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United States Regulations
40 CFR PART 720—PREMANUFACTURE NOTIFICATION
PART 720—PREMANUFACTURE NOTIFICATION
Authority: 15 U.S.C. 2604, 2607, and 2613.
Source: 48 FR 21742, May 13, 1983, unless otherwise noted.
Subpart A—General Provisions
§ 720.1 Scope.
This part establishes procedures for the reporting of new chemical substances by manufacturers and importers under section 5 of the Toxic Substances Control Act, 15 U.S.C. 2604. This part applies to microorganisms only to the extent provided by part 725 of this chapter. The rule defines the persons and chemical substances subject to the reporting requirements, prescribes the contents of section 5 notices, and establishes procedures for submitting notices. The rule also establishes EPA policy regarding claims of confidentiality for, and public disclosure of, various categories of information submitted in connection with section 5 notices.
[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 62 FR 17932, April 11, 1997]
§ 720.3 Definitions.
(a)(1) For the purposes of this part, the terms cosmetic, device, drug, food, and food additive have the meanings contained in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., and the regulations issued under it. In addition, the term “food” includes poultry and poultry products, as defined in the Poultry Products Inspection Act, 21 U.S.C. 453 et seq.; meats and meat food products, as defined in the Federal Meat Inspection Act, 21 U.S.C. 60 et seq.; and eggs and egg products, as defined in the Egg Products Inspection Act, 21 U.S.C. 1033 et seq.
(2) The term pesticide has the meaning contained in the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq. and the regulations issued under it.
(3) The terms byproduct material, source material, and special nuclear material have the meanings contained in the Atomic Energy Act of 1954, 42 U.S.C 2014 et seq. and the regulations issued under it.
(b) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
(c) Article means 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 §720.36(g)(5), except that fluids and particles are not considered articles regardless of shape or design.
(d) Byproduct means a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture.
(e) Chemical substance means 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.
(f) Commerce means 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.
(g) Customs territory of the United States means the 50 States, Puerto Rico, and the District of Columbia.
(h) Director means 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.
(j) EPA means the U.S. Environmental Protection Agency.
(k) Health and safety study or study means 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.
(l) Importer means 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 part 144. (See “principal importer.”)
(m) Impurity means a chemical substance which is unintentionally present with another chemical substance.
(n) Intermediate means 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.
(o) Inventory means 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.
(p) Known to or reasonably ascertainable by means 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.
(q) Manufacture means to produce or manufacture in the United States or import into the customs territory of the United States.
(r) Manufacture or import for commercial purposes means:
(1) To import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer or importer, and includes, among other things, “manufacture” of any amount of a chemical substance or mixture:
(i) For commercial distribution, including for test marketing.
(ii) For use by the manufacturer, including use for product research and development or as an intermediate.
(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.
(s) Manufacture solely for export means to manufacture or import 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 of this chapter.
(2) The manufacturer or importer, and any person to whom the substance is distributed for purposes of export or processing solely for export (as defined in §721.3 of this chapter), may not use the substance except in small quantities solely for research and development in accordance with §720.36.
(t) Manufacturer means 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.
(u) Mixture means 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.
(v) New chemical substance means any chemical substance which is not included on the Inventory.
(w) Nonisolated intermediate means 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.
(x) Person means 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.
(y) Possession or control means 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.
(z) Principal importer means 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.
(aa) Process means 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.
(bb) Processor means any person who processes a chemical substance or mixture.
(cc) 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, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development that are not greater than reasonably necessary for such purposes.
(dd) State means 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.
(ee) Technically qualified individual means 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.
(ff) Test data means 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.
(gg) Test marketing means 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.
(hh) United States, when used in the geographic sense, means all of the States.
[48 FR 21742, May 13, 1983, as amended at 51 FR 15101, Apr. 22, 1986]
§ 720.22 Persons who must report.
(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.
§ 720.25 Determining whether a chemical substance is on the Inventory.
(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 or 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 or import the chemical substance for commercial purposes.
(2) To establish a bona fide intent to manufacture or import a chemical substance, the person who proposes to manufacture or import the substance must submit to EPA:
(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 or import, using the currently, correct CA 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 or 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 or importer under this paragraph to determine whether it has a bona fide intent to manufacture or import the chemical substance. If necessary, EPA will compare this information either to the information requested for the confidential chemical substance under §710.7(e)(2)(v)ofthischapterorthe information requested under §720.85(b)(3)(iii).
(5) If the proposed manufacturer or importer has shown a bona fide intent to manufacture or import the substance, and provide 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 or 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 or 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 or 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]
§ 720.30 Chemicals not subject to notification requirements.
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 or imported 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 or imported in small quantities solely for research and development under §720.36.
(d) Any new chemical substance which will be manufactured or imported 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 or imported 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 or imported 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 intented, 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]
§ 720.36 Exemption for research and development.
(a) This part does not apply to a chemical substance if the following conditions are met:
(1) The chemical substance is manufactured or imported only in small quantities solely for research and development.
(2) The manufacturer or importer 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 or importer 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 or importer 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 or importer 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 or importer 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 or importer has reason to believe may be associated with the substance, as determined under paragraph (b)(1) of this section.
(2) If the manufacturer or importer distributes a chemical substance manufactured or imported under this section to persons not in its employ, the manufacturer or importer 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 or importer.
(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 or imports 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]
§ 720.38 Exemptions for test marketing.
(a) Any person may apply for an exemption to manufacture or import 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 or import 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.
(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.
[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993]
Subpart C—Notice Form
§ 720.40 General.
(a) Use of the notice form; electronic submissions. (1) Each person who is required by subpart B of this part to submit a notice must complete, sign, and submit a notice containing the information in the form and manner specified in this paragraph. The information submitted and all attachments (unless the attachment appears in the open scientific literature) must be in English. All information submitted must be true and correct.
(2) Information may be submitted on paper, or electronically, as follows:
(i) Information submitted on paper must be submitted in the form and manner set forth in EPA Form No. 7710–25, which is available from the Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Information which is not submitted on the EPA Form No. 7710-25 or a photocopy thereof (e.g., on a form created by commercial form-making software) must be in a format pre-approved by the Agency.
(ii) Information may be submitted electronically (on magnetic or other media) pursuant to an EPA published format for electronic submissions. Such submissions must comply with this format and all other media specifications published by EPA. Persons submitting electronically must still complete and submit on paper the Certification and Submitter Identification sections of Form 7710–25.
(b) When to submit a notice. Each person who is required to submit a notice must submit the notice at least 90 calendar days before manufacture or import of the new chemical substance for commercial purposes begins.
(c) Where to submit a notice. Each person who submits a notice must submit it to the address listed on the notice form.
(d) General notice requirements. (1) Each person who submits a notice must provide the information described in §720.45 and specified on the notice form, to the extent such information is known to or reasonably ascertainable by the person. In accordance with §720.50, the notice must also include any test data in the person's possession or control, and descriptions of other data which are known to or reasonably ascertainable by the person and which concern the health and environmental effects of the new chemical substance.
(2) A person who submits a notice to EPA under this part must provide EPA with an original and two complete copies of the notice, including all test data and any other information attached to the notice form. If information is claimed as confidential pursuant to §720.80, a sanitized copy must also be provided.
(e) Agency or joint submissions. (1) A manufacturer or importer may designate an agent to submit the notice. Both the manufacturer or importer and the agent must sign the certification on the form.
(2) A manufacturer or importer may authorize another person, (e.g., a foreign manufacturer or supplier, or a toll manufacturer) to report some of the information required in the notice to EPA on its behalf. If separate portions of a joint notice are not submitted together, the submitter should indicate which information will be supplied by another person and identify that person. The other person must submit the information on the appropriate part of the notice form. The manufacturer or importer and any other person supplying the information must sign the certification provided on their respective notice forms.
(3) If EPA receives a submission which does not include information required by this rule, which the submitter indicates that it has authorized another person to provide, the notice review period will not begin until EPA receives that information.
(f) New information. During the notice review period, if the submitter possesses, controls, or knows of new information that materially adds to, changes, or otherwise makes significantly more complete the information included in the notice, the submitter must that information to the address listed on the notice form within ten days of receiving the new information, but no later than five days before the end of the notice review period. The new submission must clearly identify the submitter and the notice to which the new information is related. If the new information becomes available during the last five days of the notice review period, the submitter must immediately inform its EPA contract for that notice by telephone.
(g) Chemical substances subject to a section 4 test rule. (1) Except as provided in paragraph (g)(3) of this section, if (i) A person intends to manufacture or import a new chemical substance which is subject to the notification requirements of this part, and (ii) The chemical substance is subject to a test rule promulgated under section 4 of the Act before the notice is submitted, section 5(b)(1) of the Act requires the person to submit the test data required by the testing rule with the notice. The person must submit the data in the form and manner specified in the test rule and in accordance with §720.50. If the person does not submit the test data, the submission is incomplete and EPA will follow the procedures in §720.65.
(2) If EPA has granted the submitter an exemption under section 4(c) of the Act from the requirement to conduct tests and submit data, the submitter may not submit a notice until EPA receives the test data.
(3) If EPA has granted the submitter an exemption under section 4(c) of the Act and if another person previously has submitted the test data to EPA, the exempted person may either submit the test data or provide the following information as part of the notice:
(i) The name, title, and address of the person who submitted the test data to EPA.
(ii) The date the test data were submitted to EPA.
(iii) A citation for the test rule.
(iv) A description of the exemption and a reference identifying it.
(h) Chemical substances subject to a section 5(b)(4) rule. (1) If a person (i) intends to manufacture or import a new chemical substance which is subject to the notification requirements of this part and which is subject to a rule issued under section 5(b)(4) of the Act; and (ii) is not required by a rule issued under section 4 of the Act to submit test data for the substance before the submission of a notice, the person must submit to EPA data described in paragraph (h)(2) of this section at the time the notice is submitted.
(2) Data submitted under paragraph (h)(1) of this section must be data which the person submitting the notice believes show that the manufacture, processing, distribution in commerce, use and disposal of the substance, or any combination of such activities, will not present an unreasonable risk of injury to health or the environment.
[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 60 FR 16309, Mar. 29, 1995]
§ 720.45 Information that must be included in the notice form.
Each person who submits a notice must include the information specified in the notice form to the extent it is known to or reasonably ascertainable by the submitter. However, no person is required to include information which relates solely to exposure of human or ecological populations outside of the United States. The notice form requires the following information relating to the manufacture, processing, distribution in commerce, use, and disposal of the new chemical substance:
(a)(1) The specific chemical identity of the substance that the person intends to manufacture or import, which includes the following:
(i) The currently correct Chemical Abstracts (CA) name for the substance, based on the Ninth Collective Index (9CI) of CA nomenclature rules and conventions, and consistent with listings for similar substances in the Inventory. For each substance having a chemical composition that can be represented by a specific, complete chemical structure diagram (a Class 1 substance), a CA Index Name must be provided. For each chemical substance that cannot be fully represented by a complete, specific chemical structure diagram (a Class 2 substance), or if the substance is a polymer, a CA Index Name or CA Preferred Name must be provided (whichever is appropriate based on CA 9CI nomenclature rules and conventions). In addition, for a Class 2 substance, the notice must identify the immediate chemical precursors and reactants by specific chemical name and Chemical Abstracts Service Registry Number (CASRN), if the number is available. Tradenames or generic names of chemical precursors or reactants are not acceptable as substitutes for specific chemical names.
(ii) The currently correct CASRN for the substance if a CASRN already exists for the substance.
(iii) For a Class 1 substance and for any Class 2 substance for which a definite molecular formula is known or reasonably ascertainable, the correct molecular formula.
(iv) For a Class 1 substance, a complete, correct chemical structure diagram; for a Class 2 substance or polymer, a correct representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained.
(2) For a polymer, the submitter must also report the following:
(i) The specific chemical name and CASRN, if the number is available, of each monomer and other reactant used, at any weight percent, to manufacture the polymer. Tradenames or generic names of chemical reactants or monomers are not acceptable as substitutes for specific chemical names.
(ii) The typical percent by weight of each monomer and other reactant in the polymer (weight of the monomer or other reactant expressed as a percentage of the weight of the polymeric chemical substance manufactured), and the maximum residual amount of each monomer present in the polymer.
(iii) For monomers and other reactants used at 2 weight percent or less (based on the dry weight of the polymer manufactured), indicate on the PMN form any such monomers and other reactants that should be included as part of the polymer description on the Inventory, where the weight percent is based on either (A) the weight of monomer or other reactant actually charged to the reaction vessel, or (B) the minimum weight of monomer or other reactant required in theory to account for the actual weight of monomer or other reactant molecules or fragments chemically incorporated (chemically combined) in the polymeric substance manufactured.
(iv) For a determination that 2 weight percent or less of a monomer or other reactant is incorporated (chemically combined) in a polymeric substance manufactured, as specified in paragraphs (a)(2)(iii)(B) of this section, analytical data or appropriate theoretical calculations (if it can be documented that analytical measurement is not feasible or not necessary) to support this determination must be maintained at the site of manufacture or import of the polymer.
(v) Measured or estimated values of the minimum number-average molecular weight of the polymer and the amount of low molecular weight species below 500 and below 1,000 molecular weight, with a description of how the measured or estimated values were obtained.
(3) The person must use one of the following two methods to develop or obtain the specified chemical identity information reported under paragraphs (a) (1) and (2) of this section and must identify the method used in the notice: (continued)