79.21—Information and assurances to be provided by the additive manufacturer.
Each application for registration submitted by the manufacturer of a designated fuel additive shall include the following:
(1)
If the chemical composition is not known, full disclosure of the chemical process of manufacture will be accepted in lieu thereof;
(2)
In the case of an additive for engine oil, only the name, percentage by weight, and method of analysis of each element in the additive are required provided, however, that a percentage figure combining the percentages of carbon, hydrogen, and/or oxygen may be provided unless the breakdown into percentages for these individual elements is already known to the registrant.
(3)
In the case of a purchased component, only the name, manufacturer, and percent by weight of such purchased component are required if the manufacturer of the component will, upon request, furnish the Administrator with the chemical composition thereof.
(b)
The chemical structure of each compound in the additive if such structure is known and is not adequately specified by the name given under “chemical composition.” Nominal identification is adequate if mixed isomers are present.
(c)
The description (or identification, in the case of a generally accepted method) of a suitable analytical technique (if one is known) that can be used to detect the presence of the additive in any fuel named in the designation and/or to measure its concentration therein.
(d)
The specific types of fuels designated under § 79.32 for which the fuel additive will be sold, offered for sale, or introduced into commerce, and the fuel additive manufacturer's recommended range of concentration and purpose-in-use for each such type of fuel.
(e)
Such other data and information as are specified in the designation of the additive in subpart D.
(f)
Assurances that any change in information submitted pursuant to (1) paragraphs (a), (b), (c), and (d) of this section will be provided to the Administrator in writing within 30 days of such change; and (2) paragraph (e) of this section as provided in § 79.5(b).
(g)
Assurances that the additive manufacturer will not represent, directly or indirectly, in any notice, circular, letter, or other written communication or any written, oral, or pictorial notice or other announcement in any publication or by radio or television, that registration of the additive constitutes endorsement, certification, or approval by any agency of the United States.
(h)
The manufacturer of any fuel additive which will be sold, offered for sale, or introduced into commerce for use in any type of fuel intended for use in motor vehicles manufactured after model year 1974 shall demonstrate that the fuel additive, when used at the recommended range of concentration, is substantially similar to any fuel additive included in a fuel utilized in the certification of any 1975 or subsequent model year vehicle or engine, or that the manufacturer has obtained a waiver under 42 U.S.C. 7545(f)(4).
(i)
The manufacturer shall submit, or shall reference prior submissions, including all of the test data and other information required prior to registration of the fuel additive by the provisions of subpart F of this part.