(a)(1) Any person who intends to manufacture a new chemical substance in the United States for commercial purposes must submit a notice unless the substance is excluded under § 720.30.

(2) If a person contracts with a manufacturer to manufacture or produce a new chemical substance, and (i) the manufacturer manufactures or produces the substance exclusively for that person, and (ii) that person specifies the identity of the substance, and controls the total amount produced and the basic technology for the plant process, that person must submit the notice. If it is unclear who must report, EPA should be contacted to determine who must submit the notice.

(3) Only manufacturers that are incorporated, licensed, or doing business in the United States may submit a notice.

(b)(1) Any person who intends to import a new chemical substance into the United States for commercial purposes must submit a notice, unless the substance is excluded under § 720.30 or unless the substance is imported as part of an article.

(2) When several persons are involved in an import transaction, the notice must be submitted by the principal importer. 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.

(a) A new chemical substance is any chemical substance that is not currently listed on the Inventory.

(b)(1) A chemical substance is listed in the public portion of the Inventory by a specific chemical name (either a Chemical Abstracts (CA) Index Name or a CA Preferred Name) and a Chemical Abstracts Service (CAS) Registry Number if its identity is not confidential. If its identity is confidential, it is listed in the public portion of the Inventory by a TSCA Accession Number and a generic chemical name that masks the specific substance identity. The confidential substance is listed by its specific chemical name only in the confidential portion of the Inventory, which is not available to the public. A person who intends to manufacture (including import) a chemical substance not listed by specific chemical name in the public portion of the Inventory may ask EPA whether the substance is included in the confidential Inventory. EPA will answer such an inquiry only if EPA determines that the person has a bona fide intent to manufacture (including import) the chemical substance for commercial purposes.

(2) To establish a bona fide intent to manufacture (including import) a chemical substance, the person who proposes to manufacture the substance must submit the request to EPA via CDX. Prior to submission to EPA via CDX, such bona fide intents to manufacture (including import) must be generated and completed using e-PMN software. See § 720.40(a)(2)(ii) for information on how to access the e-PMN software. A bona fide intent to manufacture (including import) must contain:

(i) Except as provided in paragraphs (b)(3)(i) and (ii) of this section, the specific chemical identity of the substance that the person intends to manufacture (including import), using the currently correct CA Index name for the substance and the other correct chemical identity information in accordance with § 720.45(a) (1), (2), and (3).

(ii) A signed statement that the person intends to manufacture (including import) that chemical substance for commercial purposes.

(iii)(A) A brief description of the research and development activities conducted to date related to the substance, including the year in which the person first started to conduct research or development activity on the substance, and the general types of research and development activities conducted thus far (e.g., synthesis, substance isolation/purification, formulating, product development, process development, end-use application, toxicity testing, etc.). The person must also indicate whether any pilot plant or production-scale plant evaluations have been conducted involving the manufacture or processing of the substance.

(B) If an importer is unable to provide the information requested in paragraph (b)(2)(iii)(A) of this section from the foreign manufacturer or supplier, the following information shall be submitted:

(1) A brief statement indicating how long the substance has been in commercial use outside of the United States.

(2) The name of a country in which it has been commercially used.

(3) Whether the importer believes that the substance has already been used commercially, in any country, for the same purpose or application that the importer is intending.

(iv) A specific description of the major intended application or use of the substance.

(v) An infrared spectrum of the substance, or alternative spectra or other data which identify the substance if infrared analysis is not suitable for the substance or does not yield a reasonable amount of structural information. When using alternative spectra or instrumental analysis, the person must submit a spectrum or instrumental readout for the substance.

(vi) The estimated date (month/year) in which the person intends to submit a Premanufacture Notice (PMN) for this substance if EPA informs the notice submitter that the substance is not on the Inventory.

(vii) The address of the facility under the control of the submitter at which the manufacture or processing of the substance would most likely occur. For an imported substance, the facility under the control of the importer at which processing of the substance would likely occur, if any.

(viii)(A) For substances intended to be manufactured in the United States, a description of the most probable manufacturing process that would be used by the submitter to produce the substance for non-exempt commercial purposes.

(B) For substances intended to be imported, a brief description of how the submitter is most likely to process or use the substance for a commercial purpose. If the substance is not expected to be processed or used at any facility under the importer's control, a statement to this effect must be included along with a description of how the substance will be processed or used at sites controlled by others, if this information is known or reasonably ascertainable.

(3)(i) If an importer cannot provide the chemical identity information required by paragraph (b)(2) (i) and (v) of this section because it is claimed confidential by its foreign manufacturer or supplier, the foreign manufacturer or supplier must supply the required information directly to EPA in accordance with § 720.45(a) (1), (2), and (3) and reference the importer's notice. If the appropriate supporting document from the foreign party is not received within 30 days after EPA receives the importer's notice, the notice will be considered incomplete.

(ii) If a manufacturer cannot provide all of the required information in accordance with § 720.45(a) (1), (2), and (3) because the new chemical substance is manufactured using a reactant that has a specific chemical identity claimed as confidential by its supplier, the notice must contain chemical identity information that is as complete as known by the manufacturer. In addition, a letter of support for the notice must then be sent to EPA by the chemical supplier of the confidential reactant, providing the specific chemical identity of the proprietary reactant. The letter of support must reference the manufacturer's notice. If the appropriate supporting document from the supplier is not received within 30 days after EPA receives the manufacturer's notice, the notice will be considered incomplete.

(4) EPA will review the information submitted by the proposed manufacturer (including importer) under this paragraph to determine whether it has a bona fide intent to manufacture (including import) the chemical substance. If necessary, EPA will compare this information to the information requested for the confidential chemical substance under § 720.85(b)(3)(iii).

(5) If the proposed manufacturer (including importer) has shown a bona fide intent to manufacture (including import) the substance, and has provided sufficient unambiguous chemical identity information so EPA can make a conclusive determination of the chemical substance's Inventory status, EPA will search the confidential Inventory and inform the proposed manufacturer (including importer) whether the chemical substance is on the confidential Inventory.

(6) If the chemical substance is found on the confidential Inventory, EPA will notify the person(s) who originally reported the chemical substance that another person has demonstrated a bona fide intent to manufacture (including import) the substance and therefore was told that the chemical substance is on the Inventory.

(7) A disclosure of a confidential chemical identity to a person with a bona fide intent to manufacture (including import) the particular chemical substance will not be considered a public disclosure of confidential business information under section 14 of the Act.

(8) EPA will answer an inquiry on whether a particular chemical substance is on the confidential Inventory within 30 days after receipt of a complete submission under paragraph (b)(2) of this section.

(9) If the required chemical identity information has not been reported correctly or completely in the notice (except as provided under paragraph (b)(3)(ii) of this section) or if any other required data or information has been omitted or is incomplete, EPA will consider the whole notice to be incomplete. As soon as an incomplete notice is identified as such by EPA, the Agency will immediately return the notice directly to the submitter. The submitter must then resubmit the whole, completed bona fide notice to EPA in order to have the Agency perform the desired Inventory search and respond to the notice.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 60 FR 16309, Mar. 29, 1995; 80 FR 42745, July 20, 2015]

The following substances are not subject to the notification requirements of this part:

(a) Any substance which is not a “chemical substance” as defined in § 720.3(e).

(b) Any mixture as defined in § 720.3(u). 1

1 A new chemical substance that is manufactured as part of a mixture is subject to the requirements of this part. This exclusion applies only to a mixture as a whole and not to any chemical substances which are part of the mixture.

(c) Any new chemical substance which will be manufactured in small quantities solely for research and development under § 720.36.

(d) Any new chemical substance which will be manufactured solely for test-marketing purposes under an exemption granted under § 720.38.

(e) Any new chemical substance manufactured solely for export if, when the substance is distributed in commerce:

(1) The substance is labeled in accordance with section 12(a)(1)(B) of the Act.

(2) The manufacturer knows that the person to whom the substance is being distributed intends to export it or process it solely for export as defined in § 721.3 of this chapter.

(f) Any new chemical substance which is manufactured under the terms of a rule promulgated under section 5(h)(4) of the Act.

(g) Any byproduct if its only commercial purpose is for use by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching soil, or (3) extract component chemical substances from it for commercial purposes. (This exclusion only applies to the byproduct; it does not apply to the component substances extracted from the byproduct.)

(h) The chemical substances described below: (Although they are manufactured for commercial purposes under the Act, they are not manufactured for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they are a part.)

(1) Any impurity.

(2) Any byproduct which is not used for commercial purposes.

(3) Any chemical substance which results from a chemical reaction that occurs incidental to exposure of another chemical substance, mixture, or article to environmental factors such as air, moisture, microbial organisms, or sunlight.

(4) Any chemical substance which results from a chemical reaction that occurs incidental to storage or disposal of another chemical substance, mixture, or article.

(5) Any chemical substance which results from a chemical reaction that occurs upon end use of another chemical substance, mixture, or article such as an adhesive, paint, miscellaneous cleanser or other housekeeping product, fuel additive, water softening and treatment agent, photographic film, battery, match, or safety flare, and which is not itself manufactured for distribution in commerce or for use as an intermediate.

(6) Any chemical substance which results from a chemical reaction that occurs upon use of curable plastic or rubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paints, or any other chemical substance formed during the manufacture of an article destined for the marketplace without further chemical change of the chemical substance except for those chemical changes that occur as described elsewhere in this paragraph.

(7) Any chemical substance which results from a chemical reaction that occurs when (i) a stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, binder, emulsifier, deemulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutralizer, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended, or (ii) a chemical substance, which is intended solely to impart a specific physiochemical characteristic, functions as intended.

(8) Any nonisolated intermediate.

(i) Any chemical substance which is manufactured solely for non-commercial research and development purposes. Non-commercial research and development purposes include scientific experimentation, research, or analysis conducted by academic, government, or independent not-for-profit research organizations (e.g., universities, colleges, teaching hospitals, and research institutes), unless the activity is for eventual commercial purposes.

[48 FR 21742, May 13, 1983, as amended at 51 FR 15101, Apr. 22, 1986; 87 FR 39763, July 5, 2022]

(a) This part does not apply to a chemical substance if the following conditions are met:

(1) The chemical substance is manufactured only in small quantities solely for research and development.

(2) The manufacturer notifies all persons in its employ or to whom it directly distributes the chemical substance, who are engaged in experimentation, research, or analysis on the chemical substance, including the manufacture, processing, use, transport, storage, and disposal of the substance associated with research and development activities, of any risk to health, identified under paragraph (b) of this section, which may be associated with the substance. The notification must be made in accordance with paragraph (c) of this section.

(3) The chemical substance is used by, or directly under the supervision of, a technically qualified individual.

(b)(1) To determine whether notification under paragraph (a)(2) of this section is required, the manufacturer must review and evaluate the following information to determine whether there is reason to believe there is any potential risk to health which may be associated with the chemical substance:

(i) Information in its possession or control concerning any significant adverse reaction by persons exposed to the chemical substance which may reasonably be associated with such exposure.

(ii) Information provided to the manufacturer by a supplier or any other person concerning a health risk believed to be associated with the substance.

(iii) Health and environmental effects data in its possession or control concerning the substance.

(iv) Information on health effects which accompanies any EPA rule or order issued under sections 4, 5, or 6 of the Act that applies to the substance and of which the manufacturer has knowledge.

(2) When the research and development activity is conducted solely in a laboratory and exposure to the chemical substance is controlled through the implementation of prudent laboratory practices for handling chemical substances of unknown toxicity, and any distribution, except for purposes of disposal, is to other such laboratories for further research and development activity, the information specified in paragraph (b)(1) of this section need not be reviewed and evaluated. (For purposes of this paragraph, a laboratory is a contained research facility where relatively small quantities of chemical substances are used on a non-production basis, and where activities involve the use of containers for reactions, transfers, and other handling of substances designed to be easily manipulated by a single individual.)

(c)(1) The manufacturer must notify the persons identified in paragraph (a)(2) of this section by means of a container labeling system, conspicuous placement of notices in areas where exposure may occur, written notification to each person potentially exposed, or any other method of notification which adequately informs persons of health risks which the manufacturer has reason to believe may be associated with the substance, as determined under paragraph (b)(1) of this section.

(2) If the manufacturer distributes a chemical substance manufactured under this section to persons not in its employ, the manufacturer must in written form:

(i) Notify those persons that the substance is to be used only for research and development purposes.

(ii) Provide the notice of health risks specified in paragraph (c)(1) of this section.

(3) The adequacy of any notification under this section is the responsibility of the manufacturer.

(d) A chemical substance is not exempt from reporting under this part if any amount of the substance, including as part of a mixture, is processed, distributed in commerce, or used, for any commercial purpose other than research and development, except where the chemical substance is processed, distributed in commerce, or used only as an impurity or as part of an article.

(e) Quantities of the chemical substance, or of mixtures or articles containing the chemical substance, remaining after completion of research and development activities may be:

(1) Disposed of as a waste in accordance with applicable Federal, state, and local regulations, or

(2) Used for the following commercial purposes:

(i) Burning it as a fuel.

(ii) Reacting or otherwise processing it to form other chemical substances for commercial purposes, including extracting component chemical substances.

(f) Quantities of research and development substances existing solely as impurities in a product or incorporated into an article, in accordance with paragraph (d) of this section, and quantities of research and development substances used solely for commercial purposes listed in paragraph (e) of this section, are not subject to the requirements of paragraphs (a), (b), and (c) of this section, once research and development activities have been completed.

(g) A person who manufactures a chemical substance in small quantities solely for research and development is not required to comply with the requirements of this section if the person's exclusive intention is to perform research and development activities solely for the purpose of determining whether the substance can be used as a pesticide.

[51 FR 15102, Apr. 22, 1986, as amended at 87 FR 39763, July 5, 2022]

(a) Any person may apply for an exemption to manufacture a new chemical substance for test marketing. EPA may grant the exemption if the person demonstrates that the chemical substance will not present an unreasonable risk to injury to health or the environment as a result of the test marketing.

(b) Persons applying for a test-marketing exemption should provide the following information:

(1) All existing data regarding health and environmental effects of the chemical substance, including physical/chemical properties or, in the absence of such data, a discussion of toxicity based on structure-activity relationships (SAR) and relevant data on chemical analogues.

(2) The maximum quantity of the chemical substance which the applicant will manufacture for test marketing.

(3) The maximum number of persons who may be provided the chemical substance during test marketing.

(4) The maximum number of persons who may be exposed to the chemical substance as a result of test marketing, including information regarding duration and route of such exposures.

(5) A description of the test-marketing activity, including its length and how it can be distinguished from full-scale commercial production and research and development.

(6) A fee payment identity number, as required in 40 CFR 700.45(g)(4).

(7) Any safety data sheet already developed for the chemical substance, including draft safety data sheets.

(c) In accordance with section 5(h)(6) of the Act, after EPA receives an application for exemption under this section, the Agency will file with the Office of the Federal Register a notice containing a summary of the information provided in the application, to the extent it has not been claimed confidential.

(d) No later than 45 days after EPA receives an application, the Agency will either approve or deny the application. Thereafter, EPA will publish a notice in the Federal Register explaining the reasons for approval or denial.

(e) In approving an application for exemption, EPA may impose any restrictions necessary to ensure that the substance will not present an unreasonable risk of injury to health and the environment as a result of test marketing.

(f) When applying for a test marketing exemption, persons are subject to fees in accordance with 40 CFR 700.45.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 83 FR 52719, Oct. 17, 2018; 87 FR 39763, July 5, 2022]