1884ss06 - Rev 2012-01-31

January 27, 2012

Supporting Statement for a Request for OMB Review under

The Paperwork Reduction Act

1. Identification of the Information Collection

1(a) Title of the Information Collection

Title: Final Rule Addendum to Partial Update of the TSCA Section 8(b) TSCA Inventory Data Base, Production and Site Reports

EPA ICR No.: 1884.06 OMB Control No.: 2070-0162

1(b) Short Characterization/Abstract

As part of the Inventory Update Reporting (IUR) Modifications final rule, EPA is changing the identification of the regulation from IUR to Chemical Data Reporting (CDR). However, EPA is retaining the use of the IUR acronym throughout this document. The reader should recognize that where IUR is used to refer to the 40 CFR 711 regulations or to future IUR submission periods, IUR and CDR are synonymous.

The following information collection request (ICR) addendum addresses the paperwork requirements contained in a final rule (RIN 2070-AJ43) that amends the information collection activities of the TSCA Inventory Update Reporting (IUR) program under the Toxic Substances Control Act (TSCA) (40 CFR Part 710). Under TSCA section 8(a) (15 USC 2607), the Environmental Protection Agency (EPA) is authorized to collect certain information on chemical substances manufactured or processed in the United States. In addition, under TSCA section 8(b), the Agency is required to compile and keep current, via periodic inquiry, the TSCA Inventory of Chemical Substances (TSCA Inventory). The TSCA Inventory is a listing of chemical substances manufactured, imported, and processed for commercial purposes in the United States. The Office of Pollution Prevention and Toxics (OPPT) has used the IUR to update the basic chemical substance production information for selected larger volume chemical substances on the TSCA Inventory six times (every four years), beginning in 1986, and to collect additional information relating to the manufacture, processing, and use of those chemical substances, beginning in 2006.

EPA has amended the IUR requirements in order to clarify the reporting requirements, improve the quality and utility of the data submitted, better match data collected with the Agency’s overall information needs, and where possible, reduce the paperwork burden on both regulated entities and EPA. Manufacturers (including importers) are required to use e-IURweb (the Agency-provided reporting tool) to submit a completed Form U (EPA Form 7740-8) electronically via the Internet. The 2012 IUR includes additional manufacturing, processing, and use exposure-related data elements, including the volume of the chemical substance used on the reporting site; the volume of the chemical substance directly exported; whether the chemical substance is being recycled, remanufactured, reprocessed or reused; and the production volume for calendar year 2010. Additional amendments to the 2012 IUR include changes to the reporting frequency from every five years to every four years; modifications to the method used to determine whether a manufacturer (including importer) is subject to IUR reporting for reporting cycles subsequent to the 2012 reporting cycle; production volumes for each year since the last principal reporting year (effective after 2012 IUR); modifications to reporting thresholds, including the phasing in of reporting thresholds for processing and use; elimination of the 25,000 lb reporting threshold for certain chemical substances that are the subject to particular TSCA rules and/or orders; revisions to industrial classifications used; revisions to the list of commercial and consumer product categories; and modifications to situations in which confidentiality may be claimed and to the process for making such claims.

OPPT will use the updated IUR data in its chemical substance risk-management efforts. Individual sites manufacturing (including importing) chemical substances will submit the required information. The information will be stored electronically for reference by EPA staff and others. Within the constraints of confidentiality claims, the information will be made public through the Agency’s IUR website (http://www.epa.gov/iur). Further discussion of how the information is used, stored, and collected is included in this document.

The collection is expected to involve an average of approximately 4,153 respondents at an annual cost of $29 million during the ICR addendum period. The details of the paperwork burden and cost estimates are discussed in this document.

2. Need for and use of the Collection

2(a) Need/Authority for the Collection

Under TSCA, EPA is required to identify, assess, and control risks of injury to human health and the environment posed by commercial chemical substances. Under TSCA section 8(b), EPA is required to compile and keep current a complete list of chemical substances manufactured or processed in the United States. TSCA section 8(a) authorizes the Administrator to promulgate rules to provide for the maintenance and collection of records from manufacturers, importers, and processors of commercial chemical substances. Sections 8(a)(1) and (2) of TSCA also authorize the Agency to collect information on the chemical substance manufacturing and importing industry. EPA possesses broad discretion in determining the information to be reported under TSCA section 8(a). The IUR rule was codified at 40 CFR 710. EPA has moved the IUR rule to a new Part at 40 CFR 711.

EPA modified the IUR rule¹ to meet four primary goals: (1) to tailor the information collected to better meet the Agency’s overall information needs; (2) to increase its ability to effectively provide public access to the information; (3) to obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory; and (4) to improve the usefulness of the information reported. EPA believes requiring electronic reporting; collecting comprehensive information for most reported chemical substances; and adjusting the specific reported information, the frequency the information is reported, and confidential business information (CBI) claim requirements will accomplish these goals.

The IUR provides basic exposure-related manufacturing, processing and use information used by EPA and others in a wide range of Agency activities. EPA’s efforts to use the 2006 IUR data have identified areas where further improvements were needed to improve risk-screening capabilities. Screening level data need not be precise, but should be accurate and reliable enough for the Agency to develop screening-level exposure assessments. The 2012 IUR will provide more detailed information needed to better understand and interpret the IUR data, further enhancing the Agency’s ability to identify, screen, and manage potential chemical substance risks. Because exposure is a key component of risk, the IUR exposure-related information will allow OPPT to screen chemical substances based on the potential for risk in order to protect human health and the environment, as required by TSCA. The exposure-related data on manufacturing, processing, and use will potentially allow the Agency and others to avoid more burdensome regulatory requirements. These enhanced data will allow EPA to conduct a more effective and efficient screening level review of chemical substances to identify candidates for further evaluation.

2(b) Practical Utility/Users of the Data

The modifications associated with reporting methods and changes to the reporting tool will ensure the information reported to EPA is accurate and in compliance with the IUR requirements.

e-IURweb Reporting Tool

Beginning with the 2012 submission period, EPA is requiring electronic reporting for all IUR submissions, including joint submissions and amendments. Persons submitting information under the IUR rule are required to use e-IURweb, the Agency-provided, web-based tool to complete Form U (the IUR reporting form). The information will be submitted electronically via the Internet, through EPA’s Central Data Exchange (CDX). Users of CDX are required to register with the system, including submitting an authorized signature agreement to EPA.

The 2012 submission process is similar to that available for the 2006 IUR, when EPA provided an opportunity for IUR respondents to send their reports electronically, through CDX, on a voluntary basis. Approximately one-third of the 2006 submissions were filed through CDX, using the 2006 e-IUR downloadable software. The elimination of paper-based submissions in favor of electronic reporting, including the use of e-IURweb, is expected to greatly improve the reporting process, both for EPA and for manufacturers (including importers).

The 2012 e-IURweb features several improved capabilities over the 2006 e-IUR software. These improvements include an enhanced validation system, which alerts users when a required field on the form is either missing information or contains certain kinds of potentially incorrect information. Other updates include automated chemical identity checks, using EPA’s Substance Registry Services (SRS), automated company and site identity checks, using EPA’s Facility Registry System (FRS), and the facilitation of joint submissions and amendments.

Electronic submission will also ensure that IUR data complete a basic validation check, can be quickly incorporated into a database and ready for immediate Agency use, and will eliminate subsequent data entry errors which occurred with paper submissions. Furthermore, EPA believes the mandatory use of e-IURweb and CDX will reduce the reporting burden on industry by reducing both the cost and the time required to review, edit and transmit data to the Agency.

CDX Registration

Each IUR submission must have an associated authorized official. The authorized official signs the certification statement and submits the IUR report via CDX. During the 2006 IUR, respondents were required to complete an electronic signature agreement (ESA) and to submit the agreement in hard copy with a wet ink signature to EPA in order to complete the CDX registration. For 2012 IUR reports, EPA modified the 2006 ESA to identify more clearly the individual(s) required to sign the agreement. To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder”) will complete ESA form. For identity authentication, the registrant will complete the ESA, and either submit the form electronically or mail the form to EPA. Once EPA receives the form, EPA will activate the registrant’s CDX account and send a notification via email.

A company may need or desire to have more than one individual complete an electronic signature agreement, so that more than one person can add information to an original IUR submission. Persons submitting supplemental information for an IUR submission on behalf of a company will also need to register with CDX by signing an ESA. The company official can authorize an unlimited number of support registrants and support registrants can work with an unlimited number of company officials. A support registrant may be an employee of the company, an outside consultant for the company, or an authorized representative agent for the company. While this individual is not able to sign the certification statement required for the initial IUR submission, he or she will be able to provide additional information, if needed, using CDX. For 2006 and prior IUR submissions, support registrants were not able to provide additional information electronically.

Data Elements for IUR Submissions

The IUR information collection is the only mechanism through which EPA can collect basic information on commercial chemical substances listed on the TSCA Inventory, including production volume and other manufacturing (including importing) processing, and use exposure-related data. This information collection is necessary because these data are not otherwise available. EPA will use the information it is collecting in the following ways:

1. U.S. Parent company identification information: Company identification information is collected already by the current IUR. EPA will require reporting of additional company identification information associated with the location of the company, and will clarify that the company information is to be for the U.S. parent company associated with the reporting plant site. These data will help ensure the company information is consistently provided.

(2) Manufacturing-related information:

• The production volume for calendar year 2010: The one-year snapshot of production volume provided by the 2006 IUR does not provide an accurate picture of the chemical substances in commerce, and may provide an erroneous view of the exposure scenarios associated with a particular chemical substance. The high turn-over of reported chemical substances from one submission period to the next indicates a dynamic, changing industry. EPA has received comments from industry concerning the year-to-year changes that occur for chemical substance production that may affect IUR reporting. For the 2012 IUR, manufactures (including importers) will need to report the production volume for calendar year 2010. This is in addition to the full manufacturing, processing, and use information for the principal reporting year (i.e., 2011). For IUR collections subsequent to the 2012 IUR collection, EPA will require reporting of production volumes for each of the years since the last principal reporting year. EPA will use these data for chemical manufacturing, and processing and use trend analyses; and for the assessment of the effectiveness of Agency and public programs, among other uses.

• The production volume of a manufactured (including imported) chemical substance used at the reporting site: This data element replaces the data element indicating that a chemical substance is site-limited. This new data element identifies whether a chemical substance is used by the reporting 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 will provide the Agency with more accurate information for exposure assessments and other data analyses.

• Whether an imported chemical substance is physically at the reporting site: This data element will enable the Agency and others to better assess manufacturing-related potential exposures, thereby enabling more accurate information for screening-level analyses and other uses of the IUR data.

• The production volume directly exported and not domestically processed or used: This data element will allow EPA to better 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. IUR processing and use information is required only for domestic use situations, and is not required for any volumes directly exported.

• Whether a manufactured (including imported) chemical substance, such as a byproduct, is being recycled, remanufactured, reprocessed, or reused: This data element will provide valuable information for Agency and public programs that encourage industry to find uses for wastes rather than disposing of the wastes, such as in a landfill.

These data will also be used in other ways, such as in chemical substance exposure and risk screening, testing and/or priority setting, and exposure estimation required by the Interagency Testing Committee (ITC) under TSCA section 4; for EPA monitoring activities of newly manufactured substances that have completed PMN review under TSCA section 5(a); to support the development of TSCA regulations under section 6; and to measure potential human and environmental exposure under TSCA section 8(e). Each data element corresponds to a data point necessary for basic risk-screening.

Under the 2006 IUR rule, only manufacturers (including importers) of larger-volume chemical substances were required to report processing and use information. Under the final rule, the reporting threshold for processing and use information will be phased in, such that the threshold is 100,000 lb for the 2012 IUR and 25,000 lb for the next IUR collection in 2016. For 2012, for example, respondents who manufacture (including import) a chemical substance in volumes of 100,000 lb or more at a single site are required to report processing and use information, unless the chemical substance is partially exempt. This change provides exposure-related processing and use information to EPA and others for moderate-volume chemical substances, enabling the Agency to address such chemical substances in the same manner as the higher-volume chemical substances.

(3) Industrial processing and use data: The final rule does not add any industrial processing and use data elements. The industrial function categories have been revised to better identify the functions of the chemical substances. The North American Industrial Classification System (NAICS) codes have been replaced with industrial sector (IS) codes. The IS codes reduce the number of choices available to the respondent, thus streamlining the reporting process and making the data easier to use.

(4) Consumer and commercial end-use exposure data: EPA added two data elements: an indication of consumer or commercial use and the number of commercial workers. These data will be used to determine exposure potential based on consumer or commercial populations. These two populations are very different from each other, and the ability to distinguish uses between the two enables better exposure-based screening of the chemical substance. The number of commercial workers is needed to better assess the size of the commercial population reasonably likely to be exposed to a chemical substance. In addition, the product categories have been revised to better identify the uses of chemical substances.

Special Considerations for Joint Submitters

In certain situations IUR submitters are allowed to report the IUR information jointly with the supplier of the chemical substance for which the submitter is reporting. For example, importers may not know the specific chemical identity of the imported TSCA Inventory 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 IUR information is submitted to EPA and may do so by submitting a joint report. For example, in the case of an imported substance, the U.S. importer, as the primary submitter, completes the majority of the required information on Form U, and provides a trade name in Part II.2.A.4 to identify the chemical substance. The primary submitter then contacts the foreign supplier, who is the secondary submitter, to notify them of the need to report the specific chemical identity information directly to EPA in the joint submission section (Part IV) of Form U, using the reporting tool, e-IURweb. For 2006 and prior IUR submissions, submitters were not able to submit joint reports electronically. EPA has added Part IV to Form U to accommodate joint submissions. Because signatures are required by each party of a joint submission, they must each register with CDX, complete their own sections on Form U, and submit their own sections 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. The reporting tool will match both submissions based upon company and chemical information provided by the manufacturer (including importer), acting as a primary submitter, and by the supplier, acting as a secondary submitter. The information provided by the primary and secondary respondents will be saved and combined as one joint submission. EPA will process the joint submission once all Form Us are received and matched by the Agency.

This information collection will allow EPA to connect submissions from the primary submitter and secondary submitter and to request clarification from the secondary submitter if needed. The data EPA will collect will be utilized in the following ways:

1. Joint Submission Information (primary registrant only): The primary submitter provides only a trade name or other designation to identify the chemical substance being reported. Therefore, the requested data are needed by the Agency to identify the chemical substance correctly and provide the company name and complete mailing address of the secondary submitter.

2. Secondary Company Identification Information: These data identify the secondary submitter’s company name and the complete mailing address of the company. The information provided will help ensure that the company information is provided consistently, and will be used to associate the secondary submitter’s company with the primary submitter’s company and site plant.

3. Technical Contact Information: The company’s technical contact information will provide EPA with the name and complete mailing address of the person who will be able to answer questions EPA may have about the reported chemical substance.

4. Primary Company Information: These data will provide the trade name and Unique Identifier for Joint Submissions number the primary submitter sent to the secondary submitter.

5. Trade Product Identification Information: These data will identify the primary submitters’ company name, site name, and site address, as well as the CAS Registry Number, the appropriate specific chemical identities, and product composition. These data are needed by EPA to combine the secondary submitters’ chemical-specific information with the primary submitters’ information to result in a complete IUR submission.

Information secured through the IUR collections is used increasingly by a wide variety of governmental and non-governmental users. Consistent with Congress’s intent that TSCA data be used to facilitate any government public health and environment efforts, IUR data have been used by EPA’s Office of Water, Office of Solid Waste and Emergency Response, and Office of Air and Radiation to identify and characterize particular chemical substances. Non-confidential IUR data are incorporated into a number of databases and products maintained by organizations including Right-To-Know-Net and INFORM². IUR data were used to identify chemical substances of particular concern for the National Institutes of Health. Non-confidential IUR data were also released to selected states to help them identify facilities manufacturing suspected endocrine disrupters.

Data reported under the 2012 IUR will enhance the capabilities of the Agency and other Federal agencies to ensure risk management actions are taken on chemical substances posing the most concern. More in-depth reporting of the processing and use data, more careful consideration of the need for confidentiality claims, and adjustments to the specific data elements will better support a robust risk assessment and management program. By enhancing the data supplied to Agency risk-screening programs, EPA expects to more effectively and expeditiously identify and address potential risks posed by chemical substances and provide improved access and information to the public.

EPA will also use the information submitted through the 2012 collection to update the Agency’s comprehensive chemical manufacturing, exposure, and use database, maintained as part of the Manage Toxic Substances (MTS) system. IUR data prior to the 2006 collection are maintained in a series of databases known as the Chemical Update System (CUS). The MTS IUR data, combined with CUS and the Chemicals in Commerce Information System (CICIS) database, serves as a primary source of information about the chemical industry for EPA, as well as other Federal Agencies. The MTS IUR data provide information about the chemical substances used, where they are produced, how much is produced or imported, and how they are processed and used. The chemical industry is dynamic, as demonstrated by the approximately 30 percent change in chemical substances reported from one IUR submission period to the next; therefore continual updating of the database is essential.

3. Non duplication, Consultations, and Other Collection Criteria

3(a) Non duplication

The data included in this information collection (i.e., production volume, chemical manufacture, exposure, and processing and use data) are not collected comprehensively or systematically at the national level. There are a variety of sources for certain data elements, but the sources are either incomplete or incompatible.

3(b) Public Notice Required Prior to ICR submission to OMB

The notice of proposed rulemaking, which served as the public notice for this ICR pursuant to 5 CFR 1320.11, published on August 13, 2010 (75 FR 49656). During the public comment period for the notice of proposed rulemaking, EPA received comments about the Agency's need for and practical utility of the proposed data elements; when reporting should be required; reporting frequency; the estimated costs and burdens associated with the updated reporting requirements, and mandatory electronic reporting. EPA considered these comments when formulating the final rule. Changes made by EPA for the final rule in response to public comments include:

• A 6-month delay to the start of the reporting period for the 2011 principal reporting year in order to provide submitters with additional time to gather all of the information required by the final rule and prepare it for submission to EPA.

• Lowering, instead of altogether eliminating, the reporting threshold for specific regulated chemical substances and phasing-in that lowered threshold so that it applies beginning with the 2016 reporting period instead of the 2012 reporting period.

• Not finalizing a proposed requirement that electronic signature agreements be submitted with a notarized signature.

EPA summarized the public comments and the Agency's response in the preamble to the final rule, and included a response to public comments document in the rulemaking docket (Docket ID EPA-HQ-OPPT-2009-0187), which can be accessed electronically at http://www.regulations.gov.

3(c) Consultations

In addition to the public notice and comment period, OMB regulations, at 5 CFR 1320.8(d)(1), require agencies to consult with potential ICR respondents and data users about specific aspects of an ICR before the agency submits the ICR to OMB for review and approval. In accordance with this regulation, EPA solicited consultation feedback from nine potential respondents and data users with respect to this final rule ICR

3(d) Effects of Less Frequent Collection

EPA has returned the reporting frequency to every four years, which was the frequency in effect from 1986 to 2006. In an effort to reduce the reporting burden associated with the 2003 amendments, EPA had changed the reporting frequency to every five years. While the less frequent reporting does reduce burden, a review of the 2006 IUR reporting has revealed an approximately 30 percent change in the chemical substances that are reported from one submission period to the next. EPA now believes that reporting every five years does not provide data sufficiently current to meet Agency and public needs and now considers every four years to be the minimum acceptable frequency. In addition, the IUR Modifications proposed rule requested comment on even more frequent reporting. Comments from industry representatives led EPA to believe that more frequent reporting creates efficiencies, both for the respondent and for EPA. With more frequent reporting, companies will be able to establish standard systems and practices to collect the required information.

The Agency needs to be able to make accurate chemical substance risk management decisions in a timely and cost effective manner, especially because alternative data sources do not exist for these data. The effect of less frequent collection of these data is to diminish significantly the Agency’s ability to understand the chemical industry and monitor the production levels of chemical substances manufactured (including imported) in the United States. As described above, the IUR data demonstrate that chemical industry product lines and manufacturing in the United States change substantially from one submission period to the next. The Agency needs up-to-date information in order to fulfill its mandate to keep the TSCA Inventory current under section 8(b) of TSCA; collecting the data every five years means the Agency is working with data which are potentially six or more years old, and therefore, cannot be considered current.

Less frequent collection could result in EPA using outdated information in its decision making. For example, changing market conditions, batch processing, or the development of new uses for the chemical substance can cause production volumes or chemical substance uses to change from one year to the next. Companies buy and sell plant sites, and the chemical substances produced at a site can change. Based on past IUR reporting, the Agency would be working with the IUR data which approximately 30 percent of the chemical substances known to be in commerce at volumes of 25,000 lb or more may not actually be in commerce at those levels.

3(e) General Guidelines

This collection does not exceed any of the Paperwork Reduction Act guidelines at 5 CFR 1320.6, with the exceptions listed below.

The record retention period of this collection is five years, as specified in 40 CFR 710.57, exceeding the PRA maximum of three years. This is necessary to ensure companies retain records long enough to facilitate completion of Form U (EPA Form 7740-8) in the next collection, which is in four years and to allow EPA’s enforcement activities to overlap two IUR reporting cycles.

Confidential Business Information (CBI) claims limit access to the IUR data, especially by the public. EPA recognizes that some information submitted to the Agency is legitimately confidential business information; because of this, EPA’s review of CBI data is an inherently governmental function that EPA must perform to protect human health and the environment.

3(f) Confidentiality

Submitters may claim information reported to EPA under this rule as confidential if such information reveals the submitter’s trade secrets or proprietary information as defined by TSCA section 14 and existing TSCA regulations. EPA has long-established procedures for handling, storing, processing, and disposing of TSCA confidential information. Transfers of this information to other governmental agencies can be made only if the other agency agrees to adhere to all TSCA confidentiality provisions. EPA will maintain standard CBI procedures to protect any confidential, trade secret, or proprietary information from disclosure in accordance with EPA’s confidentiality regulation, 40 CFR Part 2, Subpart B.

3(g) Sensitive Questions

This collection does not include questions of a sensitive nature.

4. The Respondents and the Information Requested

4(a) Respondents/NAICS Codes

The regulated community consists of companies manufacturing or importing chemical substances listed on the TSCA Inventory and regulated under TSCA section 8. In general, the industry segments that compose the regulated community for the rule are those that produce or import organic and inorganic chemical substances. Most respondents previously reported information under the IUR. The Agency’s previous experience with IUR collections has shown that the majority of the respondents affected by this collection activity are from the following North American Industrial Classification System (NAICS) code categories:

325 - Chemical Manufacturing (including importing)

324 - Petroleum and Coal Product Manufacturing (including importing)

The subsectors identified above represent the designation of sites that likely would be subject to IUR reporting. However, activities at these sites may vary, making identification of the regulated community more difficult. For example, NAICS codes reflect a site’s primary activity, omitting substantial participation a company may have in other industry activities. Second, NAICS codes selected by U.S. parent companies reflect the parent company’s primary activity, even though many U.S. parent companies are primarily holding companies with small subsidiaries. Each of these small subsidiaries may belong in a completely different industry classification based on its own primary activity. Information on U.S. parent company NAICS codes does not provide a very accurate characterization of the types of sites subject to reporting, and facilities that do not fall under these categories must still report if they meet the reporting criteria.

Generally, TSCA section 8 excludes small manufacturers (including importers) from reporting. EPA defines small manufacturers (including importers) for purposes of IUR and certain other reporting in 40 CFR 704.3.

In addition to the anticipated respondents listed above, manufacturers (including importers) of byproducts are required to report under the IUR rule. Byproduct manufacturers (including importers) may be listed under a different primary activity for a site, such as NAICS codes 22, 322, 331, and 3344; e.g., utilities, paper manufacturing, primary metal manufacturing, and semiconductor and other electronic component manufacturing. For purposes of the IUR, a byproduct is a chemical substance produced without a separate commercial intent during the manufacture, processing, use or disposal of another chemical substance or mixture (40 CFR 704.3). Such a chemical substance, like any other manufactured chemical substance, is subject to IUR reporting if it is manufactured, is listed in EPA’s Master Inventory File, is not otherwise excluded from reporting, and its manufacturer is not specifically exempted from IUR reporting requirements. For instance, a manufacturer (including importer) that uses a chemical substance in the production of an article may produce a byproduct substance that is chemically different from the starting substance; the manufacturer (including importer) therefore may incur reporting obligations under the IUR for that byproduct. While some manufacturers (including importers) of byproducts may not have reported to the IUR in the past, they should be aware now of their reporting obligations under the IUR rule.

4(b) Information Requested

1. Reporting Threshold for Certain Regulated Chemicals

Under the final rule, EPA eliminated the 25,000 lb threshold for certain chemical substances that are:

• The subject of a rule proposed or promulgated under TSCA section 5(a)(2), 5(b)(4), or 6,

• The subject of an order issued under TSCA section 5(e), or

• The subject of relief that has been granted under a civil action under TSCA section 5 or 7.

Beginning with the 2016 reporting period, respondents who manufacture (including import) a chemical substance in volumes of 2,500 lb or more at a site are required to report manufacturing information on these chemical substances. Chemical substances that are the subject of these particular TSCA actions are of demonstrated high interest to the Agency. This change will help to ensure the availability of current information when the Agency has expressed a concern in the form of regulatory action on those chemical substances manufactured below 25,000 lb EPA will use the IUR data associated with these regulated chemical substances to monitor chemical substance production and compliance with the rules.

2. Data elements, including record keeping requirements

The IUR data elements are related to or indicative of three components of exposure. These components are: (1) the number of ecosystems or size of human populations potentially exposed, (2) the potential human or environmental exposure concentrations, and (3) the frequency and duration of potential exposures. The data enhances EPA’s ability to evaluate each of these components of exposure. Respondents are required to submit certain known or reasonably ascertainable manufacturing, processing, and use exposure-related information. For the 2006 IUR, respondents were required to submit the processing and use information to the extent it was readily obtainable; the IUR Modifications rule standardizes all of the submitted information to the single “known to or reasonably ascertainable by” reporting standard.

Using e-IURweb, individuals report the data elements as follows (the following list identifies new or revised data elements and does not address the full data requirements):

• Authorized Company Official’s e-mail Address. The e-mail address of the company official authorized to sign and submit the IUR Form U.

• U.S. Parent Company Name and Address. The name and mailing address of the U. S. parent company, the requirement that the parent company reported be the U.S. parent company is part of the IUR Modifications rule. The parent company name is already required by the IUR. This is not a new requirement; rather the change better identifies the correct company name.

• Manufacturing Information. Information required for the 2012 submission period and for subsequent submission periods vary.

• For the 2012 submission period, any person who manufactured (including imported) for commercial purposes 25,000 lb or more of a reportable chemical substance at any single site owned or controlled by that person during the principal reporting year (i.e., calendar year 2011) is subject to reporting. These persons must report the total annual volume (in pounds) of each reportable chemical substance manufactured or imported at each site for calendar years 2010 and 2011.

• For the submission periods subsequent to the 2012 submission period, any person who manufactured (including imported) for commercial purposes 25,000 lb or more of a reportable chemical substance - or 2,500 lb or more of any reportable chemical substance that is the subject of a rule proposed or promulgated under TSCA section 5(a)(2), 5(b)(4), or 6, or is the subject of an order in effect under TSCA section 5(e) or 5(f), or is the subject of relief that has been granted under a civil action under TSCA section 5 or 7 - at any single site owned or controlled by that person during any calendar year since the last principal reporting year (e.g., for the 2016 submission period, consider calendar years 2012, 2013, 2014, and 2015, given that 2011 was the last principal reporting year) is subject to reporting. These persons must report the production volume for each of the years since the last principal reporting year (e.g., for the 2016 submission period, report the production volume for each of the years: 2012, 2013, 2014, and 2015).

• Regardless of submission period, if the reporting thresholds are met in any given year (2012-2015), submitters must also provide the volume of the reported chemical substance used at the reporting site; whether an imported chemical substance is physically at the reporting site; the production volume directly exported and not domestically processed or used; and whether a manufactured (including imported) chemical substance, such as a byproduct, is being recycled, reused, reprocessed, or remanufactured.

• Processing and Use Information. For the 2006 IUR, only those manufacturers (including importers) of chemical substances with production volumes of 300,000 lb or more were required to report processing and use information. For the IUR Modifications final rule, the reporting threshold for processing and use information will be phased in, such that the threshold is 100,000 lb for the 2012 IUR collection and 25,000 lb for subsequent IUR collections (e.g. 2016 IUR). Respondents are to report this information for all reported chemical substances, unless the chemical substance is specifically partially exempted.

• Industrial Processing and Use Data. For the 2006 IUR, respondents were able to select up to 10 unique combinations of the type of process or use (code), NAICS code associated with the industrial use, and industrial function category. The IUR Modifications rule revised the list of industrial function categories and replaced the NAICS codes with Industrial Sectors.

• Consumer and Commercial Use Data. For the 2006 IUR, respondents were able to select up to 10 consumer and commercial product categories. The IUR Modifications rule revised the list of consumer and commercial product categories. The respondent must indicate whether the use is consumer, commercial or both, and, if commercial, the number of reasonably likely to be exposed commercial workers must be reported as a range.

Joint Submissions

Joint submissions are allowed only in those instances where a supplier will not disclose to the respondent the specific chemical name of the imported TSCA Inventory chemical substance or of a reactant used to manufacture the TSCA Inventory substance. This may happen, for instance, when a company is importing a mixture under a trade name, and the foreign manufacturer does not want to reveal the components in the mixture. (See Special Considerations for Joint Submitters in section 2b, above.) Changes to the IUR make it easier for respondents to use electronic reporting for both the primary and the secondary portions of a joint submission. In addition to signing the certification statement and completing Parts I, II, and III, primary respondents will report on data elements in Part II, Blocks 2.A.5 through 2.A.12, on Form U as follows:

• Joint Submission Information. Trade name of the chemical substance being reported, secondary respondent name, and complete mailing address (city, state/province, zip code, and country (if applicable)).

Secondary submitters will register with CDX as secondary authorized submitter or a secondary support registrant. . They will provide the primary company’s information and the trade product name, supplied to them by the primary submitter, to gain access to the Form U containing information specific to the trade product name. After the secondary submitter is granted access to the form, they will report on data elements in Part IV on Form U as follows:

• Certification. The company official must certify by signature and date that to the best of his/her knowledge and belief: 1) all information entered on Form U has been completed in compliance with the regulatory requirements; and 2) any confidentiality claims are true and correct as to that information for which they have been asserted.

• Secondary Company Information. The secondary company name and complete mailing address (city, state, zip code, and country (if applicable)).

• Secondary Technical Contact Information. The technical contact name, phone number, complete mailing address (city/town, state/province, zip code, and country (if applicable)), and email address.

• Primary Company Information. Trade name and Unique Identifier for Joint Submissions number provided the primary submitter sent to the secondary submitter.

• Trade Product Information. The trade product name, chemical name, CAS Registry Number, ID code, and percentage of each chemical substance component of a trade product.

(iii) Submitter Activities/Information Collections (ICs)

EPA identified the following ICs in the currently-approved ICR (EPA ICR No. 1884.04) for activities that submitters would complete when complying with the rule:

• Compliance Determination;

• Rule Familiarization;

• Report Preparation and Submission – Partial Reports;

• Report Preparation and Submission - Full Reports; and

• Recordkeeping.

As a result of the final rule, EPA will include a new IC addressing the initial paperwork activities a company needs to complete in order to be able to submit reports electronically through CDX. EPA also will incorporate recordkeeping activities into the ICs that address the preparation and submission of partial and full reports, rather than include them as a stand-alone IC (see Table 1).

Table 1: Information Collections (ICs) for IUR Reporting

Information Collection	Description
Compliance Determination	Determine whether reporting is required for a chemical substance manufactured (including imported) at a particular site, based on the chemical substance’s production volume and the applicability of certain reporting exemptions. The 2012 rule modifies the method used to determine whether a manufacturer (including importer) is subject to IUR reporting. Reporting is required if the production volume of a chemical substance met or exceeded the 25,000 lb threshold in the 2011 principal reporting year for the 2012 submission period, and in any calendar year since the last principal reporting year in future reporting cycles
Rule Familiarization	Become familiar with the full requirements of the rule, which entails reading the rule, understanding the various reporting and administrative requirements, and determining the manner in which reporting requirements will be met for each chemical substance.
CDX Registration Activities	The 2012 rule requires electronic reporting, and therefore requires that all submitters complete the CDX registration process. As part of registering with CDX, each submitter will provide identifying information that will comprise all or most of the information requested in Part I of Form U (EPA Form 7740-8). This information will then be pre-populated whenever the submitter prepares a partial or full report. In order to submit electronically to EPA via CDX, the authorized official, who will be signing and submitting the site’s IUR Form U, must register with CDX and must submit an ESA. This is the same process required for electronic submissions for the 2006 IUR. Once the registration process is complete, the registered individual will be able to access the e-IURweb reporting tool.
Prepare and Submit Report, and Maintain Records- Partial Report	Compile the required information, determine the CBI status of information and fulfill appropriate substantiation measures, and use e-IURweb to complete and submit only Parts I and II (and Part IV, if a joint submission) of Form U (EPA Form 7740-8) for chemical substances specifically listed in the regulation for which there is a partial reporting exemption. Retain all records related to the submission for five years after the submission period.
Prepare and Submit Report, and Maintain Records- Full Report	Compile the required information, determine the CBI status of information and fulfill appropriate substantiation requirements, and use e-IURweb to complete and submit Parts I and II for chemical substances manufactured (including imported) in volumes of 25,000 lb or more (or 2,500 lb or more, if applicable), and Part IV, if a joint submission, of Form U (EPA Form 7740-8). Complete part III for chemical substances manufactured (including imported) in volumes of 100,000 lb or more (and Part IV, if a joint submission) of Form U (EPA Form 7740-8). Retain all records related to the submission for five years after the submission period.

5. The Information Collected–Agency Activities, Collection Methodology, and Information Management

5(a) Agency Activities

The activities routinely conducted by EPA related to the processing, analysis and storage of the information collected under this rule include the following:

• Review and verify forms as they are received;

• Answer submitter questions and provide any necessary assistance;

• Process submissions for inclusion in IUR database;

• Review requests for confidentiality in the submissions;

• Maintain the database; and

• Distribute the data.

5(b) Collection Methodology and Management

The next IUR collection will occur in 2012. All manufacturers (including importers), except for those defined as “small manufacturers” by EPA’s regulations, are required to submit information on every substance subject to the 2012 rule that they manufacture (including import) in quantities that meet or exceed the IUR thresholds. The collection will occur every four years.

(i) Collection Methodology

Submitters are required to submit information associated with this data collection electronically via the Internet using e-IURweb and CDX. The 2006 IUR allowed and encouraged electronic reporting, thus providing both submitters and the Agency the opportunity to test an electronic reporting system. Comments from submitters and lessons learned from the collection of paper, CD, and electronic submissions were used to develop the 2012 collection methodology. Some of the changes to this methodology are regulatory and are included in the IUR Modifications Final rule; others are process-oriented or internal to EPA or the respondent.

Potential submitters were notified of the need to report in three ways: (1) EPA published a Federal Register notice, (2) email notices were sent to previous IUR submitters, and (3) articles were published in the trade press. Reporting materials, including a non-submission version of the e-IURweb reporting tool and a variety of guidance documents (Instruction Manual, Q&As, Case Studies), are available on EPA’s IUR website. Submitters also can obtain these materials from the TSCA Hotline. Submitters obtain the submission version of the e-IURweb reporting tool as part of the CDX registration process, as described in section 4 of this document.

EPA will receive all IUR submissions electronically. The CDX registration process, required for all submitters, will provide a user ID which the submitter will use to access e-IURweb.

Information quality and validation begins with the e-IURweb reporting tool, which is programmed to help the submitter provide the information required, in the correct format as required by the IUR rule. Use of e-IURweb will eliminate many of the problems with incorrect chemical substance identifications experienced in the past by providing a current listing of the TSCA Inventory chemicals and their associated identification numbers. Other respondent-generated errors, such as incorrect codes, have also been eliminated due to the use of techniques such as drop-down menus, restrictions on the specific information that can be entered, and error-checking algorithms.

Mandatory IUR reporting via the Internet is the most efficient collection method for submitters and EPA. Submitters receive almost immediate notification that EPA has received their submission, and EPA is able to upload the information directly into the IUR database, which improves the efficiency of EPA’s data receipt and processing activities. This collection method also eliminates the introduction of errors by avoiding the need to scan or key-enter data submitted on paper or CD. Additional validations have been programmed into the data-entry system to further ensure the quality of the data.

To aid persons subject to this information collection, the Agency’s TSCA and CDX Hotlines are available to answer questions regarding the IUR requirements or submission process. When Hotline staff is unable to answer questions, the submitter is referred to OPPT’s Information Management Division (IMD) or Chemical Control Division (CCD), as appropriate. Other Divisions within OPPT or OEI are used as necessary.

(ii) Data Management

This section describes the Agency tasks required for efficiently processing submissions under the IUR. The tasks for which the Agency is responsible are presented under four main categories: database systems development, guidance document development, Form U processing, and additional tasks. The task descriptions presented below generally do not change from collection to collection.

IUR data is stored in a database managed by the Agency. Once updated, the IUR database is then available to EPA technical reviewers to search or export into their various analytical modeling systems and databases. The IUR database is also available for quick screening and other direct uses. The Agency makes publicly available as much information as possible, within the confines of protecting CBI.

• Database Systems Development and Maintenance -- The Agency is responsible for having adequate information systems in place to support the database that serves as the primary data storage medium for IUR collections. File servers with appropriate backup are used to contain the IUR databases. Following the 2006 IUR collection, EPA updated the technology used to store the IUR data, storing it in a larger Manage Toxic Substances (MTS) database. In addition, IUR data are tracked via the correspondence tracking system utilized by the Confidential Business Information Tracking System (CBITS) located within the Confidential Business Information Center (CBIC).

• Guidance Document Development -- The Agency is responsible for developing guidance to assist submitters in complying with IUR requirements. The guidance documents usually are developed by a contractor with oversight by Agency personnel.

• Form U Processing -- The Agency is responsible for processing IUR Form U submissions. This includes developing standard operating procedures and documentation for all stages in the IUR document life cycle, document receipt and tracking, data input, quality control, file and database maintenance, information security, CBI aggregation policy, data dissemination, and staff training. For the 2012 IUR submission period, EPA developed new processes to receive IUR submissions over the Internet, using CDX.

• Additional Activities -- The Agency develops various supporting documents associated with the reporting tool and makes them available on the Internet. In addition, the Agency is responsible for providing the TSCA Hotline with standardized responses for frequently asked questions; preparing mailings, mailing lists, and labels; and developing outgoing information materials.

5(c) Small Entity Flexibility

The final IUR regulation provides ample flexibility to small entities. This regulation affects only businesses -- governmental jurisdictions and not-for-profit organizations are not required to take any action. Small manufacturers (including importers), in accordance with TSCA section 8(b) (40 CFR Sections 710.29 and 710.28), are exempt and therefore are generally not subject to any of the reporting or recordkeeping requirements. A manufacturer (including importer) is considered a small business if (1) the firm’s total annual sales when combined with those of its U.S. parent company (if any) are less than $40 million for the submission period and (2) its total production and/or importation of the chemical substances, mixture or category, for the reporting period, does not exceed 100,000 pounds (45,000 kilograms) at an individual site owned and controlled by the firm. The Economic Analysis for the Final Inventory Update Reporting Modifications Rule determined that the impact on these companies is, on average, significantly less than one percent of revenues (EPA, 2011).

5(d) Collection Schedule

The submission period shall be from February 1, 2012 to June 30, 2012. . The submission period/schedule follows the requirements of 40 CFR 711.20.

6. Estimating the Burden and Cost of the Collection

This section presents the burden and cost estimates incurred by all affected entities as a result of the final IUR rule amendments. This addendum to the supporting statement covers the years 2011, 2012, and 2013. Therefore, it provides burden and cost estimates for the information collection corresponding to the 2012 reporting cycle (which is the first submission after the 2011 final IUR rule amendments to the IUR rule are finalized), and also for the information collection corresponding to the next reporting cycle, for which respondents will be preparing during 2013. Even though reporting occurs only once per reporting cycle (once every six years for the 2012 cycle and once every four years in the future), EPA believes that rule compliance and data collection activities, and thus, costs and burdens, are incurred over the course of the reporting cycle. Therefore, for purposes of this analysis, the burden and cost for one reporting cycle are averaged over the number of years in the reporting cycle and are presented here as average annual figures. All costs are presented in year 2008 dollars. The IUR requires reporting on a “per site” basis rather than a “per company” basis. Therefore, each site which is subject to the IUR rule is considered a respondent and will submit one Form U containing one or more chemical-specific reports. EPA estimates that a total of 4,085 respondents will respond to this information collection in the 2012 reporting cycle, and 4,289 respondents will respond in future reporting cycles.

Burden and cost calculations are based on the assumption that EPA will receive an average of 20,718 full reports and 5,135 partial reports during the first reporting cycle, and 30,287 full reports and 648 partial reports in future reporting cycles. Each report is for a single chemical/site combination. Each site is expected to submit an average of 5.07 full reports and 1.26 partial reports in the first reporting cycle and 7.06 full reports and 0.15 partial reports in the subsequent reporting cycles. The average burden per respondent, which is one site, is estimated to be 572 hours for the 2012 reporting cycle, or 95 hours annually over a six-year cycle. For future four-year reporting cycles, the average burden per respondent is estimated to be 600 hours per cycle, or 150 hours annually. Given that this ICR addendum covers a period that spans both the first and a future reporting cycle, the average annual burden over the three year period of 2011 through 2013 is 114 hours. This is higher than the burden estimated for the currently approved ICR (EPA ICR No. 1884.04), due to both program changes and an adjustment in reporting requirement criteria, including additional data requirements and modifications to reporting thresholds.

6(a) Estimating Respondent Burden

For the 2012 reporting cycle, each manufacturing site (including importers) must submit a Form U if the site meets or exceeds the 25,000 lb threshold for at least one chemical substance in the 2011 principal reporting year. In future cycles, this reporting threshold will apply for any calendar year since the last principal reporting year. For purposes of the ICR, one manufacturing site is equivalent to one respondent. Form U contains four Parts. Part I contains basic site identification information and must be completed by all sites. Part II contains manufacturing data (production volumes, etc.) specific to each chemical substance, which also must be completed by all sites. Together, Part I and Part II are considered a “partial report.” Part III contains processing and use information. Under the final amendments, in future cycles Part III would be completed for all chemical substances unless the chemical substance is specifically exempted from the requirement to do so. Part IV contains secondary company identification information and specific information identifying a chemical substance. Part IV is completed only by a secondary respondent (see Section 2(b)). For purposes of this analysis, burden and costs associated with Part IV are considered part of the burden and costs estimates of Part I (respondent identification) and the beginning of Part II (chemical identification), and therefore were not separately calculated. Together, Parts I, II, and III (and Part IV, when applicable) are considered a “full report.” One report is submitted for each unique chemical substance/site combination; that is, a site must complete a separate report for each applicable chemical substance, but Part I of Form U is completed and submitted only once per site. EPA anticipates that Part I will be completed automatically when respondents register with CDX.

To comply with the regulation, manufacturers (including importers) must complete the activities listed in Table 2. Table 2 also provides a cross-walk of the related Information Collection that corresponds to each activity.

Table 2: Cross-Walk between Industry Activities and Related Information Collections (ICs)

Activity	Description	Related IC(s)
Compliance Determination	Site staff must determine whether reporting is required for a chemical substance manufactured (including imported) at a particular site, based on the chemical substance’s production volume and the applicability of certain reporting exemptions. Submitters would report all data from 2011 and only production volume from 2010. This involves determining whether the production volume of a chemical substance met or exceeded the 25,000 lb threshold in the 2011 principal reporting year.	Compliance Determination
Rule Familiarization	Site staff must familiarize themselves with the requirements of the rule. Staff from sites that reported previously must become familiar with new requirements, and staff from sites new to reporting must become familiar with all requirements. This entails reading the rule, understanding the various reporting and administrative requirements, and determining the manner in which the reporting requirements will be met.	Rule Familiarization
CDX Registration	Before submitting Form U, all respondents must register with CDX. In addition, respondents must complete an Electronic Signature Agreement form, which is signed, dated. and either submitted electronically or mailed back to EPA.	CDX Registration Activities
Preparation of Reports	Site staff must collect all of the required information, and complete partial and/or full reports using a Form U report form, for each of the reportable chemical substances at that site. The information must be reviewed, and submitted to EPA. This task involves any research necessary to identify the correct information to report, the act of completing Form U (technical and clerical burden), and managerial review. Once Form U is completed, company staff must submit it electronically to EPA via CDX.	Prepare and Submit Report, and Maintain Records- Partial Report Prepare and Submit Report, and Maintain Records – Full Report
Recordkeeping	Respondents must keep records supporting their submissions for five years.	Prepare and Submit Report, and Maintain Records - Partial Report Prepare and Submit Report, and Maintain Records- Full Report

Burden estimates were derived originally from a survey conducted by EPA in 1996 (under OMB Control No. 2070-0034) to assess the potential burden associated with the IUR, as amended at that time. The survey was distributed to previous IUR respondents selected from the IUR database. Burden estimates were updated for a 2005 amendment to the rule as described in Economic Analysis of IUR Modifications Final Rule (EPA, 2005)³. Burden estimates for new reporting elements in the final rule were derived as described in the Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011).

Table 3 and Table 4 illustrate the burden for a typical respondent on a per-activity basis, including time required to complete each section of Form U. Because IUR reporting for all respondents occurs within a required timeframe, which EPA has changed from once every five years to once every four years, the Agency expects only one collection to occur, in 2012, during the three-year period covered by this ICR addendum. Therefore, burden hour estimates for 2011 and 2012 (Table 3) are based on the first reporting cycle burdens in the Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011). Burden hour estimates for 2013 (Table 4) are based on the future reporting cycle burdens as also described in the economic analysis (EPA, 2011).⁴ The section-by-section industry burden estimates for report preparation also include the burden of compliance determination and rule familiarization. EPA estimates the total industry burden for completing and submitting one partial report to be 53.56 hours, and the estimated burden for completing and submitting one full report, to be 136.58 hours in the first reporting cycle. Each site is expected to submit an average of 5.07 full reports and 1.26 partial reports in the first reporting cycle.

EPA calculated burden estimates for each element of Form U individually using the 1996 survey results, economic analyses for other rules with similar requirements (such as the Premanufacture Notification Electronic Reporting final rule), and EPA’s best professional judgment. More detailed information on the derivation of these estimates is found in the Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011).

Table 3: Total Industry Burden, by Activity, First Reporting Cycle

Activity				Clerical Burden (hours)		Technical Burden (hours)		Managerial Burden (hours)	Total Burden (hours)
				(a)		(b)		(c)	(d) = (a)+(b)+(c)
PREPARATION OF REPORT (Includes rule familiarization associated with each data element)
Part I. Site Identification Information
	Certification			0.00		0.85		1.01	1.86
	Company Information (U.S. Parent Company Name, D&B Number, Mailing Address, Technical Contact, Technical Contact Mailing Address)			0.00		0.04		0.02	0.06
	Plant Site Identification (Site Name, D&B Number, Mailing Address)			0.00		0.06		0.02	0.08
	Information for Joint Submissions (First Reporting Cycle Only)			0.00		0.005		0.01	0.01
	Total for Part I			0.00		0.95		1.06	2.01
Part II. Manufacturing Information
	Site-Limited, Activity, Production Volume (lb) (2011)			0.00		2.28		0.56	2.84
	Chemical Substance Identification Upfront CBI Substantiation			0.00		1.45		0.77	2.22
	Accession Number Requests			0.00		0.01		0.00	0.01
	Plant Site Upfront Substantiation			0.00		0.83		0.51	1.34
	Total Number of Workers			0.00		1.43		0.59	2.02
	Maximum Concentration, Physical Form, Percent Volume of Production			0.00		2.79		1.07	3.86
	Production Volume for 2010			0.00		1.03		0.25	1.28
	Production Volume Used On-Site			0.00		0.20		0.05	0.25
	Whether Imported Chemical Substance is Physically at Reporting Site			0.00		0.11		0.03	0.14
	Volume Exported			0.00		1.03		0.25	1.28
	Whether a Chemical Substance is to be Recycled, Remanufactured, Reprocessed, or Reused.			0.00		0.11		0.03	0.14
	Total for Part II			0.00		11.27		4.10	15.37
Part III. Processing and Use Information
			Upfront Substantiation for Processing and Use Information CBI Claims	0.00		0.43		0.26	0.69
	Industrial Processing and Use Exposure-Related Data
			Determination of Applicability	0.00		1.01		0.28	1.29
			Industrial Function Category	0.00		4.67		2.07	6.73
			Sector	0.00		0.94		0.40	1.33
			Percent of Production Volume	0.00		10.00		5.27	15.27
			Total Number of Processing and Use Sites	0.00		9.14		3.52	12.67
			Total Number of Potentially Exposed Workers	0.00		15.43		3.83	19.26
	Consumer and Commercial Use Exposure-Related Data
			Determination of Applicability	0.00		0.94		0.25	1.19
			Identification of Production Category/Use by Children	0.00		1.68		0.25	1.92
			Percent of Production Volume	0.00		1.26		0.45	1.71
			Maximum Concentration by Category	0.00		1.36		0.34	1.70
			Number of Commercial Workers Reasonably Likely to be Exposed	0.00		15.43		3.83	19.26
	Total for Part III			0.00		62.26		20.76	83.02
COMPLIANCE DETERMINATION
		Compliance Determination		0.00	2.50		0.00			2.50
RULE FAMILIARIZATION
		Rule Familiarization		0.00	19.00		9.00			28.00
CDX REGISTRATION ACTIVITIES
			CDX Registration	0.00	0.73		0.18		0.92
			CDX Electronic Signature Agreement	0.00	1.00		0.75		1.75
	Total for CDX Registration Activities			0.00	1,73		0.93		2.67
RECORDKEEPING
	Recordkeeping			0.75	1.50		0.75		3.00
TOTAL BURDEN
Burden for one Partial Report (Parts I, II, Compliance Determination, Rule Familiarization, Recordkeeping and CDX Registration Activities)				0.75	36.96			15.84	53.55
Burden for one Full Report (Parts I, II, III, Compliance Determination, Rule Familiarization, Recordkeeping and CDX Registration Activities)				0.75	99.22			36.60	136.57
Note: Totals may not sum due to rounding.
Source: Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011).

Table 4: Total Industry Burden, by Activity, Future Reporting Cycles

Activity				Clerical Burden (hours)		Technical Burden (hours)		Managerial Burden (hours)	Total Burden (hours)
				(a)		(b)		(c)	(d) = (a)+(b)+(c)
PREPARATION OF REPORT (Includes rule familiarization associated with each data element)
Part I. Site Identification Information
	Certification			0.00		0.85		1.01	1.86
	Company Information (U.S. Parent Company Name, D&B Number, Mailing Address, Technical Contact, Technical Contact Mailing Address)			0.00		0.01		0.004	0.01
	Plant Site Identification (Site Name, D&B Number, Mailing Address)			0.00		0.01		0.004	0.02
	Total for Part I			0.00		0.87		1.02	1.89
Part II. Manufacturing Information
	Site-Limited, Activity, Production Volume (lb) (2015)			0.00		1.82		0.45	2.27
	Chemical Substance Identification Upfront CBI Substantiation			0.00		1.16		0.61	1.77
	Plant Site Upfront Substantiation			0.00		0.66		0.41	1.07
	Total Number of Workers			0.00		1.14		0.47	1.61
	Maximum Concentration, Physical Form, Percent Volume of Production			0.00		2.23		0.86	3.09
	Production Volume for Each of the Years since Last Principal Reporting Year (2012 - 2014)			0.00		2.46		0.60	3.07
	Production Volume Used On-Site			0.00		0.16		0.04	0.20
	Whether Imported Chemical Substance is Physically at Reporting Site			0.00		0.09		0.02	0.11
	Volume Exported			0.00		0.82		0.20	1.02
	Whether a Chemical Substance is to be Recycled, Remanufactured, Reprocessed or Reused.			0.00		0.09		0.02	0.11
	Total for Part II			0.00		10.65		3.68	14.33
Part III. Processing and Use Information
			Upfront Substantiation for Processing and Use Information CBI Claims	0.00		0.43		0.21	0.64
	Industrial Processing and Use Exposure-Related Data
			Determination of Applicability	0.00		0.81		0.23	1.03
			Industrial Function Category	0.00		3.53		1.65	5.18
			Sector	0.00		0.75		0.32	1.06
			Percent of Production Volume	0.00		8.00		4.22	12.22
			Total Number of Processing and Use Sites	0.00		7.31		2.82	10.13
			Total Number of Potentially Exposed Workers	0.00		12.34		3.06	15.41
	Consumer and Commercial Use Exposure-Related Data
			Determination of Applicability	0.00		0.75		0.20	0.95
			Identification of Production Category/Use by Children	0.00		0.67		0.20	0.87
			Percent of Production Volume	0.00		1.01		0.36	1.37
			Maximum Concentration by Category	0.00		1.09		0.28	1.36
			Number of Commercial Workers Reasonably Likely to be Exposed	0.00		12.34		3.06	15.41
	Total for Part III			0.00		49.03		16.60	65.63
COMPLIANCE DETERMINATION
		Compliance Determination		0.00	2.50		0.00			2.50
RULE FAMILIARIZATION
		Rule Familiarization		0.00	2.00		2.00			4.00
CDX REGISTRATION ACTIVITIES
			CDX Registration	0.00	0.73		0.18		0.92
			CDX Electronic Signature Agreement	0.00	1.00		0.75		1.75
	Total for CDX Registration Activities			0.00	1.73		0.93		2.67
RECORDKEEPING
	Recordkeeping			0.75	1.50		0.75		3.00
TOTAL BURDEN
Burden for one Partial Report (Parts I, II, Compliance Determination, Rule Familiarization, Recordkeeping and CDX Registration Activities)				0.75	17.52			7.45	28.39
Burden for one Full Report (Parts I, II, III, Compliance Determination, Rule Familiarization, Recordkeeping and CDX Registration Activities)				0.75	66.54			24.05	94.02
Note: Totals may not sum due to rounding.
Source: Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011).

6(b) Estimating Submitter Cost

EPA multiplied burden estimates by standard wage rates for managerial, technical, and clerical levels developed from information published by the Bureau of Labor Statistics (BLS) and a method outlined in the document Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b). Wage data for the three occupational categories was gathered for manufacturing industries from Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006 – December 2008 (BLS, 2009).

The cost of fringe benefits, such as health insurance and vacation, is taken for each labor category from the same ECEC series. Following the methodology outlined in (EPA, 2002b), fringe benefits are calculated as a percentage of total wages for each category. EPA added 17 percent to the wages in each category to account for overhead, based on information provided by the chemical industry and chemical industry trade associations in the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a). The wages for each of the three categories were then multiplied by benefits and overhead factors to estimate loaded, annual salaries in year 2008 dollars. Table 5 contains the loaded wage rates for the managerial, technical and clerical occupation categories.

Table 5: Derivation of Loaded Wage Rates for the Private Manufacturing Sector in 2008$

	Wage1	Fringe Benefits1	Fringes as % of Wage	Overhead % of Wage2	Fringe + Overhead Factor	Loaded Wages
	(a)	(b)	(c) = (b)/(a)	(d)	(e)=(1)+(c)+(d)	(f) = (a) x (e)
Managerial	$43.22	$19.46	48.37%	17%	1.62	$70.03
Technical	$35.29	$17.55	47.58%	17%	1.67	$58.84
Clerical	$17.22	$8.33	45.03%	17%	1.65	$28.48
1 Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006 – December 2008, US Bureau of Labor Statistics, March 12, 2009 (BLS, 2009). 2 An overhead rate of 17 percent was estimated based on industry data gathered for the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a).

Table 6 contains the cost per activity of completing Form U for one respondent in the first reporting cycle. Burden hours presented in Table 3 were multiplied by the corresponding loaded wage rage in Table 5. EPA estimates the total cost for completing and submitting one partial report in the first reporting cycle is $3,305 and the cost for completing and submitting one full report is $8,422. More information on the derivation of these costs is found in the IUR EA (EPA, 2011).

Similarly, Table 7 contains the cost per activity of completing Form U for one respondent in future reporting cycles. Burden hours presented in Table 4 were multiplied by the corresponding loaded wage rage in Table 5. EPA estimates the total cost for completing and submitting one partial report in future reporting cycles is $1,574 and the cost for completing and submitting one full report is $5,621. More information on the derivation of these costs is found in the IUR EA (EPA, 2011).

Table 6: Total Industry Cost, by Activity, First Reporting Cycle

Activity						Clerical Cost (2008$)		Technical Cost (2008$)		Managerial Cost (2008$)		Total Cost (2008$)
						(a)		(b)		(c)		(d) = (a)+(b)+(c)
PREPARATION OF REPORT (Includes rule familiarization associated with each data element)
Part I. Site Identification Information
	Certification					$0.00		$50.01		$70.73		$120.74
	Company Information (U.S. Parent Company Name, D&B Number, Mailing Address, Technical Contact, Technical Contact Mailing Address)					$0.00		$2.35		$1.40		$3.75
	Plant Site Identification (Site Name, D&B Number, Mailing Address)					$0.00		$3.53		$1.40		$4.93
	Information for Joint Submissions (First Reporting Cycle Only)					$0.00		$0.27		$0.59		$0.86
	Total for Part I					$0.00		$56.17		$74.12		$130.29
Part II. Manufacturing Information
	Site-Limited, Activity, Production Volume (lb) (2011)					$0.00		$134.15		$39.22		$173.37
	Chemical Identification Upfront CBI Substantiation					$0.00		$85.32		$53.57		$138.89
	Accession Number Requests					$0.00		$0.78		$0.00		$0.78
	Plant Site Upfront Substantiation					$0.00		$48.84		$35.71		$84.55
	Total Number of Workers					$0.00		$84.14		$40.97		$125.11
	Maximum Concentration, Physical Form, Percent Volume of Production					$0.00		$164.16		$74.93		$239.09
	Production Volume for 2010					$0.00		$60.37		$17.65		$78.02
	Production Volume Used On-Site					$0.00		$11.71		$3.42		$15.14
	Whether Imported Chemical Substance is Physically at Reporting Site					$0.00		$6.71		$1.96		$8.67
	Volume Exported					$0.00		$60.37		$17.65		$78.02
	Whether a Chemical Substance is to be Recycled, Remanufactured, Reprocessed or Reused.					$0.00		$6.71		$1.96		$8.67
	Total for Part II					$0.00		$663.25		$287.03		$950.29
Part III. Processing and Use Information
				Upfront Substantiation for Processing and Use Information CBI Claims		$0.00		$25.12		$18.37		$43.49
	Industrial Processing and Use Exposure-Related Data
				Determination of Applicability		$0.00		$59.27		$19.94		$79.21
				Industrial Function Category		$0.00		$274.49		$144.64		$419.13
				Sector		$0.00		$55.01		$27.68		$82.69
				Percent of Production Volume		$0.00		$588.41		$369.34		$957.75
				Total Number of Processing and Use Sites		$0.00		$537.89		$246.72		$784.62
				Total Number of Potentially Exposed Workers		$0.00		$907.74		$268.15		$1,175.90
	Consumer and Commercial Use Exposure-Related Data
				Determination of Applicability		$0.00		$55.01		$17.56		$72.57
				Identification of Production Category/Use by Children		$0.00		$98.73		$17.26		$116.00
				Percent of Production Volume		$0.00		$74.02		$31.55		$105.57
				Maximum Concentration by Category		$0.00		$80.02		$24.11		$104.13
				Number of Commercial Workers Reasonably Likely to be Exposed		$0.00		$907.74		$268.15		$1,175.90
	Total for Part III					$0.00		$3,663.47		$1,453.48		$5,116.95
COMPLIANCE DETERMINATION
		Compliance Determination			$0.00		$147.10		$0.00		$147.10
RULE FAMILIARIZATION
		Rule Familiarization			$0.00		$1,117.95		$630.25		$1,748.19
CDX REGISTRATION ACTIVITIES
			CDX Registration			$0.00		$43.15		$12.84		$55.99
			CDX Electronic Signature Agreement			$0.00		$58.84		$52.52		$111.36
	Total for CDX Registration Activities					$0.00		$101.99		$65.36		$167.35
RECORDKEEPING
	Recordkeeping					$21.36		$88.26		$52.52		$162.14
TOTAL COST
Cost for one Partial Report (Parts I, II, Compliance Determination, Rule Familiarization, Recordkeeping and CDX Registration Activities)						$21.36		$2,174.71		$1,109.28		$3,305.35
Cost for one Full Report (Parts I, II, III, Compliance Determination, Rule Familiarization, Recordkeeping and CDX Registration Activities)						$21.36		$5,838.18		$2,562.76		$8,422.30
Note: Totals may not sum due to rounding.
Source: Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011).

Table 7: Total Industry Cost, by Activity, Future Reporting Cycles

Activity						Clerical Cost (2008$)		Technical Cost (2008$)		Managerial Cost (2008$)		Total Cost (2008$)
						(a)		(b)		(c)		(d) = (a)+(b)+(c)
PREPARATION OF REPORT (Includes rule familiarization associated with each data element)
Part I. Site Identification Information
	Certification					$0.00		$50.01		$70.73		$120.74
	Company Information (U.S. Parent Company Name, D&B Number, Mailing Address, Technical Contact, Technical Contact Mailing Address)					$0.00		$0.47		$0.28		$0.75
	Plant Site Identification (Site Name, D&B Number, Mailing Address)					$0.00		$0.71		$0.28		$0.99
	Total for Part I					$0.00		$51.19		$71.29		$122.48
Part II. Manufacturing Information
	Site-Limited, Activity, Production Volume (lb) (2015)					$0.00		$107.32		$31.37		$138.70
	Chemical Identification Upfront CBI Substantiation					$0.00		$68.25		$42.86		$111.11
	Plant Site Upfront Substantiation					$0.00		$39.07		$28.57		$67.64
	Total Number of Workers					$0.00		$67.31		$32.77		$100.08
	Maximum Concentration, Physical Form, Percent Volume of Production					$0.00		$131.33		$59.94		$191.27
	Production Volume for Each of the Years since Last Principal Reporting Year (2012 - 2014)					$0.00		$144.89		$42.35		$187.24
	Production Volume Used On-Site					$0.00		$9.37		$2.74		$12.11
	Whether Imported Chemical Substance is Physically at Reporting Site					$0.00		$5.37		$1.57		$6.93
	Volume Exported					$0.00		$48.30		$14.12		$62.41
	Whether a Chemical Substance is to be Recycled, Remanufactured, Reprocessed or Reused					$0.00		$5.37		$1.57		$6.93
	Total for Part II					$0.00		$626.57		$257.86		$884.43
Part III. Processing and Use Information
				Upfront Substantiation for Processing and Use Information CBI Claims		$0.00		$25.12		$14.70		$39.82
	Industrial Processing and Use Exposure-Related Data
				Determination of Applicability		$0.00		$25.12		$15.95		$41.07
				Industrial Function Category		$0.00		$0.00		$115.71		$115.71
				Sector		$0.00		$47.41		$22.14		$69.56
				Percent of Production Volume		$0.00		$207.82		$295.47		$503.30
				Total Number of Processing and Use Sites		$0.00		$44.01		$197.38		$241.39
				Total Number of Potentially Exposed Workers		$0.00		$470.73		$214.52		$685.25
	Consumer and Commercial Use Exposure-Related Data
				Determination of Applicability		$0.00		$47.41		$14.05		$61.46
				Identification of Production Category/Use by Children		$0.00		$207.82		$13.81		$221.63
				Percent of Production Volume		$0.00		$44.01		$25.24		$69.25
				Maximum Concentration by Category		$0.00		$470.73		$19.29		$490.01
				Number of Commercial Workers Reasonably Likely to be Exposed		$0.00		$430.32		$214.52		$644.84
	Total for Part III					$0.00		$2,884.62		$1,162.78		$4,047.40
COMPLIANCE DETERMINATION
		Compliance Determination			$0.00		$147.10		$0.00		$147.10
RULE FAMILIARIZATION
		Rule Familiarization			$0.00		$117.68		$140.05		$257.73
CDX REGISTRATION ACTIVITIES
			CDX Registration			$0.00		$43.15		$12.84		$55.99
			CDX Electronic Signature Agreement			$0.00		$58.84		$52.52		$111.36
	Total for CDX Registration Activities					$0.00		$101.99		$65.36		$167.35
RECORDKEEPING
	Recordkeeping					$21.36		$88.26		$52.52		$162.14
TOTAL COST
Cost for one Partial Report (Parts I, II, Compliance Determination, Rule Familiarization, Recordkeeping and CDX Registration Activities)						$21.36		$1,132.78		$587.08		$1,741.23
Cost for one Full Report (Parts I, II, III, Compliance Determination, Rule Familiarization, Recordkeeping and CDX Registration Activities)						$21.36		$4,017.41		$1,749.87		$5,788.63
Note: Totals may not sum due to rounding.
Source: Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011).

6(c) Estimating Agency Burden and Cost

EPA is responsible for the following activities associated with administering the IUR rule:

• Document receipt and tracking;

• Data entry and quality control of data entry;

• Backup systems operation;

• Data processing;

• Systems development;

• Contract oversight and management;

• Publication and printing of forms and materials; and

• Operation of the TSCA Hotline to handle IUR-related calls.

Costs related to EPA activities that involve using the data are not included.

EPA Staff Activities

Of the tasks listed above, Agency personnel are responsible for 1) quality control of data entry; and 2) data processing, systems development, and contract oversight and management. Contractors perform the other activities, as described below.

EPA estimates the total burden of completing Agency tasks to be one full-time equivalent at the GS 13 level for data processing, systems development, and contract oversight and management, per-reporting cycle. An estimated 0.548 FTEs are needed at the GS 12 level for quality control of data entry in the first reporting cycle and 0.193 FTEs are needed in future reporting cycles. Calculations of the Agency burden are presented in Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011).

EPA labor costs are based on annual federal wage rates published by the Office of Personnel Management for the Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV locality pay area for 2008 (OPM, 2008). Wages are presented in terms of GS-level and step. Based on previous IUR economics analyses, a Step 3 is assumed for all FTEs (EPA, 2002a and EPA, 2005). Following the methodology outlined in Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a), EPA added 58 percent to the wage rate to account for fringe benefits and overhead costs.

Table 8 shows the loaded wage rates for Agency staff at the GS-12 Step 3, and GS-13 Step 3 levels.

Table 8: Derivation of Loaded Agency Wage Rates (2008$)

Pay Grade	Annual Salary	Overhead and Fringe Benefits (% of wages)	Overhead and Fringe Benefit Cost	Total
GS 12 Step 3	$77,416	58%	$44,901	$122,317
GS 13 Step 3	$88,493	58%	$51,326	$139,819
Source: The unloaded Federal salary for 2008 is from the Office of Personnel Management salary table for Washington-Baltimore-Northern Virginia (OPM, 2008).

Table 9 and Table 10 contains the burden and cost per report for all EPA staff activities in the first and future reporting cycles. The activities performed by the GS-13 level staff member, including systems development, and contract oversight and management, are fixed costs and are not dependent on the number of reports submitted to EPA. Therefore, the total burden for systems development and contract oversight is one FTE at the GS-13 level, with a cost of $139,819 in both the first and future reporting cycles. Quality control of data entry is performed by the GS-12 level staff member and is dependent on the number of reports received. The burden for quality control of data is approximately 0.000091 FTE per report in the first reporting cycle and 0.000011 FTE in future reporting cycles. The total cost per-report is approximately $15.08 in the first reporting cycle and $1.38 in future reporting cycles. The burden and cost of processing each data element in Form U are derived in the Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011). EPA multiplied the burdens by the number of data elements in each section to estimate the total cost and burden of processing each Form U. For more detail on the derivation of these burdens, see the IUR EA (EPA, 2011).

Table 9: EPA Staff Burden and Cost of Processing One Report (First Reporting Cycle)

Activity	Agency Burden per Activity (FTE)	Agency Burden per Activity (hours)	Agency Cost per Activity (2008$)
GS-12 Step 3 per-Report Burden
Quality Control of Data for Part I	0.0000827	0.1720	$11.55
Quality Control of Data for Part II	0.0000057	0.0118	$3.14
Quality Control of Data for Part III	0.0000030	0.0063	$0.39
Total GS-12 Burden, per report	0.0000914	0.1901	$15.08
GS-13 Step 3 Fixed Cost Burden
Systems development, and contract oversight and management	1	2,080	$139,819
Total GS-13 Burden, per reporting cycle	1	2,080	$139,819

Table 10: EPA Staff Burden and Cost of Processing One Report (Future Reporting Cycles)

Activity	Agency Burden per Activity (FTE)	Agency Burden per Activity (hours)	Agency Cost per Activity (2008$)
GS-12 Step 3 per-Report Burden
Quality Control of Data for Part I	0.0000048	0.0100	$0.66
Quality Control of Data for Part II	0.0000026	0.0054	$0.33
Quality Control of Data for Part III	0.0000030	0.0063	$0.39
Total GS-12 Burden, per report	0.0000105	0.0218	$1.38
GS-13 Step 3 Fixed Cost Burden
Systems development, and contract oversight and management	1	2,080	$139,819
Total GS-13 Burden, per reporting cycle	1	2,080	$139,819

Contractor Activities

Agency costs also include payment for extramural tasks completed by contractors (this category includes costs to EPA, but not burden hours). Contractor activities include document receipt, tracking, data entry, maintaining backup systems, printing and publishing forms and materials, and managing the TSCA Hotline, as presented in Tables 11 and 12. With the exception of document receipt, tracking, and data entry, all contractor costs are fixed and are not dependent on the number of reports received. All fixed costs are taken from the last published ICR and were inflated from 2007 to 2008 dollars with an inflation factor calculated using the Employment Cost Index (ECI), seasonally adjusted, for white-collar occupations in private industry (BLS, 2009).

EPA calculated the cost estimate per report for document receipt, tracking, and data entry, $0.64 in the first reporting cycle and $0.65 in future reporting cycles, by starting with the cost estimated in the 2007 ICR, and updating it to reflect the new data elements and the electronic submission requirement in the final amendments. The reduction in burden caused by the electronic submission requirement is based on a study conducted by EPA, “A Business Case Analysis of EPA’s Central Data Exchange” (EPA, 2007), of the costs and benefits of the electronic Central Data Exchange (CDX) system. The study estimates an 88.6 percent decrease in EPA processing burden as a result of using the CDX system. For more information, see the Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011).

Table 11: Cost of Contractor Activities (First Reporting Cycle)

Activity	Annual Cost (2007$)	Inflation Factor	Annual Cost (2008$)
Variable Costs
Document receipt, tracking, and data entry for Part I	$0.78	n/a	$0.09
Document receipt, tracking, and data entry for Part II	$1.92	n/a	$0.25
Document receipt, tracking, and data entry for Part III	$2.45	n/a	$0.30
Total Cost of Document receipt, tracking, and data entry, per full report	$5.14	n/a	$0.64
Fixed Costs
Maintaining and Operating Back-Up Systems	$56,711	1.04	$59,145
Printing and Publishing Forms and Materials	$5,298	1.04	$5,525
Managing the TSCA Hotline	$42,855	1.04	$44,694
Total Fixed Cost	$104,864	n/a	$109,364

Table 12: Cost of Contractor Activities (Future Reporting Cycles)

Activity	Annual Cost 2007$	Inflation Factor	Annual Cost 2008$
Variable Costs
Document receipt, tracking, and data entry for Part I	$0.78	n/a	$0.09
Document receipt, tracking, and data entry for Part II	$1.92	n/a	$0.26
Document receipt, tracking, and data entry for Part III	$2.45	n/a	$0.30
Total Cost of Document receipt, tracking, and data entry, per full report	$5.14	n/a	$0.65
Fixed Costs
Maintaining and Operating Back Up Systems	$56,711	1.04	$59,145
Printing and Publishing Forms and Materials	$5,298	1.04	$5,525
Managing the TSCA Hotline	$42,855	1.04	$44,694
Total Fixed Cost	$104,864	n/a	$109,365

6(d) Bottom-Line Industry Burden and Cost Estimates

This section describes the estimated total social paperwork burden and cost of the IUR rule, including the final amendments. The next IUR submission period will occur in 2012 for chemical substances manufactured (including imported) during the calendar year 2011. Even though reporting occurs only once per reporting cycle (once every six years for the 2012 cycle and once every four years in the future), EPA believes rule compliance and data collection activities, and thus, costs and burdens, are incurred over the course of the reporting cycle. Therefore, for purposes of this analysis, the burden and cost for one reporting cycle are averaged over the number of years in the reporting cycle and are presented here as average annual figures. This ICR addendum supporting statement is for the three-year period of 2011 through 2013; therefore, average annual figures for each of these three years are presented below.

Respondent tally

EPA calculated the numbers of sites and reports submitted based on submission information from the December 2008 version of the IUR database, which includes data from the most recent (2006) IUR collection. The EPA IUR database contains information collected under the IUR for previous submission periods and was used to generate estimates of expected reports for the 2012 reporting cycle. In the 2011 and 2012, EPA expects a total of 4,085 sites to submit 20,718 full reports (80 percent of all reports) and 5,135 partial reports (20 percent of all reports) for a total of 25,853 reports. In future reporting cycles, EPA expects 4,289 sites to submit 30,287 full reports and 648 partial reports for a total of 30,935 reports (98 percent and two percent of all reports, respectively).

Total Industry Burden/Cost for First Reporting Cycle. EPA estimates the total industry burden for the first reporting cycle, including both current baseline burden and the burden resulting from the final amendments, to be 2.34 million hours. Given that this data collection is part of a six-year reporting cycle, EPA estimates the annual industry burden for 2011 and 2012 to be 389,771 hours. As presented in Table 13, EPA estimates the total cost to industry would be $144 million, or an annual cost of $24.0 million.

Table 13: Estimated Respondent Burden and Cost Associated with the First Reporting Cycle (2011 and 2012)

Activity	Total Burden per Activity (hours)	Total Number of Units	Total Cost per Activity (2008$)	Total Burden per Reporting Cycle (hours)	Total Cost per Reporting Cycle (2008$)	Annual Burden (hours)	Annual Cost (2008$)
Compliance Determination (per Site)	2.50	4,085 Sites	$147.10	10,213	$600,896	1,702	$100,149
Rule Familiarization (per Site)	28.00	4,085 Sites	$1,748.19	114,380	$7,141,370	19,063	$1,190,228
CDX Registration Activities (per Site)	2.67	4,085 Sites	$167.35	10,893	$683,613	1,816	$113,935
Part I Preparation (per site)	2.01	4,085 Sites	$130.29	8,223	$532,232	1,371	$88,705
Partial Report Preparation (Part II, per Report)	15.37	5,135 Partial Reports	$950.29	78,931	$4,879,729	13,155	$813,288
Full Report Preparation (Part II and Part III, per Report)	98.39	20,718 Full Reports	$6,067.24	2,038,430	$125,700,980	339,738	$20,950,163
Recordkeeping (per Report)	3.00	25,853 Reports	$162.14	77,559	$4,191,742	12,927	$698,624
Total Industry Burden and Cost for the First Reporting Cycle				2,338,629	$143,730,561	389,771	$23,955,094

Note: Totals may not sum due to rounding

Total Industry Burden and Cost for Future Reporting Cycles. EPA estimates the total industry burden for future reporting cycles, including both current baseline burden and the burden resulting from the final amendments, to be 2.57 million hours. Given that this data collection will occur every four years, EPA estimates the annual industry burden for future years to be 642,823 hours. As presented in Table 14, EPA estimates the total cost to industry would be $158 million, or an annual cost of $39.5 million.

Table 14: Estimated Annual Respondent Burden and Cost Associated with Future Reporting Cycles (2013)

Activity	Total Burden per Activity (hours)	Total Number of Units	Total Cost per Activity (2008$)	Total Burden (hours)	Total Cost per Reporting Cycle (2008$)	Annual Burden (hours)	Annual Cost (hours)
Compliance Determination (per Site)	2.50	4,289 Sites	$147.10	10,723	$630,904	2,681	$157,726
Rule Familiarization (per Site)	4.00	4,289 Sites	$257.73	17,156	$1,105,419	4,289	$276,355
CDX Registration Activities (per Site)	2.67	4,289 Sites	$167.35	11,437	$717,751	2,859	$179,438
Part I Preparation (per Site)	1.89	4,289 Sites	$122.48	8,098	$525,309	2,024	$131,327
Partial Report Preparation (Part II, per Report)	14.33	648 Partial Reports	$884.43	9,287	$573,112	2,322	$143,278
Full Report Preparation (Part II and Part III, per Report)	79.96	30,287 Full Reports	$4,931.84	2,421,786	$149,370,529	605,447	$37,342,632
Recordkeeping (per Report)	3.00	30,935 Reports	$162.14	92,829	$5,017,022	23,207	$1,254,256
Total Industry Burden and Cost for Future Reporting Cycles				2,571,291	$157,938,749	642,823	$39,484,687

Note: Totals may not sum due to rounding

Annual Industry Burden and Cost for 2011 to 2013. As shown in Table 15, EPA calculated the estimated total annual respondent burden and cost associated with this ICR addendum by taking a weighted average of the first and future reporting cycles, to reflect that the period covered by this ICR, 2011 through 2013, spans two reporting cycles with different burdens and costs. The total annual burden associated with this ICR addendum is 474,122 hours. The total annual cost is $29.1 million.

Table 15: Estimated Annual Average Burden and Cost Associated with this ICR Addendum

Activity	2011		2012		2013		2011-2013 Average
	Annual Burden (hours)	Annual Cost (2008$)	Annual Burden (hours)	Annual Cost (2008$)	Annual Burden (hours)	Annual Cost (2008$)	Total Annual Burden (hours)	Total Annual Cost (2008$)
Compliance Determination (per Site)	1,702	$100,149	1,702	$100,149	2,681	$157,726	2,028	$119,342
Rule Familiarization (per Site)	19,063	$1,190,228	19,063	$1,190,228	4,289	$276,355	14,139	$885,604
CDX Registration Activities (per Site)	1,816	$113,935	1,816	$113,935	2,859	$179,438	2,163	$135,770
Part I Preparation (per Site)	1,371	$88,705	1,371	$88,705	2,024	$131,327	1,589	$102,913
Partial Report Preparation (Part II, per Report)	13,155	$813,288	13,155	$813,288	2,322	$143,278	9,544	$589,952
Full Report Preparation (Part II and Part III, per Report)	339,738	$20,950,163	339,738	$20,950,163	605,447	$37,342,632	428,308	$26,414,320
Recordkeeping (per Report)	12,927	$698,624	12,927	$698,624	23,201	$1,253,931	16,351	$883,726
Total							474,122	$29,131,625

Average Burden and Cost per Site. As shown in Table 16, the Agency estimates the typical respondent burden for this information collection activity to be 572 hours in the first reporting cycle and 600 hours in future reporting cycles. Given that the 2011 and 2012 (first) collection is based on a six-year reporting cycle, the average annual burden for the first reporting cycle would be 95 hours. Given that a collection would occur once every four years under the final rule, the average annual burden for future cycles would be 150 hours. These burden estimates assume each site will submit an average of 5.07 full reports and 1.26 partial reports in both the next reporting cycle, and 7.06 full reports and 0.15 partial reports in future reporting cycles. This is a decrease of 2.04 partial reports per site and an increase of 1.67 full reports per site in the first cycle compared to the average number of reports completed per site presented in the currently approved ICR (EPA ICR No. 1884.04).

Table 16: Average Burden per Site

Activity	Burden Hours			Total Hours per Activity	Reports per Average Site	Total Burden (hours per average site)	Annual Burden (hours per average site)
	Managerial	Technical	Clerical
First Reporting Cycle
Rule Familiarization. Compliance Determination, CDX Registration Activities and Part I Preparation (per Site)	10.99	24.19	0.00	35.18	1.00	35.18	5.86
Partial Report Preparation (Part II, per Report)	4.10	11.27	0.00	15.37	1.26	19.32	3.22
Full Report Preparation (Part II and Part III, per Report)	24.85	73.53	0.00	98.39	5.07	499.00	83.17
Recordkeeping (per Report)	0.75	1.50	0.75	3.00	6.33	18.99	3.16
Total Hours						572	95.42
Future Reporting Cycles
Rule Familiarization. Compliance Determination, CDX Registration Activities and Part I Preparation (per site)	3.95	7.10	0.00	11.05	1.00	11.05	2.76
Partial Report Preparation (Part II, per Report)	3.68	10.65	0.00	14.33	0.15	2.17	0.54
Full Report Preparation (Part II and Part III, per Report)	20.29	59.67	0.00	79.96	7.06	564.65	141.16
Recordkeeping (per Report)	0.75	1.50	0.75	3.00	7.21	21.64	5.41
Total Hours						600	150

Table 17 presents the average cost per site, by activity, for an IUR respondent. EPA estimates the average site will submit 5.07 full reports and 1.26 partial reports in the first reporting cycle and 7.06 full reports and 0.15 partial reports in future reporting cycles and incur a total cost of $35,185 during the first reporting cycle ($5,864 annually), and $36,824 during future reporting cycles ($9,206 annually) for Form U completion and submission.

Table 17: Average Cost per Site

Activity	Cost (2008$)				Total Cost per Activity	Reports per Average Site	Total Cost (2008$ per average site)	Annual Cost (2008$ per average site)
	Managerial	Technical		Clerical
First Reporting Cycle
Rule Familiarization. Compliance Determination, CDX Registration Activities and Part I Preparation (per site)	$770		$1,423	$0.00	$2,193	1.00	$2,193	$365
Partial Report Preparation (Part II, per Report)	$287		$663	$0.00	$950	1.26	$1,195	$199
Full Report Preparation (Part II and Part III, per Report)	$1,741		$4,327	$0.00	$6,067	5.07	$30,771	$5,129
Recordkeeping (per Report)	$52.52		$88.26	$21.36	$162	6.33	$1,026	$171
Total Cost							$35,185	$5,864
Future Reporting Cycles
Rule Familiarization. Compliance Determination, CDX Registration Activities and Part I Preparation (per site)	$277		$418	$0.00	$695	1.00	$695	$174
Partial Report Preparation (Part II, per Report)	$258		$627	$0.00	$884	0.15	$134	$33.41
Full Report Preparation (Part II and Part III, per Report)	$1,421		$3,511	$0.00	$4,932	7.06	$34,826	$8,707
Recordkeeping (per Report)	$52.52		$88.26	$21.36	$162	7.21	$1,169	$292
Total Cost							$36,824	$9,206

As shown in Table 18, EPA calculated the estimated burden and cost per site associated with this ICR addendum by taking a weighted average of the first and future reporting cycles to reflect that the period covered by this ICR addendum, 2011 through 2013, spans two reporting cycles with different burdens and costs. The average annual burden per site is 114 hours and the average annual cost per site is $6,978.

Table 18: Estimated Annual Burden and Cost per Site Associated with this ICR Addendum

Activity	2011		2012		2013		2011-2013 Average
	Annual Burden (hours)	Annual Cost (2008$)	Annual Burden (hours)	Annual Cost (2008$)	Annual Burden (hours)	Annual Cost (2008$)	Annual Burden (hours)	Annual Cost (2008$)
Rule Familiarization. Compliance Determination, CDX Registration Activities and Part I Preparation (per site)	5.86	$365	5.86	$365	2.76	$174	4.83	$302
Partial Report Preparation (Part II, per Report)	3.22	$199	3.22	$199	0.54	$33	2.33	$144
Full Report Preparation (Part II and Part III, per Report)	83.17	$5,129	83.17	$5,129	141.16	$8,707	102.50	$6,321
Recordkeeping (per Report)	3.16	$171	3.16	$171	5.41	$292	3.91	$211
Total							114	$6,978

Table 19 presents the annual burden hours, organized by information collection, for both the first and future reporting cycle, and weighted, annual averages for the ICR addendum period, for IUR respondents.

Table 19: Annual Information Collection Tally for First and Future Reporting Cycles

Information Collection	No. of Respondents	No. of Responses / Respondent	Responses Subtotal	Annual Burden Hours per Response	Annual Burden Hours Subtotal
First Reporting Cycle (2011 and 2012)
Compliance Determination	4,085	1	4,085	0.42	1,702
Rule Familiarization	4,085	1	4,085	4.67	19,063
CDX Registration Activities	4,085	1	4,085	0.44	1,816
CDX Registration	4,085	1	4,085	0.15	624
ESA	4,085	1	4,085	0.29	1,191
Prepare Part I of Form U	4,085	1	4,085	0.34	1,371
Prepare and Submit Report, and Maintain Records – Partial Report	4,085	1.26	5,135	3.06	15,723
Part II of Form U	4,085	1.26	5,135	2.56	13,155
Recordkeeping	4,085	1.26	5,135	0.50	2,568
Prepare and Submit Report, and Maintain Records - Full Report	4,085	5.07	20,718	16.90	350,097
Part II and III of Form U	4,085	5.07	20,718	16.40	339,738
Recordkeeping	4,085	5.07	20,718	0.50	10,359
Future Reporting Cycles (2013)
Compliance Determination	4,289	1.00	4,289	0.63	2,681
Rule Familiarization	4,289	1	4,289	1.00	4,289
CDX Registration Activities	4,289	1	4,289	0.67	2,859
CDX Registration	4,289	1	4,289	0.23	983
ESA	4,289	1	4,289	0.44	1,876
Prepare Part I of Form U	4,289	1	4,289	0.47	2,024
Prepare and Submit Report, and Maintain Records – Partial Report	4,289	0.15	648	4.33	2,808
Part II of Form U	4,289	0.15	648	3.58	2,322
Recordkeeping	4,289	0.15	648	0.75	486
Prepare and Submit Report, and Maintain Records - Full Report	4,289	7.06	30,287	20.74	628,162
Part II and III of Form U	4,289	7.06	30,287	19.99	605,447
Recordkeeping	4,289	7.06	30,287	0.75	22,715
Average Burden for ICR Addendum Period
Compliance Determination	4,153	1	4,153	0.49	2,028
Rule Familiarization	4,153	1	4,153	3.40	14,139
CDX Registration Activities	4,153	1	4,153	0.52	2,163
Prepare Part I of Form U	4,153	1	4,153	0.38	1,589
Prepare and Submit Report, and Maintain Records – Partial Report	4,153	0.89	3,639	3.14	11,418
-- Part II of Form U	4,153	0.89	3,639	2.62	9,544
-- Recordkeeping	4,153	0.89	3,639	0.51	1,874
Prepare and Submit Report, and Maintain Records - Full Report	4,153	5.74	23,908	18.52	442,785
--Part II and III of Form U	4,153	5.74	23,908	17.92	428,308
--Recordkeeping	4,153	5.74	23,908	0.61	14,478

Some burden estimate subtotals may not calculate due to rounding of unit burden estimates

Table 20 presents the total burden hours for the ICR period (2011 – 2013), organized by information collection, for both the first and future reporting cycles, for IUR respondents.

Table 20: Information Collection Tally for ICR Reporting Period (2011- 2013)

Information Collection	No. of Respondents	No. of Responses / Respondent	Responses Subtotal	Total Burden Hours per Response	Total Burden Hours Subtotal
First Reporting Cycle (2011 and 2012)
Compliance Determination	4,085	1	4,085	0.83	3,404
Rule Familiarization	4,085	1	4,085	9.33	38,127
CDX Registration Activities	4,085	1	4,085	0.89	3,631
CDX Registration	4,085	1	4,085	0.31	1,248
ESA	4,085	1	4,085	0.58	2,383
Prepare Part I of Form U	4,085	1	4,085	0.67	2,741
Prepare and Submit Report, and Maintain Records – Partial Report	4,085	1.26	5,135	6.12	31,445
Part II of Form U	4,085	1.26	5,135	5.12	26,310
Recordkeeping	4,085	1.26	5,135	1.00	5,135
Prepare and Submit Report, and Maintain Records - Full Report	4,085	5.07	20,718	33.80	700,195
Part II and III of Form U	4,085	5.07	20,718	32.80	679,477
Recordkeeping	4,085	5.07	20,718	1.00	20,718
Future Reporting Cycles (2013)
Compliance Determination	4,289	1.00	4,289	0.63	2,681
Rule Familiarization	4,289	1	4,289	1.00	4,289
CDX Registration Activities	4,289	1	4,289	0.67	2,859
CDX Registration	4,289	1	4,289	0.23	983
ESA	4,289	1	4,289	0.44	1,876
Prepare Part I of Form U	4,289	1	4,289	0.47	2,024
Prepare and Submit Report, and Maintain Records – Partial Report	4,289	0.15	648	4.33	2,808
Part II of Form U	4,289	0.15	648	3.58	2,322
Recordkeeping	4,289	0.15	648	0.75	486
Prepare and Submit Report, and Maintain Records - Full Report	4,289	7.06	30,287	20.74	628,162
Part II and III of Form U	4,289	7.06	30,287	19.99	605,447
Recordkeeping	4,289	7.06	30,287	0.75	22,715
Burden for ICR Addendum Period
Compliance Determination	4,153	1	4,153	1.47	6,085
Rule Familiarization	4,153	1	4,153	10.21	42,416
CDX Registration Activities	4,153	1	4,153	1.56	6,490
Prepare Part I of Form U	4,153	1	4,153	1.15	4,766
Prepare and Submit Report, and Maintain Records – Partial Report	4,153	0.89	3,639	9.41	34,253
-- Part II of Form U	4,153	0.89	3,639	7.87	28,632
-- Recordkeeping	4,153	0.89	3,639	1.54	5,621
Prepare and Submit Report, and Maintain Records - Full Report	4,153	5.74	23,908	55.56	1,328,356
--Part II and III of Form U	4,153	5.74	23,908	53.75	1,284,923
--Recordkeeping	4,153	5.74	23,908	1.82	43,433

Agency Tally

Tables 21 and 22 present the Agency costs associated with the IUR rule for the first reporting cycle and future reporting cycles, respectively. EPA multiplied the costs per report by the total number of Parts I, II, and III to calculate the total burden and cost associated with the number of reports EPA expects to be submitted. In the first reporting cycle, the total burden is 0.548 FTEs and the total cost is $149,387 for variable cost activities. In future reporting cycles the burden is 0.193 FTE and the cost is $42,331 for variable cost activities. The burden and cost of the fixed cost activities remains unchanged by the number of reports submitted; the total fixed burden is one FTE per reporting cycle and the cost is $249,184. The total Agency burden is 1.548 FTEs in the first reporting cycle and 1.193 FTEs in future reporting cycles. The estimated total cost incurred by the Agency for the first reporting cycle, $398,571, and $291,515 in future reporting cycles was calculated by summing the Agency staff and contractor activities.

Table 21: Total Cost and Burden of Agency Activities (First Reporting Cycle)

Activity	Staff	Form U Section	Total Burden per Activity (FTE)	Total Number of Units	Total Cost per Activity (2008$)	Total Burden (FTE)		Total Cost (2008$)
Variable Burdens and Costs
Document receipt, tracking, and data entry	Contractor	Part I	N/A	4,085 Sites	$0.09	N/A	$377
		Part II	N/A	25,853 Part IIs	$0.25	N/A	$6,370
		Part III	N/A	20,718 Part IIIs	$0.30	N/A	$6,222
Quality Control of Data	EPA Employee (GS-12 Step 3)	Part I	0.0000827	4,085 Sites	$11.55	0.338	$47,170
		Part II	0.0000057	25,853 Part IIs	$3.14	0.147	$81,200
		Part III	0.0000030	20,718 Part IIIs	$0.39	0.063	$8,048
Total Variable Cost and Burden						0.548	$149,387
Fixed Burdens and Costs
Data Processing, Systems Development, and Contract Oversight and Management	EPA Employee (GS-13 Step 3)	N/A	N/A	N/A	N/A	1.000	$139,819
Maintaining and Operating Back Up Systems	Contractor	N/A	N/A	N/A	N/A	N/A	$59,145
Printing and Publishing Forms and Materials	Contractor	N/A	N/A	N/A	N/A	N/A	$5,525
Managing the TSCA Hotline	Contractor	N/A	N/A	N/A	N/A	N/A	$44,694
Total Fixed Cost and Burden						1	$249,184
Total Agency Cost and Burden						1.55	$398,571

Table 22: Total Cost and Burden of Agency Activities (Future Reporting Cycle)

Activity	Staff	Form U Section	Total Burden per Activity (FTE)	Total Number of Units		Total Cost per Activity (2008$)	Total Burden (FTE)			Total Cost (2008$)
Variable Burdens and Costs
Document receipt, tracking, and data entry	Contractor	Part I	N/A	4,289 Sites	$0.09			N/A	$396
		Part II	N/A	30,935 Part IIs	$0.26			N/A	$7,965
		Part III	N/A	30,287 Part IIIs	$0.30			N/A	$9,079
Quality Control of Data	EPA Employee (GS-12 Step 3)	Part I	0.0000048	4,289 Sites	$0.66			0.021	$2,843
		Part II	0.0000026	30,935 Part IIs	$0.33			0.081	$10,304
		Part III	0.0000030	30,287 Part IIIs	$0.39			0.092	$11,744
Total Variable Cost and Burden								0.193	$42,331
Fixed Burdens and Costs
Data Processing, Systems Development, and Contract Oversight and Management	EPA Employee (GS-13 Step 3)	N/A	N/A	N/A	N/A			1.000	$139,819
Maintaining and Operating Back Up Systems	Contractor	N/A	N/A	N/A	N/A			N/A	$59,145
Printing and Publishing Forms and Materials	Contractor	N/A	N/A	N/A	N/A			N/A	$5,525
Managing the TSCA Hotline	Contractor	N/A	N/A	N/A	N/A			N/A	$44,694
Total Fixed Cost and Burden								1	$249,184
Total Agency Cost and Burden								1.19	$291,515

6(e) Reasons for Change in Burden

EPA estimates industry will incur an increase of 63,637hours in annual burden compared to the estimate in the information collection request most recently approved by OMB (from 410,485 hours as reported in the currently approved ICR (EPA ICR No. 1884.04) (EPA, 2008a), to 474,122hours as estimated in Section 6(d) above). Differences in burden and costs from the previous ICR are attributed to both adjustments and program changes. Adjustments capture changes in the baseline burden not included in the currently approved ICR (EPA ICR No. 1884.04) (EPA, 2008a). These changes result from updates to the number of affected sites and wages, capturing effects of rule amendments that were not included in the currently approved ICR, and the correction of estimates in the previous ICR. Program changes reflect the amendments of the final IUR modifications rule, which affect per-site costs, the number of affected sites, and the number of final and partial reports submitted. As shown in Table 22, EPA estimates an annual 66,250 hour burden decrease as a result of adjustment changes and an annual increase of 105,534 hours as a result of program changes. More details on the adjustments and program changes are outlined below.

Adjustment Changes

The previous currently approved ICR (EPA ICR No. 1884.04) used data from the 2006 IUR database that had not gone through quality control to estimate the number of sites, and partial and full reports submitted to EPA. EPA ICR No. 1884.04 estimated that a total of 4,190 sites would submit 13,989 partial reports and 14,409 full reports. EPA has adjusted the number of sites and reports using the quality-controlled data and estimates that a total of 4,085 sites will submit 8,821 partial reports and 17,075 full reports in the baseline.

The previous ICR did not take into account the amendment in the 2006 Final IUR Revisions Rule that removed the requirement of reporting processing and use information for exports. This amendment reduced the burden associated with submitting and completing a final report by 15 percent.

The previous ICR used high-end burden estimates, while the current ICR uses midpoint estimates to be consistent with the Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011). EPA adjusted the burden estimates from the previous ICR using midpoint estimates to provide a consistent comparison across ICRs. This change reduces the per-site burden associated compliance determination, recordkeeping and submitting a report.

The previous ICR used first-year burden for each burden activity, with the exception of rule familiarization which was estimated at 4 hours per site. The first-year range for this activity is 26-30 hours. EPA adjusted the rule familiarization to the midpoint estimate (see above) of 28 hours to reflect the first-year burden.

The total of all of the adjustments results in a decrease in the baseline total burden of 149,400 hours from 2,052,423 hours to 1,903,023 and a decrease in the baseline annual burden of 29,880 hours from 410,485 hours to 380,605 hours.

All costs were inflated from 2007$ to 2008$, which slightly increased the costs associated with the rule. However, even after adjusting for inflation the total of all of the adjustments decreased the annual baseline cost from $22,628,227 to $22,041,964; a decrease of $586,263.

Program Changes

The per-site costs, the number of affected sites, and the number of final and partial reports submitted, will be impacted by several of the final modifications including:

• For the reporting cycles subsequent to the 2012 reporting cycle, a requirement was added to report whether, for any calendar year since the previous IUR principal reporting year, the subject chemical was manufactured in production volumes of 25,000 lb or greater per year;

• Replace the 300,000 lb reporting threshold for processing and use information by phasing in a lower reporting threshold. For the 2012 IUR manufacturers (including importers) of non-excluded substances with production volumes greater than 100,000 lb are required to report processing and use information. Subsequent to the 2012 reporting cycle, the reporting threshold for processing and use information will be 25,000 lb;

• Reduce the 25,000 lb threshold for reporting to 2,500 lb for specific regulated chemical substances and require manufacturers (including importers) of such chemical substances to report under the IUR rule, if production volume is greater than 2,500 lb beginning with the 2016 reporting cycle,

• Chemical substances subject to Enforceable Consent Agreements (ECAs) were made ineligible for exemptions;

• Manufactured water was fully exempted from reporting requirements;

• Certain reportable data elements, such as the company identification number, technical contact, and chemical identity, were amended;

• Submitters are required to report the chemical substance’s production volume for both 2010 and 2011. For the reporting cycles subsequent to the 2012 reporting cycle, submitters are required to report the chemical substance’s production volume for each year since the last principal reporting year;

• Submitters are required to report separately production volume used on-site;

• Submitters of imported chemical substances are required to indicate whether the chemical substance is physically at the reporting site;

• Submitters are required to report production volume exported;

• Submitters are required to indicate whether the chemical substance is to be recycled, remanufactured, reprocessed, or reused;

• For downstream processing and use information: the set of industrial function categories was revised, industrial sectors were provided instead of NAICS codes, and the set of consumer and commercial product categories was revised;

• Submitters are required to identify whether a use is a consumer use, a commercial use, or both;

• Submitters are required to report the total number of commercial workers, including those at sites not under the submitter’s control, that are reasonably likely to be exposed while using the reportable chemical substance, with respect to each commercial use;

• The reporting standard for processing and use information was changed from “readily obtainable” to “known to or reasonably ascertainable by”;

• Upfront substantiation is required for claims that processing and use data are confidential business information (CBI);

• Submitters are restricted from being able to claim not “known to or reasonably ascertainable by” data as CBI;

• Submitters are required to submit forms electronically using the reporting tool, e-IURweb and EPA’s CDX; and

• The frequency of reporting was changed from every five years to every four years.

Details on the final amendments and the burden and cost impacts of each amendment when taken individually and considered together (i.e., one amendment may change the impact of another, are described in the Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011).

Table 23: Total Estimate of Annual Burden Hours and Annualized Cost Comparisons

	Annual Burden Hours	Annual Cost
Current OMB Inventory	410,485	$22,628,227
Change in Burden due to Adjustments	-29,880	-$586,263
Change in Burden due to Program Changes	93,517	$7,089,661
Total Change in Burden	63,637	$6,503,398
Total Burden	474,122	$29,131,625

6(f) Burden Statement

The annual public burden for this collection of information is estimated to average 114 hours per respondent. According to the Paperwork Reduction Act, “burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For this collection it includes the time needed to determine whether a site is subject to the rule (Compliance Determination); review and understand instructions; prepare and submit reports (including searching data sources); complete and review the collection of information; transmit the information; and keep records.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection appears above. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register when approved, are listed in 40 CFR Part 9, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR Part 9.

EPA has established a docket for this ICR addendum under Docket ID No. EPA-HQ-OPPT-2009-0187 which is available for public viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1544 and the telephone number for the Pollution Prevention and Toxics Docket is (202) 566-0280.

An electronic version of this docket is available at http://www.regulations.gov/. Use the federal government-wide electronic docket system at http://www.regulations.gov to view public comments, access the index listing of the docket contents, and to access those documents in the docket that are available electronically. Once in the system, select “advance search,” then key in the docket ID number identified above for EPA.

7. Sources

BLS 2009. U.S. Bureau of Labor Statistics. Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006 – December 2008. (March12, 2009) http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf.

EPA, 2002a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA-HQ-OPPT-2002-0054-0260). August 2002.

EPA, 2002b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Wage Rates for Economic Analysis of the Toxics Release Inventory Program. June 10, 2002.

EPA, 2005. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of IUR Modifications Final Rule (EPA-HQ OPPT 2004-0106-0055). July 2005.

EPA, 2006. US EPA, Office of Pollution Prevention and Toxics, Instructions for Reporting for the 2006 Partial Updating of the TSCA Chemical Inventory Database. Nov. 2006. Available at http://www.epa.gov/iur/pubs/2006_inst_tsca_cheminv.pdf.

EPA, 2007. U.S. EPA, Office of Environmental Information. A Business Case Analysis of EPA’s Central Data Exchange. March, 2007.

EPA, 2008a. ICR No. 1884.04. [Information Collection Request for] Partial Update of the TSCA Section 8(b) Inventory Data Base, Production and Site Report Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act. September 5, 2008. EPA-HQ-OPPT-2008-0504-0002.

EPA, 2008b. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division, 2006 IUR Database Statistics for IUR Modifications Rule. Washington, DC. December 17, 2008.

EPA, 2009a. U.S. EPA, Office of Pollution Prevention and Toxics. TSCA Section 4 Federal Register Enforceable Consent Agreements. http://www.epa.gov/oppt/chemtest/pubs/4eca.html. Washington, DC. Updated October 1, 2009.

EPA, 2009b. U.S. EPA, Office of Pollution Prevention and Toxics, Sunset Dates of Chemicals Subject to Final TSCA Section 4 and Related 12(b) Actions, Modified on September 1, 2009. http://www.epa.gov/oppt/chemtest/pubs/sunset.html. Washington, DC. Updated September 1, 2009.

EPA, 2010. TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations; Final rule. Federal Register (75 FR 773-790), January 6, 2010)

EPA, 2011. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule. June, 2011.

OPM, 2008. Office of Personnel Management, Salary Table 2008-DCB, Washington Baltimore-Northern Virginia, DC-MD-PA-VA-WV. Accessed from http://www.opm.gov/oca/08tables/pdf/DCB.pdf.

1 The final rule is titled “TSCA Inventory Update Reporting Modifications.”

2 INFORM is a nonprofit environmental research organization.

3 The economic analysis for the 2005 Amendments assumed a 15 percent reduction in burden for the completion of Part III because submitters were no longer required to report use and downstream processing information for exports.

4 EPA believes that the burden for future reporting cycles will be reduced because of efficiencies achieved through the establishment of compliance processes; as described in the IUR EA (EPA, 2011). After a site’s first reporting cycle, the availability of data from previous reporting cycles and familiarity with reporting requirements will expedite the process for submitters who have previously submitted a Form U.

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