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§747.200 Triethanolamine salt of tricarboxylic acid.
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 to this section unless otherwise specified in this paragraph. 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]