ICR Attachment 4: 40 CFR 721, subparts A-D

OMB Control Number 2070-0173; EPA ICR Number 2327.02
ICR ATTACHMENT 4
40 CFR Part 721, Subparts A - D

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§ 721.1

40 CFR Ch. I (7–1–07 Edition)

721.10012 Manganate (MnO21-), calcium (2:1).
721.10013 Manganese
yttrium
oxide
(Mn2YO5).
721.10014 Halogenated naphthalic anhydride
(generic).
721.10015 Halogenated benzimidazole (generic).
721.10016 Dibenzimidazothianaphthalene
(generic).
721.10017 Amine terminated bisphenol A
diglycidyl ether polymer (generic).
721.10018 Calcium hydroxide oxide silicate
(Ca6(OH)2O
2(Si2O5)3).
721.10019 Benzoic acid, 2-chloro-5-nitro-, 1,1dimethyl-2-oxo-2-(2-propenyloxy)
ethyl
ester.
721.10020 Benzoic acid, 5-amino-2-chloro-,
1,1-dimethyl-2-oxo-2-(2-propenyloxy)
ethyl ester.
721.10021 Magnesium potassium titanium
oxide.
721.10022 Benzenamine, N-phenyl-, ar′-(C9rich C8-10-branched alkyl) derivs.
721.10023 Benzenamine, N-phenyl-, ar ar′-(C9rich C8-10-branched alkyl) derivs.
721.10024 10H-Phenothiazine,
ar-(C9-rich
C8-10-branched alkyl) derivs.
721.10025 10H-Phenothiazine, ar, ar′-(C9-rich
C8-10-branched alkyl) derivs.
721.10026 Cashew, nutshell liq., ethoxylated.
721.10027 Ethoxylated
alkylsulfate,
substituted alkylamine salt (generic).
721.10028 Disubstituted benzene metal salts
(generic).
721.10029 Isocyanate compound, modified
with methoxysilane (generic).
721.10030 Pyrimido[5,4-g]pteridine-2,4,6,8tetramine,
4-methylbenzenesulfonate,
base-hydrolyzed.
721.10031 Lithium
potassium
titanium
oxide.
721.10032 Acrylic acid, polymer with substituted acrylamides (generic).
721.10033 Zinc, [ethanedioato(2-)-. kappa. O1,
. kappa. O2]-.
721.10034 Substituted pyridine coupled with
diazotized substituted nitrobenzonitrile,
diazotized substituted benzenamine and
substituted
pyridinecarbonitrile
(generic).
721.10035 Alkylbenzene sulfonate (generic).
721.10036 Acetaldehyde based polymer (generic).
721.10037 Complex
halogenated
salt
of
tris(ethylatedaminocarbocyclic)methane
(generic).
721.10038 Trimellitic anhydride, polymer
with substituted glycol, alkyl phenols
and ethoxylated nonylphenol (generic).
721.10039 Diethoxybenzenamine derivative,
diazotized,
coupled
with
aminonaphthalenesulfonic acid derivative, ammonium salt (generic).
721.10040 Substituted acridine naphtha substituted benzamide (generic).

721.10041 1-Butanone, 2-(dimethylamino)-2[(4-methylphenyl)methyl]-1-[4-(4morpholinyl)phenyl]-.
721.10042 2-Propanol,
1-[bis(2-hydroxyethyl)amino]-.
721.10043 Dineopentyl-4-substituted phthalate (generic).
721.10044 Metal oxide, modified with alkyl
and vinyl terminated polysiloxanes (generic).
721.10045 Diazotized
substituted
heteromonocycle coupled with naphthalene sulfonic acid derivative, nickel
complex, alkaline salt (generic).
721.10046 Polyaromatic amine phosphate
(generic).
721.10047 Polyphosphoric
acids,
compds.
with piperazine.
721.10048 Substituted anthraquinone (generic).
721.10049 Phenol, 4,4′- cyclohexylidene bis[2methyl-.
721.10050 Disubstituted-N′hydroxybenzenecarboximidamide (generic).
721.10051 Spiro naphthoxazine (generic).
721.10052 Aminoalkyl
substituted
alkylphenol (generic).
721.10053 Alkyl silane methacrylate (generic).
721.10054 Phenol, polymer with formaldehyde,
3-[(2-aminocyclohexyl)amino]-2hydroxypropyl ethers.
721.10055 1-Propanaminium,
3-amino-N(carboxymethyl)-N,N-dimethyl-, N-soya
acyl derivs., inner salts.
721.10056 Benzenemethanaminium,
N-(3aminopropyl)-N,N-dimethyl-, N-soya acyl
derivs., chlorides.
AUTHORITY: 15 U.S.C. 2604, 2607, and 2625(c).

Subpart A—General Provisions
§ 721.1 Scope and applicability.
(a) This part identifies uses of chemical substances, except for microorganisms regulated under part 725 of this
chapter, which EPA has determined are
significant new uses under the authority of section 5(a)(2) of the Toxic Substances Control Act. In addition, it
specifies procedures for manufacturers,
importers, and processors to report on
those significant new uses. This subpart A contains general provisions applicable to this part. subpart B of this
part identifies generic requirements for
certain significant new uses cross referenced in specific provisions of subpart E of this part. subpart C of this
part identifies generic reporting requirements for certain significant new
uses cross referenced in specific provisions of subpart E of this part. subpart

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§ 721.3

E of this part identifies chemical substances and their significant new uses.
(b) This subpart A contains provisions governing submission and review
of notices for the chemical substances
and significant new uses identified in
subpart E of this part. The provisions
of this subpart A apply to the chemical
substances and significant new uses
identified in subpart E of this part, except to the extent that they are specifically modified or supplanted by specific requirements in subpart E of this
part. In the event of a conflict between
the provisions of this subpart A and the
provisions of subpart E of this part, the
provisions of subpart E of this part
shall govern.
(c) The provisions of part 720 of this
chapter apply to this part 721. For purposes of this part 721, wherever the
phrase ‘‘new chemical substance’’ appears in part 720 of this chapter, it
shall mean the chemical substance subject to this part 721. In the event of a
conflict between the provisions of part
720 of this chapter and the provisions of
this part 721, the provisions of this part
721 shall govern.
[53 FR 28358, July 27, 1988, as amended at 62
FR 17932, Apr. 11, 1997]

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§ 721.3

Definitions.

The definitions in section 3 of the
Act, 15 U.S.C. 2602, and § 720.3 of this
chapter apply to this part. In addition,
the following definitions apply to this
part:
Acutely toxic effects A chemical substance produces acutely toxic effects if
it kills within a short time period (usually 14 days):
(1) At least 50 percent of the exposed
mammalian test animals following oral
administration of a single dose of the
test substance at 25 milligrams or less
per kilogram of body weight (LD50).
(2) At least 50 percent of the exposed
mammalian test animals following dermal administration of a single dose of
the test substance at 50 milligrams or
less per kilogram of body weight
(LD50).
(3) At least 50 percent of the exposed
mammalian test animals following administration of the test substance for 8
hours or less by continuous inhalation
at a steady concentration in air at 0.5

milligrams or less per liter of air
(LC50).
CAS Number means Chemical Abstracts Service Registry Number assigned to a chemical substance on the
Inventory.
Chemical name means the scientific
designation of a chemical substance in
accordance with the nomenclature system developed by the International
Union of Pure and Applied Chemistry
or the Chemical Abstracts Service’s
rules of nomenclature, or a name which
will clearly identify a chemical substance for the purpose of conducting a
hazard evaluation.
Chemical protective clothing means
items of clothing that provide a protective barrier to prevent dermal contact
with chemical substances of concern.
Examples can include, but are not limited to: full body protective clothing,
boots, coveralls, gloves, jackets, and
pants.
Commercial use means the use of a
chemical substance or any mixture
containing the chemical substance in a
commercial enterprise providing saleable goods or a service to consumers
(e.g., a commercial dry cleaning establishment or painting contractor).
Common name means any designation
or identification such as code name,
code number, trade name, brand name,
or generic chemical name used to identify a chemical substance other than
by its chemical name.
Consumer means a private individual
who uses a chemical substance or any
product containing the chemical substance in or around a permanent or
temporary household or residence, during recreation, or for any personal use
or enjoyment.
Consumer product means a chemical
substance that is directly, or as part of
a mixture, sold or made available to
consumers for their use in or around a
permanent or temporary household or
residence, in or around a school, or in
recreation.
Customer means any person to whom
a manufacturer, importer, or processor
distributes any quantity of a chemical
substance, or of a mixture containing
the chemical substance, whether or not
a sale is involved.
Director of the Office of Pollution Prevention and Toxics means the Director

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§ 721.3

40 CFR Ch. I (7–1–07 Edition)

of the EPA Office of Pollution Prevention and Toxics or any EPA employee
delegated by the Office Director to
carry out the Office Director’s functions under this part.
Employer means any manufacturer,
importer, processor, or user of chemical substances or mixtures.
Environmentally transformed A chemical substance is ‘‘environmentally
transformed’’ when its chemical structure changes as a result of the action
of environmental processes on it.
Facility means all buildings, equipment, structures, and other stationary
items which are located on a single site
or on contiguous or adjacent sites and
which are owned or operated by the
same person (or by any person which
controls, is controlled by, or under
common control with such person).
Identity means any chemical or common name used to identify a chemical
substance or a mixture containing that
substance.
Immediate use A chemical substance
is for the ‘‘immediate use’’ of a person
if it is under the control of, and used
only by, the person who transferred it
from a labeled container and will only
be used by that person within the work
shift in which it is transferred from the
labeled container.
Impervious Chemical protective clothing is ‘‘impervious’’ to a chemical substance if the substance causes no chemical or mechanical degradation, permeation, or penetration of the chemical
protective clothing under the conditions of, and the duration of, exposure.
Manufacturing stream means all reasonably anticipated transfer, flow, or
disposal of a chemical substance, regardless of physical state or concentration, through all intended operations of
manufacture, including the cleaning of
equipment.
Metalworking fluid means a liquid of
any viscosity or color containing intentionally added water and used in
metal machining operations for the
purpose of cooling, lubricating, or rust
inhibition.
MSDS means material safety data
sheet, the written listing of data for
the chemical substance as required
under § 721.72(c).
NIOSH means the National Institute
for Occupational Safety and Health of

the U.S. Department of Health and
Human Services.
Non-enclosed process means any equipment system (such as an open-top reactor, storage tank, or mixing vessel) in
which a chemical substance is manufactured, processed, or otherwise used
where significant direct contact of the
bulk chemical substance and the workplace air may occur.
Non-industrial use means use other
than at a facility where chemical substances or mixtures are manufactured,
imported, or processed.
Personal protective equipment means
any chemical protective clothing or device placed on the body to prevent contact with, and exposure to, an identified chemical substance or substances
in the work area. Examples include,
but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or
equivalent eye protection, and various
types of respirators. Barrier creams are
not included in this definition.
Powder or dry solid form means a state
where all or part of the substance
would have the potential to become
fine, loose, solid particles.
Principal importer means the first importer who, knowing that a chemical
substance will be imported for a significant new use rather than manufactured in the United States, specifies
the chemical substance and the
amount to be imported. Only persons
who are incorporated, licensed, or
doing business in the United States
may be principal importers.
Process for commercial purposes means
the preparation of a chemical substance or mixture containing the
chemical substance, after manufacture
of the substance, for distribution in
commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical
substance or mixture containing the
chemical substance is included in this
definition. If a chemical substance or
mixture containing impurities is processed for commercial purposes, the impurities also are processed for commercial purposes.
Process solely for export means to
process for commercial purposes solely
for export from the United States

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Environmental Protection Agency

§ 721.3

under the following restrictions on activity in the United States: Processing
must be performed at sites under the
control of the processor; distribution in
commerce is limited to purposes of export; and the processor may not use the
chemical substance except in small
quantities solely for research and development.
Process stream means all reasonably
anticipated transfer, flow, or disposal
of a chemical substance, regardless of
physical
state
or
concentration,
through all intended operations of
processing, including the cleaning of
equipment.
Recipient means any person who purchases or otherwise obtains a chemical
substance directly from a person who
manufacturers, imports, or processes
the substance.
Serious acute effects means human injury or human disease processes that
have a short latency period for development, result from short-term exposure
to a chemical substance, or are a combination of these factors and which are
likely to result in death or severe or
prolonged incapacitation.
Serious chronic effects means human
injury or human disease processes that
have a long latency period for development, result from long-term exposure
to a chemical substance, or are a combination of these factors and which are
likely to result in death or severe or
prolonged incapacitation.
Short-term test indicative of carcinogenic potential means either any limited
bioassay that measures tumor or
preneoplastic induction, or any test indicative of interaction of a chemical
substance with DNA (i.e., positive response in assays for gene mutation,
chromosomal aberrations, DNA damage and repair, or cellular transformation).
Short-term test indicative of the potential to cause a developmentally toxic effect
means either any in vivo preliminary
development toxicity screen conducted
in a mammalian species, or any in vitro
developmental toxicity screen, including any test system other than the intact pregnant mammal, that has been
extensively evaluated and judged reliable for its ability to predict the potential to cause developmentally toxic effects in intact systems across a broad

range of chemicals or within a class of
chemicals that includes the substance
of concern.
Significant adverse environmental effects means injury to the environment
by a chemical substance which reduces
or adversely affects the productivity,
utility, value, or function of biological,
commercial, or agricultural resources,
or which may adversely affect a threatened or endangered species. A substance will be considered to have the
potential for significant adverse environmental effects if it has one of the
following:
(1) An acute aquatic EC50 of 1 mg/L or
less.
(2) An acute aquatic EC50 of 20 mg/L
or less where the ratio of aquatic
vertebrate 24-hour to 48-hour EC50 is
greater than or equal to 2.0.
(3) A Maximum Acceptable Toxicant
Concentration (MATC) of less than or
equal to 100 parts per billion (100 ppb).
(4) An acute aquatic EC50 of 20 mg/L
or less coupled with either a measured
bioconcentration factor (BCF) equal to
or greater than 1,000x or in the absence
of bioconcentration data a log P value
equal to or greater than 4.3.
Site means a contiguous property
unit. Property divided only by a public
right-of-way is one site. There may be
more than one manufacturing plant on
a single site.
Site-limited intermediate means an intermediate manufactured, processed,
and used only within a site and not distributed in commerce other than as an
impurity or for disposal. Imported
intermediates cannot be ‘‘site-limited.’’
Spray application means any method
of projecting a jet of vapor of finely divided liquid onto a surface to be coated; whether by compressed air, hydraulic pressure, electrostatic forces, or
other methods of generating a spray.
Use stream means all reasonably anticipated transfer, flow, or disposal of a
chemical substance, regardless of physical state or concentration, through all
intended operations of industrial, commercial, or consumer use.
Waters of the United States has the
meaning set forth in 40 CFR 122.2.
Work area means a room or defined
space in a workplace where a chemical
substance is manufactured, processed,

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40 CFR Ch. I (7–1–07 Edition)

or used and where employees are
present.
Workplace means an establishment at
one geographic location containing one
or more work areas.

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[53 FR 28358, July 27, 1988, as amended at 54
FR 31306, July 27, 1989; 58 FR 63516, Dec. 1,
1993]

§ 721.5 Persons who must report.
(a) The following persons must submit a significant new use notice as
specified under the provisions of section 5(a)(1)(B) of the Act, part 720 of
this chapter, and § 721.25:
(1) A person who intends to manufacture, import, or process for commercial
purposes a chemical substance identified in a specific section in subpart E of
this part, and intends to engage in a
significant new use of the substance
identified in that section.
(2) A person who intends to manufacture, import, or process for commercial
purposes a chemical substance identified in a specific section in subpart E of
this part, and intends to distribute the
substance in commerce. A person described in this paragraph is not required to submit a significant new use
notice if that person can document one
or more of the following as to each recipient of the substance from that person:
(i) That the person has notified the
recipient, in writing, of the specific
section in subpart E of this part which
identifies the substance and its designated significant new uses.
(ii) That the recipient has knowledge
of the specific section in subpart E of
this part which identifies the substance
and its designated significant new uses.
(iii) That the recipient cannot undertake any significant new use described
in the specific section in subpart E of
this part.
(b) A person described in paragraph
(a)(2) of this section must submit a significant new use notice if that person
has knowledge at the time of commercial distribution of the substance identified in the specific section in subpart
E of this part that a recipient intends
to engage in a designated significant
new use of that substance without submitting a notice under this part.
(c) A person who processes a chemical substance identified in a specific

section in subpart E of this part for a
significant new use of that substance is
not required to submit a significant
new use notice if that person can document each of the following:
(1) That the person does not know the
specific chemical identity of the chemical substance being processed.
(2) That the person is processing the
chemical substance without knowledge
that the substance is identified in subpart E of this part.
(d)(1) If at any time after commencing distribution in commerce of a
chemical substance identified in a specific section in subpart E of this part a
person described in paragraph (a)(2) of
this section has knowledge that a recipient of the substance is engaging in
a significant new use of that substance
designated in that section without submitting a notice under this part, the
person is required to cease supplying
the chemical substance to that recipient and to submit a significant new use
notice for that chemical substance and
significant new use, unless the person
is able to document each of the following:
(i) That the person has notified the
recipient and EPA enforcement authorities (at the address in paragraph
(d)(1)(iii) of this section), in writing
within 15 working days of the time the
person develops knowledge that the recipient is engaging in a significant new
use, that the recipient is engaging in a
significant new use without submitting
a significant new use notice.
(ii) That, within 15 working days of
notifying the recipient as described in
paragraph (d)(1)(i) of this section, the
person received from the recipient, in
writing, a statement of assurance that
the recipient is aware of the terms of
the applicable section in subpart E of
this part and will not engage in the significant new use.
(iii) That the person has promptly
provided EPA enforcement authorities
with a copy of the recepient’s statement of assurance described in paragraph (d)(1)(ii) of this section. The copy
must be sent to the Office of Enforcement and Compliance Assurance, Office
of Compliance (2224A), U.S. Environmental Protection Agency, Ariel Rios,
1200 Pennsylvania Ave., N.W., Washington, DC, 20044.

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§ 721.11

(2) If EPA notifies the manufacturer,
importer, or processor that the recipient is engaging in a significant new use
after providing the statement of assurance described in paragraph (d)(1)(ii) of
this section and without submitting a
notice under this part, the manufacturer, importer, or processor shall immediately cease distribution to that recipient until the manufacturer, importer, or processor or the recipient
has submitted a significant new use notice under this part and the notice review period has ended.
(3) If, after receiving a statement of
assurance from a recipient under paragraph (d)(1)(ii) of this section, a manufacturer, importer, or processor has
knowledge that the recipient is engaging in a significant new use without
submitting a notice under this part,
the manufacturer, importer, or processor must immediately cease distributing the substance to that recipient
and notify EPA enforcement authorities at the address identified in paragraph (d)(1)(iii) of this section. The
manufacturer, importer, or processor
may not resume distribution to that
recipient until any one of the following
has occurred:
(i) The manufacturer, importer, or
processor has submitted a significant
new use notice under this part and the
notice review period has ended.
(ii) The recipient has submitted a significant new use notice under this part
and the notice review period has ended.
(iii) The manufacturer, importer, or
processor has received notice from EPA
enforcement authorities that it may
resume distribution to that recipient.
(e) Any significant new use notice relating to import of a substance must be
submitted by the principal importer.

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[53 FR 28359, July 27, 1988, as amended at 60
FR 34464, July 3, 1995]

§ 721.11 Applicability
determination
when the specific chemical identity
is confidential.
(a) A person who intends to manufacture, import, or process a chemical
substance which is described by a generic chemical name is subpart E of
this part may ask EPA whether the
substance is subject to the requirements of this part. EPA will answer
such an inquiry only if EPA determines

that the person has a bona fide intent
to manufacture, import, or process the
chemical substance for commercial
purposes.
(b) To establish a bona fide intent to
manufacture, import, or process a
chemical substance, the person who intends to manufacture, import, or process the chemical substance must submit the following information in writing to the Document Control Office
(DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC
20460–0001, ATTN: SNUR Bonafide submissions.
(1) The specific chemical identity of
the chemical substance that the person
intends to manufacture, import, or
process.
(2) A signed statement that the person intends to manufacture, import, or
process the chemical substance for
commercial purposes.
(3) A description of the research and
development activities conducted to
date, and the purpose for which the
person will manufacture, import, or
process the chemical substance.
(4) An elemental analysis.
(5) 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
substance.
(c) If an importer or processor cannot
provide all the information required in
paragraph (b) of this section because it
is claimed as confidential business information by the importer’s or processor’s manufacturer or supplier, the
manufacturer or supplier may supply
the information directly to EPA.
(d) EPA will review the information
submitted by the manufacturer, importer, or processor under paragraph
(b) of this section to determine whether than person has shown a bona fide intent to manufacture, import, or process the chemical substance. If necessary, EPA will compare this information either to the information requested for the confidential chemical

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40 CFR Ch. I (7–1–07 Edition)

substance under § 710.7(e)(2)(v) of this
chapter or the information requested
under § 720.85(b)(3)(iii) of this chapter.
(e) If the manufacturer, importer, or
processor has shown a bona fide intent
to manufacture, import, or process the
substance and has provided sufficient
unambiguous chemical identity information to enable EPA to make a conclusive determination as to the identity of the substance, EPA will inform
the manufacturer, importer, or processor whether the chemical substance
is subject to this part and, if so, which
section in subpart E of this part applies.
(f) A disclosure to a person with a
bona fide intent to manufacture, import, or process a particular chemical
substance that the substance is subject
to this part will not be considered public disclosure of confidential business
information under section 14 of the
Act.
(g) EPA will answer an inquiry on
whether a particular chemical substance is subject to this part within 30
days after receipt of a complete submission under paragraph (b) of this section.
[53 FR 28359, July 27, 1988, as amended at 60
FR 34464, July 3, 1995; 71 FR 33641, June 12,
2006]

§ 721.20

Exports and imports.

Persons who intend to export a chemical substance identified in subpart E
of this part, or in any proposed rule
which would amend subpart E of this
part, are subject to the export notification provisions of section 12(b) of the
Act. The regulations that interpret
section 12(b) appear at 40 CFR part 707.
Persons who import a substance identified in a specific section in subpart E of
this part are subject to the import certification requirements under section
13 of the Act, which are codified at 19
CFR 12.118 through 12.127 and 127.28.
The EPA policy in support of the import certification requirements appears
at 40 CFR part 707.
[53 FR 28360, July 27, 1988]

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§ 721.25 Notice requirements and procedures.
(a) Each person who is required to
submit a significant new use notice

under this part must submit the notice
at least 90 calendar days before commencing manufacture, import, or processing of a chemical substance identified in subpart E of this part for a significant new use. The submitter must
comply with any applicable requirement of section 5(b) of the Act, and the
notice must include the information
and test data specified in section 5(d)(1)
of the Act. The notice must be submitted on EPA Form 7710–25, and must
comply with the requirements of part
720 of this chapter, except to the extent
that they are inconsistent with this
part 721.
(b) If two or more persons are required to submit a significant new use
notice for the same chemical substance
and significant new use identified in
subpart E of this part, they may submit a joint notice to EPA. Persons submitting a joint notice must individually complete the certification section of part I of the required notification form. Persons who are required to
submit individually, but elect to submit jointly, remain individually liable
for the failure to submit required information which is known to or reasonably ascertainable by them and test
data in their possession or control.
(c) EPA will process the notice in accordance with the procedures of part
720 of this chapter, expect to the extent
they are inconsistent with this part
721.
(d) Any person submitting a significant new use notice in response to the
requirements of this part 721 shall not
manufacture, import, or process a
chemical substance identified in subpart E of this part for a significant new
use until the notice review period, including all extensions and suspensions,
has expired.
[53 FR 28360, July 27, 1988, as amended at 60
FR 16311, Mar. 29, 1995]

§ 721.30 EPA approval of alternative
control measures.
(a) In certain sections of subpart E of
this part, significant new uses for the
identified substances are described as
the failure to establish and implement
programs providing for the use of either: specific measures to control
worker exposure to or release of substances which are identified in such

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Environmental Protection Agency

§ 721.35

sections, or alternative measures to
control worker exposure or environmental release which EPA has determined provide substantially the same
degree of protection as the specified
control measures. Persons who manufacture, import, or process a chemical
substance identified in such sections
and who intend to employ alternative
measures to control worker exposure
or environmental release must submit
a request to EPA for a determination
of equivalency before commencing
manufacture, import, or processing involving the alternative control measures.
(b) A request for a determination of
equivalency must be submitted in writing to the Document Control Office
(DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC
20460–0001; ATTN: SNUR Equivalency
Determination, and must contain:
(1) The name of the submitter.
(2) The specific chemical identity of
the substance.
(3) The citation for the specific section in subpart E of this part which
pertains to the substance for which the
request is being submitted.
(4) A detailed description of the activities involved.
(5) The specifications of the alternative worker exposure control measures or environmental release control
measures.
(6) An analysis justifying why such
alternative control measures provide
substantially the same degree of protection as the specific control measures identified in the specific section in
subpart E of this part which pertains to
the substance for which the request is
being submitted.
(7) The data and information described in § 720.50 (a) and (b) of this
chapter unless such data and information have already been submitted to
the Office of Pollution Prevention and
Toxics, EPA.
(c) Requests for determinations of
equivalency will be reviewed by EPA
within 45 days. Determinations under
this paragraph will be made by the Director, Office of Pollution Prevention
and Toxics, or designee. Notice of the

results of such determinations will be
mailed to the submitter.
(d) If EPA notifies the submitter
under paragraph (c) of this section that
EPA has determined that the alternative control measures provide substantially the same degree of protection as the specified control measures
identified in the specified section of
subpart E of this part which pertains to
the substance for which the request is
being submitted, the submitter may
commence manufacture, import, or
processing in accordance with the specifications for alternative worker exposure control measures or environmental release control measures identified in the submitter’s request, and
may alter any corresponding notification to workers to reflect such alternative controls. Deviations from the
activities described in the EPA notification constitute a significant new use
and are subject to the requirements of
this part.
[53 FR 28360, July 27, 1988, as amended at 60
FR 34464, July 3, 1995; 71 FR 33641, June 12,
2006]

§ 721.35 Compliance and enforcement.
(a) Failure to comply with any provision of this part is a violation of section 15(1) of the Act (15 U.S.C. 2614).
(b) Using for commercial purposes a
chemical substance which a person
knew or had reason to know was manufactured, imported, or processed in violation of this part is a violation of section 15(2) of the Act (15 U.S.C. 2614).
(c) Failure or refusal to permit access to or copying of records, as required by section 11 of the Act, is a violation of section 15(3) of the Act (15
U.S.C. 2614).
(d) Failure or refusal to permit entry
or inspection, as required by section 11
of the Act, is a violation of section
15(4) of the Act.
(e) Violators of the Act or of this
part may be subject to the civil and
criminal penalties in section 16 of the
Act (15 U.S.C. 2615) for each violation.
The submission of false or misleading
information in connection with the requirement of any provision of this part
may subject persons to penalties calculated as if they never filed a notice.
(f) Under the authority of sections 7
and 17 of the Act, EPA may:

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§ 721.40

40 CFR Ch. I (7–1–07 Edition)

(1) Seek to enjoin the manufacture,
import, or processing of a chemical
substance in violation of this part.
(2) Act to seize any chemical substance which is being manufactured,
imported, or processed in violation of
this part.
(3) Take any other appropriate action.
[53 FR 28361, July 27, 1988]

§ 721.40

Recordkeeping.

Any person subject to the requirements of this part must retain documentation of information contained in
that person’s significant new use notice. This documentation must be
maintained for a period of 5 years from
the date of the submission of the significant new use notice.
[53 FR 28361, July 27, 1988]

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§ 721.45

Exemptions.

The persons identified in § 721.5 are
not subject to the notification requirements of § 721.25 for a chemical substance identified in subpart E of this
part, unless otherwise specified in a
specific section in subpart E, if:
(a) The person has applied for and has
been granted an exemption for test
marketing the substance for a significant new use identified in subpart E of
this part in accordance with section
5(h)(1) of the Act and § 720.38 of this
chapter.
(b) The person manufactures, imports, or processes the substance for a
significant new use identified in subpart E of this part in small quantities
solely for research and development in
accordance with § 721.47.
(c) The person has applied for and
been granted an exemption under section 5(h)(5) of the Act.
(d) The person manufactures, imports, or processes the substance only
as an impurity.
(e) The person manufactures, imports, or processes the substance only
as a byproduct which is used only 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.

(f) The person imports or processes
the substance as part of an article.
(g) The person manufactures or processes the substance solely for export
and, when distributing the substance in
commerce, labels the substance in accordance with section 12(a)(1)(B) of the
Act.
(h) The person submits a significant
new use notice for the substance prior
to the promulgation date of the section
in subpart E of this part which identifies the substance, and the person receives written notification of compliance from EPA prior to the effective
date of such section. The notice submitter must comply with any applicable requirement of section 5(b) of the
Act. The notice must include the information and test data specified in section 5(d)(1) of the Act and must be submitted on the notice form in Appendix
A to part 720 of this chapter. For purposes of this exemption, the specific
section in subpart E of this part which
identifies the substance and §§ 721.1,
721.3, 721.11, 721.35, and 721.40 apply;
after the effective date of the section
in subpart E of this part which identifies the substance, § 721.5 applies and
§ 721.20 continues to apply. EPA will
provide the notice submitter with written notification of compliance only if
one of the following occurs:
(1) EPA is unable to make the finding
that the activities described in the significant new use notice will or may
present an unreasonable risk of injury
to health or the environment under
reasonably foreseeable circumstances.
(2) EPA and the person negotiate a
consent order under section 5(e) of the
Act, such order to take effect on the effective date of the section in subpart E
of this part which identifies the substance.
(i) The person is operating under the
terms of a consent order issued under
section 5(e) of the Act applicable to
that person. If a provision of such section 5(e) order is inconsistent with a
specific significant new use identified
in subpart E of this part, abiding by
the provision of the section 5(e) order
exempts the person from submitting a
significant new use notice for that specific significant new use.
[53 FR 28361, July 27, 1988]

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Environmental Protection Agency

§ 721.47

§ 721.47 Conditions for research and
development exemption.
(a) A person who manufactures, imports, or processes a chemical substance identifies in subpart E of this
part for a significant new use identified
in subpart E of this part is not subject
to the notification requirements of
§ 721.25 if the following conditions are
met:
(1) The person manufactures, imports, or processes the substance for
the significant new use in small quantities solely for research and development.
(2) The manufacturer, importer, or
processor 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 associated 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, importer, or processor must review and
evaluate the following information to
determine whether there is reason to
believe there is any risk to health
which may be associated with the
chemicals 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, importer, or processor 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 section 4, 5, or 6 of

the Act that applies to the substance
and of which the manufacturer, importer, or processor 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 (b)(2), a laboratory is defined as a contained research facility where relatively small
quantities of chemical substances are
used on a pro-production 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, importer, or
processor must notify the persons identified in 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, importer, or processor
has reason to believe may be associated
with the substance, as determined
under paragraph (b)(1) of this section.
(2) If the manufacturer, importer, or
processor distributes a chemical substance manufactured, imported, or
processed under this section to persons
not in its employ, the manufacturer,
importer, or processor 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, importer, or processor.

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§ 721.50

40 CFR Ch. I (7–1–07 Edition)

(d) 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, to the extent the
disposal activity is not identified as a
significant new use for the substance in
subpart E of this part, or
(2) Used for a commercial purpose, to
the extent the use is not identified as a
significant new use of the substance in
subpart E of this part.
(e)(1) Persons who manufacture, import, or process a chemical substance
under this section must retain the following records:
(i) Copies of or citations to information reviewed and evaluated under
paragraph (b)(1) of this section to determine the need to make any notification of risk.
(ii) Documentation of the nature and
method of notification under paragraph
(c)(1) of this section including copies of
any labels or written notices used.
(iii) Documentation of prudent laboratory practices used instead of notification and evaluation under paragraph (b)(2) of this section.
(iv) The names and addresses of any
persons other than the manufacturer,
importer, or processor to whom the
substance is distributed, the identity of
the substance, the amount distributed,
and copies of the notifications required
under paragraph (c)(2) of this section.
(2) [Reserved]
[53 FR 28361, July 27, 1988, as amended at 58
FR 34204, June 23, 1993]

Subpart B—Certain Significant
New Uses
SOURCE: 54 FR 31308, July 27, 1989, unless
otherwise noted.

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§ 721.50

Applicability.

This subpart B identifies certain significant new uses of chemical substances identified in subpart E of this
part. The provisions of this subpart B
apply only when referenced as applying
to a chemical substance identified in
subpart E of this part.

§ 721.63

Protection in the workplace.

(a) Whenever a substance is identified in subpart E of this part as being
subject to this section, a significant
new use of the substance is any manner
or method of manufacturing, importing, or processing associated with any
use of the substance without establishing a program whereby:
(1) Each person who is reasonably
likely to be dermally exposed in the
work area to the chemical substance
through direct handling of the substance or through contact with equipment on which the substance may
exist, or because the substance becomes airborne in the form listed in
paragraph (a)(6) of this section, and
cited in subpart E of this part for the
chemical substance, is provided with,
and is required to wear, personal protective equipment that provides a barrier to prevent dermal exposure to the
substance in the specific work area
where it is selected for use. Each such
item of personal protective equipment
must be selected and used in accordance with 29 CFR 1910.132 and 1910.133.
(2) In addition to any other personal
protective equipment selected in paragraph (a)(1) of this section, the following items are required:
(i) Gloves.
(ii) Full body chemical protective
clothing.
(iii) Chemical goggles or equivalent
eye protection.
(iv) Clothing which covers any other
exposed areas of the arms, legs, and
torso. Clothing provided under this
paragraph need not be tested or evaluated under the requirements of paragraph (a)(3) of this section.
(3) The employer is able to demonstrate that each item of chemical
protective clothing, including gloves,
selected provides an impervious barrier
to prevent dermal exposure during normal and expected duration and conditions of exposure within the work area
by any one or a combination of the following:
(i) Testing the material used to make
the chemical protective clothing and
the construction of the clothing to establish that the protective clothing
will be impervious for the expected duration and conditions of exposure. The

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§ 721.63

testing must subject the chemical protective clothing to the expected conditions of exposure, including the likely
combinations of chemical substances
to which the clothing may be exposed
in the work area.
(ii) Evaluating the specifications
from the manufacturer or supplier of
the chemical protective clothing, or of
the material used in construction of
the clothing, to establish that the
chemical protective clothing will be
impervious to the chemical substance
alone and in likely combination with
other chemical substances in the work
area.
(4) Each person who is reasonably
likely to be exposed to the chemical
substance by inhalation in the work
area in one or more of the forms listed
in paragraph (a)(6) of this section and
cited in subpart E of this part for the
chemical substance, is provided with,
and is required to wear, at a minimum,
a NIOSH- approved respirator from one
of the categories listed in paragraph
(a)(5) of this section, and the respirator
is used in accordance with 29 CFR
1910.134 and 30 CFR part 11.
(5) The following NIOSH approved
respirators meet the minimum requirements for paragraph (a)(4) of this section:
(i) Category 19C Type C supplied-air
respirator operated in pressure demand
or other positive pressure mode and
equipped with a full facepiece.
(ii) Category 19C Type C supplied-air
respirator operated in pressure demand
or continuous flow mode and equipped
with a tight-fitting facepiece.
(iii) Category 19C Type C supplied-air
respirator operated in pressure demand
or continuous flow mode and equipped
with a hood or helmet or tight-fitting
facepiece.
(iv) Category 21C air-purifying respirator equipped with a full facepiece
and high efficiency particulate filters.
(v) Category 21C powered air-purifying respirator equipped with a tightfitting facepiece and high efficiency
particulate filters.
(vi) Category 21C powered air-purifying respirator equipped with a loosefitting hood or helmet and high efficiency particulate filters.
(vii) Category 21C air-purifying respirator equipped with a high efficiency

particulate filter including disposable
respirators.
(viii) Category 23C air-purifying respirator equipped with a full facepiece
and combination cartridges approved
for paints, lacquers, and enamels. (Approval label may preclude use for some
paints, lacquers, or enamels.)
(ix) Category 23C powered air-purifying respirator equipped with a tightfitting facepiece and combination cartridges approved for paints, lacquers,
and enamels. (Approval label may preclude use for some paints, lacquers, or
enamels.)
(x) Category 23C powered air-purifying respirator equipped with a loosefitting hood or helmet and combination
cartridges approved for paints, lacquers, and enamels. (Approval label
may preclude use for some paints, lacquers, or enamels.)
(xi) Category 23C air-purifying respirator equipped with combination cartridges approved for paints, lacquers,
and enamels, including disposable respirators. (Approval label may preclude
use for some paints, lacquers, or enamels.)
(xii) Category 23C air-purifying respirator equipped with a full facepiece
and organic gas/vapor cartridges.
(xiii) Category 23C powered air-purifying respirator equipped with a tightfitting facepiece and organic gas/vapor
cartridges.
(xiv) Category 23C powered air-purifying respirator equipped with a loosefitting hood or helmet and organic gas/
vapor cartridges.
(xv) Category 23C air-purifying respirator equipped with organic gas/
vapor cartridges, including disposable
respirators.
(6) When cited in subpart E of this
part for a substance, the following airborne form(s) of the substance apply to
paragraphs (a) (1) and (4) of this section:
(i) Dust.
(ii) Mist.
(iii) Fume.
(iv) Smoke.
(v) Vapor.
(vi) Gas.
(b) If a substance identified in subpart E of this part is present in the
work area only as a mixture, an employer is exempt from the provisions of

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§ 721.72

40 CFR Ch. I (7–1–07 Edition)

this section if the concentration of the
substance in the mixture does not exceed a concentration set in subpart E
of this part. The exemption does not
apply if the employer has reason to believe that during intended use or processing in the work area, the substance
in the mixture may be concentrated
above the level set in subpart E of this
part.
(c)(1) If at any time after commencing distribution in commerce of a
chemical substance that is identified in
subpart E of this part as subject to this
section, the person has knowledge that
a recipient of the substance is engaging
in an activity that is not consistent
with the implementation of a program
specified in paragraph (a) of this section, the person is considered to have
knowledge that the recipient is engaging in a significant new use and is required to follow the procedures in
§ 721.5(d) unless the person is able to
document the following:
(i) That the person has notified the
recipient in writing within 15 working
days of the time the person first has
knowledge that the recipient is engaging in an activity that is not consistent with the implementation of a
program specified in paragraph (a) of
this section, and that the person has
knowledge of the failure of implementation.
(ii) That within 15 working days of
notifying the recipient that the recipient is engaging in an activity that is
not consistent with the implementation of a program specified in paragraph (a) of this section the person has
received from the recipient, in writing,
a statement of assurance that the recipient has established the program required under paragraph (a) of this section, and will take appropriate measures to avoid activities that are inconsistent with implementation of the
program required under paragraph (a)
of this section.
(2) If, after receiving a statement of
assurance from a recipient under paragraph (c)(1)(ii) of this section, a manufacturer, importer, or processor has
knowledge that the recipient is engaging in an activity that is not consistent with the implementation of the
program specified in paragraph (a) of
this section, that person is considered

to have knowledge that the person is
engaging in a significant new use and
is required to follow the procedures in
§ 721.5(d).
§ 721.72 Hazard
gram.

communication

Whenever a substance is identified in
subpart E of this part as being subject
to this section, a significant new use of
that substance is any manner or method of manufacture, import, or processing associated with any use of that
substance without establishing a hazard communication program as described in this section.
(a) Written hazard communication program. Each employer shall develop and
implement a written hazard communication program for the substance in
each workplace. The written program
will, at a minimum, describe how the
requirements of this section for labels,
MSDSs, and other forms of warning
material will be satisfied. The employer must make the written hazard
communication
program
available,
upon request, to all employees, contractor employees, and their designated representatives. The employer
may rely on an existing hazard communication program, including an existing program established under the Occupational Health and Safety Administration (OSHA) Hazard Communication
Standard (29 CFR 1900.1200), to comply
with this paragraph provided that the
existing hazard communication program satisfies the requirements of this
paragraph. The written program shall
include the following:
(1) A list of each substance identified
in subpart E of this part as subject to
this section known to be present in the
work area. The list must be maintained
in the work area and must use the
identity provided on the appropriate
MSDS for each substance required
under paragraph (c) of this section. The
list may be compiled for the workplace
or for individual work areas.
(2) The methods the employer will
use to inform employees of the hazards
of non-routine tasks involving the substance, for example, the cleaning of reactor vessels, and the hazards associated with the substance contained in
unlabeled pipes in their work area.

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§ 721.72

(3) The methods the employer will
use to inform contractors of the presence of the substance in the employer’s
workplace and of the provisions of this
part applicable to the substance if employees of the contractor work in the
employer’s workplace and are reasonably likely to be exposed to the substance while in the employer’s workplace.
(b) Labeling. (1) Each employer shall
ensure that each container of the substance in the workplace is labeled in
accordance with this paragraph (b)(1).
(i) The label shall, at a minimum,
contain the following information:
(A) A statement of health hazard(s)
and precautionary measure(s) for the
substance, if any, identified in subpart
E of this part or by the employer.
(B) The identity by which the substance may be commonly recognized.
(C) A statement of environmental
hazard(s) and precautionary measure(s)
for the substance, if any, identified in
subpart E of this part or by the employer.
(D) A statement of exposure and precautionary measure(s), if any, identified in subpart E of this part or by the
employer.
(ii) The employer may use signs,
placards, process sheets, batch tickets,
operating procedures, or other such
written materials in lieu of affixing labels to individual stationary process
containers, as long as the alternative
method identifies the containers to
which it is applicable and conveys information specified by paragraph
(b)(1)(i) of this section. Any written
materials must be readily accessible to
the employees in their work areas
throughout each work shift.
(iii) The employer need not label
portable containers into which the substance is transferred from labeled containers, and which are intended only
for the immediate use of the employee
who performs the transfer.
(iv) The employer shall not remove
or deface an existing label on incoming
containers of the substance unless the
container is immediately relabeled
with the information specified in paragraph (b)(1)(i) of this section.
(2) Each employer shall ensure that
each container of the substance leaving
its workplace for distribution in com-

merce is labeled in accordance with
this paragraph.
(i) The label shall, at a minimum,
contain the following information:
(A) The information required under
paragraph (b)(1)(i) of this section.
(B) The name and address of the manufacturer or a responsible party who
can provide additional information on
the substance for hazard evaluation
and any appropriate emergency procedures.
(ii) The label shall not conflict with
the requirements of the Hazardous Materials Transportation Act (18 U.S.C.
1801 et. seq.) and regulations issued
under that Act by the Department of
Transportation.
(3) The label, or alternative forms of
warning, shall be legible and prominently displayed.
(4) The label, or alternative forms of
warning, shall be in English; however,
the information may be repeated in
other languages.
(5) If the label or alternative form of
warning is to be applied to a mixture
containing a substance identified in
subpart E of this part as subject to this
section in combination with another
substance identified in subpart E of
this part and/or a substance defined as
a ‘‘hazardous chemical’’ under the Occupational Safety and Health Administration (OSHA) Hazard Communication
Standard (29 CFR 1900.1200), the employer may prescribe on the label,
MSDS, or alternative form of warning,
the measures to control worker exposure or environmental release which
the employer determines provide the
greatest degree of protection. However,
should these control measures differ
from the applicable measures required
under subpart E of this part, the employer must seek a determination of
equivalency for such alternative control measures pursuant to § 721.30 before prescribing them under this paragraph.
(c) Material safety data sheets. (1) Each
employer must obtain or develop a
MSDS for the substance.
(2) Each MSDS shall contain, at a
minimum, the following information:
(i) The identity used on the container
label of the substance under this section, and, if not claimed confidential,
the chemical and common name of the

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§ 721.72

40 CFR Ch. I (7–1–07 Edition)

substance. If the chemical and common
name are claimed confidential, a generic chemical name must be used.
(ii) Physical and chemical characteristics of the substance known to the
employer (such as vapor pressure, flash
point).
(iii) The physical hazards of the substance known to the employer, including the potential for fire, explosion,
and reactivity.
(iv) The potential human and environmental hazards as specified in subpart E of this part for the substance.
(v) Signs and symptoms of exposure,
and any medical conditions which are
expected to be aggravated by exposure
to the substance known to the employer.
(vi) The primary routes of exposure
to the substance.
(vii) Precautionary measures to control worker exposure and/or environmental release identified in subpart E
of this part for the substance, or alternative control measures which EPA
has determined under § 721.30 provide
substantially the same degree of protection as the identified control measures.
(viii) Any generally applicable precautions for safe handling and use of
the substance which are known to the
employer, including appropriate hygienic practices, protective measures
during repair and maintenance of contaminated equipment, and procedures
for response to spills and leaks.
(ix) Any generally applicable control
measures which are known to the employer, such as appropriate engineering
controls, work practices, or personal
protective equipment.
(x) Emergency first aid procedures
known to the employer.
(xi) The date of preparation of the
MSDS or of its last revision.
(xii) The name, address, and telephone number of the individual preparing or distributing the MSDS, or a
responsible party who can provide additional information on the substance for
hazard evaluation and any appropriate
emergency procedures.
(3) If no relevant information is
found or known for any given category
on the MSDS, the employer must mark
the MSDS to indicate that no applicable information was found.

(4) Where multiple mixtures containing the substance have similar
compositions (i.e., the chemical ingredients are essentially the same, but the
specific composition varies from mixture to mixture) and similar hazards,
the employer may prepare one MSDS
to apply to all of these multiple mixtures.
(5) If the employer becomes aware of
any significant new information regarding the hazards of the substance or
ways to protect against the hazards,
this new information must be added to
the MSDS within 3 months from the
time the employer becomes aware of
the new information. If the substance
is not currently being manufactured,
imported, processed, or used in the employer’s workplace, the employer must
add the new information to the MSDS
before the substance is reintroduced
into the workplace.
(6) The employer must ensure that
persons receiving the substance from
the employer are provided an appropriate MSDS with their initial shipment and with the first shipment after
an MSDS is revised. The employer may
either provide the MSDS with the
shipped containers or send it to the
person prior to or at the time of shipment.
(7) The employer must maintain a
copy of the MSDS in its workplace, and
must ensure that it is readily accessible during each work shift to employees when they are in their work areas.
(8) The MSDS may be kept in any
form, including as operating procedures, and may be designed to cover
groups of substances in a work area
where it may be more appropriate to
address the potential hazards of a process rather than individual substances.
However, in all cases, the required information must be provided for each
substance and must be readily accessible during each work shift to employees when they are in their work areas.
(9) The MSDS must be printed in
English; however, the information may
be repeated in other languages.
(d) Employee information and training.
Each employer must ensure that employees are provided with information

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Environmental Protection Agency

§ 721.72

and training on the substance identified in subpart E of this part. This information and training must be provided at the time of each employee’s
initial assignment to a work area containing the substance and whenever
the substance subject to this section is
introduced into the employee’s work
area for the first time.
(1) Information provided to employees under this paragraph shall include:
(i) The requirements of this section.
(ii) Any operations in the work area
where the substance is present.
(iii) The location and availability of
the written hazard communication program required under paragraph (a) of
this section, including the list of substances identified in subpart E of this
part as subject to this section, and
MSDSs required by paragraph (c) of
this section.
(2) Training provided to employees
shall include:
(i) Methods and observations that
may be used to detect the presence or
release of the substance in or from an
employee’s work area (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance, or odor of the substance
when being released).
(ii) The potential human health and
environmental hazards of the substance as specified in subpart E of this
part.
(iii) The measures employees can
take to protect themselves and the environment from the substance, including specific procedures the employer
has implemented to protect employees
and the environment from exposure to
the substance, including appropriate
work practices, emergency procedures,
personal protective equipment, engineering controls, and other measures
to control worker exposure and/or environmental release required under subpart E of the part, or alternative control measures which EPA has determined under § 721.30 provide substantially the same degree of protection as
the specified control measures.
(iv) The requirements of the hazard
communication program developed by
the employer under this section, including an explanation of the labeling
system and the MSDS required by this

section and guidance on obtaining and
using appropriate hazard information.
(e) Low concentrations in mixtures. If a
substance identified in subpart E of
this part is present in the work area
only as a mixture, an employer is exempt from the provisions of this section if the concentration of the substance in the mixture does not exceed a
concentration set in subpart E of this
part. The exemption does not apply if
the employer has reason to believe that
during intended use or processing in
the work area, the substance in the
mixture may be concentrated above
the level set in subpart E of this part.
(f) Existing hazard communication program. The employer need not take additional actions if existing programs and
procedures satisfy the requirements of
this section.
(g) Human health, environmental hazard, exposure, and precautionary statements. Whenever referenced in subpart
E of this part for a substance, the following human health and environmental hazard, exposure, and precautionary statements shall appear on
each label as specified in paragraph (b)
of this section and the MSDS as specified in paragraph (c) of this section.
Additional statements may be included
as long as they are true and do not
alter the meaning of the required
statements.
(1) Human health hazard statements:
This substance may cause:
(i) Skin irritation.
(ii) Respiratory complications.
(iii) Central nervous system effects.
(iv) Internal organ effects.
(v) Birth defects.
(vi) Reproductive effects.
(vii) Cancer.
(viii) Immune system effects.
(ix) Developmental effects.
(2) Human health hazard precautionary statements: When using
this substance:
(i) Avoid skin contact.
(ii) Avoid breathing substance.
(iii) Avoid ingestion.
(iv) Use respiratory protection.
(v) Use skin protection.
(3) Environmental hazard statements: This substance may be:
(i) Toxic to fish.
(ii) Toxic to aquatic organisms.

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§ 721.72

40 CFR Ch. I (7–1–07 Edition)

(4)
Environmental
hazard
precautionary statements: Notice to
users:
(i) Disposal restrictions apply.
(ii) Spill clean-up restrictions apply.
(iii) Do not release to water.
(5) Each human health or environmental hazard precautionary statement identified in subpart E of this
part for the label on the substance container must be followed by the statement, ‘‘See MSDS for details.’’
(h) Human health, environmental hazard exposure and precautionary statements. (1) Whenever referenced in subpart E of this part for a substance, the
following human health, environmental hazard, exposure, and precautionary statements shall appear on
each label as specified in paragraph (b)
of this section. Additional statements
may be included as long as they are
true and do not alter the meaning of
the required statements.
(i) Precautionary statements. (A) The
health effects of this chemical substance have not been determined.
(B) When using this substance, use
skin protection.
(C) Use respiratory protection when
there is a reasonable likelihood of exposure in the work area from dust,
mist, or smoke from spray application.
(D) Chemicals similar in structure to
this substance have been found to
cause cancer in laboratory animals.
(ii) Human health hazard statements.
This substance may cause:
(A) Skin irritation
(B) Respiratory complications
(C) Central nervous system effects
(D) Internal organ effects
(E) Birth defects
(F) Reproductive effects
(G) Cancer
(H) Immune system effects
(I) Developmental effects
(iii) Human health hazard precautionary statements. When using this
substance:
(A) Avoid skin contact
(B) Avoid breathing substance
(C) Avoid ingestion
(D) Use respiratory protection
(E) Use skin protection
(iv) Environmental hazard statements.
This substance may be:
(A) Toxic to fish
(B) Toxic to aquatic organisms

(v)
Environmental
hazard
precautionary statements. Notice to Users:
(A) Disposal restrictions apply
(B) Spill clean-up restrictions apply
(C) Do not release to water.
(vi)
Additional
statements.
Each
human health or environmental precautionary statement identified in subpart E of this part for the label on the
substance container must be followed
by the statement, ‘‘See MSDS for details.’’
(2) Whenever referenced in subpart E
of this part for a substance, the following human health, environmental
hazard, exposure, and precautionary
statements shall appear on each MSDS
as specified in paragraph (c) of this section. Additional statements may be included as long as they are true and do
not alter the meaning of the required
statements.
(i) Precautionary statements. (A) The
health effects of this chemical substance have not been determined.
(B) When using this substance, use
skin protection.
(C) Use respiratory protection when
there is a reasonable likelihood of exposure in the work area from dust,
mist, or smoke from spray application.
(D) Chemicals similar in structure to
this substance have been found to
cause cancer in laboratory animals.
(ii) Human health hazard statements.
This substance may cause:
(A) Skin irritation
(B) Respiratory complications
(C) Central nervous system effects
(D) Internal organ effects
(E) Birth defects
(F) Reproductive effects
(G) Cancer
(H) Immune system effects
(I) Developmental effects
(iii) Human health hazard precautionary statements. When using this
substance:
(A) Avoid skin contact
(B) Avoid breathing substance
(C) Avoid ingestion
(D) Use respiratory protection
(E) Use skin protection
(iv) Environmental hazard statements.
This substance may be:
(A) Toxic to fish
(B) Toxic to aquatic organisms
(v)
Environmental
hazard
precautionary statements. Notice to Users:

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§ 721.80

(A) Disposal restrictions apply
(B) Spill clean-up restrictions apply
(C) Do not release to water.
[54 FR 31308, July 27, 1989, as amended at 55
FR 45996, Oct. 31, 1990; 58 FR 34204, June 23,
1993]

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§ 721.80 Industrial, commercial,
consumer activities.

and

Whenever a substance is identified in
subpart E of this part as being subject
to this section, a significant new use of
the substance is:
(a) Use in non-enclosed processes.
(b) Any manner or method of manufacture in non-enclosed processes associated with any use.
(c) Any manner or method of processing in non-enclosed processes associated with any use.
(d) Use beyond the site of manufacture or import.
(e) Processing beyond the site of
manufacture or import.
(f) Any manner or method of manufacture (excluding import) of the substance associated with any use.
(g) Use other than as an intermediate.
(h) Use other than as a site-limited
intermediate.
(i) Use as an intermediate where the
concentration of the intermediate substance in the product intended for distribution in commerce exceeds the concentration specified in subpart E of
this part for the substance.
(j) Use other than as described in the
premanufacture notice referenced in
subpart E of this part for the substance.
(k) Use other than allowed by the
section 5(e) consent order referenced in
subpart E of this part for the substance.
(l) Non-industrial use.
(m) Commercial use.
(n) Non-commercial use.
(o) Use in a consumer product.
(p) Aggregate manufacture and importation volume for any use greater
than that specified in subpart E of this
part for the substance.
(q) Aggregate manufacture and importation volume for any use greater
than that allowed by the section 5(e)
consent order referenced in subpart E
of this part for the substance.

(r) Aggregate manufacture and importation volume for any use greater
than that specified in subpart E of this
part for the substance unless the manufacturer or importer has submitted
the results of the health or environmental effects studies identified in subpart E of this part for the substance
and those studies comply with the procedures and criteria for developing and
evaluating data identified in subpart E
of this part for the substance.
(s) Annual manufacture and importation volume for any use greater than
that specified in subpart E of this part
for the substance.
(t) Annual manufacture and importation volume for any use greater than
that allowed by the section 5(e) consent order referenced in subpart E of
this part for the substance.
(u) Annual manufacture and importation volume for any use greater than
that specified in subpart E of this part
for the substance unless the manufacturer or importer has submitted the results of the health or environmental effects studies identified in subpart E of
this part for the substance and those
studies comply with the procedures and
criteria for developing and evaluating
data identified in subpart E of this part
for the substance.
(v) Use in the form of:
(1) A powder.
(2) A solid.
(3) A liquid.
(4) A gas.
(w) Any manner or method of manufacture of the substance in the following form associated with any use:
(1) A powder.
(2) A solid.
(3) A liquid.
(4) A gas.
(x) Any manner or method of processing of the substance in the following
form associated with any use:
(1) A powder.
(2) A solid.
(3) A liquid.
(4) A gas.
(y) Use involving an application
method that generates:
(1) A vapor, mist, or aerosol.
(2) A dust.

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§ 721.85

40 CFR Ch. I (7–1–07 Edition)

§ 721.85 Disposal.
Whenever a substance is identified in
subpart E of this part as being subject
to this section, a significant new use of
the substance is any method of:
(a) Disposal of the process stream associated with any use of the substance
or with any manner or method of manufacturing associated with any use of
the substance other than by the following. This provision does not
supercede any applicable Federal,
State, or local laws and regulations.
(1) Incineration.
(2) Landfill.
(3) Deep well injection.
(b) Disposal of the process stream associated with any use or with any manner or method of processing associated
with any use other than by the following. This provision does not
supercede any applicable Federal,
State, or local laws and regulations.
(1) Incineration.
(2) Landfill.
(3) Deep well injection.
(c) Disposal of the use stream associated with any use, other than by the
following. This provision does not
supercede any applicable Federal,
State, or local laws and regulations.
(1) Incineration.
(2) Landfill.
(3) Deep well injection.
(d) Disposal of the substance associated with any use of the substance, or
with any manner or method of manufacture or processing in association
with any use. This provision does not
supercede any applicable Federal,
State, or local laws and regulations.

§ 721.90

Release to water.

Whenever a substance is identified in
subpart E of this part as being subject
to this section, a significant new use of
the substance is:
(a) Any predictable or purposeful release of a manufacturing stream associated with any use of the substance,
from any site:
(1) Into the waters of the United
States.
(2) Into the waters of the United
States without application of one or
more of the following treatment technologies as specified in subpart E of
this part either by the discharger or, in
the case of a release through publiclyowned treatment works, by a combination of treatment by the discharger
and the publicly-owned treatment
works:
(i) Chemical precipitation and settling.
(ii) Biological treatment (activated
sludge or equivalent) plus clarification.
(iii) Steam stripping.
(iv) Resin or activated carbon adsorption.
(v) Chemical destruction or conversion.
(vi) Primary wastewater treatment.
(3) Into the waters of the United
States without primary wastewater
treatment, and secondary wastewater
treatment as defined in 40 CFR part
133.
(4) Into the waters of the United
States if the quotient from the following formula:

exceeds the level specified in subpart E
of this part when calculated using the
methods described in § 721.91. In lieu of
calculating the above quotient, monitoring or alternative calculations may
be used to predict the surface water
concentration which will result from
the intended release of the substance,
if the monitoring procedures or calculations have been approved for such

purpose by EPA. EPA will review and
act on written requests to approve
monitoring procedures or alternative
calculations within 90 days after such
requests are received. EPA will inform
submitters of the disposition of such
requests in writing, and will explain
the reasons therefor when they are denied.

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number of kilograms/day/site released
× 1000 = N parts per billion
receiving stream flow (million liters/day)

Environmental Protection Agency

§ 721.90

(b) Any predictable or purposeful release of a process stream containing
the substance associated with any use
of the substance from any site:
(1) Into the waters of the United
States.
(2) Into the waters of the United
States without application of one or
more of the following treatment technologies as specified in subpart E of
this part either by the discharger or, in
the case of a release through publiclyowned treatment works, by a combination of treatment by the discharger
and the publicly-owned treatment
works:
(i) Chemical precipitation and settling.

(ii) Biological treatment (activated
sludge or equivalent) plus clarification.
(iii) Steam stripping.
(iv) Resin or activated carbon adsorption.
(v) Chemical destruction or conversion.
(vi) Primary wastewater treatment.
(3) Into the waters of the United
States without primary wastewater
treatment, and secondary wastewater
treatment as defined in 40 CFR part
133.
(4) Into the waters of the United
States if the quotient from the following formula:

number of kilograms/day/site released
× 1000 = N parts per billion
receiving stream flow (million liters/day)

number of kilograms/day/site released
× 1000 = N parts per billion
receiving stream flow (million liters/day)
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more of the following treatment technologies as specified in subpart E of
this part either by the discharger or, in
the case of a release through publiclyowned treatment works, by a combination of treatment by the discharger
and the publicly-owned treatment
works:
(i) Chemical precipitation and settling.
(ii) Biological treatment (activated
sludge or equivalent) plus clarification.
(iii) Steam stripping.
(iv) Resin or activated carbon adsorption.
(v) Chemical destruction or conversion.
(vi) Primary wastewater treatment.
(3) Into the waters of the United
States without primary wastewater
treatment, and secondary wastewater
treatment as defined in 40 CFR part
133.
(4) Into the waters of the United
States if the quotient from:

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exceeds the level specified in subpart E
of this part when calculated using the
methods described in § 721.91. In lieu of
calculating the above quotient, monitoring or alternative calculations may
be used to predict the surface water
concentration which will result from
the intended release of the substance,
if the monitoring procedures or calculations have been approved for such
purpose by EPA. EPA will review and
act on written requests to approve
monitoring procedures or alternative
calculations within 90 days after such
requests are received. EPA will inform
submitters of the disposition of such
requests in writing, and will explain
the reasons therefor when they are denied.
(c) Any predictable or purposeful release of a use stream containing the
substance associated with any use of
the substance from any site:
(1) Into the waters of the United
States.
(2) Into the waters of the United
States without application of one or

§ 721.91

40 CFR Ch. I (7–1–07 Edition)

exceeds the level specified in subpart E
of this part, when calculated using the
methods described in § 721.91. In lieu of
calculating the above quotient, however, monitoring or alternative calculations may be used to predict the
surface water concentration expected
to result from intended release of the
substance, if the monitoring procedures or calculations have been approved for such purpose by EPA. EPA
will review and act on written requests
to approve monitoring procedures or
alternative calculations within 90 days
after such requests are received. EPA
will inform submitters of the disposition of such requests in writing, and
will explain the reasons therefor when
they are denied.

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§ 721.91 Computation of estimated surface water concentrations: Instructions.
These instructions describe the use of
the equation specified in § 721.90(a)(4)
and (b)(4) to compute estimated surface
water concentrations which will result
from release of a substance identified
in subpart E of this part. The equation
shall be computed for each site using
the stream flow rate appropriate for
the site according to paragraph (b) of
this section, and the highest number of
kilograms calculated to be released for
that site on a given day according to
paragraph (a) of this section. Two variables shall be considered in computing
the equation, the number of kilograms
released, and receiving stream flow.
(a) Number of kilograms released. (1) To
calculate the number of kilograms of
substance to be released from manufacturing, processing, or use operations,
as specified in the numerator of the
equation, develop a process description
diagram which describes each manufacturing, processing, or use operation involving the substance. The process description must include the major unit
operation steps and chemical conversions. A unit operation is a functional
step in a manufacturing, processing, or
use operation where substances undergo chemical changes and/or changes in
location, temperature, pressure, physical state, or similar characteristics.
Include steps in which the substance is
formulated into mixtures, suspensions,
solutions, etc.

(2) Indicate on each diagram the
entry point of all feedstocks (e.g.,
reactants, solvents, and catalysts) used
in the operation. Identify each feedstock and specify its approximate
weight regardless of whether the process is continuous or batch.
(3) Identify all release points from
which the substance or wastes containing the substance will be released
into air, land, or water. Indicate these
release points on the diagram. Do not
include accidental releases or fugitive
emissions.
(4) For releases identified in the diagram that are destined for water, estimate the amount of substance that will
be released before the substance enters
control technology. The kilograms of
substance released may be estimated
based on:
(i) The mass balance of the operation,
i.e., totaling inputs and outputs, including wastes for each part of the
process such that outputs equal inputs.
The amount released to water may be
the difference between the amount of
the substance in the starting material
(or formed in a reaction) minus the
amount of waste material removed
from each part of the process and not
released to water and the amount of
the substance in the final product.
(ii) Physical properties such as water
solubility where a known volume of
water being discharged is assumed to
contain the substance at concentrations equal to its solubility in water.
This approach is particularly useful
where the waste stream results from
separation of organic/water phases or
filtration of the substance from an
aqueous stream to be discharged.
(iii) Measurements of flow rates of
the process/use stream and known concentrations of the substance in the
stream.
(5) After releases of a substance to
water are estimated for each operation
on a site, total the releases of the substance to water from all operations at
that site. The value (number of kilograms) specified in the numerator of
the equation should reflect total kilograms of substance released to water
per day from all operations at a single
site.
(6) Use the highest expected daily release of the substance for each site.

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§ 721.125

(b) Receiving stream flow. (1) The receiving stream flow shall be expressed
in million liters per day (MLD). The
flow rate data to be used must be for
the point of release on the water body
that first receives release of the substance whether by direct discharge
from a site, or by indirect discharge
through a Publicly-Owned Treatment
Works (POTW) for each site. The flow
rate reported shall be the lowest 7-day
average stream flow with a recurrence
interval of 10 years (7-Q-10). If the 7-Q10 flow rate is not available for the actual point of release, the stream flow
rate should be used from the U.S. Geological Survey (USGS) gauging station
that is nearest the point of release that
is expected to have a flow rate less
than or equal to the receiving stream
flow at the point of release.
(2) Receiving stream flow data may
be available from the National Pollutant Discharge Elimination System
(NPDES) permit for the site or the
POTW releasing the substance to surface water, from the NPDES permitwriting authority for the site or the
POTW, or from USGS publications,
such as the water-data report series.
(3) If receiving stream flow data are
not available for a stream, either the
value of 10 MLD or the daily flow of
wastewater from the site or the POTW
releasing the substance must be used
as an assumed minimum stream flow.
Similarly, if stream flow data are not
available because the location of the
point of release of the substance to surface water is a lake, estuary, bay, or
ocean, then the flow rate to be used
must be the daily flow of wastewater
from the site or the POTW releasing
the substance to surface water. Wastewater flow data may be available from
the NPDES permit or NPDES authority for the site or the POTW releasing
the substance to water.

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Subpart C—Recordkeeping
Requirements
§ 721.100 Applicability.
This subpart C identifies certain additional recordkeeping requirements
applicable to manufacturers, importers, and processors of substances identified in subpart E of this part for each
specific substance. The provisions of

this subpart C apply only when referenced in subpart E of this part for a
substance and significant new use identified in that subpart E. If the provisions in this subpart C conflict with
general provisions of subpart A of this
part, the provisions of this subpart C
shall apply.
[54 FR 31313, July 27, 1989]

§ 721.125 Recordkeeping requirements.
At the time EPA adds a substance to
subpart E of this part, EPA will specify
appropriate
recordkeeping
requirements which correspond to the significant new use designations for the substance selected from subpart B of this
part. Each manufacturer, importer,
and processor of the substance shall
maintain the records for 5 years from
the date of their creation. In addition
to the records specified in § 721.40, the
records whose maintenance this section requires may include the following:
(a) Records documenting the manufacture and importation volume of the
substance and the corresponding dates
of manufacture and import.
(b) Records documenting volumes of
the substance purchased in the United
States by processors of the substance,
names and addresses of suppliers, and
corresponding dates of purchase.
(c) Records documenting the names
and addresses (including shipment destination address, if different) of all persons outside the site of manufacture,
importation, or processing to whom
the manufacturer, importer, or processor directly sells or transfers the substance, the date of each sale or transfer, and the quantity of the substance
sold or transferred on such date.
(d) Records documenting establishment and implementation of a program
for the use of any applicable personal
protective equipment required under
§ 721.63.
(e) Records documenting the determinations required by § 721.63(a)(3) that
chemical protective clothing is impervious to the substance.
(f) Records documenting establishment and implementation of the hazard communication program required
under § 721.72.
(g) Copies of labels required under
§ 721.72(b).

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§ 721.160

40 CFR Ch. I (7–1–07 Edition)

(h) Copies of material safety data
sheets required under § 721.72(c).
(i) Records documenting compliance
with any applicable industrial, commercial, and consumer use limitations
under § 721.80.
(j) Records documenting compliance
with any applicable disposal requirements under § 721.85, including the
method of disposal, location of disposal
sites, dates of disposal, and volume of
the substance disposed. Where the estimated disposal volume is not known to
or reasonably ascertainable by the
manufacturer, importer, or processor,
that person must maintain other
records which demonstrate establishment and implementation of a program
that ensures compliance with any applicable disposal requirements.
(k) Records documenting establishment and implementation of procedures that ensure compliance with any
applicable water discharge limitations
under § 721.90.
[54 FR 31313, July 27, 1989]

Subpart D—Expedited Process for
Issuing Significant New Use
Rules for Selected Chemical
Substances and Limitation or
Revocation of Selected Significant New Use Rules

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SOURCE: 54 FR 31314, July 27, 1989, unless
otherwise noted.

§ 721.160 Notification requirements for
new chemical substances subject to
section 5(e) orders.
(a) Selection of substances. (1) In accordance with the expedited process
specified in this section, EPA will issue
significant new use notification requirements and other specific requirements for each new chemical substance
that is the subject of a final order
issued under section 5(e) of the Act, except for an order that prohibits manufacture and import of the substance,
unless EPA determines that significant
new use notification requirements are
not needed for the substance.
(2) If EPA determines that significant new use notification requirements
are not needed for a substance that is
subject to a final order issued under
section 5(e) of the Act, except for an

order that prohibits manufacture or
import of the substance, EPA will issue
a notice in the FEDERAL REGISTER explaining why the significant new use
requirements are not needed.
(b) Designation of requirements. (1) The
significant new use notification and
other specific requirements will be
based on and be consistent with the
provisions included in the final order
issued for the substance under section
5(e) of the Act. EPA may also designate
additional activities as significant new
uses which will be subject to notification. Designation of additional activities as significant new uses will be
done in accordance with the criteria
and procedures under § 721.170, or
through a separate rulemaking proceeding.
(2) Significant new use requirements
and other specific requirements designated under this section will be listed
in subpart E of this part. For each substance, subpart E will identify:
(i) The chemical name.
(ii) The activities designated as significant new uses.
(iii) Other specific requirements applicable to the substance, including
recordkeeping requirements or any
other requirements included in the
final section 5(e) order.
(c) Procedures for issuing significant
new use rules. (1) EPA will issue significant new use rules under this section
by one of the following three processes:
direct final rulemaking, interim final
rulemaking, or notice and comment
rulemaking. EPA will use the direct
final rulemaking process to issue significant new use rules unless it determines that, in a particular case, one of
the other processes is more appropriate.
(2) FEDERAL REGISTER documents
issued to propose or establish significant new uses under this section will
contain the following:
(i) The chemical identity of the substance or, if its specific identity is
claimed confidential, an appropriate
generic chemical name and an accession number assigned by EPA.
(ii) The premanufacture notice number.
(iii) The CAS number, where available and not claimed confidential.

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(iv) A summary of EPA’s findings
under section 5(e)(1)(A) of the Act for
the final order issued under section
5(e).
(v) Designation of the significant new
uses subject to, or proposed to be subject to, notification and any other applicable requirements.
(vi) Any modifications of subpart A
of this part applicable to the specific
substance and significant new uses.
(vii) If the FEDERAL REGISTER document establishes a final rule, or notifies the public that a final rule will not
be issued after public comment has
been received, the document will describe comments received and EPA’s
response.
(3) Direct final rulemaking. (i) When
EPA uses the direct final rulemaking
procedure to issue a significant new
use rule, it will issue a final rule in the
FEDERAL REGISTER following its decision to develop a significant new use
rule under this section for a specific
new chemical substance.
(ii) The FEDERAL REGISTER document
will state that, unless written notice is
received by EPA within 30 days of publication that someone wishes to submit
adverse or critical comments, the rule
will be effective 60 days from the date
of publication. The written notice of
intent to submit adverse or critical
comments should state which SNUR(s)
will be the subject of the adverse or
critical comments, if several SNURs
are established through the direct final
rule. If notice is received within 30
days that someone wishes to submit
adverse or critical comments, the section(s) of the direct final rule containing the SNUR(s) for which a notice
of intent to comment was received will
be withdrawn by EPA issuing a document in the final rule section of the
FEDERAL REGISTER, and a proposal will
be published in the proposed rule section of the FEDERAL REGISTER. The proposal will establish a 30-day comment
period.
(iii) If EPA, having considered any
timely comments submitted in response to the proposal, decides to establish
notification
requirements
under this section, EPA will issue a
final rule adding the substance to subpart E of this part and designating the

significant new uses subject to notification.
(4) Notice and comment rulemaking. (i)
When EPA uses a notice and comment
procedure to issue a significant new
use rule, EPA will issue a proposal in
the FEDERAL REGISTER following its decision to develop a significant new use
rule under this section for a specific
new chemical substance. Persons will
be given 30 days to comment on whether EPA should establish notification
requirements for the substance under
this part.
(ii) If EPA, having considered any
timely comments, decides to establish
notification requirements under this
section, EPA will issue a final rule adding the substance to subpart E of this
part and designating the significant
new uses subject to notification.
(5) Interim final rulemaking. (i) When
EPA uses the interim final rulemaking
procedure to issue a significant new
use rule, EPA will issue an interim
final rule in the final rule section of
the FEDERAL REGISTER following its decision to develop a significant new use
rule for a specific new chemical substance. The document will state EPA’s
reasons for using the interim final
rulemaking procedure.
(A) The significant new use rule will
take effect on the date of publication.
(B) Persons will be given 30 days from
the date of publication to submit comments.
(ii) Interim final rules issued under
this section shall cease to be in effect
180 days after publication unless, within the 180-day period, EPA issues a
final rule in the FEDERAL REGISTER responding to any written comments received during the 30-day comment period specified in paragraph (c)(5)(i)(B)
of this section and promulgating final
significant new use notification requirements and other requirements for
the substance.
(d) Schedule for issuing significant new
use rules. (1) Unless EPA determines
that a significant new use rule should
not be issued under this section, EPA
will issue a proposed rule, a direct final
rule, or an interim final rule within 180

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40 CFR Ch. I (7–1–07 Edition)

days of receipt of a valid notice of commencement under § 720.102 of this chapter for any substance for which the notice of commencement was received on
or after October 10, 1989.
(2) Unless EPA determines that a significant new use rule should not be
issued under this section, EPA will
issue a proposed rule, a direct final
rule, or an interim final rule within 1
year of October 10, 1989, for any substance for which the valid notice of
commencement under § 720.102 of this
chapter was received before October 10,
1989.
(3) If EPA receives adverse or critical
significant comments following publication of a proposed or interim final
rule, EPA will either withdraw the rule
or issue a final rule addressing the
comments received.

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§ 721.170 Notification requirements for
selected new chemical substances
that have completed premanufacture review.
(a) Selection of substances. In accordance with the expedited process specified in this section, EPA may issue significant new use notification and recordkeeping requirements for any new
chemical substance for which a
premanufacture notice has been submitted under part 720 of this chapter if
EPA determines that activities other
than
those
described
in
the
premanufacture notice may result in
significant changes in human exposure
or environmental release levels and/or
that concern exists about the substance’s health or environmental effects.
(b) Concern criteria. EPA may determine that concern exists about a substance’s health or environmental effects if EPA makes any one of the following findings:
(1)(i) The substance may cause carcinogenic effects because the substance:
(A) Has been shown by valid test data
to cause carcinogenic effects in humans or in at least one species of laboratory animal.
(B) Has been shown to be a possible
carcinogen based on the weight of the
evidence in short-term tests indicative
of the potential to cause carcinogenic
effects.

(C) Is closely analogous, based on
toxicologically relevant similarities in
molecular structure and physical properties, to another substance that has
been shown by test data to cause carcinogenic effects in humans or in at
least one species of laboratory animal,
provided that if there is more than one
such analogue, the greatest weight will
be given to the relevant data for the
most appropriate analogues.
(D) Is known or can reasonably be anticipated, based on valid scientific data
or established scientific principles, to
be metabolized in humans or transformed in the environment to a substance which may have the potential to
cause carcinogenic effects under the
criteria in paragraphs (b)(1)(i) (A), (B),
or (C) of this section.
(ii) No substance may be regulated
based on a finding under paragraph
(b)(1) of this section unless EPA has
also
made
the
finding
under
§ 721.170(c)(2)(ii).
(2) The substance has been shown by
valid test data to cause acutely toxic
effects in at least one species of laboratory animal or is closely analogous,
based on toxicologically relevant similarities in molecular structure and
physical properties, to another substance that has been shown by valid
test data to cause acutely toxic effects
in at least one species of laboratory
animal, provided that if there is more
than one such analogue, the greatest
weight will be given to the relevant
data for the most appropriate analogues.
(3) The substance may cause serious
chronic effects, serious acute effects,
or developmentally toxic effects under
reasonably anticipated conditions of
exposure because the substance:
(i) Has been shown by valid test data
to cause serious chronic effects, serious
acute effects, or developmentally toxic
effects in humans or in at least one
species of laboratory animal at dose
levels that could be of concern under
reasonably anticipated conditions of
exposure.
(ii) Is closely analogous, based on
toxicologically relevant similarities in
molecular structure and physical properties, to another chemical substance
that has been shown by valid test data
to cause serious chronic effects, serious

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acute effects, or developmentally toxic
effects in humans or in at least one
species of laboratory animal at dose
levels that could be of concern under
reasonably anticipated conditions of
exposure, provided that if there is more
than one such analogue, the greatest
weight will be given to the relevant
data for the most appropriate analogues.
(iii) Is known or can reasonably be
anticipated, based on valid scientific
data or established scientific principles, to be metabolized in humans or
transformed in the environment to a
substance which may have the potential to cause serious chronic effects, serious acute effects, or developmentally
toxic effects under the criteria in paragraph (b)(3) (i) and (ii) of this section.
(iv) Has been shown to potentially
cause developmentally toxic effects
based on the weight of the evidence in
short-term tests indicative of the potential to cause developmentally toxic
effects.
(4) The substance may cause significant adverse environmental effects
under reasonably anticipated conditions of release because the substance:
(i) Has been shown by valid test data
to cause significant adverse environmental effects at dose levels that could
be of concern under reasonably anticipated conditions of release.
(ii) Is closely analogous, based on
toxicologically relevant similarities in
molecular structure and physical properties, to another substance that has
been shown by valid test data to cause
significant adverse environmental effects at dose levels that could be of
concern under reasonably anticipated
conditions of release, provided that if
there is more than one such analogue,
the greatest weight will be given to the
relevant data for the most appropriate
analogues.
(iii) Has been determined, based on
calculations using the substance’s
physical and chemical properties, to be
potentially able to cause significant
adverse environmental effects at dose
levels that could be of concern under
reasonably anticipated conditions of
release.
(iv) Is known or can reasonably be
anticipated, based on valid scientific
data or established scientific prin-

ciples, to be environmentally transformed to a substance which may have
the potential to cause significant adverse environmental effects under the
criteria in paragraph (b)(4) (i), (ii), and
(iii) of this section.
(5) Concern exists about the health or
environmental effects of one or more
impurities or byproducts of the substance because the impurity or byproduct meets one or more of the criteria in
paragraph (b) (1) through (4) of this section and either:
(i) The impurity or byproduct is a
new chemical substance and may be
present in concentrations that could
cause adverse health or environmental
effects under reasonably anticipated
conditions of exposure or release.
(ii) Reasonably anticipated manufacture, processing, or use activities involving the substance for which a
premanufacture notice has been submitted may result in significantly increased human exposure to or environmental release of the impurity or byproduct compared to exposure or release levels resulting from existing activities involving the impurity or byproduct.
(c) Designation of requirements. (1)
When EPA decides to establish significant new use reporting requirements
under this section, EPA may designate
as a significant new use any one or
more of the activities set forth in subpart B of this part. In addition, EPA
may designate specific recordkeeping
requirements described under subpart
C of this part that are applicable to the
substance.
(2) EPA may designate as a significant new use only those activities that
(i) are different from those described in
the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to
the premanufacture notice, and (ii)
may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified under
paragraph (b) of this section.
(d) Procedures for issuing significant
new use rules. (1) Significant new use
requirements designated under this
section will be listed in subpart E of
this part. For each substance, subpart
E of this part will identify:

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40 CFR Ch. I (7–1–07 Edition)

(i) The chemical name.
(ii) The activities designated as significant new uses, which may include
one or more of the activities described
in paragraph (c) of this section.
(iii) Other specific requirements applicable to the substance.
(2) When EPA determines that a substance is a candidate for a significant
new use rule under this section, it will
notify the person that submitted the
premanufacture notice for the substance no later than 7 calendar days
before the expiration of the notice review period under § 720.75 of this chapter. In providing this notice, EPA will
describe the health or environmental
concerns identified under paragraph (b)
of this section and the activities under
consideration for designation as significant new uses. Such notice may be
by telephone, but in this event will be
confirmed in writing no later than 30
days after completion of the notice review period.
(3) FEDERAL REGISTER documents
issued to propose or establish significant new uses under this section will
contain the following:
(i) The chemical identity of the substance or, if its specific identity is
claimed confidential, an appropriate
generic chemical name and an accession number assigned by EPA.
(ii) The premanufacture notice number.
(iii) The CAS number, where available and not claimed confidential.
(iv) A summary of the basis for action under this section.
(v) Designation of the significant new
uses subject to, or proposed to be subject to, notification and any other applicable requirements.
(vi) Any modifications of subpart A
of this part applicable to the specific
substance and significant new uses.
(vii) If the FEDERAL REGISTER document establishes a final rule, or notifies the public that a final rule will not
be issued after public comment has
been received, the document will describe comments received and EPA’s
response.
(4) EPA will issue significant new use
rules under this section by one of the
following three processes: direct final
rulemaking, interim final rulemaking,
or notice and comment rulemaking.

EPA will use the direct final rulemaking process to issue significant
new use rules unless it determines
that, in a particular case, one of the
other processes is more appropriate.
(i)(A) When EPA uses the direct final
rulemaking procedure to issue a significant new use rule it will issue a direct final rule in the final rule section
of the FEDERAL REGISTER following its
decision to develop a significant new
use rule under this section for a specific new chemical substance.
(B) The FEDERAL REGISTER document
will state that, unless written notice is
received by EPA within 30 days after
the date of publication that someone
wishes to submit adverse or critical
comments, the SNUR will be effective
60 days from date of publication. The
written notice of intent to submit adverse or critical comments should state
which SNUR(s) will be the subject of
the adverse or critical comments, if
several SNURs are established through
the direct final rule. If notice is received within 30 days after the date of
publication that someone wishes to
submit adverse or critical comments,
the section(s) of the direct final rule
containing the SNUR(s) for which a notice of intent to comment was received
will be withdrawn by EPA issuing a
document in the final rule section of
the FEDERAL REGISTER, and EPA will
issue a proposed rule in the proposed
rule section of the FEDERAL REGISTER.
The proposed rule will establish a 30day comment period.
(C) If EPA, having considered any
timely comments submitted in response to the proposal, decides to establish
notification
requirements
under this section, EPA will issue a
final rule adding the substance to subpart E of this part and designating the
significant new uses subject to notification.
(ii)(A) When EPA uses a notice and
comment procedure to issue a significant new use rule, EPA will issue a
proposed rule in the FEDERAL REGISTER
following its decision to develop a significant new use rule under this section
for a specific new chemical substance.
Persons will be given 30 days to comment on whether EPA should establish
notification requirements for the substance under this part.

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(B) If EPA, having considered any
timely comments, decides to establish
notification requirements under this
section, EPA will issue a final rule adding the substance to subpart E of this
part and designating the significant
new uses subject to notification.
(iii)(A) When EPA uses the interim
final rulemaking procedure to issue a
significant new use rule, EPA will issue
an interim final rule in the final rule
section of the FEDERAL REGISTER following its decision to develop a significant new use rule for a specific new
chemical substance. The document will
state EPA’s reasons for using the interim final rulemaking procedure.
(1) The significant new use rule will
take effect on the date of publication.
(2) Persons will be given 30 days from
the date of publication to submit comments.
(B) An interim final rule issued under
this section shall cease to be in effect
180 days after publication unless, within the 180-day period, EPA issues a
final rule in the FEDERAL REGISTER responding to any written comments received during the 30-day comment period
specified
in
paragraph
(d)(4)(iii)(A)(2) of this section and promulgating final significant new use notification requirements and other requirements for the substance.
(e) Schedule for issuing significant new
use rules. (1) EPA will issue a proposed
rule, an interim final rule, or a direct
final rule within 270 days of receipt of
the notice of commencement under
§ 720.102 of this chapter for any substance for which the notice of commencement was received on or after
October 10, 1989.
(2) If EPA receives adverse or critical
comments within the designated comment period following publication of a
proposed rule or an interim final rule,
EPA will either withdraw the rule or
issue a final rule addressing the comments received.

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[54 FR 31314, July 27, 1989, as amended at 60
FR 16316, Mar. 29, 1995]

§ 721.185 Limitation or revocation of
certain notification requirements.
(a) Criteria for modification or revocation. EPA may at any time modify or
revoke significant new use notification
requirements for a chemical substance

which has been added to subpart E of
this part using the procedures under
§ 721.160 or § 721.170. Such action may be
taken under this section if EPA makes
one of the following determinations,
unless other information shows that
the requirements should be retained:
(1) Test data or other information obtained by EPA provide a reasonable
basis for concluding that activities designated as significant new uses of the
substance will not present an unreasonable risk of injury to human health
or the environment.
(2) EPA has promulgated a rule under
section 4 or 6 of the Act, or EPA or another agency has taken action under
another law for the substance that
eliminates the need for significant new
use notification under section 5(a)(2) of
the Act.
(3) EPA has received significant new
use notices for some or all of the activities designated as significant new
uses of the substance and, after reviewing such notices, concluded that there
is no need to require additional notice
from persons who propose to engage in
identical or similar activities.
(4) EPA has examined new information, or has reexamined the test data
or other information or analysis supporting its decision to add the substance to subpart E of this part under
§ 721.170 and has concluded that the
substance does not meet the criteria
under § 721.170(b).
(5) For a substance added to subpart
E of this part under § 721.160, EPA has
examined new information, or has reexamined the test data or other information or analysis supporting its finding
under section 5(e)(1)(A)(ii)(I) of the
Act, and has concluded that a rational
basis no longer exists for the findings
that activities involving the substance
may present an unreasonable risk of
injury to human health or the environment required under section 5(e)(1)(A)
of the Act.
(6) For a substance added to subpart
E of this part under § 721.160, certain
activities involving the substance have
been designated as significant new uses
pending the completion of testing, and
adequate test data developed in accordance with applicable procedures and
criteria have been submitted to EPA.

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(b) Procedures for limitation or revocation. Modification or revocation of significant new use notification requirements for a substance that has been
added to subpart E of this part using
the procedures described under § 721.160
or § 721.170 may occur either at EPA’s
initiative or in response to a written
request.
(1) Any affected person may request
modification or revocation of significant new use notification requirements
for a substance that has been added to
subpart E of this part using the procedures described in § 721.160 or § 721.170
by writing to the Director of the Office
of Pollution Prevention and Toxics and
stating the basis for such request. All
requests should be sent to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics
(OPPT),
Environmental
Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001. ATTN: Request to amend significant new use
rule. The request must be accompanied
by information sufficient to support
the request.
(2) The Director of the Office of Pollution Prevention and Toxics will consider the request, make a determination whether to initiate rulemaking to
modify the requirements, and notify
the requester of that determination by
certified letter. If the request is denied,
the letter will explain why EPA has
concluded that the significant new use
notification requirements for that substance should remain in effect.
(3) If EPA concludes that significant
new use notification requirements for a
substance should be limited or revoked,
EPA will propose the changes in the
FEDERAL REGISTER, briefly describe the
grounds for the action, and provide interested parties an opportunity to comment.
[54 FR 31314, July 27, 1989, as amended at 58
FR 34204, June 23, 1993; 60 FR 34464, July 3,
1995; 71 FR 33641, June 12, 2006]

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Subpart E—Significant New Uses
for Specific Chemical Substances
§ 721.225 2-Chloro-N-methyl-N-substituted acetamide (generic name).
(a) Chemical substance and significant
new uses subject to reporting. (1) The
chemical substance 2-chloro-N-methyl-

N-substituted acetamide (PMN P-84–
393) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1),
(a)(3), (b) (concentration set at 1.0 percent), and (c).
(ii) Hazard communication program.
Requirements as specified in § 721.72
(b)(2), (d), (e) (concentration set at 1.0
percent), (f), (g)(1)(iv), (g)(2)(i), and
(g)(2)(v). The provisions of § 721.72(d) requiring employees to be provided with
information on the location and availability of a written hazard communication program and MSDSs do not apply
when the written program and MSDSs
are not required under § 721.72 (a) and
(c), respectively. The provision of
§ 721.72(g) requiring placement of specific information on an MSDS does not
apply when an MSDS is not required
under § 721.72(c).
(iii) Industrial, commercial, and consumer activities. Requirements as specified § 721.80(g).
(b) Specific requirements. The provisions of subpart A of this part apply to
this section except as modified by this
paragraph.
(1) Recordkeeping. The recordkeeping
requirements as specified in § 721.125 (a)
through (g) and (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain
notification requirements. The provisions
of § 721.185 apply to this significant new
use rule.
[55 FR 32412, Aug. 9, 1990, as amended at 57
FR 20424, May 13, 1992. Redesignated at 58 FR
29946, May 24, 1993; 58 FR 34204, June 23, 1993]

§ 721.267 N-[2-[(substituted
dinitrophenyl)azo]diallylamino-4substituted phenyl] acetamide (generic name).
(a) Chemical substance and significant
new uses subject to reporting. (1) The
chemical substance identified generically
as
N-[2-[(substituted
dinitrophenyl)azo]diallylamino-4-substituted phenyl] acetamide (PMN P-95–
513) is subject to reporting under this

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