Comment:  One commenter noted that prior to finalizing the SNUR for certain chemical substances identified, EPA must ensure that the generic names for these chemicals comply with the law and conform to EPA's Generic Name Guidance (83 FR 30173; June 27, 2018). The commenter continued that despite TSCA's requirement for generic names to be specific as practicable, and EPA's stated preference in its guidance for masking only a single structural element, we have identified generic names covered by proposed SNURs that are or appear to be far from sufficiently specific. The specific chemical substances identified in this batch proposed SNUR were P-16-316 and P-16-317: Aliphatic polyester; P-16-342: Modified acrylic polymer; P-16-406 and P-16-407: Functionalized polyimide.
Response:  The statute, regulations, and guidance stipulate that generic names should be as specific as practicable and reveal the specific chemical identity to the maximum extent possible. See TSCA section 14(c)(1)(C), 40 CFR 720.85(a)(2-3), and "Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under TSCA" (see 83 FR 30173; June 27, 2018). EPA does declare PMNs incomplete if they include generic names for confidential substances that are overly generic. However, EPA more thoroughly examines generic names provided after commencement of manufacture or import (i.e., in a Notice of Commencement, or NOC), in accordance with 40 CFR 720.85(b)(6). Because this may occur after finalization of a SNUR, a generic name provided in a SNUR may be improved when the NOC is submitted to the Agency. Persons should also keep in mind that they do not have the benefit of seeing the full chemical identities of confidential substances which is necessary for determining the acceptability of generic names for such substances. Generic names that may appear overly generic may be acceptable for simple chemical substances that have very few functional groups or structural features.
Generic Use Descriptions 
Comment:  The same commenter noted that despite EPA having provided PMN submitters instructions to the contrary, many of these generic use descriptions are overly broad or vague. The commenter provided these examples in this batch proposed SNUR: P-13-307: component of manufactured consumer article  -  contained use; P-16-316 and P-16-317: drilling chemical; and P-16-406 and P-16-407: coating for solid substrates. The commenter stated that these generic use descriptions do not comply with EPA's own 2015 "Instruction Manual for Reporting under the TSCA §5 New Chemicals Program," which calls for the generic use description to include both (1) a description of the category of use, which "should reveal the intended category of use to the maximum extent possible;" and (2) a characterization of the "degree of containment," with examples cited such as "destructive use" or "open, non-dispersive use." Both components are needed; EPA's manual states: "a generic use description that solely describes the degree of containment such as `open, non-dispersive use' is not acceptable." While a few of the examples cited above come closer than others, the commenter concludes, none of them comply with the instructions.
Response:  EPA notes the generic use description issue, with regards to PMN reporting. However, this comment does not pertain to the findings or requirements of the proposed SNURs. Accordingly, EPA is not making any changes to the final SNURs based on these comments.
Significant New Uses Should Be for Any Uses Other Than What EPA Has Evaluated
Comment:  One commenter suggested that EPA should generally designate as a significant new use any use of a chemical substance other than the specific uses EPA evaluated in its PMN review and determined are not likely to present an unreasonable risk. The commenter identified P-16-406 and P-16-407 as SNURs where the specific use is claimed as confidential by the PMN submitter, but the Order and SNURs restrict generically as a coating for solid substrates. It is not clear which specific uses EPA considered. The commenter also noted that the SNUR for P-16-413 does not include designation of any use that would require notification (only process restrictions, no consumer use, application method, etc.).
Response:  The commenter suggested approach is overly broad. TSCA requires that EPA evaluate new chemicals under their conditions of use, including the intended, known and reasonably foreseen circumstances of manufacture, processing, distribution in commerce, use and disposal. Based upon EPA's review of the PMNs, the Agency identified uses that are appropriate for designation as "significant new uses" in order to ensure that EPA has an opportunity to review those uses in a SNUN submission. TSCA §5(a)(2) does not require EPA to take the broad approach advocated by the commenter. EPA believes a more tailored approach is warranted to avoid unduly burdensome regulations.
Misleading Use of 40 CFR 721.80 Reference
Comment:  One commenter noted that certain proposed SNURs state that a significant new use related to industrial, commercial, and consumer activities is listed as "requirements as specified in § 721.80" without specifying one of the 25 possible restrictions in that section.
Response:  Although this comment is not applicable to the current batch SNUR because specific 721.80 restrictions are cited, EPA understands the confusion. Future SNURs will not reference 40 CFR 721.80 when a specific section is not cited and simply write the applicable significant new use, i.e., "Industrial, commercial, and consumer activities. It is a significant new use to...."
Consistency Between Orders and SNURs: Hierarchy of Controls
Comment:  One commenter stated that the provisions in many of the proposed SNURs that address "protection in the workplace" are not consistent with the underlying Orders, do not accurately and sufficiently invoke the Industrial Hygiene Hierarchy of Controls (HOC), which is a foundational element of OSHA and NIOSH policy. The commenter cites two Orders or preambles to the SNURs for P-13-307 and P-16-570 that either fail to include language requiring preference for engineering and administrative controls over PPE or only include a general statement that encourages such controls.
Response:  EPA believes that although the SNURs may not precisely mimic the language in the underlying 5(e) Orders, the SNURs do incorporate the same requirements for HOC as found in the Orders. The commenter refers to this language generally used in 5(e) Orders:
   "Engineering control measures (e.g. enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g. workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible to each person who is reasonably likely to be [dermally exposed/exposed by inhalation] in the work area to the PMN substance ***. Where engineering, work practice, and administrative controls are not feasible or, if feasible, do not prevent exposure, each person subject to this exposure must be provided with, and is required to wear, [personal protective equipment] ***" 
The corresponding SNUR language is shortened to this: "engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible." The language in the specific references under 40 CFR 721.63(a) incorporates both the HOC and worker protection requirements of the SNUR. EPA believes that the intent and requirements are identical between the Orders and SNURs and that adding a phrase referring to PPE where engineering controls are not feasible would not serve to further clarify this SNUR notification requirement.
SNURs Should Include Workplace Protection Provisions Under 40 CFR 721.63
Comment:  The same commenter noted that many of the SNURs do not include specific provisions to incorporate requirements for protection in the workplace regulations codified at 40 CFR 721.63. Specific SNURs cited were for PMNs P-16-316, P-16-317, P-16-342, P-16-406, P-16-407, and P-16-413. None of the Orders contained workplace controls. 
Response:  For the Orders listed, EPA achieved the necessary risk reduction in the workplace via provisions other than specific worker protection requirements in 40 CFR 721.63 or prescriptive controls. For P-16-316 and P-16-317, the Order requires manufacture of the substance at a certain molecular weight and molecular weight distribution that effectively controls risk "upstream," for the kidney toxicity hazard of the substances. For P-16-342, the Order requires use up to a certain percent of the substance in industrial paint/coating formulations and a prohibition on inhalation exposures during processing and use, which address potential lung toxicity. For P-16-406/407, lung toxicity concerns are addressed by prohibition on inhalation exposures during the manufacturing process and by application method during use. Similarly, the Order for P-16-413 lung toxicity concerns are addressed by prohibition on inhalation exposures during processing and use.
Deferring Workplace Protections to OSHA or NIOSH
Comment:  One commenter favored the idea that EPA should leave workplace protection to OSHA and NIOSH. Another commenter argued against that view, stating that nothing in the TSCA statute supports the assertion that EPA should rely on OSHA to regulate new chemicals in the workplace, see 15 U.S.C. § 2604(f)(5); and due to the limitations on OSHA's authority, the protections for workers would not meet TSCA's requirement to "protect against an unreasonable risk of injury to health or the environment." 15 U.S.C. § 2604(e).
Response:  To the extent these comments argue that the Agency should or should not have issued Orders under section 5(e) or 5(f) of TSCA that include worker protection conditions, EPA believes they are beyond the scope of the SNUR for which EPA specifically solicited comments and are properly directed to the section 5(a)(3) determinations that pertain to the underlying PMNs for the SNUR. EPA is therefore not responding to these comments. TSCA section 5(a)(2) does not mandate that any specific uses be designated as significant. Instead, EPA has discretion as to which new uses to designate as significant. In exercising its discretion regarding which new uses should be designated as significant under TSCA section 5(a)(2), EPA expects compliance with federal and state laws, such as worker protection standards or disposal restrictions, unless case-specific facts indicate otherwise. As noted in the comment and response in the previous paragraph on section 40 CFR 721.63, SNUR requirements other than PPE can also limit worker exposures and risk.
CBI and Disclosure of Health and Safety Information
Comment:  One commenter stated that TSCA does not extend CBI protection to any health and safety study which is submitted under TSCA, including underlying information and occupational exposure studies. In addition to the scientific analyses developed by EPA (e.g., engineering reports, Structure Activity Team reports), which fall under this definition, other information that is generally required to be submitted with PMNs, such as toxicity studies, information on worker exposure, and the information in Safety Data Sheets, also fall under this definition. EPA must disclose this information to the public. Despite these mandates, the commenter argues that EPA has failed to disclose this health and safety information
Response:  EPA recognizes that TSCA section 14 does not protect from disclosure certain confidential information described in section 14(b), including health and safety information. However, section 14 does not require that EPA make a final confidentiality determination for all information submitted under TSCA and claimed as CBI as part of a PMN review and EPA has not made a determination regarding the eligibility for confidential treatment of the information referenced in the comment. EPA balanced the need for sufficient information in the public record to explain the bases for its decisions with the protections for CBI in section 14. EPA technical reports providing the basis for the determination are not covered by section 14(b)(2), which specifically refers to health and safety studies. EPA provided information in the public record to explain the bases for its decisions while preserving the submitter's confidentiality claims.
Vertebrate Testing
Comment:  One commenter cited the Orders for P-13-307 and P-16-570 that require animal testing by a specified production volume. The commenter requested that wherever EPA require vertebrate animal testing, it include the statutorily-mandated explanation of the basis for the such decision.
Response:  A request to review compliance with TSCA 4(h)(3) for PMNs and Orders is not relevant to the proposed SNUR. Because SNURs do not require testing and only suggest the type of information that could address hazards identified by EPA, they include opportunities for EPA to engage submitters considering conducting testing. For SNURs with time or production volume limits, or if a SNUN submitter is required to conduct testing, EPA will include consideration of TSCA section 4(h)(3). When a company consults with EPA before submitting any SNUN as recommended, EPA will have an opportunity to consider what testing if any should be conducted including consideration of TSCA section 4(h)(3).