Document ID: EPA-HQ-OPPT-2013-0721-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2021-09-21T04:00Z

Attachment 3:  Uses of Specific Data Elements
This attachment provides more specific information on a data-element basis to supplement the information provided in response to Question 2 in the ICR supporting statement. 
    Parent company, site, and technical contact information: Information about the U.S. parent company (and foreign parent company, when applicable) associated with the reporting site is used for protecting information claimed as confidential when there are multiple sites for the same parent company and for comparing data from various sources, such as is done for EPA's Toxics Release Inventory (TRI).Consistent use of parent company names makes for more meaningful comparisons of data and reduces after-reporting quality control efforts for both EPA and submitters. Site information is important because EPA and stakeholders need to know where chemical manufacturing (including import) occurs. EPA uses the technical contact information to contact submitters in the event of questions about the submission.
    NAICS codes: The reporting site's NAICS code(s) helps EPA to more accurately understand the chemical industry, including identifying sector-specific trends. 
    Manufacturing-related information:
       The identity of the chemical substance: This data element identifies the specific chemical substance for which the information is being reported. 
       The production volume of a manufactured (including imported) chemical substance used at the reporting site: This data element identifies whether a chemical substance is used on site. Either domestically manufactured or imported chemical substances can be reported as used at the reporting site. This information is related to potential exposures associated with the on-site volumes and provides the Agency with information for exposure assessments and other data analyses. 
       The production volume for each of the years since the last principal reporting year: Manufacturers (including importers) need to report production volume information for the principal reporting year (the year before the collection; i.e., for 2024 the principal reporting year would be 2023) and for each of the calendar years since the last report (i.e., 2020, 2021, 2022), if a chemical substance was manufactured (including imported) at a site in excess of the relevant production volume threshold (25,000 pounds or 2,500 pounds if subject to certain TSCA actions) for any of the four calendar years. Examples of how EPA will use these data include: chemical prioritization, evaluation, and management efforts; chemical manufacturing, processing, and use trend analyses; and assessment of Agency and public programs.
       Whether an imported chemical substance is physically at the reporting site: Imported chemical substances may never physically be located at the reporting site because, upon import, they are shipped directly to another site. This data element enables the Agency and others to better assess manufacturing-related potential exposures, thereby enabling information for screening-level analyses and other uses of the CDR data.
       The production volume directly exported and not domestically processed or used: This data element allows EPA to identify the completeness of the reported processing and use information by indicating the proportion of the production volume potentially covered by the reported processing and use information. CDR processing and use information is required only for domestic use situations and is not required for any volumes directly exported. This data element informs the exposure profile for the U.S. public.
       Percent production volume that is a byproduct: (voluntary data element) This data element helps EPA identify important submitter subpopulations and their representation in CDR with respect to production volume. With these data, EPA is able to better understand the reporting impacts on this subpopulation, including to identify those manufacturers who only report to CDR due to their byproduct production. In addition, these data help EPA to understand and connect manufacturing and downstream activities for the purposes of substance life cycle assessments and risk evaluation.  
       The number of workers exposed: This data element allows EPA to identify the number of workers reasonably likely to be exposed to each reportable chemical substance during manufacture at each site. This exposure-related information allows OPPT to screen chemical substances based on the potential for risk in order to protect human health.
       The maximum concentration of a chemical: This data element provides maximum concentration measured by percentage of weight of a reportable chemical substance at the time it is reacted on-site to produce a different chemical substance or as it leaves the site. This data element provides information relevant to the exposure profile of a chemical substance.
       Whether a manufactured (including imported) chemical substance is being recycled, remanufactured, reprocessed, or reused: This data element provides information relevant to the exposure profile of a chemical substance and indicate efficiencies within the chemical manufacturing industry. 
       The physical form of a chemical: This data element provides information needed for the Agency to understanding potential routes of exposure to the chemical substance, which is dependent in part on the physical form of the chemical substance.
    Processing and use information: Data elements that relate to processing and use help EPA and other agencies to readily screen and prioritize chemicals for the purpose of identifying potential human health and environmental effects. For example, the data are used in exposure and risk screening, testing and/or priority setting, and exposure estimates required by TSCA section 4; for EPA monitoring activities of newly manufactured substances that have completed pre-manufacture notification (PMN) review under TSCA section 5(a); and to measure potential human and environmental exposure which helps inform chemical risk evaluations, such as those required under TSCA section 6. Each data element corresponds to a data point necessary for basic risk screening.
       Industrial processing and use data: These data elements identify how the chemical is processed or used in an industrial setting, including the function of the chemical substance in any formulation or product. The industrial data elements include the type of process or use operation (TPU), the industrial sector (IS) and the industrial function category (IFC). Both IS and IFC codes were designed to consolidate information based on potential exposure-related scenarios, thereby reducing the number of choices available to the respondent, streamlining the reporting process, and making the data easier to use. Also included in this industrial processing and use section are data elements for percent production volume, number of sites, and number of workers. These data elements help to characterize the potential exposures associated with the TPU, IS, and IFC data elements.
       Consumer and commercial use data: These data are reported separately from the industrial data and are used to determine exposure potential based on uses by consumer and commercial populations. The specific data elements include product category; whether the application is intended for consumer or commercial populations (or both), including specifically for use by children, the function of the chemical in the use application, and characterizing data elements (percent production volume, maximum concentration, and number of commercial workers). This information allows EPA and the public to better understand the consumer and commercial uses of CDR chemicals, including what is in children's products, thereby enabling the Agency to better characterize chemical exposures related to children's health.
    Special considerations for Joint Submitters when Chemical Identity is Unknown: In certain situations, CDR submitters are allowed to report the information jointly with the supplier(s) of the chemical substance for which the submitter is reporting. For example, importers may not know the specific chemical identity of the imported TSCA chemical substance because the foreign supplier chooses to keep the information confidential. In addition, a manufacturer may not know the specific chemical identity of the substance being manufactured because the supplier of a reactant used to manufacture the substance chooses to keep the information confidential. In such situations, the manufacturer (including importer) is still responsible for ensuring that the CDR information is submitted to EPA and may do so by submitting a joint report.
   In the case of an imported substance, the U.S.-based importer, as the primary submitter, initiates and completes the majority of the required information on Form U, and provides a trade name to identify the chemical substance. Using e-CDRweb (the electronic reporting tool), the primary submitter then contacts the foreign supplier, as the secondary submitter, to notify them of the need to report the specific chemical identity information directly to EPA in the Secondary Form U. Because signatures are required by each party of a joint submission, each party must register with CDX, complete their own company information sections on Form U, and submit their respective portions of the same report electronically to EPA. The secondary submitter will not be able to access the information provided by the primary submitter and vice versa. EPA combines information provided separately by the primary and secondary submitters, thereby providing a complete picture of the CDR data for the subject chemical substance without breaching confidentiality.
   EPA collects certain data to enable the joint submission and to combine information from the two parties. These data will be used in the following ways:
       Joint submission information (primary submitter): The primary submitter provides a trade name or other designation in place of the specific chemical identification and the secondary company contact information (name, address, email address). This information is used by the electronic reporting tool to contact the secondary submitter and by EPA to connect the information from both parts of the submission. 
       Secondary company identification information (secondary submitter): These data identify the secondary submitter's company name and the complete mailing address of the company. The information helps ensure that the company information is provided consistently and is used to associate the secondary submitter's company with the primary submitter's company and site plant.
       Technical contact information (secondary submitter): The company's technical contact information provides EPA with the name and complete mailing address of the person who will be able to answer questions that EPA may have about the reported chemical substance.
       Trade product identification information (secondary submitter): These data identify chemicals associated with the primary submitters supplied trade product name and include the associated chemical name and Chemical Abstract Services (CAS) Registry Number. If the product contains multiple chemicals, the secondary submitter includes also the percent of formulation for each chemical substance. The secondary submitter also identifies the function of each chemical in the imported product, which EPA uses in combination with the industrial or consumer/commercial information provided by the primary submitter, as per the processing and use information discussion provided earlier in this section.
    Special considerations for Co-Manufactured Chemicals when reported jointly by the Contracting and Producing Companies:  In certain circumstances, manufacturers may choose to report their co-manufactured chemical jointly, such that each party (i.e., the contracting company and the producing company) provides certain information directly to EPA. This is primarily done when one or both parties consider some of its information as confidential.  These special considerations do not apply when co-manufacturers chose to share their information with each other, resulting in the producing company report all information to EPA.
   In the case of a jointly-reported co-manufactured chemical, the contracting company initiates the co-manufacture report by providing the chemical identity and the identity of the producing company and name (actual name, trade name, or other alias) used to identify the chemical substance in communications with the producing company. Using e-CDRweb (the electronic reporting tool), the contracting company then contacts the producing company to notify them of the need to report the manufacturing-related information directly to EPA as part of the producing company's Form U. Because signatures are required by each party of a co-manufactured chemical submission, each party must register with CDX, complete their own company information sections on Form U, and submit their respective portions of the same report electronically to EPA. The contracting company will not be able to access the information provided by the producing company and vice versa. EPA combines information provided separately by the contracting and producing companies, thereby providing a complete picture of the CDR data for the subject chemical substance without breaching confidentiality.
   EPA collects certain data to enable the joint submission and to combine information from the two parties. These data will be used in the following ways:
       Joint submission information (contracting company): The contracting provides a trade name or other designation in place of the specific chemical identification and the producing company contact information (name, address, email address). This information is used by the electronic reporting tool to contact the producing company and by EPA to connect the information from both parts of the submission. 
       Producing company identification information: These data identify the producing company's name and the complete mailing address of the company. The information helps ensure that the company information is provided consistently and is used to associate the contracting company's information with the producing company.
       Technical contact information (producing company): The company's technical contact information provides EPA with the name and complete mailing address of the person who will be able to answer questions that EPA may have about the reported chemical substance.
About certain data elements: For the most part, the contracting company provides the chemical identity and processing and use information for the co-manufactured chemical, and the producing company provides the manufacturing-related data. The uses of these data are provided earlier in this section. For selected data, the information is provided by both companies due to differing knowledge bases among different co-manufacturers. In addition, for other data elements the terminology may be changed from what is used for a non-co-manufactured chemical; however, the intent and use of the information is unchanged. Specifically:
 Production volume:  The production volume is collected from both the contracting company and the producing company as a check that there is consistency between the two companies.  In addition, other data elements are reported as "percent production volume"  -  to ensure that the calculated amount is as intended by the reporter, EPA needs the total production volume from the same reporter.
 Contracted volume directly exported from producing site: This information is collected from both the contracting company and the producing company due to a request from a contracting company.  Although the producing company may be provided the location of the recipient of the manufactured chemical, there are circumstances where the producing company could be unaware that the chemical is going to a non-U.S. destination.
 Contracted volume never physically at site: This data element, although considered a manufacturing-related data element, is reported by the contracting company.  Similar to the situation for an importer, the contracting company may never receive the chemical substance at its site.  EPA uses this information to determine the number and location of sites that have a potential for exposure to the chemical substance. 
    CBI Substantiation: Most CDR data can be claimed as CBI when the CDR reporting form is submitted to EPA. As required under TSCA as amended by the Lautenberg Act, substantiation for CBI claims must be submitted at the time the claim is made, except for CBI claims for production volume information (excludes percent production volume). The e-CDRweb electronic reporting tool is the mechanism for submitting substantiation information. For certain data elements, submitters must answer EPA substantiation questions related to whether the information is publicly known and whether public knowledge of the information would hurt a business' competitive position. EPA provides additional questions for chemical identification that is claimed CBI.