{"data":{"id":"us/40-cfr-700.43","jurisdiction":"us","citation":"40 CFR 700.43","heading":"Definitions applicable to this subpart.","body":"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:\nConsolidated 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.\nConsolidated 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).\nConsortium means an association of manufacturers and/or processors who have made an agreement to jointly split the cost of applicable fees.\nEnforceable 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.\nEPA-initiated risk evaluation means any risk evaluation conducted pursuant to section 6(b)(4)(C)(i) of the Act.\nExemption notice means any notice submitted to EPA under § 723.175 of this chapter.\nFinal 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.\nJoint submitters mean two or more persons who submit a TSCA section 5 notice together.\nManufacturer-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.\nMicrobial 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.\nPerson means a manufacturer or processor.\nPremanufacture 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.\nPrincipal 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.\nProduction volume means manufactured (including imported) amount in pounds.\nRisk evaluation means any risk evaluation conducted pursuant to section 6(b) of the Act.\nSection 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.\nSignificant 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.\nSmall 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.\nPotentially affected NAICS NAICS description Small business concern size standards (number of employees)\n324110 Petroleum Refineries 1,500 or fewer.\n325110 Petrochemical Manufacturing 1,000 or fewer.\n325120 Industrial Gas Manufacturing 1,000 or fewer.\n325130 Synthetic Dye and Pigment Manufacturing 1,000 or fewer.\n325180 Other Basic Inorganic Chemical Manufacturing 1,000 or fewer.\n325193 Ethyl Alcohol Manufacturing 1,000 or fewer.\n325194 Cyclic Crude, Intermediate, and Gum and Wood Chemical Manufacturing 1,250 or fewer.\n325199 All Other Basic Organic Chemical Manufacturing 1,250 or fewer.\n325211 Plastics Material and Resin Manufacturing 1,250 or fewer.\n325212 Synthetic Rubber Manufacturing 1,000 or fewer.\n325220 Artificial and Synthetic Fibers and Filaments Manufacturing 1,000 or fewer.\n325311 Nitrogenous Fertilizer Manufacturing 1,000 or fewer.\n325312 Phosphatic Fertilizer Manufacturing 750 or fewer.\n325314 Fertilizer (Mixing Only) Manufacturing 500 or fewer.\n325320 Pesticide and Other Agricultural Chemical Manufacturing 1,000 or fewer.\n325411 Medicinal and Botanical Manufacturing 1,000 or fewer.\n325412 Pharmaceutical Preparation Manufacturing 1,250 or fewer.\n325413 InVitro Diagnostic Substance Manufacturing 1,250 or fewer.\n325414 Biological Product (except Diagnostic) Manufacturing 1,250 or fewer.\n325510 Paint and Coating Manufacturing 1,000 or fewer.\n325520 Adhesive Manufacturing 500 or fewer.\n325611 Soap and Other Detergent Manufacturing 1,000 or fewer.\n325612 Polish and Other Sanitation Good Manufacturing 750 or fewer.\n325613 Surface Active Agent Manufacturing 750 or fewer.\n325620 Toilet Preparation Manufacturing 1,250 or fewer.\n325910 Printing Ink Manufacturing 500 or fewer.\n325920 Explosives Manufacturing 750 or fewer.\n325991 Custom Compounding of Purchased Resins 500 or fewer.\n325992 Photographic Film, Paper, Plate and Chemical Manufacturing 1,500 or fewer.\n325998 All Other Miscellaneous Chemical Product and Preparation Manufacturing 500 or fewer.\n424690 Other Chemical and Allied Products Merchant Wholesalers 150 or fewer.\n424710 Petroleum Bulk Stations and Terminals 200 or fewer.\n424720 Petroleum and Petroleum Products Merchant Wholesalers (except Bulk Stations and Terminals) 200 or fewer.\nSmall 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.\nTest order means an order to develop information pursuant to section 4(a) of the Act.\nTest rule refers to a regulation requiring the development of information pursuant to section 4(a) of the Act.","path":["Title 40—Protection of Environment","CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY","SUBCHAPTER R—TOXIC SUBSTANCES CONTROL ACT","PART 700—GENERAL","Subpart C—Fees"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-40.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:26:04Z","sha256":"fa4c681f0f7f88fa11a591cc9d731bc071b14e09d8aea205b6ac2b8dab746d60","source_id":"us-cfr","stale":true,"prev":"us/40-cfr-700.41","next":"us/40-cfr-700.45"},"notice":"GroundRules: Original legal text. Not legal advice."}