PART 717—RECORDS AND REPORTS OF ALLEGATIONS THAT CHEMICAL SUBSTANCES CAUSE SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE ENVIRONMENT Authority: 15 U.S.C. 2607(c). Source: 48 FR 38187, Aug. 22, 1983, unless otherwise noted. Subpart A—General Provisions § 717.1 Scope and compliance. Section 8 (c) of the Toxic Substances Control Act (TSCA) requires manufacturers, processors, and distributors of chemical substances and mixtures: (a) To keep “records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture.” (b) To “permit inspection and submit copies of such records”, upon request of any designated representative of the Administrator. This rule implements section 8(c) of TSCA. It describes the records to be kept and prescribes the conditions under which certain firms must submit or make the records available to a duly designated representative of the Administrator. § 717.3 Definitions. The definitions set forth in section 3 of TSCA and the following definitions apply to this part: (a) Allegation (b) Firm company (c)(1) Known human effects (i) Scientific articles or publications abstracted in standard reference sources. (ii) The firm's product labeling or material safety data sheets (MSDS). (2) However, an effect is not a “known human effect” if it: (i) Was a significantly more severe toxic effect than previously described. (ii) Was a manifestation of a toxic effect after a significantly shorter exposure period or lower exposure level than described. (iii) Was a manifestation of a toxic effect by an exposure route different from that described. (d) Manufacture process (e)(1) Manufacture for commercial purposes (i) For distribution in commerce, 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 (f) Person (g) Process for commercial purposes (h) Retailer (i) Significant adverse reactions (j) Site (k) Substance § 717.5 Persons subject to this part. (a) Manufacturers. (2) A manufacturer must collect: (i) Any allegation identifying a chemical substance it manufactures and any allegation identifying the operations in the manufacture of any chemical substance it manufactures. (ii) Any allegation identifying any of its own processing or distribution in commerce activities with respect to any chemical substance it manufactures. (iii) Any allegation identifying emissions, effluents, or other discharges from activities described in this paragraph. (iv) Any allegation identifying a substance produced coincidentally during processing, use, storage or disposal of a chemical substance it manufactures. (3) For the purpose of this part, owned or controlled means ownership of 50 percent or more of a firm's voting stock or other equity rights, or the power to control the management and policies of that firm. (b) Processors. (2) As a processor subject to this part such person must collect: (i) Any allegation identifying any mixture it produces and distributes in commerce and any allegation identifying any chemical substance or mixture it repackages and distributes in commerce. (ii) Any allegation identifying any of its own further processing or distribution in commerce activities of the products described in paragraph (b)(2)(i) of this section. (iii) Any allegation identifying emissions, effluents, or other discharges from activities described in this paragraph. (iv) Any allegation identifying a substance produced coincidentally during the processing, use, storage or disposal of the products described in paragraph (b)(2)(i) of this section. (c) SIC code. [48 FR 38187, Aug. 22, 1983, as amended at 50 FR 46769, Nov. 13, 1985] § 717.7 Persons not subject to this part. (a) Manufacturers. (2) A person is not subject to this part if the chemical substances that person causes to be produced are limited to: (i) Chemical substances that result from chemical reactions that occur incidental to exposure of another chemical substance, mixture, or article to environmental factors such as air, moisture, microbial organisms, or sunlight. (ii) Chemical substances that result from chemical reactions that occur incidental to storage or disposal of other chemical substances, mixtures, or articles. (iii) Chemical substances that result from chemical reactions that occur upon end use of other chemical substances, mixtures, or articles such as adhesives, paints, miscellaneous cleaners or other housekeeping products, fuel additives, water softening and treatment agents, photographic films, batteries, matches, or safety flares, and that are not themselves manufactured or imported for distribution in commerce for use as chemical intermediates. (iv) Chemical substances that result from chemical reactions that occur upon use of curable plastic or rubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paints, or other chemical substance formed during the manufacture of an article destined for the marketplace without further chemical change of the chemical substance. (v) Chemical substances that result from chemical reactions that occur when (A) 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 adjuster, sequestrant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended, or (B) a chemical substance, which is intended solely to impart a specific physicochemical characteristic, functions as intended. (b) [Reserved] (c) Sole distributors. (d) Retailers. [48 FR 38187, Aug. 22, 1983, as amended at 50 FR 46770, Nov. 13, 1985] § 717.10 Allegations subject to this part. (a) Allegations subject to this part are those allegations received on or after November 21, 1983 by persons subject to this part. (b) Allegations subject to this part are those that: (1) Are submitted either in writing and are signed by the alleger, or are submitted orally. In the case of an oral allegation, the firm must transcribe the allegation into written form, or it must inform the alleger that such allegation may be subject to this part and request that the alleger submit such allegation to the firm in writing and signed. (2) Implicate a substance that caused the stated significant adverse reaction by one of the following: (i) Naming the specific substance. (ii) Naming a mixture that contains a specific substance. (iii) Naming an article that contains a specific substance. (iv) Naming a company process or operation in which substances are involved. (v) Identifying an effluent, emission, or other discharge from a site of manufacturing, processing or distribution of a substance. (c) Allegations subject to this part may be made to a firm by any person, such as an employee of the firm, individual consumer, a neighbor of the firm's plant, another firm on behalf of its employees or an organization on behalf of its members. (d) EPA intends that firms should, to the maximum practical extent, provide allegers with information regarding the ultimate disposition of their allegations. For example, firms could provide a brief notice to the alleger stating that a record was created under this part based upon their allegation, or that a record was not created and briefly explain the reasons why not. § 717.12 Significant adverse reactions that must be recorded. (a) Except as provided in paragraph (b) of this section, significant adverse reactions to human health that must be recorded include but are not limited to: (1) Long-lasting or irreversible damage, such as cancer or birth defects. (2) Partial or complete impairment of bodily functions, such as reproductive disorders, neurological disorders or blood disorders. (3) An impairment of normal activities experienced by all or most of the persons exposed at one time. (4) An impairment of normal activities which is experienced each time an individual is exposed. (b) Firms are not required to record significant adverse reactions that are known human effects as defined in § 717.3(c). (c) Except as provided in paragraph (d) of this section, significant adverse reactions to the environment that must be recorded, even if restricted to the environs of a plant or disposal site, include but are not limited to: (1) Gradual or sudden changes in the composition of animal life or plant life, including fungal or microbial organisms, in an area. (2) Abnormal number of deaths of organisms (e.g., fish kills). (3) Reduction of the reproductive success or the vigor of a species. (4) Reduction in agricultural productivity, whether crops or livestock. (5) Alterations in the behavior or distribution of a species. (6) Long lasting or irreversible contamination of components of the physical environment, especially in the case of ground water, and surface water and soil resources that have limited self-cleansing capability. (d) Firms are not required to record a significant adverse reaction to the environment if the alleged cause of that significant adverse reaction can be directly attributable to an accidental spill or other accidental discharge, emission exceeding permitted limits, or other incident of environmental contamination that has been reported to the Federal Government under any applicable authority. [48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 58 FR 34204, June 23, 1993] § 717.15 Recordkeeping requirements. (a) Establishment and location of records. (b) Content of records. (1) The original allegation as received. (2) An abstract of the allegation and other pertinent information as follows: (i) The name and address of the plant site which received the allegation. (ii) The date the allegation was received at that site. (iii) The implicated substance, mixture, article, company process or operation, or site discharge. (iv) A description of the alleger (e.g., “company employee,” “individual consumer,” “plant neighbor”). If the allegation involves a health effect, the sex and year of birth of the individual should be recorded, if ascertainable. (v) A description of the alleged health effect(s). The description must relate how the effect(s) became known and the route of exposure, if explained in the allegation. (vi) A description of the nature of the alleged environmental effect(s), identifying the affected plant and/or animal species, or contaminated portion of the physical environment. (3) The results of any self-initiated investigation with respect to an allegation. (EPA does not require persons subject to this part to investigate allegations received, and no provision of this part shall be construed to imply that EPA recommends, encourages or requires such investigation.) (4) Copies of any further required records or reports relating to the allegation. For example, if an employee allegation results in a requirement for the firm to record the case on Occupational Safety and Health Form 101 or appropriate substitute (see 29 CFR part 1904 for requirements under the Occupational Safety and Health Act of 1970), a copy of that OSHA record must be included in the allegation record. (c) File structure. (1) A specific chemical identity. (2) A mixture. (3) An article. (4) A company process or operation. (5) A site emission, effluent or other discharge. (d) Retention period. (e) Transfer of records. (2) If a firm ceases to do business and there is no successor to receive and keep the records for the prescribed period, these records must be transmitted to EPA. See § 717.17(c) for the address to which such records must be sent. [48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 58 FR 34204, June 23, 1993] § 717.17 Inspection and reporting requirements. (a) Inspection. (b) Reporting. Federal Register. (c) How to report. https://cdx.epa.gov/ [48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 52 FR 20084, May 29, 1987; 53 FR 12523, Apr. 15, 1988; 58 FR 34204, June 23, 1993; 60 FR 34464, July 3, 1995; 71 FR 33641, June 12, 2006; 88 FR 37172, June 7, 2023] § 717.19 Confidentiality. Claims of confidentiality must be made in accordance with the procedures described in 40 CFR part 703. [88 FR 37172, June 7, 2023]