Attachment E 40 CFR Part 72340 CFR Protection of Environment CHAPTER I ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SUBCHAPTER R -- TOXI C SUBSTANCES CONTROLACT PART 723 -- PREMANUFACTURE NOTIFI CATI ON EXEMPTIONS Subpart A [Reserved] Sub part B -- Specific Exemptions Sec. 723.50 Chemical substances manufactured in quantities of 10,000 kilograms or less per ye ar, 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 Poly

mers. Authority : 15 U.S.C. 2604.

Subpart A [Reserved] Subpart B -- Specific Exemptions ' 7 23.50 Chemical substances manufactured in quantities of 10,000 kilograms or less per ye ar, 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 ye ar. (ii) Chemical substances with low envi ronmental 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 day s before manufacture begins, as required under paragraph (e) o f 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 S ubstances 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 an y personal use or enjo ym ent.(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 comp ound that changes the molecular identity of the parent compound. (5) Metabolite means a chemical entity produced by

one or more enzy

matic or nonenzy

matic reactions as a result of exposure of an organism to a chemical substance. (6) Serious acute effect s 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, dis figurement, 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 abil ity to use a normal bodil y or intellectual function with a consequent impairment of normal activities. (8) Significant environmental effects means: (i) An y 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 ye ar; or (iii) Any known or reasonably

anticipated los s 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 conti guous propert y unit. Property divided onl y b y a public right - of - way is one site. There may

be more than one manufacturing plant on a single site. (10) The terms by

product, EPA, importer, impurity , known to or reasonably ascertainable, manufacture, manufa cturer, 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) An y manufac turer of a new chemical substance manufactured in quantities of 10,000 kilograms or less per ye ar under the terms of this exemption. (2) An y 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 ye ar (estimated average dosage resulting from drinking water exposure in s treams 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 relea ses, 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 he alth 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 day s per y ear) 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 c hemical 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, an y reasonab ly anticipated metabolites, environmental transformation products, or by products of the substance, or any reasonabl y 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 applyi ng 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 day s before manufacture of the new chemical substance begins. The notice must be sent in writing to: TSCA Document Control Of ficer (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 b y the TSCA Document Contr ol 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 Penns yl vania 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 s ynon ym s or trade names ( ' 720.45(c)). (v) By products ( ' 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 rathe r 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 pur suant 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 an y 12 - month period during the first 3 ye ars 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/environmentalrelease 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 kn own 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 E nvironmental 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 generall y appl y "bounding estimates" (i.e., exposure estim ates higher than those incurred by persons in the population with the highest exposure) to account for uncertainties in actual exposure and release scenarios. (ix) Ty pe and category

of notice. The manufacturer must clearl y indicate on the first page of th e 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 manufacture d under paragraph (c)(1) of this section, the manufacturer intends to commence manufacture of the exempted substance for commercial purposes within 1 y ear of the date of the expiration of the 30 - day review period. (xii) Sanitized copy

of notice. (A) Th e manufacturer must make all claims of confidentiality in accordance with paragraph (l) of this section. I f any

information is claimed confidential, the manufacturer must submit a second copy of the notice, with all information claimed as confidential dele ted, 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 inf ormation required under this paragraph (e) of this section, the submission will be determined to be incomplete b y EPA. When a submission for a new chemical substance has been determined to be incomplete, a manufacturer reappl yi ng for an exemption for the n ew 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 n otices 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

appl y for an exemption under paragraph (c)(1) or (c)(2) of this section; however, EPA will not approve an y subsequent exemption application under p aragraph (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 currentl y holds an exemption, and that proposed denial is based exclusively on the cumulative human exposure or environmental rele ase 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 day s 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 y ear 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 eli gible for the exemption. The review period will end 30 day s after receipt of the notice by the TSCA Document Control Officer. To provide additional time to address an y 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 th e 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 b y telephon e that the substance is not eligible. This telephone notification will subsequently be confirmed b y certified letter that identifies the reasons for the ineligibility determination. The manufacturer may

not begin manufacture of the new chemical substance w ithout 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 an y time after the review period specified in paragraph(g) of this s ection 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 b y 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 object ions 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 determinati on 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 day s 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 day s of receipt of the objections or explanation, and subsequently by certified letter. (iv) If the Assistant Administrator determin es 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 Admin istrator 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 an y continu ing manufacture, processing, distribution in commerce, and use of the new chemical substance within 7 day s of the written notification under paragraph (h)(2)(iii) of this section. The manufacturer may

not resume manufacture, processing, distribution in co mmerce, 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 chemi cal 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 ne w chemical substance if: (A) It was actuall y 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) Itsubmits a notice on the new chemical substance under section 5(a)(1) of the Act and part720 of this chapter within 15 day s of receipt of the written notification under paragraph

(h)(2)(iii) of this section. Such manufacture, processing, distribution in commerce, and use may c ontinue 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 unde r 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 day s 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 significantl y more complete the information included in the notice, the submitter must send that information to the address listed on the notice form within 10 day s of receiving the new information, but no later than 5 day s 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 day s of the notice review period, the submitter must immediately inform its EPA contact for th at notice b y 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 phy sical 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 phy sical form described in the no tice under paragraph (e), or in a ph ys ical 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 ph ys ical form (e.g., a manufacturer which s pecifies that the new chemical substance will be produced in a non - volatile liquid form generall y ma y not change to a respirable powder form). (3) The annual production volume of chemical substances manufactured under paragraph (c)(1) of this section fo r 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) An y 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 previousexemption 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 phy sical form different than that phy sical 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 ph ys ical form approved in the previous notice. (v) Manufacturing the c hemical substance in annual production volumes above any volume designated b y 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, mus t 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, manufact ure 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 e qual 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 m aintains 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 b y the Agency in writing o r 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 day s 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, an y claim of confidentiality , and a statement that the notification is an amendm ent to the original exemption application under the terms of thissection.

(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 an y controls specified in the exemption notice. The manufacturer may notify processors and industrial users by means of a container labeling s ys tem, written notification, or any other method that adequatel y inform s 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 onl y 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 ph ys ical 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 immediatel y unless the manufacturer is able to document each of the following: (i) That the manufacturer has, within 5 working day s, notified the customer in writing that the customer ha s 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 day s of notifying the customer of the noncompliance, the manufacturer received from the customer, i n 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 sec tion, 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 suppl yi ng the new chemical substance to that customer and shall report the failure to comply to EPA within 15 day s of obtaining this knowledge. Within 30 day s 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 r esume. (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 clearl y identify the information at the time of submission to E PA by bracketing, circling, or underlining it and stamping it with "CONFIDENTIAL" or some other appropriate designation. An y information so identified will be treated in accordance with the procedures in part 2 of thischapter. An y information not claimed confidential at the time of submission may be made available to the public without further notice. (2)(i) An y person who asserts a claim of confidentiality for chemical identity

under this paragraph (l) must provide a generic chemical name that is only a s 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 su bject to EPA review and approval in accordance with the procedures specified in ' 720.85(b)(6) of this chapter. The generic name provided b y 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 an y information is claimed confidential, the manufacturer must submit a second cop y of the notice with all information claimed as confidential deleted. EPA will place the second cop y in the public file. (m) Exemption s 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 sect ion. 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) Recordk eeping. (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 y ears after their preparation. (2) The rec ords 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) An y 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 cop y 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 day s of receipt of such request. (o) Compliance. (1) Failure to comply with any provision of this section is a violation of section15 of the Act (15 U.S.C. 2614).

(2) Submitting materiall y misleading or false information in connection with the requirements of any provision o f 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 ma y 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 manufactur e 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) T o 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

wi th 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 Tox ic 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 duri ng end use, and (iii) which has either no change of chemical composition during its end use or onl y 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 ex cept that fluids and particles are not considered articles regardless of shape or design. (3) The terms by

product, 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 theAct (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 o f 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 employ ee designated by the Office Director to carry

out the Office Director's fun ctions 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 f ilm 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 an y article which will become a component of an instant photographic or peel - apart film article. (13) Special production area means a demarcated are a 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 fro m a formal or informal study , test, experiment, recorded observation, monitoring, or measurement. (ii) Information concerning the objectives, experimental methods and materials, protocols, results, data anal ys es (including risk assessments), and conclusio ns 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 subs tance, means the newchemical 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. (1 6) 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 photogr aphic 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) L imit 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 distributi on 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 i n 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 th e 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/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 L ist, U.S. Department of Health and Human Services, NIOSH publication No. 80 - 144.(ii) Waiver of respirator requirement. Emplo yees are not required to wear respirators if

monitoring information collected and anal yz ed 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/m 3 for particulates with an allowable TWA excursi on 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 analy tic methods exist, periodic monitoring in accordance with this paragraph must be done to ensure compliance with the expo sure limits of paragraphs (e)(1) and (2)(ii) of this section. (B) When suitable sampling and anal yt ic 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 determi ned b y an evaluation of monitoring data developed for a surrogate chemical substance possessing comparable phy sical - chemical properties under similar manufacturing and processing conditions. (ii) Monitoring methods. A suitable air sampling method must pe rmit personal or fixed location sampling b y conventional collection methods. A suitable anal yt ic 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 anal yt ical 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 leve l and maximum 30 - minute level of emplo yee exposure during an 8 - hour work shift. In monitoring for an 8 - hour work shift or the equivalent, samples must be collected periodicall y or continuously for the duration of the 8 - hour work shift. Samples must be tak en 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 onl y every 6 m onths 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) L ocat ion of monitoring. Air samples must be taken so as to ensure that the samples adequatel y represent the ambient air concentration of a new chemical substance present in eachworker's breathing zone.

(4) Engineering controls and exposure safeguards. Engine ering 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, h ygie ne, and work practices -- (i) Training. No employ ee 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 phy sic al - 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 h ygi ene; special handling procedures designed to limit persona l 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 b y all employ ees handling a new chemical substance in manufacturing, processing, or transfer operations. The manufacturer must provide appropriate facilities for emplo ye e 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) o f this section. Written procedures and all materials necessary for responding to emergency

situations must be immediately accessible to all employ ees in a special production area. An y spill or unanticipated emission must be controlled by speciall y 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 we ar suitable protective clothing or equipment, such as chemical - resistant coveralls, protective ey ewear, and gloves. (7) Caution signs. Each special production area must be clearl y 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 clearl y 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, h ygiene, work practices, and personal protective devices appropriate to the chemical substance in question. (9) Labeling. (i) An y new chemical substance removed from a special production area or storedor transported between operational steps mu st be clearl y 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 immediatel y adjacent to the special production area. The ambient air concentration of the new chemical substance in areas immediatel y 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 se ction 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 in stant 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 c ontained in a wet mixture. (2) Training, h ygiene 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 employ ees' acti vities and must address: Procedures for using personal exposure safeguards, applicable principles of h ygi ene, handling procedures designed to limit personal exposure, and procedures for responding to emergencies and spills. (ii) Hygiene. Appropriate standards of h ygiene that limit exposure must be observed b y all employ ees 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 subst ance 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, ey e protection, and, where necessary , respirators or chemical ly 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 ey ewear, respirators, an d 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 manu facturer must take measures to limit worker and environmental exposure to new chemical substances during these operations usingengineering controls, training, h ygiene, 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 o f 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 appropriatel y 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 ph ys ical - 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 ch emical substance's phy sical - 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 mu st 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 pro cessed. (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 b y a definite structural diagram (Class 1 substances), the notice must provide the chemical name (preferabl y CAS or IUPAC nomenclature), the molecular formula, CAS Registry Number (if available), known s ynonyms (including trade names), and a structural diagram. (B) Class 2 substances. For chemical substances that cann ot be full y represented b y a structural diagram, (Class 2 substances), the notice must provide the chemical name, the molecular formula, the CAS Registry Number (if available), and known s ynon ym s (including trade names). The notice must identify

the immedi ate precursors and reactants b y name and CAS Registry Number (if available). The notice must include a partial or incomplete structural diagram, if available. (C) Poly mers. For a pol ymer, the notice must indentify monomers and other reactants used in the manufacture of the pol ymer by chemical name and CAS Registry Number. The notice must indicate the amount of each monomer used (b y weight percent of total monomer); the maximum residual of each monomer present in the pol ym er; and a partial or incomplete structural diagram, if available. The notice must indicate the number average molecular weight of the poly mer and characterize the anticipated low molecular weight species. The notice must include thisinformation for each t ypi cal average molecular weight co mposition of the poly mer 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, b y class of substances, or by process or source. The notice also must estimate the maximum percent (b y weight) of each impurity in the new chemical substance and the percent of unknown impurities present. (iv) Phy sical - chemical properties. The notice mus t describe the ph ys ical - chemical properties of the new chemical substance. Where specific ph ys ical - chemical data are not available, reasonable estimates and the techniques used to develop these estimates must be provided. (v) By products. The notice must identify the name, CAS Registry

number (if available), and the volume of each b yp roduct 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 b y the manufacturer. (viii) I dentity

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 un der this paragraph has alread y 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 requir ed 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 c hemical 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 b y 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 analy

tic 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 employ ee engaged in the manufacture or processing of a new chemical substance, the compan y 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 an y personal exposure monitoring, the results of the quantitative fit test for the work er'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 day s 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 treate d in accordance with the procedures in part 2 of this chapter. An y 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 an y 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 a lso may amend this exemption to enlarge the exemption category or to reduce the restrictions or conditions of the exemption. (2) As required b y 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, proces sing, distribution, use, or disposal of any newchemical 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 unreasona

ble 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 materiall y 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 authorit y 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 Poly

mers. (a) Purpose and scope. (1) This section grants an exempt ion 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 thi s 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 poly mer in paragraph (b) of this section. (ii) Determine that the substance is not spe cifically 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 r equirements 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.). Biopoly mer means a poly

mer directl y 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 poly

mer means a poly

mer that contai ns a net positively charged atom(s) or associatedgroups of atoms covalently linked to its poly

mer 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 poly mer molecules are che micall y 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 poly mer - forming reaction used for the particular process. Monomer Unit means the reacted form of the monomer in a poly mer. Number - average molecular weight means the arithmetic average (mean) of the molecular weight of all molecules in a pol ymer. Oligomer means a pol ym er 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 co nditions used for the particular process, cannot become a repeating unit in the poly

mer structure. Poly ester means a chemical substance that meets the definition of poly mer and whose pol ym er molecules contain at least two carbox yl ic acid ester linkages, at least one of which links internal monomer units together. Poly mer means a chemical substance consisting of molecules characterized by the sequence of one or more t ypes 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 mo lecular weights wherein differences in the molecular weight are primaril y 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 b y units other than monomer units. Poly mer molecule means a molecule which contains a sequence of at least 3 monomer units which are covalentl y bound to at least one other monomer uni t or other reactant.Reactant means a chemical substance that is used intentionally in the manufacture of a pol ym er to become chemically

a part of the pol ym er composition. Reactive functional group means an atom or associated group of atoms in a chemi cal substance that is intended or can reasonably be anticipated to undergo further chemical reaction. Reasonabl y anticipated means that a knowledgeable person would expect a given ph ys ical or chemical composition or characteristic to occur based on such factors as the nature of the precursors used to manufacture the pol ym er, the ty pe of reaction, the t ype of manufacturing process, the products produced in poly merization, 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 "poly me r" 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) Poly mers that cannot be manufactured under this section -- (1) Cationic poly m ers. A pol ym er cannot be manufactured under this section if the poly mer is a cationic pol ymer as defined under paragraph (b) of this section or if the poly mer is reasonably

anticipated to become a cationic poly mer in a natural aquatic environment (e.g., ri vers, lakes) unless: (i) The pol ym er is a solid material that is not soluble or dispersible in water and will be used only in the solid phase (e.g., poly mers that will be used as ion exchange beads), or (ii) The combined (total) functional group equival ent weight of cationic groups in the poly mer is equal to or greater than 5,000. (2) Elemental limitations. (i) A poly mer manufactured under this section must contain as an integral part of its composition at least two of the atomic elements carbon, h ydr ogen, nitrogen, oxygen, silicon, and sulfur. (ii) A poly

mer 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 paragra ph (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 car

bon. (D) Less than 0.20 weight percent of an y combination of the atomic elements lithium, boron, phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin, and zirconium. (3) Poly mers which degrade, decompose, or depoly merize. A pol ym er cannot b e manufactured under this section if the poly mer is designed or is reasonabl y anticipated to substantially degrade, decompose, or depoly

merize, including those pol ymers 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 chemicalchange that convert a polymeric substance into simpler, smaller substances, through processes

including but not limit ed to oxidation, hydrol ys is, attack b y solvents, heat, light, or microbial action. (4) Poly mers manufactured or imported from monomers and reactants not on the TSCA Chemical Substance Inventory . A pol ym er cannot be manufactured under this section if the poly mer being manufactured or imported is prepared from monomers and/or other reactants (that are either charged to the reaction vessel or incorporated in the pol ym er at levels of greater than 2 weight percent) that are not already included on the TSCA Che mical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. (5) Water absorbing pol ymers with number average molecular weight (MW) 10,000 and greater. A poly mer cannot be manufactured under this section if the poly mer being manufactured or imported is a water absorbing pol ym er and has a number average MW greater than or equal to 10,000 daltons. For purposes of this section, a water - absorbing pol ym er is a poly meric substance that is capable of absorbing its weight of water. (e ) Exemption criteria. To be manufactured under this section, the poly mer must meet one of the following criteria: (1) Poly mers with number average MW greater than or equal to 1,000 and less than 10,000 daltons (and oligomer content less than 10 percent b elow MW 500 and less than 25 percent below MW 1,000). (i) The poly mer 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 oligo meric material below MW 1,000. (ii) The poly

mer cannot contain reactive functional groups unless it meets one of the following criteria: (A) The pol ym er contains only the following reactive functional groups: carboxylic acid groups, aliphatic hydroxyl g roups, 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., strongl y electron - withdrawing sulfone group with which the olefinic groups interact), butenedioic acid groups, those conjugated olefinic groups contained in naturally - occurring fats, oils, and carbox yl ic acids, blocked isocyanates (including ketoxime - blocked isocy anates), thiols, unconjugated nitri le groups, and halogens (except that reactive halogen - containing groups such as benz yl ic or allylichalides cannot be included). (B) The pol ym er has a combined (total) reactive group equivalent weight greater than or equal to 1,000 for the following react ive functional groups: acidhalides; acid anhydrides; aldehydes, hemiacetals; meth yl olamides, - amines or, - ureas; alkoxy silanes with alkoxy greater than C2 - alkox ys ilanes; allyl ethers; conjugated olefins;cyanates; epoxides; imines; or unsubstituted position s ortho or para to phenolic hydrox yl ; or(C) If an y 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) Poly mers 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 poly mer must have a number average M W 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) Poly ester pol ym ers. The poly mer is a pol yester as defined in paragraph (b) of this s ection and is manufactured solel y from one or more of the reactants in the following table 1: Table 1_ List of Reactants From Which Polyester May be Made

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Re actant CAS No.

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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 gl yc erid ic oils, anchov y....... 128952 - 11 - 4* Fats and gl yc eridic oils, babassu........ 91078 - 92 - 1* Fats and gl yc eridic oils, herring........ 68153 - 06 - 0* Fats and gl yc eridic oils, menhaden.....8002 - 50 - 4* Fats and gl yc eridic oils, sardine........ 93334 - 41 - 9* Fats and gl yc eridic oils, oiticica....... 8016 - 35 - 1* Fatt y acids,C[INF]16 - 18[/I NF] and 67701 - 08 - 0* C[INF]18[/I

NF] - unsatd.. Fatt y acids, castor - oil.................. 61789 - 44 - 4* Fatt y acids, coco........................ 61788 - 47 - 4* Fatt y acids, deh ydrated castor - oil....... 61789 - 45 - 5* Fatt y acids, linseed oil................. 68424 - 45 - 3* Fatt y acids, safflower oil............... Fatt y acids, so ya........................ 68308 - 53 - 2* Fatt y acids, sunflower oil............... 84625 - 38 - 7* Fatt y acids, sunflower - oil, conjugated.68953 - 27 - 5* Fatt y acids, tall - oil.................... 61790 - 12 - 3* Fatt y acids, tall - oil, conjugated*....... Fatt y acids, vegetable oil............... 61788 - 66 - 7* Glycerides, C[INF]16 - 18[/INF] and 67701 - 30 - 8* C[I NF]18[/I NF] - 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, oxid ized.................... 68649 - 95 - 6* Nonanoic acid............................ 112 - 05 - 0 Oils, Cannabis*.......................... Oils, palm kernel........................ 8023 - 79 - 8* Oils, perilla............................ 68132 - 21 - 8* Oils, w alnut............................. 8024 - 09 - 7 Safflower oil............................ 8001 - 23 - 8* Soy bean oil.............................. 8001 - 22 - 7* Sunflower oil............................ 8001 - 21 - 6* Tung oil................................ . 8001 - 20 - 5* 1 1 Di and Tri Basic Acids:........... 1,2 - Benzenedicarbox yl ic acid............. 88 - 99 - 3 1,3 - Benzenedicarbox yl ic acid............. 121 - 91 - 5 1,3 - Benzenedicarbox yl ic acid, 1459 - 93 - 4 diethyl ester. 1,4 - Benzenedicarbox yl ic acid...... ...... 100 - 21 - 0 1,4 - Benzenedicarbox yl ic acid, 636 - 09 - 9 diethyl ester. 1,4 - Benzenedicarbox yl ic acid, 120 - 61 - 6 dimethyl ester. 1,2,4 - Benzenetricarbox yl ic acid........ 528 - 44 - 9 Butanedioic acid......................... 110 - 15 - 6 Butanedioic acid, dieth yl 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 Fatt y acids, C[INF]18[/INF] - unsatd., 61788 - 89 - 4* dimers. Heptanedioic acid........................ 111 - 16 - 0 Heptanedio ic acid, dimethyl ester...... 1732 - 08 - 7 Hexanedioic acid......................... 124 - 04 - 9 Hexanedioic acid, dimethyl ester....... 627 - 93 - 0 Hexanedioic acid, dieth yl ester.......... 141 - 28 - 6 Nonanedioic acid......................... 123 - 99 - 9 Nonanedioic acid, dimethyl ester....... 1732 - 10 - 1 Nonanedioic acid, dieth yl ester.......... 624 - 17 - 9 Octanedioic acid......................... (505 - 48 - 6) Octanedioic acid, dimethyl ester......... 1732 - 09 - 8 Pentanedioic acid.................. ...... ....... 1119 - 40 - 0Pentanedioic acid, dieth yl 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] - ox yb is - .............. 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(hydrox ym ethyl) - . 115 - 77 - 5 1,3 - Propanediol, 2,2 - dimethyl - ........... 126 - 30 - 7 1,3 - Propanediol, 2 - eth yl - 2 - 77 - 99 - 6 (hydroxy methyl) - . 1,3 - Propanediol, 2 - (h ydroxy methyl) - 2 - 77 - 85 - 0 methyl - . 1,3 - propanediol, 2 - methyl................ 2163 - 42 - 0 1,2,3 - Propanetriol....................... 56 - 81 - 5 1,2,3 - Propanetriol, homopoly mer.. ........ 25618 - 55 - 7 2 - Propen - 1 - ol, pol ym er with 25119 - 62 - 4 ethen yl benzene. Modifiers Acetic acid, 2,2[prime] - oxy bis - .......... 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 - butoxy ethoxy ) - ............. 112 - 34 - 5 1 - Hexanol................................ 111 - 27 - 3 Methanol, hydroly sis products with 72318 - 84 - 4* trichlorohex yl silane and trichlorophen yl silane. 1 - Phenanthrenemethanol, tetradecah ydro - 13393 - 93 - 6 1,4a - dimethyl - 7 - (1 - methylethyl) - . Phenol, 4,4[prime] - (1 - 25036 - 25 - 3 methylethylidene)bis - , poly mer with 2,2[prime] - [(1 - methylethylidene)bis(4,1 - phenyleneoxy

methylene)] bis[oxirane]. Siloxanes and Silicones, di - Me, di - Ph, 68440 - 65 - 3* poly mers with Ph silsesquioxanes, methoxy- terminated. Siloxanes and Silicones, di - Me, methox y 68957 - 04 - 0*Ph, poly mers with Ph silsesquioxanes, methoxy- terminated. Siloxanes and Silicones, Me Ph, methoxy \ 1 \ 68957 - 06 - 2* Ph, poly mers 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 Regi stry Numbers for UVCB substances are not used in CHEMI CAL 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

b e formed by

reaction of these reactants. (f) Exemption report for poly mers 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) b y J anuary 31 of the y ear 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 s ubstances manufactured. Number of substances manufactured. The manufacturer must identify the number of pol ym ers manufactured under terms of the exemption for the first time in the y ear preceding the notice. (g) Chemical identity

information. For substan ces 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 c hemical 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 an y weight in the manufacture of the pol ym er. 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 poly mer. Manufacturers who choose the "incorporated" method must have anal yt ical data, or theoretical calculations (if it can be documented that an anal yt ical determination cannot be made or is not necessary), to demonstrate compliance with this paragraph. Reactants that i ntroduce into the poly mer elements, properties, or functional groups that would render the poly

mer ineligible for the exemption are not allowed at any level. (2) A representative structural diagram, if possible.(h) Certification. To manufacture a sub stance 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 pol ym er, is not specificall y 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 appl y and the exempt poly

mer 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 poly mer under paragraphs (e) of this section, must retain the records described in this paragraph at the manufacturing site for a period of 5 ye ars 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 pol ymer is not specificall y 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 pol ymer meets the exemption criteria in paragraphs (e)(1), (e)(2), or (e)(3) of this section. (v) Anal yt ic al data, or theoretical calculations (if it can be documented that an anal yt ical determination cannot be made or is not necessary), to demonstrate that the poly mer meets the number - average MW exemption criteria in paragraphs (e)(1) or (e)(2) of this sectio n.The analy

tical tests may

include gel permeation chromatograph y (GPC).vapor pressure osmometry

(VPO), or other such tests which will demonstrate that the poly mer meets the number - average MW criterion. (vi) Anal yt ical data, or theoretical calculations (if it can be documented that an anal yt ical determination cannot be made or is not necessary), to demonstrate that the poly mer meets the criteria in paragraphs (e)(1) or (e)(2) of this section, meets the low MW contentcriteria in paragraphs (e)(1) or (e)(2) of this section.

(vii) If applicable, anal yt ical data, or theoretical calculations (if it can be documented that an anal yt ical determination cannot be made or is not necessary) required in paragraph (g) of this section for determining monomers or reactant s charged to the reaction vessel at greater than 2 weight percent but incorporated at 2 weight percent or less in the manufactured pol ym er. (viii) The certification statements as required under paragraph (h) of this section. (3) The manufacturer must su bmit 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 day s 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 cop y 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 Penns yl vania Ave., NW., Washington, DC 20460. (l) Compliance. (1) A person who manufactures or imports a new chemical substance and fails to comply

with an y 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 dis tributed 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 cop yi ng of records, as required b y this section and se ction 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 b y s ection 11 of the Act is a violation of section 15 of the Act (15 U.S.C. 2614). (5) Violators may

be sub ject 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 an y provision of this section may be subject to pena lties 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 an y chemical substance manufactured or processed in violation of this se ction or take other actions under the authorit y 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 se ction, to verify that information submitted to EPA under this section is true and correct, and to audit data submitted to EPA under thissection.

(n) Confidentiality . If a manufacturer submits information to EPA under this section which the manufacturer claims to be confidential business information, the manufacturer must clearl y 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, a s amended at 62 FR 17932, April 11, 1997]