Document ID: EPA-HQ-OPPT-2018-0627-0127
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2019-11-25T05:00Z

Public Comments on Proposed Significant New Use Rule (18-1)
and EPA Responses  -  Public Docket EPA-HQ-OPPT-2018-0627

EPA received public comments from three identifying entities on the proposed rule.  The Agency's responses are described below.  In addition, EPA received three anonymous comments.  They were general in nature and did not pertain to the proposed rule; therefore, no response is required.
Inconsistencies with 5(e) Order and SNUR
A commenter noted the following inconsistencies between certain proposed SNURs and underlying 5(e) Order restrictions:
Comment: For P-17-24 and P-17-25, the Order requires that the substance not be manufactured or processed "involving a method that generates a vapor, mist, aerosol, or dust," whereas the proposed SNUR do not designate as a significant new use any manufacture, processing or use that would result in inhalation exposures to dust.
Response: The regulatory text of the SNURs at 40 CFR 721.11159 and 40 CFR 721.11160 have been revised to include the dust exposure.
Comment: For P-17-24 and P-17-25, the Order states that the chemical substances should not be manufactured, processed, or used for "consumer use" or for "commercial use" when the saleable good could introduce the chemical substance into consumer settings. The SNUR does not include the additional restriction on "commercial use when the saleable good could introduce the chemical substance into consumer settings."
Response: The regulatory text of the SNURs at 40 CFR 721.11159 and 40 CFR 721.11160 have been revised to specify a significant new use as commercial use when saleable goods or service could introduce the PMN substances into a consumer setting.
Comment: The consent order for P-14-627 has concentration limits that differ by use but are not listed in the SNUR. The SNUR does cite EPA's general regulations at 40 C.F.R. § 721.80(k), however designates as significant new uses only the uses themselves. 
Response:  The regulatory text of the SNUR at 40 CFR 721.11150 has been revised to specify the non-confidential uses as identified in the Consent Order.
Isocyanates
One commenter commented on proposed SNURs for aromatic isocyanate, polymer with alkyloxirane polymer with oxirane ether with alkyldiol (2:l) and alkyloxirane polymer with oxirane ether with alkyltriol (3:l) (generic) (PMN P-17-24, 40 CFR 721.11159), and aromatic isocyanate polymer with alkyloxirane, alkyloxirane polymer with oxirane ether with alkanetriol and oxirane (generic), (PMN P-17-25, 40 CFR 721.11160).
Comment:  The commenter stated that EPA should clarify the proposed SNURs to the extent it is basing them on concerns with excess or residual isocyanate monomers in mixture with an isocyanate-based polymer or prepolymer SNUR chemicals. The commenter also stated that EPA has not transparently identified those monomers as being subject to the proposed SNURs and, besides, EPA may not use its SNUR authority to address ongoing uses of the existing isocyanate monomers and must use its TSCA section 6 authority instead.
Response:  EPA is concerned about the health effects of any residual monomer as well as unreacted isocyanate groups on a polymer when assessing the risks for new chemical substances. EPA has the authority under section 5 of TSCA to address any risks associated with the manufacture, processing, and use of the new chemical substances. The SNUR applies to activities associated with the new chemical substances. Activities associated with the new chemical substance are not ongoing activities of the existing chemical substance. EPA did not receive specific, quantitative information that demonstrates the chemical substance subject to the proposed SNUR exhibit a lower potential for the hazards and potential risks or that they will specifically replace a chemical substance with a higher potential for hazards and risks. EPA is issuing the SNUR as proposed to provide the Agency with the opportunity to review any new uses for potential unreasonable risks. The diisocyanates, MDI and TDI, are well-known dermal and inhalation sensitizers in the workplace and have been documented to cause asthma, lung damage, and in severe cases, fatal reactions. EPA is concerned about potential health effects that may result from exposures of consumers or self-employed workers while using products containing uncured (unreacted) MDI and TDI and its related polyisocyanates (e.g., spray- applied foam sealants, adhesives, and coatings) or incidental exposures to the general population. Due to the nature of the potential risk posed by this chemical, EPA believes it is prudent to emphasize its concern through respiratory protection requirements where there is potential for inhalation exposure, in addition to proposing significant new uses such as consumer use and application method. Accordingly, the regulatory actions for new diisocyanates reflects EPA's policy of consistent treatment of the entire class of potentially hazardous chemicals, regardless of their statutory status as "new" or "existing" chemicals. EPA continues to work to lessen the apparent inequity between regulations of new and existing chemicals.
Comment:  The same commenter stated that EPA should clarify its basis for the imposed limitations on total residual isocyanates, because varying limitations on residual isocyanates appear in the regulatory text for this SNUR at greater than: 0.1% residual isocyanate.
Response:  For each PMN substance, where there is potential risk from residual chemicals or lower molecular weights if the polymer is manufactured differently, EPA attempts to minimize exposure based on information in the notification. This PMN contained information that the polymer was manufactured containing a certain residual isocyanate level. EPA included restrictions for residual isocyanate in the Order and the proposed SNUR to prevent potential health risks.
Comment:  The same commenter stated that EPA should delete the provisions incorporating the recordkeeping requirements in 40 CFR 721.125, as it did in the proposed TDI SNUR, 80 Fed. Reg. 2068 (Jan. 15, 2015), and some others. 
Response: The SNURs cited by the commenter are existing chemical SNURs where EPA determined recordkeeping was not needed. For example, when the significant new use for an existing chemical is "any use" there is typically no recordkeeping required because there are no records to be maintained that would inform EPA inspection or enforcement. Because the SNURs in this current rule are new chemical SNURs, EPA will continue to require recordkeeping for all new chemical SNURs to better allow EPA to inspect and enforce SNUR requirements at facilities where chemicals subject to SNURs are manufactured and processed.
Deviation from EPA's PBT Policy
Comment:  One commenter suggests that EPA has deviated from its Persistent, Bioaccumulative, and Toxic (PBT) New Chemical Substances Testing Policy (see final policy statement at 64 FR 60194; November 4, 1999) and failed to explain those deviations.  Comments relate to the chemical substance described in PMN P-17-205 which met criteria identified in the 1999 Policy Statement for persistence, bioaccumulation potential, and toxicity that would indicate they should be controlled more stringently, up to a ban on commercialization pending development of certain testing.
Response: These comments constitute challenges to certain TSCA section 5(a)(3) determinations rather than to the basis for or the content of the SNUR. EPA is not responding to these comments in this notice and declines to withdraw the SNURs on the basis of these comments, since they are not relevant to this rulemaking. The 1999 policy statement, which is not a rule, provides guidance criteria for persistence, bioaccumulation, and toxicity for new chemicals and advises the industry about our regulatory approach for chemicals meeting the criteria.  Establishment of a PBT category alerts potential PMN submitters to possible assessment or regulatory issues associated with PBT new chemicals review.  It also provides a vehicle by which the Agency may gauge the flow of PBT chemical substances through the TSCA New Chemicals Program and measure the results of its risk screening and risk management activities for PBT new chemical substances; as such, it is a major element in the Agency's overall strategy to further reduce risks from PBT pollutants.
      The Order for this PMN does state that EPA estimates that the substances will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000.  The policy statement notes that even for "very" P (persistence in the environment for more than six months) and "very" B cases (bioaccumulation factor of greater than 5,000), where "because of the increased concern, more stringent control action would be a likely outcome,...it would not be appropriate to automatically trigger a "ban pending testing" at these cutoffs given the uncertainties about substance properties, release, and environmental behavior that normally characterize PMN review." Accordingly, the Agency evaluates each PMN based on the use, exposure and release information submitted, and makes a case by case risk management decision.   The proposed SNUR terms for this substance reflect the Agency's determination under the Order, that the controls stipulated in this Order are protective or human health and environment, pending submission of further information that is identified in the Order.
      
Ad Hoc Testing Policy Change
Comment:  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, EPA has implemented a significant departure from past policy and practice by ceasing to include any testing requirements or identifying any recommended testing. Instead, each chemical-specific description in Unit IV of the direct final rule now 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 actually useful or necessary. Moreover, 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) Consent 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 first and using that test data to inform whether higher tiered testing (including testing of vertebrates) is necessary. Similarly, EPA is modifying language in its SNURs to more generally describe the information EPA believes would help characterize chemical properties, fate and/or the potential human health and environmental effects associated with a significant new use of the chemical substance, 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).
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, there are a number of 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-10-366: carbon nanomaterial, P-14-627: cyclic amide, P-15-734: polymeric sulfide, P-16-0356: quaternary ammonium salts, P-16-357: quaternary ammonium salts, P-16-572: polyamine polyacid adducts and P-16-573: polyamine polyacid adducts.
Response: The statute, regulations, and guidance do 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 declares 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 upon regarding its specificity at a later date 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:  One 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-10-366: printing application; P-16-356 and P-16-357: wellbore additives; P-16-396: specialty chemical for processing additive; P-16-572 and P-16-573: adhesive for coatings; P-17-24 and P-17-25: urethane component; P-17-174: plastic additive; and P-17-205: monomer for high performance polymer. 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 believes that EPA must also require notification for any type of chemical intermediate use other than that which EPA has reviewed. The commenter also noted that the SNURs for P-16-375, P-16-572/573, P-17-24/25, P-17-174, P-17-205, P-17-251, P-17-296, P-17-308/309, P-17-321, P-17-327, and P-17-330 do not include designation of any use that would require notification (only process restrictions, no consumer use, application method, etc.). It is not clear that EPA examined other intermediate uses beyond the specific use identified in the PMNs.  The comment also notes that the SNUR for P-16-386 appears not to require notification for a set of uses that is broader than the specific use of the chemical substance. 
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 relevant 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:  EPA understands the confusion and has deleted reference to 40 CFR 721.80 where no specific section is cited and simply writes the applicable significant new use, i.e., "Industrial, commercial, and consumer activities. It is a significant new use to...."  
Consistency Between SNURs and Orders: General
Comment: One commenter stated that the Lautenberg Act requires that SNUR requirements conform with requirements of TSCA section 5(e) and 5(f) actions and Orders or that EPA publish a statement explaining why EPA is not doing so, and that EPA should not deviate from prior policy and practice, which correctly implements the law. The commenter then identified instances where the Order requirements were not consistent with the SNUR requirements (see the previous comments and responses for the paragraph titled "Inconsistencies with 5(e) Order and SNUR"). 
Response:  In general, EPA agrees that SNURs should be consistent with the underlying action or Order; however, EPA has never considered that SNURs must have exactly the same requirements. For example, when an Order requires certain testing before manufacture exceeding a certain production limit or time limit, the corresponding SNUR requires notification before exceeding that time or production volume limit. It does not require testing before exceeding the time or production volume limit. Under a TSCA section 5(e) Order; it would be problematic to require the same test from two different entities. The purpose of the SNUR requirement is for the manufacturer to notify EPA and for EPA to determine what, if any, testing should be required based on all available information available. at the time of notification. In the sections that follow, EPA has listed those instances where the commenter identified differences between the Order and the SNUR and either explained the differences or made the change.
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, 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. The commenter also cites 20 Orders or preambles to the SNURs for P-14-627, P-15-114, P-15-734, P-16-356, P-16-357, P-16-386, P-16-396, P-17-24, P-17-25, P-17-148, P-17-174, P-17-205, P-17-251, P-17-296, P-17-308, P-17-309, P-17-321, and P-17-330 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:  One 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-15-320, P-16-375, P-16-572, P-16-573, and P-17-327. None of the Orders contained workplace controls.
Response:  For the Orders listed, EPA achieved the necessary risk reduction in the workplace via other than specific worker protection requirements. For P-15-320, the Order prohibits use of the substance other than as a dielectric medium for medium and high voltage power generation and distribution equipment. For P-16-375, the Order prohibits domestic manufacture and use of the substance other than according to the confidential molecular weight parameters specified in the Order. For P-16-572 and P-16-573, the Order prohibits manufacture the substances in any manner other than they are not amine terminated in order to maintain water solubility levels 

below 1 part per billion. For P-17-327, the Order prohibits manufacture (includes import) of the substance to have an average molecular weight of greater than 10,000 Daltons.

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: EPA believes that comments regarding worker protection conditions in Section 5(e) or 5(f) are beyond the scope of the SNUR. EPA is not responding to these comments. 
EPA disagrees with the comment that, where EPA expects that worker protection requirements under other federal/state authorities would mitigate risks to workers, EPA must designate all uses without those protections as "significant new uses". 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 designating significant new uses 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 comments and responses in the paragraph titled "SNURs should include workplace protection provisions under 40 CFR 721.63" SNUR requirements other than PPE can also limit worker exposures and risk.
Vertebrate Testing
Comment: A commenter noted that TSCA section 4(h)(3) states: "IN GENERAL. -- Any person developing information for submission under this title on a voluntary basis and not pursuant to any request or requirement by the Administrator shall first attempt to develop the information by means of an alternative test method or strategy... before conducting new vertebrate animal testing." The commenter continued that while EPA is not required to review the means by which these submitters conducted this voluntary testing, it is authorized to do so, and that reviewing compliance with this section is an opportunity to communicate TSCA's requirement and EPA's preference for alternatives to PMN submitters. Over time, the commenter states, this would lead submitters to consider such alternatives before conducting vertebrate animal tests. They requested that EPA review compliance with TSCA section 4(h)(3) whenever the results of vertebrate animal testing are included in PMNs.
Response:  A request to review compliance with TSCA 4(h)(3) for PMNs and Orders is not relevant to the proposed SNUR. 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).