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Chemical Identity Information Required under Section 5 of TSCA

Date: Jan 04, 1999


On March 29, 1995, the Environmental Protection Agency (EPA)published procedural amendments to the premanufacturenotification (PMN) requirements of section 5 of the ToxicSubstances Control Act (TSCA)(15 U.S.C. § 2601 et seq.).(1) Of particular significance toprospective submitters of notices under section 5 of TSCA (e.g.,Premanufacture Notices (PMN's)), EPA amended 40 C.F.R.§ 720.45(a) to impose additional requirements. Section720.45(a) sets forth the chemical identity information that mustbe included in certain notices submitted under section 5. Noticesaffected by revised section 720.45(a) include not only"typical" section 5 notices such as PMNs and low volumeexemption applications (LVEAs), which require the use of theEPA's standard PMN form, but also notices submitted by personsrequesting that EPA determine whether a substance is listed onthe confidential portion of the TSCA Chemical Substance Inventory(Inventory) by establishing a bona fide intent tomanufacture or import the substance.

This document discusses the chemical identity informationrequired to be included in a notice submitted under section 5 ofTSCA under the EPA's PMN amendments. How to nomenclate a newchemical substance under TSCA, i.e., a discussion ofchemical identity information, per se, is outside thescope of this document.

  1. Summary
  2. Under section 5 of TSCA, a person who intends to manufactureor import a "new chemical substance" (i.e., asubstance not listed on the TSCA Chemical Substance Inventory(Inventory)) for a non-exempt commercial purpose, must submit aPremanufacture Notice (PMN) at least ninety days prior to suchmanufacture or import. Prior to the PMN amendments, EPApreferred, but did not require, that submitters of section 5notices such as PMNs use Chemical Abstracts (CA) nomenclature todescribe reported substances. Under the PMN amendments,submitters of section 5 notices must obtain a correct CA IndexName or CA Preferred Name for each reported substance prior tosubmission of the notice.

    There are two methods by which this requirement can besatisfied. The first involves prior submission of chemicalidentity information to Chemical Abstracts Services' (CAS')Inventory Expert Service (IES), who will provide the requestorwith the required information. Under this method, the EPAgenerally would not delay or suspend the review period if anyproblems with respect to chemical identity or nomenclature duringthe PMN review period were discovered.

    As an alternative method, the EPA will allow PMN submitters todevelop their own CAS names or to use third-party contractors(other than CAS) to develop chemical identity information. Underthis approach, however, should problems regarding the name of thesubstance arise during PMN review, the EPA will declare the PMNincomplete and will not further process or review the noticeuntil the chemical identity issues were resolved. Indeed, it isnow the EPA's practice to return the submission.

    While not required under the PMN amendments, the EPA stronglyrecommends that submitters obtain a CAS Registry Number (CASRN)for each submitted substance, particularly if the substance'sidentity is not claimed confidential. A CASRN must be submittedin any event if one already exists and is known to the submitter.The amendments provide certain flexibility to manufacturers andimporters who report substances whose identity is confidential toa foreign supplier or that are manufactured using a proprietaryreactant.

  1. Chemical Identity Information Required In Section 5 Notices Under 40 C.F.R. § 720.45(a)
  2. Section 720.45(a) sets forth the chemical identity informationthat must be contained in certain notices submitted under section5 of TSCA. The most common type of section 5 notice is a PMN,which requires the use of the EPA's PMN form, 7710-25 (Rev.5/95). However, the requirements of section 720.45(a) apply toother types of section 5 notices, such as Significant New UseNotices (SNUNs), LVEAs, and Low Release and Exposure Exemption(LoRex) Applications, which also require the use of the PMN form,as well as to bona fide inquiries. Bona fideinquiries are submitted by persons who wish the EPA to informthem as to whether a substance is listed on the TSCA Inventoryincluding the confidential portion. This inquiry must besupported by establishing a bona fide intent tomanufacture in the U.S. or to import the substance into the U.S.(2) Test market exemptionapplications (TMEAs) are unaffected by the revisions to section720.45(a).(3) Although the PMNform is not required for TMEAs, we recommend that it be used.(4) In addition, because the amendedpolymer exemption does not require persons to submit chemicalidentity information, section 720.45(a) does not apply to thesimple notices required to be submitted under this provision. Fordocumenting the identity and the eligibility of exempt polymersunder the current polymer exemption, there are separaterequirements at 40 C.F.R. § 723.250(g), (h), and (j).

    Persons who submit section 5 notices must provide theinformation described in section 720.45(a) and specified in thePMN form to the extent the information is known to or reasonablyascertainable by that person. Under section 720.45(a), thechemical identity information required to be in a section 5notice depends on whether the substance to be reported is a"Class 1" substance, a "Class 2" substance,or a polymer.(5)

    A Class 1 substance is a substance that has a precisely knownchemical composition (except for impurities) and can berepresented by a definite chemical structural diagram. Examplesinclude 1,3-butadiene, benzene, and sodium chloride.

    A Class 2 substance is a substance having an indefinite orunknown composition, and which cannot be represented by adefinite, complete, chemical structure. Such substances arefrequently derived from natural sources or complex reactions.Examples include chlorinated naphthalene, the glycerol monoesterof hydrogenated cottonseed oil acids, or a "reactionproduct" of specified reactants.

    Generally speaking, polymers are substances characterized byrepetition of one or more types of identical monomeric units.(6) The EPA relies on CAS' criteriafor distinguishing polymers from non-polymers outside of thepolymer exemption. The definition of a polymer that is applied inthe United States solely for the polymer exemption is the same asthat used across the board in Canada and the European Union. Thispolymer definition is known as the one developed under theauspices of the Organization for Economic Development andCooperation.

    1. Class 1 Substances
    2. Under section 720.45(a)(1), the following chemical identityinformation must be included in a section 5 notice for a Class 1substance:

      • the currently correct CA Index Name based on the Ninth Collective Index (9CI) of CAS nomenclature rules and conventions that is consistent with listings for similar substances on the Inventory;


      • the CASRN for the substance if one exists;


      • the correct molecular formula; and


      • a complete, correct structural diagram.
    1. Class 2 Substances
    2. Under section 720.45(a)(1), the following chemical identityinformation must be included in a section 5 notice for a Class 2substance:

      • the currently correct CA Index Name or CAS Preferred Name(7) based on the Ninth Collective Index (9CI) of CAS nomenclature rules and conventions that is consistent with listings for similar substances on the Inventory;


      • the specific chemical name (and CASRN, if available) of the substance's immediate chemical precursors and reactants (Note: Trade or generic names of chemical precursors or reactants are not acceptable substitutes for specific chemical names);


      • the CASRN for the substance if one exists;


      • a definite molecular formula, if known or reasonably ascertainable; and


      • a correct representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained.

      The PMN form also requires a description of the reaction orprocess, and the range of composition or typical composition(where appropriate).

    1. Polymers
    2. Persons who submit section 5 notices for polymers must submitthe following information:

      • the currently correct CA Index Name or CAS Preferred Name based on the Ninth Collective Index (9CI) of CAS nomenclature rules and conventions that is consistent with listings for similar substances on the Inventory;


      • the CASRN for the polymer if one exists;


      • a correct representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained;


      • the specific chemical name (and CASRN, if available), of all monomers and reactants used to manufacture the polymer. (Note: As for Class 2 substances, trade or generic names are not acceptable substitutes for specific chemical names for monomers or reactants);


      • the typical percent by weight of each monomer or reactant in the polymer (expressed as a percentage of the weight of the polymeric substance manufactured);


      • the maximum residual amount of each monomer or other reactant present in the polymer when manufactured or imported for commercial purposes;


      • the monomers or other reactants(8) used at two weight percent or less (based on the dry weight of the polymer manufactured) that the submitter wishes to include as part of the polymer description on the Inventory(9); and


      • measured or estimated values of the minimum number-average molecular weight of the polymer and those species below 500 and 1000 molecular weight (not including residual monomers, reactants, or diluents), along with a description of how the measured or estimated values were obtained.
  1. Requirements for Obtaining CAS Names and CASRNs
  2. Section 720.45(a)(3) specifies two permissible methods forobtaining the CA information required under section 720.45(a)(1)and (2). The submitter can (1) obtain the information directlyfrom CAS, or (2) self-determine the information or obtain it froman alternative source or sources. The method used must bespecified in the PMN form.

    1. Method 1: CAS Registry Services Inventory Expert Service
    2. Under this method, prior to submitting the notice to the EPA,the submitter requests the required chemical identity informationdirectly from CAS Registry Services' Inventory Expert Service(IES). The IES is a special branch of CAS that focuses onidentifying substances to be submitted under TSCA. The IES willprovide the requestor with a chemical identification report,which must be submitted to the EPA along with the section 5notice.

      This approach is generally preferred. The EPA compiled theTSCA Inventory in the late 1970's largely using CAS nomenclatureand CASRNs. CAS and the EPA also have worked closely togethersince that time to maintain and update the Inventory. Due to CAS'preeminent position in the field of chemical nomenclature,believes that most submitters will find it advantageous toutilize the IES to meet the requirements of section 720.45.Indeed, the EPA "strongly recommends" this approach.(10)

      To utilize this approach, the prospective submitter simplymust complete Part I, Section B, of the PMN form (pages 4 to 6,as appropriate) except for the chemical name and CASRN of thesubject substance, complete a CAS IES Order form, and submit thecompleted PMN form pages and order form to:

      CAS Registry Services
      2540 Olentangy River Road
      Post Office Box 3343
      Columbus, Ohio 43210-0334

      Phone: 800-848-6538 ext. 2308 or 614-447-3600 ext. 2308
      FAX: 614-447-3747

      CAS indicates that within 10 days, it will return to thesubmitter, on CAS' letterhead, a CA Index name for the substance(and CASRN, if requested). The cost for this service beginning in1999 is $105.00 plus tax per form submitted. Expedition of theprocessing can be purchased for an additional $60.00 If errors,inconsistencies, or missing data are discovered during CAS'review that cannot be easily resolved, an additional fee of$165.00 per hour may apply.

      Unless otherwise requested, CAS will provide only a CA Name.Although the PMN amendments require CASRNs be reported only forsubstances that already have them, the EPA strongly recommendsthat submitters obtain and provide CASRNs for all reportedsubstances, particularly if the chemical identity is not beclaimed as confidential business information (CBI). Submittersshould note, however, that if they request assignment of a CASRNfrom CAS for a substance not already present in CAS' data baseRegistry, assignment of the CASRN makes the substance publiclyavailable in CAS Registry, which is publicly accessible. CASwould not, however, associate the submitter's identity with theCASRN in any publicly available database. Thus, CAS recommendsthat if the submitter wishes to maintain the specific chemicalidentity of the substance as confidential, it should request onlya CA Index name; the name will be provided to the submitter butwill not be placed by CAS on any on-line database.(11) The fact that a CASRN for asubstance already exists does not prohibit the submitter fromclaiming the specific chemical identity of the reported substanceas confidential. Generally, we discourage obtaining a CASRN ifnone previously existed. In some circumstances, it is wise to askthat CAS not respond as to whether or not a CASRN exists.

      Despite CAS' purported proficiency with respect to properlydetermining chemical nomenclature and the EPA's designation ofCAS as the preferred authority in this respect for the purposesof section 5 notices, the EPA has the final authority todetermine how a substance should be represented on the Inventoryand in some instances may disagree with the identificationassigned to a substance by CAS. In the event of such adisagreement, the EPA will not unduly delay processing of thePMN, but will cooperate with CAS to either modify or confirm theproposed identification. This is true, however, only so long asthe submitter provided CAS with complete information identical tothe information contained in the section 5 notice. If this is notthe case, the notice may be deemed incomplete, in which case, thereview period will not begin until the EPA receives a completenotice.(12) We suspect that theoccurrence of such a situation will be infrequent.

    1. Method 2: Independently Obtain the Required Chemical Identity Information
    2. Under this method, a submitter may obtain the requisitechemical identity information from any source, includinginformation services or consultants, or can develop the requiredinformation without assistance. In contrast to Method 1, however,if a submitter uses Method 2 and reports any chemical identityinformation that is considered by the EPA to be incorrect, thesubmitter, not the EPA, is considered responsible for correctingthe information. The associated section 5 notice would bedeclared incomplete and would not be further reviewed orprocessed until the correct information is provided. Therefore,this approach is not recommended unless the chemical identity andnomenclature associated with the reported substance arestraightforward.

      How to nomenclate a specific substance is outside the scope ofthis document; chemical nomenclature is an arcane and complexsubject. Keller and Heckman can assist clients with this task in many instances. Documents addressing this topic are available from CAS (617-447-3731), or the TSCA Assistance Information Service (202-554-1404). These documentswill not enable many persons to correctly nomenclate mostsubstances.

  1. Special Requirements For Chemical Identity Information Claimed Confidential By the Supplier
  2. Section 720.45(a)(4) and (5) contain special procedures formanufacturers and importers from which chemical identityinformation otherwise required to be in a notice is withheld by asupplier.

    An importer who cannot provide all of the requiredchemical identity information because it is claimed confidentialby the foreign supplier must have the supplier comply with theprocedures in section 720.45(a)(3), i.e., use the IES orindependently develop the required chemical identity information.The supplier must provide all of the required informationdirectly to the EPA in (1) a joint submission(13),or (2) a letter of support to the notice. These notices mustreference the importers's notice and the appropriate PMN User FeeIdentification Number established by the U.S. submitter.(14) The notice review period beginsupon receipt of all required notices.

    If a manufacturer or importer cannot provide all ofthe requisite information because the substance to be reported ismanufactured using a reactant whose identity is claimedconfidential by its supplier, the EPA makes a special exceptionto the general procedures. The manufacturer or importer need notfirst develop or obtain a correct CA identification for thesubject substance. Instead, the manufacturer or importer mustsubmit a notice directly to the EPA containing all of theinformation known by the manufacturer or importer about thechemical identity of the substance and the proprietary reactant.This would typically include a trade or generic chemical name, amaterial safety data sheet (MSDS), product literature, or anyother information the submitter may know or reasonably ascertainabout the confidential reactant or reported substance. Themanufacturer or importer must also ensure that the suppliersubmits a letter of support to the EPA, providing (1) thespecific chemical identity of the reactant, (2) the CASRN (ifavailable) and (3) the appropriate PMN or exemption number, ifapplicable. The letter of support must reference the manufactureror importer's name and the PMN User Fee Identification Number.The notice review period begins upon receipt of the notice andthe letter of support.

    Any CBI claims made by suppliers should be clearly marked innotices submitted under these provisions and letters of support.A statement should be included that the information must not beshared with the notice submitter.

  1. Other Information Related to Chemical Identity Required in a Section 5 Notice
  2. While unaffected by the 1995 PMN amendments and outside thescope of this document, submitters should note that otherparagraphs of section 720.45 require additional informationrelated to the chemical identity of the reported substances:

      • the impurities anticipated to be present in the substance, by name, CASRN, and weight percent of the total substance;


      • known synonyms or trade names of the substance; and


      • a description of the byproducts resulting from the manufacture, processing, use, and disposal of the substance.

    An impurity is a chemical substance unintentionally presentwith another chemical substance.(15)A byproduct is a chemical substance produced without a separatecommercial intent during the manufacture, processing, use, ordisposal of another chemical substance or mixture.(16) Submitters should refer to 40C.F.R. Part 720, and the PMN form and Instructions Manual forfurther information about these requirements.

Prepared by:
Keller and Heckman LLP, April 1996, revisedDecember 30, 1998

________________________________________

1. 60 Fed. Reg. 16298 (Mar. 29, 1995).EPA's PMN requirements appear at 40 C.F.R. Part 720.

2. See 40 C.F.R. § 720.25,60 Fed. Reg. at 16309.

3. 40 C.F.R. § 720.38. While the PMNform provides a block to identify a submission as a TMEA andapplicants are encouraged to use the PMN form, TMEAs need not besubmitted using the PMN or any other specific form.

4. 40 C.F.R. § 723.250, 60 Fed. Reg.at 16316.

5. Originally, polymers were Class 1substances if all of their precursors were Class 1 substances.Otherwise, polymers were Class 2 substances. Because thisdistinction was essentially of no value, polymers have come to beconsidered a separate class of substances, more meaningfullydistinguished from non-polymeric Class 1 and Class 2 substances.

6. See "Instructions Manualfor Premanufacture Notification of New Chemical Substances,"EPA Office of Toxic Substances (EPA-7710-25(I)(January 1991).Note that while the PMN Form was revised in May 1995 to conformwith the PMN amendments, the Instructions Manual is stillundergoing revisions.

7. Whichever is appropriate based on CA 9CInomenclature rules and conventions. Generally, whether to reporta CAS Index name or CAS Preferred name depends on whether thechemical identity of the substance is well-defined or poorlydefined.

8. Although the terms monomer and otherreactant are not defined in Part 720, they are defined inthe new polymer exemption (40 C.F.R. § 723.250(b)), and arediscussed in the Instructions Manual for the PMN form.

9. For the purposes of this requirement,weight percent must be based either upon (1) the weight of themonomer or reactant actually charged to the reaction vessel; or(2) the minimum weight of monomer or reactant theoreticallyrequired to account for the actual weight of monomer or reactantmolecules or fragments chemically incorporated (i.e.,chemically combined) in the polymeric substance manufactured. 40C.F.R. § 720.45(a)(2)(iii). Certain records must be kept tosupport the latter determination. 40 C.F.R.§ 720.45(a)(2)(iv).

10. 60 Fed. Reg. at 16299.

11. Because the EPA's proceduresconcerning the protection of confidential business information(CBI) generally do not apply until such information is submittedto the Agency, submitters should make suitable arrangements withthe person who develops the required chemical identityinformation with respect to protection of CBI. To this end, CASindicates that it has extensive security policies and proceduresfor handling customer-supplied information.

12. See 40 C.F.R.§ 720.65(c).

13. See 40 C.F.R.§ 720.40(e).

14. The PMN User Fee Identification Numberis a personal, six-character alphanumeric identification numberintended to link a section 5 notice with a user fee. It is placedon the first page of the PMN form and on the check. It has a"TS-" prefix. See 40 C.F.R.§ 700.45(e)(3).

15. 40 C.F.R. § 720.3(m).

16. 40 C.F.R. § 720.3(d).

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