Attachment C

Pt. 720

40 CFR Ch. I (7–1–18 Edition)

PART 720—PREMANUFACTURE
NOTIFICATION

Subpart A—General Provisions
§ 720.1

Subpart A—General Provisions
Sec.
720.1
720.3

Scope.
Definitions.

Subpart B—Applicability
720.22 Persons who must report.
720.25 Determining whether a chemical substance is on the Inventory.
720.30 Chemicals not subject to notification
requirements.
720.36 Exemption for research and development.
720.38 Exemptions for test marketing.

Subpart C—Notice Form
720.40 General.
720.45 Information that must be included in
the notice form.
720.50 Submission of test data and other
data concerning the health and environmental effects of a substance.
720.57 Imports.

Subpart D—Disposition of Notices
720.60 General.
720.62 Notice that notification is not required.
720.65 Acknowledgement of receipt of a notice; errors in the notice; incomplete submissions; and false and misleading statements.
720.70 Notice in the Federal Register.
720.75 Notice review period.
720.78 Recordkeeping.

Subpart E—Confidentiality and Public
Access to Information
720.80 General provisions.
720.85 Chemical identity.
720.87 Categories or proposed categories of
uses of a new chemical substance.
720.90 Data from health and safety studies.
720.95 Public file.

Subpart F—Commencement of
Manufacture or Import
720.102 Notice of commencement of manufacture or import.

Subpart G—Compliance and Inspections

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720.120
720.122

Compliance.
Inspections.

AUTHORITY: 15 U.S.C. 2604, 2607, and 2613.
SOURCE: 48 FR 21742, May 13, 1983, unless
otherwise noted.

Scope.

This part establishes procedures for
the reporting of new chemical substances by manufacturers and importers under section 5 of the Toxic Substances Control Act, 15 U.S.C. 2604.
This part applies to microorganisms
only to the extent provided by part 725
of this chapter. The rule defines the
persons and chemical substances subject to the reporting requirements, prescribes the contents of section 5 notices, and establishes procedures for
submitting notices. The rule also establishes EPA policy regarding claims
of confidentiality for, and public disclosure of, various categories of information submitted in connection with
section 5 notices.
[48 FR 21742, May 13, 1983, as amended at 58
FR 34204, June 23, 1993; 62 FR 17932, Apr. 11,
1997]

§ 720.3

Definitions.

(a)(1) For the purposes of this part,
the terms cosmetic, device, drug, food,
and food additive have the meanings
contained in the Federal Food, Drug,
and Cosmetic Act, 21 U.S.C. 321 et seq.,
and the regulations issued under it. In
addition, the term ‘‘food’’ includes
poultry and poultry products, as defined in the Poultry Products Inspection Act, 21 U.S.C. 453 et seq.; meats and
meat food products, as defined in the
Federal Meat Inspection Act, 21 U.S.C.
60 et seq.; and eggs and egg products, as
defined in the Egg Products Inspection
Act, 21 U.S.C. 1033 et seq.
(2) The term pesticide has the meaning contained in the Federal Insecticide, Fungicide, and Rodenticide Act, 7
U.S.C. 136 et seq. and the regulations
issued under it.
(3) The terms byproduct material,
source material, and special nuclear material have the meanings contained in the
Atomic Energy Act of 1954, 42 U.S.C
2014 et seq. and the regulations issued
under it.
(b) Act means the Toxic Substances
Control Act, 15 U.S.C. 2601 et seq.
(c) Article means a manufactured
item:
(1) Which is formed to a specific
shape or design during manufacture;

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Environmental Protection Agency

§ 720.3

(2) Which has end use function(s) dependent in whole or in part upon its
shape or design during end use; and
(3) Which has either no change of
chemical composition during its end
use or only those changes of composition which have no commercial purpose
separate from that of the article and
that may occur as described in
§ 720.30(h)(5), except that fluids and particles are not considered articles regardless of shape or design.
(d) Byproduct means a chemical substance produced without a separate
commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture.
(e) Chemical substance means any organic or inorganic substance of a particular molecular identity, including
any combination of such substances occurring in whole or in part as a result
of a chemical reaction or occurring in
nature, and any chemical element or
uncombined
radical,
except
that
‘‘chemical substance’’ does not include:
(1) Any mixture.
(2) Any pesticide when manufactured,
processed, or distributed in commerce
for use as a pesticide.
(3) Tobacco or any tobacco product.
(4) Any source material, special nuclear material, or byproduct material.
(5) Any pistol, firearm, revolver,
shells, or cartridges.
(6) Any food, food additive, drug, cosmetic, or device, when manufactured,
processed, or distributed in commerce
for use as a food, food additive, drug,
cosmetic, or device.
(f) Commerce means trade, traffic,
transportation, or other commerce (1)
between a place in a State and any
place outside of such State, or (2)
which affects trade, traffic, transportation, or commerce between a place in
a State and any place outside of such
State.
(g) Customs territory of the United
States means the 50 States, Puerto
Rico, and the District of Columbia.
(h) Director means the Director of the
EPA Office of Pollution Prevention and
Toxics.
(i) Distribute in commerce means to
sell in commerce, to introduce or deliver for introduction into commerce,
or to hold after introduction into commerce.

(j) EPA means the U.S. Environmental Protection Agency.
(k) 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 the Act.
Chemical identity is always part of a
health and safety study.
(1) 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.
(2) Examples include:
(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; acute, subchronic, and chronic
effects; and structure/activity analyses.
(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;
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,

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§ 720.3

40 CFR Ch. I (7–1–18 Edition)

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.
(v) Any assessments of risk to health
and the environment resulting from
the manufacture, processing, distribution in commerce, use, or disposal of
the chemical substance.
(l) Importer means any person who
imports a chemical substance, including a chemical substance as part of a
mixture or article, into the customs
territory of the United States. ‘‘Importer’’ includes the person primarily
liable for the payment of any duties on
the merchandise or an authorized
agent acting on his or her behalf. The
term 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; or
(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.
(See ‘‘principal importer.’’)
(m) Impurity means a chemical substance
which
is
unintentionally
present with another chemical substance.
(n) Intermediate means any chemical
substance that is consumed, in whole
or in part, in chemical reactions used
for the intentional manufacture of another chemical substance(s) or mixture(s), or that is intentionally present
for the purpose of altering the rates of
such chemical reactions.
(o) Inventory means the list of chemical substances manufactured or processed in the United States that EPA
compiled and keeps current under section 8(b) of the Act.
(p) Known to or reasonably ascertainable by means all information in a person’s possession or control, plus all information that a reasonable person
similarly situated might be expected to
possess, control, or know.
(q) Manufacture means to produce or
manufacture in the United States or

import into the customs territory of
the United States.
(r) Manufacture or import for commercial purposes means:
(1) To import, produce, or manufacture with the purpose of obtaining an
immediate or eventual commercial advantage for the manufacturer or importer, and includes, among other
things, ‘‘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) The term also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts that are separated from that other
substance or mixture and impurities
that remain in that substance or mixture. Byproducts and impurities without separate commercial value are
nonetheless produced for the purpose of
obtaining a commercial advantage,
since they are part of the manufacture
of a chemical substance for commercial
purposes.
(s) Manufacture solely for export
means to manufacture or import for
commercial purposes a chemical substance solely for export from the
United States under the following restrictions on activities in the United
States:
(1) Distribution in commerce is limited to purposes of export or processing
solely for export as defined in § 721.3 of
this chapter.
(2) The manufacturer or importer,
and any person to whom the substance
is distributed for purposes of export or
processing solely for export (as defined
in § 721.3 of this chapter), may not use
the substance except in small quantities solely for research and development in accordance with § 720.36.
(t) Manufacturer means a person who
imports, 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. A person who contracts with a manufacturer

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Environmental Protection Agency

§ 720.3

to manufacture or produce a chemical
substance is also a manufacturer if (1)
the manufacturer manufactures or produces the substance exclusively for
that person, and (2) that person specifies the identity of the substance and
controls the total amount produced
and the basic technology for the plant
process.
(u) Mixture means any combination of
two or more chemical substances if the
combination does not occur in nature
and is not, in whole or in part, the result of a chemical reaction; except
‘‘mixture’’ does include (1) any combination which occurs, in whole or in
part, as a result of a chemical reaction
if the combination could have been
manufactured for commercial purposes
without a chemical reaction at the
time the chemical substances comprising the combination were combined, and if all of the chemical substances comprising the combination
are not new chemical substances, and
(2) hydrates of a chemical substance or
hydrated ions formed by association of
a chemical substance with water, so
long as the nonhydrated form is itself
not a new chemical substance.
(v) New chemical substance means any
chemical substance which is not included on the Inventory.
(w) Nonisolated intermediate means
any intermediate that is not intentionally removed from the equipment
in which it is manufactured, including
the reaction vessel in which it is manufactured, equipment which is ancillary
to the reaction vessel, and any equipment through which the chemical substance passes during a continuous flow
process, but not including tanks or
other vessels in which the substance is
stored after its manufacture.
(x) Person means any natural person,
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.
(y) Possession or control means in possession or control of the submitter, or
of any subsidiary, partnership in which
the submitter is a general partner, parent company, or any company or part-

nership which the parent company
owns or controls, if the subsidiary, parent company, or other company or
partnership is associated with the submitter in the research, development,
test marketing, or commercial marketing of the chemical substance in
question. (A parent company owns or
controls another company if the parent
owns or controls 50 percent or more of
the other company’s voting stock. A
parent company owns or controls any
partnership in which it is a general
partner). Information is included within this definition if it is:
(1) In files maintained by submitter’s
employees who are:
(i) Associated with research, development, test marketing, or commercial
marketing of the chemical substance
in question.
(ii) Reasonably likely to have such
data.
(2) Maintained in the files of other
agents of the submitter who are associated with research, development, test
marketing, or commercial marketing
of the chemical substance in question
in the course of their employment as
such agents.
(z) Principal importer means the first
importer who, knowing that a new
chemical substance will be imported
rather than manufactured domestically, specifies the identity of the
chemical substance and the total
amount to be imported. Only persons
who are incorporated, licensed, or
doing business in the United States
may be principal importers.
(aa) Process means the preparation of
a chemical substance or mixture, after
its manufacture, for distribution in
commerce (1) in the same form or physical state as, or in a different form or
physical state from, that in which it
was received by the person so preparing
such substance or mixture, or (2) as
part of a mixture or article containing
the chemical substance or mixture.
(bb) Processor means any person who
processes a chemical substance or mixture.
(cc) Small quantities solely for research
and development (or ‘‘small quantities
solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including

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§ 720.22

40 CFR Ch. I (7–1–18 Edition)

such research or analysis for the development of a product’’) means quantities of a chemical substance manufactured, imported, or processed or proposed to be manufactured, imported, or
processed solely for research and development that are not greater than reasonably necessary for such purposes.
(dd) State means any State of the
United States and the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, the
Canal Zone, American Samoa, the
Northern Mariana Islands, and any
other territory or possession of the
United States.
(ee) Technically qualified individual
means a person or persons (1) who, because of education, training, or experience, or a combination of these factors,
is capable of understanding the health
and environmental risks associated
with the chemical substance which is
used under his or her supervision, (2)
who is responsible for enforcing appropriate methods of conducting scientific
experimentation, analysis, or chemical
research to minimize such risks, and
(3) who is responsible for the safety assessments and clearances related to the
procurement, storage, use, and disposal
of the chemical substance as may be
appropriate or required within the
scope of conducting a research and development activity.
(ff) Test data means data from a formal or informal test or experiment, including information concerning the objectives, experimental methods and
materials, protocols, results, data analyses, recorded observations, monitoring data, measurements, and conclusions from a test or experiment.
(gg) Test marketing means the distribution in commerce of no more than
a predetermined amount of a chemical
substance, mixture, or article containing that chemical substance or
mixture, by a manufacturer or processor, to no more than a defined number of potential customers to explore
market capability in a competitive situation during a predetermined testing
period prior to the broader distribution
of that chemical substance, mixture, or
article in commerce.
(hh) United States, when used in the
geographic sense, means all of the
States.

(ii) Central Data Exchange or CDX
means EPA’s centralized electronic
document receiving system, or its successors.
(jj) e-PMN software means electronicPMN software created by EPA for use
in
preparing
and
submitting
Premanufacture Notices (PMNs) and
other TSCA section 5 notices and support documents electronically to the
Agency.
(kk) Support documents means material and information submitted to EPA
in support of a TSCA section 5 notice,
including but not limited to, correspondence, amendments (if notices
for these amendments were submitted
prior to January 19, 2016), and test
data. The term ‘‘support documents’’
does not include orders under TSCA
section 5(e) (either consent orders or
orders imposed pursuant to TSCA section 5(e)(2)(B)).
[48 FR 21742, May 13, 1983, as amended at 51
FR 15101, Apr. 22, 1986; 75 FR 784, Jan. 6, 2010;
80 FR 42745, July 20, 2015]

Subpart B—Applicability
§ 720.22 Persons who must report.
(a)(1) Any person who intends to
manufacture a new chemical substance
in the United States for commercial
purposes must submit a notice unless
the substance is excluded under § 720.30.
(2) If a person contracts with a manufacturer to manufacture or produce a
new chemical substance, and (i) the
manufacturer manufactures or produces the substance exclusively for
that person, and (ii) that person specifies the identity of the substance, and
controls the total amount produced
and the basic technology for the plant
process, that person must submit the
notice. If it is unclear who must report,
EPA should be contacted to determine
who must submit the notice.
(3) Only manufacturers that are incorporated, licensed, or doing business
in the United States may submit a notice.
(b)(1) Any person who intends to import a new chemical substance into the
United States for commercial purposes
must submit a notice, unless the substance is excluded under § 720.30 or unless the substance is imported as part
of an article.

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§ 720.25

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(2) When several persons are involved
in an import transaction, the notice
must be submitted by the principal importer. If no one person fits the principal importer definition in a particular transaction, the importer
should contact EPA to determine who
must submit the notice for that transaction.
§ 720.25 Determining whether a chemical substance is on the Inventory.
(a) A new chemical substance is any
chemical substance that is not currently listed on the Inventory.
(b)(1) A chemical substance is listed
in the public portion of the Inventory
by a specific chemical name (either a
Chemical Abstracts (CA) Index Name
or a CA Preferred Name) and a Chemical Abstracts Service (CAS) Registry
Number if its identity is not confidential. If its identity is confidential, it is
listed in the public portion of the Inventory by a TSCA Accession Number
and a generic chemical name that
masks the specific substance identity.
The confidential substance is listed by
its specific chemical name only in the
confidential portion of the Inventory,
which is not available to the public. A
person who intends to manufacture (including import) a chemical substance
not listed by specific chemical name in
the public portion of the Inventory
may ask EPA whether the substance is
included in the confidential Inventory.
EPA will answer such an inquiry only
if EPA determines that the person has
a bona fide intent to manufacture (including import) the chemical substance
for commercial purposes.
(2) To establish a bona fide intent to
manufacture (including import) a
chemical substance, the person who
proposes to manufacture the substance
must submit the request to EPA via
CDX. Prior to submission to EPA via
CDX, such bona fide intents to manufacture (including import) must be generated and completed using e-PMN
software. See § 720.40(a)(2)(ii) for information on how to access the e-PMN
software. A bona fide intent to manufacture (including import) must contain:
(i) Except as provided in paragraphs
(b)(3)(i) and (ii) of this section, the specific chemical identity of the substance

that the person intends to manufacture
(including import), using the currently
correct CA Index name for the substance and the other correct chemical
identity information in accordance
with § 720.45(a) (1), (2), and (3).
(ii) A signed statement that the person intends to manufacture (including
import) that chemical substance for
commercial purposes.
(iii)(A) A brief description of the research and development activities conducted to date related to the substance, including the year in which the
person first started to conduct research
or development activity on the substance, and the general types of research and development activities conducted thus far (e.g., synthesis, substance isolation/purification, formulating, product development, process
development, end-use application, toxicity testing, etc.). The person must
also indicate whether any pilot plant
or production-scale plant evaluations
have been conducted involving the
manufacture or processing of the substance.
(B) If an importer is unable to provide the information requested in paragraph (b)(2)(iii)(A) of this section from
the foreign manufacturer or supplier,
the following information shall be submitted:
(1) A brief statement indicating how
long the substance has been in commercial use outside of the United
States.
(2) The name of a country in which it
has been commercially used.
(3) Whether the importer believes
that the substance has already been
used commercially, in any country, for
the same purpose or application that
the importer is intending.
(iv) A specific description of the
major intended application or use of
the substance.
(v) An infrared spectrum of the substance, or alternative spectra or other
data which identify the substance if infrared analysis is not suitable for the
substance or does not yield a reasonable amount of structural information.
When using alternative spectra or instrumental analysis, the person must
submit a spectrum or instrumental
readout for the substance.

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§ 720.25

40 CFR Ch. I (7–1–18 Edition)

(vi) The estimated date (month/year)
in which the person intends to submit
a Premanufacture Notice (PMN) for
this substance if EPA informs the notice submitter that the substance is
not on the Inventory.
(vii) The address of the facility under
the control of the submitter at which
the manufacture or processing of the
substance would most likely occur. For
an imported substance, the facility
under the control of the importer at
which processing of the substance
would likely occur, if any.
(viii)(A) For substances intended to
be manufactured in the United States,
a description of the most probable
manufacturing process that would be
used by the submitter to produce the
substance for non-exempt commercial
purposes.
(B) For substances intended to be imported, a brief description of how the
submitter is most likely to process or
use the substance for a commercial
purpose. If the substance is not expected to be processed or used at any
facility under the importer’s control, a
statement to this effect must be included along with a description of how
the substance will be processed or used
at sites controlled by others, if this information is known or reasonably ascertainable.
(3)(i) If an importer cannot provide
the chemical identity information required by paragraph (b)(2) (i) and (v) of
this section because it is claimed confidential by its foreign manufacturer or
supplier, the foreign manufacturer or
supplier must supply the required information directly to EPA in accordance with § 720.45(a) (1), (2), and (3) and
reference the importer’s notice. If the
appropriate supporting document from
the foreign party is not received within
30 days after EPA receives the importer’s notice, the notice will be considered incomplete.
(ii) If a manufacturer cannot provide
all of the required information in accordance with § 720.45(a) (1), (2), and (3)
because the new chemical substance is
manufactured using a reactant that
has a specific chemical identity
claimed as confidential by its supplier,
the notice must contain chemical identity information that is as complete as
known by the manufacturer. In addi-

tion, a letter of support for the notice
must then be sent to EPA by the chemical supplier of the confidential
reactant, providing the specific chemical identity of the proprietary
reactant. The letter of support must
reference the manufacturer’s notice. If
the appropriate supporting document
from the supplier is not received within
30 days after EPA receives the manufacturer’s notice, the notice will be
considered incomplete.
(4) EPA will review the information
submitted by the proposed manufacturer (including importer) under this
paragraph to determine whether it has
a bona fide intent to manufacture (including import) the chemical substance. If necessary, EPA will compare
this information to the information requested for the confidential chemical
substance under § 720.85(b)(3)(iii).
(5) If the proposed manufacturer (including importer) has shown a bona fide
intent to manufacture (including import) the substance, and has provided
sufficient unambiguous chemical identity information so EPA can make a
conclusive determination of the chemical substance’s Inventory status, EPA
will search the confidential Inventory
and inform the proposed manufacturer
(including
importer)
whether
the
chemical substance is on the confidential Inventory.
(6) If the chemical substance is found
on the confidential Inventory, EPA
will notify the person(s) who originally
reported the chemical substance that
another person has demonstrated a
bona fide intent to manufacture (including import) the substance and
therefore was told that the chemical
substance is on the Inventory.
(7) A disclosure of a confidential
chemical identity to a person with a
bona fide intent to manufacture (including import) the particular chemical substance will not be considered a
public disclosure of confidential business information under section 14 of
the Act.
(8) EPA will answer an inquiry on
whether a particular chemical substance is on the confidential Inventory
within 30 days after receipt of a complete submission under paragraph (b)(2)
of this section.

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§ 720.30

(9) If the required chemical identity
information has not been reported correctly or completely in the notice (except as provided under paragraph
(b)(3)(ii) of this section) or if any other
required data or information has been
omitted or is incomplete, EPA will
consider the whole notice to be incomplete. As soon as an incomplete notice
is identified as such by EPA, the Agency will immediately return the notice
directly to the submitter. The submitter must then resubmit the whole,
completed bona fide notice to EPA in
order to have the Agency perform the
desired Inventory search and respond
to the notice.
[48 FR 21742, May 13, 1983, as amended at 58
FR 34204, June 23, 1993; 60 FR 16309, Mar. 29,
1995; 80 FR 42745, July 20, 2015]

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§ 720.30 Chemicals not subject to notification requirements.
The following substances are not subject to the notification requirements of
this part:
(a) Any substance which is not a
‘‘chemical substance’’ as defined in
§ 720.3(e).
(b) Any mixture as defined in
§ 720.3(u). 1
(c) Any new chemical substance
which will be manufactured or imported in small quantities solely for research and development under § 720.36.
(d) Any new chemical substance
which will be manufactured or imported solely for test-marketing purposes under an exemption granted
under § 720.38.
(e) Any new chemical substance manufactured solely for export if, when the
substance is distributed in commerce:
(1) The substance is labeled in accordance with section 12(a)(1)(B) of the
Act.
(2) The manufacturer knows that the
person to whom the substance is being
distributed intends to export it or process it solely for export as defined in
§ 721.3 of this chapter.
(f) Any new chemical substance
which is manufactured or imported
1 A new chemical substance that is manufactured or imported as part of a mixture is
subject to the requirements of this part. This
exclusion applies only to a mixture as a
whole and not to any chemical substances
which are part of the mixture.

under the terms of a rule promulgated
under section 5(h)(4) of the Act.
(g) Any byproduct if its only commercial purpose is for use by public or
private organizations that (1) burn it
as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching
soil, or (3) extract component chemical
substances from it for commercial purposes. (This exclusion only applies to
the byproduct; it does not apply to the
component substances extracted from
the byproduct.)
(h) The chemical substances described below: (Although they are manufactured for commercial purposes
under the Act, they are not manufactured for distribution in commerce as
chemical substances per se and have no
commercial purpose separate from the
substance, mixture, or article of which
they are a part.)
(1) Any impurity.
(2) Any byproduct which is not used
for commercial purposes.
(3) Any chemical substance which results from a chemical reaction that occurs incidental to exposure of another
chemical substance, mixture, or article
to environmental factors such as air,
moisture, microbial organisms, or sunlight.
(4) Any chemical substance which results from a chemical reaction that occurs incidental to storage or disposal of
another chemical substance, mixture,
or article.
(5) Any chemical substance which results from a chemical reaction that occurs upon end use of another chemical
substance, mixture, or article such as
an adhesive, paint, miscellaneous
cleanser or other housekeeping product, fuel additive, water softening and
treatment agent, photographic film,
battery, match, or safety flare, and
which is not itself manufactured or imported for distribution in commerce or
for use as an intermediate.
(6) Any chemical substance which results from a chemical reaction that occurs upon use of curable plastic or rubber molding compounds, inks, drying
oils, metal finishing compounds, adhesives, or paints, or any other chemical
substance formed during the manufacture of an article destined for the marketplace without further chemical

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§ 720.36

40 CFR Ch. I (7–1–18 Edition)

change of the chemical substance except for those chemical changes that
occur as described elsewhere in this
paragraph.
(7) Any chemical substance which results from a chemical reaction that occurs when (i) 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 neutralizer, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality
control reagent functions as intented,
or (ii) a chemical substance, which is
intended solely to impart a specific
physiochemical characteristic, functions as intended.
(8) Any nonisolated intermediate.
(i) Any chemical substance which is
manufactured solely for non-commercial research and development purposes. Non-commercial research and
development purposes include scientific experimentation, research, or
analysis conducted by academic, government, or independent not-for-profit
research organizations (e.g., universities, colleges, teaching hospitals, and
research institutes), unless the activity
is for eventual commercial purposes.

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[48 FR 21742, May 13, 1983, as amended at 51
FR 15101, Apr. 22, 1986]

§ 720.36 Exemption for research and
development.
(a) This part does not apply to a
chemical substance if the following
conditions are met:
(1) The chemical substance is manufactured or imported only in small
quantities solely for research and development.
(2) The manufacturer or importer notifies all persons in its employ or to
whom it directly distributes the chemical substance, who are engaged in experimentation, research, or analysis on
the chemical substance, including the
manufacture, processing, use, transport, storage, and disposal of the substance associated with research and development activities, of any risk to
health, identified under paragraph (b)
of this section, which may be associ-

ated with the substance. The notification must be made in accordance with
paragraph (c) of this section.
(3) The chemical substance is used
by, or directly under the supervision
of, a technically qualified individual.
(b)(1) To determine whether notification under paragraph (a)(2) of this section is required, the manufacturer or
importer must review and evaluate the
following information to determine
whether there is reason to believe
there is any potential risk to health
which may be associated with the
chemical substance:
(i) Information in its possession or
control concerning any significant adverse reaction by persons exposed to
the chemical substance which may reasonably be associated with such exposure.
(ii) Information provided to the manufacturer or importer by a supplier or
any other person concerning a health
risk believed to be associated with the
substance.
(iii) Health and environmental effects data in its possession or control
concerning the substance.
(iv) Information on health effects
which accompanies any EPA rule or
order issued under sections 4, 5, or 6 of
the Act that applies to the substance
and of which the manufacturer or importer has knowledge.
(2) When the research and development activity is conducted solely in a
laboratory and exposure to the chemical substance is controlled through
the implementation of prudent laboratory practices for handling chemical
substances of unknown toxicity, and
any distribution, except for purposes of
disposal, is to other such laboratories
for further research and development
activity, the information specified in
paragraph (b)(1) of this section need
not be reviewed and evaluated. (For
purposes of this paragraph, a laboratory is a contained research facility
where relatively small quantities of
chemical substances are used on a nonproduction basis, and where activities
involve the use of containers for reactions, transfers, and other handling of
substances designed to be easily manipulated by a single individual.)
(c)(1) The manufacturer or importer
must notify the persons identified in

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Environmental Protection Agency

§ 720.38

paragraph (a)(2) of this section by
means of a container labeling system,
conspicuous placement of notices in
areas where exposure may occur, written notification to each person potentially exposed, or any other method of
notification which adequately informs
persons of health risks which the manufacturer or importer has reason to believe may be associated with the substance, as determined under paragraph
(b)(1) of this section.
(2) If the manufacturer or importer
distributes a chemical substance manufactured or imported under this section to persons not in its employ, the
manufacturer or importer must in
written form:
(i) Notify those persons that the substance is to be used only for research
and development purposes.
(ii) Provide the notice of health risks
specified in paragraph (c)(1) of this section.
(3) The adequacy of any notification
under this section is the responsibility
of the manufacturer or importer.
(d) A chemical substance is not exempt from reporting under this part if
any amount of the substance, including
as part of a mixture, is processed, distributed in commerce, or used, for any
commercial purpose other than research and development, except where
the chemical substance is processed,
distributed in commerce, or used only
as an impurity or as part of an article.
(e) Quantities of the chemical substance, or of mixtures or articles containing the chemical substance, remaining after completion of research
and development activities may be:
(1) Disposed of as a waste in accordance with applicable Federal, state,
and local regulations, or
(2) Used for the following commercial
purposes:
(i) Burning it as a fuel.
(ii) Reacting or otherwise processing
it to form other chemical substances
for commercial purposes, including extracting component chemical substances.
(f) Quantities of research and development substances existing solely as
impurities in a product or incorporated
into an article, in accordance with
paragraph (d) of this section, and quantities of research and development sub-

stances used solely for commercial purposes listed in paragraph (e) of this section, are not subject to the requirements of paragraphs (a), (b), and (c) of
this section, once research and development activities have been completed.
(g) A person who manufactures or imports a chemical substance in small
quantities solely for research and development is not required to comply
with the requirements of this section if
the person’s exclusive intention is to
perform research and development activities solely for the purpose of determining whether the substance can be
used as a pesticide.
[51 FR 15102, Apr. 22, 1986]

§ 720.38 Exemptions
keting.

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(a) Any person may apply for an exemption to manufacture or import a
new chemical substance for test marketing. EPA may grant the exemption
if the person demonstrates that the
chemical substance will not present an
unreasonable risk to injury to health
or the environment as a result of the
test marketing.
(b) Persons applying for a test-marketing exemption should provide the
following information:
(1) All existing data regarding health
and environmental effects of the chemical substance, including physical/
chemical properties or, in the absence
of such data, a discussion of toxicity
based on structure-activity relationships (SAR) and relevant data on chemical analogues.
(2) The maximum quantity of the
chemical substance which the applicant will manufacture or import for
test marketing.
(3) The maximum number of persons
who may be provided the chemical substance during test marketing.
(4) The maximum number of persons
who may be exposed to the chemical
substance as a result of test marketing, including information regarding duration and route of such exposures.
(5) A description of the test-marketing activity, including its length
and how it can be distinguished from
full-scale commercial production and
research and development.

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§ 720.40

40 CFR Ch. I (7–1–18 Edition)

(c) In accordance with section 5(h)(6)
of the Act, after EPA receives an application for exemption under this section, the Agency will file with the Office of the Federal Register a notice
containing a summary of the information provided in the application, to the
extent it has not been claimed confidential.
(d) No later than 45 days after EPA
receives an application, the Agency
will either approve or deny the application. Thereafter, EPA will publish a
notice in the FEDERAL REGISTER explaining the reasons for approval or denial.
(e) In approving an application for
exemption, EPA may impose any restrictions necessary to ensure that the
substance will not present an unreasonable risk of injury to health and the
environment as a result of test marketing.
[48 FR 21742, May 13, 1983, as amended at 58
FR 34204, June 23, 1993]

Subpart C—Notice Form

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§ 720.40

General.

(a) Use of the notice form; electronic
submissions. (1) Each person who is required by subpart B of this part to submit a notice must complete, sign, and
submit a notice containing the information in the form and manner specified in this paragraph. The information
submitted and all attachments (unless
the attachment appears in the open
scientific literature) must be in
English. All information submitted
must be true and correct.
(2) All notices must be submitted on
EPA Form 7710–25. Notices, and any
support documents related to these notices, may only be submitted in a manner set forth in this paragraph.
(i) Submission via CDX. TSCA section
5 notices and any related support documents must be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, such notices
must be generated and completed on
EPA Form 7710–25 using e-PMN software.
(ii) You can access the e-PMN software as follows:
(A) Website. Go to EPA’s TSCA New
Chemicals Program website at http://

www.epa.gov/oppt/newchems and follow
the appropriate links.
(B) Telephone. Call the EPA CDX
Help Desk at 1–888–890–1995.
(C) E-mail. [email protected].
(b) When to submit a notice. Each person who is required to submit a notice
must submit the notice at least 90 calendar days before manufacture or import of the new chemical substance for
commercial purposes begins.
(c) Where to submit a notice or support
documents. For submitting notices or
support documents via CDX, use the ePMN software.
(d) General notice requirements. (1)
Each person who submits a notice must
provide the information described in
§ 720.45 and specified on the notice
form, to the extent such information is
known to or reasonably ascertainable
by the person. In accordance with
§ 720.50, the notice must also include
any test data in the person’s possession
or control, and descriptions of other
data which are known to or reasonably
ascertainable by the person and which
concern the health and environmental
effects of the new chemical substance.
(2) If information is claimed as confidential pursuant to § 720.80, a person
who submits a notice to EPA in the
manner set forth in § 720.40(a)(2)(i), (ii),
or (iii) must also provide EPA with a
sanitized copy.
(e) Agency or joint submissions—(1) A
manufacturer
(including
importer)
may designate an agent to assist in
submitting the notice. If so, only the
manufacturer (including importer), and
not the agent, signs the certification
on the form.
(2) A manufacturer or importer may
authorize another person, (e.g., a supplier or a toll manufacturer) to report
some of the information required in the
notice to EPA on its behalf. The manufacturer or importer should indicate in
a cover letter accompanying the notice
which information will be supplied by
another person and must identify that
other person as a joint submitter where
indicated on their notice form. The
other person supplying information
(i.e., the joint submitter) may submit
the information to EPA using either
the notice form or a Letter of Support,
except that if the joint submitter is
not incorporated, licensed, or doing

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Environmental Protection Agency

§ 720.45

business in the United States, the joint
submitter must submit the information to EPA in a Letter of Support
only, not in a notice form. The joint
submitter must indicate in the notice
or Letter of Support the identity of the
manufacturer or importer. Any person
who submits a notice form or Letter of
Support for a joint submission must
sign and certify the notice form or Letter of Support.
(3) Only the Authorized Official (AO)
of a submitting company can certify
initial notices and submit all TSCA
section 5 documents.
(i) An AO can authorize other persons
to be non-certifying AOs who may conduct all section 5 business on behalf of
the submitting company except for certifying and submitting initial notices
to EPA via CDX.
(ii) An AO may grant access to a support registrant to edit section 5 documents.
(f) New information. During the notice
review period, if the submitter possesses, controls, or knows of new information that materially adds to,
changes, or otherwise makes significantly more complete the information
included in the notice, the submitter
must that information to the address
listed on the notice form within ten
days of receiving the new information,
but no later than five days before the
end of the notice review period. The
new submission must clearly identify
the submitter and the notice to which
the new information is related. If the
new information becomes available
during the last five days of the notice
review period, the submitter must immediately inform its EPA contract for
that notice by telephone.
(g) Chemical substances subject to a section 4 test rule. (1) Except as provided in
paragraph (g)(3) of this section, if (i) A
person intends to manufacture or import a new chemical substance which is
subject to the notification requirements of this part, and (ii) The chemical substance is subject to a test rule
promulgated under section 4 of the Act
before the notice is submitted, section
5(b)(1) of the Act requires the person to
submit the test data required by the
testing rule with the notice. The person must submit the data in the form
and manner specified in the test rule

and in accordance with § 720.50. If the
person does not submit the test data,
the submission is incomplete and EPA
will follow the procedures in § 720.65.
(2) If EPA has granted the submitter
an exemption under section 4(c) of the
Act from the requirement to conduct
tests and submit data, the submitter
may not submit a notice until EPA receives the test data.
(3) If EPA has granted the submitter
an exemption under section 4(c) of the
Act and if another person previously
has submitted the test data to EPA,
the exempted person may either submit the test data or provide the following information as part of the notice:
(i) The name, title, and address of the
person who submitted the test data to
EPA.
(ii) The date the test data were submitted to EPA.
(iii) A citation for the test rule.
(iv) A description of the exemption
and a reference identifying it.
(h) Chemical substances subject to a
section 5(b)(4) rule. (1) If a person (i) intends to manufacture or import a new
chemical substance which is subject to
the notification requirements of this
part and which is subject to a rule
issued under section 5(b)(4) of the Act;
and (ii) is not required by a rule issued
under section 4 of the Act to submit
test data for the substance before the
submission of a notice, the person must
submit to EPA data described in paragraph (h)(2) of this section at the time
the notice is submitted.
(2) Data submitted under paragraph
(h)(1) of this section must be data
which the person submitting the notice
believes show that the manufacture,
processing, distribution in commerce,
use and disposal of the substance, or
any combination of such activities,
will not present an unreasonable risk
of injury to health or the environment.
[48 FR 21742, May 13, 1983, as amended at 58
FR 34204, June 23, 1993; 60 FR 16309, Mar. 29,
1995; 75 FR 784, Jan. 6, 2010; 78 FR 72827, Dec.
4, 2013; 80 FR 42746, July 20, 2015]

§ 720.45 Information that must be included in the notice form.
Each person who submits a notice
must include the information specified
in the notice form to the extent it is

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§ 720.45

40 CFR Ch. I (7–1–18 Edition)

known to or reasonably ascertainable
by the submitter. However, no person
is required to include information
which relates solely to exposure of
human or ecological populations outside of the United States. The notice
form requires the following information relating to the manufacture, processing, distribution in commerce, use,
and disposal of the new chemical substance:
(a)(1) The specific chemical identity
of the substance that the person intends to manufacture or import, which
includes the following:
(i) The currently correct Chemical
Abstracts (CA) name for the substance,
based on the Ninth Collective Index
(9CI) of CA nomenclature rules and
conventions, and consistent with listings for similar substances in the Inventory. For each substance having a
chemical composition that can be represented by a specific, complete chemical structure diagram (a Class 1 substance), a CA Index Name must be provided. For each chemical substance
that cannot be fully represented by a
complete, specific chemical structure
diagram (a Class 2 substance), or if the
substance is a polymer, a CA Index
Name or CA Preferred Name must be
provided (whichever is appropriate
based on CA 9CI nomenclature rules
and conventions). In addition, for a
Class 2 substance, the notice must
identify the immediate chemical precursors and reactants by specific chemical name and Chemical Abstracts
Service Registry Number (CASRN), if
the number is available. Tradenames or
generic names of chemical precursors
or reactants are not acceptable as substitutes for specific chemical names.
(ii) The currently correct CASRN for
the substance if a CASRN already exists for the substance.
(iii) For a Class 1 substance and for
any Class 2 substance for which a definite molecular formula is known or
reasonably ascertainable, the correct
molecular formula.
(iv) For a Class 1 substance, a complete, correct chemical structure diagram; for a Class 2 substance or polymer, a correct representative or partial
chemical structure diagram, as complete as can be known, if one can be
reasonably ascertained.

(2) For a polymer, the submitter
must also report the following:
(i) The specific chemical name and
CASRN, if the number is available, of
each monomer and other reactant used,
at any weight percent, to manufacture
the polymer. Tradenames or generic
names of chemical reactants or monomers are not acceptable as substitutes
for specific chemical names.
(ii) The typical percent by weight of
each monomer and other reactant in
the polymer (weight of the monomer or
other reactant expressed as a percentage of the weight of the polymeric
chemical substance manufactured), and
the maximum residual amount of each
monomer present in the polymer.
(iii) For monomers and other
reactants used at 2 weight percent or
less (based on the dry weight of the
polymer manufactured), indicate on
the PMN form any such monomers and
other reactants that should be included
as part of the polymer description on
the Inventory, where the weight percent is based on either (A) the weight
of monomer or other reactant actually
charged to the reaction vessel, or (B)
the minimum weight of monomer or
other reactant required in theory to
account for the actual weight of monomer or other reactant molecules or
fragments
chemically
incorporated
(chemically combined) in the polymeric substance manufactured.
(iv) For a determination that 2
weight percent or less of a monomer or
other reactant is incorporated (chemically combined) in a polymeric substance manufactured, as specified in
paragraphs (a)(2)(iii)(B) of this section,
analytical data or appropriate theoretical calculations (if it can be documented that analytical measurement is
not feasible or not necessary) to support this determination must be maintained at the site of manufacture or
import of the polymer.
(v) Measured or estimated values of
the minimum number-average molecular weight of the polymer and the
amount of low molecular weight species below 500 and below 1,000 molecular weight, with a description of how
the measured or estimated values were
obtained.
(3) The person must use one of the
following two methods to develop or

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Environmental Protection Agency

§ 720.45

obtain the specified chemical identity
information reported under paragraphs
(a) (1) and (2) of this section and must
identify the method used in the notice:
(i) Method 1. Obtain the correct
chemical identity information required
by paragraphs (a) (1) and (2) of this section directly from the Chemical Abstracts Service (CAS), specifically from
the CAS Registry Services Inventory
Expert Service, prior to submitting a
notice to EPA. A copy of the chemical
identification report obtained from
CAS must be submitted with the notice.
(ii) Method 2. Obtain the correct
chemical identity information required
by paragraphs (a) (1) and (2) from any
source. The notice will be incomplete
according to § 720.65(c)(1)(vi) if the person uses Method 2 and any chemical
identity information is determined to
be incorrect by EPA.
(4) If an importer submitting the notice cannot provide all the information
specified in paragraphs (a) (1) and (2) of
this section because it is claimed as
confidential by the foreign supplier of
the substance, the importer must have
the foreign supplier follow the procedures in paragraph (a)(3) of this section
and provide the correct chemical identity information specified in paragraphs (a) (1) and (2) of this section directly to EPA in a joint submission or
as a letter of support to the notice,
which clearly references the importer’s
notice and PMN User Fee Identification Number. The statutory review
process will commence upon receipt of
both the notice and the complete, correct information.
(5) If a manufacturer cannot provide
all the information specified in paragraphs (a) (1) and (2) of this section because the new chemical substance is
manufactured using a reactant having
a specific chemical identity claimed as
confidential by its supplier, the manufacturer must submit a notice directly
to EPA containing all the information
known by the manufacturer about the
chemical identity of the reported substance and its proprietary reactant. In
addition, the manufacturer must ensure that the supplier of the confidential reactant submit a letter of support
directly to EPA providing the specific
chemical identity of the confidential

reactant, including the CAS number, if
available, and the appropriate PMN or
exemption number, if applicable. The
letter of support must reference the
manufacturer’s name and PMN User
Fee
Identification
Number
under
§ 700.45(c)(3) of this chapter. The statutory review period will commence upon
receipt of both the notice and the letter of support.
(b) The impurities anticipated to be
present in the substance by name, CAS
Registry number, and weight percent
of the total substance.
(c) Known synonyms or trade names
of the new chemical substance.
(d) A description of the byproducts
resulting from the manufacture, processing, use, and disposal of the new
chemical substance.
(e) The estimated maximum amount
to be manufactured or imported during
the first year of production and the estimated maximum amount to be manufactured or imported during any 12month period during the first three
years of production.
(f) A description of intended categories of use by function and application, the estimated percent of production volume devoted to each category
of use, and the percent of the new substance in the formulation for each
commercial or consumer use.
(g) For sites controlled by the submitter:
(1) The identity of sites where the
new substance will be manufactured,
processed, or used.
(2) A process description of each manufacture, processing, and use operation
which includes a diagram of the major
unit operations and chemical conversions, the identity and entry point of
all feedstocks, and the points of release
of the new chemical substance.
(3) Worker exposure information, including worker activities, physical
form of the new substance to which
workers may be exposed, the number of
workers, and the duration of activities.
(4) Information on release of the new
substance to the environment, including the quantity and media of release
and type of control technology used.
(h) For sites not controlled by the
submitter, a description of each type of
processing and use operation involving
the new chemical substance, including

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§ 720.50

40 CFR Ch. I (7–1–18 Edition)

identification of the estimated number
of processing or use sites, situations in
which worker exposure to and/or environmental release of the new chemical
substance will occur, the number of
workers exposed and the duration of
exposure, and controls which limit
worker exposure and environmental release.

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[48 FR 21742, May 13, 1983, as amended at 60
FR 16310, Mar. 29, 1995]

§ 720.50 Submission of test data and
other data concerning the health
and environmental effects of a substance.
(a) Test data on the new chemical substance in the possession or control of the
submitter. (1) Except as provided in
paragraph (d) of this section, each notice must contain all test data in the
submitter’s possession or control which
are related to the effects on health or
the environment of any manufacture,
processing, distribution in commerce,
use, or disposal of the new chemical
substance or any mixture or article
containing the new chemical substance, or any combination of such activities. This includes test data concerning the new chemical substance in
a pure, technical grade, or formulated
form.
(2) A full report or standard literature citation must be submitted for
the following types of test data:
(i) Health effects data.
(ii) Ecological effects data.
(iii) Physical and chemical properties
data.
(iv) Environmental fate characteristics.
(v) Monitoring data and other test
data related to human exposure to or
environmental release of the chemical
substance.
(3)(i) If the data do not appear in the
open scientific literature, the submitter must provide a full report. A
full report includes the experimental
methods and materials, results, discussion and data analysis, conclusions,
references, and the name and address of
the laboratory that developed the data.
(ii) If the data appear in the open scientific literature, the submitter need
only provide a standard literature citation. A standard literature citation includes author, title, periodical name,

date of publication, volume, and page
numbers.
(4)(i) If a study, report, or test is incomplete when a person submits a notice, the submitter must identify the
nature and purpose of the study; name
and address of the laboratory developing the data; progress to date; types
of data collected; significant preliminary results; and anticipated completion date.
(ii) If a test or experiment is completed before the notice review period
ends, the person must submit the
study, report, or test to the address
listed on the notice form, as specified
in paragraph (a)(3)(i) of this section,
within ten days of receiving it, but no
later than five days before the end of
the review period. If the test or experiment is completed during the last five
days of the review period, the submitter must immediately inform its
EPA contact for that notice by telephone.
(5) For test data in the submitter’s
possession or control which are not
listed in paragraph (a)(2) of this section, a person is not required to submit
a complete report. The person must
submit a summary of the data. If EPA
so requests, the person must submit a
full report within ten days of the request, but no later than five days before the end of the review period.
(6) All test data described by paragraph (a) are subject to these requirements, regardless of their age, quality,
or results.
(b) Other data concerning the health
and environmental effects of the new
chemical substance that are known to or
reasonably ascertainable by the submitter.
(1) Except as provided in paragraph (d)
of this section, any person who submits
a notice must describe the following
data, including any data from a health
and safety study, if the data are related to the effects on health or the environment of any manufacture, processing, distribution in commerce, use,
or disposal of the new chemical substance, of any mixture or article containing the new chemical substance, or
of any combination of such activities:
(i) Any data, other than test data, in
the submitter’s possession or control.

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Environmental Protection Agency

§ 720.62

(ii) Any data, including test data,
which are not in the submitter’s possession or control, but which are
known to or reasonably ascertainable
by the submitter. For the purposes of
this section, data are known to or reasonably ascertainable by the submitter
if the data are known to any of its employees or other agents who are associated with the research and development, test marketing, or commercial
marketing of the substance.
(2) Data that must be described include data concerning the new chemical substance in a pure, technical
grade, or formulated form.
(3) The description of data reported
under this paragraph must include:
(i) If the data appear in the open scientific literature, a standard literature
citation, which includes the author,
title, periodical name, date of publication, volume, and pages.
(ii) If the data are not contained in
the open scientific literature, a description of the type of data and summary of the results, if available, and
the names and addresses of persons the
submitter believes may have possession
or control of the data.
(4) All data described by this paragraph are subject to these requirements, regardless of their age, quality,
or results; and regardless of whether
they are complete at the time the notice is submitted.
(c) [Reserved]
(d) Data that need not be submitted—(1)
Data previously submitted to EPA. (i) A
person need not submit any data previously submitted to EPA with no
claims of confidentiality if the notice
includes the office or person to whom
the data were submitted, the date of
submission, and, if appropriate, a
standard literature citation as specified in paragraph (a)(3)(ii) of this section.
(ii) For data previously submitted to
EPA with a claim of confidentiality,
the person must resubmit the data
with the notice and any claim of confidentiality, under § 720.80.
(2) Efficacy data. This part does not
require submission of any data related
solely to product efficacy. This does
not exempt a person from submitting
any of the data specified in paragraph
(a), (b), or (c) of this section.

(3) Non-U.S. exposure data. This part
does not require submission of any
data which relates only to exposure of
humans or the environment outside the
United States. This does not exclude
nonexposure data such as data on
health effects (including epidemiological studies), ecological effects, physical and chemical properties, or environmental fate characteristics.
[48 FR 21742, May 13, 1983, as amended at 51
FR 15102, Apr. 22, 1986]

§ 720.57

Imports.

(a) Except as otherwise provided in
this section, the provisions of this subpart C apply to each person who submits a notice for a new chemcial substance which he or she intends to import for a commercial purpose. In addition, each importer must comply with
this section.
(b) EPA will hold the principal importer, or the importer that EPA determines must submit the notice when
there is no principal importer under
§ 720.22(b)(2), liable for complying with
this part, for completing the notice
form and for the completeness and
truthfulness of all information which it
submits.

Subpart D—Disposition of Notices
§ 720.60

General.

This subpart establishes procedures
that EPA will follow in reviewing notices.
§ 720.62 Notice that notification is not
required.
When EPA receives a notice, EPA
will review it to determine whether the
chemical substance is subject to the requirements of this part. If EPA determines that the chemical substance is
not subject to these requirements, EPA
will notify the submitter that section 5
of the Act does not prevent the manufacture or import of the substance and
that the submission is not a notice
under this part.
[48 FR 21742, May 13, 1983, as amended at 58
FR 34204, June 23, 1993]

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§ 720.65

40 CFR Ch. I (7–1–18 Edition)

§ 720.65 Acknowledgement of receipt
of a notice; errors in the notice; incomplete submissions; and false
and misleading statements.
(a) Notification to the submitter. EPA
will acknowledge receipt of each notice
by sending a letter via CDX or U.S.
mail to the submitter that identifies
the premanufacture notice number assigned to the new chemical substance
and date on which the review period begins. The review period will begin on
the date the notice is received by the
Office of Pollution Prevention and
Toxics Document Control Officer. The
acknowledgment does not constitute a
finding by EPA that the notice, as submitted, is in compliance with this part.
(b) Errors in the notice. (1) Within 30
days of receipt of the notice, EPA may
request that the submitter remedy errors in the notice. The following are
examples of such errors:
(i) Failure to date the notice form.
(ii) Typographical errors that cause
data to be misleading or answers to
any questions to be unclear.
(iii) Contradictory information.
(iv) Ambiguous statements or information.
(2) In the request to correct the notice, EPA will explain the action which
the submitter must take to correct the
notice.
(3) If the submitter fails to correct
the notice within 15 days of receipt of
the request, EPA may extend the notice period under section (5)(c) of the
Act, in accordance with § 720.75(c).
(c) Incomplete submissions. (1) A submission is not complete, and the notification period does not begin, if:
(i) The wrong person submits the notice form.
(ii) The submitter does not sign the
notice form.
(iii) Some or all of the information in
the notice or the attachments are not
in English, except for published scientific literature.
(iv) The submitter does not submit
the notice in the manner set forth in
§ 720.40(a)(2).
(v) The submitter does not provide
information that is required by section
5(d)(1) (B) and (C) of the Act and
§ 720.50.
(vi) The submitter does not provide
information required on the notice

form and by § 720.45 or indicate that it
is not known to or reasonably ascertainable by the submitter.
(vii) The submitter does not submit a
second copy of the submission with all
confidential information deleted for
the public file, as required by
§ 720.80(b)(2).
(viii) The submitter does not include
any information required by section
5(b)(1) of the Act and pursuant to a rule
promulgated under section 4 of the Act,
as required by § 720.40(g).
(ix) The submitter does not submit
data which the submitter believes show
that the chemical substance will not
present an unreasonable risk of injury
to health or the environment, if EPA
has listed the chemical substance
under section 5(b)(4) of the Act, as required in § 720.40(h).
(x) The submitter does not include an
identifying number and a payment
identity number as required by 40 CFR
700.45(e)(3).
(2)(i) If EPA receives an incomplete
submission, the Director, or his or her
delegate, will notify the submitter
within 30 days of receipt that the submission is incomplete and that the notice review period will not begin until
EPA receives a complete notice.
(ii) If EPA obtains additional information during the notice review period
that indicates the original submission
was incomplete, the Director, or his or
her delegate, may declare the submission incomplete within 30 days after
EPA obtains the additional information and so notify the submitter.
(3) The notification that a submission is incomplete under paragraph
(c)(2) (i) or (ii) of this section will include:
(i) A statement of the basis of EPA’s
determination that the submission is
incomplete.
(ii) The requirements for correcting
the incomplete submission.
(iii) Information on procedures under
paragraph (c)(4) of this section for filing objections to the determination or
requesting modification of the requirements for completing the submission.
(4) Within ten days after receipt of
notification by EPA that a submission
is incomplete, the submitter may file
written objections requesting that EPA
accept the submission as a complete

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Environmental Protection Agency

§ 720.75

notice or modify the requirements necessary to complete the submission.
(5)(i) EPA will consider the objections filed by the submitter. The Director, or his or her delegate, will determine whether the submission was complete or incomplete, or whether to
modify the requirements for completing the submission. EPA will notify
the submitter in writing of EPA’s response within ten days of receiving the
objections.
(ii) If the Director, or his or her delegate, determines, in response to the objection, that the submission was complete, the notice review period will be
deemed suspended on the date EPA declared the notice incomplete, and will
resume on the date that the notice is
declared complete. The submitter need
not correct the notice as EPA originally requested. If EPA can complete
its review within 90 days from the date
of the original submission, the Director, or his or her delegate, may inform
the submitter that the running of the
review period will resume on the date
EPA originally declared it incomplete.
(iii) If the Director, or his or her delegate, modifies the requirements for
completing the submission or concurs
with EPA’s original determination, the
notice review period will begin when
EPA receives a complete notice.
(d) Materially false or misleading statements. If EPA discovers at any time
that person submitted materially false
or misleading statements in the notice,
EPA may find that the notice was incomplete from the date it was submitted, and take any other appropriate
action.

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[48 FR 21742, May 13, 1983, as amended at 75
FR 785, Jan. 6, 2010]

§ 720.70 Notice in the Federal Register.
(a) Filing of FEDERAL REGISTER notice.
In accordance with section 5(d)(2) of
the Act, after EPA receives a notice,
EPA will file with the Office of the
Federal Register a notice including the
information specified in paragraph (b)
of this section.
(b) Contents of notice. (1) In the public
interest, the specific chemical identity
listed in the notice will be published in
the FEDERAL REGISTER unless the submitter has claimed chemical identity
confidential. If the submitter claims

confidentiality, a generic name will be
published
in
accordance
with
§ 720.85(a)(3).
(2) The categories of use of the new
chemical substance will be published as
reported in the notice unless this information is claimed confidential. If confidentiality is claimed, the generic information which is submitted under
§ 720.87(b) will be published.
(3) A list of data submitted in accordance with § 720.50(a) will be published.
In addition, for test data submitted in
accordance with § 720.40(g), a summary
of the data will be published.
(4) The submitter’s identity will be
published, unless the submitter has
claimed it confidential.
§ 720.75 Notice review period.
(a) Length of notice review period. The
notice review period specified in section 5(a) of the Act runs for 90 days
from the date the Document Control
Officer for the Office of Pollution Prevention and Toxics receives a complete
notice, or the date EPA determines the
notice is complete under § 720.65(c), unless the Agency extends the period
under section 5(c) of TSCA and paragraph (c) of this section.
(b) Suspension of the running of the notice review period. (1) A submitter may
voluntarily suspend the running of the
notice review period if the Director or
his or her delegate agrees. If the Director does not agree, the review period
will continue to run, and EPA will notify the submitter. A submitter may
request a suspension at any time during the notice review period. The suspension must be for a specified period
of time.
(2)(i) Oral requests. A request for a
suspension of 15 days or less may be
made orally, including by telephone, to
the submitter’s EPA contact for that
notice. Any request for a suspension
exceeding 15 days must be submitted in
the manner set forth in paragraph
(b)(2)(ii) of this section. The running of
the notice review period will be suspended upon approval of the oral request by the Director or her or his delegate.
(ii) Written requests. Requests for suspensions exceeding 15 days must be
submitted electronically to EPA via
CDX using e-PMN software. Requests

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§ 720.78

40 CFR Ch. I (7–1–18 Edition)

for suspensions of 15 days or less may
also be submitted electronically to
EPA via CDX using e-PMN software.
See § 720.40(a)(2)(ii) for information on
how to access the e-PMN software. The
running of the notice review period will
be suspended upon approval of the written request by the Director or her or
his delegate.
(c) Extension of notice review period. (1)
At any time during the notice review
period, EPA may determine that good
cause exists to extend the notice review period specified in paragraph (a)
of this section.
(2) If EPA makes such a determination, EPA will:
(i) Notify the submitter that EPA is
extending the notice review period for
a specified length of time, and state
the reasons for the extension.
(ii) Issue a notice for publication in
the FEDERAL REGISTER which states
that EPA is extending the notice review period and gives the reasons for
the extension.
(3) The initial extension may be for a
period of up to 90 days. If the initial extension is for less than 90 days, EPA
may make additional extensions. However, the total period of extensions
may not exceed 90 days for any notice.
(4) The following are examples of situations in which EPA may find that
good cause exists for extending the notice review period:
(i) EPA has reviewed the notice and
determined that there is a significant
possibility that the chemical substance
will be regulated under section 5(e) or
section 5(f) of the Act, but EPA is unable to initiate regulatory action within the initial 90-day period.
(ii) EPA has reviewed the submission
and is seeking additional information.
(iii) EPA has received significant additional information during the notice
review period.
(iv) The submitter has failed to correct a notice after receiving EPA’s request under § 720.65(b).
(d) Notice of expiration of notice review
period. EPA will notify the submitter
that the notice review period has expired or that EPA has completed its review of the notice. Expiration of the review period does not constitute EPA
approval or certification of the new
chemical substance, and does not mean

that EPA may not take regulatory action against the substance in the future. After expiration of the statutory
notice review period, in the absence of
regulatory action by EPA under section 5(e), 5(f), or 6(a) of the Act, the
submitter may manufacture or import
the chemical substance even if the submitter has not received notice of expiration.
(e) Withdrawal of a notice by the submitter. (1)(i) A submitter may withdraw
a notice during the notice review period by submitting a statement of
withdrawal in a manner set forth in
this paragraph. The withdrawal is effective upon receipt by EPA of the CDX
submission.
(ii) Submission of withdrawal notices.
EPA will accept statements of withdrawal only if submitted in accordance
with this paragraph. Statements of
withdrawal must be generated, completed, and submitted to EPA (via
CDX) using e-PMN software. See
§ 720.40(a)(2)(ii) for information on how
to obtain e-PMN software.
(2) If a manufacturer (including importer) which withdrew a notice later
resubmits a notice for the same chemical substance, a new notice review period begins.
[48 FR 21742, May 13, 1983, as amended at 53
FR 12523, Apr. 15, 1988; 58 FR 34204, June 23,
1993; 60 FR 34464, July 3, 1995; 71 FR 33641,
June 12, 2006; 75 FR 786, Jan. 6, 2010; 78 FR
72827, Dec. 4, 2013; 80 FR 42746, July 20, 2015]

§ 720.78

Recordkeeping.

(a) Any person who submits a notice
under this part must retain documentation of information in the notice,
including (1) other data, as defined in
§ 720.50(b), in the submitter’s possession
or control; and (2) records of production volume for the first three years of
production or import, the date of commencement of manufacture or import,
and documentation of this information.
This information must be retained for
five years from the date of commencement of manufacture of import.
(b)(1) Persons who manufacture or
import a chemical substance under
§ 720.36 must retain the following
records:
(i) Copies of, or citations to, information reviewed and evaluated under

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Environmental Protection Agency

§ 720.80

§ 720.36(b)(1) to determine the need to
make any notification of risk.
(ii) Documentation of the nature and
method
of
notification
under
§ 720.36(c)(1) including copies of any labels or written notices used.
(iii) Documentation of prudent laboratory practices used instead of notification
and
evaluation
under
§ 720.36(b)(2).
(iv) The names and addresses of any
persons other than the manfacturer or
importer to whom the substance is distributed, the identity of the substance
to the extent known, the amount distributed, and copies of the notifications required under § 720.36(c)(2). These
records are not required when substances are distributed as impurities or
incorporated into an article, in accordance with paragraph (d) of this section.
(2) A person who manufactures or imports a chemical substance under
§ 720.36 and who manufactures or imports the substance in quantities greater than 100 kilograms per year must retain records of the identity of the substance to the extent known, the production volume of the substance, and
the person’s disposition of the substance. The person is not required to
maintain records of the disposition of
products containing the substance as
an impurity or of articles incorporating the substances.
(3) Records under this paragraph
must be retained for 5 years after they
are developed.
(c) Any person who obtains a testmarketing exemption under this part
must retain documentation of information in the application and documentation of compliance with any restrictions imposed by EPA when it granted
the application. This information must
be retained for five years from the final
date of manufacture or import under
the exemption.
[48 FR 21742, May 13, 1983; 48 FR 33872, July
26, 1983, as amended at 51 FR 15102, Apr. 22,
1986; 58 FR 34204, June 23, 1993]

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Subpart E—Confidentiality and
Public Access to Information
§ 720.80

General provisions.

(a) A person may assert a claim of
confidentiality for any information

which he or she submits to EPA under
this part.
(b) Any claim of confidentiality must
accompany the information when it is
submitted to EPA.
(1)(i) For information submitted on
the notice form, the claim(s) must be
asserted on the form in the manner
prescribed on the notice form.
(ii) When a person submits information in an attachment, the claim(s)
must be asserted in the attachment as
described on the notice form.
(2) If any information is claimed as
confidential, the person must submit,
in addition to the copies specified by
§ 720.40, a sanitized copy of the notice
form (or electronic submission) and
any attachments.
(i) The notice and attachments must
be complete. The submitter must designate that information which is
claimed as confidential in the manner
prescribed on the notice form, via
EPA’s
e-PMN
software.
See
§ 720.40(a)(2)(iv) for information on how
to obtain e-PMN software.
(ii) The sanitized copy must be complete except that all information
claimed as confidential in the original
must be deleted. EPA will place this
sanitized copy in the public file.
(iii) If the person does not provide
the sanitized copy, or information in a
health and safety study (except information claimed as confidential in accordance with § 720.90), the submission
will be deemed incomplete and the notice review period will not begin until
EPA receives the sanitized copy or the
health and safety study information is
included,
in
accordance
with
§ 720.65(c)(1)(vii).
(c) EPA will disclose information
that is subject to a claim of confidentiality asserted under this section only
to the extent permitted by the Act,
this subpart, and part 2 of this title.
(d) If a notice submitter does not assert a claim of confidentiality for information at the time it is submitted
to EPA, EPA may make the information public and place it in the public
file without further notice to the submitter.
[48 FR 21742, May 13, 1983, as amended at 58
FR 34204, June 23, 1993; 60 FR 16311, Mar. 29,
1995; 75 FR 786, Jan. 6, 2010]

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§ 720.85

40 CFR Ch. I (7–1–18 Edition)

§ 720.85 Chemical identity.
(a) Claims applicable to the period prior
to commencement of manufacture or import. (1)(i) A person who submits information to EPA under this part may assert a claim of confidentiality for the
chemical identity of the new chemical
substance. This claim will apply only
to the period prior to the commencement of manufacture or import for
commercial purposes. A submitter may
assert this claim only if the submitter
believes that public disclosure prior to
commencement of manufacture or import of the fact that anyone intends to
manufacture or import the specific
chemical substance for commercial
purposes would reveal confidential
business information.
(ii) If the notice includes a health
and safety study concerning the new
chemical substance and if the claim for
confidentiality with respect to the
chemical identity is denied in accordance with § 720.90(c), EPA will deny a
claim asserted under this paragraph.
(2) Any person who asserts a claim of
confidentiality for chemical identity
under this paragraph must provide one
of the following items at the time the
notice is submitted:
(i) The generic name which was accepted by EPA in the prenotice consultation conducted under paragraph
(a)(3) of this section.
(ii) One generic name that is only as
generic as necessary to protect the
confidential chemical identity of the
particular chemical substance. The
name should reveal the specific chemical identity to the maximum extent
possible. The generic name will be subject to EPA review and approval at the
time a notice of commencement is submitted.
(3)(i) Any person who intends to assert a claim of confidentiality for the
chemical identity of a new chemical
substance may seek a determination by
EPA of an appropriate generic name
for the substance before submitting a
notice. For this purpose, the person
should submit to EPA:
(A) The chemical identity of the substance.
(B) A proposed generic name(s) which
in only as generic as necessary to protect the confidential chemical identity
of the new chemical substance. The

name(s) should reveal the chemical
identity of the substance to the maximum extent possible.
(ii) Within 30 days, EPA will inform
the submitter either that one of the
proposed generic names is adequate or
that none is adequate and further consultation is necessary.
(4) If a submitter claims chemical
identity to be confidential under this
paragraph, and if the submitter complies with paragraph (a)(2) of this section, EPA will issue for publication in
the FEDERAL REGISTER notice described
in § 720.70 the generic name proposed by
the submitter or one agreed upon by
EPA and the submitter.
(b) Claims applicable to the period after
commencement of manufacture or import.
(1) Any claim of confidentiality under
paragraph (a) of this section is applicable only until the substance is manufactured or imported for commercial
purposes and becomes eligible for inclusion on the Inventory. To maintain
the confidential status of the chemical
identity when the substance is added to
the Inventory, a submitter must reassert the confidentiality claim and
substantiate the claim in the notice of
commencement of manufacture required under § 720.102. A submitter may
not claim the chemical indentity confidential for the period after commencement of manufacture or import
unless the submitter claimed the
chemical identity confidential for the
period prior to commencement of manufacture or import under paragraph (a)
of this section.
(2)(i) A person who believes that public disclosure of the fact that anyone
manfactures or imports the new chemical substance for commercial purposes
would reveal confidential business information may assert a claim of confidentiality under this paragraph.
(ii) If the notice includes a health
and safety study concerning the new
chemical substance, and if the claim
for confidentiality with respect to the
chemical identity is denied in accordance with § 720.90(c), EPA will deny a
claim asserted under this paragraph.
(3) Any person who asserts a confidentiality claim for chemical identity
must:

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Environmental Protection Agency

§ 720.85

(i) Comply with the requirements of
paragraph (a)(3) of this section regarding submission of a generic name.
(ii) Agree that EPA may disclose to a
person with a bona fide intent to manufacture or import the chemical substance the fact that the particular
chemical substance is included on the
confidential Inventory for purposes of
notification under section 5(a)(1)(A) of
the Act.
(iii) Have available for the particular
chemical substance, and agree to furnish to EPA upon request:
(A) An elemental analysis.
(B) Either an X-ray diffraction pattern (for inorganic substances), a mass
spectrum (for most other substances),
or an infrared spectrum of the particular chemical substance, or if such
data do not resolve uncertainties with
respect to the identity of the chemical
substance, additional or alternative
spectra or other data to identify the
chemical substance.
(iv) Provide a detailed written substantiation of the claim, by answering
the following questions:
(A) What harmful effects to your
competitive position, if any, do you
think would result if EPA publishes on
the Inventory the identity of the chemical substance? How could a competitor
use such information given the fact
that the identity of the substance otherwise would appear on the Inventory
of chemical substances with no link between the substance and your company
or industry? How substantial would the
harmful effects of disclosure be? What
is the casual relationship between the
disclosure and the harmful effects?
(B) For what period of time should
confidential treatment be given? Until
a specific date, the occurrence of a specific event, or permanently? Why?
(C) Has the chemical substance been
patented? If so, have you granted licenses to others with respect to the
patent as it applies to the chemical
substance? If the chemical substance
has been patented and therefore disclosed through the patent, why should
it be treated as confidential for purposes of the Inventory?
(D) Has the identity of the chemical
substance been kept confidential to the
extent that your competitors do not
know it is being manufactured on im-

ported for a commercial purpose by
anyone?
(E) Is the fact that someone is manufacturing or importing this chemical
substance for commercial purposes
available to the public, e.g., in technical journals or other publications; in
libraries; or in State, local, or Federal
agency public files?
(F) What measures have you taken to
prevent undesired disclosure of the fact
that you are manufacturing or importing this substance for a commercial
purpose?
(G) To what extent has the fact that
you are manufacturing or importing
this chemical substance for a commercial purpose been disclosed to others?
What precautions have you taken in regard to these disclosures? Has this information been disclosed to the public
or to competitors?
(H) In what form does this particular
chemical substance leave the site of
manufacture, e.g., as part of a product;
in an effluent or emission stream? If
so, what measures have you taken to
guard against discovery of its identity?
(I) If the chemical substance leaves
the site of manufacture in a product
that is available to either the public or
your competitors, can they identify the
substance by analyzing the product?
(J) For what purpose do you manufacture or import the substance?
(K) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations
regarding this chemical substance? If
so, copies of such determinations must
be included in the substantiation.
(L) If the notice includes a health
and safety study concerning the new
chemical substance, the submitter
must also answer the questions in
§ 720.90(b)(2).
(4) If the submitter does not meet the
requirements of this paragraph, EPA
will deny the claim of confidentiality.
(5)(i) EPA will publish a generic
name on the public Inventory if:
(A) The submitter asserts a claim of
confidentiality in accordance with this
paragraph.
(B) No claim for confidentiality of
the specific chemical identity as part
of a health and safety study has been
denied in accordance with part 2 of this
title or § 720.90.

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§ 720.87

40 CFR Ch. I (7–1–18 Edition)

(ii) Publication of a generic name on
the public Inventory does not create a
category for purposes of the Inventory.
Any person who has a bona fide intent
to manufacture or import a chemical
substance which is described by a generic name on the public Inventory
may submit an inquiry to EPA under
§ 720.25(b) to determine whether the
particular chemical substance is included on the confidential Inventory.
(iii) Upon receipt of a request described in § 720.25(b), EPA may require
the submitter which originally asserted confidentiality for a chemical
substance to submit to EPA the information listed in paragraph (b)(3)(iii) of
this section.
(iv) Failure to submit any of the information required under paragraph
(b)(3)(iii) of this section within ten
days of a request by EPA under this
paragraph is a waiver of the original
submitter’s confidentiality claim. In
this event, EPA may place the specific
chemical identity on the public Inventory without further notice to the
original submitter.
(6) If a submitter asserts a claim of
confidentiality under this paragraph,
EPA will examine the generic chemical
name proposed by the submitter.
(i) If EPA determines that the generic name proposed by the submitter
is only as generic as necessary to protect the confidential identity of the
particular chemical substance, EPA
will place that generic name on the
public Inventory.
(ii) If EPA determines that the generic name proposed by the submitter
is more generic than necessary to protect the confidential identity, EPA will
propose in writing, for review by the
submitter, an alternative generic name
that will reveal the chemical identity
of the chemical substance to the maximum extent possible.
(iii) If the generic name proposed by
EPA is acceptable to the submitter,
EPA will place that generic name on
the public Inventory.
(iv) If the generic name proposed by
EPA is not acceptable to the submitter, the submitter must explain in
detail why disclosure of that generic
name would reveal confidential business information and propose another
generic name which is only as generic

as necessary to protect the confidential
identity. If EPA does not receive a response from the submitter within 30
days after the submitter receives the
proposed name, EPA will place EPA’s
chosen generic name on the public Inventory. If the submitter does provide
the information requested, EPA will
review the response. If the submitter’s
proposed generic name is acceptable,
EPA will publish that generic name on
the public Inventory. If the submitter’s
proposed generic name is not acceptable, EPA will notify the submitter of
EPA’s choice of a generic name. Thirty
days after this notification, EPA will
place the chosen generic name on the
public Inventory.
§ 720.87 Categories or proposed categories of uses of a new chemical
substance.
(a) A person who submits information to EPA under this part on the categories or proposed categories of use of
a new chemical substance may assert a
claim of confidentiality for this information.
(b) A submitter that asserts such a
claim must:
(1) Report the categories or proposed
categories of use of the chemical substance.
(2) Provide, in nonconfidential form,
a description of the uses that is only as
generic as necessary to protect the
confidential business information. The
generic use description will be included
in the FEDERAL REGISTER notice described in § 720.70.
(c) The person must submit the information required by paragraph (b) of
this section in the manner specified in
the notice form.
§ 720.90 Data from health and safety
studies.
(a) Information other than specific
chemical identity. Except as provided in
paragraph (b) of this section, EPA will
deny any claim of confidentiality with
respect to information included in a
health and safety study, unless the information would disclose confidential
business information concerning:
(1) Processes used in the manufacture
or processing of a chemical substance
or mixture.

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Environmental Protection Agency

§ 720.102

(2) In the case of a mixture, the portion of the mixture comprised by any
of the chemical substances in the mixture.
(3) Information which is not in any
way related to the effects of a substance on human health or the environment, such as the name of the submitting company, cost or other financial
data, product development or marketing plans, and advertising plans, for
which the person submits a claim of
confidentiality in accordance with
§ 720.80.
(b) Specific chemical identity—(1)
Claims applicable to period prior to commencement of manufacture. A claim of
confidentiality for the period prior to
commencement of manufacture or import for the chemical identity of a
chemical substance for which a health
and safety study was submitted must
be asserted in conjunction with a claim
asserted under § 720.85(a).
(2) Claims applicable to period after
commencement of manufacture or import
for commercial purposes. To maintain
the confidential status of the chemical
identity of a chemical substance for
which a health and safety study was
submitted after commencement of
manufacture or import, the claim must
be reasserted and substantiated in conjunction with a claim under § 720.85(b).
In addition to the questions set forth
in § 720.85(b)(3)(iv) of this part, the submitter must answer the following questions:
(i) Would disclosure of the chemical
identity disclose processes used in the
manufacture or processing of a chemical substance or mixture? Describe
how this would occur. In responding to
the question in § 720.85(b)(3)(iv)(A), explain what harmful competitive effects
would occur from disclosure of this
process information.
(ii) Would disclosure of the chemical
identity disclose the portion of a mixture comprised by any of the substances in the mixture? Describe how
this would occur. In responding to the
question in § 720.85(b)(3)(iv)(A), explain
what harmful competitive effects
would occur from disclosure of this information.
(iii) Do you assert that disclosure of
the chemical identity is not necessary
to interpret any of the health and safe-

ty studies you have submitted? If so,
explain how a less specific identity
would be sufficient to interpret the
studies.
(c) Denial of confidentiality claim. EPA
will deny a claim of confidentiality for
chemical identity under paragraph (b)
of this section, unless:
(1) The information would disclose
processes used in the manufacture or
processing of a chemical substance or
mixture.
(2) In the case of a mixture, the information would disclose the portion of
the mixture comprised by any of the
substances in the mixture.
(3) The specific chemical identity is
not necessary to interpret a health and
safety study.
(d) Use of generic names. When EPA
discloses a health and safety study containing a specific chemical identity,
which the submitter has claimed confidential, and if the Agency has not denied the claim under paragraph (c) of
this section, EPA will identify the
chemical substance by the generic
name selected under § 720.85.
[48 FR 21742, May 13, 1983, as amended at 58
FR 34204, June 23, 1993]

§ 720.95

Public file.

All information submitted with a notice, including any health and safety
study and other supporting documentation, will become part of the public file
for that notice, unless such materials
are claimed confidential. In addition,
EPA may add materials to the public
file, subject to subpart E of this part.
Publically available docket materials
are available at the addresses in
§ 700.17(b)(1) and (2) of this chapter.
[48 FR 21742, May 13, 1983, as amended at 53
FR 12523, Apr. 15, 1988; 60 FR 16311, Mar. 29,
1995; 60 FR 34464, July 3, 1995; 77 FR 46292,
Aug. 3, 2012]

Subpart F—Commencement of
Manufacture or Import
§ 720.102 Notice of commencement of
manufacture or import.
(a) Applicability. Any person who
commences the manufacture or import
of a new chemical substance for a nonexempt commercial purpose for which

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§ 720.120

40 CFR Ch. I (7–1–18 Edition)

that person previously submitted a section 5(a) notice under this part must
submit a notice of commencement of
manufacture or import.
(b) When to report. (1) If manufacture
or import for commercial purposes begins on or after the effective date of
this rule, the submitter must submit
the notice to EPA on, or no later than
30 calendar days, after the first day of
such manufacture or import.
(2) If manufacture or import for commercial purposes began or will begin
before the effective date of this rule,
the submitter must submit the notice
by the effective date of this rule.
(c) Information to be reported on form.
(1) The notice must be submitted on
EPA Form 7710–56, which is available
as part of EPA’s e-PMN software. See
§ 720.40(a)(2)(iv) for information on how
to obtain e-PMN software. The form
must be signed and dated by an Authorized Official (AO). All information
specified on the form must be provided.
The notice must contain the following
information:
(i) The specific chemical identity of
the PMN substance.
(ii) A generic chemical name (if the
chemical identity is claimed as confidential by the submitter).
(iii) The premanufacture notice
(PMN) number assigned by EPA.
(iv) The date of commencement for
the submitter’s manufacture or import
for a non-exempt commercial purpose
(indicating whether the substance was
initially manufactured in the United
States or imported). The date of commencement is the date of completion of
non-exempt manufacture of the first
amount (batch, drum, etc.) of new
chemical substance identified in the
submitter’s PMN. For importers, the
date of commencement is the date the
new chemical substance clears United
States customs.
(v) The name and address of the submitter.
(vi) The name of the authorized official.
(vii) The name and telephone number
of a technical contact in the United
States.
(viii) The address of the site where
commencement of manufacture occurred.

(ix) Clear indications of whether the
chemical identity, submitter identity,
and/or other information are claimed
as confidential by the submitter.
(2) If the submitter claims the chemical identity confidential, and wants
the identity to be listed on the confidential portion of the Inventory, the
claim must be reasserted and substantiated in accordance with § 720.85(b).
Otherwise, EPA will list the specific
chemical identity on the public Inventory. Submitters who did not claim the
chemical identity, submitter identity,
or other information to be confidential
in the PMN cannot claim this information as confidential in the notice of
commencement.
(d)(1) Where to submit. All notices of
commencement must be submitted to
EPA on EPA Form 7710–56. Notices
may only be submitted in a manner set
forth in this paragraph.
(2) Submission of notice of commencement. EPA will accept notices of commencement only if submitted in accordance with this paragraph. All notices of commencement must be submitted electronically to EPA via CDX.
Prior to submission to EPA via CDX,
such notices of commencement must
be generated and completed using ePMN software. See § 720.40(a)(2)(ii) for
information on how to obtain e-PMN
software.
[48 FR 21742, May 13, 1983, as amended at 48
FR 41140, Sept. 13, 1983; 51 FR 15103, Apr. 22,
1986; 53 FR 12523, Apr. 15, 1988; 60 FR 16311,
Mar. 29, 1995; 60 FR 34464, July 3, 1995; 65 FR
39304, June 26, 2000; 71 FR 33641, June 12, 2006;
75 FR 786, Jan. 6, 2010; 78 FR 72827, Dec. 4,
2013]

Subpart G—Compliance and
Inspections
§ 720.120 Compliance.
(a) Failure to comply with any provision of this part is a violation of section 15 of the Act (15 U.S.C 2614).
(b) A person who manufactures or imports a new chemical substance before
a notice is submitted and the notice review period expires is in violation of
section 15 of the Act even if that person was not requied to submit the notice under § 720.22.
(c) Using for commercial purposes a
chemical substance or mixture which a

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Environmental Protection Agency

Pt. 721

person knew or had reason to know was
manufactured, processed, or distributed in commerce in violation of section 5 of this rule is a violation of section 15 of the Act (15 U.S.C. 2614).
(d) Failure or refusal to establish and
maintain records or to permit access to
or copying of records, as required by
the Act, is a violation of section 15 of
the Act (15 U.S.C. 2614).
(e) Failure or refusal to permit entry
or inspection as required by section 11
is a violation of section 15 of the Act
(15 U.S.C. 2614).
(f) Violators may be subject to the
civil and criminal penalties in section
16 of the Act (15 U.S.C. 2615) for each
violation. Persons who submit materially misleading or false information in
connection with the requirements of
any provision of this rule may be subject to penalties calculated as if they
never filed their notices.
(g) EPA may seek to enjoin the manufacture or processing of a chemical
substance in violation of this rule or
act to seize any chemical substance
manufactured or processed in violation
of this rule or take other actions under
the authority of section 7 of this Act
(15 U.S.C. 2606) or section 17 or this Act
(15 U.S.C. 2616).
§ 720.122

Subpart B—Certain Significant New Uses
721.50 Applicability.
721.63 Protection in the workplace.
721.72 Hazard communication program.
721.80 Industrial, commercial, and consumer
activities.
721.85 Disposal.
721.90 Release to water.
721.91 Computation of estimated surface
water concentrations: Instructions.

Subpart C—Recordkeeping Requirements
721.100
721.125

PART 721—SIGNIFICANT NEW USES
OF CHEMICAL SUBSTANCES
Subpart A—General Provisions
Sec.
721.1 Scope and applicability.
721.3 Definitions.
721.5 Persons who must report.
721.11 Applicability determination when the
specific chemical identity is confidential.
721.20 Exports and imports.
721.25 Notice requirements and procedures.
721.30 EPA approval of alternative control
measures.
721.35 Compliance and enforcement.
721.40 Recordkeeping.
721.45 Exemptions.

Applicability.
Recordkeeping requirements.

Subpart D—Expedited Process for Issuing
Significant New Use Rules for Selected
Chemical Substances and Limitation
or Revocation of Selected Significant
New Use Rules
721.160 Notification requirements for new
chemical substances subject to section
5(e) orders.
721.170 Notification requirements for selected new chemical substances that
have completed premanufacture review.
721.185 Limitation or revocation of certain
notification requirements.

Subpart E—Significant New Uses for
Specific Chemical Substances

Inspections.

EPA will conduct inspections under
section 11 of the Act to assure compliance with section 5 of the Act and this
rule, to verify that information submitted to EPA under this rule is true
and correct, and to audit data submitted to EPA under this rule.

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721.47 Conditions for research and development exemption.

721.225 2-Chloro-N-methyl-N-substituted
acetamide (generic name).
721.267 N-[2-[(substituted
dinitrophenyl)azo]diallylamino-4-substituted phenyl] acetamide (generic
name).
721.275 Halogenated-N-(2-propenyl)-N-(substituted phenyl) acetamide.
721.285 Acetamide, N-[4-(pentyloxy)phenyl]-,
acetamide,
N-[2-nitro-4(pentyloxy)phenyl]-, and acetamide, N-[2amino-4-(pentyloxy)phenyl]-.
721.303 Acetic acid, 2-methoxy-, methyl
ester.
721.304 Acetic
acid,
[(5-chloro-8-quinolinyl)oxy-], 1-methyl hexyl ester.
721.305 Di-substituted acetophenone (generic).
721.320 Acrylamide-substituted epoxy.
721.321 Substituted acrylamides and acrylic
acid copolymer (generic).
721.323 Substituted acrylamide.
721.324 Alkoxylated acrylate polymer (generic).
721.329 Halogenated benzyl ester acrylate
(generic).
721.330 Aromatic acrylate (generic).
721.333 Dimethyl alkylamine salt (generic).

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