Document ID: EPA-HQ-OPPT-2019-0359-0292
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2021-08-18T04:00Z

Public Comments on Proposed Significant New Use Rule (19-2.F) and EPA Responses  -  Public Docket EPA-HQ-OPPT-2019-0359

EPA received public comments from three identifying entities pertaining to the SNURs that the Agency is finalizing with this rule. The Agency's responses are described below.
Comment specific to the SNUR for P-16-400
Comment:  Shell Chemical LP, the submitter of PMN P-16-400, commented in response to the proposed SNUR for the substance which was the subject of this PMN. Shell requested that EPA withdraw the proposed SNUR and remove the restriction for consumer use, noting that in accordance with TSCA section 5(a)(3)(C), EPA determined that the PMN substance was not likely to present an unreasonable risk of injury to health or the environment under the conditions of use. Shell further stated that the restrictions in the proposed SNUR conflict with the referenced test data and EPA's conclusion that no unreasonable risks to the general population, consumers, or the environment were identified. Shell does not expect that the use of the PMN substance will be acutely toxic by dermal or inhalation routes as identified by the proposed SNUR; therefore, there should be no restriction for consumer use. 
Response:  Although consumer use and use other than as a chemical intermediate, in cured coatings, cleaning fluids, metalworking fluids/rolling oils, and in agrochemicals were not identified as intended uses, they were identified as reasonably foreseen conditions of use by EPA during review of the PMN. EPA is concerned, based on the identified hazards for dermal irritation and lung effects, that other circumstances of use could result in unreasonable risks to consumers and workers. EPA is designating consumer use and use other than as a chemical intermediate, in cured coatings, cleaning fluids, metalworking fluids/rolling oils, and in agrochemicals as a significant new use because the Agency wants to have the opportunity to review and evaluate any prospective new use of the PMN substance before manufacture or processing for that use may commence. EPA will then make a determination regarding the use and take the required regulatory action associated with that determination. EPA is finalizing the SNUR as proposed.
Comment specific to the SNURs for PMN P-18-7 and P-18-8
Comment:  Nexoleum USA Corp., the submitter of PMNs P-18-7 and P-18-8, commented in response to the SNURs for the substances which were the subjects of these PMNs. Nexoleum recommended that EPA revise the SNURs to reflect the hazards identified by EPA for these substances. They explained that it was their understanding that EPA had intended the SNUR conditions to prohibit manufacturing, processing, or use that generates dust and to prohibit use in consumer products at greater than 20% by weight. They do not foresee conditions that would generate dust, nor do they foresee use in consumer products at greater than 20% by weight. Nexoleum requested that EPA either withdraw the SNURs or, if EPA proceeds with the SNURs, that EPA revise the SNURs to reflect the hazards that EPA identified for these substances.
Response:  EPA incorrectly identified the proposed significant new uses in the SNURs for these two substances. EPA has revised the SNURs to include the correct significant new uses as identified by the commenter:
 Manufacturing, processing, or use in any manner that generates a dust containing the substance; and
 Manufacturing or processing the substance at greater than 20% by weight in consumer products.
Protection of Drinking Water Sources
Comment:  The Association of Metropolitan Water Agencies (AMWA) identified concerns regarding environmental (surface water) release restrictions in the proposed SNURs for PMNs P-18-7, P-18-8, P-18-152, and P-19-26; and noted the importance of protecting water sources for public water supply. AMWA requested that empirical support for these restrictions be made available, expressing concern about the lack of information available for these chemicals in the public docket and about the level of redaction in sanitized support documents. AMWA explained that providing more information and greater data transparency would aid in understanding EPA's concerns and its decision to allow releases to surface waters despite the human health and/or environmental concerns identified. AMWA encouraged EPA to make its data more transparent and gather more data to better inform its decisions.
Response:  EPA assesses risks from exposure to drinking water when reviewing new chemicals and significant new uses of chemicals whenever it is determined the chemical may be released to water. EPA may also assess indirect releases to drinking water via landfill leachate, as necessary based on case-specific information. The expected environmental releases, media of release, potential human and ecological hazards, environmental fate, and other factors are considered when assessing potential risks from releases to water. EPA scientists and engineers use information provided in the premanufacture notice (PMN), reasonably available data on analogous substances, computer modeling, and their professional judgement to assess the environmental fate exposures and hazards of the chemical. When releases to water are expected, EPA uses models to estimate the potential concentrations of the substance in environmental media. EPA identifies the receiving water body based on information in the PMN or uses generic stream flow data for a particular industry sector. The predicted levels in the receiving water body are compared to the concern levels identified for human health and environmental effects to determine if there is risk.  
      When chemicals are identified as being persistent, bioaccumulative, and toxic, as described in the New Chemical Program's PBT category (see 64 FR 60194; November 4, 1999), a SNUR typically ensures EPA will receive and review a significant new use notification (SNUN) before any releases to water are permitted. EPA may also issue a SNUR to require notification and Agency review before releases occur at or above the level where EPA identified potential risk to human health or the environment under the intended conditions of use (i.e., for SNURs following TSCA orders) or where there is a concern that releases may exceed the concern levels under other conditions of use. The allowable release level is usually based on the aquatic toxicity, as this level is typically much lower than the concern level for human health based on "no observed adverse effect level" (NOAEL) and "no observed adverse effect concentration" (NOAEC). Potential risks have been evaluated for the intended uses in environmental and human health risk assessments, and notification is required for the other uses.   
      In the public docket, EPA has identified the basis for potential hazards and risks from water releases above a certain concentration. The concentrations specified in the proposed SNURs for PMNs P-18-7, P-18-8, P-18-152, and P-19-26 are all based on potential chronic risks to the aquatic environment. These surface water concentrations are protective of the environment and human health hazards identified for these chemical substances.
Comment:  AMWA recommended that for future SNURs, EPA reconsider approvals for chemicals that are known to have acute toxicity to human health and have been identified as potential contaminants of concern in drinking water supplies.  AMWA suggested that the Office of Pollution Prevention and Toxics (OPPT) should coordinate with the EPA Office of Ground Water and Drinking Water (OGWDW), which not only oversees the Safe Drinking Water Act implementation but also may have on its radar many of the chemicals being considered in this and future SNURs as potential drinking water contaminants. AMWA also suggested that OPPT utilize the knowledge base of the drinking water program at EPA's OGWDW to better inform decision making for future SNURs.
Response:  EPA agrees on the benefits of coordination of OPPT and OGWDW to protect drinking water supplies. OPPT works with the Office of Water (OW) on methods to enhance assessments of drinking water exposures. While the offices do coordinate, they must conduct risk assessments and take risk management actions consistent with the requirements of their respective laws. The Safe Drinking Water Act typically addresses comparatively data-rich existing substances now in commerce, while the TSCA new chemicals program reviews chemicals prior to entering the marketplace. OPPT will continue to coordinate with OW to ensure EPA is being protective across all environmental media programs and will explore ways to enhance collaboration on aspects of the assessments of new chemicals. 
Access to Documents and Online Resources 
Comment: AMWA recommended that EPA include in the public docket the Agency's PMN determination for each chemical in future SNURs, noting that access to these documents is necessary to allow the public to better understand the reasoning behind EPA's decisions. There is concern that EPA decision documents are not being included and/or properly marked in the docket.
Response: EPA agrees with the commenter on the importance of facilitating public access to Agency information. In 2019, EPA took significant steps to make additional information about the status of chemical reviews available to the public. EPA plans to continue to increase access to this information and will include determination documents in the public SNUR docket. 
Lack of Requirements for Testing
Comment:  AMWA also expressed concern with EPA's method of obtaining potentially useful information, since there are no testing requirements contained in the SNURs. There is concern that this method may provide a disincentive to conduct additional studies that could reveal more harmful effects.
Response: EPA evaluated potential risks to human health and the environment for these chemicals under their conditions of use. EPA has determined that additional testing was not necessary for cases which are not likely to present unreasonable risk to human health and the environment. Additionally, the SNURs issued for these chemicals contain requirements for notification to EPA for review of other conditions of use that may increase exposures and releases. EPA has identified potentially useful information in the SNUR 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. 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).