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

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