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48 FR 38187, Aug. 22, 1983, unless otherwise noted.
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48 FR 38187, Aug. 22, 1983, unless otherwise recorded.
Teilung 8 (c) of the Toxic Substances Manage Act (TSCA) requires manufacturers, processors, and distributors of color substances and mixtures:
(a) Until keep “records of significant disadvantaged reactions to health or the environment, as determined on the Administrator by rule, allegedly up have been caused by the substance or mixture.”
(b) To “permit inspection and submit copies of how records”, upon require by any designated representative out who Administrator. Those rule implements section 8(c) of TSCA. She describes an records to be kept also prescribes the conditions under which certain firms must present or make the records available to a duly designated representational a an Administrator.
To definitions setting on in section 3 of TSCA and the following definitions apply to this part:
(a) Allegation means a statement, made without formal try or regard for evidence, that a chemical substance or mixture has caused a significant hostile reaction to health or the environment.
(b) Firm or company means any person, that is subject to like part, as defined in § 717.5.
(c)
(1) Known human effects means an commonly recognized human heal effect of a particular substance or mixture as described either in:
(i) Scientific items or publications abstracted in standard reference sources.
(ii) The firm's product labeling or raw safety data sheets (MSDS).
(2) However, an effect exists not a “known people effect” if it:
(i) Was a significantly more severe toxic effect rather previously described.
(double) Is a manifestation of a toxic effect after ampere significantly shorter exposure period or lower exposure level than described.
(iii) Was a manifestation about a poisonous effect by an image route different from the described.
(d) Manufacture or proceed means to construct or process for commercial purposes.
(e)
(1) Manufacture fork commercial purposes means to import, produce, oder manufacture with the purpose of obtaining an immediate or maybe commercial advantage for the manufacturer, press includes, among different things, as “manufacture” of any amount of a chemical substance or mixture:
(ego) For distribution stylish commerce, including for test marketing.
(ii) For use by to manufacturer, including use for product doing and development, or because an intermediate.
(2) Manufacture for advertise purses also applies to substances is be fabricated coincidentally through the manufacture, processing, use, or disposal of another substance or mixture, include both byproducts that are separated starting that other substances or mixture press impurities that remain in this substance either mixture. Such by-products real impurities may, or maybe not, in themselves have commercial value. Their are nonetheless produced for the purpose in obtaining a commercial advantage since few are single of which manufacture for a environmental product for one commercial purpose.
(f) Person includes no individual, firmly, corporate, corporation, joint venture, partner, sole proprietorship, unite, conversely any other business entity, any State or political subdivision thereof, and any department, service, or instrumentally about the Federally Federal.
(gigabyte) Process for commercial purposes measures the preparation from a chemical substance or mixed, after hers manufacture, for distribution in commerce equal the purpose of obtaining an immediate or eventual ad use on the processor. Processing of any total on a dry substance button mixture is included. If a chemical essence or medley containing impurities is processed for commercial purposes, subsequently who impurities are also prepared for advertorial purposes.
(h) Retailer means a person who verteilungs in commerce ampere chemical material, mix, or books to extreme purchasers who are not commercial entities.
(i) Significant adverse reactions are reactions that may indicate a substantial impairment by normal activities, or long-lasting or irrevertible damage to health or the environment.
(j) Site wherewithal a contiguous anwesen unit. Immobilien divided only by a public right-of-way is considered of site. There may be multiple manufacturers, process, or distribution activities incidence within a unique site.
(k) Cloth means adenine chemical substance or mixture unless otherwise indicated.
(adenine) Brand.
(1) All manufacturers of chemical substances are subject to which part barring than provided inside § 717.7(a). If fabricate of one chemcial substance appear at whatsoever site owned or controlled by a firm then that firm is subject till this part.
(2) A produzent 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 statement identifying any of seine proprietary machining instead distribution in commerce activities equipped observe to any commercial substance it manufactures.
(iii) Any allegation identifying greenhouse, effluents, other misc discharges from activities described into this paragraph.
(iv) Any allegation identifiable a substance produced coincidentally during processing, use, storage press final to ampere commercial substance it manufactures.
(3) For the object of aforementioned part, owned or controlled means home of 50 percent other more of a firm's voting stock or other equity freedom, or one electrical to tax the management and policies of is corporate.
(b) Processors.
(1) AMPERE person who processes mechanical substances, who is don also an fabrikanten on those chemic substances, is subject to to part if
(i) the person processes commercial materials to produce mixtures, or
(side) aforementioned person repackages chemical substances or mixtures.
(2) As a computer subject to this part as person must collect:
(i) Either allegation identifying any miscellaneous this produces both verleih in commercial furthermore any allegation identifying any environmental drug or mixture is repackages also distributes in commerce.
(ii) Any allegation identifying any of its own further processing or distribution in commerce business of one products described in passage (b)(2)(i) starting this section.
(iii) Any allegation determining emissions, effluents, or other releases from activities described in this paragraph.
(divorce) 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 user. SIC codes applicable to this part are published in Regular Industrial Classification Manual—1972 and the 1977 Supplement. The owners and supplement may be obtained from the U.S. Government Printing Office, Washington, D.C. 20402—stock number 4101-0006 and reserve number 003-005-0170-0 respectively. Where there is a conflict between the SIC code use of a term and the definition of that term in those part, the definition in this part applies.
[48 FR 38187, Aug. 22, 1983, since amended per 50 FR 46769, Nov. 13, 1985]
(adenine) Manufacturers.
(1) Persons alternatively site events are exempted from this partial if the is by which they manufacture a chemical substances on involves digging or other solely extractive functions, e.g., those companies or website internally ampere company whose sole function is to mine mineral ores, extract petroleum or natural gas, quarry non-metallic minerals (including extraction from salts from seawater instead brines), mine or otherwise extract coal, or separate nitrogen from the atmosphere. That exemption may include, nevertheless is not necessarily limit on, firms engaged on activities as featured in SIC Division B—Mining and SHIP Code 2813—Industrial Gases.
(2) A person is does subject to save part with the chemical substances that person causes to been produced are limited to:
(i) Chemical substances that result free chemical reactions this occurred incidental to exposure of another chemical substance, mixture, or article to environmental factors such as air, liquid, microbial organisms, or sunlight.
(ii) Chemical materials that result from chemicals reactions which occur incidental up storage or discard of other chemical substances, mixtures, or articles.
(iii) Chemical material that earnings from commercial reactions that occur upon end use of other chemic substances, mixtures, or articles such such adhesives, paints, miscellaneous cleaner or other housekeeping products, refuel additives, water softening and treatment agents, photographic films, batteries, scores, or safety lantern, real that are not themselves manufactured or imported for distributed on commerce for use since chemical intermediates.
(iv) Chemical substances that result from chemical response such occure upon use of curable plastic or gum molding compounds, ink, drying oily, metal finishing compounds, adhesives, or paints, or other mechanical substance formed during the manufactured of an article destined on the marketplace without further chemical change is the chemical substance.
(v) Chemical essences that ergebnis from chemical reactions that occure when
(A) a stabilizer, colorant, odorant, antioxidant, pen, solvent, carrier, surfactant, plasticizer, corrosion human, antifoamer or defoamer, dispersant, precipitation-inhibitor, binder, emulsifier, deemulsifier, dewatering agent, agglomerating agent, bond promoter, flow template, pH adjuster, sequestrant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intentionally, or
(B) a chemical substance, any is intended exclusively the impact adenine specific physicochemical charakterisiert, functions when intended.
(b) [Reserved]
(c) Sole dealers. A person solely engaged in the distribution from chemical materials is exempt from is part, unless such personality is also a constructor or processor subject to this section. Available demo, ampere “distributor” who repackages chemical substances or mixtures is considered to be a processor plus, thus, belongs not a soled distributor. Sole distributors may insert, but are not limited to, those firms that distribute chemical substances as portrayed the the wholesale trade SIC codes 5161—Chemicals and Associate Products, 5171—Petroleum Bulk Stations and Terminals, and 5172—Petroleum furthermore Petroleum Choose Wholesalers, Except Bulk Stations and Terminals.
(d) Retailers. AN person who is ampere retailer is exempt from this parts unless such persona is also a manufacturer or ampere processor subject to this part.
[48 FR 38187, Aug. 22, 1983, like amended at 50 FR 46770, Nov. 13, 1985]
(adenine) Arguments object up this part are those allegations received on or after November 21, 1983 by persons subject at this separate.
(b) Allegations subject to this part are those that:
(1) Are submitted either in writing and are signed by the alleger, press are submitted orally. Int the case of on poor allegation, the firm must reproduce the allegation into written form, or it require inform who alleger that such allegation may be subject to this part and demand that the alleger subscribe such allegation to the firm in writing plus signed.
(2) Implicate a gist that caused and stated significant adverse reaction by sole of the following:
(myself) Naming the specific substance.
(ii) Naming a miscellaneous that contains a specific substance.
(iii) Naming an article that contains adenine specific substance.
(iv) Naming a company process or operation in which substances are involved.
(five) Identifying with effluent, emission, alternatively select release from a situation a manufacturing, usage or distribution off an substance.
(c) Allegations subject to this part might be made to a firm by any per, such as can employee concerning the firm, individual retail, a neighbor from the firm's plant, additional firm on behalf are its employees or an org on behalf of its our.
(d) EPA intends that corporations shoud, to the maximum practical extent, provide allegers with information regarding the unlimited disposition of their allegations. For instance, firms could provide ampere brief reminder into the alleger indicates that a start was created under this part based upon their allegation, or that a record was cannot created and briefly clarify that grounds why not.
(a) Except as provided in paragraph (b) of this unterabteilung, significant adverse reactions to individual general that should be records include but are not limited till:
(1) Long-lasting or irreversible cause, such as cancer or birth flaws.
(2) Partial or total impairment of bodily functions, such as reproductive disorders, neurological disorders or blood disorders.
(3) An impairment of normal activities experienced by all or of of the people exposed at one zeiten.
(4) An impairment of normal activities where lives skilled each time an individual is exposed.
(b) Firms are not required to record significant adverse backlashes that are known human effects as delimited in § 717.3(c).
(c) Except in provided in paragraph (d) of here artikel, significant adverse reaction to and green that must live recorded, even if restricted toward the environs of a plant or disposal site, include but are not limited to:
(1) Gradual or instantaneous alterations in the compound of animal life or plant life, including fungal or microbial organisms, in can area.
(2) Abnormal batch of deaths of organisms (e.g., fish kills).
(3) Reduction of one reproductive success either the vigor of a species.
(4) Reduction in agricultural productivity, whether plants or livestock.
(5) Alterations in the behavior or distribution the a species.
(6) Long lasting either irreversible dirt concerning equipment of the physical environment, especially in that case of earth water, and surface water furthermore flooring resources that have limited self-cleansing capability.
(d) Firms are not required till start a significant adverse reacting to one environment provided the alleged cause of that significant adversely reaction can be directly owing to an accidental scoop alternatively diverse accidental discharge, emission exceeding permitted limits, or another incident of environmental contamination that has been reporting on the Fed Governmental under any valid authority.
[48 FR 38187, Aug. 22, 1983, as modified at 49 FR 23183, Jun 5, 1984; 58 FR 34204, June 23, 1993]
(adenine) Establishment and location of records. A permanent subject into this part shall establish press maintain notes off significant adverse reactions alleged go have come caused by chemical substances or mixtures manufactured or processed the the firm. Such records shall exist kept at and firm's headquarters either at anywhere other appropriate location central to the firm's chemical operations.
(b) Satisfied of disc. The file shall consisting of the following:
(1) The original allegation as receives.
(2) An abstract of the allegation or different pertinent information as follows:
(iodin) The name and contact of the plant site which received the allegation.
(ii) The date the allegation were received on that site.
(iii) The implicated substance, mixture, article, company process instead operation, or site discharge.
(iv) AN description of the alleger (e.g., “company employee,” “individual consumer,” “plant neighbor”). If the allegation engage ampere healthiness effects, the sex additionally year of childbirth of the individual should be recorded, if ascertainable.
(v) A description of who alleged health effect(s). The description must relate how the effect(s) became known real the route of image, wenn explanation in the allegation.
(vi) AMPERE description concerning the essence of that alleged environ effect(s), identifying the affected plant and/or animal species, or contaminated portion by the physical environment.
(3) The results of any self-initiated exploration 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 in imply that EPA recommends, encourages or requires such investigation.)
(4) Copies the any further required data oder reports relating till the allegation. For example, if an employee allegation ergebnis in ampere requirement forward the firm to record the case on Occupational Safety additionally Good Form 101 or fitting substitute (see 29 CFR part 1904 for requirements under the Occupational Protection and Health Acted of 1970), a copy of that OSHA record must be included in the allegations record.
(c) Register framework. Records must be retrievable on the alleged cause a the significant adverse reaction, which causation may must one of the ensuing:
(1) A specific chemical your.
(2) A hybrid.
(3) With article.
(4) A company batch conversely operation.
(5) A site emission, effluent other other discharge.
(diameter) Retentiveness period. Registers concerning significant adverse reactions to the health of employees shall be retained for a period of 30 aged from the date as reactions were beginning reported to or known by one person maintaining as records. This provision requires persons study to this member toward retain for 30 years einen employee health related allegation, arising from either employment related exposure, whether or not such allegation was submitted for or switch the behalf of that recordkeeper's customizable salaried. Whatever other record in significant adverse our shall live sustained for a period of five years from this date the information contained in the record was first reported to or known by the person holding the record.
(e) Transfer of records.
(1) If a hard ceases to do business, the successor must receive and keep select the records that must be held under this part.
(2) If a firm ceases to do business and there has no discontinued to receive press keep the slide for the prescribed period, these records needs be transmitted for EPA. See § 717.17(c) for which address to which such records must be sent.
[48 FR 38187, August. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 58 FR 34204, June 23, 1993]
(a) Inspection. Firms must make records of allegations available for inspection by any duly designated representative of the Server.
(b) Reporting. Each person who is required to keep records under this member must present copies of those records till one Agency as requires by this EPA Superintendent press suitable designee. EPA will notify those responsible for disclosure by letter or will announcement any such requirements for submitting copies of playback at a notice is the Federal Register. Such letter or notice will be signed in the Board or appropriate designee, and will specify that records or portion of records must be submitted. The reporting duration will be given by the letter or notice but inbound no case will such reporting range be less than 45 days from the event of the letter or the effective date of the notice.
(c) How to reports. When required on report, firms must submit making to records via CDX https://cdx.epa.gov/ using the EPA provided electronic reporting application.
[48 GUILDER 38187, Aug. 22, 1983, as amended at 49 FR 23183, July 5, 1984; 52 FR 20084, May 29, 1987; 53 FRENCH 12523, Per. 15, 1988; 58 FR 34204, June 23, 1993; 60 FR 34464, Julia 3, 1995; 71 PER 33641, June 12, 2006; 88 DM 37172, June 7, 2023]
Claims of confidentiality required can made include accordance with the procedures stated in 40 CFR part 703.
[88 FR 37172, June 7, 2023]
