PART 723—PREMANUFACTURE NOTIFICATION EXEMPTIONS Authority: 15 U.S.C. 2604. Subpart A [Reserved] Subpart B—Specific Exemptions § 723.50 Chemical substances manufactured in quantities of 10,000 kilograms or less per year, and chemical substances with low environmental releases and human exposures. (a) Purpose and scope. (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. (1) Act (2) Consumer (3) Environment (4) Environmental transformation product (5) Metabolite (6) Serious acute effects (7) Serious chronic effects (8) Significant environmental effects (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 (10) The terms byproduct, EPA, importer, impurity, known to or reasonably ascertainable, manufacture, manufacturer, new chemical substance, person, possession or control, and test data (11) PFAS per- and poly-fluoroalkyl substance (i) R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons; (ii) R-CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons; or (iii) CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons. (12) PBT chemical substance (c) Exemption categories. (1) Any manufacturer of a new chemical substance manufactured in quantities of 10,000 kilograms or less per year under the terms of this exemption. (2) Any manufacturer of a new chemical substance satisfying all of the following low environmental release and low human exposure eligibility criteria: (i) Consumers and the general population. (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. (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. (iv) Incineration. (kg/day of release after treatment) multiplied by (number of release days per year) multiplied by (9.68 × 10 −6 (v) Land or groundwater. (d) Chemical substances that cannot be manufactured under this exemption. (1) May cause: (i) Serious acute (lethal or sublethal) effects; (ii) Serious chronic (including carcinogenic and teratogenic) effects; or (ii) Significant environmental effects. (2) Or is: (i) A PFAS. (ii) A PBT chemical substance with anticipated environmental releases and potentially unreasonable exposures to humans or environmental organisms. (e) Exemption notice. (2) The notice shall contain the information described below, pursuant to the referenced provisions of § 720.45. (i) Manufacturer identity. (ii) Chemical identity (§ 720.45(a)). (iii) Impurities (§ 720.45(b)). (iv) Known synonyms or trade names (§ 720.45(c)). (v) Byproducts (§ 720.45(d)). (vi) Production volume (§ 720.45(e)). (A) Manufacturers submitting an exemption application under paragraph (c)(1) of this section will be assumed to be manufacturing at an annual production volume of 10,000 kilograms. Manufacturers who intend to manufacture an exempted substance at annual volumes of less than 10,000 kilograms and wish EPA to conduct its risk assessment based upon such lesser annual production level rather than a 10,000-kilograms level, may so specify by writing the lesser annual production volume in the appropriate box on the PMN form and marking the adjacent binding option box. Manufacturers who opt to specify annual production levels below 10,000 kilograms and who mark the production volume binding option box shall not manufacture more than the specific annual amount of the exempted substance unless a new exemption notice for a higher (up to 10,000 kgs) manufacturing volume is submitted and approved pursuant to this section. (B) Manufacturers submitting an exemption under paragraph (c)(2) of this section shall list the estimated maximum amount to be manufactured during the first year of production and the estimated maximum amount to be manufactured during any 12-month period during the first 3 years of production. (vii) Description of intended categories of use (§ 720.45(f)). (viii) For manufacturer-controlled sites, the manufacturer shall supply identity of manufacturing sites, process descriptions, and worker exposure and environmental release information (§ 720.45(g)); for sites not controlled by the manufacturer, processing and use operation descriptions, estimated number of processing and use sites, and worker exposure/environmental release information (§ 720.45(h)). A manufacturer applying for an exemption under paragraph (c)(1) of this section need not provide information on worker exposure and environmental release referenced in paragraphs (e)(2)(viii) of this section if such information is not known or not readily available to the manufacturer. To assist in reporting this information, manufacturers may obtain a copy of EPA's Guidance for Reporting Occupational Exposure and Environmental Release Information under 40 CFR 723.50, available from the Environmental Assistance Division at the address listed in paragraph (e)(1) of this section. Where worker exposure and environmental release information is not supplied by the manufacturer, EPA will generally apply “bounding estimates” (i.e., exposure estimates higher than those incurred by persons in the population with the highest exposure) to account for uncertainties in actual exposure and release scenarios. (ix) Type and category of notice. The manufacturer must clearly indicate on the first page of the PMN form that the submission is a “TSCA section 5(h)(4) exemption notice,” and must indicate whether the notice is being submitted under paragraph (c)(1) or (c)(2) of this section. Manufacturers of chemical substances that qualify for an exemption under both paragraph (c)(1) and (c)(2) of this section may apply for either exemption, but not both. (x) Test data (§ 720.50). (xi) Certification. In addition to the certifications required in EPA form 7710-25, the following certifications shall be included in notices under this section. The manufacturer must certify that: (A) The manufacturer intends to manufacture 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. (xiii) Safety Data Sheet (§ 720.45(i)). (xiv) Physical and chemical properties and environmental fate characteristics (§ 720.45(j)). (3) Incomplete notices. (f) Multiple exemption holders. (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. (2) No person submitting a notice under paragraph (e) of this section may manufacture the new chemical substance until EPA notifies the submitter that the new chemical substance meets the terms of this section. (h) Notice of ineligibility During the review period. (2) After the review period. (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 Agency 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 EPA has made one of the five determinations as set forth in section 5(a)(3) of the Act and taken the action required in association with that determination. (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. (j) Changes in manufacturing site, use, human exposure and environmental release controls, and certain manufacturing volumes. (2) Where the manufacturer lists a specific physical form in which the new chemical substance will be manufactured, processed, and/or used, the manufacturer must continue manufacturing, processing, and/or using the new chemical substance in either the same physical form described in the notice under paragraph (e), or in a physical form which will not increase the human exposure to or environmental release of the new chemical substance over those exposures or releases resulting from the specified physical form (e.g., a manufacturer which specifies that the new chemical substance will be produced in a non-volatile liquid form generally may not change to a respirable powder form). (3) The annual production volume of chemical substances manufactured under paragraph (c)(1) of this section for which the manufacturer designated a binding annual production volume pursuant to paragraph (e)(2)(vi) of this section must not exceed that designated volume. (4) Any person who manufactures a new chemical substance under paragraph (c)(1) or (c)(2) of this section must comply with the provisions of this section, including submission of a new notice under paragraph (e) of this section, before: (i) Manufacturing the new chemical substance at a site that was not approved in a previous exemption notice for the substance, except as provided in paragraph (j)(6) of this section. (ii) Manufacturing the new chemical substance for a use that was not approved in a previous exemption notice for the substance. (iii) Manufacturing the new chemical substance without employing the human exposure and environmental release controls approved in a previous exemption notice for the substance. (iv) Manufacturing the new chemical substance in a physical form different than that physical form approved in a previous exemption notice for the substance and which form may increase the human exposure to, or environmental release of, the new chemical substance over those exposures or releases resulting from the physical form approved in the previous notice. (v) Manufacturing the chemical substance in annual production volumes above any volume designated by the manufacturer as binding under paragraph (e)(2)(vi) of this section in a previous exemption notice for the substance. (5) In an exemption notice informing EPA of a change in site, use, or worker protection, or environmental release controls, the manufacturer is not required to provide all of the same information submitted to EPA in a previous exemption notice for that chemical substance. The new exemption notice, however, must indicate the identity of the new chemical substance; the manufacturer's name; the name and telephone number of a technical contact; and location of the new site, new worker protection or environmental release controls, and new use information. The notice must also include the EPA-designated exemption number assigned to the previous notice and a new certification by the manufacturer, as described in paragraph (e)(2)(xi) of this section. (6)(i) A manufacturer may, without submitting a new notice, manufacture the new chemical substance at a site not listed in its exemption application under the following conditions: (A) the magnitude, frequency, and duration of exposure of individual workers to the new chemical substance at the new manufacturing site is equal to, or less than, the magnitude, frequency, and duration of exposure of the individual workers to the new chemical substance at the manufacturing site for which the EPA performed its original risk-assessment pursuant to the original exemption notice; and (B) Either ( 1 2 (ii) The manufacturer shall notify EPA of any new manufacturing site no later than 30 days after the commencement of manufacture of the new chemical substance under the exemption at the new manufacturing site as follows: (A) The notification must contain the EPA-designated exemption number to which the notification applies, manufacturer identity, the street address of the new manufacturing site, the date on which manufacture commenced at the new site, the name and telephone number of a technical contact at the new site, any claim of confidentiality, and a statement that the notification is an amendment to the original exemption application under the terms of this section. (B) The notification must be submitted electronically to EPA via CDX as a support document to the original notification. Prior to submission to EPA via CDX, such notices must be generated and completed using the e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to access the e-PMN software. (k) Customer notification. (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. (m) Exemptions granted under superseded regulations. (n) Recordkeeping. (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. (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). (p) Subject to a significant new use rule or listed on TSCA Inventory. [60 FR 16346, Mar. 29, 1995, as amended at 60 FR 34465, July 3, 1995; 62 FR 17932, Apr. 11, 1997; 64 FR 31989, June 15, 1999; 71 FR 33642, June 12, 2006; 75 FR 787, Jan. 6, 2010; 77 FR 46292, Aug. 3, 2012; 78 FR 72828, Dec. 4, 2013; 80 FR 42746, July 20, 2015; 87 FR 39769, July 5, 2022; 88 FR 37173, June 7, 2023; 89 FR 102798, Dec. 18, 2024] Editorial Note: At 89 FR 102798, Dec. 18, 2024, § 723.50 was amended in part by revising paragraph (a)(1). However, the set-out text included revised text for the introductory paragraph of (a)(1), and not the subparagraphs. § 723.175 Chemical substances used in or for the manufacture or processing of instant photographic and peel-apart film articles. (a) Purpose and scope. (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) through (h) of this section. (iii) Comply with all recordkeeping requirements under paragraph (j) of this section. (iv) Remit the applicable fee specified in § 700.45(c) of this chapter. (b) Definitions Act et seq. (2) An article (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, site (4) The term category of chemical substances (5) The terms chemical substance, distribute in commerce, distribution in commerce, environment, manufacture, new chemical substance, process (6) Director of the Office of Pollution Prevention and Toxics (7) The term exemption category (8) The term instant photographic film article (9) Intermediate (10) Known to or reasonably ascertainable (11) The term peel-apart film article (12) Photographic article (13) Special production area (14) Test data (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, (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 (c) Exemption category. (d) Applicability. (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. (1) Exposure limits. 3 (2) Respiratory protection Respirator requirement. (ii) Waiver of respirator requirement. 3 (iii) Quantitative fit test. (3) Monitoring When to monitor. (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. (iii) Monitoring frequency. (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. (4) Engineering controls and exposure safeguards. (5) Training, hygiene, and work practices Training. (ii) Hygiene. (iii) Work practices. (6) Personal protection devices. (7) Caution signs. (8) Removal for storage or transportation. (9) Labeling. (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. (f) Conditions of processing outside the special production area. (1) Engineering controls and exposure safeguards. (2) Training, hygiene and work practices Training. (ii) Hygiene. (iii) Work practices. (3) Personal protection devices. (g) Incorporation of photographic articles into instant photographic and peel-apart film articles. (h) Environmental release and waste treatment Release to land. (2) Release to water. (3) Release to air. (i) Exemption notice. (1) Contents of exemption notice. (i) Manufacturer and sites. (ii) Chemical identification. (A) Class 1 substances. (B) Class 2 substances. (C) Polymers. (iii) Impurities. (iv) Physical-chemical properties. (v) Byproducts. (vi) Production volume. (vii) Test data. (viii) Identity of the article. (ix) Release to water. (x) Certification. (xi) Fee payment ID number. (2) Duplication of information in premanufacture notice. (3) Address. (j) Recordkeeping. (i) Production records. (ii) Exposure monitoring records. (iii) Training and exposure records. (iv) Treatment records. (2) The manufacturer must make the records listed in paragraph (j)(1) of this section available to EPA upon written request by the Director of the Office of Pollution Prevention and Toxics. The manufacturer must provide these records within 15 working days of receipt of this request. (k) Confidentiality. (l) Amendment and repeal. (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. (n) Enforcement. (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). [83 FR 52719, Oct. 17, 2018] § 723.250 Polymers. (a) Purpose and scope. (2) To manufacture a new chemical substance under the terms of this section, a manufacturer must: (i) Determine that the substance meets the definition of polymer in paragraph (b) of this section. (ii) Determine that the substance is not specifically excluded by paragraph (d) of this section. (iii) Ensure that the substance meets the exemption criteria of paragraph (e) of this section. (iv) Submit a report as required under paragraph (f) of this section. (v) Comply with the recordkeeping requirements of paragraph (j) of this section. (b) Definitions. Act et seq. Biopolymer Category of chemical substances Cationic polymer 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 Equivalent weight of a functional group Fluorotelomers 2 2 Internal monomer unit Monomer Monomer Unit Number-average molecular weight Oligomer Other reactant Perfluoroalkyl carboxylate (PFAC) Perfluoroalkyl sulfonate (PFAS) Polyester Polymer Polymer molecule Reactant Reactive functional group Reasonably anticipated (c) Applicability. (d) Polymers that cannot be manufactured under this section Cationic polymers. (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. (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 = = 2 = 3 = = 2 − − −. (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. (4) Polymers manufactured or imported from monomers and reactants not on the TSCA Chemical Substance Inventory. (5) Water absorbing polymers with number average molecular weight (MW) 10,000 and greater. (6) Polymers which contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length. (i) Any polymer that has been manufactured previously in full compliance with the requirements of this section prior to February 26, 2010 may no longer be manufactured under this section after January 27, 2012. (ii) [Reserved] (e) Exemption criteria. (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). (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 C 2 ortho para (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) (3) Polyester polymers. Table 1—List of Reactants From Which Polyester May be Made Reactant CAS No. Monobasic Acids and Natural Oils Benzoic acid 65-85-0 Canola oil 120962-03-0 Coconut oil 8001-31-8* Corn oil 8001-30-7* Cottonseed oil 8001-29-4* Dodecanoic acid 143-07-7 Fats and glyceridic oils, anchovy 128952-11-4* Fats and glyceridic oils, babassu 91078-92-1* Fats and glyceridic oils, herring 68153-06-0* Fats and glyceridic oils, menhaden 8002-50-4* Fats and glyceridic oils, sardine 93334-41-9* Fats and glyceridic oils, oiticica 8016-35-1* Fatty acids,C 16-18 18 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, C 16-18 18 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 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, C 18 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 1119-40-0 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 1 Silsesquioxanes, Ph Pr 1 * 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. https://cdx.epa.gov/ (1) Manufacturer's name. (2) Number of substances manufactured. (g) Chemical identity information. (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. (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. (j) Recordkeeping. (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. (l) Compliance. (2) Using for commercial purposes a chemical substance or mixture which a person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of section 5 of the Act is a violation of section 15 of the Act (15 U.S.C. 2614). (3) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by this section and section 11 of the Act, is a violation of section 15 of the Act (15 U.S.C. 2614). (4) Failure or refusal to permit entry or inspection as required by section 11 of the Act is a violation of section 15 of the Act (15 U.S.C. 2614). (5) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who submit materially misleading or false information in connection with the requirements of any provision of this section may be subject to penalties calculated as if they never filed their notices. (6) EPA may seek to enjoin the manufacture or processing of a chemical substance in violation of this section or act to seize any chemical substance manufactured or processed in violation of this section or take other actions under the authority of section 7 of the Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616). (m) Inspections. (n) Confidentiality. [60 FR 16332, Mar. 29, 1995, as amended at 62 FR 17932, Apr. 11, 1997; 75 FR 4305, Jan. 27, 2010; 87 FR 39769, July 5, 2022; 88 FR 37173, June 7, 2023; 89 FR 12250, Feb. 16, 2024]