Document ID: EPA-HQ-OPPT-2020-0588-0070
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2022-12-02T05:00Z

Public Comments on Proposed Significant New Use Rule (21-1.5e) 
and EPA Responses  -  Public Docket EPA-HQ-OPPT-2020-0588

EPA received public comments from three identifying entities on the proposed rule. The Agency's responses to these comments are described below.
Comment Specific to the SNUR for PMN P-19-131
Comment: A commenter  noted that a specific exception phrase that was worked on to finalize the consent order for P-19-131 was left out of the SNUR. The phrase "except after the New Chemical Substance has been completely reacted or destroyed (e.g., reacting to bind with clay)" was not included in the proposed SNUR. The commenter stated this this critical exception was understood to be included in the SNUR. 
Response: The Agency reviewed the proposed SNUR language and agrees that the language was included in the consent order and was unintentionally omitted in the proposed SNUR. The regulatory text of the final SNUR will include this exception.
Vertebrate Testing 
Comment: The Physicians Committee for Responsible Medicine (PCRM) has requested the Agency accept PCRM comments pertaining to the underlying TSCA 5(e) Orders that form the basis for the proposed SNURs in this rule. PCRM stated that the most recent Orders are written in a revised template which omits mention of the amended TSCA's provision for the reduction of testing on vertebrates. PCRM urged EPA to revise the Consent Order template to remind PMN submitters of the objectives of TSCA sections 4(a) and 4(h) to reduce the use of animals in chemical testing and to direct submitters to the section 4(h)-mandated List of Alternative Test Methods and Strategies.
Response: EPA has revised the consent order template and now includes language in all consent orders under the "Potentially Useful Information" section that references TSCA section 4(h) and the reduction of testing in vertebrate animals. 
Comment: PCRM stated that the results of animal tests were submitted with the PMNs for some of the chemical substances subject to the proposed SNURs. TSCA section 4(a)(3) authorizes EPA to review whether PMN submitters first attempt to develop information by means of alternative test methods or strategies before conducting new vertebrate animal testing. PCRM urged EPA to review compliance with these provisions whenever the results of vertebrate animal testing are included in PMNs, noting that EPA's statement that the Company is not required to submit potentially useful information implies that any such submission would be voluntary and subject to these provisions.
Response:  EPA believes that PCRM's request for the Agency to review compliance with TSCA section 4(h)(3) and the discussion of the Agency's review of test data submitted with PMNs is beyond the scope of the proposed rule for which EPA specifically solicited comments. Regarding voluntary testing associated with SNUNs, EPA strongly encourages potential SNUN submitters, before performing any testing, to consult with the Agency pertaining to protocol selection. This recommendation is conveyed in both the proposed and final SNUR Federal Register notices. EPA believes that the Agency's preference for alternatives is already made clear and that conducting TSCA section 4(h)(3) reviews is not normally necessary.
Comment: PCRM noted that the TSCA section 5(e) consent orders for P-16-167 and P-20-42 request that specific animal tests be conducted, while the corresponding proposed SNURs identify potentially useful information. In another case, P-19-53, the Order requests that one of seven skin sensitization tests be conducted. Two of the options are local lymph node assays (LLNAs) in mice along with five nonanimal methods listed. No mention is made of TSCA's preference for the use of test methods and strategies that reduce or replace the use of vertebrate animals while providing information of equivalent or better scientific quality and relevance.
Response:  SNURs do not contain testing requirements. Instead, EPA includes potentially useful information in its notices of proposed rulemaking for new chemical SNURs so that manufacturers or processors wishing to submit a Significant New Use Notice (SNUN) for a use designated by the SNUR can develop information to better characterize the potential risks. As described in the preamble to this rule, any recommendation for information identified by EPA was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the chemical substance. Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.
Consistency Between Orders and SNURs: Hierarchy of Controls 
Comment:  The Environmental Defense Fund (EDF) stated that the provisions in many of the proposed SNURs that address "protection in the workplace" are not consistent with the underlying Orders, and unlike the Orders, do not accurately and sufficiently invoke the Industrial Hygiene Hierarchy of Controls (HOC), which is a foundational element of OSHA and NIOSH policy. EDF also noted that they recognize EPA proposed updates to its SNUR regulations in 2016 and that the proposed modifications have not been finalized. EDF also commented that the Order's preamble descriptions of workplace requirements are inaccurate because they do not include or accurately describe the requirements for use of engineering control measures and refer only to the consent orders' requirements regarding use of PPE.
Response: EPA believes that although the SNURs do not have exactly the same language as 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 regulatory text under 40 CFR 721.63(a) incorporates both the HOC and worker protection requirements of the Order. 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 further clarify this SNUR notification requirement. The final rule updating general SNUR regulations was published in the Federal Register of July 5, 2022 (87 FR 39756). EPA will use the language in the revised regulations to incorporate the HOC into worker protection requirements for new chemical SNURs. 
      Pertaining to the Order's preamble description of workplace requirements. Many of the preamble descriptions are general descriptions of SNUR requirements. The protection in the workplace regulatory text in Orders adequately describes the requirements for use of engineering control measures. However, the Agency will consider adding some additional information in future preambles mentioning the engineering controls. 
SNURs Should Include Workplace Protection Provisions 
Comment: EDF also noted that EPA should add provisions addressing "protection in the workplace" for fifteen of the PMNs covered by the proposed rule: P-17-235 and P-18-226, P-17-0259, P-18-43, P-18-256, P-18-298, P-18-318, P-18-405, P-19-77, P-19-131, P-19-143 and P-19-144, P-19-145, P-20-29, and P-20-104. EDF listed its concerns for each PMN and expressed that omission of any the workplace controls mentioned could pose concerns directly relevant to workers and that it is not clear from the proposed SNURs, consent orders or other documents on these chemicals available in the docket why EPA has not included specific workplace exposure provisions in the proposed SNURs.
Response: The comment is directed primarily to the determination made for each PMN which was the basis of the SNUR. EPA's response will not address the determinations made for the PMNs. For some of the PMNs listed, EPA addressed the potential unreasonable risk in the workplace via means other than specific worker protection requirements. These requirements include manufacture, processing or use in any manner resulting in inhalation exposure, uses other than those identified in the PMN, no spray application, and limits on residual isocyanates and other requirements. EPA has made a determination for these PMNs that EPA believes is protective and the SNURs were written to match the requirements of the Order and extend the same requirements to other manufacturers and processors. The PMN determinations cannot be amended and the SNURs will not include additional significant new uses for worker protection requirements under 40 CFR 721.63 as those requirements are not included in the Orders and the significant new uses of use without worker PPE now would be considered ongoing uses.