['Toxic Substances Control Act - EPA']
['Toxic Substances - EPA']
12/14/2023
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[EPA–HQ–OPPT–2021–0227; FRL–8985–02–OCSPP]
RIN 2070–AB27
Significant New Use Rules on Certain Chemical Substances (21–2.F)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances which were 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. This action further requires that persons not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice (SNUN), and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any risk management actions as are required as a result of that determination.
DATES: This rule is effective on June 12, 2023. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on April 25, 2023.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: William Wysong, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 564–4163; email address: wysong.william@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
1. General Applicability
This action may apply to you if you manufacture (import), process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
- Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the import provisions of TSCA section 13 (15 U.S.C. 2612), the requirements promulgated at 19 CFR 12.118 through 12.127 (see also 19 CFR 127.28), and the EPA policy in support of import certification 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, including regulations issued under TSCA sections 5, 6, 7 and Title IV.
In addition, pursuant to 40 CFR 721.20, this action may also apply to 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)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
B. How can I access the docket?
The docket includes information considered by the Agency in developing the proposed and final rules. The docket for this action, identified by docket identification (ID) number EPA–HQ–OPPT–2021–0227, is available online at https://www.regulations.gov and in person at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets.
II. Background
A. What action is the Agency taking?
EPA is finalizing SNURs under TSCA section 5(a)(2) for certain chemical substances which were the subject of PMNs. 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 November 17, 2021 (86 FR 64115 (FRL–8985–01–OCSPP)), EPA proposed SNURs for these chemical substances. More information on the specific chemical substances subject to this final rule can be found in the Federal Register document proposing the SNURs. The docket includes information considered by the Agency in developing the proposed and final rules, including the public comments received on the proposed rules that are described in Unit IV.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (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 four TSCA section 5(a)(2) factors listed in Unit III.
C. Do the SNUR general provisions apply?
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. Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same 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 sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before manufacture or processing for the significant new use can commence. If EPA determines that the 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.
III. Significant New Use Determination
A. Determination Factors
TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
- The projected volume of manufacturing and processing of a chemical substance.
- The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
- The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
- The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
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 substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit.
During its review of the chemical substances that are the subjects of these SNURs and as further discussed in Unit VI., EPA identified potential risk concerns associated with other circumstances of use that, while not intended or reasonably foreseen, may occur in the future. EPA is designating those other circumstances of use as significant new uses.
B. Procedures for Significant New Uses Claimed as Confidential Business Information (CBI)
By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. When this rule was proposed in 2021, EPA cross referenced 40 CFR 721.1725(b)(1), the procedures to deal with the situation where a specific significant new use is CBI, in order to apply it other SNURs where certain significant new uses have been claimed as CBI. Since the proposed rule, however, EPA has finalized amendments to 40 CFR 721.11 (87 FR 39756, July 5, 2022 (FRL–5605–02–OCSPP)), which now provides a means by which bona fide submitters can determine whether their substance is subject to the SNUR and for EPA to disclose the confidential significant new use designations to a manufacturer or processor who has established a bona fide intent to manufacture or process a particular chemical substance. As such, EPA has removed the proposed references to 40 CFR 721.1725(b)(1) for SNURs that certain significant new uses have been claimed as CBI because the procedure in 40 CFR 721.11 now applies to all SNURs containing any CBI, including the significant new use.
Under these procedures a manufacturer or processor may request EPA to determine whether a specific use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.11 into a single step to identify if a chemical substance is subject to part 721 and if a specific use would be a significant new use under the rule.
IV. Public Comments
EPA received public comments from two identifying entities on the proposed rules. The Agency's responses are presented in the Response to Public Comments document that is available in the docket for this rulemaking. EPA did not make any changes to the requirements presented in the proposed rules, as described in the response to comments.
V. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping requirements for chemical substances in 40 CFR part 721, subpart E. In Unit IV. of the proposed SNURs, EPA provided the following information for each chemical substance:
- PMN number.
- Chemical name (generic name, if the specific name is claimed as CBI).
- Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).
- Basis for the SNUR.
- Potentially useful information.
- CFR citation assigned in the regulatory text section of this final rule.
The regulatory text section of these rules specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the rules, may be claimed as CBI.
VI. Rationale and Objectives of the Rule
A. Rationale
The chemical substances that are the subjects of these SNURs received “not likely to present an unreasonable risk” determinations under TSCA section 5(a)(3)(C) based on EPA's review of the intended, known, and reasonably foreseen conditions of use. However, EPA has identified other circumstances that, should they occur in the future, even if not reasonably foreseen, may present risk concerns. Specifically, EPA has determined that deviations from the protective measures identified in the PMN submissions could result in changes in the type or form of exposure to the chemical substances, 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. These SNURs identify as a significant new use manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the protective measures identified in the submissions. As a result, those significant new uses cannot occur without first going through a separate, subsequent EPA review and determination process associated with a SNUN.
B. Objectives
EPA is issuing these SNURs because the Agency wants:
- To have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
- To be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.
- To be able to complete its review and determination on each of the PMN substances, while deferring analysis on the significant new uses proposed in these rules unless and until the Agency receives a SNUN.
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 https://www.epa.gov/tsca-inventory.
VII. Applicability of the Rules to Uses Occurring Before the Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted, EPA concludes that the designated significant new uses are not ongoing.
When the chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, the identities of many of the chemical substances subject to this rule have been claimed as confidential (per 40 CFR 720.85). 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 rule are ongoing.
EPA designated October 12, 2021 (the date of FR publication of the proposed rule) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.
Persons who began commercial manufacture or processing of the chemical substances for a significant new use identified on or after that date will 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 EPA would have to take action under section 5 allowing manufacture or processing to proceed.
VIII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, Order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.
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 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, which may assist with EPA's analysis of the SNUN.
EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol election. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
The potentially useful information described in Unit IV. of the proposed rule may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:
- Human exposure and environmental release that may result from the significant new use of the chemical substances.
IX. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 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 40 CFR 720.40 and 721.25. E–PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
X. Economic Analysis
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 for this rulemaking.
XI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulations and Regulatory Review
This action establishes SNURs for new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
This action does not impose any new information collection burden under the PRA, 44 U.S.C. 3501 et seq. OMB has previously approved the information collection activities contained in the existing SNUR regulations under OMB Control No. 2070–0038 (EPA ICR No. 1188.13). If an entity were to submit a SNUN to the Agency, the annual burden is estimated to be less than 100 hours per response, and the estimated burden for export notifications is less than 1.5 hours per notification. In both cases, if the firm submitting either a SNUN or export notification is already registered in CDX, the burden would be lower than the presented estimates.
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 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. The Information Collection Request (ICR) covering the SNUR activities 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.
C. Regulatory Flexibility Act (RFA)
Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., I hereby certify that promulgation of this SNUR would not have a significant adverse economic impact on a substantial number of small entities. 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 final rule as a “significant new 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 SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018. Only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. 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.
D. Unfunded Mandates Reform Act (UMRA)
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 will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132: Federalism
This action will not have federalism implications because it is not expected to have a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
This action will not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments, and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not a significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
Since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.
J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).
K. Congressional Review Act (CRA)
This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA will submit a rule report containing this rule and other required information to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Dated: April 3, 2023.
Denise Keehner,
Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I is amended as follows:
PART 9—OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136–136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 21 U.S.C. 331j, 346a; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971–1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 6901–6992k, 7401–7671q, 7542, 9601–9657, 11023, 11048.
2. In §9.1, amend the table by adding entries for §§721.11604 through 721.11634 in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:
§9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
| 40 CFR citation | OMB control No. |
|---|---|
| * * * * | * * * * |
| Significant New Uses of Chemical Substances | |
| 721.11659 | 2070–0038 |
| 721.11660 | 2070–0038 |
| 721.11661 | 2070–0038 |
| 721.11662 | 2070–0038 |
| 721.11663 | 2070–0038 |
| 721.11664 | 2070–0038 |
| 721.11665 | 2070–0038 |
| 721.11666 | 2070–0038 |
| 721.11667 | 2070–0038 |
| 721.11668 | 2070–0038 |
| 721.11669 | 2070–0038 |
| 721.11670 | 2070–0038 |
| 721.11671 | 2070–0038 |
| 721.11672 | 2070–0038 |
| 721.11673 | 2070–0038 |
| 721.11674 | 2070–0038 |
| 721.11675 | 2070–0038 |
| 721.11676 | 2070–0038 |
| 721.11677 | 2070–0038 |
| 721.11678 | 2070–0038 |
| 721.11679 | 2070–0038 |
| 721.11680 | 2070–0038 |
| 721.11681 | 2070–0038 |
| 721.11682 | 2070–0038 |
| 721.11683 | 2070–0038 |
| 721.11684 | 2070–0038 |
| 721.11685 | 2070–0038 |
| 721.11686 | 2070–0038 |
| * * * * | * * * * |
* * * * *
PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
4. Add §§721.11659 through 721.11686 to subpart E to read as follows:
* * * * *
Sec.
721.11659 Mixed amine salt (generic).
721.11660 Oxyalkylene modified polyalkyl amine alkyl diacid polymer with 2-(chloromethyl)oxirane (generic).
721.11661 Formaldehyde, homopolymer, reaction products with N-propyl-1-propanamine.
721.11662 2-Propenoic acid, polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid.
721.11663 Benzoic acid, alkyl derivs. (generic).
721.11664 Aminoalkylated imidazole (generic).
721.11665 Fatty acids and fatty acid unsatd., reaction products with ethyleneamines and maleic anhydride (generic).
721.11666 Aromatic anhydride polymer with bisalkylbiphenylbisamine compound with alkylamino acrylate ester (generic).
721.11667 Propanoic acid, hydroxyl- (hydroxyalkyl)-alkyl-, polymer with 1,6-diisocyanatoalkane and poly[oxy(alkyl-alkanediyl)] ether with alkyl (hydroxyalkyl)- alkanediol, 2-propenoate (ester), lithium salt, glycerol monoacrylate 1-neodecanoate- and alkylene glycol monoacrylate-blocked (generic).
721.11668 Polyol adduct of bisaldehyde (generic).
721.11669 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl amide, sodium salts (generic).
721.11670 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy- substituted butyl[3-[2-[1-[[(2-methoxyphenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]substituted, sodium salts (generic).
721.11671 Butanamide, 2-[2-[(substituted phenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxo- (generic).
721.11672 Polycyclic substituted alkane, polymer with cyclicalkylamine, epoxide, and polycyclic epoxide ether, reaction products with dialkylamine substituted alkyl amine (generic).
721.11673 Polycyclic alkane, polymer with monocyclic amine, polycyclic epoxide ether, reaction products with dialkylamine alkyl amine (generic).
721.11674 Polycyclic substituted alkane, polymer with epoxide, reaction products with cyclicalkylamine and dialkylamine substituted alkyl amine (generic).
721.11675 Substituted carbopolycyclic dicarboxylic acid dialkyl ester, polymer with alkanediol and carbopolycyclic bis(substituted carbopolycycle) bisalkanol (generic).
721.11676 D-Glucopyranose, oligomeric, Bu glycosides, polymers with epichlorohydrin, 2-hydroxy-3-sulfopropyl ethers, sodium salts.
721.11677 Alkyl polyoxyethylene ethers, carboxymethylated (generic).
721.11678 Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products, potassium salts (generic).
721.11679 Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid potassium salt (1:1)-potassium 2-oxoacetate (1:1) reaction products, potassium salts (generic).
721.11680 Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products, sodium salts (generic).
721.11681 Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid sodium salt (1:1)-sodium 2-oxoacetate (1:1) reaction products, sodium salts (generic).
721.11682 Alkaneic acid, dialkyl ester polymer with alkanediol, (isocyanatocarbomonocycle) alkyl)carbomonocycle) carbamate (generic).
721.11683 Amides, from C8-18 and C18-unsatd. glycerides and diethylenetriamine, ethoxylated.
721.11684 Amides, from diethylenetriamine and palm kernel-oil, ethoxylated.
721.11685 Amides, from coconut oil and diethylenetriamine, ethoxylated.
721.11686 Phenol-formaldehyde polymer with amino-oxirane copolymer and benzoates (generic).
§721.11659 Mixed amine salt (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed amine salt (PMN P–15–632) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(y)(1) and (2).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11660 Oxyalkylene modified polyalkyl amine alkyl diacid polymer with 2-(chloromethyl)oxirane (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as oxyalkylene modified polyalkyl amine alkyl diacid polymer with 2-(chloromethyl)oxirane (PMN P–17–233) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.
(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=20.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11661 Formaldehyde, homopolymer, reaction products with N-propyl-1-propanamine.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as formaldehyde, homopolymer, reaction products with N-propyl-1-propanamine (PMN P–17–298; CAS No. 1374859–50–3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to use the PMN substance other than as a hydrogen sulfide scavenger used in controlling hydrogen sulfide in the vapor space of fuel storage, shipping vessels, and pipelines.
(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=3.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11662 2-Propenoic acid, polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propenoic acid, polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid (PMN P–17–325; CAS No. 40623–75–4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N = 50.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11663 Benzoic acid, alkyl derivs. (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as benzoic acid, alkyl derivs. (PMN P–17–355) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11664 Aminoalkylated imidazole (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aminoalkylated imidazole (PMN P–17–396) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(j) and (o).
(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N = 33.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11665 Fatty acids and fatty acid unsatd., reaction products with ethyleneamines and maleic anhydride (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids and fatty acid unsatd., reaction products with ethyleneamines and maleic anhydride (PMN P–18–29) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11666 Aromatic anhydride polymer with bisalkylbiphenylbisamine compound with alkylamino acrylate ester (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic anhydride polymer with bisalkylbiphenylbisamine compound with alkylamino acrylate ester (PMN P–18–108) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(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 PMN substance in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11667 Propanoic acid, hydroxyl- (hydroxyalkyl)-alkyl-, polymer with 1,6-diisocyanatoalkane and poly[oxy(alkyl-alkanediyl)] ether with alkyl (hydroxyalkyl)- alkanediol, 2-propenoate (ester), lithium salt, glycerol monoacrylate 1-neodecanoate- and alkylene glycol monoacrylate-blocked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as propanoic acid, hydroxyl- (hydroxyalkyl)-alkyl-, polymer with 1,6-diisocyanatoalkane and poly[oxy(alkyl-alkanediyl)] ether with alkyl (hydroxyalkyl)- alkanediol, 2-propenoate (ester), lithium salt, glycerol monoacrylate 1-neodecanoate- and alkylene glycol monoacrylate-blocked (PMN P–18–114) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to use the PMN substance in spray applications.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11668 Polyol adduct of bisaldehyde (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyol adduct of bisaldehyde (PMN P–18–133) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(y)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11669 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl amide, sodium salts (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2,5-furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl amide, sodium salts (PMN P–18–165) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.
(ii) Release to water. Requirements as specified in §721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11670 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy- substituted butyl[3-[2-[1-[[(2-methoxyphenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]substituted, sodium salts (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2,5-furandione, polymer with ethenylbenzene, 4-hydroxy- substituted butyl[3-[2-[1-[[(2-methoxyphenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]substituted, sodium salts (PMN P–18–166) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.
(ii) Release to water. Requirements as specified in §721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11671 Butanamide, 2-[2-[(substituted phenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxo- (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as butanamide, 2-[2-[(substituted phenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxo- (PMN P–18–167) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80 (o). It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.
(ii) Release to water. Requirements as specified in §721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11672 Polycyclic substituted alkane, polymer with cyclicalkylamine, epoxide, and polycyclic epoxide ether, reaction products with dialkylamine substituted alkyl amine (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polycyclic substituted alkane, polymer with cyclicalkylamine, epoxide, and polycyclic epoxide ether, reaction products with dialkylamine substituted alkyl amine (PMN P–18–214) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to use the PMN substance in a spray application method other than the method described in the spray analysis report submitted with the PMN.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11673 Polycyclic alkane, polymer with monocyclic amine, polycyclic epoxide ether, reaction products with dialkylamine alkyl amine (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polycyclic alkane, polymer with monocyclic amine, polycyclic epoxide ether, reaction products with dialkylamine alkyl amine (PMN P–18–215) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to use the PMN substance in a spray application method other than the method described in the spray analysis report submitted with the PMN.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11674 Polycyclic substituted alkane, polymer with epoxide, reaction products with cyclicalkylamine and dialkylamine substituted alkyl amine (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polycyclic substituted alkane, polymer with epoxide, reaction products with cyclicalkylamine and dialkylamine substituted alkyl amine (PMN P–18–216) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to use the PMN substance in a spray application method other than the method described in the spray analysis report submitted with the PMN.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11675 Substituted carbopolycyclic dicarboxylic acid dialkyl ester, polymer with alkanediol and carbopolycyclic bis(substituted carbopolycycle) bisalkanol (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted carbopolycyclic dicarboxylic acid dialkyl ester, polymer with alkanediol and carbopolycyclic bis(substituted carbopolycycle) bisalkanol (PMN P–18–329) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11676 D-Glucopyranose, oligomeric, Bu glycosides, polymers with epichlorohydrin, 2-hydroxy-3-sulfopropyl ethers, sodium salts.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as D-glucopyranose, oligomeric, Bu glycosides, polymers with epichlorohydrin, 2-hydroxy-3-sulfopropyl ethers, sodium salts (PMN P–18–385; CAS No. 2139271–53–5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11677 Alkyl polyoxyethylene ethers, carboxymethylated (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl polyoxyethylene ethers, carboxymethylated (PMN P–19–135) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.
(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N = 60.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11678 Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products, potassium salts (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products, potassium salts (PMN P–19–148) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(f) and (j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11679 Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid potassium salt (1:1)-potassium 2-oxoacetate (1:1) reaction products, potassium salts (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid potassium salt (1:1)-potassium 2-oxoacetate (1:1) reaction products, potassium salts (PMN P–19–149) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(f) and (j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11680 Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products, sodium salts (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products, sodium salts (PMN P–19–150) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(f) and (j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11681 Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid sodium salt (1:1)-sodium 2-oxoacetate (1:1) reaction products, sodium salts (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid sodium salt (1:1)-sodium 2-oxoacetate (1:1) reaction products, sodium salts (PMN P–19–151) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(f) and (j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11682 Alkaneic acid, dialkyl ester polymer with alkanediol, (isocyanatocarbomonocycle) alkyl)carbomonocycle) carbamate (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkaneic acid, dialkyl ester polymer with alkanediol, (isocyanatocarbomonocycle) alkyl)carbomonocycle) carbamate (PMN P–19–152) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture the PMN substance with greater than 25.0% residual isocyanate by weight. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11683 Amides, from C8-18 and C18-unsatd. glycerides and diethylenetriamine, ethoxylated.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as amides, from C8-18 and C18-unsatd. glycerides and diethylenetriamine, ethoxylated (PMN P–19–155; CAS No. 2173332–72–2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture or process the PMN substance in any manner that results in inhalation exposure. It is a significant new use to use the PMN substance other than as an adjuvant for industrial herbicide agrochemical formulations.
(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N = 2.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11684 Amides, from diethylenetriamine and palm kernel-oil, ethoxylated.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as amides, from diethylenetriamine and palm kernel-oil, ethoxylated (PMN P–19–156; CAS No. 2173332–69–7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture or process the PMN substance in any manner that results in inhalation exposure. It is a significant new use to use the PMN substance other than as an adjuvant for industrial herbicide agrochemical formulations.
(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N = 2.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11685 Amides, from coconut oil and diethylenetriamine, ethoxylated.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as amides, from coconut oil and diethylenetriamine, ethoxylated (PMN P–19–157; CAS No. 2173332–70–0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture or process the PMN substance in any manner that results in inhalation exposure. It is a significant new use to use the PMN substance other than as an adjuvant for industrial herbicide agrochemical formulations.
(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N = 2.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11686 Phenol-formaldehyde polymer with amino-oxirane copolymer and benzoates (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenol-formaldehyde polymer with amino-oxirane copolymer and benzoates (PMN P–20–24) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(j) and (o). It is a significant new use to use the PMN substance in final product formulation at a concentration greater than 8%.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
[FR Doc. 2023–07458 Filed 4–10–23; 8:45 am]
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