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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.
[62 FR 17931, Apr. 11, 1997; 83 FR 52713, Oct. 17, 2018; 89 FR 12974, Feb. 21, 2024]