Document ID: EPA-HQ-OPPT-2007-0094-0015
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-12-18T05:00Z

Attachment C

40 CFR Part 720

40 CFR  Protection of Environment 

CHAPTER I

ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

SUBCHAPTER R -- TOXIC SUBSTANCES CONTROL ACT 

PART 720 -- PREMANUFACTURE NOTIFICATION

Subpart A -- General Provisions

Sec.

720.1   Scope.

720.3   Definitions.

                                    Subpart B -- Applicability

720.22   Persons who must report.

720.25   Determining whether a chemical substance is on the Inventory.

720.30   Chemicals not subject to notification requirements.

720.36   Exemption for research and development.

720.38   Exemptions for test marketing.

                                    Subpart C -- Notice Form

720.40   General.

720.45   Information that must be included in the notice form.

720.50   Submission of test data and other data concerning the health
and environmental effects of a substance.

720.57   Imports.

                                 Subpart D -- Disposition of Notices

720.60   General.

720.62   Notice that notification is not required.

720.65   Acknowledgment of receipt of a notice; errors in the notice;
incomplete submissions; false and misleading statements.

720.70   Notice in the FEDERAL REGISTER.

720.75   Notice review period.

720.78   Recordkeeping.

                        Subpart E -- Confidentiality and Public Access
to Information

720.80   General provisions.

720.85   Chemical identity.

720.87   Categories or proposed categories of uses of a new chemical
substance.

720.90   Data from health and safety studies.

720.95   Public file.

                          Subpart F -- Commencement of Manufacture or
Import

720.102   Notice of commencement of manufacture or import.

                               Subpart G -- Compliance and Inspections

720.120   Compliance.

720.122   Inspections.

Authority: 15 U.S.C. 2604, 2607, and 2613.

Source: 48 FR 21742, May 13, 1983, unless otherwise noted.

                                Subpart A -- General Provisions

(720.1    Scope.

This part establishes procedures for the reporting of new chemical
substances by manufacturers and importers under section 5 of the Toxic
Substances Control Act, 15 U.S.C. 2604. This part applies to
microorganisms only to the extent provided by part 725 of this chapter.
The rule defines the persons and chemical substances subject to the
reporting requirements, prescribes the contents of section 5 notices,
and establishes procedures for submitting notices.

The rule also establishes EPA policy regarding claims of confidentiality
for, and public disclosure of, various categories of information
submitted in connection with section 5 notices. 

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 62
FR 17932, April 11, 1997]

(720.3    Definitions.

(a)(1) For the purposes of this part, the terms cosmetic, device, drug,
food, and food additive have the meanings contained in the Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., and the regulations
issued under it. In addition, the term "food" includes poultry and
poultry products, as defined in the Poultry Products Inspection Act, 21
U.S.C. 453 et seq.; meats and meat food products, as defined in the
Federal Meat Inspection Act, 21 U.S.C. 60 et seq.; and eggs and egg
products, as defined in the Egg Products Inspection Act, 21 U.S.C. 1033
et seq. 

(2) The term pesticide has the meaning contained in the Federal
Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq. and
the regulations issued under it. 

(3) The terms byproduct material, source material, and special nuclear
material have the meanings contained in the Atomic Energy Act of 1954,
42 U.S.C 2014 et seq. and the regulations issued under it. 

(b) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq. 

(c) Article means a manufactured item (1) which is formed to a specific
shape or design during manufacture, (2) which has end use function(s)
dependent in whole or in part upon its shape or design during end use,
and (3) which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article and that may occur as
described in (720.36(g)(5), except that fluids and

particles are not considered articles regardless of shape or design. 

(d) Byproduct means a chemical substance produced without a separate
commercial intent during the manufacture, processing, use, or disposal
of another chemical substance or mixture. 

(e) Chemical substance means any organic or inorganic substance of a
particular molecular identity, including any combination of such
substances occurring in whole or in part as a result of a chemical
reaction or occurring in nature, and any chemical element or uncombined
radical, except that "chemical substance" does not include: 

(1) Any mixture. 

(2) Any pesticide when manufactured, processed, or distributed in
commerce for use as a pesticide. 

(3) Tobacco or any tobacco product. 

(4) Any source material, special nuclear material, or byproduct
material. 

(5) Any pistol, firearm, revolver, shells, or cartridges. 

(6) Any food, food additive, drug, cosmetic, or device, when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic, or device. 

(f) Commerce means trade, traffic, transportation, or other commerce (1)
between a place in a State and any place outside of such State, or (2)
which affects trade, traffic, transportation, or commerce between a
place in a State and any place outside of such State. 

(g) Customs territory of the United States means the 50 States, Puerto
Rico, and the District of Columbia. 

(h) Director means the Director of the EPA Office of Pollution
Prevention and Toxics. 

(i) Distribute in commerce means to sell in commerce, to introduce or
deliver for introduction into commerce, or to hold after introduction
into commerce. 

(j) EPA means the U.S. Environmental Protection Agency. 

(k) Health and safety study or study means any study of any effect of a
chemical substance or mixture on health or the environment or on both,
including underlying data and epidemiological studies, studies of
occupational exposure to a chemical substance or mixture, toxicological,
clinical, and ecological, or other studies of a chemical substance or
mixture, and any test performed under the Act. Chemical identity is
always part of a health and safety study. 

(1) Not only is information which arises as a result of a formal,
disciplined study included, but other information relating to the
effects of a chemical substance or mixture on health or the environment
is also included. Any data that bear on the effects of a chemical
substance on health or the environment would be included. 

(2) Examples include: 

(i) Long- and short-term tests of mutagenicity, carcinogenicity, or
teratogenicity; data on behavioral disorders; dermatoxicity;
pharmacological effects; mammalian absorption, distribution, metabolism,
and excretion; cumulative, additive, and synergistic effects; acute,
subchronic, and chronic effects; and structure/activity analyses. 

(ii) Tests for ecological or other environmental effects on
invertebrates, fish, or other animals, and plants, including: Acute
toxicity tests, chronic toxicity tests, critical life stage tests,
behavioral tests, algal growth tests, seed germination tests, plant
growth or damage tests, microbial function tests, bioconcentration or
bioaccumulation tests, and model

ecosystem (microcosm) studies. 

(iii) Assessments of human and environmental exposure, including
workplace exposure, and impacts of a particular chemical substance or
mixture on the environment, including surveys, tests, and studies of:
Biological, photochemical, and chemical degradation; air, water, and
soil transport; biomagnification and bioconcentration; and chemical and
physical properties, e.g., boiling point, vapor pressure, evaporation
rates from soil and water, octanol/water partition

coefficient, and water solubility. 

(iv) Monitoring data, when they have been aggregated and analyzed to
measure the exposure of humans or the environment to a chemical
substance or mixture. 

(v) Any assessments of risk to health and the environment resulting from
the manufacture, processing, distribution in commerce, use, or disposal
of the chemical substance. 

(l) Importer means any person who imports a chemical substance,
including a chemical substance as part of a mixture or article, into the
customs territory of the United States. "Importer" includes the person
primarily liable for the payment of any duties on the merchandise or an
authorized agent acting on his or her behalf. The term also includes, as
appropriate: 

(1) The consignee. 

(2) The importer of record. 

(3) The actual owner if an actual owner's declaration and superseding
bond has been filed in accordance with 19 CFR 141.20; or 

(4) The transferee, if the right to draw merchandise in a bonded
warehouse has been transferred in accordance with subpart C of 19 CFR
part 144. (See "principal importer.") 

(m) Impurity means a chemical substance which is unintentionally present
with another chemical substance. 

(n) Intermediate means any chemical substance that is consumed, in whole
or in part, in chemical reactions used for the intentional manufacture
of another chemical substance(s) or mixture(s), or that is intentionally
present for the purpose of altering the rates of such chemical
reactions. 

(o) Inventory means the list of chemical substances manufactured or
processed in the United States that EPA compiled and keeps current under
section 8(b) of the Act. 

(p) Known to or reasonably ascertainable by means all information in a
person's possession or control, plus all information that a reasonable
person similarly situated might be expected to possess, control, or
know. 

(q) Manufacture means to produce or manufacture in the United States or
import into the customs territory of the United States. 

(r) Manufacture or import for commercial purposes means: 

(1) To import, produce, or manufacture with the purpose of obtaining an
immediate or eventual commercial advantage for the manufacturer or
importer, and includes, among other things, "manufacture" of any amount
of a chemical substance or mixture: 

(i) For commercial distribution, including for test marketing. 

(ii) For use by the manufacturer, including use for product research and
development or as an intermediate. 

(2) The term also applies to substances that are produced coincidentally
during the manufacture, processing, use, or disposal of another
substance or mixture, including byproducts that are separated from that
other substance or mixture and impurities that remain in that substance
or mixture. Byproducts and impurities without separate commercial value
are nonetheless produced for the purpose of obtaining a commercial
advantage, since they are part of the manufacture

of a chemical substance for commercial purposes. 

(s) Manufacture solely for export means to manufacture or import for
commercial purposes a chemical substance solely for export from the
United States under the following restrictions on activities in the
United States: 

(1) Distribution in commerce is limited to purposes of export or
processing solely for export as defined in (721.3 of this chapter.

(2) The manufacturer or importer, and any person to whom the substance
is distributed for purposes of export or processing solely for export
(as defined in (721.3 of this chapter), may not use the substance except
in small quantities solely for research and development in accordance
with (720.36. 

(t) Manufacturer means a person who imports, produces, or manufactures a
chemical substance. A person who extracts a component chemical substance
from a previously existing chemical substance or a complex combination
of substances is a manufacturer of that component chemical substance. A
person who contracts with a manufacturer to manufacture or produce a
chemical substance is also a manufacturer if (1) the manufacturer
manufactures or produces the substance exclusively for that person, and
(2) that person specifies the identity of the substance and controls the
total amount produced and the basic technology for the plant process. 

(u) Mixture means any combination of two or more chemical substances if
the combination does not occur in nature and is not, in whole or in
part, the result of a chemical reaction; except "mixture" does include
(1) any combination which occurs, in whole or in part, as a result of a
chemical reaction if the combination could have been manufactured for
commercial purposes  without a chemical reaction at the time the
chemical substances comprising the combination

were combined, and if all of the chemical substances comprising the
combination are not new chemical substances, and (2) hydrates of a
chemical substance or hydrated ions formed by association of a chemical
substance with water, so long as the nonhydrated form is itself not a
new chemical substance. 

(v) New chemical substance means any chemical substance which is not
included on the Inventory. 

(w) Nonisolated intermediate means any intermediate that is not
intentionally removed from the equipment in which it is manufactured,
including the reaction vessel in which it is manufactured, equipment
which is ancillary to the reaction vessel, and any equipment through
which the chemical substance passes during a continuous flow process,
but not including tanks or other vessels in which the substance is
stored after its manufacture. 

(x) Person means any natural person, firm, company, corporation,
joint-venture, partnership, sole proprietorship, association, or any
other business entity, any State or political subdivision thereof, any
municipality, any interstate body, and any department, agency or
instrumentality of the Federal Government. 

(y) Possession or control means in possession or control of the
submitter, or of any subsidiary, partnership in which the submitter is a
general partner, parent company, or any company or partnership which the
parent company owns or controls, if the subsidiary, parent company, or
other company or partnership is associated with the submitter in the
research, development, test marketing, or commercial marketing of the
chemical substance in question. (A parent

company owns or controls another company if the parent owns or controls
50 percent or more of the other company's voting stock. A parent company
owns or controls any partnership in which it is a general partner).
Information is included within this definition if it is: 

(1) In files maintained by submitter's employees who are: 

(i) Associated with research, development, test marketing, or commercial
marketing of the chemical substance in question. 

(ii) Reasonably likely to have such data. 

(2) Maintained in the files of other agents of the submitter who are
associated with research, development, test marketing, or commercial
marketing of the chemical substance in question in the course of their
employment as such agents. 

(z) Principal importer means the first importer who, knowing that a new
chemical substance will be imported rather than manufactured
domestically, specifies the identity of the chemical substance and the
total amount to be imported. Only persons who are incorporated,
licensed, or doing business in the United States may be principal
importers. 

(aa) Process means the preparation of a chemical substance or mixture,
after its manufacture, for distribution in commerce (1) in the same form
or physical state as, or in a different form or physical state from,
that in which it was received by the person so preparing such substance
or mixture, or (2) as part of a mixture or article containing the
chemical substance or mixture. 

(bb) Processor means any person who processes a chemical substance or
mixture. 

(cc) Small quantities solely for research and development (or "small
quantities solely for purposes of scientific experimentation or analysis
or chemical research on, or analysis of, such substance or another
substance, including such research or analysis for the development of a
product") means quantities of a chemical substance manufactured,
imported, or processed or proposed to be manufactured, imported, or
processed solely for research and development

that are not greater than reasonably necessary for such purposes. 

(dd) State means any State of the United States and the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the
Canal Zone, American Samoa, the Northern Mariana Islands, and any other
territory or possession of the United States. 

(ee) Technically qualified individual means a person or persons (1) who,
because of education, training, or experience, or a combination of these
factors, is capable of understanding the health and environmental risks
associated with the chemical substance which is used under his or her
supervision, (2) who is responsible for enforcing appropriate methods of
conducting scientific  experimentation, analysis, or chemical research
to minimize such risks, and (3) who is responsible for the safety
assessments and clearances related to the procurement, storage, use, and
disposal of the chemical substance as may be appropriate or required
within the scope of conducting a research and development activity. 

(ff) Test data means data from a formal or informal test or experiment,
including information concerning the objectives, experimental methods
and materials, protocols, results, data analyses, recorded observations,
monitoring data, measurements, and conclusions from a test or
experiment. 

(gg) Test marketing means the distribution in commerce of no more than a
predetermined amount of a chemical substance, mixture, or article
containing that chemical substance or mixture, by a manufacturer or
processor, to no more than a defined number of potential customers to
explore market capability in a competitive situation during a
predetermined testing period prior to the broader distribution of that
chemical substance, mixture, or article in

commerce. 

(hh) United States, when used in the geographic sense, means all of the
States. 

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

                                  Subpart B -- Applicability

(720.22   Persons who must report.

(a)(1) Any person who intends to manufacture a new chemical substance in
the United States for commercial purposes must submit a notice unless
the substance is excluded under (720.30. 

(2) If a person contracts with a manufacturer to manufacture or produce
a new chemical substance, and (i) the manufacturer manufactures or
produces the substance exclusively for that person, and (ii) that person
specifies the identity of the substance, and controls the total amount
produced and the basic technology for the plant process, that person
must submit the notice. If it is unclear who must report, EPA should be
contacted to determine who must submit the notice. 

(3) Only manufacturers that are incorporated, licensed, or doing
business in the United States may submit a notice. 

(b)(1) Any person who intends to import a new chemical substance into
the United States for commercial purposes must submit a notice, unless
the substance is excluded under (720.30 or unless the substance is
imported as part of an article. 

(2) When several persons are involved in an import transaction, the
notice must be submitted by the principal importer. If no one person
fits the principal importer definition in a particular transaction, the
importer should contact EPA to determine who must submit the notice for
that transaction. 

(720.25   Determining whether a chemical substance is on the Inventory.

(a) A new chemical substance is any chemical substance that is not
currently listed on the Inventory. 

(b)(1) A chemical substance is listed in the public portion of the
Inventory by a specific chemical name (either a Chemical Abstracts (CA)
Index Name or a CA Preferred Name) and a Chemical Abstracts Service
(CAS) Registry Number if its identity is not confidential. If its
identity is confidential, it is listed in the public portion of the
Inventory by a TSCA Accession Number and a generic chemical name that
masks the specific substance identity. The confidential substance is
listed by its specific chemical name only in the confidential portion of
the Inventory, which is not available to the public. A person who
intends to manufacture or import a chemical substance not listed by
specific chemical name in the public portion of the Inventory may ask
EPA whether the substance is included in the confidential Inventory. EPA
will answer such an inquiry only if EPA determines that the person has a
bona fide intent to manufacture or import the chemical substance for
commercial purposes. 

(2) To establish a bona fide intent to manufacture or import a chemical
substance, the person who proposes to manufacture or import the
substance must submit to EPA: 

(i) Except as provided in paragraphs (b)(3) (i) and (ii) of this
section, the specific chemical identity of the substance that the person
intends to manufacture or import, using the currently, correct CA name
for the substance and the other correct chemical identity information in
accordance with ((720.45(a) (1), (2), and (3). 

(ii) A signed statement that the person intends to manufacture or import
that chemical substance for commercial purposes. 

(iii)(A) A brief description of the research and development activities
conducted to date related to the substance, including the year in which
the person first started to conduct research or development activity on
the substance, and the general types of research and development
activities conducted thus far (e.g., synthesis, substance
isolation/purification, formulating, product development, process
development, end-use application, toxicity testing, etc.). The person
must also indicate whether any pilot plant or production-scale plant
evaluations have been conducted involving the manufacture or processing
of the substance. 

(B) If an importer is unable to provide the information requested in
paragraph (b)(2)(iii)(A) of this section from the foreign manufacturer
or supplier, the following information shall be submitted: 

(1) A brief statement indicating how long the substance has been in
commercial use outside of the United States. 

(2) The name of a country in which it has been commercially used. 

(3) Whether the importer believes that the substance has already been
used commercially, in any country, for the same purpose or application
that the importer is intending. 

(iv) A specific description of the major intended application or use of
the substance. 

(v) An infrared spectrum of the substance, or alternative spectra or
other data which identify the substance if infrared analysis is not
suitable for the substance or does not yield a reasonable amount of
structural information. When using alternative spectra or instrumental
analysis, the person must submit a spectrum or instrumental readout for
the substance. 

(vi) The estimated date (month/year) in which the person intends to
submit a Premanufacture Notice (PMN) for this substance if EPA informs
the notice submitter that the substance is not on the Inventory. 

(vii) The address of the facility under the control of the submitter at
which the manufacture or processing of the substance would most likely
occur. For an imported substance, the facility under the control of the
importer at which processing of the substance would likely occur, if
any. 

(viii)(A) For substances intended to be manufactured in the United
States, a description of the most probable manufacturing process that
would be used by the submitter to produce the substance for non-exempt
commercial purposes. 

(B) For substances intended to be imported, a brief description of how
the submitter is most likely to process or use the substance for a
commercial purpose. If the substance is not expected to be processed or
used at any facility under the importer's control, a statement to this
effect must be included along with a description of how the substance
will be processed or used at sites controlled by others, if this
information is known or reasonably ascertainable. 

(3)(i) If an importer cannot provide the chemical identity information
required by paragraph (b)(2) (i) and (v) of this section because it is
claimed confidential by its foreign manufacturer or supplier, the
foreign manufacturer or supplier must supply the required information
directly to EPA in accordance with (720.45(a) (1), (2), and (3) and
reference the importer's notice. If the appropriate supporting document
from the foreign party is not received within 30 days after EPA receives
the importer's notice, the notice will be considered incomplete. 

(ii) If a manufacturer cannot provide all of the required information in
accordance with (720.45(a) (1), (2), and (3) because the new chemical
substance is manufactured using a reactant that has a specific chemical
identity claimed as confidential by its supplier, the notice must
contain chemical identity information that is as complete as known by
the manufacturer. In addition, a letter of support for the notice must
then be sent to EPA by the chemical supplier of the confidential
reactant, providing the specific chemical identity of the proprietary
reactant. The letter of support must reference the manufacturer's
notice. If the appropriate supporting document from the supplier is not
received within 30 days after EPA receives the manufacturer's notice,
the notice will be considered incomplete. 

(4) EPA will review the information submitted by the proposed
manufacturer or importer under this paragraph to determine whether it
has a bona fide intent to manufacture or import the chemical substance.
If necessary, EPA will compare this information either to the
information requested for the confidential chemical substance under
(710.7(e)(2)(v) of this chapter or the information requested under
(720.85(b)(3)(iii). 

(5) If the proposed manufacturer or importer has shown a bona fide
intent to manufacture or import the substance, and provide sufficient
unambiguous chemical identity information so EPA can make a conclusive
determination of the chemical substance's Inventory status, EPA will
search the confidential Inventory and inform the proposed manufacturer
or importer whether the chemical substance is on the confidential
Inventory.  

(6) If the chemical substance is found on the confidential Inventory,
EPA will notify the person(s) who originally reported the chemical
substance that another person has demonstrated a bona fide intent to
manufacture or import the substance and therefore was told that the
chemical substance is on the Inventory. 

(7) A disclosure of a confidential chemical identity to a person with a
bona fide intent to manufacture or import the particular chemical
substance will not be considered a public disclosure of confidential
business information under section 14 of the Act. 

(8) EPA will answer an inquiry on whether a particular chemical
substance is on the confidential Inventory within 30 days after receipt
of a complete submission under paragraph (b)(2) of this section. 

(9) If the required chemical identity information has not been reported
correctly or completely in the notice (except as provided under
paragraph (b)(3)(ii) of this section) or if any other required data or
information has been omitted or is incomplete, EPA will consider the
whole notice to be incomplete. As soon as an incomplete notice is
identified as such by EPA, the Agency will immediately return the notice
directly to the submitter. The submitter must then resubmit the

whole, completed bona fide notice to EPA in order to have the Agency
perform the desired Inventory search and respond to the notice. 

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 60
FR 16309, Mar. 29, 1995]

(720.30    Chemicals not subject to notification requirements.

The following substances are not subject to the notification
requirements of this part: 

(a) Any substance which is not a "chemical substance" as defined in
(720.3(e). 

(b) Any mixture as defined in (720.3(u).  A new chemical substance that
is manufactured or imported as part of a mixture is subject to the
requirements of this part. This exclusion applies only to a mixture as a
whole and not to any chemical substances which are part of the mixture.

(c) Any new chemical substance which will be manufactured or imported in
small quantities solely for research and development under (720.36. 

(d) Any new chemical substance which will be manufactured or imported
solely for test-marketing purposes under an exemption granted under
(720.38. 

(e) Any new chemical substance manufactured solely for export if, when
the substance is distributed in commerce: 

(1) The substance is labeled in accordance with section 12(a)(1)(B) of
the Act. 

(2) The manufacturer knows that the person to whom the substance is
being distributed intends to export it or process it solely for export
as defined in (721.3 of this chapter. 

(f) Any new chemical substance which is manufactured or imported under
the terms of a rule promulgated under section 5(h)(4) of the Act. 

(g) Any byproduct if its only commercial purpose is for use by public
or private organizations that (1) burn it as a fuel, (2) dispose of it
as a waste, including in a landfill or for enriching soil, or (3)
extract component chemical substances from it for commercial purposes.
(This exclusion only applies to the byproduct; it does not apply to the
component substances extracted from the byproduct.) 

(h) The chemical substances described below: (Although they are
manufactured for commercial purposes under the Act, they are not
manufactured for distribution in commerce as chemical substances per se
and have no commercial purpose separate from the substance, mixture, or
article of which they are a part.) 

(1) Any impurity. 

(2) Any byproduct which is not used for commercial purposes. 

(3) Any chemical substance which results from a chemical reaction that
occurs incidental to exposure of another chemical substance, mixture, or
article to environmental factors such as air, moisture, microbial
organisms, or sunlight. 

(4) Any chemical substance which results from a chemical reaction that
occurs incidental to storage or disposal of another chemical substance,
mixture, or article. 

(5) Any chemical substance which results from a chemical reaction that
occurs upon end use of another chemical substance, mixture, or article
such as an adhesive, paint, miscellaneous cleanser or other housekeeping
product, fuel additive, water softening and treatment agent,
photographic film, battery, match, or safety flare, and which is not
itself manufactured or imported for distribution in commerce or for use
as an intermediate. 

(6) Any chemical substance which results from a chemical reaction that
occurs upon use of curable plastic or rubber molding compounds, inks,
drying oils, metal finishing compounds, adhesives, or paints, or any
other chemical substance formed during the manufacture of an article
destined for the marketplace without further chemical change of the
chemical substance except for those chemical changes that occur as
described elsewhere in this paragraph. 

(7) Any chemical substance which results from a chemical reaction that
occurs when (i) a stabilizer, colorant, odorant, antioxidant, filler,
solvent, carrier, surfactant, plasticizer, corrosion inhibitor,
antifoamer or defoamer, dispersant, precipitation inhibitor, binder,
emulsifier, deemulsifier, dewatering agent, agglomerating agent,
adhesion promoter, flow

modifier, pH neutralizer, sequesterant, coagulant, flocculant, fire
retardant, lubricant, chelating agent, or quality control reagent
functions as intented, or (ii) a chemical substance, which is intended
solely to impart a specific physiochemical characteristic, functions as
intended. 

(8) Any nonisolated intermediate. 

(i) Any chemical substance which is manufactured solely for
non-commercial research and development purposes. Non-commercial
research and development purposes include scientific experimentation,
research, or analysis conducted by academic, government, or independent
not-for-profit research organizations (e.g., universities, colleges,
teaching hospitals, and research institutes), unless the activity is for
eventual commercial purposes. 

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

(720.36   Exemption for research and development.

(a) This part does not apply to a chemical substance if the following
conditions are met: 

(1) The chemical substance is manufactured or imported only in small
quantities solely for research and development. 

(2) The manufacturer or importer notifies all persons in its employ or
to whom it directly distributes the chemical substance, who are engaged
in experimentation, research, or analysis on the chemical substance,
including the manufacture, processing, use, transport, storage, and
disposal of the substance associated with research and development
activities, of any risk to health, identified under paragraph (b) of
this section, which may be 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 or importer must review and
evaluate the following information to determine whether there is reason
to believe there is any potential risk to health which may be associated
with the chemical substance: 

(i) Information in its possession or control concerning any significant
adverse reaction by persons exposed to the chemical substance which may
reasonably be associated with such exposure. 

(ii) Information provided to the manufacturer or importer by a supplier
or any other person concerning a health risk believed to be associated
with the substance. 

(iii) Health and environmental effects data in its possession or control
concerning the substance. 

(iv) Information on health effects which accompanies any EPA rule or
order issued under sections 4, 5, or 6 of the Act that applies to the
substance and of which the manufacturer or importer has knowledge. 

(2) When the research and development activity is conducted solely in a
laboratory and exposure to the chemical substance is controlled through
the implementation of prudent laboratory practices for handling chemical
substances of unknown toxicity, and any distribution, except for
purposes of disposal, is to other such laboratories for further research
and development activity, the information specified in paragraph (b)(1)
of this section need not be reviewed and evaluated. (For purposes of
this paragraph, a laboratory is a contained research facility where
relatively small quantities of chemical substances are used on a
non-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 or importer 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 or importer has reason to believe may be
associated with the substance, as determined under

paragraph (b)(1) of this section. 

(2) If the manufacturer or importer distributes a chemical substance
manufactured or imported under this section to persons not in its
employ, the manufacturer or importer must in written form: 

(i) Notify those persons that the substance is to be used only for
research and development purposes. 

(ii) Provide the notice of health risks specified in paragraph (c)(1) of
this section. 

(3) The adequacy of any notification under this section is the
responsibility of the manufacturer or importer. 

(d) A chemical substance is not exempt from reporting under this part if
any amount of the substance, including as part of a mixture, is
processed, distributed in commerce, or used, for any commercial purpose
other than research and development, except where the chemical substance
is processed, distributed in commerce, or used only as an impurity or as
part of an article. 

(e) Quantities of the chemical substance, or of mixtures or articles
containing the chemical substance, remaining after completion of
research and development activities may be: 

(1) Disposed of as a waste in accordance with applicable Federal, state,
and local regulations, or 

(2) Used for the following commercial purposes: 

(i) Burning it as a fuel. 

(ii) Reacting or otherwise processing it to form other chemical
substances for commercial purposes, including extracting component
chemical substances. 

(f) Quantities of research and development substances existing solely as
impurities in a product or incorporated into an article, in accordance
with paragraph (d) of this section, and quantities of research and
development substances used solely for commercial purposes listed in
paragraph (e) of this section, are not subject to the requirements of
paragraphs (a), (b), and (c) of this section, once research and
development activities have been completed. 

(g) A person who manufactures or imports a chemical substance in small
quantities solely for research and development is not required to comply
with the requirements of this section if the person's exclusive
intention is to perform research and development activities solely for
the purpose of determining whether the substance can be used as a
pesticide. 

[51 FR 15102, Apr. 22, 1986]

(720.38   Exemptions for test marketing. 

(a) Any person may apply for an exemption to manufacture or import a new
chemical substance for test marketing. EPA may grant the exemption if
the person demonstrates that the chemical substance will not present an
unreasonable risk to injury to health or the environment as a result of
the test marketing. 

(b) Persons applying for a test-marketing exemption should provide the
following information: 

(1) All existing data regarding health and environmental effects of the
chemical substance, including physical/chemical properties or, in the
absence of such data, a discussion of toxicity based on
structure-activity relationships (SAR) and relevant data on chemical
analogues. 

(2) The maximum quantity of the chemical substance which the applicant
will manufacture or import for test marketing.

(3) The maximum number of persons who may be provided the chemical
substance during test marketing. 

(4) The maximum number of persons who may be exposed to the chemical
substance as a result of test marketing, including information regarding
duration and route of such exposures. 

(5) A description of the test-marketing activity, including its length
and how it can be distinguished from full-scale commercial production
and research and development. 

(c) In accordance with section 5(h)(6) of the Act, after EPA receives an
application for exemption under this section, the Agency will file with
the Office of the Federal Register a notice containing a summary of the
information provided in the application, to the extent it has not been
claimed confidential. 

(d) No later than 45 days after EPA receives an application, the Agency
will either approve or deny the application. Thereafter, EPA will
publish a notice in the FEDERAL REGISTER explaining the reasons for
approval or denial. 

(e) In approving an application for exemption, EPA may impose any
restrictions necessary to ensure that the substance will not present an
unreasonable risk of injury to health and the environment as a result of
test marketing. 

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993]

                                 Subpart C -- Notice Form

(720.40   General. 

(a) Use of the notice form; electronic submissions. (1) Each person who
is required by subpart B of this part to submit a notice must complete,
sign, and submit a notice containing the information in the form and
manner specified in this paragraph. The information submitted and all
attachments (unless the attachment appears in the open scientific
literature) must be in English. All information submitted must be true
and correct.  

(2) Information may be submitted on paper, or electronically, as
follows: 

(i) Information submitted on paper must be submitted in the form and
manner set forth in EPA Form No. 7710-25, which is available from the
Environmental Assistance Division (7408), Office of Pollution Prevention
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460. Information which is not submitted on the EPA
Form No. 7710-25 or a photocopy thereof (e.g., on a form created by
commercial form-making software)  must be in a format pre-approved by
the Agency. 

(ii) Information may be submitted electronically (on magnetic or other
media) pursuant to an EPA published format for electronic submissions.
Such submissions must comply with this format and all other media
specifications published by EPA. Persons submitting electronically must
still complete and submit on paper the Certification and Submitter
Identification sections of Form 7710-25. 

(b) When to submit a notice. Each person who is required to submit a
notice must submit the notice at least 90 calendar days before
manufacture or import of the new chemical substance for commercial
purposes begins.  

(c) Where to submit a notice. Each person who submits a notice must
submit it to the address listed on the notice form. 

(d) General notice requirements. (1) Each person who submits a notice
must provide the information described in (720.45 and specified on the
notice form, to the extent such information is known to or reasonably
ascertainable by the person. In accordance with (720.50, the notice 
must also include any test data in the person's possession or control,
and descriptions of other data which are known to or reasonably
ascertainable by the person and which

concern the health and environmental effects of the new chemical
substance. 

(2) A person who submits a notice to EPA under this part must provide
EPA with an original and two complete copies of the notice, including
all test data and any other information attached to the notice form. If
information is claimed as confidential pursuant to (720.80, a sanitized
copy  must also be provided. 

(e) Agency or joint submissions. (1) A manufacturer or importer may
designate an agent to submit the notice. Both the manufacturer or
importer and the agent must sign the certification on the form. 

(2) A manufacturer or importer may authorize another person, (e.g., a
foreign manufacturer or supplier, or a toll manufacturer) to report some
of the information required in the notice to EPA on its behalf. If
separate portions of a joint notice are not submitted together, the
submitter should indicate which information will be supplied by another
person and identify that person. The other person must submit the
information on the appropriate part of the notice form. The manufacturer
or importer and any other person supplying the information must sign the
certification provided on their respective notice forms. 

(3) If EPA receives a submission which does not include information
required by this rule, which the submitter indicates that it has
authorized another person to provide, the notice review period will not
begin until EPA receives that information. 

(f) New information. During the notice review period, if the submitter
possesses, controls, or knows of new information that materially adds
to, changes, or otherwise makes significantly more complete the
information included in the notice, the submitter must that information
to the address listed on the notice form within ten days of receiving
the new information, but no later than five days before the end of the
notice review period. The new submission must clearly  identify the
submitter and the notice to which the new information is related. If the
new  information becomes available during the last five days of the
notice review period, the submitter must immediately inform its EPA
contract for that notice by telephone. 

(g) Chemical substances subject to a section 4 test rule. (1) Except as
provided in paragraph (g)(3) of this section, if (i) A person intends to
manufacture or import a new chemical substance which is subject to the
notification requirements of this part, and (ii) The chemical substance
is subject to a test rule promulgated under section 4 of the Act before
the notice is submitted, section 5(b)(1) of the Act requires the person
to submit the test data required by the testing rule with the notice.
The person must submit the data in the form and manner specified in the
test rule and in accordance with (720.50. If the person does not submit
the test data, the submission is incomplete and EPA will follow the
procedures in (720.65. 

(2) If EPA has granted the submitter an exemption under section 4(c) of
the Act from the requirement to conduct tests and submit data, the
submitter may not submit a notice until EPA receives the test data. 

(3) If EPA has granted the submitter an exemption under section 4(c) of
the Act and if another person previously has submitted the test data to
EPA, the exempted person may either submit the test data or provide the
following information as part of the notice: 

(i) The name, title, and address of the person who submitted the test
data to EPA. 

(ii) The date the test data were submitted to EPA. 

(iii) A citation for the test rule. 

(iv) A description of the exemption and a reference identifying it. 

(h) Chemical substances subject to a section 5(b)(4) rule. (1) If a
person (i) intends to manufacture or import a new chemical substance
which is subject to the notification requirements of this part and which
is subject to a rule issued under section 5(b)(4) of the Act; and (ii)
is not required by a rule issued under section 4 of the Act to submit
test data for the substance before the submission of a notice, the
person must submit to EPA data described in

paragraph (h)(2) of this section at the time the notice is submitted. 

(2) Data submitted under paragraph (h)(1) of this section must be data
which the person submitting the notice believes show that the
manufacture, processing, distribution in commerce, use and disposal of
the substance, or any combination of such activities, will not present
an unreasonable risk of injury to health or the environment.  

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 60
FR 16309, Mar. 29, 1995]

(720.45    Information that must be included in the notice form.

Each person who submits a notice must include the information specified
in the notice form to the extent it is known to or reasonably
ascertainable by the submitter. However, no person is required to
include information which relates solely to exposure of human or
ecological populations outside of the United States. The notice form
requires the following information relating to the manufacture,
processing, distribution in commerce, use, and disposal of the new

chemical substance: 

(a)(1) The specific chemical identity of the substance that the person
intends to manufacture or import, which includes the following: 

(i) The currently correct Chemical Abstracts (CA) name for the
substance, based on the Ninth Collective Index (9CI) of CA nomenclature
rules and conventions, and consistent with listings for similar
substances in the Inventory. For each substance having a chemical
composition that can be represented by a specific, complete chemical
structure diagram (a Class 1 substance), a CA Index Name must be
provided. For each chemical substance that cannot be fully represented
by a complete, specific chemical structure diagram (a Class 2
substance), or if the substance is a polymer,a CA Index Name or CA
Preferred Name must be provided (whichever is appropriate based on CA
9CI nomenclature rules and conventions). In addition, for a Class 2
substance, the notice must identify the immediate chemical precursors
and reactants by specific chemical name and Chemical Abstracts Service
Registry Number (CASRN), if the number is available. Tradenames or
generic names of chemical precursors or reactants are not acceptable as
substitutes for specific chemical names. 

(ii) The currently correct CASRN for the substance if a CASRN already
exists for the substance. 

(iii) For a Class 1 substance and for any Class 2 substance for which a
definite molecular formula is known or reasonably ascertainable, the
correct molecular formula. 

(iv) For a Class 1 substance, a complete, correct chemical structure
diagram; for a Class 2 substance or polymer, a correct representative or
partial chemical structure diagram, as complete as can be known, if one
can be reasonably ascertained. 

(2) For a polymer, the submitter must also report the following: 

(i) The specific chemical name and CASRN, if the number is available, of
each monomer and other reactant used, at any weight percent, to
manufacture the polymer. Tradenames or generic names of chemical
reactants or monomers are not acceptable as substitutes for specific
chemical names. 

(ii) The typical percent by weight of each monomer and other reactant in
the polymer (weight of the monomer or other reactant expressed as a
percentage of the weight of the polymeric chemical substance
manufactured), and the maximum residual amount of each monomer present
in the polymer. 

(iii) For monomers and other reactants used at 2 weight percent or less
(based on the dry weight of the polymer manufactured), indicate on the
PMN form any such monomers and other reactants that should be included
as part of the polymer description on the Inventory, where the weight
percent is based on either (A) the weight of monomer or other reactant
actually charged to the  reaction vessel, or (B) the minimum weight of
monomer or other reactant required in theory to account for the actual
weight of monomer or other reactant molecules or fragments chemically
incorporated (chemically combined) in the polymeric substance
manufactured. 

(iv) For a determination that 2 weight percent or less of a monomer or
other reactant is incorporated (chemically combined) in a polymeric
substance manufactured, as specified in paragraphs (a)(2)(iii)(B) of
this section, analytical data or appropriate theoretical calculations
(if it can be documented that analytical measurement is not feasible or
not necessary) to support this determination must be maintained at the
site of manufacture or import of the polymer. 

(v) Measured or estimated values of the minimum number-average molecular
weight of the polymer and the amount of low molecular weight species
below 500 and below 1,000 molecular weight, with a description of how
the measured or estimated values were obtained. 

(3) The person must use one of the following two methods to develop or
obtain the specified chemical identity information reported under
paragraphs (a) (1) and (2) of this section and must identify the method
used in the notice: 

(i) Method 1. Obtain the correct chemical identity information required
by paragraphs (a) (1) and (2) of this section directly from the Chemical
Abstracts Service (CAS), specifically from the CAS Registry Services
Inventory Expert Service, prior to submitting a notice to EPA. A copy of
the chemical identification report obtained from CAS must be submitted
with the notice. 

(ii) Method 2. Obtain the correct chemical identity information required
by paragraphs (a) (1) and (2) from any source. The notice will be
incomplete according to (720.65(c)(1)(vi) if the person uses Method 2
and any chemical identity information is determined to be incorrect by
EPA. 

(4) If an importer submitting the notice cannot provide all the
information specified in paragraphs (a) (1) and (2) of this section
because it is claimed as confidential by the foreign supplier of the
substance, the importer must have the foreign supplier follow the
procedures in paragraph (a)(3) of this section and provide the correct
chemical identity information specified in paragraphs (a) (1) and (2) of
this section directly to EPA in a joint submission or as a letter of
support to the notice, which clearly references the importer's notice
and PMN User Fee  Identification Number. The statutory review process
will commence upon receipt of both the notice and the complete, correct
information. 

(5) If a manufacturer cannot provide all the information specified in
paragraphs (a) (1) and (2) of this section because the new chemical
substance is manufactured using a reactant having a specific chemical
identity claimed as confidential by its supplier, the manufacturer must
submit a notice directly to EPA containing all the information known by
the manufacturer about the chemical identity of the reported substance
and its proprietary reactant. In addition, the

manufacturer must ensure that the supplier of the confidential reactant
submit a letter of support directly to EPA providing the specific
chemical identity of the confidential reactant, including the CAS
number, if available, and the appropriate PMN or exemption number, if
applicable. The letter of support must reference the manufacturer's name
and PMN User Fee Identification Number under (700.45(c)(3) of this
chapter. The statutory review period will commence upon receipt of both
the notice and the letter of support. 

(b) The impurities anticipated to be present in the substance by name,
CAS Registry number, and weight percent of the total substance. 

(c) Known synonyms or trade names of the new chemical substance. 

(d) A description of the byproducts resulting from the manufacture,
processing, use, and disposal of the new chemical substance. 

(e) The estimated maximum amount to be manufactured or imported during
the first year of production and the estimated maximum amount to be
manufactured or imported during any 12-month period during the first
three years of production. 

(f) A description of intended categories of use by function and
application, the estimated percent  of production volume devoted to each
category of use, and the percent of the new substance in the formulation
for each commercial or consumer use. 

(g) For sites controlled by the submitter: 

(1) The identity of sites where the new substance will be manufactured,
processed, or used. 

(2) A process description of each manufacture, processing, and use
operation which includes a diagram of the major unit operations and
chemical conversions, the identity and entry point of all feedstocks,
and the points of release of the new chemical substance. 

(3) Worker exposure information, including worker activities, physical
form of the new sub-stance to which workers may be exposed, the number
of workers, and the duration of activities. 

(4) Information on release of the new substance to the environment,
including the quantity and media of release and type of control
technology used. 

(h) For sites not controlled by the submitter, a description of each
type of processing and use operation involving the new chemical
substance, including identification of the estimated number of
processing or use sites, situations in which worker exposure to and/or
environmental release of the new chemical substance will occur, the
number of workers exposed and the duration of exposure, and controls
which limit worker exposure and environmental release. 

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

(720.50    Submission of test data and other data concerning the health
and environmental effects of a substance.

(a) Test data on the new chemical substance in the possession or control
of the submitter. (1) Except as provided in paragraph (d) of this
section, each notice must contain all test data in the submitter's
possession or control which are related to the effects on health or the
environment of any manufacture, processing, distribution in commerce,
use, or disposal of the new chemical substance or any mixture or article
containing the new chemical substance, or any combination of such
activities. This includes test data concerning the new chemical
substance in a pure, technical

grade, or formulated form. 

(2) A full report or standard literature citation must be submitted for
the following types of test data:  (i) Health effects data. 

(ii) Ecological effects data. 

(iii) Physical and chemical properties data. 

(iv) Environmental fate characteristics. 

(v) Monitoring data and other test data related to human exposure to or
environmental release of the chemical substance. 

(3)(i) If the data do not appear in the open scientific literature, the
submitter must provide a full report. A full report includes the
experimental methods and materials, results, discussion and data
analysis, conclusions, references, and the name and address of the
laboratory that developed the data. 

(ii) If the data appear in the open scientific literature, the submitter
need only provide a standard literature citation. A standard literature
citation includes author, title, periodical name, date of publication,
volume, and page numbers. 

(4)(i) If a study, report, or test is incomplete when a person submits a
notice, the submitter must identify the nature and purpose of the study;
name and address of the laboratory developing the data; progress to
date; types of data collected; significant preliminary results; and
anticipated completion date. 

(ii) If a test or experiment is completed before the notice review
period ends, the person must submit the study, report, or test to the
address listed on the notice form, as specified in paragraph (a)(3)(i)
of this section, within ten days of receiving it, but no later than five
days before the end of the review period. If the test or experiment is
completed during the last five days of the review period, the submitter
must immediately inform its EPA contact for that notice by telephone. 

(5) For test data in the submitter's possession or control which are not
listed in paragraph (a)(2) of this section, a person is not required to
submit a complete report. The person must submit a summary of the data.
If EPA so requests, the person must submit a full report within ten days
of the request, but no later than five days before the end of the review
period. 

(6) All test data described by paragraph (a) are subject to these
requirements, regardless of their age, quality, or results. 

(b) Other data concerning the health and environmental effects of the
new chemical substance that are known to or reasonably ascertainable by
the submitter. 

(1) Except as provided in paragraph (d) of this section, any person who
submits a notice must describe the following data, including any data
from a health and safety study, if the data are related to the effects
on health or the environment of any manufacture, processing,
distribution in commerce, use, or disposal of the new chemical
substance, of any mixture or article containing the new chemical
substance, or of any combination of such activities: 

(i) Any data, other than test data, in the submitter's possession or
control. 

(ii) Any data, including test data, which are not in the submitter's
possession or control, but which are known to or reasonably
ascertainable by the submitter. For the purposes of this section, data
are known to or reasonably ascertainable by the submitter if the data
are known to any of its employees or other agents who are associated
with the research and development, test marketing, or commercial
marketing of the substance. 

(2) Data that must be described include data concerning the new chemical
substance in a pure, technical grade, or formulated form. 

(3) The description of data reported under this paragraph must include: 

(i) If the data appear in the open scientific literature, a standard
literature citation, which includes the author, title, periodical name,
date of publication, volume, and pages. 

(ii) If the data are not contained in the open scientific literature, a
description of the type of data and summary of the results, if
available, and the names and addresses of persons the submitter believes
may have possession or control of the data. 

(4) All data described by this paragraph are subject to these
requirements, regardless of their age, quality, or results; and
regardless of whether they are complete at the time the notice is
submitted. 

(c) [Reserved] 

(d) Data that need not be submitted -- (1) Data previously submitted to
EPA. 

(i) A person need not submit any data previously submitted to EPA with
no claims of confidentiality if the notice includes the office or person
to whom the data were submitted, the date of submission, and, if
appropriate, a standard literature citation as specified in paragraph
(a)(3)(ii) of this section. 

(ii) For data previously submitted to EPA with a claim of
confidentiality, the person must resubmit the data with the notice and
any claim of confidentiality, under (720.80. 

(2) Efficacy data. This part does not require submission of any data
related solely to product efficacy. This does not exempt a person from
submitting any of the data specified in paragraph (a), (b), or (c) of
this section. 

(3) Non-U.S. exposure data. This part does not require submission of any
data which relates only to exposure of humans or the environment outside
the United States. This does not exclude nonexposure data such as data
on health effects (including epidemiological studies), ecological
effects, physical and chemical properties, or environmental fate
characteristics. 

[48 FR 21742, May 13, 1983, as amended at 51 FR 15102, Apr. 22, 1986]

(720.57    Imports. 

(a) Except as otherwise provided in this section, the provisions of
this subpart C apply to each person who submits a notice for a new
chemical substance which he or she intends to import for a commercial
purpose. In addition, each importer must comply with this section. 

(b) EPA will hold the principal importer, or the importer that EPA
determines must submit the notice when there is no principal importer
under (720.22(b)(2), liable for complying with this part, for completing
the notice form and for the completeness and truthfulness of all
information which it submits. 

                              Subpart D -- Disposition of Notices 

(720.60    General. 

This subpart establishes procedures that EPA will follow in reviewing
notices. 

(720.62    Notice that notification is not required. 

When EPA receives a notice, EPA will review it to determine whether the
chemical substance is subject to the requirements of this part. If EPA
determines that the chemical substance is not subject to these
requirements, EPA will notify the submitter that section 5 of the Act
does not prevent the manufacture or import of the substance and that the
submission is not a notice under this part. 

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993]

(720.65    Acknowledgment of receipt of a notice; errors in the notice;
incomplete submissions; false and misleading statements. 

(a) Notification to submitter. EPA will acknowledge receipt of each
notice by sending the submitter a letter that identifies the
premanufacture notice number assigned to the new chemical substance and
the date on which the review period begins. The review period will begin
on the date the notice is received by the Office of Pollution Prevention
and Toxics Document Control Officer. The acknowledgment does not
constitute a finding by EPA that the notice, as submitted, is in
compliance with this part. 

(b) Errors in the notice. (1) Within 30 days of receipt of the notice,
EPA may request that the submitter remedy errors in the notice. The
following are examples of such errors: 

(i) Failure to date the notice form. 

(ii) Typographical errors that cause data to be misleading or answers to
any questions to be unclear. 

(iii) Contradictory information. 

(iv) Ambiguous statements or information. 

(2) In the request to correct the notice, EPA will explain the action
which the submitter must take to correct the notice.

(3) If the submitter fails to correct the notice within 15 days of
receipt of the request, EPA may extend the notice period under section
(5)(c) of the Act, in accordance with (720.75(c). 

(c) Incomplete submissions. (1) A submission is not complete, and the
notification period does not begin, if: 

(i) The wrong person submits the notice form. 

(ii) The submitter does not sign the notice form. 

(iii) Some or all of the information in the notice or the attachments
are not in English, except for published scientific literature. 

(iv) The submitter does not use the notice form. 

(v) The submitter does not provide information that is required by
section 5(d)(1) (B) and (C) of the Act and (720.50. 

(vi) The submitter does not provide information required on the notice
form and by (720.45 or indicate that it is not known to or reasonably
ascertainable by the submitter. 

(vii) The submitter does not submit a second copy of the submission with
all confidential information deleted for the public file, as required by
(720.80(b)(2). 

(viii) The submitter does not include any information required by
section 5(b)(1) of the Act and pursuant to a rule promulgated under
section 4 of the Act, as required by (720.40(g). 

(ix) The submitter does not submit data which the submitter believes
show that the chemical substance will not present an unreasonable risk
of injury to health or the environment, if EPA has listed the chemical
substance under section 5(b)(4) of the Act, as required in (720.40(h). 

(2)(i) If EPA receives an incomplete submission, the Director, or his or
her delegate, will notify the submitter within 30 days of receipt that
the submission is incomplete and that the notice review period will not
begin until EPA receives a complete notice. 

(ii) If EPA obtains additional information during the notice review
period that indicates the original submission was incomplete, the
Director, or his or her delegate, may declare the submission incomplete
within 30 days after EPA obtains the additional information and so
notify the submitter. 

(3) The notification that a submission is incomplete under paragraph
(c)(2) (i) or (ii) of this section will include: 

(i) A statement of the basis of EPA's determination that the submission
is incomplete. 

(ii) The requirements for correcting the incomplete submission. 

(iii) Information on procedures under paragraph (c)(4) of this section
for filing objections to the determination or requesting modification of
the requirements for completing the submission. 

(4) Within ten days after receipt of notification by EPA that a
submission is incomplete, the submitter may file written objections
requesting that EPA accept the submission as a complete notice or modify
the requirements necessary to complete the submission. 

(5)(i) EPA will consider the objections filed by the submitter. The
Director, or his or her delegate, will determine whether the submission
was complete or incomplete, or whether to modify the requirements for
completing the submission. EPA will notify the submitter in writing of
EPA's response within ten days of receiving the objections. 

(ii) If the Director, or his or her delegate, determines, in response to
the objection, that the submission was complete, the notice review
period will be deemed suspended on the date EPA declared the notice
incomplete, and will resume on the date that the notice is declared
complete. The submitter need not correct the notice as EPA originally
requested. If EPA can complete its review within 90 days from the date
of the original submission, the Director, or his or her delegate, may
inform the submitter that the running of the review period will resume
on the date EPA originally declared it incomplete. 

(iii) If the Director, or his or her delegate, modifies the requirements
for completing the submission or concurs with EPA's original
determination, the notice review period will begin when EPA receives a
complete notice. 

(d) Materially false or misleading statements. If EPA discovers at any
time that person submitted materially false or misleading statements in
the notice, EPA may find that the notice was incomplete from the date it
was submitted, and take any other appropriate action. 

 

(720.70    Notice in the Federal Register.

(a) Filing of FEDERAL REGISTER notice. In accordance with section
5(d)(2) of the Act, after EPA receives a notice, EPA will file with the
Office of the Federal Register a notice including the information
specified in paragraph (b) of this section. 

(b) Contents of notice. (1) In the public interest, the specific
chemical identity listed in the notice will be published in the FEDERAL
REGISTER unless the submitter has claimed chemical identity
confidential. If the submitter claims confidentiality, a generic name
will be published in accordance with (720.85(a)(3). 

(2) The categories of use of the new chemical substance will be
published as reported in the notice unless this information is claimed
confidential. If confidentiality is claimed, the generic information
which is submitted under (720.87(b) will be published. 

(3) A list of data submitted in accordance with (720.50(a) will be
published. In addition, for test data submitted in accordance with
(720.40(g), a summary of the data will be published. 

(4) The submitter's identity will be published, unless the submitter has
claimed it confidential. 

(720.75    Notice review period. 

(a) Length of notice review period. The notice review period specified
in section 5(a) of the Act runs for 90 days from the date the Document
Control Officer for the Office of Pollution Prevention and Toxics
receives a complete notice, or the date EPA determines the notice is
complete under (720.65(c), unless the Agency extends the period under
section 5(c) of TSCA and paragraph (c) of this section. 

(b) Suspension of the running of the notice review period. (1) A
submitter may voluntarily suspend the running of the notice review
period if the Director or his or her delegate agrees. If the Director
does not agree, the review period will continue to run, and EPA will
notify the  submitter. A submitter may request a suspension at any time
during the notice review period. The suspension must be for a specified
period of time. 

(2) A request for suspension may be made in writing to the Document
Control Office (7407), Office of Pollution Prevention and Toxics, U.S.
Environmental Protection Agency, Room G-099, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460. The suspension also may be made orally,
including by telephone, to the submitter's EPA contact for that notice.
EPA will send the submitter a written confirmation that the suspension
has been granted. 

(i) An oral request may be granted for 15 days only. To obtain a longer
suspension, the Document Control Officer for the Office of Pollution
Prevention and Toxics must receive written confirmation of the oral
request. The notice review period is suspended as of the date of the
oral request. 

(ii) If the submitter has not made a previous oral request, the running
of the notice review period is suspended as of the date of receipt of
the written request by the Document Control Officer for the Office of
Pollution Prevention and Toxics. 

(c) Extension of notice review period. (1) At any time during the notice
review period, EPA may determine that good cause exists to extend the
notice review period specified in paragraph (a) of this section. 

(2) If EPA makes such a determination, EPA will: 

(i) Notify the submitter that EPA is extending the notice review period
for a specified length of time, and state the reasons for the extension.

(ii) Issue a notice for publication in the FEDERAL REGISTER which states
that EPA is extending the notice review period and gives the reasons for
the extension. 

(3) The initial extension may be for a period of up to 90 days. If the
initial extension is for less than 90 days, EPA may make additional
extensions. However, the total period of extensions may not exceed 90
days for any notice. 

(4) The following are examples of situations in which EPA may find that
good cause exists for extending the notice review period: 

(i) EPA has reviewed the notice and determined that there is a
significant possibility that the chemical substance will be regulated
under section 5(e) or section 5(f) of the Act, but EPA is unable to
initiate regulatory action within the initial 90-day period. 

(ii) EPA has reviewed the submission and is seeking additional
information. 

(iii) EPA has received significant additional information during the
notice review period. 

(iv) The submitter has failed to correct a notice after receiving EPA's
request under (720.65(b). 

(d) Notice of expiration of notice review period. EPA will notify the
submitter that the notice review period has expired or that EPA has
completed its review of the notice. Expiration of the review period does
not constitute EPA approval or certification of the new chemical
substance, and does not mean that EPA may not take regulatory action
against the substance in the future. After expiration of the statutory
notice review period, in the absence of regulatory action by EPA under
section 5(e), 5(f), or 6(a) of the Act, the submitter may manufacture or
import the chemical

substance even if the submitter has not received notice of expiration. 

(e) Withdrawal of a notice by the submitter. (1) A submitter may
withdraw a notice during the notice review period. A statement of
withdrawal must be made in writing to the Document Control Office
(7407), Office of Pollution Prevention and Toxics, U.S. Environmental
Protection Agency, Room G-099, 1200 Pennsylvania Ave., NW., Washington,
DC 20460. The withdrawal is effective upon receipt of the statement by
the Document Control Officer.  

(2) If a manufacturer or importer which withdrew a notice later
resubmits a notice for the same chemical substance, a new notice review
period begins. 

[48 FR 21742, May 13, 1983, as amended at 53 FR 12523, Apr. 15, 1988; 58
FR 34204, June 23, 1993; 60 FR 34464, July 3, 1995]

(720.78    Recordkeeping.

(a) Any person who submits a notice under this part must retain
documentation of information in the notice, including (1) other data, as
defined in (720.50(b), in the submitter's possession or control; and (2)
records of production volume for the first three years of production or
import, the date of commencement of manufacture or import, and
documentation of this information. This information must be retained for
five years from the date of commencement of manufacture of import. 

(b)(1) Persons who manufacture or import a chemical substance under
(720.36 must retain the following records: 

(i) Copies of, or citations to, information reviewed and evaluated under
(720.36(b)(1) to determine the need to make any notification of risk. 

(ii) Documentation of the nature and method of notification under
(720.36(c)(1) including copies of any labels or written notices used. 

(iii) Documentation of prudent laboratory practices used instead of
notification and evaluation under (720.36(b)(2). 

(iv) The names and addresses of any persons other than the manfacturer
or importer to whom the substance is distributed, the identity of the
substance to the extent known, the amount distributed, and copies of the
notifications required under (720.36(c)(2). These records are not
required when  substances are distributed as impurities or incorporated
into an article, in accordance with paragraph (d) of this section. 

(2) A person who manufactures or imports a chemical substance under
(720.36 and who manufactures or imports the substance in quantities
greater than 100 kilograms per year must retain records of the identity
of the substance to the extent known, the production volume of the
substance, and the person's disposition of the substance. The person is
not required to maintain records of the disposition of products
containing the substance as an impurity or of articles

incorporating the substances. 

(3) Records under this paragraph must be retained for 5 years after they
are developed. 

(c) Any person who obtains a test-marketing exemption under this part
must retain documentation of information in the application and
documentation of compliance with any restrictions imposed by EPA when it
granted the application.  This information must be retained for five
years from the final date of manufacture or import under the exemption. 

[48 FR 21742, May 13, 1983; 48 FR 33872, July 26, 1983, as amended at 51
FR 15102, Apr. 22, 1986; 58 FR 34204, June 23, 1993]

                    Subpart E -- Confidentiality and Public Access to
Information

(720.80    General provisions.

(a) A person may assert a claim of confidentiality for any information
which he or she submits to EPA under this part. 

(b) Any claim of confidentiality must accompany the information when it
is submitted to EPA. 

(1)(i) For information submitted on the notice form, the claim(s) must
be asserted on the form in the manner prescribed on the notice form. 

(ii) When a person submits information in an attachment, the claim(s)
must be asserted in the attachment as described on the notice form. 

(2) If any information is claimed as confidential, the person must
submit, in addition to the copies specified by (720.40, a sanitized copy
of the notice form (or electronic submission) and any attachments. 

(i) The original and two copies of the notice, specified at (720.40 (or
electronic submission) and attachments must be complete. The submitter
must designate that information which is claimed as confidential in the
manner prescribed on the notice form (or in EPA's electronic submission
instructions). 

(ii) The sanitized copy must be complete except that all information
claimed as confidential in the original must be deleted. EPA will place
this sanitized copy in the public file. 

(iii) If the person does not provide the sanitized copy, or information
in a health and safety study (except information claimed as confidential
in accordance with (720.90), the submission will be deemed incomplete
and the notice review period will not begin until EPA receives the
sanitized copy or the health and safety study information is included,
in accordance with (720.65(c)(1)(vii). 

(c) EPA will disclose information that is subject to a claim of
confidentiality asserted under this section only to the extent permitted
by the Act, this subpart, and part 2 of this title. 

(d) If a notice submitter does not assert a claim of confidentiality for
information at the time it is submitted to EPA, EPA may make the
information public and place it in the public file without further
notice to the submitter. 

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 60
FR 16311, Mar. 29, 1995]

(720.85   Chemical identity. 

(a) Claims applicable to the period prior to commencement of manufacture
or import. (1)(i) A person who submits information to EPA under this
part may assert a claim of confidentiality for the chemical identity of
the new chemical substance. This claim will apply only to the period
prior to the commencement of manufacture or import for commercial
purposes. A submitter may assert this claim only if the submitter
believes that public disclosure prior to commencement of manufacture or
import of the fact that anyone intends to manufacture or import the
specific chemical substance for commercial purposes would reveal
confidential business information. 

(ii) If the notice includes a health and safety study concerning the new
chemical substance and if the claim for confidentiality with respect to
the chemical identity is denied in accordance with (720.90(c), EPA will
deny a claim asserted under this paragraph. 

(2) Any person who asserts a claim of confidentiality for chemical
identity under this paragraph must provide one of the following items at
the time the notice is submitted: 

(i) The generic name which was accepted by EPA in the prenotice
consultation conducted under paragraph (a)(3) of this section. 

(ii) One generic name that is only as generic as necessary to protect
the confidential chemical identity of the particular chemical substance.
The name should reveal the specific chemical identity to the maximum
extent possible. The generic name will be subject to EPA review and
approval at the time a notice of commencement is submitted. 

(3)(i) Any person who intends to assert a claim of confidentiality for
the chemical identity of a new chemical substance may seek a
determination by EPA of an appropriate generic name for the substance
before submitting a notice. For this purpose, the person should submit
to EPA: 

(A) The chemical identity of the substance. 

(B) A proposed generic name(s) which in only as generic as necessary to
protect the confidential chemical identity of the new chemical
substance. The name(s) should reveal the chemical identity of the
substance to the maximum extent possible. 

(ii) Within 30 days, EPA will inform the submitter either that one of
the proposed generic names is adequate or that none is adequate and
further consultation is necessary. 

(4) If a submitter claims chemical identity to be confidential under
this paragraph, and if the submitter complies with paragraph (a)(2) of
this section, EPA will issue for publication in the FEDERAL REGISTER
notice described in (720.70 the generic name proposed by the submitter
or one agreed upon by EPA and the submitter. 

(b) Claims applicable to the period after commencement of manufacture or
import. (1) Any claim of confidentiality under paragraph (a) of this
section is applicable only until the substance is manufactured or
imported for commercial purposes and becomes eligible for inclusion on
the Inventory. To maintain the confidential status of the chemical
identity when the substance is added to the Inventory, a submitter must
reassert the confidentiality claim and substantiate the claim in the
notice of commencement of manufacture required under (720.102. A
submitter may not claim the chemical indentity confidential for the
period after commencement of manufacture or import unless the submitter
claimed the chemical identity confidential for the period prior to
commencement of manufacture or import under paragraph (a) of this
section. 

(2)(i) A person who believes that public disclosure of the fact that
anyone manfactures or imports the new chemical substance for commercial
purposes would reveal confidential business information may assert a
claim of confidentiality under this paragraph. 

(ii) If the notice includes a health and safety study concerning the new
chemical substance, and if the claim for confidentiality with respect to
the chemical identity is denied in accordance with (720.90(c), EPA will
deny a claim asserted under this paragraph. 

(3) Any person who asserts a confidentiality claim for chemical identity
must: 

(i) Comply with the requirements of paragraph (a)(3) of this section
regarding submission of a generic name. 

(ii) Agree that EPA may disclose to a person with a bona fide intent to
manufacture or import the chemical substance the fact that the
particular chemical substance is included on the confidential Inventory
for purposes of notification under section 5(a)(1)(A) of the Act. 

(iii) Have available for the particular chemical substance, and agree to
furnish to EPA upon request: 

(A) An elemental analysis. 

(B) Either an X-ray diffraction pattern (for inorganic substances), a
mass spectrum (for most other substances), or an infrared spectrum of
the particular chemical substance, or if such data do not resolve
uncertainties with respect to the identity of the chemical substance,
additional or alternative spectra or other data to identify the chemical
substance. 

(iv) Provide a detailed written substantiation of the claim, by
answering the following questions: 

(A) What harmful effects to your competitive position, if any, do you
think would result if EPA publishes on the Inventory the identity of the
chemical substance? How could a competitor use such information given
the fact that the identity of the substance otherwise would appear on
the Inventory of chemical substances with no link between the substance
and your company or industry? How substantial would the harmful effects
of disclosure be? What is the casual relationship between the disclosure
and the harmful effects? 

(B) For what period of time should confidential treatment be given?
Until a specific date, the occurrence of a specific event, or
permanently? Why? 

(C) Has the chemical substance been patented? If so, have you granted
licenses to others with respect to the patent as it applies to the
chemical substance? If the chemical substance has been patented and
therefore disclosed through the patent, why should it be treated as
confidential for purposes of the Inventory? 

(D) Has the identity of the chemical substance been kept confidential to
the extent that your competitors do not know it is being manufactured on
imported for a commercial purpose by anyone? 

(E) Is the fact that someone is manufacturing or importing this chemical
substance for commercial purposes available to the public, e.g., in
technical journals or other publications; in libraries; or in State,
local, or Federal agency public files? 

(F) What measures have you taken to prevent undesired disclosure of the
fact that you are manufacturing or importing this substance for a
commercial purpose? 

(G) To what extent has the fact that you are manufacturing or importing
this chemical substance for a commercial purpose been disclosed to
others? What precautions have you taken in regard to these disclosures?
Has this information been disclosed to the public or to competitors? 

(H) In what form does this particular chemical substance leave the site
of manufacture, e.g., as part of a product; in an effluent or emission
stream? If so, what measures have you taken to guard against discovery
of its identity?  

(I) If the chemical substance leaves the site of manufacture in a
product that is available to either the public or your competitors, can
they identify the substance by analyzing the product? 

(J) For what purpose do you manufacture or import the substance? 

(K) Has EPA, another Federal agency, or any Federal court made any
pertinent confidentiality determinations regarding this chemical
substance? If so, copies of such determinations must be included in the
substantiation.  

(L) If the notice includes a health and safety study concerning the new
chemical substance, the submitter must also answer the questions in
(720.90(b)(2). 

(4) If the submitter does not meet the requirements of this paragraph,
EPA will deny the claim of confidentiality. 

(5)(i) EPA will publish a generic name on the public Inventory if: 

(A) The submitter asserts a claim of confidentiality in accordance with
this paragraph. 

(B) No claim for confidentiality of the specific chemical identity as
part of a health and safety study has been denied in accordance with
part 2 of this title or (720.90. 

(ii) Publication of a generic name on the public Inventory does not
create a category for purposes of the Inventory. Any person who has a
bona fide intent to manufacture or import a chemical substance which is
described by a generic name on the public Inventory may submit an
inquiry to EPA under (720.25(b) to determine whether the particular
chemical substance is included on the confidential Inventory. 

(iii) Upon receipt of a request described in (720.25(b), EPA may require
the submitter which originally asserted confidentiality for a chemical
substance to submit to EPA the information listed in paragraph
(b)(3)(iii) of this section. 

(iv) Failure to submit any of the information required under paragraph
(b)(3)(iii) of this section within ten days of a request by EPA under
this paragraph is a waiver of the original submitter's confidentiality
claim. In this event, EPA may place the specific chemical identity on
the public Inventory without further notice to the original submitter. 

(6) If a submitter asserts a claim of confidentiality under this
paragraph, EPA will examine the generic chemical name proposed by the
submitter. 

(i) If EPA determines that the generic name proposed by the submitter is
only as generic as necessary to protect the confidential identity of the
particular chemical substance, EPA will place that generic name on the
public Inventory. 

(ii) If EPA determines that the generic name proposed by the submitter
is more generic than necessary to protect the confidential identity, EPA
will propose in writing, for review by the submitter, an alternative
generic name that will reveal the chemical identity of the chemical
substance to the maximum extent possible. 

(iii) If the generic name proposed by EPA is acceptable to the
submitter, EPA will place that generic name on the public Inventory. 

(iv) If the generic name proposed by EPA is not acceptable to the
submitter, the submitter must explain in detail why disclosure of that
generic name would reveal confidential business information and propose
another generic name which is only as generic as necessary to protect
the confidential identity. If EPA does not receive a response from the
submitter within 30 days after the submitter receives the proposed name,
EPA will place EPA's chosen generic name on the public Inventory. If the
submitter does provide the information requested, EPA will review the
response. If the submitter's proposed generic name is acceptable, EPA
will publish that generic name on the public Inventory. If the
submitter's proposed generic name is not acceptable, EPA will notify the
submitter of EPA's choice of a generic name.  Thirty days after this
notification, EPA will place the chosen generic name on the public
Inventory. 

(720.87   Categories or proposed categories of uses of a new chemical
substance.

(a) A person who submits information to EPA under this part on the
categories or proposed categories of use of a new chemical substance may
assert a claim of confidentiality for this information. 

(b) A submitter that asserts such a claim must: 

(1) Report the categories or proposed categories of use of the chemical
substance. 

(2) Provide, in nonconfidential form, a description of the uses that is
only as generic as necessary to protect the confidential business
information. The generic use description will be included in the FEDERAL
REGISTER notice described in (720.70. 

(c) The person must submit the information required by paragraph (b) of
this section in the manner specified in the notice form. 

 

(720.90   Data from health and safety studies.

(a) Information other than specific chemical identity. Except as
provided in paragraph (b) of this section, EPA will deny any claim of
confidentiality with respect to information included in a health and
safety study, unless the information would disclose confidential
business information concerning: 

(1) Processes used in the manufacture or processing of a chemical
substance or mixture. 

(2) In the case of a mixture, the portion of the mixture comprised by
any of the chemical substances in the mixture. 

(3) Information which is not in any way related to the effects of a
substance on human health or the environment, such as the name of the
submitting company, cost or other financial data, product development or
marketing plans, and advertising plans, for which the person submits a
claim of confidentiality in accordance with (720.80. 

(b) Specific chemical identity -- (1) Claims applicable to period prior
to commencement of manufacture. A claim of confidentiality for the
period prior to commencement of manufacture or import for the chemical
identity of a chemical substance for which a health and safety study was
submitted must be asserted in conjunction with a claim asserted under
(720.85(a). 

(2) Claims applicable to period after commencement of manufacture or
import for commercial purposes. To maintain the confidential status of
the chemical identity of a chemical substance for which a health and
safety study was submitted after commencement of manufacture or import,
the claim must be reasserted and substantiated in conjunction with a
claim under (720.85(b). In addition to the questions set forth in
(720.85(b)(3)(iv) of this part, the submitter must answer the following
questions: 

(i) Would disclosure of the chemical identity disclose processes used in
the manufacture or processing of a chemical substance or mixture?
Describe how this would occur. In responding to the question in
(720.85(b)(3)(iv)(A), explain what harmful competitive effects would
occur from disclosure of this process information. 

(ii) Would disclosure of the chemical identity disclose the portion of a
mixture comprised by any of the substances in the mixture? Describe how
this would occur. In responding to the question in (720.85(b)(3)(iv)(A),
explain what harmful competitive effects would occur from disclosure of
this information. 

(iii) Do you assert that disclosure of the chemical identity is not
necessary to interpret any of the health and safety studies you have
submitted? If so, explain how a less specific identity would be
sufficient to interpret the studies. 

(c) Denial of confidentiality claim. EPA will deny a claim of
confidentiality for chemical identity under paragraph (b) of this
section, unless: 

(1) The information would disclose processes used in the manufacture or
processing of a chemical substance or mixture. 

(2) In the case of a mixture, the information would disclose the portion
of the mixture comprised by any of the substances in the mixture. 

(3) The specific chemical identity is not necessary to interpret a
health and safety study. 

(d) Use of generic names. When EPA discloses a health and safety study
containing a specific chemical identity, which the submitter has claimed
confidential, and if the Agency has not denied the claim under paragraph
(c) of this section, EPA will identify the chemical substance by the
generic name selected under (720.85. 

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993]

(720.95    Public file. 

All information submitted with a notice, including any health and safety
study and other supporting documentation, will become part of the public
file for that notice, unless such materials are claimed confidential. In
addition, EPA may add materials to the public file, subject to subpart E
of this part. Any of the nonconfidential material described in this
subpart will be available for public inspection in the Non-Confidential
Information Center (NCIC) (7407), Office of Pollution Prevention and
Toxics, U.S. Environmental Protection Agency, Room B-607 NEM, 401 M St.,
SW., Washington, DC 20460, between the hours of 12 p.m. and 4 p.m.
weekdays excluding legal holidays. 

[48 FR 21742, May 13, 1983, as amended at 53 FR 12523, Apr. 15, 1988; 60
FR 16311, Mar. 29, 1995; 60 FR 34464, July 3, 1995] 

                      Subpart F -- Commencement of Manufacture or Import

 

(720.102    Notice of commencement of manufacture or import. 

(a) Applicability. Any person who commences the manufacture or import of
a new chemical substance for a nonexempt commercial purpose for which
that person previously submitted a section 5(a) notice under this part
must submit a notice of commencement of manufacture or import. 

(b) When to report. (1) If manufacture or import for commercial purposes
begins on or after the effective date of this rule, the submitter must
submit the notice to EPA on, or no later than 30 calendar days, after
the first day of such manufacture or import. 

(2) If manufacture or import for commercial purposes began or will begin
before the effective date of this rule, the submitter must submit the
notice by the effective date of this rule. 

(c) Information to be reported on form. (1) The notice must be submitted
on EPA (Form 7710-56), which is available from the Environmental
Assistance Division (7408), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. The form must be signed and dated by an authorized
official. All information specified on the form must be provided. The
notice must contain the following

information: 

(i) The specific chemical identity of the PMN substance. 

(ii) A generic chemical name (if the chemical identity is claimed as
confidential by the submitter). 

(iii) The premanufacture notice (PMN) number assigned by EPA. 

(iv) The date of commencement for the submitter's manufacture or import
for a non-exempt commercial purpose (indicating whether the substance
was initially manufactured in the United States or imported). The date
of commencement is the date of completion of non-exempt manufacture of
the first amount (batch, drum, etc.) of new chemical substance
identified in the submitter's PMN. For importers, the date of
commencement is the date the new

chemical substance clears United States customs. 

(v) The name and address of the submitter. 

(vi) The name of the authorized official. 

(vii) The name and telephone number of a technical contact in the United
States. 

(viii) The address of the site where commencement of manufacture
occurred. 

(ix) Clear indications of whether the chemical identity, submitter
identity, and/or other information are claimed as confidential by the
submitter. 

(2) If the submitter claims the chemical identity confidential, and
wants the identity to be listed on the confidential portion of the
Inventory, the claim must be reasserted and substantiated in accordance
with (720.85(b). Otherwise, EPA will list the specific chemical identity
on the public Inventory. Submitters who did not claim the chemical
identity, submitter identity, or other information to be confidential in
the PMN cannot claim this information as confidential in the

notice of commencement. 

(d) Where to submit. Notices of commencement of manufacture or import
should be submitted to the Document Control Office (7407), Office of
Pollution Prevention and Toxics, U.S. Environmental Protection Agency,
Room G-099, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 

[48 FR 21742, May 13, 1983, as amended at 48 FR 41140, Sept. 13, 1983;
51 FR 15103, Apr. 22, 1986; 53 FR 12523, Apr. 15, 1988; 60 FR 16311,
Mar. 29, 1995; 60 FR 34464, July 3, 1995; 65 FR 39304, June 26, 2000]

                            Subpart G -- Compliance and Inspections

(720.120    Compliance.

(a) Failure to comply with any provision of this part is a violation of
section 15 of the Act (15 U.S.C 2614). 

(b) A person who manufactures or imports a new chemical substance before
a notice is submitted and the notice review period expires is in
violation of section 15 of the Act even if that person was not requied
to submit the notice under (720.22. 

(c) Using for commercial purposes a chemical substance or mixture which
a person knew or had reason to know was manufactured, processed, or
distributed in commerce in violation of section 5 of this rule is a
violation of section 15 of the Act (15 U.S.C. 2614). 

(d) Failure or refusal to establish and maintain records or to permit
access to or copying of records, as required by the Act, is a violation
of section 15 of the Act (15 U.S.C. 2614). 

(e) Failure or refusal to permit entry or inspection as required by
section 11 is a violation of section 15 of the Act (15 U.S.C. 2614). 

(f) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who
submit materially misleading or false information in connection with the
requirements of any provision of this rule may be subject to penalties
calculated as if they never filed their notices. 

(g) EPA may seek to enjoin the manufacture or processing of a chemical
substance in violation of this rule or act to seize any chemical
substance manufactured or processed in violation of this rule or take
other actions under the authority of section 7 of this Act (15 U.S.C.
2606) or section 17 or this Act (15 U.S.C. 2616). 

(720.122    Inspections.

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