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e-CFR data is current as of January 13, 2021

Title 40Chapter ISubchapter RPart 721Subpart E → §721.1450

Title 40: Protection of Environment
Subpart E—Significant New Uses for Specific Chemical Substances

§721.1450   1,3-Benzenediamine, 4-(1,1-dimethylethyl)-ar-methyl.

(a) Chemical substance and significant new uses subject to reporting. (1) The following chemical substance, referred to by its PMN number and chemical name, is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section: P-85-929; 1,3-Benzenediamine, 4-(l,1-dimethylethyl)-ar-methyl.

(2) The significant new uses are:

(i) Use other than for applications where the substance will be completely reacted (cured or used as a chemical intermediate).

(ii) Any method of disposal other than by landfill, incineration, or for wastewater from vent scrubbers, steam vacuum ejectors, pad washings, equipment washouts, and stormwater runoffs, wastewater treatment in permitted industrial wastewater treatment facilities. Each method of disposal must meet all applicable local, State, and Federal laws and regulations.

(iii) Any manner or method of manufacturing, importing, or processing without establishing a program whereby:

(A) Any person who may be exposed dermally to the substance wears:

(1) Gloves which have been determined to be impervious to the substance under the conditions of exposure, including the duration of exposure. This determination is made either by testing the gloves under the conditions of exposure or by evaluating the specifications provided by the manufacturer of the gloves. Testing or evaluation of specifications includes consideration of permeability, penetration, and potential chemical and mechanical degradation by the substance and associated chemical substances.

(2) Clothing which covers any other exposed areas of the arms, legs, and torso.

(3) Chemical safety goggles or equivalent eye protection.

(B) Any person who may be exposed to the substance through inhalation during manufacture, in addition to the dermal protective equipment described in paragraph (a)(2)(iii)(A) of this section, wears at a minimum, a National Institute for Occupational Safety and Health approved, category 23C respirator, organic vapor type. Use of the respirator must be according to 29 CFR 1910.134 and 30 CFR part 11. If a full-face type respirator is selected and worn, the chemical safety goggles requirement in paragraph (a)(2)(iii)(A)(3) of this section is waived.

(C)(1) All persons who may be exposed to the substance are informed, in writing, and by presenting the information as part of a training program in safety meetings at which attendance is recorded, by means of the following statement:

WARNING: Avoid all contact. Chemicals similar in structure to [insert appropriate name] have been found to cause chronic organ and systemic effects and cancer in laboratory animals. To protect yourself, you must wear chemical safety goggles or equivalent eye protection, impervious gloves, and protective clothing while handling this material.

(2) During manufacture, the warning statement in paragraph (a)(2)(iii)(C)(1) of this section shall include the additional following statement:

Respirators are required during clean-up or loading of bulk material.

(D) All persons that receive the PMN substance are notified by means of a Material Safety Data Sheet (“MSDS”) which includes, at a minimum, the language specified in paragraph (a)(2)(iii)(C)(1) of this section, and specifies the requirements for protective equipment in paragraph (a)(2)(iii)(A) and (a)(2)(iii)(B) of this section.

(E) Each container of the substance distributed in commerce has affixed to it a label which includes a Warning Statement which consists, at a minimum, of the language specified in paragraph (a)(2)(iii)(C)(1) of this section. The first word of the Warning Statement is capitalized, and the type size of the first word is no smaller than 6-point type for a label 5 square inches or less in area, 10-point type for a label above 5 but no greater than 10 square inches in area, 12-point type for a label above 10 but no greater than 15 square inches in area, 14-point type for a label above 15 but no greater than 30 square inches in area, or 18-point type for a label over 30 square inches in area. The type size of the remainder of the Warning Statement is no smaller than 6-point type. All required label text is of sufficient prominence, and is placed with such conspicuousness relative to other label text and graphic material, to ensure that the Warning Statement is read and understood by the ordinary individual under customary conditions of purchase and use.

(iv) Manufacturing and importing the substance for any use at greater than the aggregrate volumes allowed under the consent order issued for Premanufacture Notice P-85-929, without submitting to EPA the corresponding scientifically valid toxicity test data required under that order, developed according to EPA's Good Laboratory Practice standards at 40 CFR part 792 and EPA's testing guidelines at 40 CFR 798.2650 and 798.3300.

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

(1) Determining whether a use is a significant new use. (i) Any person who intends to manufacture or import the substance identified in paragraph (a)(1) of this section shall, before commencing any manufacture or import, submit to EPA the information required under §721.11(b).

(ii) EPA will review this information to determine whether the person has a bona fide intent to manufacture or import the substance. If EPA determines that the person has a bona fide intent to manufacture or import the substance, EPA will tell the person the specific production volumes which would constitute a significant new use under paragraph (a)(2)(iv) of this section.

(iii) A disclosure to a person with a bona fide intent to manufacture or import the substance of the specific production volumes which would constitute a significant new use under paragraph (a)(2)(iv) of this section will not be considered public disclosure of confidential business information under section 14 of the Act.

(2) Recordkeeping. In addition to the requirements of §721.40, manufacturers, importers, and processors must maintain the following records for 5 years after the date they are created:

(i) Any determination that gloves are impervious to the substance.

(ii) Names of persons who have attended safety meetings in accordance with paragraph (a)(2)(iii)(C) of this section, the dates of such meetings, and copies of any written information provided in accordance with paragraph (a)(2)(iii)(C) of this section.

(iii) Copies of any MSDSs used.

(iv) Names and addresses of all persons to whom the substance is sold or transferred including shipment destination address if different, the date of each transfer, and the quantity of substance sold or transferred on such date.

(v) Copies of any labels used.

(vi) Any names used for the substance and the corresponding dates of use.

(vii) Quantities of the substance manufactured or imported, with the corresponding dates of manufacture or import.

(viii) Quantities of the substance purchased in the United States by processors of the substance, names and addresses of suppliers, and corresponding dates of purchase.

(ix) Information on disposal of the substance, including dates waste material is disposed of, location of disposal sites, volume of disposed solid material, estimated volume of any disposed liquid wastes containing the substance, and method of disposal.

[55 FR 20795, May 21, 1990. Redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 34204, June 23, 1993]

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