Document ID: EPA-HQ-OPPT-2010-1011-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-08-03T04:00Z

Attachment E

40 CFR Part 723

40 CFR  Protection of Environment 

CHAPTER I

ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

SUBCHAPTER R -- TOXIC SUBSTANCES CONTROL ACT 

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 

(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. 604(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. 

(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
short-term 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 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). 

(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: 

(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 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 the EPA at least 30 days before manufacture of the
new chemical substance begins. The notice must be sent in writing to:
TSCA Document Control Officer (7407), Office of Pollution Prevention and
Toxics, U.S. Environmental Protection Agency, Room G-099, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The date of submission
will be the date on which the notice is received by the TSCA

Document Control Officer. EPA will acknowledge the receipt of the notice
by letter. The letter will identify the date on which the review period
begins. The notice shall be submitted using EPA Form No. 7710-25 ("the
PMN form"), which may be obtained from EPA by writing the Environmental
Assistance Division, (7408), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, or

by calling the TSCA Assistance Information Service at (202) 554-1404;
TDD (202) 554-0551; online service modem (202) 554-5603. 

(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. 

(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 manufacturer 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 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 Prevention, Pesticides, and Toxic
Substances ("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 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 non-volatile 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. 

(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 may be submitted on EPA form 7710-56 "Notice of
Commencement of Manufacture;" however, the manufacturer must add the
statement required under paragraph (j)(6)(ii)(A) of this section that
the notification is an amendment to the original exemption. 

(C) The notification must contain an original signature of an authorized
official of the manufacturer. 

(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
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 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, April 11, 1997; 64 FR 31989, June 15, 1999]

(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.

(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 peel-apart 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. 

(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 &mu;g/m 3 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 &mu;g/m 3 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-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. 

(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
peel-apart 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 chemical 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 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 diagram (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 chemical 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
physical-chemical properties of the new chemical substance. Where
specific physical-chemical 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 peel-apart 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 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 (7407), Office of Pollution Prevention and Toxics, U.S.
Environmental Protection Agency, Room G-099,  1200 Pennsylvania Ave.,
NW., Washington, DC 20460. 

(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. 

(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, April 11, 1997; 68 FR 906, Jan. 7,
2003] 

(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: 

(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. 

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. 

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. 

(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. 

(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 isocyanates (including ketoxime-blocked isocyanates), thiols,
unconjugated nitrile groups, and halogens (except that reactive
halogen-containing 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: 

       Table 1_ List of Reactants From Which Polyester May be Made

------------------------------------------------------------------------

                  Reactant                             CAS No.

------------------------------------------------------------------------

                    Monobasic Acids and Natural Oils

Benzoic acid.............................  	65-85-0

Canola oil...............................  	120962-03-0

Coconut oil..............................  	8001-31-8*

Corn oil.................................  	8001-30-7*

Cottonseed oil...........................  	8001-29-4*

Dodecanoic acid..........................  	143-07-7

Fats and glyceridic oils, anchovy....... 128952-11-4*

Fats and glyceridic oils, babassu........ 91078-92-1*

Fats and glyceridic oils, herring........  68153-06-0*

Fats and glyceridic oils, menhaden.....8002-50-4*

Fats and glyceridic oils, sardine........  93334-41-9*

Fats and glyceridic oils, oiticica.......   8016-35-1*

Fatty acids,C[INF]16-18[/INF] and     67701-08-0*

   C[INF]18[/INF]-unsatd..

Fatty acids, castor-oil.................. 	 61789-44-4*

Fatty acids, coco........................ 	 61788-47-4*

Fatty acids, dehydrated castor-oil....... 61789-45-5*

Fatty acids, linseed oil.................  	 68424-45-3*

Fatty acids, safflower oil...............

Fatty acids, soya........................  	 68308-53-2*

Fatty acids, sunflower oil...............  	 84625-38-7*

Fatty acids, sunflower-oil, conjugated.68953-27-5*

Fatty acids, tall-oil....................  	 61790-12-3*

Fatty acids, tall-oil, conjugated*.......

Fatty acids, vegetable oil...............  	 61788-66-7*

Glycerides, C[INF]16-18[/INF] and    67701-30-8*

   C[INF]18[/INF]-unsatd..

Heptanoic acid...........................   	 111-14-8

Hexanoic acid............................   	 142-62-1

Hexanoic acid, 3,3,5-trimethyl-.........  3302-10-1

Linseed oil..............................  	 8001-26-1*

Linseed oil, oxidized....................  	 68649-95-6*

Nonanoic acid............................  	 112-05-0

Oils, Cannabis*..........................

Oils, palm kernel........................  	 8023-79-8*

Oils, perilla............................  	 68132-21-8*

Oils, walnut.............................  	 8024-09-7

Safflower oil............................  	 8001-23-8*

Soybean oil..............................  	 8001-22-7*

Sunflower oil............................  	 8001-21-6*

Tung oil.................................  	 8001-20-5*

   1  1  Di and Tri Basic Acids:...........

1,2-Benzenedicarboxylic acid............. 88-99-3

1,3-Benzenedicarboxylic acid............. 121-91-5

1,3-Benzenedicarboxylic acid, 	  1459-93-4

   diethyl ester.

1,4-Benzenedicarboxylic acid............  100-21-0

1,4-Benzenedicarboxylic acid,      	  636-09-9

   diethyl ester.

1,4-Benzenedicarboxylic acid,     	  120-61-6

   dimethyl ester.

1,2,4-Benzenetricarboxylic acid........   528-44-9

Butanedioic acid.........................          110-15-6

Butanedioic acid, diethyl ester..........   123-25-1

Butanedioic acid, dimethyl ester........  106-65-0

2-Butenedioic acid (E)-..................      110-17-8

Decanedioic acid.........................         111-20-6

Decanedioic acid, diethyl ester..........   110-40-7

Decanedioic acid, dimethyl ester........ 106-79-6

Dodecanedioic acid.......................       693-23-2

Fatty acids, C[INF]18[/INF]-unsatd.,   61788-89-4*

   dimers.

Heptanedioic acid........................         111-16-0

Heptanedioic acid, dimethyl ester......  1732-08-7

Hexanedioic acid.........................         124-04-9

Hexanedioic acid, dimethyl ester.......   627-93-0

Hexanedioic acid, diethyl ester..........   141-28-6

Nonanedioic acid.........................  	  123-99-9

Nonanedioic acid, dimethyl ester.......   1732-10-1

Nonanedioic acid, diethyl ester..........   624-17-9

Octanedioic acid.........................         (505-48-6)

Octanedioic acid, dimethyl ester......... 1732-09-8

Pentanedioic acid........................ .......  1119-40-0

Pentanedioic acid, diethyl ester.........    818-38-2

Undecanedioic acid.......................        1852-04-6

                                 Polyols

1,3-Butanediol...........................  	   107-88-0

1,4-Butanediol...........................  	   110-63-4

1,4-Cyclohexanedimethanol................  105-08-8

1,2-Ethanediol...........................  	   107-21-1

Ethanol, 2,2[prime]-oxybis-..............     111-46-6

1,6-Hexanediol...........................  	    629-11-8

1,3-Pentanediol, 2,2,4-trimethyl-........    144-19-4

1,2-Propanediol,.........................  	     57-55-6

1,3-Propanediol, 2,2-bis(hydroxymethyl)-. 115-77-5

1,3-Propanediol, 2,2-dimethyl-...........     126-30-7

1,3-Propanediol, 2-ethyl-2-                      77-99-6

   (hydroxymethyl)-.

1,3-Propanediol, 2-(hydroxymethyl)-2-   77-85-0

   methyl-.

1,3-propanediol, 2-methyl................        2163-42-0

1,2,3-Propanetriol.......................              56-81-5

1,2,3-Propanetriol, homopolymer..........   25618-55-7

2-Propen-1-ol, polymer with                     25119-62-4

   ethenylbenzene.

                                Modifiers

Acetic acid, 2,2[prime]-oxybis-..........  110-99-6

1-Butanol................................               71-36-3**

Cyclohexanol.............................            108-93-0

Cyclohexanol, 4,4[prime]-(1-                80-04-6

   methylethylidene)bis-.

Ethanol, 2-(2-butoxyethoxy)-.............    112-34-5

1-Hexanol................................  	    111-27-3

Methanol, hydrolysis products with        72318-84-4*

   trichlorohexylsilane and

   trichlorophenylsilane.

1-Phenanthrenemethanol, tetradecahydro- 13393-93-6

   1,4a-dimethyl-7-(1-methylethyl)-.

Phenol, 4,4[prime]-(1-                              25036-25-3

   methylethylidene)bis-, polymer with

   2,2[prime]- [(1-methylethylidene)bis(4,1-

   phenyleneoxymethylene)] bis[oxirane].

Siloxanes and Silicones, di-Me, di-Ph,     68440-65-3*

   polymers with Ph silsesquioxanes,

   methoxy-terminated.

Siloxanes and Silicones, di-Me, methoxy 68957-04-0*

   Ph, polymers with Ph silsesquioxanes,

   methoxy-terminated.

Siloxanes and Silicones, Me Ph, methoxy  \1\68957-06-2*

   Ph, polymers with Ph silsesquioxanes,

   methoxy- and Ph-terminated.

Silsesquioxanes, Ph Pr...................            \1\68037-90-1*

------------------------------------------------------------------------

[SU]*[/SU] 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.

[SU]**[/SU] 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 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 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. 

 

[60 FR 16332, Mar. 29, 1995, as amended at 62 FR 17932, April 11, 1997]