ICR Attachment 2 - 40 CFR 717; Records and Reports of Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment

Pt. 717

40 CFR Ch. I (7–1–11 Edition)
Category

CAS No.

Special Exemptions

1,3,5-Triazine-2,4,6(1H,3H,5H)-trione,
1,3,5-tris(6isocyanatohexyl)-.
1,3,5-Triazine-2,4-diamine,
6-chloro-N-(1,1dimethylethyl)-N’-ethyl-.
1,3,5-Triazine-2,4-diamine,
6-chloro-N,N’-bis(1methylethyl)-.
1,3,5-Triazine-2,4-diamine,
6-chloro-N-ethyl-N’-(1methylethyl)-.
Urea, (hydroxymethyl)- .....................................................

3779–63–3 .....

§ 716.21(a)(7)

5915–41–3 .....

§ 716.21(a)(7)

139–40–2 .......

§ 716.21(a)(7)

1912–24–9 .....

§ 716.21(a)(7)

1000–82–4 .....

§ 716.21(a)(7)

Urea, N’-(3,4-dichlorophenyl)-N,N-dimethyl- ....................

330–54–1 .......

§ 716.21(a)(7)

Urea, sulfate (1:1) ............................................................

21351–39–3 ...

§ 716.21(a)(7)

Urea, sulfate (2:1) ............................................................

17103–31–0 ...

§ 716.21(a)(7)

Effective
Date

Sunset Date

September
29, 2006
September
29, 2006
September
29, 2006
September
29, 2006
September
29, 2006
September
29, 2006
September
29, 2006
September
29, 2006

November
28, 2006
November
28, 2006
November
28, 2006
November
28, 2006
November
28, 2006
November
28, 2006
November
28, 2006
November
28, 2006

[53 FR 38645, Sept. 30, 1988]
EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 716.120, see the List of CFR
Sections Affected, which appears in the Finding Aids section of the printed volume and at
www.fdsys.gov.
EFFECTIVE DATE NOTE: At 59 FR 14115, Mar. 25, 1994, in § 716.120 paragraph (d), the chemical
substances under the category ‘‘propylene glycol ethers and esters’’ and all related dates,
were stayed effective March 25, 1994.

PART 717—RECORDS AND REPORTS
OF ALLEGATIONS THAT CHEMICAL SUBSTANCES CAUSE SIGNIFICANT ADVERSE REACTIONS
TO HEALTH OR THE ENVIRONMENT
Subpart A—General Provisions
Sec.
717.1 Scope and compliance.
717.3 Definitions.
717.5 Persons subject to this part.
717.7 Persons not subject to this part.
717.10 Allegations subject to this part.
717.12 Significant adverse reactions that
must be recorded.
717.15 Recordkeeping requirements.
717.17 Inspection and reporting requirements.
717.19 Confidentiality.
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 envi-

ronment, 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 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 § 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.

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Environmental Protection Agency

§ 717.5

(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
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 imme-

diate 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-of-way 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.
§ 717.5 Persons subject to this part.
(a) Manufacturers. (1) All manufacturers of chemical substances are subject
to this part except as provided in
§ 717.7(a). If manufacture of a chemcial
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

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§ 717.7

40 CFR Ch. I (7–1–11 Edition)

power to control the management and
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]

§ 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-metal-

lic 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 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

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Environmental Protection Agency

§ 717.12

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]

§ 717.10 Allegations
part.

subject

to

this

(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.

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§ 717.15

40 CFR Ch. I (7–1–11 Edition)

(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. 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.
(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

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Environmental Protection Agency

Pt. 720

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 § 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. 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 (DCO)
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–0001,
ATTN: 8(c) Allegations.

tiality 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.

[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]

§ 717.19 Confidentiality.
(a) Any person submitting copies of
records may assert a business confiden-

PART 720—PREMANUFACTURE
NOTIFICATION
Subpart A—General Provisions
Sec.
720.1
720.3

Scope.
Definitions.

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