CCLME.ORG - 40 CFR PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
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(continued)

(B) The parties to be notified are as follows.

(1) The Director, Water Management Division (or, in the case of Regions 5 and 10, Water Division) at the headquarters of the EPA region in which the specific buyer or transferee is located.

(2) The Agency, Department, or Office of the State or U.S. Territory with jurisdiction over point source water discharges in the State or Territory in which the specific buyer or transferee is located (EPA is available for consultation regarding the identity and address of the appropriate Agency, etc.)

(3) The Publicly Owned Treatment Works (POTW) authority, if any, expected to receive the discharge of the PMN substance from the specific buyer or transferee.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping requirements. The following recordkeeping requirements are applicable to manufacturers, importers, and processors of this substance as specified in §721.125 (a), (b), (c), (d), (f), (g), (h), (i), and records documenting notification to parties identified in §721.90.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this significant new use rule.

(3) Determining whether a specific use is subject to this section. The provisions of §721.1725(b)(1) apply to this section.

[56 FR 15792, Apr. 17, 1991. Redesignated and amended at 58 FR 29946, May 24, 1993; 58 FR 34204, June 23, 1993; 60 FR 34464, July 3, 1995]

§ 721.4320 Hydrazinecarboxamide, N,N'-(methylenedi-4,1-phenylene)bis [2,2-dimethyl-.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance hydrazinecarboxamide, N,N'-(methylenedi-4,1-phenylene)bis[2,2-dimethyl- (PMN P-88–522) 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) Protection in the workplace. Requirements as specified in §721.63 (a)(1), (a)(3), (a)(4), (a)(5)(viii) through (a)(5)(xiv), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 percent), and (c).

(ii) Hazard communication program. Requirements as specified in §721.72 (b)(2), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(iv) (and blood effects), (g)(1)(vii), (g)(2)(iv), (g)(2)(v), (g)(4)(iii), and (g)(5). The provisions of §721.72(d) requiring employees to be provided with information on the location and availability of a written hazard communication program and MSDSs do not apply when the written program and MSDS are not required under §721.72 (a) and (c), respectively. The provision of §721.72(g) requiring placement of specific information on an MSDS does not apply when an MSDS is not required under §721.72(c).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80 (f) and (l).

(iv) Release to water. Requirements as specified in §721.90 (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.

(1) Recordkeeping. The following recordkeeping requirements are applicable to manufacturers, importers, and processors of this substance, as specified in §721.125 (a), (b), (c), (e), (f), (g), (h), and (k).

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this significant new use rule.

[55 FR 46773, Nov. 6, 1990. Redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 34204, June 23, 1993]

§ 721.4340 Substituted thiazino hydrazine salt (generic name).
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance substituted thiazino hydrazine salt (PMN P-88–63) 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) Protection in the workplace. Requirements as specified in §721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iii) through (a)(5)(vii), and (a)(6)(i), (b) [concentration set at 0.1 percent], and (c).

(ii) Hazard communication program. Requirements as specified in §721.72 (a), (b)(2), (c), (d), (e) [concentration set at 0.1 percent], (f), and (g)(1)(iv) and (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), and (g)(2)(v), (g)(4)(i), and (g)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80 (g) and (l).

(iv) Disposal. Requirements as specified in §721.85 (a)(1) and (a)(2) and (b)(1) and (b)(2).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. The following recordkeeping requirements are applicable to manufacturers, importers, and processors of this substance, as specified in §721.125 (a) through (i).

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this significant new use rule.

[55 FR 26112, June 26, 1990. Redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR 34204, June 23, 1993]

§ 721.4360 Certain hydrogen containing chlorofluorocarbons.
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(a) Chemical substances and significant new uses subject to reporting.

(1) The chemical substances ethane, 2-chloro-1,1,1-trifluoro- (CAS Number 75–88–7) and ethane, 1,2-dichloro-1,1-difluoro- (CAS Number 1649–08–7) are subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new use is: Use other than as an intermediate.

(b) [Reserved]

[55 FR 35632, Aug. 31, 1990. Redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 34204, June 23, 1993]

§ 721.4365 Substituted ethoxylated hydrocarbon (generic).
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Substituted ethoxylated hydrocarbon (PMN P-99–0313) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified §721.90 (a)(4), (b)(4), and (c)(4) (N=1 ppb).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[65 FR 81400, Dec. 26, 2000]

§ 721.4380 Modified hydrocarbon resin.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a modified hydrocarbon resin (P-91–1418) 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) Hazard communication program. A significant new use of this substance is any manner or method of manufacture, import, or processing associated with any use of this substance without providing risk notification as follows:

(A) If as a result of the test data required under the section 5(e) consent order for this substance, the employer becomes aware that this substance may present a risk of injury to human health, the employer must incorporate this new information, and any information on methods for protecting against such risk, into an MSDS as described in §721.72(c) within 90 days from the time the employer becomes aware of the new information. If this substance is not being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to an MSDS before the substance is reintroduced into the workplace.

(B) The employer must ensure that persons who will receive this substance from the employer, or who have received the substance from the employer within 5 years from the date the employer becomes aware of the information described in paragraph (a)(2)(i)(A) of this section, are provided an MSDS as described in §721.72(c) containing the information required under paragraph (a)(2)(i)(A) of this section within 90 days from the time the employer becomes aware of the new information.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(q).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping requirements. Requirements as specified in §721.125 (a), (h), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of §721.1725(b)(1) apply to this section.

[57 FR 44067, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 58 FR 34204, June 23, 1993]

§ 721.4385 Hydrofluoric acid, reaction products with heptane.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a hydrofluoric acid, reaction products with heptane (PMN P-98–1036; CAS No. 207409–71–0) is subject to reporting under this section for the significant new use 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(g).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[65 FR 370, Jan. 5, 2000]

§ 721.4390 Trisubstituted hydroquinone diester.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as trisubstituted hydroquinone diester (PMN No. P-92–329) 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) Hazard communication program. Requirements as specified in §721.72 (a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).

(ii) Release to water. Requirements as specified in §721.90 (a)(4), (b)(4) (where N = 30 ppb).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), (f), (g), (h), (j), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this significant new use rule.

[58 FR 32239, June 8, 1993]

§ 721.4420 Substituted hydroxylamine.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted hydroxylamine (PMN P-84–492) 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) Protection in the workplace. Requirements as specified in §721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and (c).

(ii) Hazard communicatiom program. Requirements as specified in §721.72 (b)(2), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(vii), and (g)(2)(i) through (g)(2)(iii). The provisions of §721.72(d) requiring employees to be provided with information on the location and availability of a written hazard communication program and MSDSs do not apply when the written program and MSDS are not required under §721.72 (a), and (c), respectively. The provision of §721.72(g) requiring placement of specific information on an MSDS does not apply when an MSDS is not required under §721.72(c).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(k).

(iv) Release to water. Requirements as specified in §721.90 (a)(4) (chemically treated liquid wastes must contain no more than 10 ppm of the substance prior to discharge), (b)(4) (chemically treated liquid wastes must contain no more than 10 ppm of the substance prior to discharge), and (c)(4) (chemically treated liquid wastes must contain no more than 10 ppm of the substance prior to discharge).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. The following recordkeeping requirements are applicable to manufacturers, importers, and processors of this substance, as specified in §721.125 (a), (b), (c), (e), (f), and (j).

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this significant new use rule.

(3) Determining whether a specific use is subject to this section. The provisions of §721.1725(b)(1) apply to this section.

[55 FR 46773, Nov. 6, 1990. Redesignated and amended at 58 FR 29946, May 24, 1993; 58 FR 34204, June 23, 1993]

§ 721.4460 Amidinothiopropionic acid hydrochloride.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as amidinothiopropionic acid hydrochloride (PMN P-91–102) 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).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping requirements. Requirements as specified in §721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[57 FR 46466, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]

§ 721.4461 Hydrofluoric acid, reaction products with octane (generic).
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a hydrofluoric acid, reaction products with octane (PMN P-99–0052) is subject to reporting under this section for the significant new use 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)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[65 FR 81400, Dec. 26, 2000]

§ 721.4462 Hydrochlorofluorocarbon.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a hydrochlorofluorocarbon (PMN P-95–1317) 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(g).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[63 FR 3428, Jan. 22, 1998]

§ 721.4463 Hydrochlorofluorocarbon.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a hydrochlorofluorocarbon (PMN P-94–1453) 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(g).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[60 FR 45082, Aug. 30, 1995]

§ 721.4464 Mixture of hydrofluoro alkanes and hydrofluoro alkene.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as a mixture of hydrofluoro alkanes and hydrofluoro alkene (PMNs P-96–945/946/947/948) are 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(g).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements specified as in §721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of these substances.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[63 FR 3428, Jan. 22, 1998]

§ 721.4465 Hydrofluoroalkane.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a hydrofluoroalkane (PMN P-96–1288) 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(h).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a) and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[63 FR 3428, Jan. 22, 1998]

§ 721.4467 Quaternary ammonium hydroxide.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a quaternary ammonium hydroxide (PMN P-95–1806) 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)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[63 FR 3429, Jan. 22, 1998]

§ 721.4468 1H-Imidazole, 2-ethyl-4,5-dihydro-4-methyl-.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1H-imidazole, 2-ethyl-4,5-dihydro-4-methyl- (PMN P-97–217; CAS No. 931–35–1) 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) (N = 40).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[63 FR 3429, Jan. 22, 1998]

§ 721.4469 Imidazolethione.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as an imidazolethione (PMNs P-91–1131 and P-90–564) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. Formulations or mixtures containing the PMN substance in concentrations at or below 10 percent by weight or volume are exempt from the provisions of this rule.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in §721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and (c).

(ii) Hazard communication program. Requirements as specified in §721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(ix), (g)(2)(i), (g)(2)(v), and (g)(5). The label and MSDS as required by this paragraph shall also include the following statements: This substance may cause thyroid cancer. This substance may cause thyroid effects.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), (d), (e), (f), (g), and (h) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[63 FR 3429, Jan. 22, 1998]

§ 721.4470 2,4-Imidazolidinedione, bromochloro-5,5-dimethyl-.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance 2,4-imidazolidinedione, bromochloro-5,5-dimethyl- (PMN P-94–34) 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 (v)(3), (w)(3), and (x)(3).

(ii) Release to water. Requirements as specified in §721.90 (a)(4), (b)(4), and (c)(4) (where N = 10 ppb).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping requirements. Recordkeeping requirements specified in §721.125 (a), (b), (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[60 FR 11043, Mar. 1, 1995]

§ 721.4472 Phenyl, alkyl, hydroxyalkyl substituted imidazole (generic).
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenyl, alkyl, hydroxyalkyl substituted imidazole (PMNs P-98–843 and P-86–65) are 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) Protection in the workplace. Requirements as specified in §721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (b) (concentration set at 1.0 percent), and (c).

(ii) Hazard communication program. Requirements as specified in §721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), and (g)(1)(iii).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(r) (56,000 kg) (acute oral study (OPPTS 870.1100 test guideline) followed by a (90-day subchronic inhalation study in rats (40 CFR 799.9346). A person may not manufacture or import the substance beyond the aggregate production volume limit, unless that person conducts this study on the substance and submits all final reports and underlying data in accordance with the procedures and criteria specified in paragraphs (a)(2)(iii)(A), (a)(2)(iii)(B), (a)(2)(iii)(C), and (a)(2)(iii)(D) of this section.

(A) Each study required to be performed pursuant to this section must be scientifically valid. Scientifically valid means that the study was conducted according to:

(1) The test guidelines specified in paragraph (a)(2)(iii) of this section.

(2) An EPA-approved protocol.

(3) TSCA Good Laboratory Practice Standards at 40 CFR part 792.

(4) Using methodologies generally accepted at the time the study is initiated.

(5) Any deviation from these requirements must be approved in writing by EPA.

(B) Before starting to conduct any of the studies in paragraph (a)(2)(iii) of this section, the person must obtain approval of test protocols from EPA by submitting written protocols. EPA will respond to the person within 4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (a)(2)(iii) of this section (e.g., 40 CFR part 797 or part 798) provide general guidance for development of test protocols, but are not themselves acceptable protocols.

(C) The person shall:

(1) Conduct each study in good faith with due care.

(2) Promptly furnish to EPA the results of any interim phase of each study.

(3) Submit, in triplicate (with an additional sanitized copy, if confidential business information is involved), the final report of each study and all underlying data (“the report and data”) to EPA no later than 14 weeks prior to exceeding the applicable production volume limit. The final report shall contain the contents specified in 40 CFR 792.185.

(D)(1) Except as described in paragraph (a)(2)(iii)(D)(2), if, within 6 weeks of EPA's receipt of a test report and data, the person receives written notice that EPA finds that the data generated by a study are scientifically invalid, the person is prohibited from further manufacture and import of the PMN substance beyond the applicable production volume limit.

(2) The person may continue to manufacture and import the PMN substance beyond the applicable production limit only if so notified, in writing, by EPA in response to the person's compliance with either of the following paragraphs (a)(2)(iii)(D)(2)(i) or (a)(2)(iii)(D)(2)(ii) of this section.

(i) The person may reconduct the study. If there is sufficient time to reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by paragraph (a)(2)(iii)(C)(3) of this section, the person shall comply with paragraph (a)(2)(iii)(C)(3) of this section. If there is insufficient time for the person to comply with paragraph (a)(2)(iii)(C)(3) of this section, the person may exceed the production limit and shall submit the report and data in triplicate to EPA within a reasonable period of time, all as specified by EPA in the notice described in paragraph (a)(2)(iii)(D)(1) of this section. EPA will respond to the person in writing, within 6 weeks of receiving the person's report and data.

(ii) The person may, within 4 weeks of receiving from EPA the notice described in paragraph (a)(2)(iii)(D)(1) of this section, submit to EPA a written report refuting EPA's finding. EPA will respond to the person in writing, within 4 weeks of receiving the person's report.

(E) The person is not required to conduct a study specified in paragraph (a)(2)(iii) of this section if notified in writing by EPA that it is unnecessary to conduct that study.

(iv) 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.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[65 FR 370, Jan. 5, 2000]

§ 721.4473 Dialkylamidoimidazoline.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as dialkylamidoimidazoline (PMN P-94–1864) 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(h).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a) and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[60 FR 45082, Aug. 30, 1995]

§ 721.4476 Substituted imines.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as substituted imines (PMNs P-95–1557/1558) are 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)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of these substances.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[63 FR 3429, Jan. 22, 1998]

§ 721.4480 2-Imino-1,3-thiazin-4-one-5,6-dihydromonohydrochloride.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-imino-1,3-thiazin-4-one-5,6-dihydromonohydrochloride (PMN P-91–101) 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), (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), and (x)(2).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping requirements. Requirements as specified in §721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[57 FR 46466, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]

§ 721.4484 Halogenated indane (generic name).
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a halogenated indane (PMN P-94–351) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to P-94–351 after incorporation into a plastic, resin matrix, or pelletized so humans are not reasonally likely to be exposed.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements during manufacture as specified in §721.63 (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5(vii), (a)(6)(i), (b) (concentration set at 0.1 percent), and (c).

(ii) Hazard communication program. Requirements during manufacture as specified in §721.72 (a), (b), (c), (d), (e), (f), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(q).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of §721.1725(b)(1) apply to this section.

[61 FR 63737, Dec. 2, 1996, as amended at 62 FR 27694, May 21, 1997]

§ 721.4486 Propanoic acid, 2-methyl-, (1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl ester, rel-.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified as propanoic acid, 2-methyl-, (1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl ester, rel- (PMNs P-98–0497 and P-98–0509; CAS No. 85586–67–0) are subject to reporting under this section for the significant new use 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(p) (15,000 kg/yr).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[68 FR 15084, Mar. 28, 2003]

§ 721.4490 Capped aliphatic isocyanate.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a capped aliphatic isocyanate (PMN P-86–1146) 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) Protection in the workplace. Requirements as specified in §721.63 (a)(1), (a)(3), (a)(4), (a)(5)(xi), (a)(6)(v), (b) (concentration set at 0.1 percent), and (c).

(ii) Hazard communication program. Requirements as specified in §721.72 (a), (b), (d), (e) (concentration set at 0.1 percent), (f), (h)(1)(ii)(G), (h)(1)(iii)(A), (h)(1)(iii)(B), (h)(1)(iii)(D), and (h)(1)(iii)(E).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(h).

(iv) Disposal. Requirements as specified in §721.90 (a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b) through (g), (i), and (j) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[58 FR 51685, Oct. 4, 1993]

§ 721.4494 Polycyclic isocyanate.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as a polycyclic isocyanate (PMN P-94–437) 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) Protection in the workplace. Requirements as specified in §721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), (b) (concentration set at 1.0%), and (c).

(ii) Hazard communication program. Requirements as specified in §721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). In addition the following human health and environmental hazard and precautionary statements shall appear on each label as specified in paragraph (b) of this section and the MSDS as specified in paragraph (c) of this section: This substance may cause skin sensitization. This substance may cause pulmonary sensitization.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(q).

(iv) Release to water. Requirements as specified in §721.90 (a)(3), (b)(3), and (c)(3).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a) through (i) and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of §721.1725(b)(1) apply to this section.

[61 FR 63737, Dec. 2, 1996]

§ 721.4497 Aliphatic polyisocyanates (generic name).
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as aliphatic polyisocyanates (P-91–1210 and P-92–714) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. Non-spray uses are exempt from the provisions of this rule.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in §721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (concentration set at 1.0 percent), and (c).

(ii) Hazard communication program. Requirements as specified in §721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5). Manufacturers, importers, and processors who implement the product stewardship provisions of the section 5(e) consent order for these substances are exempt from the requirements of §§721.63 and 721.72.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a) through (h) are applicable to manufacturers, importers, and processors of this substance. Manufacturers, importers, and processors who implement the product stewardship provisions or keep records as required by the section 5(e) consent order for these substances are exempt from the requirements of §721.125.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

(3) Applicability of §721.5. The provisions of §721.5 do not apply to manufacturers, importers, and processors, implementing the product stewardship provisions in the section 5(e) consent order for these substances.

[61 FR 63737, Dec. 2, 1996]

§ 721.4500 Isopropylamine distillation residues and ethylamine distillation residues.
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(a) Chemical substances and significant new use subject to reporting. (1) The following chemical substances referred to by their Chemical Abstracts Service (CAS) register numbers and chemical names are subject to reporting under this section for the significant new use identified in paragraph (a)(2) of this section: CAS No. 79771–08–7, isopropylamine distillation residues, and CAS No. 79771–09–98, ethylamine distillation residues.

(2) The significant new use is use in metalworking fluids.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Notice Requirements and Procedures. Section 721.10 applies to this section, except persons submitting a notice must complete only Parts I and III of the notice form.

(2) [Reserved]

(Sec. 5, Pub. L. 94–469, 90 Stat. 2012 (15 U.S.C. 2604))

[49 FR 46378, Nov. 26, 1984. Redesignated at 51 FR 23539, June 30, 1986, and 53 FR 2845, Feb. 2, 1988. Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 34204, June 23, 1993]

§ 721.4520 Isopropylidene, bis(1,1-dimethylpropyl) derivative.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as isopropylidene, bis(1,1-dimethylpropyl) derivative (PMN P-85–648) 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) Protection in the workplace. Requirements as specified in §721.63 (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3) (applies to gloves only), (b) (concentration set at 0.1 percent), and (c).

(ii) Hazard communication program. Requirements as specified in §721.72 (a), (b)(2), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(vii), (g)(2)(i), (g)(2)(v), and (g)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(k).

(iv) Release to water. Requirements as specified in §721.90 (a)(2)(ii), (b)(2)(ii), and (c)(2)(ii).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping requirements. Requirements as specified in §721.125 (a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of §721.1725(b)(1) apply to this section.

[57 FR 44067, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 58 FR 34204, June 23, 1993]

§ 721.4550 Diperoxy ketal.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as diperoxy ketal (PMN–92–1394) 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) Hazard communication program. Requirements as specified in §721.72 (a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), and (g)(5).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(q).

(iii) 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.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of §721.1725(b)(1) apply to this section.

[58 FR 51705, Oct. 4, 1993]

§ 721.4565 Modified hydroxystyrene homopolymer (generic).
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as Modified hydroxystyrene homopolymer (PMN P-99–0610) is subject to reporting under this section for the significant new use 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).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of §721.1725(b)(1) apply to this section.

[65 FR 81401, Dec. 26, 2000]

§ 721.4568 Methylpolychloro aliphatic ketone.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as methylpolychloro aliphatic ketone (PMN No. P-91–1321) 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) Protection in the workplace. Requirements as specified in §721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (a)(6)(ii), (a)(6)(iii), (a)(6)(v), (b) (concentration set at 0.1 percent), and (c). The employer is able to demonstrate that the gloves selected for handling P-91–1321 provide an impervious barrier to prevent dermal exposure during normal and expected duration and conditions of exposure within the work area by testing the material used to make the gloves and the construction of the gloves to establish that they will be impervious for the expected duration and conditions of exposure. The testing must subject the gloves to the expected conditions of exposure, including the likely combinations of chemical substances to which the gloves may be exposed in the work area. There must be no permeation of P-91–1321 greater than 0.017 mg/cm 2 /min after 8 h of testing in accordance with the most recent versions of the American Society for Testing and Materials (ASTM) F739 “Standard Test Method for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases” and ASTM F1194 “Guide for Documenting the Results of Chemical Permeation Testing of Protective Clothing Materials.” The employer must submit all test data to the Agency and must receive written Agency approval of the test results for each type of glove tested prior to use of such gloves. Neoprene gloves with a minimum thickness of 1.50 mm have already been tested and found to satisfy the terms of this rule. Nitrile gloves with a minimum thickness of 0.61 mm also satisfy the terms of this rule, as long as the duration of exposure to P-91–1321 is less than 2 h per work shift. If the duration of exposure is longer than 2 h, nitrile gloves shall be discarded and replaced every 2 h. Unless otherwise indicated, gloves contaminated with P-91–1321 shall be disposed of after every work shift.

(ii) Hazard communication program. Requirements as specified in §721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80 (g) and (q).

(iv) Release to water. Requirements as specified in §721.90(a)(1), (b)(1), (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (d) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this significant new use rule.

(3) Determining whether a specific use is subject to this section. The provisions of §721.1725(b)(1) apply to this section.

[58 FR 32239, June 8, 1993, as amended at 58 FR 29946, May 24, 1993]

§ 721.4575 L-aspartic acid, N,N'- [(1E) - 1,2 - ethenediylbis[(3-sulfo-4, 1-phenylene)imino [6-(phenylamino)-1,3,5-triazine- 4,2- diyl]]]bis-, hexasodium salt.
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(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as l-aspartic acid, N,N'- [(1E) - 1,2 - ethenediylbis[(3-sulfo-4, 1-phenylene) imino[6-(phenylamino)-1,3,5-triazine-4,2-diyl]]]bis-, hexasodium salt (PMN P-99–1167; CAS No. 205764–98–3) is subject to reporting under this section for the significant new use 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 (v)(1), (w)(1), (x)(1), and (f).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section. (continued)