Source: https://www.federalregister.gov/documents/2020/06/09/2020-10986/significant-new-use-rules-on-certain-chemical-substances-19-4b
Timestamp: 2020-07-05 22:51:36
Document Index: 794449889

Matched Legal Cases: ['art 707', 'art 707', 'art 721', 'art 721', 'art 700', 'art 720', 'art 721', 'art 9', 'art 9', 'art 1320', '§\u20099', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721']

Federal Register :: Significant New Use Rules on Certain Chemical Substances (19-4.B)
This rule is effective on August 10, 2020. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on June 23, 2020.
35191-35198 (8 pages)
EPA-HQ-OPPT-2019-0442
FRL-10008-71
P-17-0347-0352 PMN Sanitized
P-19-0062 PMN Sanitized
P-18-0392 PMN Sanitized
P-18-0392 EXP Report Sanitized
P-18-0392 HLTH Report POST FOCUS Final 08-09-19 Sanitized
P-18-0392 ENG Report Sanitized
P-18-0155-0156 HLTH Report POST FOCUS Final 07-22-19 Rcvd...
P-18-0155c.en5 ENG Report Final Rcvd 08-06-19 Sanitized
P-18-0155 EXP Report Final Rcvd 08-06-19 Sanitized
Economic Analysis of Significant New Use Rule for 17 Chemical...
https://www.federalregister.gov/d/2020-10986
EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances which are the subject of premanufacture notices (PMNs). This action requires persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by this rule. The required notification initiates EPA's evaluation of the chemical under the conditions of use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required as a result of that determination.
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 provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. 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 these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
EPA is finalizing a SNUR under TSCA section 5(a)(2) for chemical substances which were the subject of PMNs P-16-92, P-17-346, P-17-347/348/349/350/351/352, P-17-395, P-18-35, P-18-103, P-18-155/156, P-18-286, P-18-392, P-19-29, and P-19-62. These SNURs require persons who intend to manufacture 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.
Previously, in the Federal Register of August 14, 2019 (84 FR 40371) (FRL-9997-73), EPA proposed a SNUR for these chemical substances in 40 CFR part 721, subpart E. More information on the specific chemical substances subject to this final rule can be found in the Federal Register documents proposing the SNUR. The record for the SNUR was established in the docket under docket ID number EPA-HQ-OPPT-2019-0442. That docket includes information considered by the Agency in developing the proposed and final rules, public comments submitted for the rule, and EPA's responses to public comments received on the proposed rule.
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 40 CFR 721.1(c), persons subject to these SNURs must comply with the same significant new use notice (SNUN) 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 must either determine that the significant new use under the conditions of use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that Start Printed Page 35192the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA's findings.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors. In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with the conditions of use of the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit. During its review of these chemicals, EPA identified certain conditions of use that are not intended by the submitters, but reasonably foreseen to occur. EPA is proposing to designate those reasonably foreseen conditions of use as significant new uses.
EPA received public comments from three identifying entities on the proposed rule. The Agency's responses are described in a separate Response to Public Comments document contained in the public docket for this rule, EPA-HQ-OPPT-2019-0442.
EPA is establishing significant new use and recordkeeping requirements for chemical substances in 40 CFR part 721, subpart E. In Unit IV of the August 14, 2019 proposed rule, EPA provided the following information for each chemical substance:
Potentially Useful Information. This is information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.
The chemical substances that are the subject of these SNURs completed premanufacture review. In addition to those conditions of use intended by the submitter, EPA has identified certain other reasonably foreseen conditions of use. EPA has preliminarily determined that the chemicals under their intended conditions of use are not likely to present an unreasonable risk. However, EPA has not assessed risks associated with the reasonably foreseen conditions of use for these chemicals. As such, EPA is designating these reasonably foreseen conditions of use and/or other potential circumstances of use as significant new uses. As a result, before any of those uses may occur, they must first go through a separate, subsequent EPA review and determination process associated with a SNUN.
During review of the PMNs submitted for the chemical substances that are the subject of these SNURs and as further discussed in Unit IV. of the August 14, 2019 proposed rule, EPA identified certain reasonably foreseen conditions of use and/or other circumstances different from the intended conditions of use identified in the PMNs and determined that those changes could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances.
EPA designated August 14, 2019 (the date of web posting of the proposed rule) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the final rule.Start Printed Page 35193
In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of August 14, 2019, that person will have to cease any such activity upon the effective date of the final rule. To resume their activities, that person would have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.
In the absence of a rule, Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. of the August 14, 2019 proposed rule lists potentially useful information for all SNURs listed here. Descriptions are provided for informational purposes. The potentially useful information identified in Unit IV. of the proposed rule will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance.
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2019-0442.
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 the Start Printed Page 35194PRA, 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 is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. 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.
Start List of Subjects Start Printed Page 35195
2. In § 9.1, add §§ 721.11330 through 721.11345 in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:
721.11330 2070-0012
721.11331 2070-0012
721.11332 2070-0012
721.11333 2070-0012
721.11334 2070-0012
721.11335 2070-0012
721.11336 2070-0012
721.11337 2070-0012
721.11338 2070-0012
721.11339 2070-0012
721.11340 2070-0012
721.11341 2070-0012
721.11342 2070-0012
721.11343 2070-0012
721.11344 2070-0012
721.11345 2070-0012
4. Add §§ 721.11330 through 721.11345 to subpart E to read as follows:
721.11330
Polymer of polyethylene polyamine and alkanediol diglycidyl ether (generic).
721.11331
Triarylalkyl phosphonium halide salt (generic).
721.11332
Oxirane, 2-methyl-, polymer with oxirane, mono(2-butyloctyl) ether.
721.11333
Oxirane, 2-methyl-, polymer with oxirane, mono(2-hexyldecyl) ether.
721.11334
Oxirane, 2-methyl-, polymer with oxirane, mono(2-octyldodecyl) ether.
721.11335
Oxirane, 2-methyl-, polymer with oxirane, mono(2-decyltetradecyl) ether.
721.11336
Oxirane, 2-methyl-, polymer with oxirane, mono(2-dodecylhexadecyl) ether.
721.11337
Oxirane, 2-methyl-, polymer with oxirane, mono(2-tetradecyloctadecyl) ether.
721.11338
Alkyl tri dithiocarbamate tri salt (generic).
721.11339
Methacrylic acid heterocyclic alkyl ester (generic).
721.11340
Alkylnitrile imidazole (generic).
721.11341
Crosslinked polymer of alkyl acrylamides, acrylate esters, and alkyl acrylamide sulfonate salt (generic).
721.11342
Propane, 1,1,1,3,3,3-hexafluoro-2-methoxy-.
721.11343
Heteromonocycle, alkenyl alkyl (generic).
721.11344
Phosphonium, tributylethyl-, diethyl phosphate (1:1).
721.11345
Hydrochlorofluoroolefin (generic).
§ 721.11330
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polymer of polyethylene polyamine and alkanediol diglycidyl ether (PMN P-16-92) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11331
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as triarylalkyl phosphonium halide salt (PMN P-17-346) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=5.
§ 721.11332
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2-methyl-, polymer with oxirane, mono(2-butyloctyl) ether (PMN P-17-347, CAS No. 252756-20-0) 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) and (s) (5,000 kilograms). It is a significant new use to manufacture, process or use the PMN substances in a manner that results in inhalation exposure.Start Printed Page 35196
§ 721.11333
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2-methyl-, polymer with oxirane, mono(2-hexyldecyl) ether (PMN P-17-348, CAS No. 125005-52-9) 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) and (s) (5,000 kilograms). It is a significant new use to manufacture, process or use the PMN substances in a manner that results in inhalation exposure.
§ 721.11334
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2-methyl-, polymer with oxirane, mono(2-octyldodecyl) ether (PMN P-17-349, CAS No. 102640-44-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11335
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2-methyl-, polymer with oxirane, mono(2-decyltetradecyl) ether (PMN P-17-350, CAS No, 72484-69-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11336
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2-methyl-, polymer with oxirane, mono(2-dodecylhexadecyl) ether (PMN P-17-351, CAS No. 102640-42-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11337
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2-methyl-, polymer with oxirane, mono(2-tetradecyloctadecyl) ether (PMN P-17-352, CAS No. 102640-46-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.Start Printed Page 35197
§ 721.11338
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl tri dithiocarbamate tri salt (PMN P-17-395) 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). It is a significant new use to manufacture, process, or use the substance in a manner that results in inhalation exposure.
§ 721.11339
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as methacrylic acid heterocyclic alkyl ester (PMN P-18-35) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11340
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylnitrile imidazole (PMN P-18-103) 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. It is a significant new use to manufacture, process or use the PMN substance for use other than as an intermediate for amine manufacture. It is a significant new use to manufacture, process or use the PMN substance in a manner that results in inhalation exposure.
§ 721.11341
(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as crosslinked polymer of alkyl acrylamides, acrylate esters, and alkyl acrylamide sulfonate salt (PMNs P-18-155 and P-18-156) are 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). It is a significant new use to manufacture the PMN substances with greater than 10% of the particles less than 10 microns.
§ 721.11342
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propane, 1,1,1,3,3,3-hexafluoro-2-methoxy- (PMN P-18-286, CAS No. 13171-18-1) 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). It is a significant new use to manufacture, process or use the substance without the transport container loading process described in the PMN.
§ 721.11343
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as heteromonocycle, alkenyl alkyl (PMN P-18-392) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).Start Printed Page 35198
§ 721.11344
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphonium, tributylethyl-, diethyl phosphate (1:1) (PMN P-19-29, CAS No. 20445-94-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=51.
§ 721.11345
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrochlorofluoroolefin (PMN P-19-62) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
[FR Doc. 2020-10986 Filed 6-8-20; 8:45 am]