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EPA ICR No. 1031.10; OMB Control No. 2070-0017

Attachment 2

Records and Reports of Allegations that Chemical Substances Cause Significant Adverse 

Reactions to Health or the Environment

40 CFR 717
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TITLE 40--PROTECTION OF ENVIRONMENT

CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

PART 717--RECORDS AND REPORTS OF ALLEGATIONS THAT CHEMICAL 

SUBSTANCES CAUSE SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE 

ENVIRONMENT--Table of Contents

Subpart A--General Provisions

Sec. 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.

Sec. 717.3 Definitions.

 The definitions set forth in section 3 of TSCA and the following definitions apply to 

this part:

 (a) Allegation means a statement, made without formal proof or regard for evidence, 

that a chemical substance or mixture has caused a significant adverse reaction to health or the 

environment.

 (b) Firm or company means any person, that is subject to this part, as defined in Sec. 

717.5.

 (c)(1) Known human effects means a commonly recognized human health effect of a 

particular substance or mixture as described either in:

 (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 or process means to manufacture or process for commercial purposes.

 (e)(1) Manufacture for commercial purposes means to import, produce, or manufacture 

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 
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mixture:

 (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 also applies to substances that are produced 

coincidentally during the manufacture, processing, use, or disposal of another substance or 

mixture, including both byproducts that are separated from that other substances or mixture and 

impurities that remain in that substance or mixture. 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.

 (f) Person includes any individual, firm, company, corporation, joint venture, 

partnership, sole proprietorship, association, or any other business entity, any State or political 

subdivision thereof, and any department, agency, or instrumentally of the Federal Government.

 (g) 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.

 (h) Retailer means a person who distributes in commerce a chemical substance, 

mixture, or article to ultimate purchasers who are not commercial entities.

 (i) Significant adverse reactions are reactions that may indicate a substantial 

impairment of normal activities, or long-lasting or irreversible damage to health or the 

environment.

 (j) Site means a contiguous property unit. Property divided only by a public right-ofway is considered one site. There may be multiple manufacturing, processing, or distribution 

activities occurring within a single site.

 (k) Substance means a chemical substance or mixture unless otherwise indicated.

Sec. 717.5 Persons subject to this part.

 (a) Manufacturers. (1) All manufacturers of chemical substances are subject to this part 

except as provided in Sec. 717.7(a). If manufacture of a chemical substance occurs at any site 

owned or controlled by a firm then that firm is subject to this part.

 (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 
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policies of that firm.

 (b) Processors. (1) A person who processes chemical substances, who is not also a 

manufacturer of those chemical substances, is subject to this part if (i) the person processes 

chemical substances to produce mixtures, or (ii) the person repackages chemical substances or 

mixtures.

 (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. SIC codes applicable to this part are published in Standard Industrial 

Classification Manual--1972 and the 1977 Supplement. This manual and supplement may be 

obtained from the U.S. Government Printing Office, Washington, D.C. 20402--stock number 

4101-0006 and stock 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 this part, the definition in this part 

applies.

[48 FR 38187, Aug 22, 1983, as amended at 50 FR 46769, Nov. 13, 1985]

Sec. 717.7 Persons not subject to this part.

 (a) Manufacturers. (1) Persons or site activities are exempt from this part if the means 

by which they manufacture a chemical substance solely involves mining or other solely

extractive functions, e.g., those companies or sites within a company whose sole function is to 

mine mineral ores, extract petroleum or natural gas, quarry non-metallic minerals (including 

extraction of salts from seawater or brines), mine or otherwise extract coal, or separate gases 

from the atmosphere. This exemption may include, but is not necessarily limited to, firms 

engaged in activities as described in SIC Division B--Mining and SIC Code 2813--Industrial 

Gases.

 (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 
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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. A person solely engaged in the distribution of chemical 

substances is exempt from this part, unless such person is also a manufacturer or processor 

subject to this part. For example, a “distributor” who repackages chemical substances or 

mixtures is considered to be a processor and, thus, is not a sole distributor. Sole distributors may

include, but are not limited to, those firms that distribute chemical substances as described in the 

wholesale trade SIC codes 5161--Chemicals and Allied Products, 5171--Petroleum Bulk Stations 

and Terminals, and 5172--Petroleum and Petroleum Products Wholesalers, Except Bulk Stations 

and Terminals.

 (d) Retailers. A person who is a retailer is exempt from this part unless such person is 

also a manufacturer or a processor subject to this part.

[48 FR 38187, Aug 22, 1983, as amended at 50 FR 46770, Nov. 13, 1985]

Sec. 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 
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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.

Sec. 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 Sec. 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]

Sec. 717.15 Recordkeeping requirements.

 (a) Establishment and location of records. A firm subject to this part shall establish and 

maintain records of significant adverse reactions alleged to have been caused by chemical 

substances or mixtures manufactured or processed by the firm. Such records shall be kept at the 

firm’s headquarters or at any other appropriate location central to the firm’s chemical operations.
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 (b) Content of records. The record shall consist of the following:

 (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. Records must be retrievable by the alleged cause of the significant 

adverse reaction, which cause may be one of the following:

 (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. Records of significant adverse reactions to the health of 

employees shall be retained for a period of 30 years from the date such reactions were first 

reported to or known by the person maintaining such records. This provision requires persons 

subject to this part to retain for 30 years an employee health related allegation, arising from any

employment related exposure, whether or not such allegation was submitted by or on the behalf 

of that recordkeeper’s own employee. Any other record of significant adverse reactions shall be 

maintained for a period of five years from the date the information contained in the record was 

first reported to or known by the person maintaining the record.

 (e) Transfer of records. (1) If a firm ceases to do business, the successor must receive 

and keep all the records that must be kept under this part.

 (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 Sec. 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]
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Sec. 717.17 Inspection and reporting requirements.

 (a) Inspection. Firms must make records of allegations available for inspection by any

duly designated representative of the Administrator.

 (b) Reporting. Each person who is required to keep records under this part must submit 

copies of those records to the Agency as required by the EPA Administrator or appropriate 

designee. EPA will notify those responsible for reporting by letter or will announce any such 

requirements for submitting copies of records by a notice in the Federal Register. Such letter or 

notice will be signed by the Administrator or appropriate designee, and will specify which 

records or portion of records must be submitted. The reporting period will be specified by the 

letter or notice but in no case will such reporting period be less than 45 days from the date of the 

letter or the effective date of the notice.

 (c) How to report. When required to report, firms must submit copies of records 

(preferably by certified mail) to the Document Control Office (7407), Office of Pollution 

Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 401 M St., SW., 

Washington, DC., 20460, ATTN: 8(c) Allegations.

[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]

Sec. 717.19 Confidentiality.

 (a) Any person submitting copies of records may assert a business confidentiality claim 

covering all or part of the submitted information. Any information covered by a claim will be 

disclosed by EPA only as provided in procedures set forth at part 2 of this title.

 (b) If no claim accompanies a document at the time it is submitted to EPA, the 

document will be placed in an open file available to the public without further notice to the 

respondent.

 (c) To asset a claim of confidentiality for information contained in a submitted record, 

the respondent must submit two copies of the document.

 (1) One copy must be complete. In that copy, the respondent must indicate what 

information, if any, is claimed as confidential by marking the specific information on each page 

with a label such as “confidential,” “proprietary,” or “trade secret” and briefly state the basis of 

the claim.

 (2) If some information is claimed as confidential, the respondent must submit a 

second copy of the record. The second copy must be complete, except that all information 

claimed as confidential in the first copy must be deleted.

 (3) The first copy will be for internal use by EPA. The second copy will be placed in 

an open file to be available to the public.

 (4) Failure to furnish a second copy when information is claimed as confidential in the 

first copy will be considered a presumptive waiver of the claim of confidentiality. EPA will 

notify the respondent by certified mail that a finding of a presumptive waiver of the claim of 

confidentiality has been made. The respondent will be given 30 days from the date of receipt of 

notification to submit the required second copy. If the respondent fails to submit the second copy 

within the 30 days, EPA will place the first copy in the public file.