July 2010 Office of Pollution P

 U.S. Environmen

IUR Modifications Rule 

Development of Definitions for 40 CFR 711.3 

Where term currently defined 

Term Proposed 711.3 Definition 704.3 710.3 710.43 TSCA sec 3 

Administrator None x x Rely on staArticle None x x Rely on 70Byproduct None x x Rely on 70Byproduct material, source material, and special nuclear material 

None x x Rely on sta

CDX – Central Data Exchange 

EPA's centralized electronic document receiving system, or its successors, including associated instructions for registering to submit electronic documents. 

Chemical substance 

None x x Rely on sta

Commerce None x x Rely on staCommercial Use The use of a chemical substance or a 

mixture containing a chemical substance (including as part of an article) in a commercial enterprise providing saleable goods or services. 

x 

Consumer use The use of a chemical substance or a 

mixture containing a chemical substance (including as part of an article) when sold to or made available to consumers for their use. 

x 

Cosmetic, device, drug, food, and 

None x x Rely on sta

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July 2010 Office of Pollution P

 U.S. Environmen

Where term currently defined 

Term Proposed 711.3 Definition 704.3 710.3 710.43 TSCA sec 3 

food additiveDistribute in commerce and distribution in commerce 

None x x Rely on sta

e-IURweb Electronic, web-based IUR software 

provided by EPA for the completion and submission of the IUR data. 

EPA None x x Rely on 70Importer None x x Rely on 70Impurity None x x Rely on 70Industrial function 

The intended physical or chemical characteristic for which a chemical substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, reaction product, or article; repackaged; or used. 

Industrial use Use at a site at which one or more 

chemical substances or mixtures are manufactured (including imported) or processed. 

x No change 

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July 2010 Office of Pollution P

 U.S. Environmen

Where term currently defined 

Term Proposed 711.3 Definition 704.3 710.3 710.43 TSCA sec 3 

Intended for use by children 

The chemical substance or mixture is used in or on a product that is specifically intended for use by children age 14 or younger. A chemical substance or mixture is intended for use by children when the submitter answers “yes” to at least one of the following questions for the product into which the submitter's chemical substance or mixture is incorporated: (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for children age 14 or younger? (2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger? (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or younger? 

x No change 

Intermediate None x x Rely on 70Known to or reasonably ascertainable by 

None x x Rely on 70

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July 2010 Office of Pollution P

 U.S. Environmen

Where term currently defined 

Term Proposed 711.3 Definition 704.3 710.3 710.43 TSCA sec 3 

Manufacture To manufacture, produce, or import for 

commercial purposes. Manufacture includes the extraction, for commercial purposes, of a component chemical substance from a previously existing chemical substance or a complex combination of chemical substances. When a chemical substance, manufactured other than by import, is (1) produced exclusively for another person who contracts for such production, and (2) that other person specifies the identity of the chemical substance and controls the total amount produced and the basic technology for the plant process, that chemical substance is jointly manufactured by the producing manufacturer and the person contracting for such production. 

x x x 

Manufacture or import “for commercial purposes” 

None x x Rely on 70

Manufacturer A person who manufactures a chemical 

substance. 

x x Added new 

confusion 

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July 2010 Office of Pollution P

 U.S. Environmen

Where term currently defined 

Term Proposed 711.3 Definition 704.3 710.3 710.43 TSCA sec 3 

Master Inventory File 

EPA's comprehensive list of chemical substances which constitute the TSCA Chemical Substance Inventory compiled under section 8(b) of the Act. It includes chemical substances reported under part 710 of this chapter and chemical substances reported under part 720 of this chapter for which a Notice of Commencement of Manufacture or Import has been received under §720.120 of this chapter. 

x No change 

Mixture None x x Rely on staNew chemical substance 

None x x Rely on sta

Non-Isolated intermediate 

None x x Rely on 70

Person None x x Rely on 70Pesticide None x x Rely on staPrincipal reporting year 

The last complete calendar year preceding the submission period.

x Revised, fr

reporting y

Process None x x x x Rely on 70Process for “commercial purposes” 

None x x Rely on 70

Processor None x x x Rely on 70Readily obtainable information 

None x Deleting d

to eliminat

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July 2010 Office of Pollution P

 U.S. Environmen

Where term currently defined 

Term Proposed 711.3 Definition 704.3 710.3 710.43 TSCA sec 3 

Reasonably likely to be exposed 

An exposure to a chemical substance which, under foreseeable conditions of manufacture (including import), processing, distribution in commerce, or use of the chemical substance, is more likely to occur than not to occur. Such exposures would normally include, but would not be limited to, activities such as charging reactor vessels, drumming, bulk loading, cleaning equipment, maintenance operations, materials handling and transfers, and analytical operations. Covered exposures include exposures through any route of entry (inhalation, ingestion, skin contact, absorption, etc.), but excludes accidental or theoretical exposures. 

x No change 

Repackaging The physical transfer of a chemical 

substance or mixture, as is, from one container to another container or containers in preparation for distribution 

of the chemical substance or mixture in commerce. 

x No change 

Reportable chemical substance 

A chemical substance described in §711.5. x No change 

other than 

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July 2010 Office of Pollution P

 U.S. Environmen

Where term currently defined 

Term Proposed 711.3 Definition 704.3 710.3 710.43 TSCA sec 3 

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Site A contiguous property unit. Property 

divided only by a public right-of-way shall be considered one site. More than one plant may be located on a single site. (a) For chemical substances manufactured under contract, i.e., by a toll manufacturer, the site is the location where the chemical substance is physically manufactured. (b)The site for an importer who imports a chemical substance described in §711.5 is the U.S. site of the operating unit within the person's organization that is directly responsible for importing the chemical substance. The import site, in some cases, may be the organization's headquarters in the United States. If there is no such operating unit or headquarters in the 

United States, the site address for the importer is the U.S. address of an agent acting on behalf of the importer who is authorized to accept service of process for the importer. (c) For portable manufacturing units sent out to different locations from a single distribution center, the distribution center 

shall be considered the site. 

x x Revised de
July 2010 Office of Pollution P

 U.S. Environmen

Where term currently defined 

Term Proposed 711.3 Definition 704.3 710.3 710.43 TSCA sec 3 

Site-limited A chemical substance is manufactured and 

processed only within a site and is not distributed for commercial purposes as a chemical substance or as part of a mixture or article outside the site. Imported chemical substances are never site-limited. Although a site-limited chemical substance is not distributed for commercial purposes outside the site at which it is manufactured and processed, the chemical substance is considered to have been manufactured and processed for commercial purposes. 

x No change 

Definition by other paeven thougask compachemical s

Small quantities for research and development 

None x x Rely on 70

State None x x Rely on staSubmission period 

The period in which the manufacturing, processing, and use data are submitted to EPA. 

x Revised de

Technically qualified individual 

None x Deleted be

purposes 

Test marketing None x x Rely on 70The Toxic Substances Control Act, 15 U.S.C 2601 et seq 

None x Rely on 70

United States None x x Rely on sta

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July 2010 Office of Pollution P

 U.S. Environmen

Where term currently defined 

Term Proposed 711.3 Definition 704.3 710.3 710.43 TSCA sec 3 

Use Any utilization of a chemical substance or 

mixture that is not otherwise covered by the terms manufacture or process.

Relabeling or redistributing a container holding a chemical substance or mixture where no repackaging of the chemical substance or mixture occurs does not constitute use or processing of the chemical substance or mixture. 

x No change 

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