July 2010Office of Pollution Prevention and ToxicsU.S. Environmental Protection AgencyIUR Modifications RuleDevelopment of Definitions for 40 CFR 711.3Where term currently definedTermProposed711.3 Definition704.3710.3710.43TSCAsec 3CommentAdministratorNonexxRely on statutory definitionArticleNonexxRely on 704.3 definitionByproductNonexxRely on 704.3 definitionByproductmaterial, sourcematerial, andspecial nuclearmaterialNonexxRely on statutory definitionCDX – CentralData ExchangeEPA's centralized electronic documentreceiving system, or its successors,including associated instructions forregistering to submit electronicdocuments.ChemicalsubstanceNonexxRely on statutory definitionCommerceNonexxRely on statutory definitionCommercial UseThe use of a chemical substance or amixture containing a chemical substance(including as part ofan article) in acommercial enterpriseproviding saleablegoods or services.xConsumer useThe use of a chemical substance or amixture containing a chemical substance(including as part of anarticle) when soldto or made available to consumers for theiruse.xCosmetic, device,drug, food,andNonexxRely on statutory definition1July 2010Office of Pollution Prevention and ToxicsU.S. Environmental Protection AgencyWhere term currently definedTermProposed711.3 Definition704.3 710.3 710.43 TSCAsec 3Commentfood additiveDistribute incommerceanddistribution incommerceNonexxRely on statutory definitione-IURwebElectronic, web-based IUR softwareprovided by EPA for the completion andsubmission of the IUR data.EPANonexxRely on 704.3 definitionImporterNonexxRely on 704.3 definitionImpurityNonexxRely on 704.3 definitionIndustrialfunctionThe intended physical or chemicalcharacteristic for which a chemicalsubstance or mixture is consumed as areactant; incorporated into a formulation,mixture, reaction product, or article;repackaged; or used.Industrial useUse at a site at which one or morechemical substances or mixtures aremanufactured (including imported) orprocessed.xNo change from 710.43 definition2July 2010Office of Pollution Prevention and ToxicsU.S. Environmental Protection AgencyWhere term currently definedTermProposed711.3 Definition704.3 710.3 710.43 TSCAsec 3CommentIntended for useby childrenThe chemical substance or mixture is usedin or on a product that is specificallyintended for use by children age 14 oryounger. A chemical substance or mixtureis intended for use by children when thesubmitter answers “yes” to at least one ofthe following questions for the productinto which the submitter's chemicalsubstance or mixture is incorporated:(1) Is the product commonly recognized(i.e., by a reasonable person) as beingintended for children age 14 or younger?(2) Does the manufacturer of the productstate through product labeling or otherwritten materials that the product isintended for or will be used by childrenage 14 or younger?(3) Is the advertising, promotion, ormarketing of the product aimed at childrenage 14 or younger?xNo change from 710.43 definitionIntermediateNonexxRely on 704.3 definitionKnown to orreasonablyascertainable byNonexxRely on 704.3 definition3July 2010Office of Pollution Prevention and ToxicsU.S. Environmental Protection AgencyWhere term currently definedTermProposed711.3 Definition704.3 710.3 710.43 TSCAsec 3CommentManufactureTo manufacture, produce, or import forcommercial purposes. Manufactureincludes the extraction, for commercialpurposes, of a component chemicalsubstance from a previously existingchemical substance or a complexcombination of chemical substances.When a chemical substance, manufacturedother than by import, is (1) producedexclusively for another person whocontracts for such production, and (2) thatother person specifiesthe identity of thechemical substance and controls the totalamount produced and the basic technologyfor the plant process, that chemicalsubstance is jointly manufactured by theproducing manufacturer and the personcontracting for such production.xxxManufacture orimport “forcommercialpurposes”NonexxRely on 704.3 definitionManufacturerA person who manufactures a chemicalsubstance.xxAdded new definition to avoidconfusion with the 704.3 definition4July 2010Office of Pollution Prevention and ToxicsU.S. Environmental Protection AgencyWhere term currently definedTermProposed711.3 Definition704.3 710.3 710.43 TSCAsec 3CommentMaster InventoryFileEPA's comprehensive list of chemicalsubstances which constitute the TSCAChemical Substance Inventory compiledunder section 8(b) of the Act. It includeschemical substances reported under part710 of this chapter and chemicalsubstances reported under part 720 of thischapter for which a Notice ofCommencement of Manufacture or Importhas been received under §720.120 of thischapter.xNo change from 710.43 definitionMixtureNonexxRely on statutory definitionNew chemicalsubstanceNonexxRely on statutory definitionNon-IsolatedintermediateNonexxRely on 704.3 definitionPersonNonexxRely on 704.3 definitionPesticideNonexxRely on statutory definitionPrincipalreporting yearThe last complete calendar year precedingthe submission period.xRevised, from 710.43 definition ofreporting yearProcessNonexxxxRely on 704.3 definitionProcess for“commercialpurposes”NonexxRely on 704.3 definitionProcessorNonexxxRely on 704.3 definitionReadilyobtainableinformationNonexDeletingdefinition as part of proposalto eliminate this reporting standard5July 2010Office of Pollution Prevention and ToxicsU.S. Environmental Protection AgencyWhere term currently definedTermProposed711.3 Definition704.3 710.3 710.43 TSCAsec 3CommentReasonably likelyto be exposedAn exposure to a chemical substancewhich, under foreseeable conditions ofmanufacture (including import),processing, distribution in commerce, oruse of the chemical substance, is morelikely to occur than not to occur. Suchexposures would normally include, butwould not be limited to, activities such ascharging reactor vessels, drumming, bulkloading, cleaning equipment, maintenanceoperations, materials handling andtransfers, and analytical operations.Covered exposures include exposuresthrough any route of entry (inhalation,ingestion, skin contact, absorption, etc.),but excludes accidental or theoreticalexposures.xNo change from 710.43 definitionRepackagingThe physical transfer of a chemicalsubstance or mixture, as is, from onecontainer to another container orcontainers in preparation for distributionof the chemical substance or mixture incommerce.xNo change from 710.43 definitionReportablechemicalsubstanceA chemical substance described in §711.5.xNo change from 710.43 definitionother than reference update6July 2010Office of Pollution Prevention and ToxicsU.S. Environmental Protection AgencyWhere term currently definedTermProposed711.3 Definition704.3 710.3 710.43 TSCAsec 3Comment7SiteA contiguous property unit. Propertydivided only by a public right-of-way shallbe considered one site. More than oneplant may be located on a single site.(a) For chemical substances manufacturedunder contract, i.e., by a toll manufacturer,the site is the location where the chemicalsubstance is physically manufactured.(b)The site for an importer who imports achemical substance described in §711.5 isthe U.S. site of the operating unit withinthe person's organization that is directlyresponsible for importing the chemicalsubstance. The import site, in some cases,may be the organization's headquarters inthe United States. If there is no suchoperating unit or headquarters in theUnited States, the site address for theimporter is the U.S. address of an agentacting on behalf of the importer who isauthorized to accept service of process forthe importer.(c) For portable manufacturing units sentout to different locations from a singledistribution center, the distribution centershall be considered the site.xxRevised definitionJuly 2010Office of Pollution Prevention and ToxicsU.S. Environmental Protection AgencyWhere term currently definedTermProposed711.3 Definition704.3 710.3 710.43 TSCAsec 3CommentSite-limitedA chemical substanceis manufactured andprocessed only within a site and is notdistributed for commercial purposes as achemical substance or as part of a mixtureor article outside the site. Importedchemical substances are never site-limited.Although a site-limited chemicalsubstance is not distributed for commercialpurposes outside the site at which it ismanufactured and processed, the chemicalsubstance is considered to have beenmanufactured and processed forcommercial purposes.xNo change from 710.43 definitionDefinition retained because it is usedby other parts of the regulatory text,even though the IUR would no longerask companies to identify if thechemical substance is site limited.Small quantitiesfor research anddevelopmentNonexxRely on 704.3 definitionStateNonexxRely on statutory definitionSubmissionperiodThe period in which the manufacturing,processing, and use data are submitted toEPA.xRevised definitionTechnicallyqualifiedindividualNonexDeleted because not needed for IURpurposesTest marketingNonexxRely on 704.3 definitionThe ToxicSubstancesControl Act, 15U.S.C 2601 etseqNonexRely on 704.3 definitionUnited StatesNonexxRely on statutory definition8July 2010Office of Pollution Prevention and ToxicsU.S. Environmental Protection AgencyWhere term currently definedTermProposed711.3 Definition704.3 710.3 710.43 TSCAsec 3CommentUseAny utilization of a chemical substance ormixture that is not otherwise covered bythe termsmanufactureorprocess.Relabeling or redistributing a containerholding a chemical substance or mixturewhere no repackaging of the chemicalsubstance or mixture occurs does notconstitute use or processing of thechemical substance or mixture.xNo change from 710.43 definition9