TSCA Section 8(b) - Bergeson & Campbell, P.C.

Daily EnvironmentReport NUMBER 16 JANUARY 26, 2012REPORTINGTOXIC SUBSTANCESBased on written communications from the Environmental Protection Agency’s Office ofPollution Prevention and Toxics, questions have been raised as to the agency’s interpretationof the six chemical categories created under Toxic Substances Control Act Section8(b)(2) authority. Chemicals long considered part of these well-established categories identifieddecades ago are complex reaction products that fall under the TSCA Section 8(b)(2)category listing. Given the statements from EPA over the past several years and recognizingthat reporting under the TSCA Chemical Data Reporting (CDR) rule is just around thecorner, a critically important question is whether chemicals that would otherwise fit withinthe Section 8(b)(2) categories are subject to reporting under the CDR. This article examinesthis question by considering the regulatory history and guidance, prior reporting that hasoccurred, and business issues associated with the question.Are TSCA Section 8(b)(2) Statutory Mixture Categories Subject to Reporting Underthe Chemical Data Reporting Rule?BY LISA R. BURCHI, CHARLES M. AUER,KATHLEEN M. ROBERTS, LYNN L. BERGESONTheIntroductionToxic Substances Control Act regulates chemicalsubstances. 1 Few TSCA requirements apply tomixtures, 2 which are expressly excluded from the1 TSCA §§ 2-412, 15 U.S.C. §§ 2601-2692. Chemical substanceis defined as ‘‘any organic or inorganic substance of aparticular molecular identity, including - (i) any combinationof such substances occurring in whole or in part as a result ofa chemical reaction or occurring in nature and (ii) any elementor uncombined radical’’ except ‘‘[s]uch term does not include- (i) any mixture,’’ or other specifically excluded subjects includingpesticides, food, food additives, drugs, cosmetics ormedical devices. TSCA § 3(2), 15 U.S.C. § 2602(2).2 Mixture is defined as ‘‘any combination of two or morechemical substances if the combination does not occur in natureand is not, in whole or in part, the result of a chemical reaction;except that such term does include any combinationwhich occurs, in whole or in part, as a result of a chemical reactionif none of the chemical substances comprising the combinationis a new chemical substance and if the combinationcould have been manufactured for commercial purposes withouta chemical reaction at the time the chemical substancescomprising the combination were combined.’’ TSCA § 3(8), 15U.S.C. § 2602(8). See also 40 C.F.R.§ 710.4(c)(2) (excludingmixtures from the Inventory). A note to 40 C.F.R. § 710.4(c)(2)states: ‘‘Note: A chemical substance that is manufactured asCOPYRIGHT 2012 BY THE BUREAU OF NATIONAL AFFAIRS, INC. ISSN 1060-2976

2TSCA statutory definition of chemical substance. 3TSCA does not regulate products per se, but insteadregulates the chemical components that may constituteproducts, unless expressly excluded in the statutorydefinition of chemical substance.TSCA Section 8(b)(1) directs EPA to ‘‘compile, keepcurrent, and publish a list of each chemical substancewhich is manufactured or processed in the UnitedStates.’’ 4 This list is known as the TSCA Chemical SubstanceInventory (TSCA Inventory or Inventory). TSCASection 8(b)(2) states: ‘‘To the extent consistent withthe purposes of this [Act], the Administrator may, inlieu of listing, pursuant to paragraph (1), a chemicalsubstance individually, list a category of chemical substancesin which such substance is included.’’ 5 Section26(c)(1) discusses the concept of ‘‘categories’’ moregenerally under TSCA and clarifies that ‘‘[a]ny actionauthorized or required . . . under any provision of this[Act] with respect to a chemical substance’’ may betaken ‘‘in accordance with that provision with respect toa category of chemical substances.’’ 6 Section 26(c)(2)goes on to state that ‘‘[t]he term ‘category of chemicalsubstances’ means a group of chemical substances themembers of which are similar in molecular structure, inphysical, chemical, or biological properties. . . . ’’ 7 Interestingly,Sections 8(b)(2) and 26(c) are the only TSCAprovisions where the category authority is specificallyenumerated.The initial Inventory reporting rules were publishedon Dec. 23, 1977. 8 EPA identified six statutory chemicalcategories under its Section 8(b)(2) authority when theInventory was first established, with some input fromindustry. 9 They are:s Cement, Portland, Chemicals (CASRN 65997-15-1)s Cement, Alumina, Chemicals (CASRN 65997-16-2)s Glass, Oxide Chemicals (CASRN 65997-17-3)s Frits, Chemicals (CASRN 65997-18-4)s Steel Manufacture, Chemicals (CASRN 65997-19-5)s Ceramic Materials and Wares, Chemicals (CASRN66402-68-4)Once the Inventory was created, those chemical substanceson the Inventory were referred to as ‘‘existing’’chemical substances. ‘‘New chemical substance’’ refersto any chemical substance not listed on the TSCA Inventory.10 Under the authority of TSCA Section 5, EPArequires companies to submit premanufacture notifications(PMN) before the commercial manufacture or importationof ‘‘new’’ chemical substances. Accordingly,the Inventory establishes the TSCA regulatory status ofand requirements on new versus existing chemical substances.The Inventory is thus critically important forcompanies and other regulated entities to knowwhether chemical substances commercially manufacturedor imported are listed on the Inventory, either individuallyunder Section 8(b)(1) or because they arepart of a ‘‘category of chemical substances’’ under Section8(b)(2), or are new chemical substances subject toSection 5 requirements.EPA has in the more recent past indicated that it intendsto publish a ‘‘clarification’’ notice in the FederalRegister for comment, in which EPA will clarify ‘‘theguidance on chemical identification of certain statutorymixtures for purposes of the . . . TSCA Inventory.’’ EPAstated that ‘‘[f]or the initial reporting period that establishedthe TSCA Inventory, EPA developed broad listingcriteria (‘category listings’) for the complex reactionproducts known as statutory mixtures’’ and that EPAwill clarify which chemical substances comprise complexreaction products that fall under the TSCA Section8(b)(2) ‘‘category listings’’ and those chemical substances‘‘not currently on the TSCA Inventory’’ wouldbe considered to be new chemical substances underTSCA and thus subject to notification under TSCA Section5. The TSCA Inventory status of the chemical substancescontained in these six categories is thus a significantissue to be resolved.Another important and uniquely pressing issue thatEPA’s ‘‘clarification,’’ and any potential change inpolicy, may raise concerns the reporting requirementsthat may apply to these chemical substances. It is importantto note that the six statutory mixture categoriesare composed of inorganic chemicals. Although inorganicchemicals had been fully exempted from InventoryUpdate Rule (IUR) reporting commencing with theinitial reporting in 1986, EPA amended the reporting requirementsin 2003, in part to phase-in reporting for inorganicchemicals beginning with the 2006 IUR. Inorganicchemicals are also now subject to somewhat expartof a mixture is subject to these reporting regulations. Thisexclusion applies only to the mixture and not to the chemicalsubstances of which the mixture is comprised. The term ‘‘mixture’’includes alloys, inorganic glasses, ceramics, frits, and cements,including Portland cement.’’3 Mixtures may be subject to TSCA § 4 test rules, directregulation under TSCA § 6, and TSCA § 8 recordkeeping andreporting requirements.4 TSCA § 8(b)(1), 15 U.S.C. § 2607(b)(1).5 15 U.S.C. § 2607(b)(2).6 15 U.S.C. § 2625(c)(1).7 15 U.S.C. § 2625(c)(2).8 42 Fed. Reg. 64,572 (Dec. 23, 1977).9 EPA, Toxic Substances Control Act Inventory Representationfor Products Containing Two or More Substances: Formulatedand Statutory Mixtures (1995) at 4, available at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/policy.html (1995 Statutory Mixtures Policy) (‘‘When the initialInventory was being developed, both EPA and industry recognizedthat the individual substances comprising these mixturesare complex solids and would be very difficult to identify.Therefore, instead of requiring industry to identify and reportevery such substance for the Inventory, several special categorieswere created to include the various substances formedwhen cement, glass, frit or ceramic are produced.’’)10 TSCA § 3(9), 15 U.S.C. § 2602(9).To request permission to reuse or share this document, please contact permissions@bna.com. In your request, be sure to include the following information:(1) your name, company, mailing address, e-mail and telephone number; (2) name of the document and/or a link to the document PDF;(3) reason for request (what you want to do with the document); and (4) the approximate number of copies to be made or URL address (if posting toa website).1-26-12 COPYRIGHT 2012 BY THE BUREAU OF NATIONAL AFFAIRS, INC. DEN ISSN 1060-2976

3panded reporting requirements (relative to those in the2006 IUR) under the recently issued Chemical Data Reporting(CDR) rule for which reporting will begin onFeb. 1. EPA changed the name of the reporting rulefrom IUR to CDR. 11 Under the CDR rule, inorganicchemicals are potentially subject to reporting if they area ‘‘chemical substance that is in the Master InventoryFile at the beginning of a submission period.’’ 12 The‘‘Master Inventory File’’ is defined as ‘‘EPA’s comprehensivelist of chemical substances which constitutesthe TSCA Inventory compiled under TSCA section8(b).’’ 13 Considering the above, a key question iswhether chemical substances that would otherwise fallwithin the Section 8(b)(2) categories are chemical substancessubject to reporting as the category under theCDR. This article examines this question and the issuesthis core question inspires.TSCA’s Sections 8(b)(2) and 26(c) LegislativeHistoryTSCA emerged from S. 3149 and H.R. 14032. S. 3149did not include a TSCA Section 8(b)(2) or any similarprovision. 14 The Senate bill did contemplate providingEPA with authority to take action with respect to categoriesof chemical substances or mixtures underTSCA Section 26(c), which provides:ACTION WITH RESPECT TO CATEGORIES. —(1) Any action authorized or required to be takenby the Administrator under any provision ofthis Act with respect to a chemical substanceor mixture may be taken by the Administratorin accordance with that provision with respectto a category of chemical substances or mixtures.Whenever the Administrator takes actionunder a provision of this Act with respectto a category of chemical substances or mixtures,any reference in this Act to a chemicalsubstance or mixture (insofar as it relates tosuch action) shall be deemed to be a referenceto each chemical substance or mixture in suchcategory.(2) For purposes of paragraph (1):(A) The term ‘‘category of chemical substances’’means a group of chemical substances themembers of which are similar in molecularstructure, in physical, chemical, or biologicalproperties, in use, or in mode of entranceinto the human body or into the environment,or the members of which are insome other way suitable for classification assuch for purposes of this Act, except thatsuch term does not mean a group of chemicalsubstances which are grouped together11 76 Fed. Reg. 50,816 (Aug. 16, 2011) (to be codified at 40C.F.R. Part 711). See also 149 DEN A-3, 8/3/11.12 76 Fed. Reg. 50,860 (to be codified at 40 C.F.R. § 711.5).13 Id. (to be codified at 40 C.F.R. § 711.3).14 Legislative History of the Toxic Substances Control ActTogether with a Section-By-Section Index Prepared by the Environmentand Natural Resources Policy Division of the Libraryof Congress for the House Committee on Interstate andForeign Commerce (Dec. 1976) at 113-114 (Legislative History).See also id. at 178,281.solely on the basis of their being new chemicalsubstances.(B) The term ‘‘category of mixtures’’ means agroup of mixtures the members of which aresimilar in molecular structure, in physical,chemical, or biological properties, in use, orin the mode of entrance into the humanbody or into the environment, or the membersof which are in some other way suitablefor classification as such for purposes of thisAct. 15When discussing the authority to take action with respectto categories of chemical substances or mixtures,the Senate Report (S. Rep. No. 94-698) accompanyingS. 3149 states:This authority is given to the Administrator to facilitatethe efficient and effective administrationof this act and is not to be used in any way thatwould frustrate the intent of any provision of thisAct. Thus, for example, categories might be appropriatelyused for purposes of compiling the inventoryof section 8(b) so that every variation inthe distribution of a polymer chain length wouldnot be automatically subject to the premarket notificationrequirement. However, categories arenot to be used in the section 8(b) inventory so asto effectively provide exemptions for new chemicalsubstances intended to be covered under thepremarket notification provision. 16H.R. 14032 included the following language, which isthe same as the current TSCA Section 8(b)(2):To the extent consistent with the purposes of thisAct, the Administrator may, in lieu of listing, pursuantto paragraph (1), a chemical substance individually,list a category of chemical substances inwhich such substance is included. 17The House report (H.R. Rep. No. 94-1341) that accompaniedH.R. 14032 states the following with regardto Section 8(b)(2):Paragraph 2 of subsection (b) provides that to theextent consistent with the purposes of this bill, theAdministrator may in compiling and maintainingthe inventory, list a category of chemical substancesrather than list individually each chemicalsubstance within the category. By listing a categoryof chemical substances, minor modificationsor variations in the formulation or structureof a chemical substance which would have insignificanthealth or environmental consequenceswould not automatically be subject to the notificationrequirements of section 5. For instance, theAdministrator could use categories so that reportingwould not be required as a result of changessuch as the following: polymers or co-polymerswhich vary only in the proportion of starting materialsor catalysts used, or in molecular weight,molecular weight distribution, chain structure orcrystallinity; changes within an existing chemicalsubstance in the proportions of colorants, stabiliz-15 Legislative History at 47.16 Legislative History at 187.17 Legislative History at 358.DAILY ENVIRONMENT REPORT ISSN 1060-2976 BNA 1-26-12

4ers, antioxidants, fillers, solvents, carriers, surfactants,plasticizers, and other adjuvants which arethemselves reported as existing substances; variationsin the proportion of alloyed metals in ironand steel products and other metal alloys; variationsin naturally occurring substances or mixtures(such as crude oil, natural gas, minerals, orores) and the resulting variations in extracts or refinedproducts therefrom; variations in reportedreactive mixtures whose commercial or end-useproduct is electric energy (batteries); and saleswhich result from the combination of an existinginorganic anion with an existing inorganic cation.The Committee realizes that many chemicalcompanies, particularly small ones, are able tocompete in the chemical industry only by continuallyreformulating or making slight changes in existingchemical substances. It would be extremelyburdensome on them as well as on the Administratorif every insignificant change were subject tothe premarket notification requirements of section5. By using categories in the inventory, theAdministrator will be able to minimize such burdens.However, the Committee also realizes thatminor modifications of innocuous compoundsmay produce highly toxic chemicals. Thus, the useof categories should be limited to areas where theeffects of such minor modifications are well understoodto have insignificant health and environmentalconsequences. 18The House bill also included the same language forSection 26(c) that appeared in S. 3149 and became thelanguage that ultimately was enacted. 19 When discussingthis provision in the report accompanying H.R.14032, the report includes as an example of EPA’s authorityunder Section 26(c) that EPA could issue a Section4(a) test rule with respect to a category of chemicalsubstances upon making the necessary findings. Thereport states further: ‘‘It should be noted that in takingaction under any provision of the bill respecting a categoryof chemical substances, the Administrator willnot have to make the requisite finding for such actionwith respect to every chemical within the category.’’ 20When the House was considering H.R. 14032, the followingwas stated by Sen. James Broyhill (R-N.C.):There is one thing that I would like to bring out inthis colloquy. The gentleman from Nebraska hasreferred to the premarket notification section ofthe bill [Sec. 5] and indeed that is perhaps themost controversial portion. He did mention certainexemptions and perhaps one other thingneeds pointing out. This is on page 163 with respectto the administrative authority in identifyinga chemical substance. It states:[Sec. 8(b)] (2) To the extent consistent with thepurposes of this Act the Administrator may, inlieu of listing, pursuant to paragraph (1), achemical substance individually, list a categoryof chemical substances in which such substanceis included.I may say to the gentleman, I think this is an extremelyimportant leeway to the Administrator.Say for instance a chemical substance is manufacturedand produced inhouse in an oil and chemicalrefinery. That chemical substance may be acatalyst that undergoes successive changes. Underthese provisions we felt that instead of requiringa 90-day notice every time a change was madethat had the result of changing the chemical constituencyof the substance, the single categorycomment.I think that the gentleman will agree with me thisis one of the provisions in which we carefully examineddifficulties which could result from toorigid an act and met those possible objections. 21The conference report that accompanied the finalbill, which included what is now Section 8(b)(2), doesnot address Section 8(b)(2):Senate bill (section 8) . . . To determine whichsubstances are new chemical substances for thepurpose of the pre-market notification provisionsof section 5, subsection (b) requires the Administratorto publish an inventory of existing chemicalsubstances or mixtures which any person reportto be commercially manufactured or processedwithin the United States under subsection (a) orunder section 5(a). The Administrator shall publishsuch list not later than 270 days after the dateof enactment....House amendment (section 8) . . . With respect tothe inventory of existing chemical substances requiredby subsection (b), the House amendmentprovides that the inventory shall include at leasteach chemical substance which any person reportsunder section 5 or under section 8(a) wascommercially manufactured or processed in theUnited States within 3 years before the effectivedate of the rules promulgated under section 8(a).The House amendment requires the publication ofsuch inventory within 1 year after the effectivedate of the Act....Conference substitute (section 8) . . . The conferencesubstitute adopts, with some clarification,the House amendment in subsection (b) which requiresthe Administrator to compile, keep current,and publish an inventory of chemical substancesand mixtures manufactured or processed in theUnited States. The conference committee compromisedon the date that the Administrator shall firstpublish the inventory, which publication shalltake place 315 days after the effective date of theAct. 22The conference report states that the House amendmentincludes a Section 26(c) provision similar to S.3149, and further states that the ‘‘conferees expect thatthe Administrator will find the authority to categorizeespecially helpful in promulgating rules under section18 Legislative History at 451.19 Legislative History at 400-401.20 Legislative History at 468.21 Legislative History at 523 (excerpted from CongressionalRecord).22 Legislative History at 691-694.1-26-12 COPYRIGHT 2012 BY THE BUREAU OF NATIONAL AFFAIRS, INC. DEN ISSN 1060-2976

55(a)(2) concerning what constitutes significant new useof chemical substances.’’ 23Section 8(b)(2) Regulatory HistoryWhen EPA issued regulations implementing the initialTSCA Inventory over 30 years ago, EPA providedexamples of the types of ‘‘mixtures’’ that were excludedfrom Inventory listing by ‘‘definition of section 8(b) ofTSCA.’’ Specifically, in the December 1977 FederalRegister notice establishing the TSCA Inventory reportingregulations, EPA stated:710.4 Scope of Inventory(c) Substances excluded by definition or section8(b) of TSCA. The following substances are excludedfrom the inventory: . . . (2) Any mixture asdefined in § 710.2(q); NOTE.—A chemical substancethat is manufactured as part of a mixture issubject to these reporting regulations. This exclusionapplies only to the mixture and not to thechemical substances of which the mixture is comprised.The term ‘‘mixture’’ includes alloys, inorganicglasses, ceramics, frits, and cements, includingPortland cement. 24EPA also provided the following commentary:Comment 33: Manufacturers of alloys includingsteel, glasses, ceramics, enamels, Portland cement,and similar combinations of chemical substancesshould not be required to report for the inventory.Response: The Administrator agrees with thiscomment. Alloys, inorganic glasses, ceramics,frits, and cements, including Portland cement, aremixtures under TSCA; manufacturers of theseproducts are not required to report them. However,as stated in a note at § 710.4(c), the exclusionof these products applies only to the mixtureand not to the chemical substances of which themixture is comprised. Thus, the metals in the caseof alloys, or oxides in the case of glasses and ceramics,and any additives or components otherthan impurities, should be included on the inventory.The manufacturers of the metals, oxides, andadditives would be responsible for reportingthem. 25Subsequently, EPA published in 1978 various addendato assist companies in determining Inventory statusfrom its Candidate List of Chemical Substances. In AddendumIII, EPA identified Class 2 substances (i.e., achemical substance the composition of which cannot berepresented by a definite chemical structural diagram)and provided a mechanism for identifying and reportingothers. 26 In this addendum, EPA stated the followingregarding Section 8(b)(2) category mixtures:23 Legislative History at 715.24 42 Fed. Reg. 64,577.25 42 Fed. Reg. 64,585.26 EPA, Toxic Substances Control Act (TSCA) Pub. L. No.94-469, Candidate List of Chemical Substances, Addendum III,Chemical Substances of Unknown or Variable Composition,Complex Reaction Products and Biological Materials (Mar.1978) at 1 (Candidate List of Chemical Substances, AddendumIII), available at http://op.bna.com/env.nsf/r?Open=jsun-8qu3sq.Certain common materials of commerce, such asinorganic glasses, are defined by the InventoryReporting Regulations as mixtures. To facilitatereporting, this addendum defines certain categorieswhich encompass the individual chemicalsubstances manufactured in the production ofthese mixtures.[A]ny persons who manufacture such substancesmay use the nomenclature presented in this addendumto report for the Inventory if this nomenclatureaccurately describes the chemical substancesthey manufacture. 27EPA went on to describe six mixtures and the‘‘chemical substances manufactured in the productionof’’ steel, Portland cement, high-alumina cement, inorganicglass, and frit, 28 including providing a CAS RegistryNumber for each of the six category mixtures.Attempts were made to develop a summary of the reportingon the Section 8(b)(2) statutory mixture categorieswhich occurred during the initial Inventory reporting,however, the authors were not able to find a publiclyaccessible copy of the information. Nonetheless,EPA has stated that initial Inventory reporting occurred.29In a letter in 1986, EPA responded to a questionposed about the TSCA Inventory status of substancesformed during the production of ceramic materials bystating that it ‘‘intends that the TSCA definition of ceramicsinclude all chemical substances formed as a resultof the process used in the production of the ceramicmaterial, i.e., heating and scintering, and concurrentlyincorporated in the ceramic mixture as stated in the Inventorydefinition of Ceramic materials and wares,chemicals [CAS Registry Number 66402-68-4].’’ 30 In1989, EPA responded to another question about theTSCA Inventory status related to the Ceramic Section8(b)(2) category definition, and went perhaps a bit fartherin recognizing that these category definitions werenot permanently restricted to only those materials specificallylisted by EPA:During the TSCA Initial Inventory reporting period,the Agency, in cooperation with the CeramicIndustry, developed a generic Inventory definitionto cover all ceramic materials and processesknown to be in use by the ceramic industry at thattime. Recognizing the fact that the ceramic industrytechnology would likely change with time,EPA did not intend that the category be limited tothose materials made by the processes known tobe in use to produce ceramic materials at the timethat the original definition was developed. In fact,the Agency has subsequently modified the definitionof a ceramic material to extend the list of elementsthat may be used in the manufacture of ceramics.3127 Id. (emphasis added)28 Id. at 41, 77-80.29 See, e.g., 1995 Statutory Mixtures Policy at 4.30 Letter from Carol A. Farris, Ph.D., Chief, Chemical InventorySection, EPA, to Ms. Alison A. Kerester, McKenna, Conner,and Cuneo (Oct. 9, 1986).31 Letter from Henry P. Lau, Ph.D., Chief, Chemical InventorySection, EPA to Mr. John S. Kazazis, Chemical SubstanceControl Manager, AT&T (June 20, 1989).DAILY ENVIRONMENT REPORT ISSN 1060-2976 BNA 1-26-12

7that are applied to listings of certain mixtures inthe TSCA Inventory. 40Appendix D referred to by EPA is its 1995 StatutoryMixtures Policy. None of this language or the policy isincluded in EPA’s final instructions. 41 There does notappear to be a publicly available explanation clarifyingthe reasons for its deletion.A summary of the reporting on the Section 8(b)(2)statutory mixture categories which occurred during the2006 IUR reporting based on EPA’s publicly availableIUR database 42 is as follows:s Cement, Portland: 18 entities at 32 productionsites, reported > 1 billion pounds (total);s Cement, Alumina, Chemicals: Four entities at foursites, reported 1 to 10 million pounds;s Glass, Oxide, Chemicals: Seven entities at eightsites reported 50 to 100 million pounds;s Frits, Chemicals: Four entities at five locations reported50 to 100 million pounds;s Steel Manufacture, Chemicals: 47 entities at 87sites reported > 1 billion pounds; ands Ceramic Materials and Wares, Chemicals: 10 entitiesat 18 sites reported > 1 billion pounds.These numbers may reflect an inconsistency in howstatutory mixture categories were reported under the2006 IUR, since certain categories have volumes in themillions and others having volumes in the billions, althoughthese differences may also be explained if certainmanufacturers claimed their data as confidentialbusiness information. In the final CDR rule, EPA statedthat it was replacing the 5-digit NAICS codes with 48 IndustrialSector (IS) codes, and one of the codes is for‘‘Non-metallic Mineral Product Manufacturing (includesclay, glass, cement, concrete, lime, gypsum, andother non-metallic mineral product manufacturing)’’ althoughthere is no discussion of how this IS code relatesto any reporting obligations on statutory mixture categories.43When industry sought clarification in 2007 regardingthe Section 8(b)(2) chemical categories and potentialPMN requirements, EPA’s response raised several concernsabout EPA’s current interpretation of its Section8(b)(2) Statutory Mixtures Policy. The first EPA letter,dated September 18, 2007, responded to four questionsrelated to the TSCA Inventory status for ‘‘Glass, oxide,chemicals’’ and ‘‘Ceramic material and wares, chemicals.’’44 In response to a question asking EPA to ‘‘reaffirmEPA’s longstanding guidance on the use of CAS-40 EPA, Draft Instructions for Reporting for the 2006 PartialUpdating of the TSCA Chemical Inventory Database (Nov.2004) at 2-11, available at http://www.regulations.gov bysearching for EPA-HQ-OPPT-2005-0008-0003.41 EPA, Instructions for Reporting for the 2006 Partial Updatingof the TSCA Chemical Inventory Database (Nov. 2006),available at www.epa.gov/iur/pubs/2006_inst_tsca_cheminv.pdf.42 EPA, IUR Data for 2006, available at http://www.epa.gov/iur/tools/data/2006archivedata.html.43 76 Fed. Reg. 50,827.44 Letter from Tracy C. Williamson, Ph.D., Chief, IndustrialChemistry Branch, EPA, to Greg McCarney, 3M Toxicologyand Regulatory Services (Sept. 18, 2007) (2007 EPA Letter).RNs that were established for the six categories,’’ EPAresponded in part:Consistent with this regulatory text [at Section710.4(c)(2) and its Note], EPA did not intend forthese six chemical descriptions and CASRNs,which the Agency sometimes refers to as ‘‘statutorymixtures,’’ to be used to establish chemicalnomenclature and determine Inventory status foractual chemical substances manufactured or importedfor commercial purposes that may in a genericsense be thought of or described as eitherPortland cement, alumina cement, glass, frits,steel, or ceramics. The CASRNs for these ‘‘statutorymixtures’’ were included in the Initial Inventoryfor the purpose of defining the scope of thesevery broad categories of substances, with the expectationthat particular substances or mixturecomponents that fall within one of these categoriesof materials and that are intended to be commerciallymanufactured would be subject to TSCAreporting if they were not already explicitly listedin the Inventory. 45In response to another question regarding EPA’sview whether manufacturers and importers of chemicalmaterials covered by the category descriptions shouldobtain unique CASRNs, EPA responded in the letter asfollows:Regarding substances that may fit within the definitionsof the six ‘‘statutory mixture’’ categories,specific chemical identifications that represent reactionproducts instead of starting materialsshould be used for TSCA purposes whenever themanufacture of the substances involves newchemical bond formation. In these types of materials,the new bonding may yield crystalline orsemi-crystalline matrices. It is the specific identityof the chemical reaction product composition thatmust be either already included in the Inventoryor reported as a new chemical.For example, with a ceramic type of material, if aparticular chemical substance is to be manufacturedas a result of a high temperature calcinationprocess that causes new bond formation, the specificchemical identity of that chemical productneeds to be included in the Inventory beforemanufacture may commence for a non-exemptcommercial purpose. Such a chemical productmust be either listed in the Inventory or reportedin a TSCA Section 5 new chemical notice accordingto its synthesized chemical composition. It isnot considered covered for TSCA purposes by the‘‘statutory mixture’’ category ‘‘Ceramic materialsand wares, chemicals’’ (CASRN 66402-68-4).On the other hand, if a product associated withone of these categories does not involve intendedchemical reactions, such that no chemical bondsform during its manufacture, the product compositionis considered a mixture and identified bythe starting materials charged in the manufactureof the material.It has always been TSCA Inventory policy to listsubstances as specifically as possible. For materi-45 Id. at 2.DAILY ENVIRONMENT REPORT ISSN 1060-2976 BNA 1-26-12

8als that can be grouped within the six categoricaldescriptions you mentioned, many individualchemical substances that constitute chemical reactionproducts actually formed during the manufactureof the materials have been reported andlisted in the Inventory since the Initial Inventoryreporting period. 46On May 28, 2008, EPA issued another letter ‘‘regardingmaterials that EPA and the regulated communityhave sometimes referred to as statutory mixtures.’’ 47 Inthe letter, EPA states:EPA believes that, consistent with this regulatorytext [Section 710.4(c)(2)], the Agency did not intendfor the descriptions and correspondingChemical Abstracts Service (CAS) Registry Numbers(CASRNs) for the very broad existing categoricalchemical names – including materialssuch as ceramics, cements, inorganic glasses, andfrits – to be used to establish chemical nomenclature,TSCA reportability, Inventory listing policy,or Inventory status, for actual chemical substancesmanufactured or imported for commercialpurposes. These categorical descriptions and theirCASRNs, each of which represents a broad classof substances, were included in the Initial Inventoryfor the purpose of defining their scope to thepublic. Section 710.4(c)(2) of the Inventory ReportingRegulations again indicates that these categoriesare excluded from reporting. Specificchemical substances that might fall within one ofthese broad categories of materials, and that areintended to be commercially manufactured, aresubject to TSCA reporting if they are not alreadyindividually listed in the Inventory. Since by regulationthe individual chemical substances manufacturedas part of mixtures cannot be excludedfrom reporting for TSCA purposes, the manufacturedcomponent chemical substances of the materialsreferred to as statutory mixtures can in thisrespect be treated the same under TSCA as thecomponent substances produced in other types ofsynthesized mixtures. 48After noting that EPA has had a longstanding policyto list chemical substances on the Inventory as specificallyas possible, EPA further states with regard tochemical mixtures:EPA has observed an industry trend toward thecommercial development of ceramic-like materialsthat are better defined compositionally, arechemically more specific, and often require relativelyprecise stoichiometric and compositionalcontrol during their manufacture. These substancesalso can exhibit definite elemental ratios,and unit cell structure and atomic coordinationsites may be able to be determined. These characteristicstypically enable them to perform in morespecified and higher technological uses. Thesecharacteristics also lend them to be more appropriatelyidentified and described using much more46 Id. at 3.47 Letter from Tracy C. Williamson, Ph.D., Chief, IndustrialChemistry Branch, EPA, to Michael P. Walls, American ChemistryCouncil (May 28, 2008) at 1 (2008 EPA Letter).48 2008 EPA Letter at 1-2.specific chemical names than the categorical descriptionof ceramics. . . . EPA believes that it isconsistent with long-standing policy for theAgency to review and/or list particular substancesof a ceramic or inorganic glass nature, for example,that are commercially manufactured or imported.49Several industry trade associations and individualcompanies requested that EPA withdraw its September2007 and May 2008 letters, finding EPA’s statements inconsistentwith the statute and EPA’s longstandingguidance and interpretations of the Section 8(b)(2) categorylistings. It was argued that the six products (e.g.,Portland cement, glass, steel) are mixtures that are exemptfrom Inventory listing regardless of any ‘‘statutorymixture’’ classification; it is the chemical substancesthat are manufactured during the production of thesemixtures that are ‘‘existing’’ chemical substances aspart of the statutory mixture categories created by EPAwhen the Inventory was first developed. Industry alsonoted its concern that EPA’s decision potentially to revisesignificantly the manner in which it interpretsTSCA Section 8(b)(2) would have potentially devastatingimpacts on business, costs, and innovation. 50In the most recent development, and notwithstandingindustry’s comments, EPA appears to be moving forward,albeit slowly, with its ‘‘clarification’’ of Section8(b)(2) and how it applies to TSCA Inventory categorylistings. In its December 2009 Action Initiation List andits spring 2010 semiannual regulatory agenda, EPA provideda notice of its intent to continue with its ‘‘clarification’’of the scope and coverage of the Section 8(b)(2)category listings, and indicated that the effort would affectat least three of the statutory mixture categories.While describing the planned action as a ‘‘clarification,’’EPA has indicated that this action is in the proposedrule stage. EPA describes its planned action in2009 and 2010 as follows:TSCA Inventory; Clarification for Chemical IdentificationDescribing Statutory Mixtures, IncludingCeramic Materials, Cements, and Frits forTSCA Inventory PurposesEPA is clarifying the guidance on chemical identificationof certain statutory mixtures for purposesof the [TSCA] Chemical Substance Act Inventory(TSCA Inventory). For the initial reporting periodthat established the TSCA Inventory, EPA developedbroad listing criteria (‘‘category listings’’) forthe complex reaction products known as statutorymixtures. These include ceramics, cements andfrits. Since that time, there has been inconsistentguidance for manufacturers of such substanceswith regard to whether new chemical notification49 2008 EPA Letter at 3.50 Letter from Alan J. Olson, P.E., Director of Product Stewardship,Ferro Corporation to Stephen A. Owens, Assistant Administratorfor the Office of Chemical Safety and PollutionPrevention, EPA (Feb. 4, 2011); Letter from J. Lawrence Robinson,President, Color Pigments Manufacturers AssociationInc., to Stephen A. Owens, Assistant Administrator for the Officeof Chemical Safety and Pollution Prevention, EPA (Aug.31, 2010); Letter from American Chemistry Council Coalitionto Stephen A. Owens, Assistant Administrator for the Office ofChemical Safety and Pollution Prevention, EPA (June 16,2010).1-26-12 COPYRIGHT 2012 BY THE BUREAU OF NATIONAL AFFAIRS, INC. DEN ISSN 1060-2976

9under Section 5 of TSCA was required for suchnew substances. Under this action, EPA willclarify which chemical substances comprise complexreaction products that fall under the ‘‘categorylistings’’ and which chemical substances(not currently on the TSCA Inventory) would beconsidered to be ‘‘new’’ chemical substances underTSCA and thus be subject to new chemical notificationunder TSCA Section 5. 51Statutory mixtures are not the only substances forwhich EPA has indicated an intent to clarify TSCA Inventorystatus. On February 24, 2010, EPA issued in theFederal Register notice a ‘‘final clarification’’ describingthose ‘‘activated phosphors’’ that are not on theTSCA Inventory and thus ‘‘new’’ chemical substancesfor which PMNs would be required. 52 In the notice,EPA states that:Partly as a result of the Agency’s incomplete informationand understanding of the chemistry involvedin manufacturing activated phosphors,from 1978 through 2003, EPA was inconsistent inits statements to potential submitters and in its actionsregarding whether activated phosphors areconsidered distinct chemical substances for purposesof the TSCA Inventory. 53EPA states further:Because EPA does not view activated phosphorsas mixtures, some previous EPA statements thatsuch materials may not need to be reviewedthrough the new chemicals process were incorrect.As a result of certain past EPA statements,some manufacturers of activated phosphors havenot submitted new chemical notices under TSCAsection 5 because those statements incorrectly indicatedthat activated phosphors were covered forTSCA purposes if the phosphors and activatorswere already on the TSCA Inventory. 54As a result of this clarification, EPA provided companieswith 18 months to submit PMNs for any commercialmanufacture or import of any activated phosphorsthat were not on the TSCA Inventory but for whichPMNs were now required. If EPA were to issue a ‘‘clarification’’for statutory mixtures, the way in which EPAaddressed activated phosphors could be a model that itattempts to apply to statutory mixture categories. It appearsthat in both cases, EPA has noted that increasedunderstanding of the chemistry at issue and ‘‘inconsistent’’guidance from EPA are some of the reasons EPAhas sought to ‘‘clarify’’ these issues.There are, however, significant differences betweenthese cases. Importantly, activated phosphors are notone of the categories of statutory mixtures (and thus51 EPA, ‘‘Action Initiation List’’ (AIL) Regulation IdentifierNumber (RIN) 2070-AJ68 (Dec. 2009), available at http://www.epa.gov/lawsregs/search/ail.html. See also EPA 2010semiannual regulatory agenda at 105-106, available at http://www.epa.gov/lawsregs/documents/regagendabookspring10.pdf.See also 27 DEN A-6, 2/11/10.52 75 Fed. Reg. 8266 (Feb. 24, 2010).53 Id. at 8267.54 Id. at 8268. It is important to note that the discussion foractivated phosphors relates to TSCA’s definition and exclusionfrom TSCA Inventory listings for ‘‘mixtures’’ (see supra note2) and not TSCA Section 8(b)(2) statutory mixture categories.EPA did not previously develop a Section 8(b)(2) categoryfor activated phosphors). EPA also appears to admitmore freely that EPA’s communications regardingthe TSCA Inventory status of activated phosphors were‘‘incorrect’’ and not just ‘‘inconsistent.’’Implications/Next StepsWhile industry’s recent letters and EPA’s responsesaddress the TSCA Inventory status of these statutorymixture categories and their components, less attentionhas been paid to how any such clarification may affectCDR reporting requirements now that manufacturersand importers must report inorganic substances. The issueof reporting Section 8(b)(2) category mixtures wasnot discussed in detail when either the 2003 IURAs orthe 2011 CDR were issued. What is known is that underthe CDR, a chemical substance, including an inorganicchemical substance, can be subject to reporting if it is a‘‘chemical substance that is in the Master Inventory Fileat the beginning of a submission period.’’ 55It seems clear that, as has been acknowledged byEPA in prior rulemakings and guidance noted above, 56and despite informal statements offered in more recentEPA correspondence, 57 the Section 8(b)(2) statutorymixture categories are ‘‘listed’’ on the TSCA Inventorybecause they are in the Master Inventory File. It is alsothe case that reporting occurred on these categoriesduring both the initial Inventory and the 2006 IUR ( thatwas the first IUR not to exempt inorganic chemicals) reportingcycles.While EPA has stated its intent to issue a clarificationon the TSCA Section 8(b)(2) categories and their TSCAInventory status, it has not yet issued such a notice andthus there is no change from the situation described immediatelyabove. It thus would appear that manufacturersand importers of chemical substances falling withinthe Section 8(b)(2) statutory mixture categories shouldbe reporting as required under the terms applicable inthe 2012 CDR reporting cycle (i.e., included in MasterInventory File and meets other reporting criteria) usingthe CASRN and chemical name that identifies the relevantstatutory mixture category and which includes‘‘the various substances formed when [such a statutorymixture] is produced.’’While based on the results of this analysis this seemslike a reasonable answer, this is admittedly an obscureissue 58 and it is less than clear how widely this understandingis held by the chemical industry. It is clear tothe authors that this issue was not discussed when the2003 IURAs and associated guidance documents weredeveloped. Based on the results of the 2006 IUR reporting,it appears that some—but potentially not all—55 76 Fed. Reg. 50,860 (to be codified at 40 C.F.R. § 711.5).56 See, e.g., Candidate List of Chemical Substances, AddendumIII, at Introduction; 1995 Statutory Mixtures Policy at 4.57 2007 EPA Letter, 2008 EPA Letter.58 This paper presents essentially everything that could beidentified and obtained on the topic of Section 8(b)(2) statutorymixture categories. Attempts were made to identify relevantjournal articles via searches of bibliographic databasesusing various combinations of terms such as ‘‘TSCA Section8(b)(2)’’ or ‘‘statutory mixture.’’ The searches did not produceany articles relevant to the topic which suggests that it has notreceived much discussion or recognition over the 30-plus yearssince the TSCA Inventory was developed, and particularly littleattention with regard to IUR/CDR reporting.DAILY ENVIRONMENT REPORT ISSN 1060-2976 BNA 1-26-12

10affected entities recognized the issue. Surprisingly, theissue did not surface from the public nor was it raisedby EPA in the recent proposed revisions to the IUR thatwere promulgated as the CDR, with reporting to beginearly in 2012. All of which may leave the affected industryin a bit of a quandary.Thus, companies that manufacture or import chemicalsubstances falling within these statutory mixturecategories may wish to consider the benefits of compilingthe necessary information and submitting reports toEPA consistent with CDR reporting requirements.Seemingly such information would at a minimum be ofconsiderable value in clarifying the scale of productionand the scope of the entities that commercially manufactureor import the statutory mixture categories. Suchinformation may be helpful to EPA as it continues toponder its ‘‘clarification’’ of the issue.About the authors:Lisa R. Burchi is Of Counsel at Bergeson & CampbellPC, a Washington, D.C., law firm concentrating on theregulation and business issues associated with industrial,agricultural, biocidal, and specialty chemicalsand Food and Drug Administration-regulatedproducts. Charles M. Auer is President of CharlesAuer & Associates LLC and formerly director of EPA’sOffice of Pollution Prevention and Toxics. KathleenM. Roberts is Vice-President of B&C Consortia ManagementLLC and was previously a Senior Directorwith Regulatory and Technical Affairs at the AmericanChemistry Council. Lynn L. Bergeson is a ManagingPrincipal of Bergeson & Campbell PC.The opinions expressed in this article are solely thoseof the authors and do not reflect a position of BNA,which welcomes other views.1-26-12 COPYRIGHT 2012 BY THE BUREAU OF NATIONAL AFFAIRS, INC. DEN ISSN 1060-2976