Source: https://www.federalregister.gov/documents/2013/01/28/2013-01589/proposed-modification-of-significant-new-uses-of-ethaneperoxoic-acid-11-dimethylpropyl-ester
Timestamp: 2018-08-20 17:21:38
Document Index: 186157583

Matched Legal Cases: ['art 2', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', 'art 721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009720', '§\u2009720', '§\u2009721', 'art 9', 'art 9', 'art 1320', '§\u2009721', '§\u2009721', '§\u2009721']

Federal Register :: Proposed Modification of Significant New Uses of Ethaneperoxoic Acid, 1,1-Dimethylpropyl Ester
A Proposed Rule by the Environmental Protection Agency on 01/28/2013
78 FR 5761
5761-5765 (5 pages)
EPA-HQ-OPPT-2012-0864
FRL-9370-5
Modification of Significant New Use Rule for 1,1-Dimethylpropyl peroxyacetate
TSCA New Chemical Program Chemical Categories Document
Action Letter for Modification of Consent Order and SNUR
Consent Order for P85-0680
Direct Final SNUR Issued June 1990
Premanufacture Notice Submission P85-0680
RFA Certification
PMN Number P-85-680
V. Applicability of Proposed Rule to Uses Occurring Before Effective Date of the Final Rule
https://www.federalregister.gov/d/2013-01589 https://www.federalregister.gov/d/2013-01589
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2012-0864, by one of the following methods:
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Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2012-0864. 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.
You may be potentially affected by this action if you manufacture, import, process, or use the chemical substance identified as ethaneperoxoic acid, 1,1-dimethylpropyl ester (PMN P-85-680). Potentially affected entities may include, but are not limited to:
Manufacturers, importers, or processors of the subject chemical substance (NAICS codes 325 and 324110), e.g., chemical manufacturers and petroleum refineries.
1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the Start Printed Page 5762disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
In the Federal Register of June 26, 1990 (55 FR 26102), EPA published a final SNUR (codified at § 721.1560 and redesignated as § 721.3020) for the chemical substance identified as ethaneperoxoic acid, 1,1-dimethylpropyl ester (PMN P-85-680), in accordance with the procedures at § 721.160. A SNUR requires persons who intend to manufacture, import, or process the chemical substance for an activity designated as a significant new use to notify EPA at least 90 days before commencing that activity.
EPA is proposing to amend the scope and requirements of the SNUR as detailed in this unit. Because the chemical identity of the chemical substance is no longer confidential, EPA is using the specific chemical name and CAS number to identify the chemical substance. The docket established for this proposed SNUR is available under docket ID number EPA-HQ-OPPT-2012-0864. The docket includes information considered by the Agency in developing the proposed rule and the modified TSCA section 5(e) consent order negotiated with the PMN submitter.
Chemical name: Ethaneperoxoic acid, 1,1-dimethylpropyl ester.
CAS number: 690-83-5
Effective date of the TSCA section 5(e) consent order: January 30, 1986.
Federal Register publication date and reference: June 26, 1990 (55 FR 26111).
Basis for modification of the SNUR: The TSCA section 5(e) consent order was issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(II) based on the finding that the chemical substance may present an unreasonable risk of injury to human health. To prevent any unreasonable risk the order required dermal and respiratory protection to exposed workers, establishment of a hazard communication program, limited the specific use of the PMN substance as described in the consent order, and required disposal into a waste disposal well. EPA subsequently modified the consent order to allow disposal by landfill and incineration. The proposed SNUR for this chemical substance is based on and consistent with the new data and findings discussed in the two paragraphs below. The proposed SNUR designates as a “significant new use” any purposeful or predictable releases of the PMN substance in concentrations that exceed 61 parts per billion (ppb) in surface waters.
Human health toxicity: EPA received a petition from a second manufacturer to revoke the SNUR based on toxicity testing on structurally analogous peroxide compounds, conducted after the SNUR was issued. Based on the new data EPA concurred with the finding that the PMN substance did not present a carcinogenicity hazard. EPA has also changed its human health findings for the TSCA new chemicals program peroxide category (http://www.epa.gov/​oppt/​newchems/​pubs/​npcchemicalcategories.pdf).
Ecotoxicity concerns: Based on data from ecotoxicity studies on structurally analogous peroxy esters and neutral organic chemicals, also conducted after the SNUR was issued, EPA identified potential environmental concerns if the PMN substance was released to surface waters. The second manufacturer also conducted and submitted the results of an acute algal study on the PMN substance. Based on the submitted ecotoxicity testing for algae and analogue data, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 61 ppb of the PMN substance in surface waters.
The Agency concluded, after examining the new human health toxicity information, that its finding under section 5(e)(1)(A)(ii)(I) of TSCA in the original TSCA section 5(e) consent order that certain activities involving the substance may present an unreasonable risk of injury to human health is no longer supported. The Agency also concluded based on the ecotoxicity information, that the PMN substance meets the concern criteria at § 721.170 (b)(4)(i) and (b)(4)(ii).
To conform with these findings, the Agency is proposing the following modifications to the SNUR:
1. Removing the significant new use requirements for protective equipment, hazard communication, and specific uses identified in the consent order.
2. Modifying significant new use requirements for environmental releases by removing notification requirements for disposal, and adding notification requirements for water releases above 61 ppb.
3. Revising the recordkeeping requirements to reflect the modified SNUR requirements.
CFR citation: 40 CFR 721.3020.
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the TSCA section 5(a)(2) factors, listed in Unit III. of this document. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) and 40 CFR part 721 requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use. Persons who must report are described in § 721.5.
EPA may respond to SNUNs by, among other things, issuing or modifying a TSCA section 5(e) consent order and/or amending the SNUR Start Printed Page 5763promulgated under TSCA section 5(a)(2). Amendment of the SNUR will often be necessary to allow persons other than the SNUN submitter to engage in the newly authorized use(s), because even after a person submits a SNUN and the review period expires, other persons still must submit a SNUN before engaging in the significant new use. Procedures and criteria for modifying or revoking SNUR requirements appear at § 721.185.
The extent to which a use changes the type or form of exposure to human beings or the environment to a chemical substance.
To determine what would constitute a significant new use for the chemical substance identified as ethaneperoxoic acid, 1,1-dimethylpropyl ester (PMN P-85-680), EPA considered relevant information about the toxicity of the chemical substance, likely human exposures and environmental releases associated with possible uses, taking into consideration the four bulleted TSCA section 5(a)(2) factors listed in this unit.
During review of PMN P-85-680, the chemical substance identified as ethaneperoxoic acid, 1,1-dimethylpropyl ester, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of this chemical substance. The basis for such findings is outlined in Unit II. of this document and in the Federal Register document of June 26, 1990 (55 FR 26102). Based on these findings, a TSCA section 5(e) consent order requiring the use of appropriate exposure controls were negotiated with the PMN submitter. The SNUR provisions for this chemical substance are consistent with the provisions of the original TSCA section 5(e) consent order. This SNUR was promulgated pursuant to § 721.160.
After the review of new test data subsequent to issuance of the TSCA section 5(e) consent order for P-85-680 and associated SNUR (see Unit II.), and consideration of the factors included in TSCA section 5(a)(2) (see Unit III.), EPA determined that the chemical substance meets one or more of the concern criteria in § 721.170(b), but that these criteria are no longer met for the personal protective equipment, hazard communication, and specific use notification requirements. Consequently, EPA is proposing this modification to the SNUR at § 721.3020 according to procedures in §§ 721.160 and 721.185.
To establish a significant “new” use, EPA must determine that the use is not ongoing. EPA solicits comments on whether any of the uses proposed as significant new uses are ongoing. As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant new use as of the date of publication of the proposed rule, rather than as of the effective date of the final rule. If uses begun after publication of the proposed rule were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements, because a person could defeat the SNUR by initiating the significant new use before the rule became final, and then argue that the use was ongoing as of the effective date of the final rule.
Thus, any persons who begin commercial manufacture, import, or processing activities with the chemical substances that are not currently a significant new use under the current rule but which would be regulated as a “significant new use” if this proposed rule is finalized, must cease any such activity as of the effective date of the rule if and when finalized. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires.
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 this case, EPA recommends persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the Harmonized Test Guidelines referenced in this document electronically, please go to http://www.epa.gov/​ocspp and select “Test Methods and Guidelines.”
The modified TSCA section 5(e) consent order for the chemical substance that would be regulated under this proposed rule does not require submission of the test at any specified time or volume. However, the restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance would remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information. These restricted activities cannot be commenced unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by this chemical substance. The test specified in the modified TSCA section 5(e) consent order is included in Unit II. The proposed SNUR would contain the same restrictions as the modified TSCA section 5(e) consent order. Persons who intend to commence non-exempt commercial manufacture, import, or processing for those activities proposed as significant new uses would be required to notify the Agency by submitting a SNUN at least 90 days in advance of commencement of those activities.
The recommended testing specified in Unit II. of this document may not be the Start Printed Page 5764only means of addressing the potential risks of the chemical substance. However, SNUNs submitted without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
According to 40 CFR 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 on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in §§ 721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/​opptintr/​newchems.
EPA 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. The Agency's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2012-0864.
This proposed rule would modify a SNUR for a chemical substance that is the subject of a PMN and 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 Paperwork Reduction Act (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 the 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 has amended the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this proposed 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.
This proposed rule is within the scope of the February 18, 2012 certification. Based on the economic analysis discussed in Unit VIII. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reason to believe that any State, local, or Tribal government would be impacted by this proposed rule. As such, EPA has determined that this proposed rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).
This proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR Start Printed Page 576567249, November 9, 2000), do not apply to this proposed rule.
This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR7629, February 16, 1994).
2. Amend § 721.3020 as follows:
b. Revise paragraphs (a)(1), (a)(2)(i), and (a)(2)(ii).
c. Remove paragraphs (a)(2)(iii) and (a)(2)(iv).
§ 721.3020
(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=61).
[FR Doc. 2013-01589 Filed 1-25-13; 8:45 am]