environmental protection agency §723legismex.mty.itesm.mx/secc_inter/40cfr/40cfrpart723.pdf ·...

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(2) The significant new use is: Manu-facture, import, or processing of 10,000pounds or more per year per facility forany use.

(b) Specific requirements. The provi-sions of subpart A of this part apply tothis section except as modified by thisparagraph.

(1) Recordkeeping. The following rec-ordkeeping requirements are applicableto manufacturers, importers, and proc-essors of this substance, as specified in§ 721.125 (a), (b), and (c).

(2) [Reserved]

[58 FR 63518, Dec. 1, 1993]

§ 721.9970 o-Xylene compound (genericname).

(a) Chemical substance and significantnew uses subject to reporting. (1) Thechemical substance identified generi-cally as an o-xylene compound (PMNP–95–1030) is subject to reporting underthis section for the significant newuses described in paragraph (a)(2) ofthis section.

(2) The significant new uses are:(i) Industrial, commercial, and con-

sumer activities. Requirements as speci-fied in § 721.80(j).

(ii) [Reserved](b) Specific requirements. The provi-

sions of subpart A of this part apply tothis section except as modified by thisparagraph.

(1) Recordkeeping. Recordkeeping re-quirements as specified in § 721.125 (a),(b), (c), and (i) are applicable to manu-facturers, importers, and processors ofthis substance.

(2) Limitations or revocation of certainnotification requirements. The provisionsof § 721.185 apply to this section.

[61 FR 63740, Dec. 2, 1996]

PART 723—PREMANUFACTURENOTIFICATION EXEMPTIONS

Subpart A—[Reserved]

Subpart B—Specific Exemptions

Sec.723.50 Chemical substances manufactured in

quantities of 10,000 kilograms or less peryear, and chemical substances with lowenvironmental releases and human expo-sures.

723.175 Chemical substances used in or forthe manufacture or processing of instant

photographic and peel-apart film arti-cles.

723.250 Polymers.

AUTHORITY: 15 U.S.C. 2604.

Subpart A—[Reserved]

Subpart B—Specific Exemptions

§ 723.50 Chemical substances manufac-tured in quantities of 10,000 kilo-grams or less per year, and chemi-cal substances with low environ-mental releases and human expo-sures.

(a) Purpose and scope. (1) This sectiongrants an exemption from thepremanufacture notice requirements ofsection 5(a)(1)(A) of the Toxic Sub-stances Control Act (15 U.S.C.2604(a)(1)(A)) for the manufacture of:

(i) Chemical substances manufac-tured in quantities of 10,000 kilogramsor less per year.

(ii) Chemical substances with low en-vironmental releases and human expo-sures.

(2) To manufacture a new chemicalsubstance under the terms of this ex-emption a manufacturer must:

(i) Submit a notice of intent to man-ufacture 30 days before manufacturebegins, as required under paragraph (e)of this section.

(ii) Comply with all other provisionsof this section.

(3) This section does not apply tomicroorganisms subject to part 725 ofthis chapter.

(b) Definitions. The following defini-tions apply to this subpart.

(1) Act means the Toxic SubstancesControl Act (15 U.S.C. 2601 et seq).

(2) Consumer means a private individ-ual who uses a chemical substance orany product containing the chemicalsubstance in or around a permanent ortemporary household or residence, dur-ing recreation, or for any personal useor enjoyment.

(3) Environment has the same mean-ing as in section 3 of the Act (15 U.S.C.2602).

(4) Environmental transformation prod-uct means any chemical substance re-sulting from the action of environ-mental processes on a parent com-pound that changes the molecular iden-tity of the parent compound.

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(5) Metabolite means a chemical en-tity produced by one or more enzy-matic or nonenzymatic reactions as aresult of exposure of an organism to achemical substance.

(6) Serious acute effects means humandisease processes or other adverse ef-fects that have short latency periodsfor development, result from short-term exposure, or are a combination ofthese factors and that are likely to re-sult in death, severe or prolonged inca-pacitation, disfigurement, or severe orprolonged loss of the ability to use anormal bodily or intellectual functionwith a consequent impairment of nor-mal activities.

(7) Serious chronic effects meanshuman disease processes or other ad-verse effects that have long latency pe-riods for development, result fromlong-term exposure, are long-term ill-nesses, or are a combination of thesefactors and that are likely to result indeath, severe or prolonged incapacita-tion, disfigurement, or severe or pro-longed loss of the ability to use a nor-mal bodily or intellectual functionwith a consequent impairment of nor-mal activities.

(8) Significant environmental effectsmeans:

(i) Any irreversible damage to bio-logical, commercial, or agricultural re-sources of importance to society;

(ii) Any reversible damage to biologi-cal, commercial, or agricultural re-sources of importance to society if thedamage persists beyond a single gen-eration of the damaged resource or be-yond a single year; or

(iii) Any known or reasonably antici-pated loss of members of an endangeredor threatened species. Endangered orthreatened species are those speciesidentified as such by the Secretary ofthe Interior in accordance with the En-dangered Species Act, as amended (16U.S.C. 1531).

(9) Site means a contiguous propertyunit. Property divided only by a publicright-of-way is one site. There may bemore than one manufacturing plant ona single site.

(10) The terms byproduct, EPA, im-porter, impurity, known to or reasonablyascertainable, manufacture, manufac-turer, new chemical substance, person,possession or control, and test data have

the same meanings as in §720.3 of thischapter.

(c) Exemption categories. Except asprovided in paragraph (d) of this sec-tion, this exemption applies to:

(1) Any manufacturer of a new chemi-cal substance manufactured in quan-tities of 10,000 kilograms or less peryear under the terms of this exemp-tion.

(2) Any manufacturer of a new chemi-cal substance satisfying all of the fol-lowing low environmental release andlow human exposure eligibility cri-teria:

(i) Consumers and the general popu-lation. For exposure of consumers andthe general population to the newchemical substance during all manu-facturing, processing, distribution incommerce, use, and disposal of the sub-stance:

(A) No dermal exposure.(B) No inhalation exposure (except as

described in paragraph (c)(2)(iv) of thissection.

(C) Exposure in drinking water nogreater than a 1 milligram per year (es-timated average dosage resulting fromdrinking water exposure in streamsfrom the maximum allowable con-centration level from ambient surfacewater releases established under para-graph (c)(2)(iii) of this section or ahigher concentration authorized byEPA under paragraph (c)(2)(iii) of thissection).

(ii) Workers. For exposure of workersto the new chemical substance duringall manufacturing, processing, dis-tribution in commerce, use and dis-posal of the substance:

(A) No dermal exposure (this cri-terion is met if adequate dermal expo-sure controls are used in accordancewith applicable EPA guidance).

(B) No inhalation exposure (this cri-terion is considered to be met if ade-quate inhalation exposure controls areused in accordance with applicableEPA guidance).

(iii) Ambient surface water. For ambi-ent surface water releases, no releasesresulting in surface water concentra-tions above 1 part per billion, cal-culated using the methods prescribedin §§721.90 and 721.91, unless EPA hasapproved a higher surface water con-centration supported by relevant and


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scientifically valid data submitted toEPA in a notice under paragraph (e) ofthis section on the substance or a closestructural analogue of the substancewhich demonstrates that the new sub-stance will not present an unreason-able risk of injury to aquatic species orhuman health at the higher concentra-tion.

(iv) Incineration. For ambient air re-leases from incineration, no releases ofthe new chemical substance above 1microgram per cubic meter maximumannual average concentration, cal-culated using the formula:

(kg/day of release after treatment) multi-plied by (number of release days per year)multiplied by (9.68 × 10-6) micrograms percubic meter.

(v) Land or groundwater. For releasesto land or groundwater, no releases togroundwater, to land, or to a landfillunless the manufacturer has dem-onstrated to EPA’s satisfaction in anotice under paragraph (e) of this sec-tion that the new substance has neg-ligible groundwater migration poten-tial.

(d) Chemical substances that cannot bemanufactured under this exemption. Anew chemical substance cannot bemanufactured under this section, not-withstanding satisfaction of the cri-terion of paragraphs (c)(1) or (c)(2) ofthis section, if EPA determines, in ac-cordance with paragraph (g) of this sec-tion, that the substance, any reason-ably anticipated metabolites, environ-mental transformation products, or by-products of the substance, or any rea-sonably anticipated impurities in thesubstance may cause, under antici-pated conditions of manufacture, proc-essing, distribution in commerce, use,or disposal of the new chemical sub-stance:

(1) Serious acute (lethal or sublethal)effects.

(2) Serious chronic (including car-cinogenic and teratogenic) effects.

(3) Significant environmental effects.(e) Exemption notice. (1) A manufac-

turer applying for an exemption undereither paragraph (c)(1) or (c)(2) of thissection must submit an exemption no-tice to the EPA at least 30 days beforemanufacture of the new chemical sub-stance begins. The notice must be sentin writing to: TSCA Document Control

Officer, (7407), Office of Pollution Pre-vention and Toxics, EnvironmentalProtection Agency, 401 M St., SW.,Washington, DC 20460. The date of sub-mission will be the date on which thenotice is received by the TSCA Docu-ment Control Officer. EPA will ac-knowledge the receipt of the notice byletter. The letter will identify the dateon which the review period begins. Thenotice shall be submitted using EPAForm No. 7710–25 (‘‘the PMN form’’),which may be obtained from EPA bywriting the Environmental AssistanceDivision, (7408), Office of Pollution Pre-vention and Toxics, EnvironmentalProtection Agency, 401 M St., SW.,Washington, DC. 20460, or by callingthe TSCA Assistance Information Serv-ice at (202) 554–1404; TDD (202) 554–0551;online service modem (202) 554–5603.

(2) The notice shall contain the infor-mation described below, pursuant tothe 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 ex-emption application under paragraph(c)(1) of this section will be assumed tobe manufacturing at an annual produc-tion volume of 10,000 kilograms. Manu-facturers who intend to manufacturean exempted substance at annual vol-umes of less than 10,000 kilograms andwish EPA to conduct its risk assess-ment based upon such lesser annualproduction level rather than a 10,000–kilograms level, may so specify bywriting the lesser annual productionvolume in the appropriate box on thePMN form and marking the adjacentbinding option box. Manufacturers whoopt to specify annual production levelsbelow 10,000 kilograms and who markthe production volume binding optionbox shall not manufacture more thanthe specific annual amount of the ex-empted substance unless a new exemp-tion notice for a higher (up to 10,000kgs) manufacturing volume is submit-ted and approved pursuant to this sec-tion.

(B) Manufacturers submitting an ex-emption under paragraph (c)(2) of this


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section shall list the estimated maxi-mum amount to be manufactured dur-ing the first year of production and theestimated maximum amount to bemanufactured during any 12–month pe-riod during the first 3 years of produc-tion.

(vii) Description of intended cat-egories of use (§720.45(f)).

(viii) For manufacturer-controlledsites, the manufacturer shall supplyidentity of manufacturing sites, proc-ess descriptions, and worker exposureand environmental release information(§720.45(g)); for sites not controlled bythe manufacturer, processing and useoperation descriptions, estimated num-ber of processing and use sites, andworker exposure/environmental releaseinformation (§720.45(h)). A manufac-turer applying for an exemption underparagraph (c)(1) of this section neednot provide information on worker ex-posure and environmental release ref-erenced in paragraphs (e)(2)(viii) of thissection if such information is notknown or not readily available to themanufacturer. To assist in reportingthis information, manufacturers mayobtain a copy of EPA’s Guidance forReporting Occupational Exposure andEnvironmental Release Informationunder 40 CFR 723.50, available from theEnvironmental Assistance Division atthe address listed in paragraph (e)(1) ofthis section. Where worker exposureand environmental release informationis not supplied by the manufacturer,EPA will generally apply ‘‘bounding es-timates’’ (i.e., exposure estimates high-er than those incurred by persons inthe population with the highest expo-sure) to account for uncertainties inactual exposure and release scenarios.

(ix) Type and category of notice. Themanufacturer must clearly indicate onthe first page of the PMN form that thesubmission is a ‘‘TSCA section 5(h)(4)exemption notice,’’ and must indicatewhether the notice is being submittedunder paragraph (c)(1) or (c)(2) of thissection. Manufacturers of chemicalsubstances that qualify for an exemp-tion under both paragraph (c)(1) and(c)(2) of this section may apply for ei-ther exemption, but not both.

(x) Test data (§720.50).(xi) Certification. In addition to the

certifications required in EPA form

7710–25, the following certificationsshall be included in notices under thissection. The manufacturer must certifythat:

(A) The manufacturer intends tomanufacture or import the new chemi-cal substance for commercial purposes,other than in small quantities solelyfor research and development, underthe terms of this section.

(B) The manufacturer is familiarwith the terms of this section and willcomply with those terms.

(C) The new chemical substance forwhich the notice is submitted meets allapplicable exemption conditions.

(D) For substances manufacturedunder paragraph (c)(1) of this section,the manufacturer intends to commencemanufacture of the exempted sub-stance for commercial purposes within1 year of the date of the expiration ofthe 30–day review period.

(xii) Sanitized copy of notice. (A) Themanufacturer must make all claims ofconfidentiality in accordance withparagraph (l) of this section. If any in-formation is claimed confidential, themanufacturer must submit a secondcopy of the notice, with all informationclaimed as confidential deleted, in ac-cordance with paragraph (l)(3) of thissection.

(B) If the manufacturer does not pro-vide the second copy, the submissionwill be considered incomplete.

(3) Incomplete notices. If EPA receivesa submission which does not include allof the information required under thisparagraph (e) of this section, the sub-mission will be determined to be in-complete by EPA. When a submissionfor a new chemical substance has beendetermined to be incomplete, a manu-facturer reapplying for an exemptionfor the new chemical substance mustsubmit a new exemption notice con-taining all the information requiredunder this paragraph (e) of this sectionincluding a certification page contain-ing an original dated signature; partialsubmissions sent to EPA to supplementnotices declared incomplete will not beaccepted. Photocopied pages from pre-viously submitted exemption formswill be accepted provided that the cer-tifications page contains an originaldated signature.


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(f) Multiple exemption holders. (1) Amanufacturer who intends to manufac-ture a substance for which an exemp-tion under this section was previouslyapproved may apply for an exemptionunder paragraph (c)(1) or (c)(2) of thissection; however, EPA will not approveany subsequent exemption applicationunder paragraph (c)(1) of this sectionunless it can determine that the poten-tial human exposure to, and environ-mental release of, the new chemicalsubstance at the higher aggregate pro-duction volume will not present an un-reasonable risk of injury to humanhealth or the environment.

(2)(i) If EPA proposes to deny an ex-emption application for a substance forwhich another manufacturer currentlyholds an exemption, and that proposeddenial is based exclusively on the cu-mulative human exposure or environ-mental release of the substance whichprecludes the EPA from determiningthat the subsequent applicant’s activi-ties will not present an unreasonablerisk of injury to human health or theenvironment, the EPA will notify thefirst exemption holder that it must,within 21 days of its receipt of EPA’snotice, either:

(A) Provide a new certification thatit has commenced, or that it will com-mence, manufacture of the new chemi-cal substance under this section within1 year of the expiration of its exemp-tion review period; or

(B) Withdraw its exemption for thenew chemical substance.

(ii) If the first exemption holder doesnot respond to the EPA’s notice underparagraph (f)(2)(i) of this section with-in the prescribed time period, EPAshall issue a notice of ineligibility tothe first exemption holder under theprovisions of paragraph (h)(2) of thissection.

(g) Review period. (1) EPA will reviewthe notice submitted under paragraph(e) of this section to determine whethermanufacture of the new chemical sub-stance is eligible for the exemption.The review period will end 30 days afterreceipt of the notice by the TSCA Doc-ument Control Officer. To provide addi-tional time to address any unresolvedissues concerning an exemption appli-cation, the exemption applicant may,at any time during the review period,

request a suspension of the review pe-riod pursuant to the provisions of§720.75(b) of this chapter.

(2) Upon expiration of the 30–day re-view period, if EPA has taken no ac-tion, the manufacturer may considerits exemption approved and begin tomanufacture the new chemical sub-stance under the terms described in itsnotice and in this section.

(h) Notice of ineligibility—(1) Duringthe review period. If the EPA determinesduring the review period that manufac-ture of the new chemical substancedoes not meet the terms of this sectionor that there are issues concerning tox-icity or exposure that require furtherreview which cannot be accomplishedwithin the 30–day review period, EPAwill notify the manufacturer by tele-phone that the substance is not eligi-ble. This telephone notification willsubsequently be confirmed by certifiedletter that identifies the reasons forthe ineligibility determination. Themanufacturer may not begin manufac-ture of the new chemical substancewithout complying with section 5(a)(1)of the Act or submitting a new noticeunder paragraph (e) of this section thatsatisfies EPA’s concerns.

(2) After the review period. (i)(A) If atany time after the review period speci-fied in paragraph (g) of this section theAssistant Administrator for the Officeof Prevention, Pesticides, and ToxicSubstances (‘‘the Assistant Adminis-trator’’) makes a preliminary deter-mination that manufacture of the newchemical substance does not meet theterms of this section, the Assistant Ad-ministrator will notify the manufac-turer by certified letter that EPA be-lieves that the new chemical substancedoes not meet the terms of the section.

(B) The manufacturer may continueto manufacture, process, distribute incommerce, and use the substance afterreceiving the notice under paragraph(h)(2)(i)(A) of this section if the manu-facturer was manufacturing, process-ing, distributing in commerce, or usingthe substance at the time of the notifi-cation and if the manufacturer submitsobjections or an explanation underparagraph (h)(2)(ii) of this section.Manufacturers not manufacturing,processing, distributing in commerce,or using the substance at the time of


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the notification may not begin manu-facture until EPA makes its final de-termination under paragraph (h)(2)(iii)of this section.

(ii) A manufacturer who has receivednotice under paragraph (h)(2)(i)(A) ofthis section may submit, within 15days of receipt of written notification,detailed objections to the determina-tion or an explanation of its diligenceand good faith efforts in attempting tocomply with the terms of this section.

(iii) The Assistant Administrator willconsider any objections or explanationsubmitted under paragraph (h)(2)(ii) ofthis section and will make a final de-termination. The Assistant Adminis-trator will notify the manufacturer ofthe final determination by telephonewithin 15 days of receipt of the objec-tions or explanation, and subsequentlyby certified letter.

(iv) If the Assistant Administratordetermines that manufacture of thenew chemical substance meets theterms of this section, the manufacturermay continue or resume manufacture,processing, distribution in commerce,and use in accordance with the termsof this section.

(v) If the Assistant Administrator de-termines that manufacture of the newchemical substance does not meet theterms of this section and that the man-ufacturer did not act with due dili-gence and in good faith to meet theterms of this section, the manufacturermust cease any continuing manufac-ture, processing, distribution in com-merce, and use of the new chemicalsubstance within 7 days of the writtennotification under paragraph (h)(2)(iii)of this section. The manufacturer maynot resume manufacture, processing,distribution in commerce, and use ofthe new chemical substance until itsubmits a notice under section 5(a)(1)of the Act and part 720 of this chapterand the notice review period has ended.

(vi) If the Assistant Administratordetermines that manufacture of thenew chemical substance does not meetthe terms of this section and that themanufacturer acted with due diligenceand in good faith to meet the terms ofthis section, the manufacturer maycontinue manufacture, processing, dis-tribution in commerce, and use of thenew chemical substance if:

(A) It was actually manufacturing,processing, distributing in commerce,or using the chemical substance at thetime it received the notification speci-fied in paragraph (h)(2)(i)(A) of thissection.

(B) It submits a notice on the newchemical substance under section5(a)(1) of the Act and part 720 of thischapter within 15 days of receipt of thewritten notification under paragraph(h)(2)(iii) of this section. Such manu-facture, processing, distribution incommerce, and use may continue un-less EPA takes action under section5(e) or 5(f) of the Act.

(3) Action under this paragraph doesnot preclude action under sections 7,15, 16, or 17 of the Act.

(i) Additional information. If the man-ufacturer of a new chemical substanceunder the terms of this exemption ob-tains test data or other information in-dicating that the new chemical sub-stance may not qualify under terms ofthis section, the manufacturer mustsubmit these data or information toEPA within 15 working days of receiptof the information. If, during the no-tice review period specified in para-graph (g) of this section, the submitterobtains possession, control, or knowl-edge of new information that materi-ally adds to, changes, or otherwisemakes significantly more complete theinformation included in the notice, thesubmitter must send that informationto the address listed on the notice formwithin 10 days of receiving the new in-formation, but no later than 5 days be-fore the end of the notice review pe-riod. The new submission must clearlyidentify the submitter and the exemp-tion notice to which the new informa-tion is related. If the new informationbecomes available during the last 5days of the notice review period, thesubmitter must immediately inform itsEPA contact for that notice by tele-phone.

(j) Changes in manufacturing site, use,human exposure and environmental re-lease controls, and certain manufacturingvolumes. (1) Except as provided in para-graph (j)(6) of this section, chemicalsubstances manufactured under thissection must be manufactured at thesite or sites described, for the uses de-scribed, and under the human exposure


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and environmental release controls de-scribed in the exemption notice underparagraph (e) of this section.

(2) Where the manufacturer lists aspecific physical form in which the newchemical substance will be manufac-tured, processed, and/or used, the man-ufacturer must continue manufactur-ing, processing, and/or using the newchemical substance in either the samephysical form described in the noticeunder paragraph (e), or in a physicalform which will not increase thehuman exposure to or environmentalrelease of the new chemical substanceover those exposures or releases result-ing from the specified physical form(e.g., a manufacturer which specifiesthat the new chemical substance willbe produced in a non-volatile liquidform generally may not change to arespirable powder form).

(3) The annual production volume ofchemical substances manufacturedunder paragraph (c)(1) of this sectionfor which the manufacturer designateda binding annual production volumepursuant to paragraph (e)(2)(vi) of thissection must not exceed that des-ignated volume.

(4) Any person who manufactures anew chemical substance under para-graph (c)(1) or (c)(2) of this sectionmust comply with the provisions ofthis section, including submission of anew notice under paragraph (e) of thissection, before:

(i) Manufacturing the new chemicalsubstance at a site that was not ap-proved in a previous exemption noticefor the substance, except as provided inparagraph (j)(6) of this section.

(ii) Manufacturing the new chemicalsubstance for a use that was not ap-proved in a previous exemption noticefor the substance.

(iii) Manufacturing the new chemicalsubstance without employing thehuman exposure and environmental re-lease controls approved in a previousexemption notice for the substance.

(iv) Manufacturing the new chemicalsubstance in a physical form differentthan that physical form approved in aprevious exemption notice for the sub-stance and which form may increasethe human exposure to, or environ-mental release of, the new chemicalsubstance over those exposures or re-

leases resulting from the physical formapproved in the previous notice.

(v) Manufacturing the chemical sub-stance in annual production volumesabove any volume designated by themanufacturer as binding under para-graph (e)(2)(vi) of this section in a pre-vious exemption notice for the sub-stance.

(5) In an exemption notice informingEPA of a change in site, use, or workerprotection, or environmental releasecontrols, the manufacturer is not re-quired to provide all of the same infor-mation submitted to EPA in a previousexemption notice for that chemicalsubstance. The new exemption notice,however, must indicate the identity ofthe new chemical substance; the manu-facturer’s name; the name and tele-phone number of a technical contact;and location of the new site, new work-er protection or environmental releasecontrols, and new use information. Thenotice must also include the EPA-des-ignated exemption number assigned tothe previous notice and a new certifi-cation by the manufacturer, as de-scribed in paragraph (e)(2)(xi) of thissection.

(6)(i) A manufacturer may, withoutsubmitting a new notice, manufacturethe new chemical substance at a sitenot listed in its exemption applicationunder the following conditions:

(A) the magnitude, frequency, andduration of exposure of individualworkers to the new chemical substanceat the new manufacturing site is equalto, or less than, the magnitude, fre-quency, and duration of exposure of theindividual workers to the new chemicalsubstance at the manufacturing sitefor which the EPA performed its origi-nal risk-assessment pursuant to theoriginal exemption notice; and

(B) Either (1) at the new manufactur-ing site, the manufacturer does not re-lease to surface waters any of the newchemical substance, or any wastestreams containing the new chemicalsubstance; or (2) at the new manufac-turing site, the manufacturer main-tains surface water concentrations ofthe chemical substance, resulting fromdirect or indirect discharges from themanufacturing site, at or below 1 partper billion, or at or below an alter-native concentration level approved by


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the Agency in writing or under the pro-cedures described in paragraph(c)(2)(iii) of this section, using thewater concentration calculation meth-od described at §§721.90 and 721.91.

(ii) The manufacturer shall notifyEPA of any new manufacturing site nolater than 30 days after the commence-ment of manufacture of the new chemi-cal substance under the exemption atthe new manufacturing site as follows:

(A) The notification must containthe EPA-designated exemption numberto which the notification applies, man-ufacturer identity, the street addressof the new manufacturing site, the dateon which manufacture commenced atthe new site, the name and telephonenumber of a technical contact at thenew site, any claim of confidentiality,and a statement that the notificationis an amendment to the original ex-emption application under the terms ofthis section.

(B) The notification may be submit-ted on EPA form 7710–56 ‘‘Notice ofCommencement of Manufacture;’’ how-ever, the manufacturer must add thestatement required under paragraph(j)(6)(ii)(A) of this section that the no-tification is an amendment to theoriginal exemption.

(C) The notification must contain anoriginal signature of an authorized offi-cial of the manufacturer.

(k) Customer notification. (1) Manufac-turers of new chemical substances de-scribed in paragraphs (c)(1) and (c)(2) ofthis section must notify processors andindustrial users that the substance canbe used only for the uses specified inthe exemption notice at paragraph (e)of this section. The manufacturer mustalso inform processors and industrialusers of any controls specified in theexemption notice. The manufacturermay notify processors and industrialusers by means of a container labelingsystem, written notification, or anyother method that adequately informsthem of use restrictions or controls.

(2) A manufacturer of a new chemicalsubstance described in paragraph (c)(2)of this section may distribute thechemical substance only to other per-sons who agree in writing to not fur-ther distribute the substance until ithas been reacted, incorporated into anarticle, or otherwise rendered into a

physical form or state in which envi-ronmental releases and human expo-sures above the eligibility criteria inparagraph (c)(2) of this section are notlikely to occur.

(3) If the manufacturer learns that adirect or indirect customer is process-ing or using the new substance in vio-lation of use restrictions or withoutimposing prescribed worker protectionor environmental release controls, themanufacturer must cease distributionof the substance to the customer or thecustomer’s supplier immediately un-less the manufacturer is able to docu-ment each of the following:

(i) That the manufacturer has, within5 working days, notified the customerin writing that the customer has failedto comply with the conditions specifiedin this section and the exemption no-tice under paragraph (e) of this section.

(ii) That, within 15 working days ofnotifying the customer of the non-compliance, the manufacturer receivedfrom the customer, in writing, a state-ment of assurance that the customer isaware of the terms of this section andthe exemption notice and will complywith those terms.

(4) If, after receiving a statement ofassurance from a customer under para-graph (k)(3)(ii) of this section, themanufacturer obtains knowledge thatthe customer has again failed to com-ply with any of the conditions specifiedin this section or the exemption notice,the manufacturer shall cease supplyingthe new chemical substance to thatcustomer and shall report the failureto comply to EPA within 15 days of ob-taining this knowledge. Within 30 daysof its receipt of the report, EPA willnotify the manufacturer whether, andunder what conditions, distribution ofthe chemical substance to the cus-tomer may resume.

(l) Confidentiality. (1) If the manufac-turer submits information to EPAunder this section which the manufac-turer claims to be confidential businessinformation, the manufacturer mustclearly identify the information at thetime of submission to EPA by bracket-ing, circling, or underlining it andstamping it with ‘‘CONFIDENTIAL’’ orsome other appropriate designation.Any information so identified will be


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treated in accordance with the proce-dures in part 2 of this chapter. Any in-formation not claimed confidential atthe time of submission may be madeavailable to the public without furthernotice.

(2)(i) Any person who asserts a claimof confidentiality for chemical identityunder this paragraph (l) must provide ageneric chemical name that is only asgeneric as necessary to protect theconfidential chemical identity of theparticular chemical substance. Thename should reveal the specific chemi-cal identity to the maximum extentpossible.

(ii) The generic name provided by themanufacturer will be subject to EPAreview and approval in accordance withthe procedures specified in §720.85(b)(6)of this chapter. The generic name pro-vided by the submitter or an alter-native selected by EPA under theseprocedures will be placed on a publiclist of substances exempt under thissection.

(3) If any information is claimed con-fidential, the manufacturer must sub-mit a second copy of the notice with allinformation claimed as confidential de-leted. EPA will place the second copyin the public file.

(m) Exemptions granted under super-seded regulations. Manufacturers hold-ing exemptions granted under the su-perseded requirements of this section(as in effect on May 26, 1995) shall ei-ther continue to comply with those re-quirements (including the productionvolume limit) or apply for a new ex-emption pursuant to this section. EPAwill not accept requests to amend ex-emptions granted under the supersededrequirements; manufacturers wishingto amend such exemptions must sub-mit a new exemption under paragraph(e) of this section. If a new exemptionfor a new chemical substance is grant-ed under this exemption to the manu-facturer holding an exemption underthe superseded requirements, the ex-emption under the superseded require-ments for such substance shall be void.

(n) Submission of information. Informa-tion submitted to EPA under this sec-tion must be sent in writing to theDocument Control Office (7407), Officeof Pollution Prevention and Toxics,U.S. Environmental Protection Agen-

cy, Room G–099, 401 M St., SW., Wash-ington, DC., 20460.

(o) Compliance. (1) Failure to complywith any provision of this section is aviolation of section 15 of the Act (15U.S.C. 2614).

(2) Submitting materially misleadingor false information in connection withthe requirements of any provision ofthis section is a violation of this sec-tion and therefore a violation of sec-tion 15 of the Act (15 U.S.C. 2614).

(3) Violators may be subject to thecivil and criminal penalties in section16 of the Act (15 U.S.C. 2615) for eachviolation.

(4) EPA may seek to enjoin the man-ufacture or processing of a chemicalsubstance in violation of this section,or act to seize any chemical substancemanufactured or processed in violationof this section, or take other actionunder the authority of section 7 of theAct (15 U.S.C. 2606) or section 17 of theAct (15 U.S.C. 1616).

[60 FR 16346, Mar. 29, 1995, as amended at 60FR 34465, July 3, 1995; 62 FR 17932, April 11,1997]

§ 723.175 Chemical substances used inor for the manufacture or process-ing of instant photographic andpeel-apart film articles.

(a) Purpose and scope. (1) This sectiongrants an exemption from thepremanufacture notice requirements ofsection 5(a)(1)(A) of the Toxic Sub-stances Control Act (15 U.S.C.2604(a)(1)(A)) for the manufacture andprocessing of new chemical substancesused in or for the manufacture or proc-essing of instant photographic andpeel-apart film articles. This sectiondoes not apply to microorganisms sub-ject to part 725 of this chapter.

(2) To manufacture a new chemicalsubstance under the terms of this ex-emption, a manufacturer of instantphotographic or peel-apart film arti-cles must:

(i) Submit an exemption notice whenmanufacture begins under paragraph (i)of this section.

(ii) Comply with certain require-ments to limit exposure to the newchemical substance under paragraphs(e), (f), (g), and (h) of this section.


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(iii) Comply with all recordkeepingrequirements under paragraph (j) ofthis section.

(b) Definitions. (1) Act means theToxic Substances Control Act (15U.S.C. 2601 et seq.).

(2) An article is a manufactured item(i) which is formed to a specific shapeor design during manufacture, (ii)which has end use function(s) depend-ent in whole or in part upon its shapeor design during end use, and (iii)which has either no change of chemicalcomposition during its end use or onlythose changes of composition whichhave no commercial purpose separatefrom that of the article and that mayoccur as described in § 710.2 of thischapter except that fluids and particlesare not considered articles regardlessof shape or design.

(3) The term byproduct, EPA, impuri-ties, person, and site have the samemeanings as in § 710.2 of this chapter.

(4) The term category of chemical sub-stances has the same meaning as in sec-tion 26(c)(2) of the Act (15 U.S.C. 2625).

(5) The terms chemical substance, dis-tribute in commerce, distribution in com-merce, environment, manufacture, newchemical substance, and process have thesame meanings as in section 3 of theAct (15 U.S.C. 2602).

(6) Director of the Office of PollutionPrevention and Toxics means the Direc-tor of the EPA Office of Pollution Pre-vention and Toxics or any EPA em-ployee designated by the Office Direc-tor to carry out the Office Director’sfunctions under this section.

(7) The term exemption categorymeans a category of chemical sub-stances for which a person(s) has ap-plied for or been granted an exemptionunder section 5(h)(4) of the Act (15U.S.C. 2604).

(8) The term instant photographic filmarticle means a self-developing photo-graphic film article designed so thatall the chemical substances containedin the article, including the chemicalsubstances required to process the film,remain sealed during distribution anduse.

(9) Intermediate means any chemicalsubstance which is consumed in wholeor in part in a chemical reaction(s)used for the intentional manufacture ofanother chemical substance.

(10) Known to or reasonably ascertain-able means all information in a per-son’s possession or control, plus all in-formation that a reasonable personsimilarly situated might be expected topossess, control, or know, our could ob-tain without unreasonable burden orcost.

(11) The term peel-apart film articlemeans a self-developing photographicfilm article consisting of a positiveimage receiving sheet, a light sensitivenegative sheet, and a sealed reagentpod containing a developer reagent anddesigned so that all the chemical sub-stances required to develop or processthe film will not remain sealed withinthe article during and after the devel-opment of the film.

(12) Photographic article means anyarticle which will become a componentof an instant photographic or peel-apart film article.

(13) Special production area means ademarcated area within which all man-ufacturing, processing, and use of anew chemical substance takes place,except as provided in paragraph (f) ofthis section, in accordance with the re-quirements of paragraph (e) of this sec-tion.

(14) Test data means:(i) Data from a formal or informal

study, test, experiment, recorded ob-servation, monitoring, or measure-ment.

(ii) Information concerning the ob-jectives, experimental methods andmaterials, protocols, results, data anal-yses (including risk assessments), andconclusions from a study, test, experi-ment, recorded observation, monitor-ing, or measurement.

(15) Used in or for the manufacturing orprocessing of an instant photographic orpeel-apart film article, when used to de-scribe activities involving a new chem-ical substance, means the new chemi-cal substance (i) is included in the arti-cle, or (ii) is an intermediate to achemical substance included in the ar-ticle or is one of a series of intermedi-ates used to manufacture a chemicalsubstance included in the article.

(16) Wet mixture means a water or or-ganic solvent-based suspension, solu-tion, dispersion, or emulsion used inthe manufacture of an instant photo-graphic or peel-apart film article.


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(c) Exemption category. The exemptioncategory includes new chemical sub-stances used in or for the manufactureor processing of instant photographicor peel-apart film articles which aremanufactured and processed under theterms of this section.

(d) Applicability. This exemption ap-plies only to manufacturers of instantphotographic or peel-apart film arti-cles who:

(1) Manufacture the new chemicalsubstances used in or for the manufac-ture or processing of the instant photo-graphic or peel-apart film articles.

(2) Limit manufacture and processingof a new chemical substance to thesite(s) listed in the exemption noticefor that new chemical substance sub-mitted under paragraph (i) of this sec-tion.

(3) Comply with the requirements ofparagraphs (e), (f), (g), (h), and (j) ofthis section.

(4) Do not distribute in commerce oruse a peel-apart film article containinga new chemical substance until submis-sion of a premanufacture notice undersection 5(a)(1)(A) of the Act (15 U.S.C.2604) and until the review period for thenotice has ended without EPA actionto prevent distribution or use.

(e) Conditions of manufacture and proc-essing in the special production area. Allmanufacturing, processing, and use op-erations involving the new chemicalsubstance must be performed in a spe-cial production area under the condi-tions set forth in this paragraph untilthe new chemical substance has beenincorporated into a wet mixture, pho-tographic article, or instant photo-graphic or peel-apart film article.

(1) Exposure limits. In the special pro-duction area, the ambient air con-centration of the new chemical sub-stance during manufacture, processing,and use cannot exceed an 8-hour timeweighted average (TWA) of 10 ppm forgases and vapors and 50 µg/m3for partic-ulates, with an allowable TWA excur-sion of 50 percent above those con-centrations for a duration of 30 min-utes or less.

(2) Respiratory protection—(i) Res-pirator requirement. Except as specifiedin paragraph (e)(2)(ii) of this section,each person in the special productionarea must wear an appropriate res-

piratory protection device to protectagainst dusts, fumes, vapors, and otherairborne contaminants, as described in29 CFR 1910.134. Selection of an appro-priate respirator must be made accord-ing to the guidance of American Na-tional Standard Practices for Res-piratory Protection Z88.2–1969 and theNIOSH Certified Equipment List, U.S.Department of Health and HumanServices, NIOSH publication No. 80–144.

(ii) Waiver of respirator requirement.Employees are not required to wearrespirators if monitoring informationcollected and analyzed in accordancewith paragraph (e)(3) of this sectiondemonstrates that the ambient 8-hourTWA concentration of the new chemi-cal substance in the area is less than 1ppm for gases and vapors and 5 µg/m3forparticulates with an allowable TWA ex-cursion of 50 percent above these con-centrations for a duration of 30 min-utes or less.

(iii) Quantitative fit test. Each res-pirator must be issued to a specific in-dividual for personal use. A quan-titative fit test must be performed foreach respirator before its first use bythat person in a special productionarea.

(3) Monitoring—(i) When to monitor.(A) When suitable sampling and ana-lytic methods exist, periodic monitor-ing in accordance with this paragraphmust be done to ensure compliancewith the exposure limits of paragraphs(e)(1) and (2)(ii) of this section.

(B) When suitable sampling and ana-lytic methods do not exist, compliancewith the exposure limits of paragraph(e)(1) and the requirements of para-graph (e)(10) of this section must be de-termined by an evaluation of monitor-ing data developed for a surrogatechemical substance possessing com-parable physical-chemical propertiesunder similar manufacturing and proc-essing conditions.

(ii) Monitoring methods. A suitable airsampling method must permit personalor fixed location sampling by conven-tional collection methods. A suitableanalytic method must have adequatesensitivity for the volume of sampleavailable and be specific for the newchemical substance being monitored. Ifchemical-specific monitoring methodsare not available, nonspecific methods


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may be used if the concentration of thenew chemical substance is assumed tobe the total concentration of chemicalsubstances monitored.

(iii) Monitoring frequency. (A) Whensuitable air sampling and analyticalprocedures are available, monitoringmust be done in each special produc-tion area during the first three 8-hourwork shifts involving the manufactureor processing of each new chemicalsubstance. Thereafter, monitoringmust be done in each special produc-tion area for at least one 8-hour periodper month, during a production run inwhich the new chemical substance ismanufactured or processed. Samplesmust be of such frequency and patternas to represent with reasonable accu-racy the mean level and maximum 30-minute level of employee exposure dur-ing an 8-hour work shift. In monitoringfor an 8-hour work shift or the equiva-lent, samples must be collected peri-odically or continuously for the dura-tion of the 8-hour work shift. Samplesmust be taken during a period which islikely to represent the maximum em-ployee exposure.

(B) If the manufacturer demonstratescompliance with the exposure limitsfor 3 consecutive months, further mon-itoring of the identical process must beperformed only every 6 months there-after, unless there is a significantchange in the process, process design,or equipment. If there is such a change,the manufacturer must begin monitor-ing again according to the schedule inparagraph (e)(3)(iii)(A) of this section.

(iv) Location of monitoring. Air sam-ples must be taken so as to ensure thatthe samples adequately represent theambient air concentration of a newchemical substance present in eachworker’s breathing zone.

(4) Engineering controls and exposuresafeguards. Engineering controls suchas, but not limited to, isolation, enclo-sure, local exhaust ventilation, anddust collection must be used to ensurecompliance with the exposure limitsprescribed in paragraphs (e)(1) or(e)(2)(ii) of this section.

(5) Training, hygiene, and work prac-tices—(i) Training. No employee mayenter a special production area beforethe completion of a training program.The training program must be adapted

to the individual circumstances of themanufacturer and must address: Theknown physical-chemical and toxi-cological properties of the chemicalsubstances handled in the area; proce-dures for using and maintaining res-pirators and other personal safeguards;applicable principles of hygiene; spe-cial handling procedures designed tolimit personal exposure to, and inad-vertent release of, chemical sub-stances; and procedures for respondingto emergencies or spills.

(ii) Hygiene. Appropriate standards ofhygiene must be observed by all em-ployees handling a new chemical sub-stance in manufacturing, processing, ortransfer operations. The manufacturermust provide appropriate facilities foremployee changing and wash-up. Food,beverages, tobacco products, and cos-metics must not be allowed in specialproduction areas.

(iii) Work practices. Operating proce-dures such as those related to chemicalweighing and filtering, or the charging,discharging and clean-up of processequipment, must be designed and con-ducted to ensure compliance with theexposure limits prescribed in para-graph (e)(1) or (e)(2)(ii) of this section.Written procedures and all materialsnecessary for responding to emergencysituations must be immediately acces-sible to all employees in a special pro-duction area. Any spill or unantici-pated emission must be controlled byspecially trained personnel using theequipment and protective clothing de-scribed in paragraph (e)(6) of this sec-tion.

(6) Personal protection devices. Allworkers engaged in the manufactureand processing of a new chemical sub-stance in the special production areamust wear suitable protective clothingor equipment, such as chemical-resist-ant coveralls, protective eyewear, andgloves.

(7) Caution signs. Each special produc-tion area must be clearly posted withsigns identifying the area as a specialproduction area where new chemicalsubstances are manufactured and proc-essed under controlled conditions. Eachsign must clearly restrict entry intothe special production area to qualifiedpersonnel who are properly trained and


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equipped with appropriate personal ex-posure safeguards.

(8) Removal for storage or transpor-tation. A new chemical substance thatis not incorporated into a wet mixture,photographic article, or instant photo-graphic or peel-apart film article maybe removed from the special productionarea for purposes of storage betweenoperational steps or for purposes oftransportation to another special pro-duction area. Such storage or transpor-tation must be conducted in a mannerthat limits worker and environmentalexposure through the use of engineer-ing controls, training, hygiene, workpractices, and personal protective de-vices appropriate to the chemical sub-stance in question.

(9) Labeling. (i) Any new chemicalsubstance removed from a special pro-duction area or stored or transportedbetween operational steps must beclearly labeled. The label must showthe identity of the new chemical sub-stance or an appropriate identificationcode, a statement of any known haz-ards associated with it, a list of specialhandling instructions, first aid infor-mation, spill control directions, andwhere applicable, the appropriate U.S.Department of Transportation nota-tions.

(ii) No label is required if the newchemical substance has been incor-porated into a photographic article, orif it is contained in a sealed reactionvessel or pipeline, or if it has been in-corporated into an instant photo-graphic or peel-apart film article.

(10) Areas immediately adjacent to thespecial production area. The ambient airconcentration of the new chemical sub-stance in areas immediately adjacentto the special production area must notexceed the exposure limit establishedin paragraph (e)(2)(ii) of this sectionfor waiver of respirator protectionwithin the special production area.Periodic monitoring in accordancewith paragraph (e)(3) of this sectionmust be performed in immediately ad-jacent areas where it is reasonable toexpect a risk of inhalation exposure.

(f) Conditions of processing outside thespecial production area. A wet mixturemay be incorporated into a photo-graphic article or an instant photo-graphic or peel-apart film article out-

side the special production area underthe conditions listed in this paragraph:

(1) Engineering controls and exposuresafeguards. Engineering controls mustlimit the exposure to a new chemicalsubstance contained in a wet mixture.

(2) Training, hygiene and work prac-tices—(i) Training. Training of employ-ees involved in the handling of wetmixtures containing a new chemicalsubstance must be adapted to the indi-vidual circumstances of the employees’activities and must address: Proce-dures for using personal exposure safe-guards, applicable principles of hy-giene, handling procedures designed tolimit personal exposure, and proce-dures for responding to emergenciesand spills.

(ii) Hygiene. Appropriate standards ofhygiene that limit exposure must beobserved by all employees handling wetmixtures that contain new chemicalsubstances.

(iii) Work practices. Work practicesand operating procedures must be de-signed to limit exposure to any newchemical substance contained in wetmixtures. Any spills or unanticipatedreleases of a wet mixture must be con-trolled by trained personnel wearingappropriate protective clothing orequipment such as gloves, eye protec-tion, and, where necessary, respiratorsor chemically imprevious clothing.

(3) Personal protection devices. Allworkers engaged in the processing of awet mixture containing a new chemicalsubstance must wear suitable protec-tive clothing or equipment such as cov-eralls, protective eyewear, respirators,and gloves.

(g) Incorporation of photographic arti-cles into instant photographic and peel-apart film articles. A photographic arti-cle may be incorporated into the in-stant photographic or peel-apart filmarticle outside the special productionarea. The manufacturer must takemeasures to limit worker and environ-mental exposure to new chemcial sub-stances during these operations usingengineering controls, training, hy-giene, work practices, and personalprotective devices.

(h) Environmental release and wastetreatment—(1) Release to land. Process


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waste from manufacturing and process-ing operations in the special produc-tion area that contain a new chemicalsubstance are considered to be hazard-ous waste and must be handled in ac-cordance with the requirements ofparts 262 through 267 and parts 122 and124 of this chapter.

(2) Release to water. All wastewater ordischarge which contain the newchemcial subtance must be appro-priately pretreated before release to aPublicly Owned Treatment Works(POTW) or other receiving body ofwater. In the case of release to aPOTW, the pretreatment must preventstructural damage to, obstruction of,or interference with the operation ofthe POTW. The treatment of direct re-lease to a receiving body of water mustbe appropriate for the new chemicalsubstance’s physical-chemical prop-erties and potential toxicity.

(3) Release to air. All process emis-sions released to the air which containthe new chemical substance must bevented through control devices appro-priate for the new chemical substance’sphysical-chemical properties and po-tential toxicity.

(i) Exemption notice. An exemptionnotices must be submitted to EPAwhen manufacture of the new chemicalsubstance begins.

(1) Contents of exemption notice. Theexemption notice must include the fol-lowing information:

(i) Manufacturer and sites. The noticemust identify the manufacturer andthe sites and locations where the newchemical substance and the instantphotographic or peel-apart film arti-cles will be manufactured and proc-essed.

(ii) Chemical identification. The noticemust identify the new chemical sub-stance as follows:

(A) Class 1 substances. For chemicalsubstances whose composition can berepresented by a definite structuraldisagram (Class 1 substances), the no-tice must provide the chemical name(preferably CAS or IUPAC nomen-clature), the molecular formula, CASRegistry Number (if available), knownsynonyms (including trade names), anda structural diagram.

(B) Class 2 substances. For chemicalsubstances that cannot be fully rep-

resented by a structural diagram,(Class 2 substances), the notice mustprovide the chemical name, the molec-ular formula, the CAS Registry Num-ber (if available), and known synonyms(including trade names). The noticemust identify the immediate precur-sors and reactants by name and CASRegistry Number (if available). The no-tice must include a partial or incom-plete structural diagram, if available.

(C) Polymers. For a polymer, the no-tice must indentify monomers andother reactants used in the manufac-ture of the polymer by chemical nameand CAS Registry Number. The noticemust indicate the amount of each mon-omer used (by weight percent of totalmonomer); the maximum residual ofeach monomer present in the polymer;and a partial or incomplete structuraldiagram, if available. The notice mustindicate the number average molecularweight of the polymer and characterizethe anticipated low molecular weightspecies. The notice must include thisinformation for each typical averagemolecular weight composition of thepolymer to be manufactured.

(iii) Impurities. The notice must iden-tify the impurities that can be reason-ably anticipated to be present in thenew chemcial substance when manu-factured under the exemption by nameand CAS Registry Number, by class ofsubstances, or by process or source.The notice also must estimate themaximum percent (by weight) of eachimpurity in the new chemical sub-stance and the percent of unknown im-purities present.

(iv) Physical-chemical properties. Thenotice must describe the physical-chemical properties of the new chemi-cal substance. Where specific physical-chemical data are not available, rea-sonable estimates and the techniquesused to develop these estimates mustbe provided.

(v) Byproducts. The notice must iden-tify the name, CAS Registry number (ifavailable), and the volume of each by-product that would be manufacturedduring manufacture of the new chemi-cal substance.

(vi) Production volume. The noticemust include an estimate of the antici-pated maximum annual production vol-ume.


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(vii) Test data. The notice must in-clude all information and test data onthe new chemical substance’s healthand environmental effects that areknown to or reasonably ascertainableby the manufacturer.

(viii) Identity of the article. The noticemust identify and describe the instantphotographic film article(s) or peel-apart film article(s) that will containthe new chemical substance.

(ix) Release to water. The notice mustinclude a description of the methodsused to control and treat wastewateror discharge released to a POTW orother receiving body of water. The no-tice must also identify the POTW or re-ceiving body of water.

(x) Certification. The manufacturermust certify in the notice that it is fa-miliar with the terms of the exemptionand that the manufacture, processing,distribution, use, and disposal of thenew chemical substance will complywith those terms.

(2) Duplication of information inpremanufacture notice. If a manufac-turer who submits an exemption noticeunder this paragraph has already sub-mitted, or simultaneously submits, apremanufacture notice under section5(a)(1)(A) of the Act for the new chemi-cal substance, it may, in lieu of sub-mitting the information required bythis paragraph, reference the requiredinformation to the extent it is includedin the premanufacture notice. At aminimum, the exemption notice mustidentify the manufacturer and the newchemical substance, and contain thecertification required by paragraph(i)(1)(x) of this section.

(3) Address. The exemption noticemust be addressed to the DocumentControl Office (7407), Office of Pollu-tion Prevention and Toxics, U.S. Envi-ronmental Protection Agency, RoomG–099, 401 M St., SW., Washington, DC.,20460.

(j) Recordkeeping. (1) Manufacturersof a new chemical substance under thisexemption must keep the followingrecords for 30 years from the final dateof manufacture.

(i) Production records. Each manufac-turer must maintain records of the an-nual production volume of each newchemical substance manufacturedunder the terms of the exemption. This

record must indicate when manufac-ture of the new chemical substancebegan.

(ii) Exposure monitoring records. Man-ufacturers must maintain an accuraterecord of all monitoring required bythis section. Monitoring records maybe adapted to the individual cir-cumstances of the manufacturer but,at a minimum, must contain the fol-lowing information: The chemical iden-tity of the new chemical substance,date of the monitoring, the actualmonitoring data for each monitoringlocation and sampling, and a referenceto or description of the collection andanalytic techniques. If the manufac-turer does not monitor, the manufac-turer must maintain a record of thereasons for not monitoring and themethods used to determine compliancewith the exposure limits of paragraph(e)(1) of this section.

(iii) Training and exposure records. Foreach employee engaged in the manu-facture or processing of a new chemicalsubstance, the company must developand maintain a record of the worker’sparticipation in required training. Thisrecord must also demonstrate the regu-lar use of personal exposure safeguards,including the results of any personalexposure monitoring, the results of thequantitative fit test for the worker’spersonal respirator, and any additionalinformation related to the worker’s oc-cupational exposure.

(iv) Treatment records. Manufacturerswho release treated wastewater or dis-charge containing a new chemical sub-stance to a POTW or other receivingbody of water must maintain records ofthe method of treatment.

(2) The manufacturer must make therecords listed in paragraph (j)(1) of thissection available to EPA upon writtenrequest by the Director of the Office ofPollution Prevention and Toxics. Themanufacturer must provide theserecords within 15 working days of re-ceipt of this request.

(k) Confidentiality. If the manufac-turer submits information under para-graph (i) or (j) of this section which itclaims to be confidential business in-formation, the manufacturer mustclearly identify the information at thetime of submission to the Agency bybracketing, circling, or underlining it


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and stamping it with ‘‘CONFIDEN-TIAL’’ or some other appropriate des-ignation. Any information so identifiedwill be treated in accordance with theprocedures in part 2 of this chapter.Any information not claimed confiden-tial at the time of submission will bemade available to the public withoutfurther notice to the submitter.

(l) Amendment and repeal. (1) EPAmay amend or repeal any term of thisexemption if it determines that themanufacture, processing, distribution,use, and disposal of new chemical sub-stances under the terms of the exemp-tion may present an unreasonable riskof injury to health or the environment.EPA also may amend this exemption toenlarge the exemption category or toreduce the restrictions or conditions ofthe exemption.

(2) As required by section 5(h)(4) ofthe Act, EPA will amend or repeal thesubstantive terms of an exemptiongranted under this part only by the for-mal rulemaking procedures describedin section 6(c)(2) and (3) of the Act (15U.S.C. 2605(c)).

(m) Prohibition of use of the exemption.The Director of the Office of PollutionPrevention and Toxics may prohibitthe manufacture, processing, distribu-tion, use, or disposal of any new chemi-cal substance under the terms of thisexemption if he or she determines thatthe manufacture, processing, distribu-tion in commerce, use, or disposal ofthe new chemical substance maypresent an unreasonable risk of injuryto health or the environment.

(n) Enforcement. (1) A failure to com-ply with any provision of this part is aviolation of section 15 of the Act (15U.S.C. 2614).

(2) Submitting materially misleadingor false information in connection withthe requirements of any provision ofthis part is a violation of this regula-tion and therefore a violation of sec-tion 15 of the Act (15 U.S.C. 2614).

(3) Violators may be subject to thecivil and criminal penalties in section16 of the Act (15 U.S.C. 2615) for eachviolation.

(4) EPA may seek to enjoin the man-ufacture of a new chemical substancein violation of this exemption or act toseize any chemical substances manu-factured in violation of the exemption

under the authority of section 17 of theAct (15 U.S.C. 2616).

[47 FR 24317, June 4, 1982, as amended at 53FR 12523, Apr. 15, 1988; 60 FR 34465, July 3,1995; 62 FR 17932, April 11, 1997]

§723.250 Polymers.(a) Purpose and scope. (1) This section

grants an exemption from certain ofthe premanufacture notice require-ments of section 5(a)(1)(A) of the ToxicSubstances Control Act (15 U.S.C.2604(a)(1)(A)) for the manufacture ofcertain polymers. This section does notapply to microorganisms subject topart 725 of this chapter.

(2) To manufacture a new chemicalsubstance under the terms of this sec-tion, a manufacturer must:

(i) Determine that the substancemeets the definition of polymer inparagraph (b) of this section.

(ii) Determine that the substance isnot specifically excluded by paragraph(d) of this section.

(iii) Ensure that the substance meetsthe exemption criteria of paragraph (e)of this section.

(iv) Submit a report as requiredunder paragraph (f) of this section.

(v) Comply with the recordkeepingrequirements of paragraph (j) of thissection.

(b) Definitions. In addition to the defi-nitions under section 3 of the Act, 15U.S.C. 2602, the following definitionsapply to this part.

Act means the Toxic Substances Con-trol Act (15 U.S.C. 2601 et seq.).

Biopolymer means a polymer directlyproduced by living or once-living cellsor cellular components.

Category of chemical substances hasthe same meaning as in section 26(c)(2)of the Act (15 U.S.C. 2625).

Cationic polymer means a polymerthat contains a net positively chargedatom(s) or associated groups of atomscovalently linked to its polymer mol-ecule.

Chemical substance, Director, EPA, im-porter, impurity, Inventory, known to orreasonably ascertainable, manufacture,manufacturer, mixture, new chemical,person, possession or control, process andtest data have the same meanings as in§720.3 of this chapter.

Equivalent weight of a functional groupmeans the ratio of the molecular


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weight to the number of occurrences ofthat functional group in the molecule.It is the weight of substance that con-tains one formula-weight of the func-tional group.

Internal monomer unit means a mono-mer unit that is covalently bonded toat least two other molecules. Internalmonomer units of polymer moleculesare chemically derived from monomermolecules that have formed covalentbonds between two or more other mon-omer molecules or other reactants.

Monomer means a chemical substancethat is capable of forming covalentbonds with two or more like or unlikemolecules under the conditions of therelevant polymer-forming reactionused for the particular process.

Monomer Unit means the reacted formof the monomer in a polymer.

Number-average molecular weightmeans the arithmetic average (mean)of the molecular weight of all mol-ecules in a polymer.

Oligomer means a polymer moleculeconsisting of only a few monomer units(dimer, trimer, tetramer)

Other reactant means a moleculelinked to one or more sequences ofmonomer units but which, under therelevant reaction conditions used forthe particular process, cannot becomea repeating unit in the polymer struc-ture.

Polyester means a chemical substancethat meets the definition of polymerand whose polymer molecules containat least two carboxylic acid ester link-ages, at least one of which links inter-nal monomer units together.

Polymer means a chemical substanceconsisting of molecules characterizedby the sequence of one or more types ofmonomer units and comprising a sim-ple weight majority of molecules con-taining at least 3 monomer units whichare covalently bound to at least oneother monomer unit or other reactantand which consists of less than a sim-ple weight majority of molecules of thesame molecular weight. Such mol-ecules must be distributed over a rangeof molecular weights wherein dif-ferences in the molecular weight areprimarily attributable to differences inthe number of monomer units. In thecontext of this definition, sequencemeans that the monomer units under

consideration are covalently bound toone another and form a continuousstring within the molecule, uninter-rupted by units other than monomerunits.

Polymer molecule means a moleculewhich contains a sequence of at least 3monomer units which are covalentlybound to at least one other monomerunit or other reactant.

Reactant means a chemical substancethat is used intentionally in the manu-facture of a polymer to become chemi-cally a part of the polymer composi-tion.

Reactive functional group means anatom or associated group of atoms in achemical substance that is intended orcan reasonably be anticipated to under-go further chemical reaction.

Reasonably anticipated means that aknowledgeable person would expect agiven physical or chemical compositionor characteristic to occur based onsuch factors as the nature of the pre-cursors used to manufacture the poly-mer, the type of reaction, the type ofmanufacturing process, the productsproduced in polymerization, the in-tended uses of the substance, or associ-ated use conditions.

(c) Applicability. This section appliesto manufacturers of new chemical sub-stances that otherwise must submit apremanufacture notice to EPA under§720.22 of this chapter. New substancesare eligible for exemption under thissection if they meet the definition of‘‘polymer’’ in paragraph (b) of this sec-tion, and the criteria in paragraph (e)of this section, and if they are not ex-cluded from the exemption under para-graph (d) of this section.

(d) Polymers that cannot be manufac-tured under this section—(1) Cationicpolymers. A polymer cannot be manu-factured under this section if the poly-mer is a cationic polymer as definedunder paragraph (b) of this section or ifthe polymer is reasonably anticipatedto become a cationic polymer in a nat-ural aquatic environment (e.g., rivers,lakes) unless:

(i) The polymer is a solid materialthat is not soluble or dispersible inwater and will be used only in the solidphase (e.g., polymers that will be usedas ion exchange beads), or


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(ii) The combined (total) functionalgroup equivalent weight of cationicgroups in the polymer is equal to orgreater than 5,000.

(2) Elemental limitations. (i) A polymermanufactured under this section mustcontain as an integral part of its com-position at least two of the atomic ele-ments carbon, hydrogen, nitrogen, oxy-gen, silicon, and sulfur.

(ii) A polymer cannot be manufac-tured under this section if it containsas an integral part of its composition,except as impurities, any elementsother 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 monatomiccounterions Na∂, Mg∂2, Al∂3, K∂,Ca∂2, Cl-, Br-, or I-.

(C) Fluorine, chlorine, bromine, andiodine covalently bound to carbon.

(D) Less than 0.20 weight percent ofany combination of the atomic ele-ments lithium, boron, phosphorus, tita-nium, manganese, iron, nickel, copper,zinc, tin, and zirconium.

(3) Polymers which degrade, decompose,or depolymerize. A polymer cannot bemanufactured under this section if thepolymer is designed or is reasonablyanticipated to substantially degrade,decompose, or depolymerize, includingthose polymers that could substan-tially decompose after manufactureand use, even though they are not actu-ally intended to do so. For the purposesof this section, degradation, decompo-sition, or depolymerization mean thosetypes of chemical change that converta polymeric substance into simpler,smaller substances, through processesincluding but not limited to oxidation,hydrolysis, attack by solvents, heat,light, or microbial action.

(4) Polymers manufactured or importedfrom monomers and reactants not on theTSCA Chemical Substance Inventory. Apolymer cannot be manufactured underthis section if the polymer being manu-factured or imported is prepared frommonomers and/or other reactants (thatare either charged to the reaction ves-sel or incorporated in the polymer atlevels of greater than 2 weight percent)that are not already included on theTSCA Chemical Substance Inventory

or manufactured under an applicableTSCA section 5 exemption.

(5) Water absorbing polymers with num-ber average molecular weight (MW) 10,000and greater. A polymer cannot be man-ufactured under this section if thepolymer being manufactured or im-ported is a water absorbing polymerand has a number average MW greaterthan or equal to 10,000 daltons. For pur-poses of this section, a water-absorbingpolymer is a polymeric substance thatis capable of absorbing its weight ofwater.

(e) Exemption criteria. To be manufac-tured under this section, the polymermust meet one of the following cri-teria:

(1) Polymers with number average MWgreater than or equal to 1,000 and lessthan 10,000 daltons (and oligomer contentless than 10 percent below MW 500 andless than 25 percent below MW 1,000). (i)The polymer must have a number aver-age MW greater than or equal to 1,000and less than 10,000 daltons and containless than 10 percent oligomeric mate-rial below MW 500 and less than 25 per-cent oligomeric material below MW1,000.

(ii) The polymer cannot contain reac-tive functional groups unless it meetsone of the following criteria:

(A) The polymer contains only thefollowing reactive functional groups:carboxylic acid groups, aliphatichydroxyl groups, unconjugated olefinicgroups that are considered ‘‘ordi-nary,’’(i.e., not specially activated ei-ther by being part of a larger func-tional group, such as a vinyl ether, orby other activating influences, e.g.,strongly electron-withdrawing sulfonegroup with which the olefinic groupsinteract), butenedioic acid groups,those conjugated olefinic groups con-tained in naturally-occurring fats, oils,and carboxylic acids, blockedisocyanates (including ketoxime-blocked isocyanates), thiols,unconjugated nitrile groups, andhalogens (except that reactive halogen-containing groups such as benzylic orallylichalides cannot be included).

(B) The polymer has a combined(total) reactive group equivalentweight greater than or equal to 1,000for the following reactive functionalgroups: acidhalides; acid anhydrides;


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aldehydes, hemiacetals;methylolamides,- amines or,- ureas;alkoxysilanes with alkoxy greater thanC2-alkoxysilanes; allyl ethers; con-jugated olefins;cyanates; epoxides;imines; or unsubstituted positionsortho or para to phenolic hydroxyl; or

(C) If any reactive functional groupsnot included in paragraph (e)(1)(ii)(A)and (B) of this section are present, thecombined (total) reactive group equiva-lent weight, including any groups list-ed in paragraph (e)(1)(ii)(B), is greaterthan or equal to 5,000.

(2) Polymers with number average MWgreater than or equal to 10,000 (andoligomer content less than 2 percent belowMW 500 and less than 5 percent belowMW 1,000) . The polymer must have anumber average MW greater than orequal to 10,000 daltons and contain lessthan 2 percent oligomeric materialbelow MW 500 and less than 5 percentoligomeric material below MW 1000.

(3) Polyester polymers. The polymer isa polyester as defined in paragraph (b)of this section and is manufacturedsolely from one or more of thereactants in the following table 1:

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

Reactant CAS No.

Monobasic Acids and Natural OilsBenzoic acid ................................................................................................................................................... 65–85–0Canola oil ....................................................................................................................................................... 120962–03–0Coconut oil ..................................................................................................................................................... 8001–31–8*Corn oil ........................................................................................................................................................... 8001–30–7*Cottonseed oil ................................................................................................................................................ 8001–29–4*Dodecanoic acid ............................................................................................................................................. 143–07–7Fats 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,C16-18 and C18-unsatd. ................................................................................................................. 67701–08–0*Fatty acids, castor-oil ..................................................................................................................................... 61789–44–4*Fatty acids, coco ............................................................................................................................................ 61788–47–4*Fatty acids, dehydrated castor-oil .................................................................................................................. 61789–45–5*Fatty acids, linseed oil .................................................................................................................................... 68424–45–3*Fatty acids, safflower oil .................................................................................................................................Fatty acids, soya ............................................................................................................................................ 68308–53–2*Fatty acids, sunflower oil ................................................................................................................................ 84625–38–7*Fatty acids, sunflower-oil, conjugated ............................................................................................................ 68953–27–5*Fatty acids, tall-oil .......................................................................................................................................... 61790–12–3*Fatty acids, tall-oil, conjugated* .....................................................................................................................Fatty acids, vegetable oil ............................................................................................................................... 61788–66–7*Glycerides, C16-18 and C18-unsatd. ................................................................................................................ 67701–30–8*Heptanoic acid ................................................................................................................................................ 111–14–8Hexanoic acid ................................................................................................................................................. 142–62–1Hexanoic acid, 3,3,5-trimethyl- ....................................................................................................................... 3302–10–1Linseed oil ...................................................................................................................................................... 8001–26–1*Linseed oil, oxidized ....................................................................................................................................... 68649–95–6*Nonanoic acid ................................................................................................................................................. 112–05–0Oils, Cannabis* ...............................................................................................................................................Oils, palm kernel ............................................................................................................................................ 8023–79–8*Oils, perilla ...................................................................................................................................................... 68132–21–8*Oils, walnut ..................................................................................................................................................... 8024–09–7Safflower 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 ......................................................................................................................... 88–99–31,3-Benzenedicarboxylic acid ......................................................................................................................... 121–91–51,3-Benzenedicarboxylic acid, dimethyl ester ................................................................................................ 1459–93–41,4-Benzenedicarboxylic acid ......................................................................................................................... 100–21–01,4-Benzenedicarboxylic acid, diethyl ester ................................................................................................... 636–09–91,4-Benzenedicarboxylic acid, dimethyl ester ................................................................................................ 120–61–61,2,4-Benzenetricarboxylic acid ..................................................................................................................... 528–44–9Butanedioic acid ............................................................................................................................................. 110–15–6Butanedioic acid, diethyl ester ....................................................................................................................... 123–25–1Butanedioic acid, dimethyl ester .................................................................................................................... 106–65–0


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

Reactant CAS No.

2-Butenedioic acid (E)– .................................................................................................................................. 110–17–8Decanedioic acid ............................................................................................................................................ 111–20–6Decanedioic acid, diethyl ester ...................................................................................................................... 110–40–7Decanedioic acid, dimethyl ester ................................................................................................................... 106–79–6Dodecanedioic acid ........................................................................................................................................ 693–23–2Fatty acids, C18-unsatd., dimers .................................................................................................................... 61788–89–4*Heptanedioic acid ........................................................................................................................................... 111–16–0Heptanedioic acid, dimethyl ester .................................................................................................................. 1732–08–7Hexanedioic acid ............................................................................................................................................ 124–04–9Hexanedioic acid, dimethyl ester ................................................................................................................... 627–93–0Hexanedioic acid, diethyl ester ...................................................................................................................... 141–28–6Nonanedioic acid ............................................................................................................................................ 123–99–9Nonanedioic acid, dimethyl ester ................................................................................................................... 1732–10–1Nonanedioic acid, diethyl ester ...................................................................................................................... 624–17–9Octanedioic acid ............................................................................................................................................. (505–48–6)Octanedioic acid, dimethyl ester .................................................................................................................... 1732–09–8Pentanedioic acid ........................................................................................................................................... (110–94–1)Pentanedioic acid, dimethyl ester .................................................................................................................. 1119–40–0Pentanedioic acid, diethyl ester ..................................................................................................................... 818–38–2Undecanedioic acid ........................................................................................................................................ 1852–04–6

Polyols1,3-Butanediol ................................................................................................................................................ 107–88–01,4-Butanediol ................................................................................................................................................ 110–63–41,4-Cyclohexanedimethanol ........................................................................................................................... 105–08–81,2-Ethanediol ................................................................................................................................................ 107–21–1Ethanol, 2,2′-oxybis- ....................................................................................................................................... 111–46–61,6-Hexanediol ............................................................................................................................................... 629–11–81,3-Pentanediol, 2,2,4-trimethyl- .................................................................................................................... 144–19–41,2-Propanediol, ............................................................................................................................................. 57–55–61,3-Propanediol, 2,2-bis(hydroxymethyl)- ...................................................................................................... 115–77–51,3-Propanediol, 2,2-dimethyl- ....................................................................................................................... 126–30–71,3-Propanediol, 2-ethyl-2-(hydroxymethyl)- .................................................................................................. 77–99–61,3-Propanediol, 2-(hydroxymethyl)-2-methyl- ............................................................................................... 77–85–01,3-propanediol, 2-methyl ............................................................................................................................... 2163–42–01,2,3-Propanetriol ........................................................................................................................................... 56–81–51,2,3-Propanetriol, homopolymer ................................................................................................................... 25618–55–72-Propen-1-ol, polymer with ethenylbenzene ................................................................................................ 25119-62–4

ModifiersAcetic acid, 2,2′-oxybis- ................................................................................................................................. 110–99–61-Butanol ........................................................................................................................................................ 71–36–3**Cyclohexanol .................................................................................................................................................. 108–93–0Cyclohexanol, 4,4′-(1-methylethylidene)bis- .................................................................................................. 80–04–6Ethanol, 2-(2-butoxyethoxy)- .......................................................................................................................... 112–34–51-Hexanol ....................................................................................................................................................... 111–27–3Methanol, hydrolysis products with trichlorohexylsilane and trichlorophenylsilane ....................................... 72318–84–4*1-Phenanthrenemethanol, tetradecahydro-1,4a-dimethyl-7-(1-methylethyl)- ................................................. 13393–93–6Phenol, 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-termi-

nated.168957–06–2*

Silsesquioxanes, Ph Pr .................................................................................................................................. 168037–90–1*

* Chemical substance of unknown or variable composition,complex reaction products, and biological materials (UVCB). TheCAS 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 as-sociated with esters, which may be formed by reaction of these reactants.

(f) Exemption report for polymers manu-factured under the terms of this section.For substances exempt under para-graphs (e)(1), (e)(2), and (e)(3) of thissection a report of manufacture or im-port must be submitted (postmarked)by January 31 of the year subsequent

to initial manufacture. The noticemust include:

(1) Manufacturer’s name. This includesthe name and address of the manufac-turer and the name and telephone num-ber of a technical contact.

(2) Number of substances manufactured.Number of substances manufactured.


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The manufacturer must identify thenumber of polymers manufacturedunder terms of the exemption for thefirst time in the year preceding the no-tice.

(g) Chemical identity information. Forsubstances exempt under paragraph (e)of this section the manufacturer mustto the extent known to or reasonablyascertainable by the manufactureridentify the following and maintain therecords in accordance with paragraph(j) of this section:

(1) A specific chemical name and CASRegistry Number (or EPA assigned Ac-cession Number) for each ‘‘reactant,’’as that term is defined in paragraph (b)of this section, used at any weight inthe manufacture of the polymer. Forpurposes of determining chemical iden-tity, the manufacturer may determinewhether a reactant is used at greaterthan two weight percent according toeither the weight of the reactantcharged to the reaction vessel or theweight of the chemically combined (in-corporated) reactant in the polymer.Manufacturers who choose the ‘‘incor-porated’’ method must have analyticaldata, or theoretical calculations (if itcan be documented that an analyticaldetermination cannot be made or is notnecessary), to demonstrate compliancewith this paragraph. Reactants that in-troduce into the polymer elements,properties, or functional groups thatwould render the polymer ineligible forthe exemption are not allowed at anylevel.

(2) A representative structural dia-gram, if possible.

(h) Certification. To manufacture asubstance under the terms of this sec-tion, a manufacturer must as of thedate of first manufacture, make thefollowing certification statements andmaintain them in accordance withparagraph (j) of this section:

(1) The substance is manufactured orimported for a commercial purposeother than for research and develop-ment.

(2) All information in the certifi-cation is truthful.

(3) The new chemical substancemeets the definition of a polymer, isnot specifically excluded from the ex-emption in paragraph (d) of this sec-tion, and meets the conditions of the

exemption in paragraph (e) of this sec-tion.

(i) Exemptions granted under super-seded regulations. Manufacturers grant-ed exemptions under the superseded re-quirements of §723.250 (as in effect onMay 26, 1995) shall either continue tocomply with those requirements or fol-low all procedural and recordkeepingrequirements pursuant to this section.If an exemption holder continues tofollow the superseded regulations, theNotice of Commencement requirementsapply and the exempt polymer willcontinue to be listed on the Inventorywith exclusion criteria and exemptioncategory restrictions on residual mono-mer/reactant and low molecular weightspecies content limitations.

(j) Recordkeeping. (1) A manufacturerof a new polymer under paragraphs (e)of this section, must retain the recordsdescribed in this paragraph at the man-ufacturing site for a period of 5 yearsfrom the date of commencement ofmanufacture or import.

(2) The records must include the fol-lowing to demonstrate compliance withthe terms of this section:

(i) Chemical identity information asrequired in paragraph (g) of this sec-tion.

(ii) Information to demonstrate thatthe new polymer is not specifically ex-cluded from the exemption.

(iii) Records of production volume forthe first 3 years of manufacture andthe date of commencement of manufac-ture.

(iv) Information to demonstrate thatthe new polymer meets the exemptioncriteria in paragraphs (e)(1), (e)(2), or(e)(3) of this section.

(v) Analytical data, or theoreticalcalculations (if it can be documentedthat an analytical determination can-not be made or is not necessary), todemonstrate that the polymer meetsthe number-average MW exemption cri-teria in paragraphs (e)(1) or (e)(2) ofthis section.The analytical tests mayinclude gel permeation chroma-tography (GPC).vapor pressure osmom-etry (VPO), or other such tests whichwill demonstrate that the polymermeets the number-average MW cri-terion.

(vi) Analytical data, or theoreticalcalculations (if it can be documented


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40 CFR Ch. I (7–1–98 Edition)Pt. 725

that an analytical determination can-not be made or is not necessary), todemonstrate that the polymer meetsthe criteria in paragraphs (e)(1) or(e)(2) of this section, meets the low MWcontent criteria in paragraphs (e)(1) or(e)(2) of this section.

(vii) If applicable, analytical data, ortheoretical calculations (if it can bedocumented that an analytical deter-mination cannot be made or is not nec-essary) required in paragraph (g) ofthis section for determining monomersor reactants charged to the reactionvessel at greater than 2 weight percentbut incorporated at 2 weight percent orless in the manufactured polymer.

(viii) The certification statements asrequired under paragraph (h) of thissection.

(3) The manufacturer must submitthe records listed in paragraph (j)(2) ofthis section to EPA upon written re-quest by EPA. The manufacturer mustprovide these records within 15 work-ing days of receipt of this request. Inaddition, any person who manufacturesa new chemical substance under theterms of this section, upon request ofEPA, must permit such person at allreasonable times to have access to andto copy these records.

(k) Submission of information. Infor-mation submitted to EPA under thissection must be sent in writing to:TSCA Document Control Officer, (7407),Office of Pollution Prevention andToxics, Environmental ProtectionAgency, 401 M St., SW., Washington,DC 20460.

(l) Compliance. (1) A person who man-ufactures or imports a new chemicalsubstance and fails to comply with anyprovision of this section is in violationof section 15 of the Act (15 U.S.C. 2614).

(2) Using for commercial purposes achemical substance or mixture which aperson knew or had reason to know wasmanufactured, processed, or distrib-uted in commerce in violation of sec-tion 5 of the Act is a violation of sec-tion 15 of the Act (15 U.S.C. 2614).

(3) Failure or refusal to establish andmaintain records or to permit access toor copying of records, as required bythis 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 entryor inspection as required by section 11of the Act is a violation of section 15 ofthe Act (15 U.S.C. 2614).

(5) Violators may be subject to thecivil and criminal penalties in section16 of the Act (15 U.S.C. 2615) for eachviolation. Persons who submit materi-ally misleading or false information inconnection with the requirements ofany provision of this section may besubject to penalties calculated as ifthey never filed their notices.

(6) EPA may seek to enjoin the man-ufacture or processing of a chemicalsubstance in violation of this sectionor act to seize any chemical substancemanufactured or processed in violationof this section or take other actionsunder the authority of section 7 of theAct (15 U.S.C. 2606) or section 17 of theAct (15 U.S.C. 2616).

(m) Inspections. EPA will conduct in-spections under section 11 of the Act toassure compliance with section 5 andthis section, to verify that informationsubmitted to EPA under this section istrue and correct, and to audit data sub-mitted to EPA under this section.

(n) Confidentiality. If a manufacturersubmits information to EPA under thissection which the manufacturer claimsto be confidential business informa-tion, the manufacturer must clearlyidentify the information at the time ofsubmission to EPA by bracketing, cir-cling, or underlining it and stamping itwith ‘‘CONFIDENTIAL’’ or some otherappropriate designation. Any informa-tion so identified will be treated in ac-cordance with the procedures in 40 CFRpart 2. Any information not claimedconfidential at the time of submissionmay be made available to the publicwithout further notice.

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

PART 725—REPORTING REQUIRE-MENTS AND REVIEW PROCESSESFOR MICROORGANISMS

Subpart A—General Provisions andApplicability

Sec.725.1 Scope and purpose.725.3 Definitions.725.8 Coverage of this part.


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