700.43—Definitions.
Definitions in section 3 of the Act (15 U.S.C. 2602 ), as well as definitions contained in §§ 704.3, 720.3, and 725.3 of this chapter, apply to this subpart unless otherwise specified in this section. In addition, the following definitions apply:
Consolidated microbial commercial activity notice or consolidated MCAN means any MCAN submitted to EPA that covers more than one microorganism (each being assigned a separate MCAN number by EPA) as a result of a prenotice agreement with EPA.
Consolidated premanufacture notice or consolidated PMN means any PMN submitted to EPA that covers more than one chemical substance (each being assigned a separate PMN number by EPA) as a result of a prenotice agreement with EPA (See 48 FR 21734 ).
Exemption application means any application submitted to EPA under section 5(h)(2) of the Act.
Exemption notice means any notice submitted to EPA under § 723.175 of this chapter.
Final product means a new chemical substance (as “new chemical substance” is defined in § 720.3 of this chapter) that is manufactured by a person for distribution in commerce, or for use by the person other than as an intermediate.
Intermediate premanufacture notice or intermediate PMN means any PMN submitted to EPA for a chemical substance which is an intermediate (as “intermediate” is defined in § 720.3 of this chapter) in the production of a final product, provided that the PMN for the intermediate is submitted to EPA at the same time as, and together with, the PMN for the final product and that the PMN for the intermediate identifies the final product and describes the chemical reactions leading from the intermediate to the final product. If PMNs are submitted to EPA at the same time for several intermediates used in the production of a final product, each of those is an intermediate PMN if they all identify the final product and every other associated intermediate PMN and are submitted to EPA at the same time as, and together with, the PMN for the final product.
Joint submitters means two or more persons who submit a section 5 notice together.
Microbial commercial activity notice or MCAN means any notice for microorganisms submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with subpart D of part 725 of this chapter.
Person means a manufacturer, importer, or processor.
Premanufacture notice or PMN means any notice submitted to EPA pursuant to section 5(a)(1)(A) of the Act in accordance with part 720 of this chapter or § 723.250 of this chapter.
Section 5 notice means any PMN, consolidated PMN, intermediate PMN, significant new use notice, exemption notice, exemption application, any MCAN or consolidated MCAN submitted under section 5 of the Act.
Significant new use notice means any notice submitted to EPA pursuant to section 5(a)(1)(B) of the Act in accordance with part 721 of this chapter.
Small business concern means any person whose total annual sales in the person's fiscal year preceding the date of the submission of the applicable section 5 notice, when combined with those of the parent company (if any), are less than $40 million.