# February 9, 2011



# Table of Comparison of 2012 CDR v 2006 IUR Definitions

Page 1 of 13 U.S. Environmental Protection Agency

Office of Pollution Prevention and Toxics 

# In forming 40 CFR 711, EPA sought to si mplify the definition section and remove

unnecessary duplication of regulat ory terms. Note that applic able statutory definitions

from TSCA section 3 are not included in the following list.

2006 IUR: The regulations governing the 2006 I UR were chiefly located in 40 CFR 710

Subpart C. The primary defin ition section was in 710.43, which had the following

introduction:

In addition to the definitions in §704.3 of this chapter and §710.3, the following

definitions also apply to subpart C of this part:

2012 CDR: The regulations governing the 2012 CDR are chiefly located in 40 CFR

711. The primary definition section is in 711.3, which has the following introduction:

The definitions in this section and the def initions in TSCA section 3 apply to this

part. In addition, the definitions in 40 CF R 704.3 also apply to this part, except

the definitions manufacture and manufacturer in 40 CFR 704.3.Comparison of 2006 IUR Definitions and 2012 CDR DefinitionsPage 2 of 13U.S. Environmental Protection AgencyOffice of Pollution Prevention and ToxicsTermDefinition used for 2012 CDR(40 CFR 704.3 and 40 CFR 711.3)Definition(s) used for 2006 IUR(40 CFR 710.43, 40 CFR 710.3, and 40CFR 704.3)CommentArticleUses the 704.3 definition.704.3 – A manufactured item (1) which is formed to aspecific shape or design during manufacture, (2) whichhas end use function(s) dependent in whole or in partupon its shape or design during end use, and (3) whichhas either no change of chemical composition during itsend use or only those changes of composition whichhave no commercial purposeseparate from that of thearticle, and that result from a chemical reaction thatoccurs upon end use of other chemical substances,mixtures, or articles; exceptthat fluids and particles arenot considered articles regardless of shape or design.710.3 - A manufactured item: (1) Which is formed to aspecific shape or design during manufacture, (2) Whichhas end use function(s) dependent in whole or in partupon its shape or design during end use, and (3) Whichhas either no change of chemical composition during itsend use or only those changes of composition whichhave no commercial purposeseparate from that of thearticle and that may occur as described in §710.4(d)(5);except that fluids and particles are not consideredarticles regardless of shape or design.ByproductUses the 704.3 definition.704.3 – A chemical substance produced without aseparate commercial intentduring the manufacture,processing, use, or disposal of another chemicalsubstance(s) or mixture(s).710.3 - A chemical substance produced withoutseparate commercial intent during the manufacture orprocessing of another chemical substance(s) ormixture(s).CDX orCentral DataExchangeEPA's centralized electronic document receivingsystem, or its successors.New definitionCommercialuseThe use of a chemical substance or a mixturecontaining a chemical substance (including as partof an article) in a commercial enterprise providingsaleable goods or services.710.43 - The use of a chemicalsubstance or mixture ina commercial enterprise providing saleable goods orservices (e.g., dry cleaning establishment, paintingcontractor).Revised to make moreconsistent with definitionscollaboratively developedwith Canada.Comparison of 2006 IUR Definitions and 2012 CDR DefinitionsPage 3 of 13U.S. Environmental Protection AgencyOffice of Pollution Prevention and ToxicsTermDefinition used for 2012 CDR(40 CFR 704.3 and 40 CFR 711.3)Definition(s) used for 2006 IUR(40 CFR 710.43, 40 CFR 710.3, and 40CFR 704.3)CommentConsumeruseThe use of a chemical substance or a mixturecontaining a chemical substance (including as partof an article) when sold to or made available toconsumers for their use.710.43 - The use of a chemical substance that isdirectly, or as part of a mixture, sold to or madeavailable to consumers for their use in or around apermanent or temporary household or residence, in oraround a school, or in or around recreational areas.Revised to make moreconsistent with definitionscollaboratively developedwith Canada.e-CDRwebThe electronic, web-based tool provided by EPA forthe completion and submission of the CDR data.New definitionEPAUses the 704.3 definition.704.3 – The United StatesEnvironmental ProtectionAgency710.3 - The U.S. Environmental Protection AgencyImporterUses the 704.3 definition with the following technicalcorrection:704.3 – (1) any person who imports any chemicalsubstance or any chemical substance as part of amixture or article into the customs territory of theUnited States, and includes:(i) The person primarily liable for the payment ofany duties on the merchandise, or(ii) An authorized agent acting on his behalf.(2) Importer also includes, as appropriate:(i) The consignee.(ii) The importer of record.(iii) The actual owner if an actual owner'sdeclaration and superseding bond have beenfiled in accordance with 19 CFR 141.20.(iv) The transferee, if the right to drawmerchandise in a bonded warehouse has beentransferred in accordance with subpart C of 19CFR part 144.(3) For the purposes of this definition, the customsterritory of the United States consists of the 50States, Puerto Rico, and the District of Columbia.704.3 – (1) Any person who imports any chemicalsubstance or any chemical substance as part of amixture or article into the customs territory of the UnitedStates, and includes:(i) The person primarily liable for the payment of anyduties on the merchandise, or(ii) An authorized agent acting on his behalf (asdefined in 19 CFR 1.11).(2) Importer also includes, as appropriate:(i) The consignee.(ii) The importer of record.(iii) The actual owner if an actual owner'sdeclaration and superseding bond have been filed inaccordance with 19 CFR 141.20.(iv) The transferee, if the right to draw merchandisein a bonded warehouse has been transferred inaccordance with subpart C of 19 CFR part 144.(3) For the purposes of this definition, the customsterritory of the United Statesconsists of the 50 States,Puerto Rico, and the District of Columbia.710.3 - Any person who imports any chemicalsubstance or any chemical substance as part of amixture or article into the customs territory of the U.S.and includes:(1) The person primarily liable for the payment ofany duties on the merchandise, or(2) An authorized agent acting on his/her behalf (asdefined in 19 CFR 1.11).Comparison of 2006 IUR Definitions and 2012 CDR DefinitionsPage 4 of 13U.S. Environmental Protection AgencyOffice of Pollution Prevention and ToxicsTermDefinition used for 2012 CDR(40 CFR 704.3 and 40 CFR 711.3)Definition(s) used for 2006 IUR(40 CFR 710.43, 40 CFR 710.3, and 40CFR 704.3)CommentImpurityUses the 704.3 definition.704.3 – a chemical substance which is unintentionallypresent with another chemical substance.710.3 - a chemical substance which is unintentionallypresent with another chemical substance.IndustrialfunctionThe intended physical or chemical characteristic forwhich a chemical substance or mixture is consumedas a reactant; incorporated into a formulation,mixture, reaction product, or article; repackaged; orused.New definitionIndustrialuseIdentical to the710.43 definition.710.43 – Use at a site at which one or more chemicalsubstances or mixturesare manufactured (includingimported) or processed.Intended foruse bychildrenIdentical to the710.43 definition.710.43 – The chemical substance or mixture is used inor on a product that is specifically intended for use bychildren age 14 or younger. A chemical substance ormixture is intended for use by children when thesubmitter answers “yes” to at least one of the followingquestions for the product into which the submitter'schemical substance or mixture is incorporated:(1) Is the product commonly recognized (i.e., by areasonable person) as being intended for children age14 or younger?(2) Does the manufacturer ofthe product state throughproduct labeling or other written materials that theproduct is intended for or will be used by children age14 or younger?(3) Is the advertising, promotion, or marketing of theproduct aimed at children age 14 or younger?Comparison of 2006 IUR Definitions and 2012 CDR DefinitionsPage 5 of 13U.S. Environmental Protection AgencyOffice of Pollution Prevention and ToxicsTermDefinition used for 2012 CDR(40 CFR 704.3 and 40 CFR 711.3)Definition(s) used for 2006 IUR(40 CFR 710.43, 40 CFR 710.3, and 40CFR 704.3)CommentIntermediateUses the 704.3 definition.704.3 – Any chemical substance that is consumed, inwhole or in part, in chemical reactions used for theintentional manufacture of other chemical substances ormixtures, or that is intentionally present for the purposeof altering the rates of such chemical reactions710.3 - Any chemical substance:(1) Which is intentionally removed from the equipmentin which it is manufactured, and(2) Which either is consumed in whole or in part inchemical reaction(s) used for the intentionalmanufacture of other chemical substance(s) ormixture(s), or is intentionally present for the purpose ofaltering the rate of such chemical reaction(s).Note: Theequipment in which it was manufacturedincludes the reaction vessel in which the chemicalsubstance was manufactured and other equipmentwhich is strictly ancillary to the reaction vessel, and anyother equipment through which the chemical substancemay flow during a continuous flow process, but doesnot include tanks or other vessels in which the chemicalsubstance is stored after its manufacture.Known to orreasonablyascertainable byUses the 704.3 definition.704.3 – All information in a person's possession orcontrol, plus all information that a reasonable personsimilarly situated might be expected to possess, control,or know.710.43 - All information in a person's possession orcontrol, plus all information that a reasonable personsimilarly situated might be expected to possess, control,or know.Comparison of 2006 IUR Definitions and 2012 CDR DefinitionsPage 6 of 13U.S. Environmental Protection AgencyOffice of Pollution Prevention and ToxicsTermDefinition used for 2012 CDR(40 CFR 704.3 and 40 CFR 711.3)Definition(s) used for 2006 IUR(40 CFR 710.43, 40 CFR 710.3, and 40CFR 704.3)CommentManufactureTo manufacture, produce, or import, for commercialpurposes. Manufacture includes the extraction, forcommercial purposes, of a component chemicalsubstance from a previously existing chemicalsubstance or complex combination of chemicalsubstances. When a chemical substance,manufactured other than by import, is: (1) Producedexclusively for another person who contracts forsuch production, and (2) that other person specifiesthe identity of the chemical substance and controlsthe total amount produced and the basic technologyfor the plant process, thenthat chemical substanceis co-manufactured by the producing manufacturerand the person contracting for such production704.3 - To manufacture for commercial purposes.710.3 - To manufacture, produce, or import forcommercial purposesRevisedmanufacturetoinclude certain elementsfrom the 704.3 and 720.3definitions formanufacturer,specifically:extraction of acomponent chemicalsubstance andcontract (toll)manufacturing.The Agency is also adding asimple definition for the termmanufacturer(See below).Note that EPA also added aparagraph (c) to theregulation at 40 CFR 711.22to clarify the reportingrelationship between thecontracting company and thetoll manufacturer. Thecontracting company and thetoll manufacturer shouldconfer with each other toavoid duplicate reporting,and both the contractingcompany and the tollmanufacturer are liable if noreport is made.Comparison of 2006 IUR Definitions and 2012 CDR DefinitionsPage 7 of 13U.S. Environmental Protection AgencyOffice of Pollution Prevention and ToxicsTermDefinition used for 2012 CDR(40 CFR 704.3 and 40 CFR 711.3)Definition(s) used for 2006 IUR(40 CFR 710.43, 40 CFR 710.3, and 40CFR 704.3)CommentManufacture“forcommercialpurposes”Uses the 704.3 definition.704.3 – (1) To import, produce, or manufacture with thepurpose of obtaining an immediate or eventualcommercial advantage for the manufacturer, andincludes among other things, such “manufacture” of anyamount of a chemical substance or mixture:(i) For commercial distribution, including for testmarketing.(ii) For use by the manufacturer, including use forproduct research and development, or as anintermediate.(2) Manufacture for commercial purposes also appliesto substances that are produced coincidentally duringthe manufacture, processing,use, or disposal ofanother substance or mixture, including bothbyproducts that are separated from that othersubstance or mixture and impurities that remain in thatsubstance or mixture. Suchbyproducts and impuritiesmay, or may not, in themselves have commercial value.They are nonetheless produced for the purpose ofobtaining a commercial advantage since they are partof the manufacture of a chemical product for acommercial purpose.710.3 - To manufacture, produce, or import with thepurpose of obtaining an immediate or eventualcommercial advantage, and includes, for example, themanufacture or import of any amount of a chemicalsubstance or mixture:(1) For commercial distribution, including for testmarketing, or(2) For use by the manufacturer, including use forproduct research and development, or as anintermediate.Comparison of 2006 IUR Definitions and 2012 CDR DefinitionsPage 8 of 13U.S. Environmental Protection AgencyOffice of Pollution Prevention and ToxicsTermDefinition used for 2012 CDR(40 CFR 704.3 and 40 CFR 711.3)Definition(s) used for 2006 IUR(40 CFR 710.43, 40 CFR 710.3, and 40CFR 704.3)CommentManufacturerA person who manufactures a chemical substance. 704.3 - A person who imports, produces, ormanufactures a chemical substance. A person whoextracts a component chemical substance from apreviously existing chemical substance or a complexcombination of substancesis a manufacturer of thatcomponent chemical substance.Added new definition toavoid confusion with the704.3 definition formanufacturer. Part of the704.3 definition was used inthe new 711 definition formanufacture.Seediscussion, above.MasterInventoryFileEPA's comprehensive list of chemical substanceswhich constitutes the TSCA Inventory compiledunder section 8(b). It includes chemical substancesreported under 40 CFR part 710 and substancesreported under 40 CFR part 720 for which a Noticeof Commencement of Manufacture or Import hasbeen received under 40 CFR 720.120.710.43 - EPA's comprehensive list of chemicalsubstances which constitutethe Chemical SubstancesInventory compiled under section 8(b) of the Act. Itincludes substances reported under subpart A of thispart and substances reported under part 720 of thischapter for which a Notice of Commencement ofManufacture or Import has been received under§720.120 of this chapter.Slight, non-substantivechange from 710.43definition.Non-isolatedintermediateUses the 704.3 definition.704.3 – Any intermediate that is not intentionallyremoved from the equipment in which it ismanufactured, including the reaction vessel in which itis manufactured, equipment which is ancillary to thereaction vessel, and any equipment through which thesubstance passes during a continuous flow process, butnot including tanks or other vessels in which thesubstance is stored after itsmanufacture. Mechanical orgravity transfer through a closed system is notconsidered to be intentional removal, but storage ortransfer to shipping containers “isolates” the substanceby removing it from process equipment in which it ismanufactured.710.3 - Any intermediate thatis not intentionallyremoved from the equipment in which it ismanufactured, including the reaction vessel in which itis manufactured, equipment which is ancillary to thereaction vessel, and any equipment through which thesubstance passes during a continuous flow process, butnot including tanks or other vessels in which thesubstance is stored after its manufacture.Comparison of 2006 IUR Definitions and 2012 CDR DefinitionsPage 9 of 13U.S. Environmental Protection AgencyOffice of Pollution Prevention and ToxicsTermDefinition used for 2012 CDR(40 CFR 704.3 and 40 CFR 711.3)Definition(s) used for 2006 IUR(40 CFR 710.43, 40 CFR 710.3, and 40CFR 704.3)CommentPersonUses the 704.3 definition.704.3 – Any individual, firm, company, corporation, jointventure, partnership, sole proprietorship, association, orany other business entity;any State or politicalsubdivision thereof; any municipality; any interstatebody; and any department, agency, or instrumentality ofthe Federal Government.710.3 - Any natural or juridical person including anyindividual, corporation, partnership, or association, anyState or political subdivision thereof, or anymunicipality, any interstate body and any department,agency, or instrumentality of the Federal Government.PrincipalreportingyearThe latest complete calendar year preceding thesubmission period.710.43 -Reporting yearmeans the calendar year inwhich information to be reported to EPA during an IURsubmission period is generated, i.e., calendar year2005 and the calendar year at 5–year intervalsthereafter.Revised to reflect newreporting requirements.ProcessUses the 704.3 definition. 704.3 – To process for commercial purposes710.3 - The preparation of achemical substance ormixture, after its manufacture, for distribution incommerce:(1) In the same form or physical state as, or in adifferent form or physical state from, that in which it wasreceived by the person so preparing such substance ormixture, or(2) As part of a mixture or article containing thechemical substance or mixture.Comparison of 2006 IUR Definitions and 2012 CDR DefinitionsPage 10 of 13 U.S. Environmental Protection AgencyOffice of Pollution Prevention and ToxicsTermDefinition used for 2012 CDR(40 CFR 704.3 and 40 CFR 711.3)Definition(s) used for 2006 IUR(40 CFR 710.43, 40 CFR 710.3, and 40CFR 704.3)CommentProcess forcommercialpurposesUses the 704.3 definition.704.3 – The preparation ofa chemical substance ormixture after its manufacture for distribution incommerce with the purpose of obtaining an immediateor eventual commercial advantage for the processor.Processing of any amount ofa chemical substance ormixture is included in this definition. If a chemicalsubstance or mixture containing impurities is processedfor commercial purposes, then the impurities also areprocessed for commercial purposes.710.3 - To process:(1) For distribution in commerce, including for testmarketing purposes, or(2) For use as an intermediate.ProcessorUses the 704.3 definition.704.3 – Any person who processes a chemicalsubstance or mixture.710.3 - Any person who processes a chemicalsubstance or mixture.ReadilyobtainableinformationN/A 710.43 - Information which is known by managementand supervisory employees of the submitter companywho are responsible for manufacturing, processing,distributing, technical services, and marketing of thereportable chemical substance. Extensive file searchesare not required.This reporting standard isno longer in use.Reasonablylikely to beexposedIdentical to the 710.43 definition. 710.43 –An exposure to a chemical substance which,under foreseeable conditions of manufacture (includingimport), processing, distribution in commerce, or use ofthe chemical substance, ismore likely to occur than notto occur. Such exposures would normally include, butwould not be limited to, activities such as chargingreactor vessels, drumming, bulk loading, cleaningequipment, maintenance operations, materials handlingand transfers, and analytical operations. Coveredexposures include exposuresthrough any route of entry(inhalation, ingestion, skin contact, absorption, etc.), butexcludes accidental or theoretical exposures.Comparison of 2006 IUR Definitions and 2012 CDR DefinitionsPage 11 of 13 U.S. Environmental Protection AgencyOffice of Pollution Prevention and ToxicsTermDefinition used for 2012 CDR(40 CFR 704.3 and 40 CFR 711.3)Definition(s) used for 2006 IUR(40 CFR 710.43, 40 CFR 710.3, and 40CFR 704.3)CommentRepackagingIdentical to the 710.43 definition. 710.43 – The physical transfer of a chemical substanceor mixture, as is, from one container to anothercontainer or containers in preparation for distribution ofthe chemical substance or mixture in commerce.ReportablechemicalsubstanceA chemical substance described in §711.5. 710.43 - Chemicalsubstance described in §710.45. To reflect a referenceupdate.SiteA contiguous property unit. Property divided only bya public right-of-way shall be considered one site.More than one plant may be located on a single site.(1) For chemical substances manufactured undercontract, i.e., by a toll manufacturer, the site is thelocation where the chemical substance is physicallymanufactured.(2)The site for an importer who imports a chemicalsubstance described in §711.5 is the U. S. site ofthe operating unit within the person's organizationthat is directly responsible for importing the chemicalsubstance. The import site, in some cases, may bethe organization's headquarters in the United States.If there is no such operating unit or headquarters inthe United States, the site address for the importeris the U.S. address of an agent acting on behalf ofthe importer who is authorized to accept service ofprocess for the importer.(3) For portable manufacturing units sent out todifferent locations from a single distribution center,the distribution center shall be considered the site.704.3 - A contiguous property unit. Property dividedonly by a public right-of-way shall be considered onesite. There may be more than one plant on a single site.The site for a person who imports a substance is thesite of the operating unit within the person'sorganization which is directly responsible for importingthe substance and which controls the import transactionand may in some cases be the organization'sheadquarters office in the United States.710.3 - A contiguous property unit. Property dividedonly by a public right-of-way will be considered one site.There may be more than one manufacturing plant on asingle site. For the purposes of imported chemicalsubstances, the site will be the business address of theimporter.Revised definition to clarifythat the importer’s site mustbe a U.S. address, toaccommodatemanufacturing undercontract, and toaccommodate portablemanufacturing units.Site-limitedIdentical to the710.43 definition.710.43 – A chemical substance is manufactured andprocessed only within a site and is not distributed forcommercial purposes as a substance or as part of amixture or article outside the site. Imported substancesare never site-limited. Although a site-limited chemicalsubstance is not distributed for commercial purposesoutside the site at which it is manufactured andprocessed, the chemical substance is considered tohave been manufactured and processed for commercialpurposes.Definition retained becauseit is used by other parts ofthe regulatory text, eventhough the CDR will nolonger ask companies toidentify if the substance issite limited.Comparison of 2006 IUR Definitions and 2012 CDR DefinitionsPage 12 of 13 U.S. Environmental Protection AgencyOffice of Pollution Prevention and ToxicsTermDefinition used for 2012 CDR(40 CFR 704.3 and 40 CFR 711.3)Definition(s) used for 2006 IUR(40 CFR 710.43, 40 CFR 710.3, and 40CFR 704.3)CommentSmallquantities forresearch anddevelopmentUses the 704.3 definition.704.3 – (or “small quantities solely for purposes ofscientific experimentation oranalysis or chemicalresearch on, or analysis of, such substance or anothersubstance, including such research or analysis for thedevelopment of a product”) means quantities of achemical substance manufactured, imported, orprocessed or proposed to bemanufactured, imported,or processed solely for research and development thatare not greater than reasonably necessary for suchpurposes.710.3 -Small quantities for purposes of scientificexperimentation or analysis orchemical research on, oranalysis of, such substance or another substance,including any such research or analysis for thedevelopment of a product(hereinafter sometimesshortened tosmall quantities for research anddevelopment) means quantities of a chemicalsubstance manufactured, imported, or processed orproposed to be manufactured,imported, or processedthat:(1) Are no greater than reasonably necessary for suchpurposes, and(2) After the publication of the revised inventory, areused by or directly under the supervision of atechnically qualified individual(s).Note: Any chemical substances manufactured,imported, or processed in quantities less than 1,000 lbs.(454 kg) annually will be presumed to be manufactured,imported, or processed for research and developmentpurposes. No person may report for the inventory anychemical substance in such quantities unless thatperson can certify that the substance was notmanufactured, imported, or processed solely in smallquantities for research and development, as defined inthis section.SubmissionperiodThe period in which manufacturing, processing, anduse data are submitted to EPA.710.43 - The period in whichthe information generatedduring the reporting year is submitted to EPA.Revised definitionComparison of 2006 IUR Definitions and 2012 CDR DefinitionsPage 13 of 13 U.S. Environmental Protection AgencyOffice of Pollution Prevention and ToxicsTermDefinition used for 2012 CDR(40 CFR 704.3 and 40 CFR 711.3)Definition(s) used for 2006 IUR(40 CFR 710.43, 40 CFR 710.3, and 40CFR 704.3)CommentTestmarketingUses the 704.3 definition 704.3 – the distribution in commerce of no more than apredetermined amount ofa chemical substance,mixture, article containingthat chemical substance ormixture, or a mixture containing that substance, by amanufacturer or processor, to no more than a definednumber of potential customers to explore marketcapability in a competitive situation during apredetermined testing period prior to the broaderdistribution of that chemicalsubstance, mixture, orarticle in commerce.710.3 - The distribution in commerce of no more than apredetermined amount ofa chemical substance,mixture, or article containingthat chemical substance ormixture, by a manufacturer or processor to no morethan a defined number of potential customers to exploremarket capability in a competitive situation during apredetermined testing period prior to the broaderdistribution of that chemicalsubstance, mixture, orarticle in commerce.UseIdentical to the 710.43 definition. 710.43 – Any utilization ofa chemical substance ormixture that is not otherwise covered by the termsmanufacture or process.Relabeling or redistributing acontainer holding a chemical substance or mixturewhere no repackaging of thechemical substance ormixture occurs does not constitute use or processing ofthe chemical substance or mixture.