This section identifies activities with respect to two chemical substances which are prohibited and requires that warnings and instructions accompany the substances when distributed in commerce.
(a) Chemical substances subject to this section. The following chemical substances, referred to by their premanufacture notice numbers and generic chemical names, are subject to this section:
P-83-1005, triethanolamine salt of tricarboxylic acid; and
P-83-1062, tricarboxylic acid.
(b) Definitions. Definitions in section 3 of the Act, 15 U.S.C. 2602,apply. In addition, the following definitions apply:
(1) The terms Act, article, byproducts, chemical substance, commerce, imported, impurity, Inventory, manufacture or import for commercial purposes, manufacture solely for export, manufacturer, new chemical substance, person, process, processor, and small quantities solely for research and development have the same meaning as in § 720.3 of this chapter.
(2) Metalworking fluid means a liquid of any viscosity or color containing intentionally added water used in metal machining operations for the purpose of cooling or lubricating.
(3) Nitrosating agent means any substance that has the potential to transfer a nitrosyl group (—NO) to a secondary or tertiary amine to form the corresponding nitrosamine.
(c) Use limitations. (1) Any person producing a metalworking fluid, or a product which could be used in or as a metalworking fluid, which includes as one of its components P-83-1005 is prohibited from adding any nitrosating agent to the metalworking fluid or product.
(2) Any person using as metalworking fluid a product containing P-83-1005 is prohibited from adding any nitrosating agent to the product.
(d) Warnings and instructions. (1) Any person who distributes in commerce P-83-1005 in a metalworking fluid, or in any form in which it could be used as a component of a metalworking fluid, must sent to each recipient of P-83-1005 and confirm receipt prior to the first shipment to that person:
(i) A letter that includes the following statements:
A substance, identified generically as triethanolamine salt, of tricarboxylic acid, contained in the product (insert distributor's trade name or other identifier for product containing P-83-1005) has been regulated by the Environmental Protection Agency, at 40 CFR 747.200, as published in the Federal Register of January 23, 1984. A copy of the regulation is enclosed. The regulation prohibits the addition of any nitrosating agent, including nitrites, to the triethanolamine salt of tricarboxylic acid, when the substance is or could be used in metalworking fluids. The addition of nitrites or other nitrosating agents to this substance leads to formation of a substance known to cause cancer in laboratory animals. The triethanolamine salt of the tricarboxylic acid, has been specifically designed to be used without nitrites. Consult the enclosed regulation for further information.
(ii) A copy of this rule.
(2) Any person who distributes in commerce a metalworking fluid containing P-83-1005 must affix to each container containing the fluid a label that includes, in letters no smaller than ten point type, the following statement:
WARNING! Do Not Add Nitrites to This Metalworking Fluid under Penalty of Federal Law. Addition of nitrite leads to formation of a substance known to cause cancer. This product is designed to be used without nitrites.
(3) Any person who distributes in commerce P-83-1062 in any form in which it could be combined with water and triethanolamine to produce P-83-1005 must send to each recipient of P-83-1062, and confirm receipt prior to the first shipment to that person:
(i) A letter that includes the following statements:
A substance, identified generically as tricarboxylic acid, contained in the product (insert distributor's trade name or other identifier for product containing P-83-1062) has been regulated by the Environmental Protection Agency (40 CFR 747.200 published in the Federal Register of January 23, 1984. A copy of the regulation is enclosed. Combining tricarboxylic acid with water and the triethanolamine produces a substance, identified generically as the triethanolamine salt of the tricarboxylic acid. The regulation prohibits the addition of nitrosating agents, including nitrites, to the triethanolamine salt of tricarboxylic acid, when that substance is or could be used in metalworking fluids. The addition of nitrites or other nitrosating agents to that substance leads to formation of a substance known to cause cancer in laboratory animals. Consult the enclosed regulation for further information.
(ii) A copy of this rule.
(e) Liability and determining whether a chemical substance is subject to this section. (1) If a manufacturer or importer of a chemical substance which is described by one of the generic names in paragraph (a) of this section makes an inquiry under § 710.7(g) of this chapter or § 720.25(b) of this chapter as to whether the specific substance is on the Inventory and EPA informs the manufacturer or importer that the substance is on the Inventory, EPA will also inform the manufacturer or importer whether the substance is subject to this section.
(2) Except for manufacturers and importers of P-83-1005 and P-83-1062, no processor, distributor, or user of P-83-1005 or P-83-1062 will be in violation of this section unless that person has received a letter specified in paragraph (d)(1) or (3) of this section or a container with the label specified in paragraph (d)(2) of this section.
(f) Exemptions and exclusions. The chemical substances identified in paragraph (a) of this section are not subject to the requirements of paragraphs (c) and (d) of this section, if:
(1) The substance is manufactured, imported, processed, distributed in commerce, and used only in small quantities solely for research and development, and if the substance is manufactured, imported, processed, distributed in commerce, and used in accordance with section 5(h)(3) of the Act.
(2) The substance is manufactured, imported, processed, distributed in commerce, or used only as an impurity.
(3) The substance is imported, processed, distributed in commerce, or used only as part of an article.
(4) The substance is manufactured solely for export.
(g) Enforcement. (1) Failure to comply with any provision of this section is a violation of section 15 of the Act (15 U.S.C. 2614).
(2) Failure or refusal to permit access to or copying of records, as required under section 11 of the Act, is a violation of a section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to permit entry or inspection, as required under section 11 of the Act, is a violation of section 15 of the Act (15 U.S.C. 2614).
(4) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C 2615) for each violation.
(5) EPA may seek to enjoin the processing, distribution in commerce, or use of a chemical substance in violation of this section, act to seize any chemical substance, processed, distributed in commerce, or used in violation of this section or take other actions under the authority of section 7 or 17 of the Act (15 U.S.C. 2605 or 2616).
[49 FR 2772, Jan. 23, 1984]