Source: https://www.federalregister.gov/documents/2013/04/18/2013-09155/proposed-significant-new-use-rules-on-certain-chemical-substances
Timestamp: 2017-08-19 20:52:49
Document Index: 87993857

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A Proposed Rule by the Environmental Protection Agency on 04/18/2013
23184-23192 (9 pages)
FRL-9377-8
https://www.federalregister.gov/d/2013-09155 https://www.federalregister.gov/d/2013-09155
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for eight chemical substances which were the subject of premanufacture notices (PMNs) P-11-327, P-11-328, P-11-329, P-11-330, P-11-331, P-11-332, P-12-298, and P-12-299. This action would require persons who intend to manufacture, import, or process any of the chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit the activity before it occurs.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2012-0740, by one of the following methods:
Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN: Docket ID Number EPA-HQ-OPPT-2012-0740. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2012-0740. EPA's policy is that all comments received will be included in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign Start Printed Page 23185the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.
EPA is proposing these SNURs under section 5(a)(2) of TSCA for eight chemical substances which were the subject of PMNs P-11-327, P-11-328, P-11-329, P-11-330, P-11-331, P-11-332, P-12-298, and P-12-299. These SNURs would require persons who intend to manufacture, import, or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.
In the Federal Register of November 2, 2012 (77 FR 66149) (FRL-9366-7), EPA issued direct final SNURs on these eight chemical substances in accordance with the procedures at § 721.160(c)(3)(i). EPA received notices of intent to submit adverse comments on these SNURs. Therefore, as required by § 721.160(c)(3)(ii), EPA removed the direct final SNURs in a separate document, published in the Federal Register of December 21, 2012 (77 FR 75566) (FRL 9373-8), and is now issuing this proposed rule on the eight chemical substances. The record for the direct final SNURs on these chemical substances was established as docket number EPA-HQ-OPPT-2012-0740. That record includes information considered by the Agency in developing the direct final rule and the notice of intent to submit adverse comments.
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). 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 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the Start Printed Page 23186activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.
To determine what would constitute a significant new use for the eight chemical substances that are the subject of this proposed rule, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.
EPA is proposing significant new use and recordkeeping requirements for eight chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:
The regulatory text section of this proposed rule specifies the activities designated as significant new uses.
This proposed rule includes PMN substances P-11-327, P-11-328, P-11-329, P-11-330, P-11-331, and P-11-332, that are subject to a “risk-based” consent order under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. This consent order requires protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “section 5(e) SNURs” on these PMN substances are proposed pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent order. The section 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent order.
This proposed rule also includes a SNUR on PMN substances P-12-298 and P-12-299 that were not subject to a consent order under TSCA section 5(e). In this case, EPA did not find that the use scenario described in the PMNs triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMNs could result in increased exposures, thereby constituting a “significant new use.” This so-called “non-section 5(e) SNUR” is proposed pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-section 5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, “(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.
Chemical names: Distillates (lignocellulosic), C5-40 (P-11-327); Paraffin waxes
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) uses of the PMN substances will be as a distillation feedstock after hydrotreatment (P-11-327), as a feedstock (P-11-328), as a blend-stock for conventional fossil fuels (P-11-329, P-11-330, and P-11-331), and use in a manner comparable to gas oil as it is currently used in industry (P-11-332). These PMNs are complex mixtures and have been assessed based on the toxic components within their mixture. The most important and primary component present is benzene. Based on this analysis, EPA identified concerns for oncogenicity, immunosuppression, and skin sensitization (defatting of the skin tissue) to workers exposed to the PMN substances. The EPA Maximum Contaminant Level for benzene in drinking water is 5 parts per billion (ppb). The PMNs' New Chemical Exposure Limit (NCEL) is 0.32 milligram/cubic meter (mg/m3) as an 8-hour time-weighted average. In addition, based on ecological structure activity relationship (EcoSAR) analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 82 ppb for each of the following: P-11-329 and P-11-331, and 180 ppb for each of the following: P-11-327, P-11-328, P-11-330, and P-11-332. However, EPA does not expect risk to aquatic organisms at the expected levels and duration of exposure as described in the PMNs. The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that these substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires:
1. Use of personal protective equipment including dermal protection when there is potential dermal exposure and a National Institute for Occupational Safety and Health Start Printed Page 23187(NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10,000, or compliance with a NCEL of 0.32 mg/m3 as an 8-hour time-weighted average when there is potential inhalation exposure.
CFR citations: 40 CFR 721.10612 (P-11-327); 721.10613 (P-11-328); 721.10614 (P-11-329); 721.10615 (P-11-330); 721.10616 (P-11-331); and 721.10617 (P-11-332).
Chemical name: Vinylidene ester (generic).
Basis for action: The PMNs state that the generic uses of the substances will be adhesives. Based on EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 ppb of the PMN substances in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early-life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substances to surface water exceed releases from the use described in the PMNs. For the described use in the PMNs, significant environmental releases are not expected because environmental releases did not result in surface water concentrations exceeding 7 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that combined production volume of the two PMN substances exceeding 20,000 kilograms per year could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.10623.
During review of the PMNs submitted for the eight chemical substances that are subject to these proposed SNURs, EPA concluded that for six of the substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health and environmental effects of the chemical substances. For two of the eight substances, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met. The basis for these findings is outlined in Unit IV.
When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the final rule is issued, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) consent orders have been issued for six of the eight chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which would be designated as significant new uses. The other two chemical substances contained in this proposed rule are not regulated with TSCA section 5(e) consent orders. The identities of these two chemical substances have been claimed as confidential, and EPA has received no post-PMN bona fide submissions (per § 720.25 and § 721.11). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.
If uses begun after the direct final rule was published on November 2, 2012, were considered ongoing rather than new, any person could defeat the SNUR by initiating the significant new use Start Printed Page 23188before the final rule was issued. Therefore EPA designates November 2, 2012 as the cutoff date for determining whether the new use is ongoing. Persons who begin commercial manufacture, import, or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires. If such a person met the conditions of advance compliance under § 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the Federal Register document of April 24, 1990 (55 FR 17376) for a more detailed discussion of the cutoff date for ongoing uses.
In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see § 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/​ocspp and select “Test Methods and Guidelines.”
According to § 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 § 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in §§ 720.40 and 721.25. E-PMN software is available electronically at http://www.epa.gov/​opptintr/​newchems.
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, and processors of the chemical substances during the development of the direct final rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2012-0740.
This proposed rule would establish SNURs for eight chemical substances that were the subject of PMNs, and in six cases, a TSCA section 5(e) consent order. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
According to the PRA, 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA would amend the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this proposed rule, if the SNUR is subsequently issued as a final rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment.
On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial Start Printed Page 23189number of small entities where the following are true:
In addition, since this action would not involve any technical standards the National Technology Transfer and Advancement Act (NTTAA), section 12(d) (15 U.S.C. 272 note), would not apply to this action.
2. Add § 721.10612 to subpart E to read as follows:
§ 721.10612
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), 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 following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of 10,000 meet the minimum requirements for § 721.63(a)(4): Any NIOSH-certified pressure-demand or other positive pressure mode (e.g., open/closed circuit) self-contained breathing apparatus (SCBA) equipped with a hood or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in paragraph (a)(2)(i) of this section, a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.32 milligram/cubic meter (mg/m3) as an 8-hour time-weighted average. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order.
(ii) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), and (g).
(iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of releases for the following substances: Distillates (lignocellulosic), C5-40 (PMN P-11-327; CAS No. 1267611-99-3); paraffin waxes (lignocellulosic) hydrotreated, C5-40-branched, cyclic Start Printed Page 23190and linear (PMN P-11-328; CAS No. 1267611-06-2); naphtha (lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329; CAS No. 1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (PMN P-11-330; CAS No. 1267611-14-2); distillates (lignocellulosic), hydrotreated, C8-26-branched, cyclic, and linear (PMNP-11-331; CAS No. 1267611-11-9); and residual oils (lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear (PMN P-11-332; CAS No. 1267611-71-1)).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a) through (h) and (k) are applicable to manufacturers, importers, and processors of this substance.
3. Add § 721.10613 to subpart E to read as follows:
§ 721.10613
(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of releases for the following substances: Distillates (lignocellulosic), C5-40 (PMN P-11-327; CAS No. 1267611-99-3); paraffin waxes (lignocellulosic) hydrotreated, C5-40-branched, cyclic and linear (PMN P-11-328; CAS No. 1267611-06-2); naphtha (lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329; CAS No. 1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (PMN P-11-330; CAS No. 1267611-14-2); distillates (lignocellulosic), hydrotreated, C8-26-branched, cyclic, and linear (PMN P-11-331; CAS No. 1267611-11-9); and residual oils (lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear (PMN P-11-332; CAS No. 1267611-71-1)).
4. Add § 721.10614 to subpart E to read as follows:
§ 721.10614
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63 (a)(1) and (a)(4), 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 following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of 10,000 meet the minimum requirements for § 721.63(a)(4): Any NIOSH-certified pressure-demand or other positive pressure mode (e.g., open/closed circuit) self-contained breathing apparatus (SCBA) equipped with a hood or helmet or a full facepiece.
(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), and (g).
(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of releases for the following substances: Distillates (lignocellulosic), C5-40 (PMN P-11-327; CAS No. 1267611-99-3); paraffin waxes (lignocellulosic) Start Printed Page 23191hydrotreated, C5-40-branched, cyclic and linear (PMN P-11-328; CAS No. 1267611-06-2); naphtha (lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329; CAS No. 1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (PMN P-11-330; CAS No. 1267611-14-2); distillates (lignocellulosic), hydrotreated, C8-26-branched, cyclic, and linear (PMN P-11-331; CAS No. 1267611-11-9); and residual oils (lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear (PMN P-11-332; CAS No. 1267611-71-1)).
5. Add § 721.10615 to subpart E to read as follows:
§ 721.10615
(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of releases for the following substances: Distillates (lignocellulosic), C5-40 (PMN P-11-327; CAS No. 1267611-99-3); paraffin waxes (lignocellulosic) hydrotreated, C5-40-branched, cyclic and linear (PMN P-11-328; CAS No. 1267611-06-2); naphtha (lignocellulosic), hydrotreated, C5-12- branched, cyclic and linear (PMN P-11-329; CAS No. 1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (PMN P-11-330; CAS No. 1267611-14-2); distillates (lignocellulosic), hydrotreated, C8-26-branched, cyclic, and linear (PMN P-11-331; CAS No. 1267611-11-9); and residual oils (lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear (PMN P-11-332; CAS No. 1267611-71-1)).
6. Add § 721.10616 to subpart E to read as follows:
§ 721.10616
(iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of releases for the following substances: Distillates (lignocellulosic), C5-40 (PMN P-11-327; CAS No. 1267611-99-Start Printed Page 231923); paraffin waxes (lignocellulosic) hydrotreated, C5-40-branched, cyclic and linear (PMN P-11-328; CAS No. 1267611-06-2); naphtha (lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329; CAS No. 1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (PMN P-11-330; CAS No. 1267611-14-2); distillates (lignocellulosic), hydrotreated, C8-26-branched, cyclic, and linear (PMN P-11-331; CAS No. 1267611-11-9); and residual oils (lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear (PMN P-11-332; CAS No. 1267611-71-1)).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (h) and (k) are applicable to manufacturers, importers, and processors of this substance.
7. Add § 721.10617 to subpart E to read as follows:
§ 721.10617
8. Add § 721.10623 to subpart E to read as follows:
§ 721.10623
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(s) (20,000 kilograms of the aggregate of the two chemical substances).
[FR Doc. 2013-09155 Filed 4-17-13; 8:45 am]