Source: https://www.federalregister.gov/documents/2010/04/02/2010-7191/proposed-significant-new-use-rule-for-1-propene-2333-tetrafluoro-
Timestamp: 2017-09-24 20:29:30
Document Index: 149178509

Matched Legal Cases: ['art 707', '§\u2009721', 'art 707', '§\u2009721', '§\u2009721', '§\u2009721', 'art 721', 'art 700', '§\u2009721', 'art 720', 'art 707', '§\u2009721', 'art 707', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009720', '§\u2009721', '§\u2009720', '§\u2009721', '§\u2009721', 'art 9', 'art 9', 'art 1320', '§\u2009721', '§\u2009721']

Federal Register :: Proposed Significant New Use Rule for 1-Propene, 2,3,3,3-tetrafluoro-
Proposed Significant New Use Rule for 1-Propene, 2,3,3,3-tetrafluoro-
A Proposed Rule by the Environmental Protection Agency on 04/02/2010
Comments must be received on or before May 3, 2010.
75 FR 16706
16706-16711 (6 pages)
EPA-HQ-OPPT-2008-0918
FRL-8818-2
2010-7191
Honeywell AC Study: "Refrigerant Exposure to Service Personnel...
Monitoring Date for Honeywell Study on HFO-1234yf
Honeywell International Compliance with Good Laboratory Practices
Risk Assessment of Single Exposures to HFO-1234yf (P07-0601)
EPA Review of HFO-1234yf: A 2-Phase Inhalation Screening Study...
HFO-1234yf: A 2-Phase Inhalation Screening Study and Single...
USEPA Email Response to February 6, 2010 Letter: Data Needs to...
Honeywell Response to USEPA Questions on Submitted Exposure Study
USEPA Questions to Honeywell on Submitted Exposure Study
Appendix G: Technical Support Document Staff Analysis on...
IV. Substance Subject to this Proposed Rule and Basis for the Action
https://www.federalregister.gov/d/2010-7191 https://www.federalregister.gov/d/2010-7191
EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified as 1-Propene, 2,3,3,3-tetrafluoro- (CAS No. 754-12-1) which was subject to premanufacture notice (PMN) P-07-601. This proposed rule would require persons who intend to manufacture, import, or process the substance for an activity that is designated as a significant new use 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-2008-0918, by one of the following methods:
Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2008-0918. 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-2008-0918. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless Start Printed Page 16707the 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 e-mail. The regulations.gov website 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 e-mail comment directly to EPA without going through regulations.gov, your e-mail 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 contained in this proposed rule. Potentially affected entities may include, but are not limited to:
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28 (the corresponding EPA policy appears at 40 CFR part 707, subpart B). Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to a final SNUR must certify their compliance with the SNUR requirements. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after May 3, 2010 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20) and must comply with the export notification requirements in 40 CFR part 707, subpart D.
EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) of TSCA for the chemical substance Start Printed Page 16708identified as 1-Propene, 2,3,3,3-tetrafluoro- (PMN P-07-601; CAS No. 754-12-1). This SNUR would require persons who intend to manufacture, import, or process the chemical substance for any activity designated as a significant new use to notify EPA at least 90 days before commencing the activity.
In the Federal Register of February 1, 2010 (75 FR 4983) (FRL-8438-4), EPA issued a direct final SNUR for the substance in accordance with the procedures at § 721.170(d)(4)(i). EPA received notice of intent to submit adverse comments on this SNUR. Therefore, as required by at § 721.170(d)(4)(i), EPA is withdrawing the direct final SNUR, which is published elsewhere in this Federal Register and is now issuing this proposed SNUR on this substance. The record for the direct final SNUR on this substance was established as docket EPA-HQ-OPPT-2009-0918. That record includes information considered by the Agency in developing the direct final rule and the notice of intent to submit adverse comments.
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 those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) 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. The mechanism for reporting under this requirement is established under § 721.5.
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 final rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to this SNUR 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 section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 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 activities 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.
Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127, and 19 CFR 127.28 (the corresponding EPA policy appears at 40 CFR part 707, subpart B). Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemical substances subject to a final SNUR must certify their compliance with the SNUR requirements. In addition, any persons who export or intend to export a chemical substance identified in a final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611 (b)) (see § 721.20) and must comply with the export notification requirements in 40 CFR part 707, subpart D.
For the chemical substance 1-Propene, 2,3,3,3-tetrafluoro- (PMN P-07-601; CAS No. 754-12-1), EPA did not find that the use scenarios described in the PMN triggered the determination set forth under section 5(e) of TSCA. EPA did, however, determine that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” EPA has determined that activities proposed as a “significant new use” satisfy 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.
EPA is proposing to establish significant new use and recordkeeping requirements for the chemical substance identified as 1-Propene, 2,3,3,3-tetrafluoro- (PMN P-07-601; CAS No. 754-12-1). The specific activities proposed as significant new uses and other requirements are listed in 40 CFR 721.10182 of the proposed regulatory text.
PMN Number P-07-601
Basis for action: The PMN states that the substance will be used as a motor vehicle air conditioning (MVAC) refrigerant in new passenger cars and vehicles (i.e., as defined in 40 CFR 82.32 (c) and (d)). Initial charging of MVAC units with the PMN substance will be done by the motor vehicle original equipment manufacturer. All servicing, maintenance, and disposal involving the PMN substance will be done only by Clean Air Act (CAA) section 609 certified technicians using CAA section 609 certified refrigerant handling equipment. Based on test data on the PMN substance, EPA identified health concerns for developmental toxicity and lethality to workers and consumers if they were exposed to a significant amount of the PMN substance via inhalation. The PMN substance has an ozone depletion potential of zero, and, based on test data, has a low global warming potential (GWP100 of about 4). For the use scenario described in the PMN, significant industrial or commercial worker exposure is unlikely Start Printed Page 16709due to the use of CAA section 609 certified refrigerant handling equipment and other protective measures. Potential consumer (vehicle passenger) exposure from refrigerant leaks into the passenger compartment of a vehicle is not expected to present significant risk of serious health effects. Flammability concerns with the PMN substance are being addressed through regulatory actions by EPA's Office of Air and Radiation (see the following paragraph). Further, “do-it-yourself” consumer exposures are not expected because the PMN substance only will be sold or distributed in 20-pound containers or larger. Therefore, EPA has not determined that the manufacturing, processing, or use of the substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that (1) use of the substance other than as a MVAC refrigerant in new passenger cars and vehicles as defined in 40 CFR 82.32 (c) and (d), (2) initial charging of MVAC units with the PMN substance by any person other than CAA section 609 certified technicians without using CAA section 609 certified refrigerant handling equipment, (3) servicing, maintenance, and disposal involving the PMN substance by persons other than CAA section 609 certified technicians without using CAA section 609 certified refrigerant handling equipment, or (4) sale or distribution of the PMN substance in containers smaller than 20-pounds (net weight) may cause serious health effects in accordance with 40 CFR 721.170(b)(3)(i).
This proposed SNUR is intended to complement recently proposed and forthcoming regulations on the PMN substance under the CAA in that this SNUR addresses health risk issues of the subject refrigerant. On October 19, 2009, EPA published a proposed rule on the PMN substance entitled “Protection of Stratospheric Ozone: New Substitute in the Motor Vehicle Air Conditioning Sector under the Significant New Alternatives Policy (SNAP) Program” (74 FR 53445) (FRL-8969-7). The SNAP Program, mandated under section 612 of the CAA, requires EPA to develop a program for evaluating alternatives to ozone-depleting substances and to create lists of substitutes for specific uses that do not present greater overall risk to human health and the environment than other alternatives that are available. In the October 19, 2009, action, EPA proposed to find HFO-1234yf acceptable, subject to certain use conditions, as a substitute for CFC-12 in new motor vehicle air conditioning systems (passenger cars and trucks). The proposed use conditions include incorporation of engineering strategies and/or devices to mitigate flammability risks for this substance (see Unit V. of the proposed SNAP rule). Use of most flammable refrigerants, including the PMN substance, in existing MVAC systems as a retrofit has previously been determined by EPA to be unacceptable. The proposed SNAP rule would require a petition and a new SNAP submission specifically for the use of the PMN substance in existing MVAC equipment as a retrofit before EPA would consider allowing such use (see Unit VI. of the proposed SNAP rule). EPA also intends to promulgate a follow-on rulemaking under section 609 of the CAA to address service equipment, technician certification, and end-of-life disposal specifications.
Recommended testing: EPA has determined that the results of an acute inhalation toxicity study (OPPTS Harmonized Test Guideline 870.1300 or Organisation for Economic Co-operation and Development (OECD) 403 test guideline) with rabbits would help characterize the human health effects of the PMN substance. Exposure concentrations of 10,000, 50,000, and 100,000 parts per million (ppm) should be used. Further, rabbits should be exposed for 1 hour, and pregnant rabbits should be exposed on Gravid Day 12.
During the review of the chemical substance P-07-601, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.
EPA is proposing this SNUR for a chemical substance that has undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this proposed rule:
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/​opptintr/​newchems/​pubs/​invntory.htm.
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 TSCA section 5(a)(1)(B) 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 before the effective date of the final rule. Thus, persons who begin commercial manufacture, import, or processing with the chemical substances that would be regulated as a “significant new use” through this proposed rule, must cease any such activity before 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.
EPA has promulgated provisions to allow persons to comply with this proposed SNUR before the effective date. If a person were to meet the conditions of advance compliance under § 721.45(h), the person would be considered to have met the requirements of the final SNUR, for those activities.
EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN, except where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)). Start Printed Page 16710Persons 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. EPA recommended certain testing listed in Unit IV. 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 OPPTS harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/​oppts and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
The recommended test(s) may not be the only means of addressing the potential risks of the chemical substance. However, SNUNs submitted for significant new uses 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 test(s).
SNUN submitters should be aware that EPA would be better able to evaluate SNUNs which provide detailed information on the following:
As stated in Unit II.C., 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 to the Environmental Protection Agency on EPA Form No. 7710-25 in accordance with the procedures set forth in §§ 721.25 and 720.40. This form is available from the Environmental Assistance Division (7408M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 (see §§ 721.25 and 720.40). Forms and information are also 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 substance at the time of the direct final rule. The Agency's complete economic analysis is available in the public docket for the direct final rule (EPA-HQ-OPPT-2008-0918).
The official record for this proposed rule has been established. The following is a listing of the documents that have been placed in the proposed rule phase of the docket under docket ID number EPA-HQ-OPPT-2008-0918, which is available for inspection as specified under ADDRESSES. These documents serve as supplementary information specific to P-07-601 (aka HFO-1234yf) for consideration when submitting comments.
1. Letter Confirming Release of CBI Claims for HFO-1234yf Gradient Report.
2. Gradient Corporation. 2008. Risk Assessment for Alternative Refrigerant HFO-1234yf.
3. WIL Research Laboratories, LLC. 2008. An Inhalation Prenatal Developmental Toxicity Study of HFO-1234yf (2,3,3,3-tetrafluoropropene) in Rabbits.
4. United States Environmental Protection Agency (EPA). 2009. Addendum to Risk Assessment: PMN P-07-601.
This proposed rule would establish a SNUR for a chemical substance that was the subject of a PMN. 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 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. 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.
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of this SNUR would not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is discussed in this unit. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant Start Printed Page 16711new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of over 1,400 SNURs, the Agency receives on average only 5 notices per year. Of those SNUNs submitted from 2006-2008, only one appears to be from a small entity. In addition, the estimated reporting cost for submission of a SNUN (see Unit IX.) is minimal regardless of the size of the firm. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.
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 reasons 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 affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
This proposed rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.
2. Add § 721.10182 to subpart E to read as follows:
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-propene, 2,3,3,3-tetrafluoro- (PMN P-07-601; CAS No. 754-12-1; also known as HFO-1234yf) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (use as a motor vehicle air conditioning (MVAC) refrigerant in new passenger cars and vehicles as defined in 40 CFR 82.32 (c) and (d). The initial charging of MVAC units with the PMN substance will be done by the motor vehicle original equipment manufacturer. All servicing, maintenance, and disposal involving the PMN substance will be done only by Clean Air Act (CAA) section 609 certified technicians using CAA section 609 certified refrigerant handling equipment. The PMN substance only will be sold or distributed in 20-pound (net weight) containers or larger.
[FR Doc. 2010-7191 Filed 4-1-10; 8:45 am]