§ 700.43 - Definitions applicable to this subpart.

§ 700.43 Definitions applicable to this subpart.

Cross Reference

Link to an amendment published at 89 FR 12974, Feb. 21, 2024.

Definitions in section 3 of the Act (15 U.S.C. 2602), as well as definitions contained in §§ 704.3, 720.3, 723.175(b), 725.3, and 790.3 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).

Consortium means an association of manufacturers and/or processors who have made an agreement to jointly split the cost of applicable fees.

Enforceable consent agreement means a consent agreement used by EPA to accomplish testing where a consensus exists among EPA and interested parties (as identified in § 790.22(b)(2)) concerning the need for and scope of testing under section 4 of the Act.

EPA-initiated risk evaluation means any risk evaluation conducted pursuant to section 6(b)(4)(C)(i) 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.

Joint submitters mean two or more persons who submit a TSCA section 5 notice together.

Manufacturer-requested risk evaluation means any chemical substance risk evaluation conducted at the request of one or more manufacturers of that chemical substance pursuant to section 6(b)(4)(C)(ii) of the Act.

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 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.

Principal sponsor means a person who assumes primary responsibility for the direction of study, the payment of fees to EPA, and for oral and written communication with EPA.

Production volume means manufactured (including imported) amount in pounds.

Risk evaluation means any risk evaluation conducted pursuant to section 6(b) of the Act.

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 or SNUN 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 a manufacturer or processor who meets the size standards identified in the following table. The number of employees indicates the maximum allowed for a manufacturer or processor to be considered small. If the North American Industry Classification System (NAICS) code of a manufacturer or processor is not represented in the table, it will be considered small if it has 500 or fewer employees. When calculating the number of employees, a manufacturer or processor must include the employees of all of its “parent companies” (if any) and all companies it “owns or controls,” as defined by 40 CFR 704.3. The number of employees are calculated as the average number of people employed for each pay period of the business' latest 12 calendar months, regardless of hours worked or temporary status.

Potentially affected NAICS	NAICS description	Small business concern size standards (number of employees)
324110	Petroleum Refineries	1,500 or fewer.
325110	Petrochemical Manufacturing	1,000 or fewer.
325120	Industrial Gas Manufacturing	1,000 or fewer.
325130	Synthetic Dye and Pigment Manufacturing	1,000 or fewer.
325180	Other Basic Inorganic Chemical Manufacturing	1,000 or fewer.
325193	Ethyl Alcohol Manufacturing	1,000 or fewer.
325194	Cyclic Crude, Intermediate, and Gum and Wood Chemical Manufacturing	1,250 or fewer.
325199	All Other Basic Organic Chemical Manufacturing	1,250 or fewer.
325211	Plastics Material and Resin Manufacturing	1,250 or fewer.
325212	Synthetic Rubber Manufacturing	1,000 or fewer.
325220	Artificial and Synthetic Fibers and Filaments Manufacturing	1,000 or fewer.
325311	Nitrogenous Fertilizer Manufacturing	1,000 or fewer.
325312	Phosphatic Fertilizer Manufacturing	750 or fewer.
325314	Fertilizer (Mixing Only) Manufacturing	500 or fewer.
325320	Pesticide and Other Agricultural Chemical Manufacturing	1,000 or fewer.
325411	Medicinal and Botanical Manufacturing	1,000 or fewer.
325412	Pharmaceutical Preparation Manufacturing	1,250 or fewer.
325413	InVitro Diagnostic Substance Manufacturing	1,250 or fewer.
325414	Biological Product (except Diagnostic) Manufacturing	1,250 or fewer.
325510	Paint and Coating Manufacturing	1,000 or fewer.
325520	Adhesive Manufacturing	500 or fewer.
325611	Soap and Other Detergent Manufacturing	1,000 or fewer.
325612	Polish and Other Sanitation Good Manufacturing	750 or fewer.
325613	Surface Active Agent Manufacturing	750 or fewer.
325620	Toilet Preparation Manufacturing	1,250 or fewer.
325910	Printing Ink Manufacturing	500 or fewer.
325920	Explosives Manufacturing	750 or fewer.
325991	Custom Compounding of Purchased Resins	500 or fewer.
325992	Photographic Film, Paper, Plate and Chemical Manufacturing	1,500 or fewer.
325998	All Other Miscellaneous Chemical Product and Preparation Manufacturing	500 or fewer.
424690	Other Chemical and Allied Products Merchant Wholesalers	150 or fewer.
424710	Petroleum Bulk Stations and Terminals	200 or fewer.
424720	Petroleum and Petroleum Products Merchant Wholesalers (except Bulk Stations and Terminals)	200 or fewer.

Small quantities solely for research and development (or “small quantities solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including such research or analysis for the development of a product”) means quantities of a chemical substance manufactured (including imported), or processed or proposed to be manufactured (including imported), or processed solely for research and development that are not greater than reasonably necessary for such purposes.

Test order means an order to develop information pursuant to section 4(a) of the Act.

Test rule refers to a regulation requiring the development of information pursuant to section 4(a) of the Act.

[53 FR 31252, Aug. 17, 1988, as amended at 62 FR 17931, Apr. 11, 1997; 83 FR 52713, Oct. 17, 2018; 89 FR 12974, Feb. 21, 2024]