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Title 40: Protection of Environment

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PART 723—PREMANUFACTURE NOTIFICATION EXEMPTIONS 

Section Contents

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.

§ 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] 

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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. 

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(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. 

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(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 

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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 

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Officer, Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), 

Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. 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 the Environmental Assistance Division (7408M), Office of Pollution 

Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone number: (202) 554–1404; e-mail address: TSCAHotline@epa.gov . 

(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 

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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 

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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 

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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 EPAdesignated 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 

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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 

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“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; 71 FR 33642, June 12, 2006] 

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§ 723.175 Chemical substances used in or for the manufacture or processing of 

instant photographic and peel-apart film articles. 

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(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 

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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 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 

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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-

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, 

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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. 

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(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 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 substance's physicalchemical 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 physical-chemical properties of the new 

chemical substance. Where specific physical-chemical data are not available, reasonable estimates and 

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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 (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. 

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(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; 71 FR 33642, June 12, 2006] 

§ 723.250 Polymers. 

 top

(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. 

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(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. 

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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: 

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(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*

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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,C16-18and C18-unsatd. 67701–

08–0*

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, C16-18and C18-unsatd. 67701–

30–8*

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

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Safflower oil 8001–23–

8*

Soybean oil 8001–22–

7*

Sunflower oil 8001–21–

6*

Tung oil 8001–20–

5*

Di and Tri Basic Acids:

1,2-Benzenedicarboxylic acid 88–99–3

1,3-Benzenedicarboxylic acid 121–91–5

1,3-Benzenedicarboxylic acid, dimethyl ester 1459–93–

4

1,4-Benzenedicarboxylic acid 100–21–0

1,4-Benzenedicarboxylic acid, diethyl ester 636–09–9

1,4-Benzenedicarboxylic acid, dimethyl ester 120–61–6

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, C18-unsatd., dimers 61788–

89–4*

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 (110–94–

1)

Pentanedioic acid, dimethyl ester 1119–40–

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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′-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-(hydroxymethyl)- 77–99–6

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

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 ethenylbenzene 25119-62–

4

Modifiers

Acetic acid, 2,2′-oxybis- 110–99–6

1-Butanol 71–36–3**

Cyclohexanol 108–93–0

Cyclohexanol, 4,4′-(1-methylethylidene)bis- 80–04–6

Ethanol, 2-(2-butoxyethoxy)- 112–34–5

1-Hexanol 111–27–3

Methanol, hydrolysis products with trichlorohexylsilane and 

trichlorophenylsilane

72318–

84–4*

1-Phenanthrenemethanol, tetradecahydro-1,4a-dimethyl-7-

(1-methylethyl)-

13393–

93–6

Phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2,2′- [(1-

methylethylidene)bis(4,1-phenyleneoxymethylene)] bis

[oxirane]

25036-25–

3

Siloxanes and Silicones, di-Me, di-Ph, polymers with Ph 

silsesquioxanes, methoxy-terminated

68440–

65–3*

Siloxanes and Silicones, di-Me, methoxy Ph, polymers with 

Ph silsesquioxanes, methoxy-terminated

68957–

04–0*

Siloxanes and Silicones, Me Ph, methoxy Ph, polymers with 

Ph silsesquioxanes, methoxy- and Ph-terminated

168957–

06–2*

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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 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 

Silsesquioxanes, Ph Pr 168037–

90–1*

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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 

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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] 

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