Attachment E

SUBCHAPTER R—TOXIC SUBSTANCES CONTROL ACT
(1) Act means the Toxic Substances
Control Act (15 U.S.C. 2601 et seq).
(2) Consumer means a private individual who uses a chemical substance
or any product containing the chemical
substance in or around a permanent or
temporary household or residence, during recreation, or for any personal use
or enjoyment.
(3) Environment has the same meaning as in section 3 of the Act (15 U.S.C.
2602).
(4) Environmental transformation product means any chemical substance resulting from the action of environmental processes on a parent compound that changes the molecular identity of the parent compound.
(5) Metabolite means a chemical entity produced by one or more enzymatic
or nonenzymatic reactions as a result
of exposure of an organism to a chemical substance.
(6) Serious acute effects means human
disease processes or other adverse effects that have short latency periods
for development, result from shortterm exposure, or are a combination of
these factors and that are likely to result in death, severe or prolonged incapacitation, disfigurement, or severe or
prolonged loss of the ability to use a
normal bodily or intellectual function
with a consequent impairment of normal activities.
(7) Serious chronic effects means
human disease processes or other adverse effects that have long latency periods for development, result from
long-term exposure, are long-term illnesses, or are a combination of these
factors and that are likely to result in
death, severe or prolonged incapacitation, disfigurement, or severe or prolonged loss of the ability to use a normal bodily or intellectual function
with a consequent impairment of normal activities.
(8) Significant environmental effects
means:
(i) Any irreversible damage to biological, commercial, or agricultural resources of importance to society;
(ii) Any reversible damage to biological, commercial, or agricultural resources of importance to society if the

PART 723—PREMANUFACTURE
NOTIFICATION EXEMPTIONS
Subpart A [Reserved]
Subpart B—Specific Exemptions
Sec.
723.50 Chemical substances manufactured in
quantities of 10,000 kilograms or less per
year, and chemical substances with low
environmental releases and human exposures.
723.175 Chemical substances used in or for
the manufacture or processing of instant
photographic and peel-apart film articles.
723.250 Polymers.
AUTHORITY: 15 U.S.C. 2604.

Subpart A [Reserved]
Subpart B—Specific Exemptions

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§ 723.50 Chemical substances manufactured in quantities of 10,000 kilograms or less per year, and chemical substances with low environmental releases and human exposures.
(a) Purpose and scope. (1) This section
grants
an
exemption
from
the
premanufacture notice requirements of
section 5(a)(1)(A) of the Toxic Substances
Control
Act
(15
U.S.C.
2604(a)(1)(A)) for the manufacture of:
(i) Chemical substances manufactured in quantities of 10,000 kilograms
or less per year.
(ii) Chemical substances with low environmental releases and human exposures.
(2) To manufacture a new chemical
substance under the terms of this exemption a manufacturer must:
(i) Submit a notice of intent to manufacture 30 days before manufacture
begins, as required under paragraph (e)
of this section.
(ii) Comply with all other provisions
of this section.
(3) This section does not apply to
microorganisms subject to part 725 of
this chapter.
(b) Definitions. The following definitions apply to this subpart.

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§ 723.50

40 CFR Ch. I (7–1–18 Edition)
(ii) Workers. For exposure of workers
to the new chemical substance during
all manufacturing, processing, distribution in commerce, use and disposal of the substance:
(A) No dermal exposure (this criterion is met if adequate dermal exposure controls are used in accordance
with applicable EPA guidance).
(B) No inhalation exposure (this criterion is considered to be met if adequate inhalation exposure controls are
used in accordance with applicable
EPA guidance).
(iii) Ambient surface water. For ambient surface water releases, no releases
resulting in surface water concentrations above 1 part per billion, calculated using the methods prescribed
in §§ 721.90 and 721.91, unless EPA has
approved a higher surface water concentration supported by relevant and
scientifically valid data submitted to
EPA in a notice under paragraph (e) of
this section on the substance or a close
structural analogue of the substance
which demonstrates that the new substance will not present an unreasonable risk of injury to aquatic species or
human health at the higher concentration.
(iv) Incineration. For ambient air releases from incineration, no releases of
the new chemical substance above 1
microgram per cubic meter maximum
annual average concentration, calculated using the formula:

damage persists beyond a single generation of the damaged resource or beyond a single year; or
(iii) Any known or reasonably anticipated loss of members of an endangered
or threatened species. Endangered or
threatened species are those species
identified as such by the Secretary of
the Interior in accordance with the Endangered Species Act, as amended (16
U.S.C. 1531).
(9) Site means a contiguous property
unit. Property divided only by a public
right-of-way is one site. There may be
more than one manufacturing plant on
a single site.
(10) The terms byproduct, EPA, importer, impurity, known to or reasonably
ascertainable, manufacture, manufacturer, new chemical substance, person,
possession or control, and test data have
the same meanings as in § 720.3 of this
chapter.
(c) Exemption categories. Except as
provided in paragraph (d) of this section, this exemption applies to:
(1) Any manufacturer of a new chemical substance manufactured in quantities of 10,000 kilograms or less per
year under the terms of this exemption.
(2) Any manufacturer of a new chemical substance satisfying all of the following low environmental release and
low human exposure eligibility criteria:
(i) Consumers and the general population. For exposure of consumers and
the general population to the new
chemical substance during all manufacturing, processing, distribution in
commerce, use, and disposal of the substance:
(A) No dermal exposure.
(B) No inhalation exposure (except as
described in paragraph (c)(2)(iv) of this
section.
(C) Exposure in drinking water no
greater than a 1 milligram per year (estimated average dosage resulting from
drinking water exposure in streams
from the maximum allowable concentration level from ambient surface
water releases established under paragraph (c)(2)(iii) of this section or a
higher concentration authorized by
EPA under paragraph (c)(2)(iii) of this
section).

(kg/day of release after treatment) multiplied by (number of release days per year)
multiplied by (9.68 × 10¥6) micrograms per
cubic meter.

(v) Land or groundwater. For releases
to land or groundwater, no releases to
groundwater, to land, or to a landfill
unless the manufacturer has demonstrated to EPA’s satisfaction in a
notice under paragraph (e) of this section that the new substance has negligible groundwater migration potential.
(d) Chemical substances that cannot be
manufactured under this exemption. A
new chemical substance cannot be
manufactured under this section, notwithstanding satisfaction of the criterion of paragraphs (c)(1) or (c)(2) of

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Environmental Protection Agency

§ 723.50

this section, if EPA determines, in accordance with paragraph (g) of this section, that the substance, any reasonably anticipated metabolites, environmental transformation products, or byproducts of the substance, or any reasonably anticipated impurities in the
substance may cause, under anticipated conditions of manufacture, processing, distribution in commerce, use,
or disposal of the new chemical substance:
(1) Serious acute (lethal or sublethal)
effects.
(2) Serious chronic (including carcinogenic and teratogenic) effects.
(3) Significant environmental effects.
(e) Exemption notice. (1) A manufacturer applying for an exemption under
either paragraph (c)(1) or (c)(2) of this
section must submit an exemption notice to EPA at least 30 days before
manufacture of the new chemical substance begins. Exemption notices and
modifications must be submitted to
EPA on EPA Form No. 7710–25 via CDX
using e-PMN software in the manner
set forth in this paragraph. See 40 CFR
720.40(a)(2)(ii) for information on how
to obtain e-PMN software. Notices and
any related support documents, must
be generated and completed (via CDX)
using e-PMN software. See 40 CFR
720.40(a)(2)(ii) for information on how
to obtain e-PMN software.
(2) The notice shall contain the information described below, pursuant to
the referenced provisions of § 720.45.
(i) Manufacturer identity.
(ii) Chemical identity (§ 720.45(a)).
(iii) Impurities (§ 720.45(b)).
(iv) Known synonyms or trade names
(§ 720.45(c)).
(v) Byproducts (§ 720.45(d)).
(vi) Production volume (§ 720.45(e)).
(A) Manufacturers submitting an exemption application under paragraph
(c)(1) of this section will be assumed to
be manufacturing at an annual production volume of 10,000 kilograms. Manufacturers who intend to manufacture
an exempted substance at annual volumes of less than 10,000 kilograms and
wish EPA to conduct its risk assessment based upon such lesser annual
production level rather than a 10,000–
kilograms level, may so specify by
writing the lesser annual production
volume in the appropriate box on the

PMN form and marking the adjacent
binding option box. Manufacturers who
opt to specify annual production levels
below 10,000 kilograms and who mark
the production volume binding option
box shall not manufacture more than
the specific annual amount of the exempted substance unless a new exemption notice for a higher (up to 10,000
kgs) manufacturing volume is submitted and approved pursuant to this
section.
(B) Manufacturers submitting an exemption under paragraph (c)(2) of this
section shall list the estimated maximum amount to be manufactured during the first year of production and the
estimated maximum amount to be
manufactured during any 12–month period during the first 3 years of production.
(vii) Description of intended categories of use (§ 720.45(f)).
(viii) For manufacturer-controlled
sites, the manufacturer shall supply
identity of manufacturing sites, process descriptions, and worker exposure
and environmental release information
(§ 720.45(g)); for sites not controlled by
the manufacturer, processing and use
operation descriptions, estimated number of processing and use sites, and
worker exposure/environmental release
information (§ 720.45(h)). A manufacturer applying for an exemption under
paragraph (c)(1) of this section need
not provide information on worker exposure and environmental release referenced in paragraphs (e)(2)(viii) of this
section if such information is not
known or not readily available to the
manufacturer. To assist in reporting
this information, manufacturers may
obtain a copy of EPA’s Guidance for
Reporting Occupational Exposure and
Environmental Release Information
under 40 CFR 723.50, available from the
Environmental Assistance Division at
the address listed in paragraph (e)(1) of
this section. Where worker exposure
and environmental release information
is not supplied by the manufacturer,
EPA will generally apply ‘‘bounding estimates’’ (i.e., exposure estimates higher than those incurred by persons in
the population with the highest exposure) to account for uncertainties in
actual exposure and release scenarios.

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§ 723.50

40 CFR Ch. I (7–1–18 Edition)

(ix) Type and category of notice. The
manufacturer must clearly indicate on
the first page of the PMN form that the
submission is a ‘‘TSCA section 5(h)(4)
exemption notice,’’ and must indicate
whether the notice is being submitted
under paragraph (c)(1) or (c)(2) of this
section. Manufacturers of chemical
substances that qualify for an exemption under both paragraph (c)(1) and
(c)(2) of this section may apply for either exemption, but not both.
(x) Test data (§ 720.50).
(xi) Certification. In addition to the
certifications required in EPA form
7710–25, the following certifications
shall be included in notices under this
section. The manufacturer must certify
that:
(A) The manufacturer intends to
manufacture or import the new chemical substance for commercial purposes, other than in small quantities
solely for research and development,
under the terms of this section.
(B) The manufacturer is familiar
with the terms of this section and will
comply with those terms.
(C) The new chemical substance for
which the notice is submitted meets all
applicable exemption conditions.
(D) For substances manufactured
under paragraph (c)(1) of this section,
the manufacturer intends to commence
manufacture of the exempted substance for commercial purposes within
1 year of the date of the expiration of
the 30–day review period.
(xii) Sanitized copy of notice. (A) The
manufacturer must make all claims of
confidentiality in accordance with
paragraph (l) of this section. If any information is claimed confidential, the
manufacturer must submit a second
copy of the notice, with all information
claimed as confidential deleted, in accordance with paragraph (l)(3) of this
section.
(B) If the manufacturer does not provide the second copy, the submission
will be considered incomplete.
(3) Incomplete notices. If EPA receives
a submission which does not include all
of the information required under this
paragraph (e) of this section, the submission will be determined to be incomplete by EPA. When a submission
for a new chemical substance has been
determined to be incomplete, a manu-

facturer reapplying for an exemption
for the new chemical substance must
submit a new exemption notice containing all the information required
under this paragraph (e) of this section
including a certification page containing an original dated signature;
partial submissions sent to EPA to
supplement notices declared incomplete will not be accepted. Photocopied
pages from previously submitted exemption forms will be accepted provided that the certifications page contains an original dated signature.
(f) Multiple exemption holders. (1) A
manufacturer who intends to manufacture a substance for which an exemption under this section was previously
approved may apply for an exemption
under paragraph (c)(1) or (c)(2) of this
section; however, EPA will not approve
any subsequent exemption application
under paragraph (c)(1) of this section
unless it can determine that the potential human exposure to, and environmental release of, the new chemical
substance at the higher aggregate production volume will not present an unreasonable risk of injury to human
health or the environment.
(2)(i) If EPA proposes to deny an exemption application for a substance for
which another manufacturer currently
holds an exemption, and that proposed
denial is based exclusively on the cumulative human exposure or environmental release of the substance which
precludes the EPA from determining
that the subsequent applicant’s activities will not present an unreasonable
risk of injury to human health or the
environment, the EPA will notify the
first exemption holder that it must,
within 21 days of its receipt of EPA’s
notice, either:
(A) Provide a new certification that
it has commenced, or that it will commence, manufacture of the new chemical substance under this section within 1 year of the expiration of its exemption review period; or
(B) Withdraw its exemption for the
new chemical substance.
(ii) If the first exemption holder does
not respond to the EPA’s notice under
paragraph (f)(2)(i) of this section within the prescribed time period, EPA
shall issue a notice of ineligibility to
the first exemption holder under the

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Environmental Protection Agency

§ 723.50

provisions of paragraph (h)(2) of this
section.
(g) Review period. (1) EPA will review
the notice submitted under paragraph
(e) of this section to determine whether
manufacture of the new chemical substance is eligible for the exemption.
The review period will end 30 days after
receipt of the notice by the TSCA Document Control Officer. To provide additional time to address any unresolved
issues concerning an exemption application, the exemption applicant may,
at any time during the review period,
request a suspension of the review period pursuant to the provisions of
§ 720.75(b) of this chapter.
(2) Upon expiration of the 30–day review period, if EPA has taken no action, the manufacturer may consider
its exemption approved and begin to
manufacture the new chemical substance under the terms described in its
notice and in this section.
(h) Notice of ineligibility—(1) During
the review period. If the EPA determines
during the review period that manufacture of the new chemical substance
does not meet the terms of this section
or that there are issues concerning toxicity or exposure that require further
review which cannot be accomplished
within the 30–day review period, EPA
will notify the manufacturer by telephone that the substance is not eligible. This telephone notification will
subsequently be confirmed by certified
letter that identifies the reasons for
the ineligibility determination. The
manufacturer may not begin manufacture of the new chemical substance
without complying with section 5(a)(1)
of the Act or submitting a new notice
under paragraph (e) of this section that
satisfies EPA’s concerns.
(2) After the review period. (i)(A) If at
any time after the review period specified in paragraph (g) of this section the
Assistant Administrator for the Office
of Chemical Safety and Pollution Prevention (‘‘the Assistant Administrator’’) makes a preliminary determination that manufacture of the new
chemical substance does not meet the
terms of this section, the Assistant Administrator will notify the manufacturer by certified letter that EPA believes that the new chemical substance
does not meet the terms of the section.

(B) The manufacturer may continue
to manufacture, process, distribute in
commerce, and use the substance after
receiving the notice under paragraph
(h)(2)(i)(A) of this section if the manufacturer was manufacturing, processing, distributing in commerce, or
using the substance at the time of the
notification and if the manufacturer
submits objections or an explanation
under paragraph (h)(2)(ii) of this section. Manufacturers not manufacturing, processing, distributing in commerce, or using the substance at the
time of the notification may not begin
manufacture until EPA makes its final
determination
under
paragraph
(h)(2)(iii) of this section.
(ii) A manufacturer who has received
notice under paragraph (h)(2)(i)(A) of
this section may submit, within 15
days of receipt of written notification,
detailed objections to the determination or an explanation of its diligence
and good faith efforts in attempting to
comply with the terms of this section.
(iii) The Assistant Administrator will
consider any objections or explanation
submitted under paragraph (h)(2)(ii) of
this section and will make a final determination. The Assistant Administrator will notify the manufacturer of
the final determination by telephone
within 15 days of receipt of the objections or explanation, and subsequently
by certified letter.
(iv) If the Assistant Administrator
determines that manufacture of the
new chemical substance meets the
terms of this section, the manufacturer
may continue or resume manufacture,
processing, distribution in commerce,
and use in accordance with the terms
of this section.
(v) If the Assistant Administrator determines that manufacture of the new
chemical substance does not meet the
terms of this section and that the manufacturer did not act with due diligence and in good faith to meet the
terms of this section, the manufacturer
must cease any continuing manufacture, processing, distribution in commerce, and use of the new chemical
substance within 7 days of the written
notification under paragraph (h)(2)(iii)
of this section. The manufacturer may
not resume manufacture, processing,
distribution in commerce, and use of

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§ 723.50

40 CFR Ch. I (7–1–18 Edition)

the new chemical substance until it
submits a notice under section 5(a)(1)
of the Act and part 720 of this chapter
and the notice review period has ended.
(vi) If the Assistant Administrator
determines that manufacture of the
new chemical substance does not meet
the terms of this section and that the
manufacturer acted with due diligence
and in good faith to meet the terms of
this section, the manufacturer may
continue manufacture, processing, distribution in commerce, and use of the
new chemical substance if:
(A) It was actually manufacturing,
processing, distributing in commerce,
or using the chemical substance at the
time it received the notification specified in paragraph (h)(2)(i)(A) of this
section.
(B) It submits a notice on the new
chemical substance under section
5(a)(1) of the Act and part 720 of this
chapter within 15 days of receipt of the
written notification under paragraph
(h)(2)(iii) of this section. Such manufacture, processing, distribution in
commerce, and use may continue unless EPA takes action under section
5(e) or 5(f) of the Act.
(3) Action under this paragraph does
not preclude action under sections 7,
15, 16, or 17 of the Act.
(i) Additional information. If the manufacturer of a new chemical substance
under the terms of this exemption obtains test data or other information indicating that the new chemical substance may not qualify under terms of
this section, the manufacturer must
submit these data or information to
EPA within 15 working days of receipt
of the information. If, during the notice review period specified in paragraph (g) of this section, the submitter
obtains possession, control, or knowledge of new information that materially adds to, changes, or otherwise
makes significantly more complete the
information included in the notice, the
submitter must send that information
to the address listed on the notice form
within 10 days of receiving the new information, but no later than 5 days before the end of the notice review period. The new submission must clearly
identify the submitter and the exemption notice to which the new information is related. If the new information

becomes available during the last 5
days of the notice review period, the
submitter must immediately inform its
EPA contact for that notice by telephone.
(j) Changes in manufacturing site, use,
human exposure and environmental release controls, and certain manufacturing
volumes. (1) Except as provided in paragraph (j)(6) of this section, chemical
substances manufactured under this
section must be manufactured at the
site or sites described, for the uses described, and under the human exposure
and environmental release controls described in the exemption notice under
paragraph (e) of this section.
(2) Where the manufacturer lists a
specific physical form in which the new
chemical substance will be manufactured, processed, and/or used, the manufacturer must continue manufacturing, processing, and/or using the
new chemical substance in either the
same physical form described in the
notice under paragraph (e), or in a
physical form which will not increase
the human exposure to or environmental release of the new chemical
substance over those exposures or releases resulting from the specified
physical form (e.g., a manufacturer
which specifies that the new chemical
substance will be produced in a nonvolatile liquid form generally may not
change to a respirable powder form).
(3) The annual production volume of
chemical
substances
manufactured
under paragraph (c)(1) of this section
for which the manufacturer designated
a binding annual production volume
pursuant to paragraph (e)(2)(vi) of this
section must not exceed that designated volume.
(4) Any person who manufactures a
new chemical substance under paragraph (c)(1) or (c)(2) of this section
must comply with the provisions of
this section, including submission of a
new notice under paragraph (e) of this
section, before:
(i) Manufacturing the new chemical
substance at a site that was not approved in a previous exemption notice
for the substance, except as provided in
paragraph (j)(6) of this section.

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§ 723.50

(ii) Manufacturing the new chemical
substance for a use that was not approved in a previous exemption notice
for the substance.
(iii) Manufacturing the new chemical
substance without employing the
human exposure and environmental release controls approved in a previous
exemption notice for the substance.
(iv) Manufacturing the new chemical
substance in a physical form different
than that physical form approved in a
previous exemption notice for the substance and which form may increase
the human exposure to, or environmental release of, the new chemical
substance over those exposures or releases resulting from the physical form
approved in the previous notice.
(v) Manufacturing the chemical substance in annual production volumes
above any volume designated by the
manufacturer as binding under paragraph (e)(2)(vi) of this section in a previous exemption notice for the substance.
(5) In an exemption notice informing
EPA of a change in site, use, or worker
protection, or environmental release
controls, the manufacturer is not required to provide all of the same information submitted to EPA in a previous
exemption notice for that chemical
substance. The new exemption notice,
however, must indicate the identity of
the new chemical substance; the manufacturer’s name; the name and telephone number of a technical contact;
and location of the new site, new worker protection or environmental release
controls, and new use information. The
notice must also include the EPA-designated exemption number assigned to
the previous notice and a new certification by the manufacturer, as described in paragraph (e)(2)(xi) of this
section.
(6)(i) A manufacturer may, without
submitting a new notice, manufacture
the new chemical substance at a site
not listed in its exemption application
under the following conditions:
(A) the magnitude, frequency, and
duration of exposure of individual
workers to the new chemical substance
at the new manufacturing site is equal
to, or less than, the magnitude, frequency, and duration of exposure of the
individual workers to the new chemical

substance at the manufacturing site
for which the EPA performed its original risk-assessment pursuant to the
original exemption notice; and
(B) Either (1) at the new manufacturing site, the manufacturer does not
release to surface waters any of the
new chemical substance, or any waste
streams containing the new chemical
substance; or (2) at the new manufacturing site, the manufacturer maintains surface water concentrations of
the chemical substance, resulting from
direct or indirect discharges from the
manufacturing site, at or below 1 part
per billion, or at or below an alternative concentration level approved by
the Agency in writing or under the procedures
described
in
paragraph
(c)(2)(iii) of this section, using the
water concentration calculation method described at §§ 721.90 and 721.91.
(ii) The manufacturer shall notify
EPA of any new manufacturing site no
later than 30 days after the commencement of manufacture of the new chemical substance under the exemption at
the new manufacturing site as follows:
(A) The notification must contain
the EPA-designated exemption number
to which the notification applies, manufacturer identity, the street address
of the new manufacturing site, the date
on which manufacture commenced at
the new site, the name and telephone
number of a technical contact at the
new site, any claim of confidentiality,
and a statement that the notification
is an amendment to the original exemption application under the terms of
this section.
(B) The notification must be submitted electronically to EPA via CDX
as a support document to the original
notification. Prior to submission to
EPA via CDX, such notices must be
generated and completed using the ePMN
software.
See
40
CFR
720.40(a)(2)(ii) for information on how
to access the e-PMN software.
(k) Customer notification. (1) Manufacturers of new chemical substances described in paragraphs (c)(1) and (c)(2) of
this section must notify processors and
industrial users that the substance can
be used only for the uses specified in
the exemption notice at paragraph (e)
of this section. The manufacturer must
also inform processors and industrial

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40 CFR Ch. I (7–1–18 Edition)

users of any controls specified in the
exemption notice. The manufacturer
may notify processors and industrial
users by means of a container labeling
system, written notification, or any
other method that adequately informs
them of use restrictions or controls.
(2) A manufacturer of a new chemical
substance described in paragraph (c)(2)
of this section may distribute the
chemical substance only to other persons who agree in writing to not further distribute the substance until it
has been reacted, incorporated into an
article, or otherwise rendered into a
physical form or state in which environmental releases and human exposures above the eligibility criteria in
paragraph (c)(2) of this section are not
likely to occur.
(3) If the manufacturer learns that a
direct or indirect customer is processing or using the new substance in
violation of use restrictions or without
imposing prescribed worker protection
or environmental release controls, the
manufacturer must cease distribution
of the substance to the customer or the
customer’s supplier immediately unless the manufacturer is able to document each of the following:
(i) That the manufacturer has, within
5 working days, notified the customer
in writing that the customer has failed
to comply with the conditions specified
in this section and the exemption notice under paragraph (e) of this section.
(ii) That, within 15 working days of
notifying the customer of the noncompliance, the manufacturer received
from the customer, in writing, a statement of assurance that the customer is
aware of the terms of this section and
the exemption notice and will comply
with those terms.
(4) If, after receiving a statement of
assurance from a customer under paragraph (k)(3)(ii) of this section, the
manufacturer obtains knowledge that
the customer has again failed to comply with any of the conditions specified
in this section or the exemption notice,
the manufacturer shall cease supplying
the new chemical substance to that
customer and shall report the failure
to comply to EPA within 15 days of obtaining this knowledge. Within 30 days
of its receipt of the report, EPA will
notify the manufacturer whether, and

under what conditions, distribution of
the chemical substance to the customer may resume.
(l) Confidentiality. (1) If the manufacturer submits information to EPA
under this section which the manufacturer claims to be confidential business
information, the manufacturer must
clearly identify the information at the
time of submission to EPA by bracketing, circling, or underlining it and
stamping it with ‘‘CONFIDENTIAL’’ or
some other appropriate designation.
Any information so identified will be
treated in accordance with the procedures in part 2 of this chapter. Any information not claimed confidential at
the time of submission may be made
available to the public without further
notice.
(2)(i) Any person who asserts a claim
of confidentiality for chemical identity
under this paragraph (l) must provide a
generic chemical 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.
(ii) The generic name provided by the
manufacturer will be subject to EPA
review and approval in accordance with
the procedures specified in § 720.85(b)(6)
of this chapter. The generic name provided by the submitter or an alternative selected by EPA under these
procedures will be placed on a public
list of substances exempt under this
section.
(3) If any information is claimed confidential, the manufacturer must submit a second copy of the notice with all
information claimed as confidential deleted. EPA will place the second copy
in the public file.
(m) Exemptions granted under superseded regulations. Manufacturers holding exemptions granted under the superseded requirements of this section
(as in effect on May 26, 1995) shall either continue to comply with those requirements (including the production
volume limit) or apply for a new exemption pursuant to this section. EPA
will not accept requests to amend exemptions granted under the superseded
requirements; manufacturers wishing

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Environmental Protection Agency

§ 723.175

to amend such exemptions must submit a new exemption under paragraph
(e) of this section. If a new exemption
for a new chemical substance is granted under this exemption to the manufacturer holding an exemption under
the superseded requirements, the exemption under the superseded requirements for such substance shall be void.
(n) Recordkeeping. (1) A manufacturer
of a new chemical substance under
paragraph (c) of this section must
maintain the records described in this
paragraph at the manufacturing site or
site of importation for a period of 5
years after their preparation.
(2) The records must include the following to demonstrate compliance with
this section:
(i) Records of annual production volume and import volume.
(ii) Records documenting compliance
with the applicable requirements and
restrictions of paragraphs (c), (e), (f),
(h), (i), (j), and (k) of this section.
(3) Any person who manufactures a
new chemical substance under the
terms of this section must, upon request of a duly designated representative of EPA, permit such person at all
reasonable times to have access to and
to copy records kept under paragraph
(n)(2) of this section.
(4) The manufacturer must submit
the records listed in paragraph (n)(2) of
this section to EPA upon request. Manufacturers must provide these records
within 15 working days of receipt of
such request.
(o) Compliance. (1) Failure to comply
with any provision of this section is a
violation of section 15 of the Act (15
U.S.C. 2614).
(2) Submitting materially misleading
or false information in connection with
the requirements of any provision of
this section is a violation of this section and therefore a violation of section 15 of the Act (15 U.S.C. 2614).
(3) Violators may be subject to the
civil and criminal penalties in section
16 of the Act (15 U.S.C. 2615) for each
violation.
(4) EPA may seek to enjoin the manufacture or processing of a chemical
substance in violation of this section,
or act to seize any chemical substance
manufactured or processed in violation
of this section, or take other action

under the authority of section 7 of the
Act (15 U.S.C. 2606) or section 17 of the
Act (15 U.S.C. 1616).
[60 FR 16346, Mar. 29, 1995, as amended at 60
FR 34465, July 3, 1995; 62 FR 17932, Apr. 11,
1997; 64 FR 31989, June 15, 1999; 71 FR 33642,
June 12, 2006; 75 FR 787, Jan. 6, 2010; 77 FR
46292, Aug. 3, 2012; 78 FR 72828, Dec. 4, 2013; 80
FR 42746, July 20, 2015]

§ 723.175 Chemical substances used in
or for the manufacture or processing of instant photographic and
peel-apart film articles.
(a) Purpose and scope. (1) This section
grants
an
exemption
from
the
premanufacture notice requirements of
section 5(a)(1)(A) of the Toxic Substances
Control
Act
(15
U.S.C.
2604(a)(1)(A)) for the manufacture and
processing of new chemical substances
used in or for the manufacture or processing of instant photographic and
peel-apart film articles. This section
does not apply to microorganisms subject to part 725 of this chapter.
(2) To manufacture a new chemical
substance under the terms of this exemption, a manufacturer of instant
photographic or peel-apart film articles must:
(i) Submit an exemption notice when
manufacture begins under paragraph (i)
of this section.
(ii) Comply with certain requirements to limit exposure to the new
chemical substance under paragraphs
(e), (f), (g), and (h) of this section.
(iii) Comply with all recordkeeping
requirements under paragraph (j) of
this section.
(b) Definitions—(1) Act means the
Toxic Substances Control Act (15
U.S.C. 2601 et seq.).
(2) An article is a manufactured item
(i) which is formed to a specific shape
or design during manufacture, (ii)
which has end use function(s) dependent in whole or in part upon its shape
or design during end use, and (iii)
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 § 710.2 of this
chapter except that fluids and particles
are not considered articles regardless
of shape or design.

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§ 723.175

40 CFR Ch. I (7–1–18 Edition)

(3) The terms byproduct, EPA, impurities, person, and site have the same
meanings as in § 710.3 of this chapter.
(4) The term category of chemical substances has the same meaning as in section 26(c)(2) of the Act (15 U.S.C. 2625).
(5) The terms chemical substance, distribute in commerce, distribution in commerce, environment, manufacture, new
chemical substance, and process have the
same meanings as in section 3 of the
Act (15 U.S.C. 2602).
(6) Director of the Office of Pollution
Prevention and Toxics means the Director of the EPA Office of Pollution Prevention and Toxics or any EPA employee designated by the Office Director to carry out the Office Director’s
functions under this section.
(7) The term exemption category
means a category of chemical substances for which a person(s) has applied for or been granted an exemption
under section 5(h)(4) of the Act (15
U.S.C. 2604).
(8) The term instant photographic film
article means a self-developing photographic film article designed so that
all the chemical substances contained
in the article, including the chemical
substances required to process the film,
remain sealed during distribution and
use.
(9) Intermediate means any chemical
substance which is consumed in whole
or in part in a chemical reaction(s)
used for the intentional manufacture of
another chemical substance.
(10) Known to or reasonably ascertainable 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, our could obtain without unreasonable burden or
cost.
(11) The term peel-apart film article
means a self-developing photographic
film article consisting of a positive
image receiving sheet, a light sensitive
negative sheet, and a sealed reagent
pod containing a developer reagent and
designed so that all the chemical substances required to develop or process
the film will not remain sealed within
the article during and after the development of the film.
(12) Photographic article means any
article which will become a component

of an instant photographic or peelapart film article.
(13) Special production area means a
demarcated area within which all manufacturing, processing, and use of a
new chemical substance takes place,
except as provided in paragraph (f) of
this section, in accordance with the requirements of paragraph (e) of this section.
(14) Test data means:
(i) Data from a formal or informal
study, test, experiment, recorded observation, monitoring, or measurement.
(ii) Information concerning the objectives, experimental methods and
materials, protocols, results, data analyses (including risk assessments), and
conclusions from a study, test, experiment, recorded observation, monitoring, or measurement.
(15) Used in or for the manufacturing or
processing of an instant photographic or
peel-apart film article, when used to describe activities involving a new chemical substance, means the new chemical substance (i) is included in the article, or (ii) is an intermediate to a
chemical substance included in the article or is one of a series of intermediates used to manufacture a chemical
substance included in the article.
(16) Wet mixture means a water or organic solvent-based suspension, solution, dispersion, or emulsion used in
the manufacture of an instant photographic or peel-apart film article.
(c) Exemption category. The exemption
category includes new chemical substances used in or for the manufacture
or processing of instant photographic
or peel-apart film articles which are
manufactured and processed under the
terms of this section.
(d) Applicability. This exemption applies only to manufacturers of instant
photographic or peel-apart film articles who:
(1) Manufacture the new chemical
substances used in or for the manufacture or processing of the instant photographic or peel-apart film articles.
(2) Limit manufacture and processing
of a new chemical substance to the
site(s) listed in the exemption notice
for that new chemical substance submitted under paragraph (i) of this section.

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Environmental Protection Agency

§ 723.175

(3) Comply with the requirements of
paragraphs (e), (f), (g), (h), and (j) of
this section.
(4) Do not distribute in commerce or
use a peel-apart film article containing
a new chemical substance until submission of a premanufacture notice under
section 5(a)(1)(A) of the Act (15 U.S.C.
2604) and until the review period for the
notice has ended without EPA action
to prevent distribution or use.
(e) Conditions of manufacture and processing in the special production area. All
manufacturing, processing, and use operations involving the new chemical
substance must be performed in a special production area under the conditions set forth in this paragraph until
the new chemical substance has been
incorporated into a wet mixture, photographic article, or instant photographic or peel-apart film article.
(1) Exposure limits. In the special production area, the ambient air concentration of the new chemical substance during manufacture, processing,
and use cannot exceed an 8-hour time
weighted average (TWA) of 10 ppm for
gases and vapors and 50 μg/m3 for particulates, with an allowable TWA excursion of 50 percent above those concentrations for a duration of 30 minutes or less.
(2) Respiratory protection—(i) Respirator requirement. Except as specified
in paragraph (e)(2)(ii) of this section,
each person in the special production
area must wear an appropriate respiratory protection device to protect
against dusts, fumes, vapors, and other
airborne contaminants, as described in
29 CFR 1910.134. Selection of an appropriate respirator must be made according to the guidance of American National Standard Practices for Respiratory Protection Z88.2–1969 and the
NIOSH Certified Equipment List, U.S.
Department of Health and Human
Services, NIOSH publication No. 80–144.
(ii) Waiver of respirator requirement.
Employees are not required to wear
respirators if monitoring information
collected and analyzed in accordance
with paragraph (e)(3) of this section
demonstrates that the ambient 8-hour
TWA concentration of the new chemical substance in the area is less than
1 ppm for gases and vapors and 5 μg/m3
for particulates with an allowable TWA

excursion of 50 percent above these
concentrations for a duration of 30
minutes or less.
(iii) Quantitative fit test. Each respirator must be issued to a specific individual for personal use. A quantitative fit test must be performed for
each respirator before its first use by
that person in a special production
area.
(3) Monitoring—(i) When to monitor.
(A) When suitable sampling and analytic methods exist, periodic monitoring in accordance with this paragraph must be done to ensure compliance with the exposure limits of paragraphs (e)(1) and (2)(ii) of this section.
(B) When suitable sampling and analytic methods do not exist, compliance
with the exposure limits of paragraph
(e)(1) and the requirements of paragraph (e)(10) of this section must be determined by an evaluation of monitoring data developed for a surrogate
chemical substance possessing comparable physical-chemical properties
under similar manufacturing and processing conditions.
(ii) Monitoring methods. A suitable air
sampling method must permit personal
or fixed location sampling by conventional collection methods. A suitable
analytic method must have adequate
sensitivity for the volume of sample
available and be specific for the new
chemical substance being monitored. If
chemical-specific monitoring methods
are not available, nonspecific methods
may be used if the concentration of the
new chemical substance is assumed to
be the total concentration of chemical
substances monitored.
(iii) Monitoring frequency. (A) When
suitable air sampling and analytical
procedures are available, monitoring
must be done in each special production area during the first three 8-hour
work shifts involving the manufacture
or processing of each new chemical
substance.
Thereafter,
monitoring
must be done in each special production area for at least one 8-hour period
per month, during a production run in
which the new chemical substance is
manufactured or processed. Samples
must be of such frequency and pattern
as to represent with reasonable accuracy the mean level and maximum 30-

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§ 723.175

40 CFR Ch. I (7–1–18 Edition)

minute level of employee exposure during an 8-hour work shift. In monitoring
for an 8-hour work shift or the equivalent, samples must be collected periodically or continuously for the duration of the 8-hour work shift. Samples
must be taken during a period which is
likely to represent the maximum employee exposure.
(B) If the manufacturer demonstrates
compliance with the exposure limits
for 3 consecutive months, further monitoring of the identical process must be
performed only every 6 months thereafter, unless there is a significant
change in the process, process design,
or equipment. If there is such a change,
the manufacturer must begin monitoring again according to the schedule
in paragraph (e)(3)(iii)(A) of this section.
(iv) Location of monitoring. Air samples must be taken so as to ensure that
the samples adequately represent the
ambient air concentration of a new
chemical substance present in each
worker’s breathing zone.
(4) Engineering controls and exposure
safeguards. Engineering controls such
as, but not limited to, isolation, enclosure, local exhaust ventilation, and
dust collection must be used to ensure
compliance with the exposure limits
prescribed in paragraphs (e)(1) or
(e)(2)(ii) of this section.
(5) Training, hygiene, and work practices—(i) Training. No employee may
enter a special production area before
the completion of a training program.
The training program must be adapted
to the individual circumstances of the
manufacturer and must address: The
known physical-chemical and toxicological properties of the chemical
substances handled in the area; procedures for using and maintaining respirators and other personal safeguards;
applicable principles of hygiene; special handling procedures designed to
limit personal exposure to, and inadvertent release of, chemical substances; and procedures for responding
to emergencies or spills.
(ii) Hygiene. Appropriate standards of
hygiene must be observed by all employees handling a new chemical substance in manufacturing, processing, or
transfer operations. The manufacturer
must provide appropriate facilities for

employee changing and wash-up. Food,
beverages, tobacco products, and cosmetics must not be allowed in special
production areas.
(iii) Work practices. Operating procedures such as those related to chemical
weighing and filtering, or the charging,
discharging and clean-up of process
equipment, must be designed and conducted to ensure compliance with the
exposure limits prescribed in paragraph (e)(1) or (e)(2)(ii) of this section.
Written procedures and all materials
necessary for responding to emergency
situations must be immediately accessible to all employees in a special production area. Any spill or unanticipated emission must be controlled by
specially trained personnel using the
equipment and protective clothing described in paragraph (e)(6) of this section.
(6) Personal protection devices. All
workers engaged in the manufacture
and processing of a new chemical substance in the special production area
must wear suitable protective clothing
or equipment, such as chemical-resistant coveralls, protective eyewear, and
gloves.
(7) Caution signs. Each special production area must be clearly posted with
signs identifying the area as a special
production area where new chemical
substances are manufactured and processed under controlled conditions. Each
sign must clearly restrict entry into
the special production area to qualified
personnel who are properly trained and
equipped with appropriate personal exposure safeguards.
(8) Removal for storage or transportation. A new chemical substance that
is not incorporated into a wet mixture,
photographic article, or instant photographic or peel-apart film article may
be removed from the special production
area for purposes of storage between
operational steps or for purposes of
transportation to another special production area. Such storage or transportation must be conducted in a manner
that limits worker and environmental
exposure through the use of engineering controls, training, hygiene, work
practices, and personal protective devices appropriate to the chemical substance in question.

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§ 723.175

(9) Labeling. (i) Any new chemical
substance removed from a special production area or stored or transported
between operational steps must be
clearly labeled. The label must show
the identity of the new chemical substance or an appropriate identification
code, a statement of any known hazards associated with it, a list of special
handling instructions, first aid information, spill control directions, and
where applicable, the appropriate U.S.
Department of Transportation notations.
(ii) No label is required if the new
chemical substance has been incorporated into a photographic article, or
if it is contained in a sealed reaction
vessel or pipeline, or if it has been incorporated into an instant photographic or peel-apart film article.
(10) Areas immediately adjacent to the
special production area. The ambient air
concentration of the new chemical substance in areas immediately adjacent
to the special production area must not
exceed the exposure limit established
in paragraph (e)(2)(ii) of this section
for waiver of respirator protection
within the special production area.
Periodic monitoring in accordance
with paragraph (e)(3) of this section
must be performed in immediately adjacent areas where it is reasonable to
expect a risk of inhalation exposure.
(f) Conditions of processing outside the
special production area. A wet mixture
may be incorporated into a photographic article or an instant photographic or peel-apart film article outside the special production area under
the conditions listed in this paragraph:
(1) Engineering controls and exposure
safeguards. Engineering controls must
limit the exposure to a new chemical
substance contained in a wet mixture.
(2) Training, hygiene and work practices—(i) Training. Training of employees involved in the handling of wet
mixtures containing a new chemical
substance must be adapted to the individual circumstances of the employees’
activities and must address: Procedures for using personal exposure safeguards, applicable principles of hygiene, handling procedures designed to
limit personal exposure, and procedures for responding to emergencies
and spills.

(ii) Hygiene. Appropriate standards of
hygiene that limit exposure must be
observed by all employees handling wet
mixtures that contain new chemical
substances.
(iii) Work practices. Work practices
and operating procedures must be designed to limit exposure to any new
chemical substance contained in wet
mixtures. Any spills or unanticipated
releases of a wet mixture must be controlled by trained personnel wearing
appropriate protective clothing or
equipment such as gloves, eye protection, and, where necessary, respirators
or chemically imprevious clothing.
(3) Personal protection devices. All
workers engaged in the processing of a
wet mixture containing a new chemical
substance must wear suitable protective clothing or equipment such as coveralls, protective eyewear, respirators,
and gloves.
(g) Incorporation of photographic articles into instant photographic and peelapart film articles. A photographic article may be incorporated into the instant photographic or peel-apart film
article outside the special production
area. The manufacturer must take
measures to limit worker and environmental exposure to new chemcial substances during these operations using
engineering controls, training, hygiene, work practices, and personal
protective devices.
(h) Environmental release and waste
treatment—(1) Release to land. Process
waste from manufacturing and processing operations in the special production area that contain a new chemical
substance are considered to be hazardous waste and must be handled in
accordance with the requirements of
parts 262 through 267 and parts 122 and
124 of this chapter.
(2) Release to water. All wastewater or
discharge which contain the new
chemcial subtance must be appropriately pretreated before release to a
Publicly Owned Treatment Works
(POTW) or other receiving body of
water. In the case of release to a
POTW, the pretreatment must prevent
structural damage to, obstruction of,
or interference with the operation of
the POTW. The treatment of direct release to a receiving body of water must
be appropriate for the new chemical

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40 CFR Ch. I (7–1–18 Edition)

substance’s physical-chemical properties and potential toxicity.
(3) Release to air. All process emissions released to the air which contain
the new chemical substance must be
vented through control devices appropriate for the new chemical substance’s
physical-chemical properties and potential toxicity.
(i) Exemption notice. An exemption
notices must be submitted to EPA
when manufacture of the new chemical
substance begins.
(1) Contents of exemption notice. The
exemption notice must include the following information:
(i) Manufacturer and sites. The notice
must identify the manufacturer and
the sites and locations where the new
chemical substance and the instant
photographic or peel-apart film articles will be manufactured and processed.
(ii) Chemical identification. The notice
must identify the new chemical substance as follows:
(A) Class 1 substances. For chemical
substances whose composition can be
represented by a definite structural
disagram (Class 1 substances), the notice must provide the chemical name
(preferably CAS or IUPAC nomenclature), the molecular formula, CAS
Registry Number (if available), known
synonyms (including trade names), and
a structural diagram.
(B) Class 2 substances. For chemical
substances that cannot be fully represented by a structural diagram,
(Class 2 substances), the notice must
provide the chemical name, the molecular formula, the CAS Registry Number (if available), and known synonyms
(including trade names). The notice
must identify the immediate precursors and reactants by name and CAS
Registry Number (if available). The notice must include a partial or incomplete structural diagram, if available.
(C) Polymers. For a polymer, the notice must indentify monomers and
other reactants used in the manufacture of the polymer by chemical name
and CAS Registry Number. The notice
must indicate the amount of each monomer used (by weight percent of total
monomer); the maximum residual of
each monomer present in the polymer;
and a partial or incomplete structural

diagram, if available. The notice must
indicate the number average molecular
weight of the polymer and characterize
the anticipated low molecular weight
species. The notice must include this
information for each typical average
molecular weight composition of the
polymer to be manufactured.
(iii) Impurities. The notice must identify the impurities that can be reasonably anticipated to be present in the
new chemcial substance when manufactured under the exemption by name
and CAS Registry Number, by class of
substances, or by process or source.
The notice also must estimate the
maximum percent (by weight) of each
impurity in the new chemical substance and the percent of unknown impurities present.
(iv) Physical-chemical properties. The
notice must describe the physicalchemical properties of the new chemical substance. Where specific physicalchemical data are not available, reasonable estimates and the techniques
used to develop these estimates must
be provided.
(v) Byproducts. The notice must identify the name, CAS Registry number (if
available), and the volume of each byproduct that would be manufactured
during manufacture of the new chemical substance.
(vi) Production volume. The notice
must include an estimate of the anticipated maximum annual production volume.
(vii) Test data. The notice must include all information and test data on
the new chemical substance’s health
and environmental effects that are
known to or reasonably ascertainable
by the manufacturer.
(viii) Identity of the article. The notice
must identify and describe the instant
photographic film article(s) or peelapart film article(s) that will contain
the new chemical substance.
(ix) Release to water. The notice must
include a description of the methods
used to control and treat wastewater
or discharge released to a POTW or
other receiving body of water. The notice must also identify the POTW or receiving body of water.
(x) Certification. The manufacturer
must certify in the notice that it is familiar with the terms of the exemption

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§ 723.175

and that the manufacture, processing,
distribution, use, and disposal of the
new chemical substance will comply
with those terms.
(2) Duplication of information in
premanufacture notice. If a manufacturer who submits an exemption notice
under this paragraph has already submitted, or simultaneously submits, a
premanufacture notice under section
5(a)(1)(A) of the Act for the new chemical substance, it may, in lieu of submitting the information required by
this paragraph, reference the required
information to the extent it is included
in the premanufacture notice. At a
minimum, the exemption notice must
identify the manufacturer and the new
chemical substance, and contain the
certification required by paragraph
(i)(1)(x) of this section.
(3) Address. The exemption notice
must be addressed to the Document
Control Office (DCO) (7407M), Office of
Pollution
Prevention
and
Toxics
(OPPT),
Environmental
Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001.
(j) Recordkeeping. (1) Manufacturers
of a new chemical substance under this
exemption must keep the following
records for 30 years from the final date
of manufacture.
(i) Production records. Each manufacturer must maintain records of the annual production volume of each new
chemical
substance
manufactured
under the terms of the exemption. This
record must indicate when manufacture of the new chemical substance
began.
(ii) Exposure monitoring records. Manufacturers must maintain an accurate
record of all monitoring required by
this section. Monitoring records may
be adapted to the individual circumstances of the manufacturer but,
at a minimum, must contain the following information: The chemical identity of the new chemical substance,
date of the monitoring, the actual
monitoring data for each monitoring
location and sampling, and a reference
to or description of the collection and
analytic techniques. If the manufacturer does not monitor, the manufacturer must maintain a record of the
reasons for not monitoring and the
methods used to determine compliance

with the exposure limits of paragraph
(e)(1) of this section.
(iii) Training and exposure records. For
each employee engaged in the manufacture or processing of a new chemical
substance, the company must develop
and maintain a record of the worker’s
participation in required training. This
record must also demonstrate the regular use of personal exposure safeguards, including the results of any
personal exposure monitoring, the results of the quantitative fit test for the
worker’s personal respirator, and any
additional information related to the
worker’s occupational exposure.
(iv) Treatment records. Manufacturers
who release treated wastewater or discharge containing a new chemical substance to a POTW or other receiving
body of water must maintain records of
the method of treatment.
(2) The manufacturer must make the
records listed in paragraph (j)(1) of this
section available to EPA upon written
request by the Director of the Office of
Pollution Prevention and Toxics. The
manufacturer must provide these
records within 15 working days of receipt of this request.
(k) Confidentiality. If the manufacturer submits information under paragraph (i) or (j) of this section which it
claims to be confidential business information, the manufacturer must
clearly identify the information at the
time of submission to the Agency by
bracketing, circling, or underlining it
and stamping it with ‘‘CONFIDENTIAL’’ or some other appropriate designation. Any information so identified
will be treated in accordance with the
procedures in part 2 of this chapter.
Any information not claimed confidential at the time of submission will be
made available to the public without
further notice to the submitter.
(l) Amendment and repeal. (1) EPA
may amend or repeal any term of this
exemption if it determines that the
manufacture, processing, distribution,
use, and disposal of new chemical substances under the terms of the exemption may present an unreasonable risk
of injury to health or the environment.
EPA also may amend this exemption to
enlarge the exemption category or to
reduce the restrictions or conditions of
the exemption.

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§ 723.250

40 CFR Ch. I (7–1–18 Edition)
(i) Determine that the substance
meets the definition of polymer in
paragraph (b) of this section.
(ii) Determine that the substance is
not specifically excluded by paragraph
(d) of this section.
(iii) Ensure that the substance meets
the exemption criteria of paragraph (e)
of this section.
(iv) Submit a report as required
under paragraph (f) of this section.
(v) Comply with the recordkeeping
requirements of paragraph (j) of this
section.
(b) Definitions. In addition to the definitions under section 3 of the Act, 15
U.S.C. 2602, the following definitions
apply to this part.
Act means the Toxic Substances Control Act (15 U.S.C. 2601 et seq.).
Biopolymer means a polymer directly
produced by living or once-living cells
or cellular components.
Category of chemical substances has
the same meaning as in section 26(c)(2)
of the Act (15 U.S.C. 2625).
Cationic polymer means a polymer
that contains a net positively charged
atom(s) or associated groups of atoms
covalently linked to its polymer molecule.
Chemical substance, Director, EPA, importer, impurity, Inventory, known to or
reasonably ascertainable, manufacture,
manufacturer, mixture, new chemical,
person, possession or control, process and
test data have the same meanings as in
§ 720.3 of this chapter.
Equivalent weight of a functional group
means the ratio of the molecular
weight to the number of occurrences of
that functional group in the molecule.
It is the weight of substance that contains one formula-weight of the functional group.
Fluorotelomers means the products of
telomerization, which is the reaction of
a telogen (such as pentafluoroethyl iodide) with an ethylenic compound
(such as tetrafluoroethylene) to form
low molecular weight polymeric compounds, which contain an array of saturated carbon atoms covalently bonded
to each other (C-C bonds) and to fluorine atoms (C-F bonds). This array is
predominantly a straight chain, and
depending on the telogen used produces
a compound having an even number of
carbon atoms. However, the carbon

(2) As required by section 5(h)(4) of
the Act, EPA will amend or repeal the
substantive terms of an exemption
granted under this part only by the formal rulemaking procedures described
in section 6(c)(2) and (3) of the Act (15
U.S.C. 2605(c)).
(m) Prohibition of use of the exemption.
The Director of the Office of Pollution
Prevention and Toxics may prohibit
the manufacture, processing, distribution, use, or disposal of any new chemical substance under the terms of this
exemption if he or she determines that
the manufacture, processing, distribution in commerce, use, or disposal of
the new chemical substance may
present an unreasonable risk of injury
to health or the environment.
(n) Enforcement. (1) A failure to comply with any provision of this part is a
violation of section 15 of the Act (15
U.S.C. 2614).
(2) Submitting materially misleading
or false information in connection with
the requirements of any provision of
this part is a violation of this regulation and therefore a violation of section 15 of the Act (15 U.S.C. 2614).
(3) Violators may be subject to the
civil and criminal penalties in section
16 of the Act (15 U.S.C. 2615) for each
violation.
(4) EPA may seek to enjoin the manufacture of a new chemical substance
in violation of this exemption or act to
seize any chemical substances manufactured in violation of the exemption
under the authority of section 17 of the
Act (15 U.S.C. 2616).
[47 FR 24317, June 4, 1982, as amended at 53
FR 12523, Apr. 15, 1988; 60 FR 34465, July 3,
1995; 62 FR 17932, Apr. 11, 1997; 68 FR 906, Jan.
7, 2003; 71 FR 33642, June 12, 2006]

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§ 723.250

Polymers.

(a) Purpose and scope. (1) This section
grants an exemption from certain of
the premanufacture notice requirements of section 5(a)(1)(A) of the Toxic
Substances Control Act (15 U.S.C.
2604(a)(1)(A)) for the manufacture of
certain polymers. This section does not
apply to microorganisms subject to
part 725 of this chapter.
(2) To manufacture a new chemical
substance under the terms of this section, a manufacturer must:

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Environmental Protection Agency

§ 723.250

chain length of the fluorotelomer varies widely. The perfluoroalkyl groups
formed by this process are usually, but
do not have to be, connected to the
polymer through a functionalized
ethylene group as indicated by the following structural diagram: (Rf-CH2CH2Anything).
Internal monomer unit means a monomer unit that is covalently bonded to
at least two other molecules. Internal
monomer units of polymer molecules
are chemically derived from monomer
molecules that have formed covalent
bonds between two or more other monomer molecules or other reactants.
Monomer means a chemical substance
that is capable of forming covalent
bonds with two or more like or unlike
molecules under the conditions of the
relevant
polymer-forming
reaction
used for the particular process.
Monomer Unit means the reacted form
of the monomer in a polymer.
Number-average
molecular
weight
means the arithmetic average (mean)
of the molecular weight of all molecules in a polymer.
Oligomer means a polymer molecule
consisting of only a few monomer units
(dimer, trimer, tetramer)
Other reactant means a molecule
linked to one or more sequences of
monomer units but which, under the
relevant reaction conditions used for
the particular process, cannot become
a repeating unit in the polymer structure.
Perfluoroalkyl
carboxylate
(PFAC)
means a group of saturated carbon
atoms covalently bonded to each other
in a linear, branched, or cyclic array
and covalently bonded to a carbonyl
moiety and where all carbon-hydrogen
(C-H) bonds have been replaced with
carbon-fluorine (C-F) bonds. The carbonyl moiety is also covalently bonded
to a hetero atom, typically, but not
necessarily oxygen (O) or nitrogen (N).
Perfluoroalkyl sulfonate (PFAS) means
a group of saturated carbon atoms
covalently bonded to each other in a
linear, branched, or cyclic array and
covalently bonded to a sulfonyl moiety
and where all carbon - hydrogen (C-H)
bonds have been replaced with carbon fluorine (C-F) bonds. The sulfonyl moiety is also covalently bonded to a

hetero atom, typically, but not necessarily oxygen (O) or nitrogen (N).
Polyester means a chemical substance
that meets the definition of polymer
and whose polymer molecules contain
at least two carboxylic acid ester linkages, at least one of which links internal monomer units together.
Polymer means a chemical substance
consisting of molecules characterized
by the sequence of one or more types of
monomer units and comprising a simple weight majority of molecules containing at least 3 monomer units which
are covalently bound to at least one
other monomer unit or other reactant
and which consists of less than a simple weight majority of molecules of the
same molecular weight. Such molecules must be distributed over a range
of molecular weights wherein differences in the molecular weight are
primarily attributable to differences in
the number of monomer units. In the
context of this definition, sequence
means that the monomer units under
consideration are covalently bound to
one another and form a continuous
string within the molecule, uninterrupted by units other than monomer
units.
Polymer molecule means a molecule
which contains a sequence of at least 3
monomer units which are covalently
bound to at least one other monomer
unit or other reactant.
Reactant means a chemical substance
that is used intentionally in the manufacture of a polymer to become chemically a part of the polymer composition.
Reactive functional group means an
atom or associated group of atoms in a
chemical substance that is intended or
can reasonably be anticipated to undergo further chemical reaction.
Reasonably anticipated means that a
knowledgeable person would expect a
given physical or chemical composition
or characteristic to occur based on
such factors as the nature of the precursors used to manufacture the polymer, the type of reaction, the type of
manufacturing process, the products
produced in polymerization, the intended uses of the substance, or associated use conditions.

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§ 723.250

40 CFR Ch. I (7–1–18 Edition)

(c) Applicability. This section applies
to manufacturers of new chemical substances that otherwise must submit a
premanufacture notice to EPA under
§ 720.22 of this chapter. New substances
are eligible for exemption under this
section if they meet the definition of
‘‘polymer’’ in paragraph (b) of this section, and the criteria in paragraph (e)
of this section, and if they are not excluded from the exemption under paragraph (d) of this section.
(d) Polymers that cannot be manufactured under this section—(1) Cationic
polymers. A polymer cannot be manufactured under this section if the polymer is a cationic polymer as defined
under paragraph (b) of this section or if
the polymer is reasonably anticipated
to become a cationic polymer in a natural aquatic environment (e.g., rivers,
lakes) unless:
(i) The polymer is a solid material
that is not soluble or dispersible in
water and will be used only in the solid
phase (e.g., polymers that will be used
as ion exchange beads), or
(ii) The combined (total) functional
group equivalent weight of cationic
groups in the polymer is equal to or
greater than 5,000.
(2) Elemental limitations. (i) A polymer
manufactured under this section must
contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.
(ii) A polymer cannot be manufactured under this section if it contains
as an integral part of its composition,
except as impurities, any elements
other than the following:
(A) The elements listed in paragraph
(d)(2)(i) of this section.
(B) Sodium, magnesium, aluminum,
potassium, calcium, chlorine, bromine,
and
iodine
as
the
monatomic
counterions Na = , Mg = 2, Al = 3, K = , Ca
= 2, Cl¥, Br¥, or I¥.
(C) Fluorine, chlorine, bromine, and
iodine covalently bound to carbon.
(D) Less than 0.20 weight percent of
any combination of the atomic elements lithium, boron, phosphorus, titanium, manganese, iron, nickel, copper,
zinc, tin, and zirconium.
(3) Polymers which degrade, decompose,
or depolymerize. A polymer cannot be
manufactured under this section if the

polymer is designed or is reasonably
anticipated to substantially degrade,
decompose, or depolymerize, including
those polymers that could substantially decompose after manufacture
and use, even though they are not actually intended to do so. For the purposes
of this section, degradation, decomposition, or depolymerization mean those
types of chemical change that convert
a polymeric substance into simpler,
smaller substances, through processes
including but not limited to oxidation,
hydrolysis, attack by solvents, heat,
light, or microbial action.
(4) Polymers manufactured or imported
from monomers and reactants not on the
TSCA Chemical Substance Inventory. A
polymer cannot be manufactured under
this section if the polymer being manufactured or imported is prepared from
monomers and/or other reactants (that
are either charged to the reaction vessel or incorporated in the polymer at
levels of greater than 2 weight percent)
that are not already included on the
TSCA Chemical Substance Inventory
or manufactured under an applicable
TSCA section 5 exemption.
(5) Water absorbing polymers with number average molecular weight (MW) 10,000
and greater. A polymer cannot be manufactured under this section if the
polymer being manufactured or imported is a water absorbing polymer
and has a number average MW greater
than or equal to 10,000 daltons. For purposes of this section, a water-absorbing
polymer is a polymeric substance that
is capable of absorbing its weight of
water.
(6) Polymers which contain certain
perfluoroalkyl moieties consisting of a
CF3- or longer chain length. Except as
provided in paragraph (d)(6)(i), after
February 26, 2010, a polymer cannot be
manufactured under this section if the
polymer contains as an integral part of
its composition, except as impurities,
one
or
more
of
the
following
perfluoroalkyl moieties consisting of a
CF3or
longer
chain
length:
Perfluoroalkyl
sulfonates
(PFAS),
perfluoroalkyl carboxylates (PFAC),
fluorotelomers,
or
perfluoroalkyl
moieties that are covalently bound to
either a carbon or sulfur atom where
the carbon or sulfur atom is an integral part of the polymer molecule.

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Environmental Protection Agency

§ 723.250
isocyanates
(including
ketoximeblocked
isocyanates),
thiols,
unconjugated
nitrile
groups,
and
halogens (except that reactive halogencontaining groups such as benzylic or
allylichalides cannot be included).
(B) The polymer has a combined
(total)
reactive
group
equivalent
weight greater than or equal to 1,000
for the following reactive functional
groups: acidhalides; acid anhydrides;
aldehydes,
hemiacetals;
methylolamides,- amines or,- ureas;
alkoxysilanes with alkoxy greater than
C2-alkoxysilanes; allyl ethers; conjugated olefins; cyanates; epoxides;
imines; or unsubstituted positions
ortho or para to phenolic hydroxyl; or
(C) If any reactive functional groups
not included in paragraph (e)(1)(ii)(A)
and (B) of this section are present, the
combined (total) reactive group equivalent weight, including any groups listed in paragraph (e)(1)(ii)(B), is greater
than or equal to 5,000.
(2) Polymers with number average MW
greater than or equal to 10,000 (and
oligomer content less than 2 percent below
MW 500 and less than 5 percent below
MW 1,000) . The polymer must have a
number average MW greater than or
equal to 10,000 daltons and contain less
than 2 percent oligomeric material
below MW 500 and less than 5 percent
oligomeric material below MW 1000.
(3) Polyester polymers. The polymer is
a polyester as defined in paragraph (b)
of this section and is manufactured
solely from one or more of the
reactants in the following table 1:

(i) Any polymer that has been manufactured previously in full compliance
with the requirements of this section
prior to February 26, 2010 may no
longer be manufactured under this section after January 27, 2012.
(ii) [Reserved]
(e) Exemption criteria. To be manufactured under this section, the polymer
must meet one of the following criteria:
(1) Polymers with number average MW
greater than or equal to 1,000 and less
than 10,000 daltons (and oligomer content
less than 10 percent below MW 500 and
less than 25 percent below MW 1,000). (i)
The polymer must have a number average MW greater than or equal to 1,000
and less than 10,000 daltons and contain
less than 10 percent oligomeric material below MW 500 and less than 25 percent oligomeric material below MW
1,000.
(ii) The polymer cannot contain reactive functional groups unless it meets
one of the following criteria:
(A) The polymer contains only the
following reactive functional groups:
carboxylic
acid
groups,
aliphatic
hydroxyl groups, unconjugated olefinic
groups that are considered ‘‘ordinary,’’(i.e., not specially activated either by being part of a larger functional group, such as a vinyl ether, or
by other activating influences, e.g.,
strongly electron-withdrawing sulfone
group with which the olefinic groups
interact), butenedioic acid groups,
those conjugated olefinic groups contained in naturally-occurring fats, oils,
and
carboxylic
acids,
blocked

TABLE 1—LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE

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Reactant

CAS No.

Monobasic Acids and Natural Oils
Benzoic acid ...................................................................................................................................................
Canola oil .......................................................................................................................................................
Coconut oil .....................................................................................................................................................
Corn oil ...........................................................................................................................................................
Cottonseed oil ................................................................................................................................................
Dodecanoic acid .............................................................................................................................................
Fats and glyceridic oils, anchovy ...................................................................................................................
Fats and glyceridic oils, babassu ..................................................................................................................
Fats and glyceridic oils, herring .....................................................................................................................
Fats and glyceridic oils, menhaden ...............................................................................................................
Fats and glyceridic oils, sardine ....................................................................................................................
Fats and glyceridic oils, oiticica .....................................................................................................................
Fatty acids,C16-18 and C18-unsatd. .................................................................................................................
Fatty acids, castor-oil .....................................................................................................................................
Fatty acids, coco ............................................................................................................................................
Fatty acids, dehydrated castor-oil ..................................................................................................................
Fatty acids, linseed oil ...................................................................................................................................
Fatty acids, safflower oil.

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65–85–0
120962–03–0
8001–31–8*
8001–30–7*
8001–29–4*
143–07–7
128952–11–4*
91078–92–1*
68153–06–0*
8002–50–4*
93334–41–9*
8016–35–1*
67701–08–0*
61789–44–4*
61788–47–4*
61789–45–5*
68424–45–3*

§ 723.250

40 CFR Ch. I (7–1–18 Edition)

TABLE 1—LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE—Continued

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Reactant

CAS No.

Fatty acids, soya ............................................................................................................................................
Fatty acids, sunflower oil ...............................................................................................................................
Fatty acids, sunflower-oil, conjugated ............................................................................................................
Fatty acids, tall-oil ..........................................................................................................................................
Fatty acids, tall-oil, conjugated*.
Fatty acids, vegetable oil ...............................................................................................................................
Glycerides, C16-18 and C18-unsatd. ................................................................................................................
Heptanoic acid ...............................................................................................................................................
Hexanoic acid ................................................................................................................................................
Hexanoic acid, 3,3,5-trimethyl- ......................................................................................................................
Linseed oil ......................................................................................................................................................
Linseed oil, oxidized ......................................................................................................................................
Nonanoic acid ................................................................................................................................................
Oils, Cannabis*.
Oils, palm kernel ............................................................................................................................................
Oils, perilla .....................................................................................................................................................
Oils, walnut ....................................................................................................................................................
Safflower oil ...................................................................................................................................................
Soybean oil ....................................................................................................................................................
Sunflower oil ..................................................................................................................................................
Tung oil ..........................................................................................................................................................
Di and Tri Basic Acids:
1,2-Benzenedicarboxylic acid ........................................................................................................................
1,3-Benzenedicarboxylic acid ........................................................................................................................
1,3-Benzenedicarboxylic acid, dimethyl ester ................................................................................................
1,4-Benzenedicarboxylic acid ........................................................................................................................
1,4-Benzenedicarboxylic acid, diethyl ester ...................................................................................................
1,4-Benzenedicarboxylic acid, dimethyl ester ................................................................................................
1,2,4-Benzenetricarboxylic acid .....................................................................................................................
Butanedioic acid .............................................................................................................................................
Butanedioic acid, diethyl ester .......................................................................................................................
Butanedioic acid, dimethyl ester ....................................................................................................................
2-Butenedioic acid (E)– ..................................................................................................................................
Decanedioic acid ............................................................................................................................................
Decanedioic acid, diethyl ester ......................................................................................................................
Decanedioic acid, dimethyl ester ...................................................................................................................
Dodecanedioic acid ........................................................................................................................................
Fatty acids, C18-unsatd., dimers ....................................................................................................................
Heptanedioic acid ..........................................................................................................................................
Heptanedioic acid, dimethyl ester ..................................................................................................................
Hexanedioic acid ............................................................................................................................................
Hexanedioic acid, dimethyl ester ...................................................................................................................
Hexanedioic acid, diethyl ester ......................................................................................................................
Nonanedioic acid ...........................................................................................................................................
Nonanedioic acid, dimethyl ester ...................................................................................................................
Nonanedioic acid, diethyl ester ......................................................................................................................
Octanedioic acid .............................................................................................................................................
Octanedioic acid, dimethyl ester ....................................................................................................................
Pentanedioic acid ...........................................................................................................................................
Pentanedioic acid, dimethyl ester ..................................................................................................................
Pentanedioic acid, diethyl ester .....................................................................................................................
Undecanedioic acid ........................................................................................................................................
Polyols
1,3-Butanediol ................................................................................................................................................
1,4-Butanediol ................................................................................................................................................
1,4-Cyclohexanedimethanol ...........................................................................................................................
1,2-Ethanediol ................................................................................................................................................
Ethanol, 2,2′-oxybis- ......................................................................................................................................
1,6-Hexanediol ...............................................................................................................................................
1,3-Pentanediol, 2,2,4-trimethyl- ....................................................................................................................
1,2-Propanediol, .............................................................................................................................................
1,3-Propanediol, 2,2-bis(hydroxymethyl)- ......................................................................................................
1,3-Propanediol, 2,2-dimethyl- .......................................................................................................................
1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)- ..................................................................................................
1,3-Propanediol, 2-(hydroxymethyl)-2-methyl- ...............................................................................................
1,3-propanediol, 2-methyl ..............................................................................................................................
1,2,3-Propanetriol ...........................................................................................................................................
1,2,3-Propanetriol, homopolymer ...................................................................................................................
2-Propen-1-ol, polymer with ethenylbenzene ................................................................................................
Modifiers
Acetic acid, 2,2′-oxybis- .................................................................................................................................

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68308–53–2*
84625–38–7*
68953–27–5*
61790–12–3*
61788–66–7*
67701–30–8*
111–14–8
142–62–1
3302–10–1
8001–26–1*
68649–95–6*
112–05–0
8023–79–8*
68132–21–8*
8024–09–7
8001–23–8*
8001–22–7*
8001–21–6*
8001–20–5*
88–99–3
121–91–5
1459–93–4
100–21–0
636–09–9
120–61–6
528–44–9
110–15–6
123–25–1
106–65–0
110–17–8
111–20–6
110–40–7
106–79–6
693–23–2
61788–89–4*
111–16–0
1732–08–7
124–04–9
627–93–0
141–28–6
123–99–9
1732–10–1
624–17–9
(505–48–6)
1732–09–8
(110–94–1)
1119–40–0
818–38–2
1852–04–6
107–88–0
110–63–4
105–08–8
107–21–1
111–46–6
629–11–8
144–19–4
57–55–6
115–77–5
126–30–7
77–99–6
77–85–0
2163–42–0
56–81–5
25618–55–7
25119-62–4
110–99–6

Environmental Protection Agency

§ 723.250

TABLE 1—LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE—Continued
Reactant

CAS No.

1-Butanol ........................................................................................................................................................
Cyclohexanol ..................................................................................................................................................
Cyclohexanol, 4,4′-(1-methylethylidene)bis- ..................................................................................................
Ethanol, 2-(2-butoxyethoxy)- ..........................................................................................................................
1-Hexanol .......................................................................................................................................................
Methanol, hydrolysis products with trichlorohexylsilane and trichlorophenylsilane .......................................
1-Phenanthrenemethanol, tetradecahydro-1,4a-dimethyl-7-(1-methylethyl)- ................................................
Phenol,
4,4′-(1-methylethylidene)bis-,
polymer
with
2,2′[(1-methylethylidene)bis(4,1phenyleneoxymethylene)] bis[oxirane].
Siloxanes and Silicones, di-Me, di-Ph, polymers with Ph silsesquioxanes, methoxy-terminated .................
Siloxanes and Silicones, di-Me, methoxy Ph, polymers with Ph silsesquioxanes, methoxy-terminated ......
Siloxanes and Silicones, Me Ph, methoxy Ph, polymers with Ph silsesquioxanes, methoxy- and Ph-terminated.
Silsesquioxanes, Ph Pr ..................................................................................................................................

71–36–3**
108–93–0
80–04–6
112–34–5
111–27–3
72318–84–4*
13393–93–6
25036-25–3
68440–65–3*
68957–04–0*
168957–06–2*
168037–90–1*

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* Chemical substance of unknown or variable composition,complex reaction products, and biological materials (UVCB). The
CAS Registry Numbers for UVCB substances are not used in CHEMICAL ABSTRACTS and its indexes.
** These substances may not be used in a substance manufactured from fumaric or maleic acid because of potential risks associated with esters, which may be formed by reaction of these reactants.

(f) Exemption report for polymers manufactured under the terms of this section.
For substances exempt under paragraphs (e)(1), (e)(2), and (e)(3) of this
section a report of manufacture or import must be submitted (postmarked)
by January 31 of the year subsequent
to initial manufacture. The notice
must include:
(1) Manufacturer’s name. This includes
the name and address of the manufacturer and the name and telephone number of a technical contact.
(2) Number of substances manufactured.
Number of substances manufactured.
The manufacturer must identify the
number of polymers manufactured
under terms of the exemption for the
first time in the year preceding the notice.
(g) Chemical identity information. For
substances exempt under paragraph (e)
of this section the manufacturer must
to the extent known to or reasonably
ascertainable by the manufacturer
identify the following and maintain the
records in accordance with paragraph
(j) of this section:
(1) A specific chemical name and CAS
Registry Number (or EPA assigned Accession Number) for each ‘‘reactant,’’
as that term is defined in paragraph (b)
of this section, used at any weight in
the manufacture of the polymer. For
purposes of determining chemical identity, the manufacturer may determine
whether a reactant is used at greater
than two weight percent according to
either the weight of the reactant
charged to the reaction vessel or the

weight of the chemically combined (incorporated) reactant in the polymer.
Manufacturers who choose the ‘‘incorporated’’ method must have analytical
data, or theoretical calculations (if it
can be documented that an analytical
determination cannot be made or is not
necessary), to demonstrate compliance
with this paragraph. Reactants that introduce into the polymer elements,
properties, or functional groups that
would render the polymer ineligible for
the exemption are not allowed at any
level.
(2) A representative structural diagram, if possible.
(h) Certification. To manufacture a
substance under the terms of this section, a manufacturer must as of the
date of first manufacture, make the
following certification statements and
maintain them in accordance with
paragraph (j) of this section:
(1) The substance is manufactured or
imported for a commercial purpose
other than for research and development.
(2) All information in the certification is truthful.
(3) The new chemical substance
meets the definition of a polymer, is
not specifically excluded from the exemption in paragraph (d) of this section, and meets the conditions of the
exemption in paragraph (e) of this section.
(i) Exemptions granted under superseded regulations. Manufacturers granted exemptions under the superseded requirements of § 723.250 (as in effect on

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§ 723.250

40 CFR Ch. I (7–1–18 Edition)

May 26, 1995) shall either continue to
comply with those requirements or follow all procedural and recordkeeping
requirements pursuant to this section.
If an exemption holder continues to
follow the superseded regulations, the
Notice of Commencement requirements
apply and the exempt polymer will
continue to be listed on the Inventory
with exclusion criteria and exemption
category restrictions on residual monomer/reactant and low molecular
weight species content limitations.
(j) Recordkeeping. (1) A manufacturer
of a new polymer under paragraphs (e)
of this section, must retain the records
described in this paragraph at the manufacturing site for a period of 5 years
from the date of commencement of
manufacture or import.
(2) The records must include the following to demonstrate compliance with
the terms of this section:
(i) Chemical identity information as
required in paragraph (g) of this section.
(ii) Information to demonstrate that
the new polymer is not specifically excluded from the exemption.
(iii) Records of production volume for
the first 3 years of manufacture and
the date of commencement of manufacture.
(iv) Information to demonstrate that
the new polymer meets the exemption
criteria in paragraphs (e)(1), (e)(2), or
(e)(3) of this section.
(v) Analytical data, or theoretical
calculations (if it can be documented
that an analytical determination cannot be made or is not necessary), to
demonstrate that the polymer meets
the number-average MW exemption criteria in paragraphs (e)(1) or (e)(2) of
this section. The analytical tests may
include
gel
permeation
chromatography (GPC).vapor pressure osmometry (VPO), or other such tests which
will demonstrate that the polymer
meets the number-average MW criterion.
(vi) Analytical data, or theoretical
calculations (if it can be documented
that an analytical determination cannot be made or is not necessary), to
demonstrate that the polymer meets
the criteria in paragraphs (e)(1) or
(e)(2) of this section, meets the low MW

content criteria in paragraphs (e)(1) or
(e)(2) of this section.
(vii) If applicable, analytical data, or
theoretical calculations (if it can be
documented that an analytical determination cannot be made or is not necessary) required in paragraph (g) of
this section for determining monomers
or reactants charged to the reaction
vessel at greater than 2 weight percent
but incorporated at 2 weight percent or
less in the manufactured polymer.
(viii) The certification statements as
required under paragraph (h) of this
section.
(3) The manufacturer must submit
the records listed in paragraph (j)(2) of
this section to EPA upon written request by EPA. The manufacturer must
provide these records within 15 working days of receipt of this request. In
addition, any person who manufactures
a new chemical substance under the
terms of this section, upon request of
EPA, must permit such person at all
reasonable times to have access to and
to copy these records.
(k) Submission of information. Information submitted to EPA under this
section must be sent in writing to:
TSCA Document Control Officer, (7407),
Office of Pollution Prevention and
Toxics,
Environmental
Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
(l) Compliance. (1) A person who manufactures or imports a new chemical
substance and fails to comply with any
provision of this section is in violation
of section 15 of the Act (15 U.S.C. 2614).
(2) 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 the Act is a violation of section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to establish and
maintain records or to permit access to
or copying of records, as required by
this section and section 11 of the Act,
is a violation of section 15 of the Act
(15 U.S.C. 2614).
(4) Failure or refusal to permit entry
or inspection as required by section 11
of the Act is a violation of section 15 of
the Act (15 U.S.C. 2614).
(5) Violators may be subject to the
civil and criminal penalties in section

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Environmental Protection Agency

Pt. 725
Subpart B—Administrative Procedures

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 section may be
subject to penalties calculated as if
they never filed their notices.
(6) EPA may seek to enjoin the manufacture or processing of a chemical
substance in violation of this section
or act to seize any chemical substance
manufactured or processed in violation
of this section or take other actions
under the authority of section 7 of the
Act (15 U.S.C. 2606) or section 17 of the
Act (15 U.S.C. 2616).
(m) Inspections. EPA will conduct inspections under section 11 of the Act to
assure compliance with section 5 and
this section, to verify that information
submitted to EPA under this section is
true and correct, and to audit data submitted to EPA under this section.
(n) Confidentiality. If a manufacturer
submits information to EPA under this
section which the manufacturer claims
to be confidential business information, the manufacturer must clearly
identify the information at the time of
submission to EPA by bracketing, circling, or underlining it and stamping it
with ‘‘CONFIDENTIAL’’ or some other
appropriate designation. Any information so identified will be treated in accordance with the procedures in 40 CFR
part 2. Any information not claimed
confidential at the time of submission
may be made available to the public
without further notice.

725.20 Scope and purpose.
725.25 General administrative requirements.
725.27 Submissions.
725.28 Notice that submission is not required.
725.29 EPA acknowledgement of receipt of
submission.
725.32 Errors in the submission.
725.33 Incomplete submissions.
725.36 New information.
725.40 Notice in the Federal Register.
725.50 EPA review.
725.54 Suspension of the review period.
725.56 Extension of the review period.
725.60 Withdrawal of submission by the submitter.
725.65 Recordkeeping.
725.67 Applications to exempt new microorganisms from this part.
725.70 Compliance.
725.75 Inspections.

Subpart C—Confidentiality and Public
Access to Information
725.80 General provisions for confidentiality
claims.
725.85 Microorganism identity.
725.88 Uses of a microorganism.
725.92 Data from health and safety studies
of microorganisms.
725.94 Substantiation requirements.
725.95 Public file.

Subpart D—Microbial Commercial
Activities Notification Requirements
725.100 Scope and purpose.
725.105 Persons who must report.
725.110 Persons not subject to this subpart.
725.150 Procedural requirements for this
subpart.
725.155 Information to be included in the
MCAN.
725.160 Submission of health and environmental effects data.
725.170 EPA review of the MCAN.
725.190 Notice of commencement of manufacture or import.

[60 FR 16332, Mar. 29, 1995, as amended at 62
FR 17932, Apr. 11, 1997; 75 FR 4305, Jan. 27,
2010]

PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES
FOR MICROORGANISMS

Subpart E—Exemptions for Research and
Development Activities

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Subpart A—General Provisions and
Applicability

725.200 Scope and purpose.
725.205 Persons who may report under this
subpart.
725.232 Activities subject to the jurisdiction
of other Federal programs or agencies.
725.234 Activities conducted inside a structure.
725.235 Conditions of exemption for activities conducted inside a structure.
725.238 Activities conducted outside a structure.
725.239 Use of specific microorganisms in
activities conducted outside a structure.

Sec.
725.1 Scope and purpose.
725.3 Definitions.
725.8 Coverage of this part.
725.12 Identification of microorganisms for
Inventory and other listing purposes.
725.15 Determining
applicability
when
microorganism identity or use is confidential or uncertain.
725.17 Consultation with EPA.

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