Title 40—Protection of Environment--Volume 1
PART 716—HEALTH AND SAFETY DATA REPORTING
§ 716.1   Scope and compliance.
(a) This subpart sets forth requirements for the submission of lists and copies of health and safety studies on chemical substances and mixtures selected for priority consideration for testing rules under section 4(a) of the Toxic Substances Control Act (TSCA) and on other chemical substances and mixtures for which EPA requires health and safety information in fulfilling the purposes of TSCA.
(b) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit information required under this subpart. Section 16 provides that a violation of section 15 renders a person liable to the United States for a civil penalty and possible criminal prosecution. Under section 17, the district courts of the United States have jurisdiction to restrain any violation of section 15.
§ 716.3   Definitions.
The definitions in section 3 of TSCA apply to this subpart. In addition, the following definitions are provided for the purposes of this subpart:
Byproduct means a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s).
Central Data Exchange or CDX means EPA's centralized electronic submission receiving system.
Chemical Information Submission System or CISS means EPA's electronic, web-based tool for the completion and submission of data, reports, and other information, or its successors.
Co-product means a chemical substance produced for a commercial purpose during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s).
Copy of study means the written presentation of the purpose and methodology of a study and its results.
EPA means the United States Environmental Protection Agency.
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 TSCA.
(1) It is intended that the term health and safety study be interpreted broadly. 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. Chemical identity is part of, or underlying data to, a health and safety study.
(2) Examples are:
(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; and acute, subchronic, and chronic effects.
(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; structure/activity relationships; 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.
Import means to import for commercial purposes.
Import for commercial purposes means to import with the purpose of obtaining an immediate or eventual commercial advantage for the importer, and includes the importation of any amount of a chemical substance or mixture. If a chemical substance or mixture containing impurities is imported for commercial purposes, then those impurities are also imported for commercial purposes.
Importer means any person who imports a chemical substance, including a chemical substance as a part of a mixture or article, into the customs territory of the United States and includes the person primarily liable for the payment of any duties on the merchandise or an authorized agent acting on his behalf (as defined in 19 CFR 1.11). Importer 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.
(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. For the purpose of this definition, the customs territory of the United States consists of the 50 States, Puerto Rico, and the District of Columbia.
Impurity means a chemical substance which is unintentionally present with another chemical substance.
Listed mixture means any mixture listed in § 716.120.
Manufacture means to manufacture for commercial purposes.
Manufacture for commercial purposes means: (1) To produce, with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, and includes among other things such “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) Manufacture for commercial purposes also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts and impurities. Such byproducts and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose.
Manufacturer means a person who 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.
Person includes any individual, 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.
Process means to process for commercial purposes.
Process for commercial purposes means the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included. If a chemical substance or mixture containing impurities is processed for commercial purposes, then those impurities are also processed for commercial purposes.
Propose to manufacture, import, or process means that a person has made a management decision to commit financial resources toward the manufacture, importation, or processing of a substance or mixture.
Substance means chemical substance as defined at section 3(2)(A) of TSCA, 15 U.S.C. 2602(2)(A).
TSCA means the Toxic Substances Control Act (15 U.S.C. 2601 et seq. ).
§ 716.5   Persons who must report.
(a) Except as provided in paragraphs (b) and (c) of this section, only those persons described in this section are required to report under this part. Persons who must report include manufacturers (including importers) who fall within the North American Industry Classification System (NAICS) (in effect as of January 1, 1997) Subsector 325 (chemical manufacturing and allied products) or Industry Group 32411 (petroleum refineries), who:
(1) In the 10 years preceding the effective date on which a substance or mixture is added to § 716.120, either had proposed to manufacture (including import), or had manufactured (including imported) the listed substance or listed mixture (including as a known byproduct), are required to report during the reporting period specified in § 716.65.
(2) As of the effective date on which a substance or mixture is added to § 716.120, and who propose to manufacture (including import), or who are manufacturing (including importing) the listed substance or listed mixture (including as a known byproduct), are required to report during the reporting period specified in § 716.65.
(3) After the effective date on which a substance or mixture is added to § 716.120, and who propose to manufacture (including import) the listed substance or listed mixture (including as a known byproduct), are required to report during the reporting period specified in § 716.65.
(b) A rule promulgated under the authority of 15 U.S.C. 2607(d) may require that any person who does not fall within NAICS (in effect as of January 1, 1997) Subsector 325 or Industry Group 32411, and who had proposed to manufacture (including import) or process, had manufactured (including imported) or processed, proposes to manufacture (including import) or process, or is manufacturing (including importing) or processing a substance or mixture listed in § 716.120 must report under this part.
(c) Processors and persons who propose to process a substance or mixture otherwise subject to the reporting requirements imposed by this part are not subject to this part unless EPA specifically states otherwise in a particular notice or rule promulgated under the authority of 15 U.S.C. 2607(d).
§ 716.10   Studies to be reported.
(a) In general, health and safety studies, as defined in § 716.3, on any substance or listed mixture listed in § 716.120, that are unpublished are reportable, i.e., must be submitted or listed. However, this requirement has limitations according to the nature of the material studied, so that:
(1) All studies of substances and listed mixtures are reportable. However, in the case of physical and chemical properties, only those studies listed in § 716.50 must be submitted.
(2) Studies of mixtures known to contain substances or listed mixtures listed in § 716.120 are reportable except for studies of physical and chemical properties and the studies exempted at § 716.20(a)(6) (i) through (vi).
(3) Studies of substances or listed mixtures that a person who is reporting has manufactured, imported, or processed or proposed to manufacture, import, or process only as impurities are not generally reportable under § 716.20(a)(9).
(4) Underlying data, such as medical or health records, individual files, lab notebooks, and daily monitoring records supporting studies do not have to be submitted initially. EPA may request underlying data later under § 716.40.
(b) [Reserved]
§ 716.20   Studies not subject to the reporting requirements.
(a) Excluding paragraph (a)(3) of this section, the following types of studies are exempt from the copy and list submission requirements of §§ 716.30 and 716.35.
(1) Studies which have been published in the scientific literature.
(2) Studies previously submitted to the EPA Office of Pollution Prevention and Toxics. These studies are limited to section 8(e) submissions, studies submitted during section 4 proceedings, studies submitted with premanufacture notices or significant new use notices, and studies submitted “for your information” (FYI submissions) in support of EPA's TSCA Existing Chemicals Program. Studies which have been initiated pursuant to a TSCA section 4(a) test rule, for which the person has submitted a letter of intent to conduct testing in accordance with the provisions of § 790.25 of part 790 of this chapter, are exempt from the list submission requirements of § 716.35.
(3) Except for those studies described in paragraph (a)(2) of this section, studies previously submitted to any Federal agency with no claims of confidentiality are exempt only from the copy submission requirements of § 716.30, and must be listed in accordance with the provisions of § 716.35.
(4) Studies conducted or initiated by or for another person who is subject to, and who will report the studies under §§ 716.30 and 716.35.
(5) Studies of chemical substances which are not on the TSCA Chemical Substances Inventory. This exemption applies only to those substances within categories listed under § 716.120(c).
(6) The following types of studies when the subject of the study is a mixture known to contain a substance or listed mixture listed under § 716.120.
(i) Acute oral toxicity studies.
(ii) Acute dermal toxicity studies.
(iii) Acute inhalation toxicity studies.
(iv) Primary eye irritation studies.
(v) Primary dermal irritation studies.
(vi) Dermal sensitization studies.
(vii) Physical and chemical properties.
(7) Analyzed aggregations of monitoring data based on monitoring data acquired more than 5 years preceding the date the substance or listed mixture was added to the list under § 716.120.
(8) Analyzed aggregations of monitoring data on mixtures known to contain one or more substances or listed mixtures listed in § 716.120, when the monitoring data are not analyzed to determine the exposure or concentration levels of the substances or listed mixture listed under § 716.120.
(9) Studies on a substance or listed mixture listed under § 716.120 that the person who is reporting has manufactured, imported, or processed or proposed to manufacture, import, or process only as an impurity. When reporting of such studies is to be required, that reporting will be separately proposed in the Federal Register.
(10) Studies of chemical substances or listed mixtures previously submitted by trade associations in accordance with the provisions of § 716.30.
(b) The following types of studies on substances or listed mixtures listed under § 716.120 are exempt from the copy and list submission requirements of §§ 716.30 and 716.35.
(1) For the listed ureaformaldehyde resins (CAS Nos. 9011-05-6 and 68611-64-3), studies on agronomic plant growth or damage which demonstrate only that the resins stimulate plant growth or cause plant damage when applied as a fertilizer.
(2) For the specified chemicals in § 716.120(d) under the category “Siloxanes,” acute oral, dermal, and inhalation toxicity studies and primary eye and dermal irritation studies.
(3) For the listed chemicals under § 716.120(d) in the category “OSHA Chemicals in Need of Dermal Absorption Testing,” studies on ecological effects.
(4) For the chemicals listed at § 716.120 with a special exemption referencing this paragraph, studies on mixtures containing the listed substance at levels below 1 percent of the mixture, except when a purpose of the study includes the investigation of the effects of the listed substance at levels below 1 percent.
(5) Rulemaking proceedings that add substances and mixtures to § 716.120 will specify the types of health and/or environmental effects studies that must be reported and will specify the chemical grade/purity requirements that must be met or exceeded in individual studies. Chemical grade/purity requirements will be specified on a per chemical basis or for a category of chemicals for which reporting is required.
§ 716.21   Chemical specific reporting requirements.
(a) Health and safety studies reportable under part 716 for the following chemical substances, mixtures, or categories of chemical substances, as listed in § 716.120, must be submitted or listed only as specified in this section:
(1) For 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- and imidazo[4,5-d]imidazole-2,5-(1H,3H)-dione, tetrahydro-, all unpublished environmental effects studies and health effects studies on pharmacokinetics, genotoxicity, subchronic toxicity, immunotoxicity, carcinogenicity, reproductive effects, and developmental toxicity where the purity of 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- or imidazo[4,5-d]imidazole-2,5-(1H,3H)-dione, tetrahydro- is greater than or equal to 90% of the test substance by weight must be submitted.
(2) For benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)-, all unpublished environmental effects studies including bioconcentration, environmental fate studies on biodegradation, and health effects studies on pharmacokinetics, subchronic toxicity, mutagenicity, reproductive effects, and developmental toxicity, and carcinogenicity where the purity of benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- is greater than or equal to 90% of the test substance by weight must be submitted.
(3) For stannane, dimethylbis[(1-oxoneodecyl)oxy]-, all unpublished environmental effects studies including bioconcentration, environmental fate studies on hydrolysis and biodegradation and health effects studies on pharmacokinetics, subchronic toxicity, mutagenicity, neurotoxicity, reproductive effects, and developmental toxicity, and carcinogenicity where the purity of stannane, dimethylbis[(1-oxoneodecyl)oxy]- is greater than or equal to 90% of the test substance by weight must be submitted.
(4) For benzene, 1,3,5-tribromo-2-(2-propenyloxy)-, all unpublished environmental effects studies including bioconcentration, environmental fate studies on biodegradation and health effects studies on pharmacokinetics, subchronic toxicity, neurotoxicity, reproductive effects, and developmental toxicity, and carcinogenicity where the purity of benzene, 1,3,5-tribromo-2-(2-propenyloxy)- is greater than or equal to 90% of the test substance by weight must be submitted.
(5) For 1-triazene, 1,3-diphenyl-, all unpublished health effects studies on pharmacokinetics, genotoxicity, subchronic and chronic toxicity, reproductive effects, and developmental toxicity where the purity of 1-triazene, 1,3-diphenyl- is greater than or equal to 90% of the test substance by weight must be submitted.
(6) For the 9 chemicals in the indium compound category, all unpublished health effects studies on pharmacokinetics, genotoxicity, subchronic and chronic toxicity, reproductive effects, and developmental toxicity where the purity of the indium compound is greater than or equal to 90% of the test substance by weight must be submitted.
(7) For all voluntary HPV Challenge Program orphan (unsponsored) chemicals:
(i) All unpublished environmental fate studies, meeting the criteria set forth in paragraph (a)(7)(iv) of this section, on water solubility; adsorption/desorption on particulate surfaces, e.g., soil; vapor pressure; octanol/water partition coefficient; density/relative density (specific gravity); particle size distribution for insoluble solids; dissociation constant; degradation by photochemical mechanisms—aquatic and atmospheric; degradation by chemical mechanisms—hydrolytic, reductive, and oxidative; degradation by biological mechanisms—aerobic and anaerobic. Studies of physical and chemical properties meeting the criteria set forth in paragraph (a)(7)(iv) of this section must be reported if performed for the purpose of determining the environmental or biological fate of a substance, and only if they investigated one or more of the properties listed in this paragraph. In addition, all unpublished studies meeting the criteria set forth in paragraph (a)(7)(iv) of this section on melting point and boiling point must be submitted.
(ii) All unpublished health effects studies meeting the criteria set forth in paragraph (a)(7)(iv) of this section including pharmacokinetics, genotoxicity, acute toxicity, subacute toxicity, subchronic toxicity, chronic toxicity, reproductive toxicity, developmental toxicity, immunotoxicity, neurotoxicity, and oncogenicity/carcinogenicity.
(iii) All unpublished environmental effects studies meeting the criteria set forth in paragraph (a)(7)(iv) of this section including acute and chronic toxicity studies of aquatic and terrestrial vertebrates and invertebrates and aquatic plants.
(iv) Only studies where the voluntary HPV Challenge Program orphan (unsponsored) chemical is ≥90% of the test substance by weight should be submitted. In addition, only studies that were conducted using TSCA, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Organization for Economic Cooperation and Development (OECD) or other internationally accepted test guidelines or voluntary consensus standards should be submitted. Studies performed where the voluntary HPV Challenge Program orphan (unsponsored) chemical is <90% of the test substance by weight are not requested at this time.
(8)(i) Reporting requirements apply only to manufacturers (including importers) of consumer products intended for use by children who also manufacture (including import) lead or lead compounds. For the category “lead and lead compounds,” all unpublished health and safety studies that:
(A) Relate to the lead content of consumer products that are “intended for use by children” as that term is defined at 40 CFR 710.43 (excluding children's metal jewelry), or
(B) Assess children's exposure to lead from such products (including studies of bioavailability).
(ii) With regard to purity, studies showing any measurable lead content in such products must be submitted.
(9) For 1,3-Butadiene (106-99-0), Butyl benzyl phthalate (BBP)—1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester (85-68-7), Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester) (84-74-2), o-Dichlorobenzene (95-50-1), p-Dichlorobenzene (106-46-7), trans-1,2-Dichloroethylene (156-60-5), 1,2-Dichloropropane (78-87-5), Dicyclohexyl phthalate (84-61-7), Di-ethylhexyl phthalate (DEHP)—(1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester) (117-81-7), Di-isobutyl phthalate (DIBP)—(1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester) (84-69-5), Formaldehyde (50-00-0), 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB) (1222-05-5), Phthalic anhydride (85-44-9), 4,4′-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) (79-94-7), and 1,1,2-Trichloroethane (79-00-5), all unpublished studies on health effects (including toxicity studies (in vivo and in vitro) on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity); toxicokinetics (absorption, distribution, metabolism, or elimination), including modelling studies, in humans or animals; environmental effects; environmental fate; physical-chemical properties if performed as described in 40 CFR 716.50; and occupational (both users and non-users), general population, consumer, bystander, and environmental exposure must be submitted. Studies showing any measurable content of the High-Priority Substance in the tested substance (single substances or mixture) must be reported. The composition and purity of test substances must be reported if included as part of the study. Studies previously submitted to EPA pursuant to a requirement under TSCA or of the submitter's own accord and studies conducted or to be conducted pursuant to a TSCA section 4 action are exempt from the submission of lists of health and safety studies required under 40 CFR 716.35 and the submission of studies required under this rule.
(10) For purposes of this paragraph, the term organohalogen flame retardant includes any substances listed in paragraph(d) of this section under the category “Organohalogen flame retardants”. For any organohalogen flame retardant, all unpublished studies on health effects (including toxicity studies (in vivo and in vitro) on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity); toxicokinetics (absorption, distribution, metabolism, or elimination), including modelling studies, in humans or animals; environmental fate; physical-chemical properties if performed as described in 40 CFR 716.50; and occupational (both users and non-users), general population, consumer, bystander, and environmental exposure must be submitted. Studies showing any measurable content of the organohalogen flame retardant in the tested substance (single substances or mixture) must be reported. The composition and purity of test substances must be reported if included as part of the study. Studies previously submitted to EPA pursuant to a requirement under TSCA or of the submitter's own accord and studies conducted or to be conducted pursuant to a TSCA section 4 action are exempt from the submission of lists of health and safety studies requirements under 40 CFR 716.35 and the submission of studies requirements under this rule.
(11) For 4,4-Methylene bis(2-chloraniline) (101-14-4); 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (140-66-9); Acetaldehyde (75-07-7); Acrylonitrile (107-13-1); Benzenamine (62-53-3); Benzene (71-43-2); Bisphenol A (80-5-7); Ethylbenzene (100-41-4); Naphthalene (91-20-3); Vinyl Chloride (75-01-4); Styrene (100-42-5); Tribomomethane (Bromoform) (75-25-2); Triglycidyl isocyanurate (2451-62-9); Hydrogen fluoride (7664-39-3); N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) (793-24-8); and 2-anilino-5-[(4-methylpentan-2-yl)amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (2754428-18-5), all unpublished studies on health effects (including toxicity studies (in vivo and in vitro) on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity); toxicokinetics (absorption, distribution, metabolism, or elimination), including modelling studies, in humans or animals; environmental effects; environmental fate; physical-chemical properties if performed as described in 40 CFR 716.50; and occupational (both users and non-users), general population, consumer, bystander, and environmental exposure must be submitted. Studies showing any measurable content of the substance in the tested substance (single substances or mixture) must be reported. The composition and purity of test substances must be reported if included as part of the study. Studies previously submitted to EPA pursuant to a requirement under TSCA or of the submitter's own accord and studies conducted or to be conducted pursuant to a TSCA section 4 action are exempt from the submission of lists of health and safety studies required under 40 CFR 716.35 and the submission of studies required under this rule.
(b) [Reserved]
§ 716.25   Adequate file search.
The scope of a person's responsibility to search records is limited to records in the location(s) where the required information is typically kept, and to records kept by the person or the person's individual employee(s) who is/are responsible for keeping such records or advising the person on the health and environmental effects of chemicals. Persons are not required to search for reportable information dated before January 1, 1977, to comply with this subpart unless specifically required to do so in a rule.
§ 716.30   Submission of copies of studies.
(a)(1) Except as provided in §§ 716.5, 716.20, and 716.50, persons must send to EPA copies of any health and safety studies in their possession for the substances or mixtures listed in § 716.120. Persons are responsible for submitting copies on only the substances or listed mixtures which they: Have manufactured, imported, or processed or proposed to manufacture, import, or process (including as known byproducts) within the 10 years preceding the effective date for reporting on the substances or listed mixtures; manufacture, import, or process on the effective date for reporting on the substances or listed mixtures; and propose to manufacture, import, or process following the effective date for reporting on the substances or listed mixtures. Persons who list studies as ongoing or initiated under § 716.35(a) (1) and (2) must submit them when they are completed.
(2) [Reserved]
(b) Submissions under paragraph (a) of this section must be identified either on the face of the study or otherwise by the applicable chemical name and CAS number (if any) listed in § 716.120(a) (1) and (2), and must be accompanied by a cover letter containing the name, job title, address and telephone number of the submitting official, and the name and address of the manufacturing or processing establishment on whose behalf the submission is made. In the cover letter, submitters must identify any impurity or additive known to have been present in the substance or listed mixtures as studied unless its presence is specifically noted in the study itself. The cover letter accompanying a study submitted by a trade association must also state that the submission is to satisfy reporting requirements under this part.
(c) Persons must use the CISS tool to complete and submit all data, reports, and other information required by 40 CFR part 716, via CDX. Submission requires registration with CDX, and must be made only as set forth in this section.
(d) To access the CISS tool go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html.
§ 716.35   Submission of lists of studies.
(a) Except as provided in §§ 716.5, 716.20, and 716.50, persons subject to this rule must send lists of studies to EPA for each of the listed substances or listed mixtures (including as a known byproduct) in § 716.120 which they are manufacturing, importing, or processing, or which they propose to manufacture (including import) or process.
(1) Ongoing studies. As of the date a person becomes subject to this part, a list of ongoing health and safety studies being conducted by or initiated for them, noting for each entry: The beginning date of the study, the purpose of the study, the types of data to be collected, the anticipated date of completion, and the name and address of the laboratory conducting the study.
(2) Initiated studies. After the date a person becomes subject to this part, a list of studies initiated by or for them, noting for each entry: The beginning date of the study, the purpose of the study, the types of data to be collected, the anticipated date of completion, and the name and address of the laboratory conducting the study.
(3) Studies which are known but without possession of copies. As of the date a person becomes subject to this part, a list of unpublished health and safety studies known to them of which they do not have copies. The name and address of any person known to them to possess a copy of the unpublished study must accompany each entry on the list. For purposes of this section only, an unpublished study will be considered to be “known to” a person, if the study can be discovered by a file search in accordance with § 716.25.
(4) Studies previously sent to Federal agencies without confidentiality claims. A list of unpublished studies which have been sent to a Federal Agency with no claims of confidentiality. The submission must for each study: Identify the study by title, state the name and address to whom the study was sent, and the month and year in which the study was submitted. Any study identified will be treated as if it were submitted under section 8(d) and will be available for public disclosure under section 14(b) of TSCA. Persons subject to this requirement may submit either a list of unpublished health and safety studies previously submitted to any Federal agency without claims of confidentiality in accordance with § 716.35(a)(4), or copies of each such study in accordance with § 716.30.
(b) Submission under paragraph (a) of this section must be identified either on the face of the study or otherwise by the applicable chemical name and CAS number (if any) listed in § 716.120(a) (1) and (2), and must be accompanied by a cover letter containing the name, job title, address and telephone numbers of the submitting official, and the name and address of the manufacturing or processing establishment on whose behalf the submission is made.
(c) Persons must use the CISS tool to complete and submit all data, reports, and other information required by 40 CFR part 716, via CDX. Submission requires registration with CDX, and must be made only as set forth in this section.
(d) To access the CISS tool go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html.
§ 716.40   EPA requests for submission of further information.
EPA may, by letter, request a person to submit or make available for review the following information after the initial reporting under §§ 716.30 and 716.35. If the requested submissions are not made, EPA may subpoena them under section 11 of TSCA, 15 U.S.C. 2610.
(a) Submission of underlying data of the kind described in § 716.10(a)(4) by persons who submit copies of studies under § 716.30 or list studies under § 716.35(a)(1) or § 716.35(a)(2).
(b) Submission of preliminary reports of ongoing studies by persons who list the studies under § 716.35(a)(1) or § 716.35(a)(2).
(c) Submission of copies of studies by persons listed under § 716.35(a)(3) as possessing them.
§ 716.45   How to report on substances and mixtures.
Section 716.120 lists substances and mixtures, in order by Chemical Abstract Service Registry Number and by alphabetical order. Studies of listed substances and listed mixtures shall be reported as follows:
(a) When a substance is individually listed under § 716.120(a), studies of the substance and studies of mixtures known to contain the substance must be reported as studies of that substance.
(b) When two or more substances are listed as a mixture under § 716.120(b), studies of the listed mixture and studies of any mixture known to contain the listed mixture must be reported as studies of the listed mixture.
(c) Studies of the following preparations of a substance must be reported as studies of the substance itself, not as studies of mixtures known to contain the substance.
(1) The substance in aqueous solution.
(2) The substance containing a small amount of an additive, such as a stabilizer, emulsifier, or other chemical added for purposes of maintaining the integrity or physical form of the substance.
(3) The substance of the grade/purity specified in each rule promulgated under 15 U.S.C. 2607(d).
§ 716.50   Reporting physical and chemical properties.
Studies of physical and chemical properties must be reported under this subpart if performed for the purpose of determining the environmental or biological fate of a substance, and only if they investigated one or more of the following properties:
(a) Water solubility.
(b) Adsorption/desorption on particulate surfaces, e.g., soil.
(c) Vapor pressure.
(d) Octanol/water partition coefficient.
(e) Density/relative density (specific gravity).
(f) Particle size distribution for insoluble solids.
(g) Dissociation constant.
(h) Degradation by photochemical mechanisms—aquatic and atmospheric.
(i) Degradation by chemical mechanisms—hydrolytic, reductive, and oxidative.
(j) Degradation by biological mechanisms—aerobic and anaerobic.
§ 716.55   Confidentiality claims.
Claims of confidentiality must be made in accordance with the procedures described in 40 CFR part 703.
§ 716.60   Reporting schedule.
(a) General requirements. Except as provided in § 716.5 and paragraphs (b) and (c) of this section, submissions under §§ 716.30 and 716.35 must be submitted using the electronic method specified in §§ 716.30(c) and 716.35(c), on or before 60 days after the effective date of the listing of a substance or mixture in § 716.120 or within 60 days of proposing to manufacture (including import) or process a listed substance or listed mixture (including as a known byproduct) if first done after the effective date of the substance or mixture being listed in § 716.120.
(b)(1) Submission of lists of initiated studies. Persons subject to the listing requirements of § 716.35(a)(2) must inform EPA of the initiated study within 30 days of its initiation.
(2) Submission of copies of completed studies. Persons must submit studies listed as ongoing or initiated under § 716.35(a)(1) and (2) within 30 days of completing the study, using the method specified in §§ 716.30(c) and 716.35(c).
(c) Requests for extensions of time. Respondents who cannot meet a deadline under this section may apply for a reasonable extension of time. Extension requests must be submitted on or before 40 days after the effective date of the listing of a substance or mixture in § 716.120, using the electronic method specified in §§ 716.30(c) and 716.35(c). The Director of EPA's Office of Pollution Prevention and Toxics will grant or deny extension requests.
(d) Submission methods. Persons must use the CISS tool to complete and submit all data, reports, and other information required by 40 CFR part 716, via CDX. Submission requires registration with CDX, and must be made only as set forth in this section.
(e) To access the CISS tool go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html.
§ 716.65   Reporting period.
Unless otherwise required in a rule promulgated under 15 U.S.C. 2607(d) relating to a listed chemical substance or listed mixture [hereinafter “rule”], the reporting period for a listed chemical substance or listed mixture will terminate 60 days after the effective date on which the listed chemical substance or listed mixture is added to 40 CFR 716.120. EPA may require reporting for a listed chemical substance or listed mixture beyond the 60 day period in a rule promulgated under 15 U.S.C. 2607(d), however EPA will not extend any reporting period later than 2 years after the effective date on which a listed chemical substance or listed mixture is added to 40 CFR 716.120. After the applicable reporting period terminates, any person subject to the rule under 40 CFR 716.5 (a)(2) or (a)(3) and who has submitted to EPA lists of ongoing or initiated studies under 40 CFR 716.35 (a)(1) or (a)(2) must submit a copy of any such study within 30 days after its completion, regardless of the study's completion date.
§ 716.105   Additions of substances and mixtures to which this subpart applies.
The requirements of this subpart will be extended periodically to cover additional substances and mixtures. Two procedures will be used to add substances and mixtures.
(a) Except as provided in paragraph (b) of this section, substances and mixtures will be added to § 716.120 after publication in the Federal Register of a notice of proposed amendment to this subpart. There will be at least a 30-day public comment period on the notice. After consideration of the comments, EPA will amend § 716.120 by final rule to add the substances and listed mixtures.
(b) Except as provided in paragraph (c) of this section, chemical substances, mixtures, and categories of chemical substances that have been added to the TSCA section 4(e) Priority List by the Interagency Testing Committee, established under section 4 of TSCA, will be added to § 716.120 but only to the extent that the total number of designated and recommended substances, mixtures and categories of chemical substances has not exceeded 50 in any 1 year. The addition of such chemical substances, mixtures, and categories of chemical substances to § 716.120 will be effective 30 days after publication of a notice to that effect in the Federal Register.
(c) Prior to the effective date of an amendment under paragraph (b) of this section, the Assistant Administrator for Chemical Safety and Pollution Prevention may for good cause withdraw a chemical substance, mixture, or category of chemical substances from § 716.120. Any information submitted showing why a chemical substance, mixture, or category of chemical substances should be withdrawn from the amendment must be received by EPA within 14 days after the date of publication of the notice under paragraph (b) of this section. If a chemical substance, mixture, or category of chemical substances is withdrawn, a Federal Register notice announcing this decision will be published no later than the effective date of the amendment under paragraph (b) of this section.
(d) Persons who wish to submit information that shows why a substance should be withdrawn must submit their comments by using the CISS tool to complete and submit all data, reports, and other information required by 40 CFR part 716, via CDX. Submission requires registration with CDX, and must be made only as set forth in this section.
(e) To access the CISS tool go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html.
§ 716.120   Substances and listed mixtures to which this subpart applies.
Substances listed in this section appear in order by Chemical Abstract Service Registry Number. Chemical mixtures and categories are listed separately and by alphabetical order. Chemical substances listed within a category are provided only as examples of the category, and are not included on the list of substances. When a chemical substance in the substance or category list had been listed previously by a trivial (or common) name, it appears first, followed by the Chemical Abstract Service (CAS) name appearing in the TSCA Chemical Substance Inventory.
(a) List of substances. The following chemical substances are subject to all the provisions of part 716. Manufacturers, importers, and processors of a listed substance are subject to the reporting requirements of subpart A for that substance.
(b) [Reserved]
(c) By category. The following categories are listed in alphabetical order. Chemical substances listed within a category are provided only as examples of the category. All chemical substances within a category are subject to all the provisions of part 716 for the time period from the effective date of the category until the sunset date. Manufacturers, importers, and processors of any chemical substance within a category are subject to the reporting requirements of subpart A for that category, except when the sunset date for the particular substance predates the sunset date for the category, or when the exemption of § 716.20(b) of this part applies.
(d) Listed members of categories. The following categories are listed in alphabetical order with the chemical substances identified in each category also listed alphabetically. Only those chemical substances specifically listed within a category are subject to all provisions of part 716 for the time period from the effective date of the rule until the sunset date.
Table 3 to Paragraph ( d )