['Toxic Substances Control Act - EPA']
['Toxic Substances - EPA', 'Toxic Subtances Control Act - EPA']
08/29/2024
Copyright 2024 J. J. Keller & Associate, Inc. For re-use options please contact copyright@jjkeller.com or call 800-558-5011.
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Anyone who intends to manufacture (including import) a “new chemical substance” for a non-exempt commercial purpose is required to submit a pre-manufacture notice (PMN) at least 90 days prior to the manufacture of the chemical. If a chemical is on the Toxic Substances Control Act (TSCA) Inventory, the substance is considered an “existing” chemical substance in U.S. commerce. Therefore, any chemical that is not on the Inventory is considered a new chemical substance.
After EPA risk assessors consider all of the submitted information during the EPA new chemicals review process, the agency makes a final determination whether to allow the chemical to enter into commerce and whether to set restrictions for entering into commerce. This process ensures that new chemicals that enter into commerce do not present an unreasonable risk to human health or the environment.
Note: This ezExpanation does not cover reporting requirements for microorganisms per 40 CFR 725.
Scope
Mandated by Section 5 of TSCA, the following persons must submit a premanufacture notification unless the substance is excluded under 720.30:
- Any person who intends to manufacture a new chemical substance in the U.S. for commercial purposes (only manufacturers that are incorporated, licensed, or doing business in the U.S. may submit a notice);
- Any person that contracts with a manufacturer to manufacture or produce a new chemical substance, and:
- The manufacturer manufactures or produces the substance exclusively for that person, and
- The person specifies the identity of the substance and controls the total amount produced and the basic technology for the plant process;
- Any person who intends to import a new chemical substance into the U.S. for commercial purposes, unless the substance is imported as part of an article.
Notes: If it is unclear who must report, EPA should be contacted to determine who must submit the notice. When several persons are involved in an import transaction, the notice must be submitted by the principal importer, but if no one person fits the principal importer definition in a particular transaction, the importer should contact EPA to determine who must submit the notice for that transaction.
Regulatory citations
- 40 CFR 720 — Premanufacture notification
- 40 CFR 723 — Premanufacture notification exemptions
Key definitions
- Act: The Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
- Article: A manufactured item: (1) Which is formed to a specific shape or design during manufacture; (2) Which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (3) Which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article and that may occur as described in 720.30(h)(5), except that fluids and particles are not considered articles regardless of shape or design.
- Byproduct: A chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture.
- Central Data Exchange or CDX: EPA’s centralized electronic document receiving system, or its successors.
- Chemical substance: Any organic or inorganic substance of a particular molecular identity, including any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any chemical element or uncombined radical, except that “chemical substance” does not include: (1) Any mixture. (2) Any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide. (3) Tobacco or any tobacco product. (4) Any source material, special nuclear material, or byproduct material. (5) Any pistol, firearm, revolver, shells, or cartridges. (6) Any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.
- Commerce: Trade, traffic, transportation, or other commerce (1) between a place in a State and any place outside of such State, or (2) which affects trade, traffic, transportation, or commerce between a place in a State and any place outside of such State.
- Customs territory of the United States: The 50 States, Puerto Rico, and the District of Columbia.
- Director: The Director of the EPA Office of Pollution Prevention and Toxics. (i) Distribute in commerce means to sell in commerce, to introduce or deliver for introduction into commerce, or to hold after introduction into commerce.
- Distribute in commerce: To sell in commerce, to introduce or deliver for introduction into commerce, or to hold after introduction into commerce.
- e-PMN software: Electronic-PMN software created by EPA for use in preparing and submitting Premanufacture Notices (PMNs) and other TSCA section 5 notices and support documents electronically to EPA.
- Health and safety study or study: Any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological, or other studies of a chemical substance or mixture, and any test performed under the Act. Chemical identity is always part of a health and safety study. (1) Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical substance or mixture on health or the environment is also included. Any data that bear on the effects of a chemical substance on health or the environment would be included. (2) Examples include: (i) Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; data on behavioral disorders; dermatoxicity; pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; acute, subchronic, and chronic effects; and structure/activity analyses. (ii) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, critical life stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem (microcosm) studies. (iii) Assessments of human and environmental exposure, including workplace exposure, and impacts of a particular chemical substance or mixture on the environment, including surveys, tests, and studies of: Biological, photochemical, and chemical degradation; air, water, and soil transport; biomagnification and bioconcentration; and chemical and physical properties, e.g., boiling point, vapor pressure, evaporation rates from soil and water, octanol/water partition coefficient, and water solubility. (iv) Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mixture. (v) Any assessments of risk to health and the environment resulting from the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance.
- Importer: Any person who imports a chemical substance, including a chemical substance as part of a mixture or article, into the customs territory of the United States. “Importer” includes the person primarily liable for the payment of any duties on the merchandise or an authorized agent acting on his or her behalf. The term also includes, as appropriate: (1) The consignee. (2) The importer of record. (3) The actual owner if an actual owner’s declaration and superseding bond has been filed in accordance with 19 CFR 141.20; or (4) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with Subpart C of 19 CFR 144. (See “principal importer.”)
- Impurity: A chemical substance which is unintentionally present with another chemical substance.
- Intermediate: Any chemical substance that is consumed, in whole or in part, in chemical reactions used for the intentional manufacture of another chemical substance(s) or mixture(s), or that is intentionally present for the purpose of altering the rates of such chemical reactions.
- Inventory: The list of chemical substances manufactured or processed in the United States that EPA compiled and keeps current under section 8(b) of the Act.
- Known to or reasonably ascertainable by: All information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.
- Manufacture: To produce or manufacture in the United States or import into the customs territory of the United States.
- Manufacture for commercial purposes: (1) To manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, and includes, among other things, “manufacture” of any amount of a chemical substance or mixture. (2) The term also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Byproducts and impurities without separate commercial value are nonetheless produced for the purpose of obtaining a commercial advantage, since they are part of the manufacture of a chemical substance for commercial purposes.
- Manufacture solely for export: To manufacture for commercial purposes a chemical substance solely for export from the United States under the following restrictions on activities in the United States: (1) Distribution in commerce is limited to purposes of export or processing solely for export as defined in 721.3. (2) The manufacturer and any person to whom the substance is distributed for purposes of export or processing solely for export (as defined in 721.3), may not use the substance except in small quantities solely for research and development in accordance with 720.36.
- Manufacturer: A person who imports, produces, or manufactures a chemical substance. A person who extracts a component chemical substance from a previously existing chemical substance or a complex combination of substances is a manufacturer of that component chemical substance. A person who contracts with a manufacturer to manufacture or produce a chemical substance is also a manufacturer if (1) the manufacturer manufactures or produces the substance exclusively for that person, and (2) that person specifies the identity of the substance and controls the total amount produced and the basic technology for the plant process.
- Mixture: Any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except “mixture” does include (1) any combination which occurs, in whole or in part, as a result of a chemical reaction if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined, and if all of the chemical substances comprising the combination are not new chemical substances, and (2) hydrates of a chemical substance or hydrated ions formed by association of a chemical substance with water, so long as the nonhydrated form is itself not a new chemical substance.
- New chemical substance: Any chemical substance which is not included on the Inventory.
- Nonisolated intermediate: Any intermediate that is not intentionally removed from the equipment in which it is manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the chemical substance passes during a continuous flow process, but not including tanks or other vessels in which the substance is stored after its manufacture.
- Person: Any natural person, firm, company, corporation, joint-venture, partnership, sole proprietorship, association, or any other business entity, any State or political subdivision thereof, any municipality, any interstate body, and any department, agency or instrumentality of the Federal Government.
- Pesticide: As defined in the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq. and the regulations issued under it.
- Possession or control: In possession or control of the submitter, or of any subsidiary, partnership in which the submitter is a general partner, parent company, or any company or partnership which the parent company owns or controls, if the subsidiary, parent company, or other company or partnership is associated with the submitter in the research, development, test marketing, or commercial marketing of the chemical substance in question. (A parent company owns or controls another company if the parent owns or controls 50 percent or more of the other company’s voting stock. A parent company owns or controls any partnership in which it is a general partner). Information is included within this definition if it is: (1) In files maintained by submitter’s employees who are: (i) Associated with research, development, test marketing, or commercial marketing of the chemical substance in question. (ii) Reasonably likely to have such data. (2) Maintained in the files of other agents of the submitter who are associated with research, development, test marketing, or commercial marketing of the chemical substance in question in the course of their employment as such agents.
- Principal importer: The first importer who, knowing that a new chemical substance will be imported rather than manufactured domestically, specifies the identity of the chemical substance and the total amount to be imported. Only persons who are incorporated, licensed, or doing business in the United States may be principal importers.
- Process: The preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce (1) in the same form or physical state as, or in a different form or physical state from, that in which it was received by the person so preparing such substance or mixture, or (2) as part of a mixture or article containing the chemical substance or mixture.
- Processor: Any person who processes a chemical substance or mixture.
- 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”): Quantities of a chemical substance manufactured or processed or proposed to be manufactured or processed solely for research and development that are not greater than reasonably necessary for such purposes.
- State: Any State of the United States and the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana Islands, and any other territory or possession of the United States.
- Support documents: Material and information submitted to EPA in support of a TSCA section 5 notice, including but not limited to, correspondence, amendments (if notices for these amendments were submitted prior to January 19, 2016), and test data. The term “support documents” does not include orders under TSCA section 5(e) (either consent orders or orders imposed pursuant to TSCA section 5(e)(2)(B)).
- Technically qualified individual: A person or persons (1) who, because of education, training, or experience, or a combination of these factors, is capable of understanding the health and environmental risks associated with the chemical substance which is used under his or her supervision, (2) who is responsible for enforcing appropriate methods of conducting scientific experimentation, analysis, or chemical research to minimize such risks, and (3) who is responsible for the safety assessments and clearances related to the procurement, storage, use, and disposal of the chemical substance as may be appropriate or required within the scope of conducting a research and development activity.
- Test data: Data from a formal or informal test or experiment, including information concerning the objectives, experimental methods and materials, protocols, results, data analyses, recorded observations, monitoring data, measurements, and conclusions from a test or experiment.
- Test marketing: The distribution in commerce of no more than a predetermined amount of a chemical substance, mixture, or article containing that chemical substance or mixture, by a manufacturer or processor, to no more than a defined number of potential customers to explore market capability in a competitive situation during a predetermined testing period prior to the broader distribution of that chemical substance, mixture, or article in commerce.
- United States: When used in the geographic sense, means all of the States.
Summary of requirements
A summary of requirements includes the following:
- Submit a PMN to EPA if you intend to manufacture a new chemical substance for a commercial purpose, unless the substance is excluded under 720.30. (However, submit an exemption notice instead for low-volumes, low releases, low exposures, and test marketing, if applicable.)
- Submit a PMN if you intend to import a new chemical substance into the U.S. for commercial purposes, unless the substance is excluded under 720.30 or unless the substance is imported as part of an article.
- Make PMN submissions on EPA Form 7710-25 using the electronic PMN software (e-PMN). The e-PMN software enables manufacturers (including importers) of TSCA chemical substances to use the Internet, through EPA’s Central Data Exchange (CDX), to submit TSCA section 5 notices to the agency.
- Follow 40 CFR 703 and 720 Subpart E when making confidential business information (CBI) claims. All CBI claims must be substantiated at the time the information is claimed confidential, unless exempt.
- Have a third party provide a letter of support to EPA with the chemical identity information for any confidential substance that is withheld from you as a PMN submitter. Also have an agreement with your third-party supplier to ensure that you are informed of any changes in composition that can change the chemical identity of the confidential substance.
- If EPA determines that a chemical substance is “not likely to present an unreasonable risk,” then you may commence manufacture (or import) of the substance.
- If you commence the manufacture (or import) of a new chemical substance, then electronically submit a Notice of Commencement of Manufacture or Import Form (EPA Form 7710-56 generated and completed using e-PMN software) to EPA via CDX. This must be submitted within 30 calendar days of the date the substance is first manufactured or imported for nonexempt commercial purposes. Be sure to assert and substantiate any CBI claims via EPA Form 7710-56, in accordance with 40 CFR 703 and 720.102.
In addition, it is a good idea to consider the following:
- Review 40 CFR 720, 40 CFR 723, and EPA’s “Instruction Manual for Reporting under TSCA section 5 New Chemicals Program.”
- Look closely at the exclusions and exemptions listed at 40 CFR 720.30 and 723.
- Check if the chemical substance is on the public TSCA Inventory.
- Submit a Bona Fide Intent to Manufacture or Import Notice if a substance you intend to manufacture or import is not on the published Inventory but you think it may be in commerce based on a confidential Inventory listing. See 40 CFR 720.25. The e-PMN software enables manufacturers (including importers) of TSCA chemical substances to use the Internet, through EPA’s CDX, to submit TSCA section 5 notices to the agency, including the bona fide notice.
- Set up a “pre-notice consultation” with EPA to discuss any upcoming new chemical submission.
- Get pre-approval before a PMN is submitted in order to consolidate PMN submissions of up to six closely similar substances. Consolidation lowers your fee.
- If EPA identifies risks in the “initial risk assessment” stage or “regulatory decision/action development” stage, you may elect to provide clarifying information to EPA and/or to amend your PMN.
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['Toxic Substances Control Act - EPA']
['Toxic Substances - EPA', 'Toxic Subtances Control Act - EPA']
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Copyright 2024 J. J. Keller & Associate, Inc. For re-use options please contact copyright@jjkeller.com or call 800-558-5011.