July 19, 2010 [NPRM: RIN 2070-AJ43]

Page 1 of 48 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: Proposed Rule Addendum to Pa rtial Update of the TSCA Section 8(b) Inventory Data Base, Production and Site Reports

EPA ICR No.: 1884.05 OMB Control No.: 2070-0162

1(b) Short Characterization/Abstract

The following information collection request (ICR) addendum addresses the paperwork requirements contained in a proposed rule (RIN 2070-AJ43) that would amend the information

collection activities of the Inventory Update Reporting (IU R) 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 chemicals manufactured or processe d in the United States. In a ddition, under TSCA section 8(b), the Agency is required to compile and keep cu rrent, via periodic i nquiry, the Inventory of Chemical Substances in Commerce (TSCA Invent ory). The TSCA Invent ory 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 production information for se lected larger volume chemicals in the TSCA Inventory six times (every four years), beginn ing in 1986, and to collect additional information relating to the manufacture, processing, and use of those chemicals, beginning in 2006.

EPA is proposing to amend the current IUR requi rements 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 EP A. Manufacturers (including im porters) would be required to use e-IURweb (the Agency-provided reporting t ool) to submit a completed Form U (EPA Form 7740-8) electronically via the In ternet. As proposed, the 2011 IUR would include additional manufacturing, processing, and use exposure-related data elements , including the volume of the chemical used on the reporting site; the volume of the chemical directly exported; whether the chemical is being recycled, remanufactured, reprocessed, reused, or reworked; and the production volumes for the previous years since the last principal re porting year. Additional amendments to the 2011 IUR would include change s to the reporting frequency from every five years to every four years; modi fications to the method used to determine whether a manufacture (including importer) is subject to IUR reporting for reporting cycles subsequent to the 2011 reporting cycle; modifications to reporting thresholds, including eliminating the upper threshold;

revisions to industrial classifi cations used; revisions to the list of commercial and consumer product categories; and modifications to situatio ns in which confidentiality may be claimed and to the process for making such claims.Page 2 of 48

OPPT will use the updated IUR da ta in its chemical risk-management efforts. Individual sites manufacturing, including importing, chemicals 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 inform ation will be made public through the Agency’s IUR website ( 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 4,221 respondents at an annual cost of $40.3 million during the ICR a ddendum 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, asse ss, and control risks of injury to human health and the environment posed by commercial chemicals. 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 collec tion of records from ma nufacturers, importers, and processors of commercial chemicals. Sectio ns 8(a)(1) and (2) of TS CA also authorize the Agency to collect information on the chemi cal manufacturing and importing industry. EPA possesses broad discretion in determining the in formation to be reported under TSCA section 8(a). The IUR rule currently is codified at 40 CFR 710. EPA is proposing to move the IUR rule

to a new Part at 40 CFR 711.

EPA is proposing now to modify the IUR rule 1 to meet four primary goals: (1) to tailor the information collected to better meet the Agen cy’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 subs et 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 chemicals; and adjusting the specific reported information, the frequency the information is reported, and confidential business information (CBI) clai m requirements would accomplish these goals.

The IUR provides basic exposure-related ma nufacturing, processing and use information used by EPA and others in a wide range of Agen cy activities. EPA’s e fforts to use the 2006 IUR

data have identified areas wher e further improvements are needed to improve risk-screening capabilities. Screening level data need not be pr ecise, but should be accurate and reliable enough for the Agency to develop sc reening-level exposure assessmen ts. The 2011 IUR would provide

more detailed information needed to better understand and interpret the IUR data, further enhancing the Agency’s ability to identify, scree n, and manage potential chemical risks. Because exposure is a key component of risk, the IUR e xposure-related information would allow OPPT to screen chemicals based on the potential for ri sk in order to protect human health and the environment, as required by TSCA. The exposure -related data on manufacturing, processing, and

1 The proposed rule is titled “TSCA Inventory Update Modifications.”Page 3 of 48

use potentially allow the Agency and others to avoid more burde nsome regulatory requirements.

These enhanced data would allow EPA to conduct a more effective and efficient screening level

review of chemicals to identify candidates fo r further evaluation.

2(b) Practical Utilit y/Users of the Data

The proposed modifications associated w ith reporting methods and changes to the reporting software would ensure the information reported to EPA is accurate and in compliance with the IUR requirements.

e-IURweb Reporting Software

Beginning with the 2011 submission period, EPA is proposing to require electronic reporting for all IUR submissions, including jo int submissions and amendments. Persons submitting information under the IUR rule would be required to use e-IURweb, the Agencyprovided, web-based software to complete Form U (the IUR reporting form). The information would be submitted electronically via the Inte rnet, 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 2011 submission process will be 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-thi rd of the 2006 submissions were filed through CDX, using the 2006 e-IUR downloadable software. The elimination of pa per-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 2011 e-IURweb would feature several improved capabilities over the 2006 e-IUR software. These improvements include an enhan ced validation system, which would alert users when a required field on the form is either missing information or contains certain kinds of potentially incorrect information. EPA expects other updates to include automated chemical identity checks, automated company and site identity checks, and the facilitation of joint

submissions and amendments.

Electronic submission would also ensure that IUR data would have completed a basic validation check, could be quickly incorporated into a database and ready for immediate Agency use, and would eliminate subsequent data entry errors which occurred with paper submissions. Furthermore, EPA believes the mandatory us e of e-IURweb and CDX would reduce the reporting burden on industry by re ducing 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 elec tronic signature agreem ent (ESA) and to submit the agreement in hard copy with a wet ink signa ture to EPA in order to complete the CDXPage 4 of 48

registration. For 2011 IUR reports, EPA is modifyi ng the 2006 ESA to identify more clearly the individual(s) required to sign th e agreement. To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder”) would download two fo rms: the Electronic Signature Agreement and the Verification of Company Authorizing Official. For identity authentication, the registrant would complete the ESA, sign and date it, ha ve the form notarized, and mail it to EPA. The Verification of Comp any Authorizing Offici al form requires the signature of an immediate supervis or or witnessing offi cial verifying that the registrant is the person who should sign their name in the cer tification statement box on Form U. Once EPA receives both forms, EPA would activate the re gistrant’s CDX account and send a notification

via email.

Respondents may need or desire to have more than one individual complete an electronic signature agreement, so that other individuals can add info rmation to an original IUR submission. Persons submitting supplemental information for an IUR submission on behalf of a company would need to register with CDX by signing an ESA and Verification of Support Submitter form. The Verification of Support S ubmitter form requires the signature of an immediate supervisor or witnessi ng official from the company a nd anyone he/she authorizes to submit additional information. The company offi cial can authorize an unlimited number of support respondents, but will have to complete a form for each support respondent. Support respondents can work with an unlimited number of company officials, but will need an agreement with each company official (even if the company officials work at the same company). A support respondent may be an employ ee of the company, an outside consultant for the company, or an authorized representative ag ent for the company. While this individual would not be able to sign the certific ation statement required for the initial IUR submission, he or she would be able to provide additional informati on, if needed, using CDX. For 2006 and prior IUR submissions, respondents were not able to pr ovide additional information electronically.

Data Elements for IUR Submissions

The IUR information collection is the onl y mechanism through which EPA can collect

basic information on commercial chemicals lis ted on the TSCA Inventory of Chemical Substances, including production volume a nd other manufacturing (including importing) processing, and use exposure-related data. This in formation collection is necessary because these

data are not otherwise available. EPA would use the information it is proposing to collect in the following ways:

(1) Parent company identification information : Company identification information is collected already by the current IUR. EPA is proposing to require reporting of additional company identification information associated with the location of the company, and is clarifying that the company information is to be for the ultimate domestic parent company associated with the reporting plan t site. These data w ould help ensure the company information is consistently provided.

(2) Manufacturing-related information :

 The production volume for each of the years since the last principal reporting

year : The one-year snapshot of producti on volume provided by the currentPage 5 of 48

IUR does not provide an accurate pictur e of the chemicals in commerce, and may provide an erroneous view of the exposure scenarios associated with a particular chemical substance. The hi gh turn-over of reported chemicals from one submission period to the next in dicates a dynamic, changing industry.

EPA has received comments from indus try concerning the year-to-year changes that occur for chemical pr oduction that may affect IUR reporting.

EPA would use these data for chemi cal 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 manufactu red (including imported) chemical substance used at the reporting site : This data element would replace the data element indicating that a chemical is site-limited. This new data element

identifies whether a chemical is used by the reporting site. A domestically

manufactured chemical would be identifie d as a site-limited chemical (or that a portion of the chemical is site-limite d). An imported chemical would be identified as used by the importer. This information is related to potential exposures associated with the on-site volumes, and would provide the Agency with more accurate information for exposure assessments and other data analyses.

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

 The production volume directly export ed and not domestically processed or

used : This data element would allow EPA to better identify the completeness of the reported processing and use in formation, by indicating the proportion of the production volume potentially covere d by the reported processing and use information. IUR processing and use information is required only for domestic use situations, a nd is not required for any volumes directly exported.

 Whether a manufactured (including importe d) chemical, such as a byproduct, is being recycled, remanufacture d, reprocessed, reused, or reworked : This data element would provide valuable information for Agency and public programs that encourage indus try to find uses for wastes rather than disposing of the wastes, such as in a landfill.

These data would also be used in other wa ys, such as in chemical exposure and risk screening, testing and/or priority set ting, and exposure estimation required by the Interagency Testing Committee (ITC) under TSCA section 4; for EPA monitoring activities of newly manufactured substan ces 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 environmen tal exposure under TSCA section 8(e). Each data element would correspond to a data point necessary for basic risk-screening.Page 6 of 48

Under the current IUR rule, only manufacturer s (including importers) of larger-volume chemicals are required to report processing and use information. As proposed, respondents would be required to report processing and use in formation for all reported chemical substances, regardless of production volume, unless the chem ical substance is partially exempt. This proposed change provides exposure-related proce ssing and use information to EPA and others for moderate-volume chemicals, enabling the Agency to address such chemicals in the same manner as the higher-volume chemicals.

(3) Industrial processing and use data : This proposal does not add any industrial processing and use data elements. The industr ial function categories would be revised to better identify the functions of the chemical substances. The North American Industrial Classification System (NAICS) codes would be replaced with industrial sector (IS) codes.

The IS codes reduce the number of choices av ailable to the respondent, thus streamlining the reporting process and making the data easier to use.

(4) Consumer and commercial end-use exposure data: EPA is proposing to add two data

elements: an indication of consumer or co mmercial use and the number of commercial

workers. These data would be used to dete rmine exposure potential based on consumer or commercial populations. These two populations ar e very different from each other, and the ability to distinguish uses between the two enables bette r exposure-based screening of

the chemical. The number of commercial worker s is needed to better assess the size of the commercial population. In addition, the prod uct categories would be revised to better identify the uses of the chemical substances.

Special Considerations for Joint Respondents

In certain situations IUR re spondents currently are allowed to report the IUR information jointly with the supplier of the chemical subs tance for which the respondent is reporting. For example, importers may not know the specific ch emical identity of the imported Inventory substance because the foreign suppl ier chooses to keep the inform ation confidential. In addition, a manufacturer may not know the specific chemical identity of the subs tance being manufactured because the supplier of a reactant used to manufacture th e substance chooses to keep the information confidential. In such situations, the manufacturer (including importer) is still responsible for ensuring that the IUR inform ation 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 respondent, completes the majority of the required information on Form U, and provides a trade name in Part II.2.A.4 to id entify the chemical substance. The primary respondent then contacts the forei gn supplier, who is the secondary respondent, to notify them of the need to report the specific chemical identi ty information directly to EPA in the joint submission section (Part IV) of Form U, using the e-IURweb reporting software.

For 2006 and prior IUR submissions, respondents 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 respondent will not be able to access the information provided by the primary respondent and vice ve rsa. The reporting tool will match bothPage 7 of 48

submissions based upon company and chemical information provided by the manufacturer (including importer), acting as a primary respondent, and by the s upplier, acting as a secondary respondent. EPA will also use the identifying numb er assigned to the primary respondent during CDX registration to link the joint reports in an internal database. 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 al l Form Us are received and matched by the Agency.

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

(1) Joint Submission Information (primary respondent only): The primary respondent provides only a trade name or other desi gnation 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 respondent.

(2) Secondary Company Identi fication Information : These data would identify the secondary respondent’s company name a nd the complete mailing address of the company. The information provided would help ensure that the company information is provided consistently, and would be used to associate the s econdary respondent’s company with the primary respondent’s company and site plant.

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

(4) Primary Company Identification Information : These data would provide the primary respondent’s parent company name and the co mplete address of the company to help ensure that the company information is pr ovided consistently, and would be used to associate the primary respondent’s compa ny and site plant with the secondary respondent’s company.

(5) Trade Product Identific ation Information : These data would identify the primary respondent’s company name, site name, and si te address, as well as the CAS Registry Number, the appropriate speci fic chemical identities, and product composition. These data are needed by EPA to combine the secondary respondent’s chemical-specific information with the primary respondent’s 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 governme nt public health and environment efforts, IUR data have been used by EPA’s Office of Water, Office of Solid Waste and Emergency Re sponse, and Office of Air and Radiation to identify a nd characterize particular chemi cal substances. Non-confidential IUR data are incorporated into a number of data bases and products maintained by organizationsPage 8 of 48

including Right-To-Know-Net and INFORM 2 . IUR data were used to identify chemicals of particular concern for the National Institutes of Health. Non-confidential IUR data were also released to selected states to help them id entify facilities manufactur ing suspected endocrine disrupters.

Data reported under the 2011 IUR would enha nce the capabilities of the Agency and other Federal agencies to ensure risk manage ment actions are taken on chemicals posing the most concern. More in-depth reporting of the processing and use data, more careful consideration of the need for confidentiality clai ms, and adjustments to the specific data elements would better support a robust risk assessment and management program. By enhancing the data supplied to Agency risk-screeni ng programs, EPA expects to more effectively and expeditiously identify and address potential risks pose d by chemicals and provide improved access and information to the public.

EPA would also use the information subm itted through the 2011 collection to update the Agency’s comprehensive chemical manufacturing , exposure, and use database, maintained as part of the Manage Toxic Substances (MTS) sy stem. 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 informa tion about the chemical industry for EPA, as well as other Federal Agencies. The MTS IUR data provide information about the chemicals 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 chemicals reported from one IUR su bmission period to the ne xt; 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 us e 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 Prio r to ICR submission to OMB

The proposed rulemaking serves as the public notice for this ICR. Interested parties should submit comments referencing Docket ID No. EPA-HQ-OPPT-2009-0187 to the address listed at the end of this document. Responses wi ll be taken into account in developing the final rulemaking.

3(c) Consultations

2 INFORM is a nonprofit environmental research organization.Page 9 of 48

In addition to the public notice and co mment 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 su bmits the ICR to OMB for review and approval. In accordance with this regulati on, EPA will solicit consultation f eedback from nine potential respondents and data users with re spect to this final rule ICR.

3(d) Effects of Less Frequent Collection

EPA is proposing to return the reporting fre quency to every four years, which was the frequency in effect from 1986 to 2006. In an e ffort to reduce the reporting burden associated with the 2003 amendments, EPA had changed the re porting frequency to every five years. While the less frequent reporting doe s reduce burden, a review of th e 2006 IUR reporting has revealed an approximately 30 percent change in the ch emicals that are reporte d from one submission period to the next. EPA now be lieves that reporting every five years does not provide data sufficiently current to meet Agency and public n eeds and now considers every four years to be the minimum acceptable frequency. In addition, the IUR Modifications proposed rule requests comment on even more frequent reporting. Comme nts from industry representatives have led EPA to believe that more frequent reporting cr eates efficiencies, both for the respondent and for EPA. With more frequent reporting, companies w ould be able to establish standard systems and practices to collect th e required information.

The Agency needs to be able to make accura te chemical risk management decisions in a timely and cost effective manner, especially be cause alternative data sources do not exist for

these data. The effect of less fr equent collection of these data is to diminish significantly the Agency’s ability to understand the chemical industry and mon itor the producti on levels of chemicals 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 peri od to the next. The Agency needs up-to-date

information in order to fulfill its mandate to k eep the TSCA Inventory current under section 8(b) of TSCA; collecting the data ever y five years means the Agency is working with data which are potentially six or more years old, and th erefore, cannot be co nsidered current.

Less frequent collection could result in EP A using outdated informa tion in its decision making. For example, changing market conditions , batch processing, or the development of new uses for the chemical can cause pr oduction volumes or chemical uses to change from one year to the next. Companies buy and sell plant sites, a nd the chemicals produced at a site can change. Based on past IUR reporting, the Agency woul d be working with the IUR data which approximately 30 percent of the chemical substa nces 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 exceptio ns listed below.

The record retention period of this collection is five year s, as specified in 40 CFR 710.57, exceeding the PRA maximum of three years. This is necessary to ensure companies retainPage 10 of 48

records long enough to facilita te completion of Form U (EPA Form 7740-8) in the next collection, which is in four years (as proposed), and to allow EPA’s enforcement activities to overlap two IUR reporting cycles.

Confidential Business Information (CBI) clai ms limit access to the IUR data, especially by the public. EPA recognizes that some informa tion 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

Respondents may claim information reported to EPA under this rule as confidential if such information would reveal the respondents’ trade secrets or proprietary information as defined by TSCA section 14 and existing TS CA regulations. EPA has long-established procedures for handling, stori ng, processing, and disposing of TSCA confidential information. Transfers of this information to other governme ntal agencies can be made only if the other agency agrees to adhere to all TSCA confidentia lity provisions. EPA will maintain standard CBI procedures to protect any confiden tial, trade secret, or proprietary information from disclosure in

accordance with EPA’s confid entiality 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 comp anies manufacturing or importing chemicals 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 chemicals. 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 coll ection activity are from the following North American Industrial Classification System (NAICS) code categories:

325 - Chemical Manufactu ring (including importing)

324 - Petroleum and Coal Product Ma nufacturing (including importing)

The subsectors identified above represent the designation of sites that likely would be subject to IUR reporting. However, activities at th ese sites may vary, maki ng identification of the regulated community more difficult. For example, NAICS codes reflect a site’s primary activity, omitting substantial participation a company ma y have in other industry activities. Second, NAICS codes selected by parent companies refl ect the parent company’s primary activity, even though many parent companies are primarily holding companies with small subsidiaries. Each of these small subsidiaries may belong in a complete ly different industry cl assification based on its own primary activity. Informati on on parent company NAICS codes does not provide a veryPage 11 of 48

accurate characterization of the t ypes of sites subject to reporting, and facilities that do not fall under these categories must still report if they m eet the reporting criteria.

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

In addition to the anticipated responden ts listed above, manu facturers (including importers) of byproducts may be required to re port under the IUR rule . Byproduct manufacturers (including importers) may be listed under a differe nt 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 substan ce 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) th at uses a chemical substance in the production of an article may produce a byproduct s ubstance that is chemically different from the starting substance; the manufacturer (inc luding importer) therefore may incur reporting obligations under the IUR for th at 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 un der the IUR rule.

4(b) Information Requested

(i) 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 ecosyst ems or size of human populations potentially exposed, (2) the potential human or environm ental exposure concentr ations, and (3) the frequency and duration of potentia l exposures. The data enhances EPA’s ability to evaluate each of these components of exposure. Respondent s are required to submit certain known or reasonably ascertainable manuf acturing, processing, and use exposure-related information. For the 2006 IUR, respondents were required to subm it the processing and use information to the extent it was readily obtainable; the IUR Modifications rule propos es to standardize all of the submitted information to the single “known to or reasonably ascertainable by” reporting

standard.

Using e-IURweb, individuals would report the proposed 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.Page 12 of 48

 Parent Company Name and Address . The name and mailing address of the ultimate domestic parent company. The requirement th at the ultimate parent company reported be the ultimate domestic parent company is part of the IUR Modifications proposal; the parent company name is already re quired by the IUR. This is not a new requirement; rather the change better identifies the correct company name.

 Manufacturing Information. The production volume for each of the years since the last principal reporting year; the volume of the reported chemical substance used at the reporting site; whether an imported chemi cal is physically at the reporting site; the production volume directly exported and not domestically processed or used; and whether a manufactured (including imported) chemical, such as a byproduct, is being recycled, reused, reprocessed, remanufactured, or reworked.

 Processing and Use Information. For the 2006 IUR, only those manufacturers (including importers) of chemicals with production volumes of 300,000 lb. or more were required to report processing and us e information. The IUR Modifications rule proposes to require respondents to report this information for all reported chemicals, unless the chemical 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 t ype of process or use (code), NAICS code associated with the industrial use, and industrial functi on category. The IUR Modifications rule proposes to revise the li st of industrial function categories and to replace the NAICS codes w ith Industrial Sectors.

 Consumer and Commercial Use Data. For the 2006 IUR, respondents were able to select up to 10 consumer and commercial pr oduct categories. The IUR Modifications rule proposes to revise th e list of consumer and comme rcial 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 commer cial 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 Inventor y substance or of a reactant

used to manufacture the Inventor y substance. This may happen, fo r instance, when a company is importing a mixture under a trade name, and the fore ign manufacturer does not want to reveal the components in the mixture. (See Special Considerations for Joint Respondents in section 2b, above) Proposed changes to the IUR would 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 wouldPage 13 of 48

report on proposed data elements in Part II, Blocks 2.A.4 through 2.A.10, on Form U as follows (see Attachment A):

 Joint Submission Information. Trade name of the chemical substance being reported, secondary company name, and complete ma iling address (city, state, zip code, and country (if applicable)).

Secondary respondents would register with CDX and request to s ubmit a joint report by selecting “Joint submission-as secondary res pondent” on the main pa ge of the e-IURweb reporting tool. They would provide the primar y company’s information and the trade product name, supplied to them by the primary respondent , to gain access to the Form U containing information specific to the trade product name. Af ter the secondary responde nt is granted access to the form, it would report on proposed data el ements in Part IV on Form U as follows (see Attachment A):

 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 info rmation 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, state, zip code, and country (if applicable)), and

email address.

 Primary Company Information. The primary company name, site name, and complete mailing address ((city, state, and zip code).

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

(ii) Respondent Activities/Information Collections (ICs)

EPA identified the following ICs in the cu rrently-approved ICR (EPA ICR No. 1884.04) for activities that respondent s would complete when complying with the existing rule:

 Compliance Determination;

 Rule Familiarization;

 Report Preparation and Submission – Partial Reports;

 Report Preparation and Submission - Full Reports; and

 Recordkeeping.

As a result of this proposed rule, EPA woul d include a new IC addressing the initial paperwork activities a company woul d need to complete in order to be able to submit reportsPage 14 of 48

electronically through CDX. EPA also would inco rporate recordkeeping ac tivities into the ICs that address the preparation and submission of partial and full repor ts, 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 manufactured (including imported) at a particular site, based on the chemical’s production volume and the applicability of certain reporting exemptions.

Beginning with reporting cycles subse quent to the 2011 reporting cycle, the proposed rule would modify the method used to determine whether a manufacturer (including importer) is subject to IUR reporting. For example, for a 2015 submission period, reporting would be required if the production volume of a chemical substance met or exceeded the 25,000 lb. threshold in the 2014 prin cipal reporting year for the 2015 submission period, and in any calendar year since the last the last principal reporting year (i.e., since 2010 for the 2011 reporting cycle)

Rule Familiarization Become fam iliar with the full requirement s of the rule, which entails reading the rule, understanding the va rious reporting and administrative requirements, and determining the manner in which reporting requirements will be met for each chemical. CDX Registration

Activities The proposed rule would require el ectronic reporti ng, and therefore would require that all respondent s complete the CDX registration process. As part of registering wi th CDX, each respondent would provide identifying information that woul d 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 respondent prepares a partial or full report.

In order to submit electronically to EPA via CDX, the respondent’s authorized official, who will be si gning and submitting the site’s IUR Form U, must register with CDX and must submit an Electronic Signature Agreement (ESA) and a Ve rification of Company Authorizing Official form. This is the same process required for electronic

submissions for the 2006 IUR.

Once the registration process is co mpleted, the registered individual

would receive a case number and be able to acce ss the e-IURweb reporting software. Prepare and Submit Report, and Maintain

Records- Partial Report Compile the required information, determine the CBI status ofinformation and fulfill appropriate substantiation measures, and use eIURweb to complete and submit only Part s I and II (and Part IV, if a joint submission) of Form U (EPA Form 7740-8) for chemicals specifically listed in the proposed regulation for which there is a partial reportingPage 15 of 48

exemption. Retain all records relate d 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 Part s I, II, and III (and Part IV, if a joint submission) of Form U (EPA Form 7740-8) for all reportable

chemical substances. Retain all record s related to the submission for five years after the submission period.

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

5(a) Agency Activities

The activities routinel y 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 respondent questions and pr ovide any necessary assistance;

 Process submissions for inclusion in IUR database;

 Review requests for confiden tiality in the submissions;

 Maintain the database; and

 Distribute the data.

5(b) Collection Methodology and Management

The next IUR collection will occur in 2011. 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 this pr oposed rule that they manufacture (including import) in quantities that meet or exceed the IUR thresholds. As proposed, the collection would occur every four years.

(i) Collection Methodology

Respondents would be required to submit inform ation 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 respondents and the Agency the opportunity to test an electronic reporting system . Comments from respondents and less ons learned from the collection of paper, CD, and electronic submissions were used to develop the 2011 collection methodology. Some of the changes to this methodology ar e regulatory and are included in the IUR Modifications proposal; others ar e process-oriented or internal to EPA or the respondent.

Potential respondents would be notified of th e need to report in three ways: (1) EPA plans to publish a Federal Regist er notice, (2) email notices wi ll be sent to previous IUR respondents, and (3) articles will be published in the trade press. Reporting materials, including a non-submission version of the e-IURweb repor ting software and a variety of guidancePage 16 of 48

documents (Instruction Manual, Q&As, Case Studi es), will be available on EPA’s IUR website. Respondents also can obtain these materials from the TSCA Hotline. Respondents obtain the submission version of the e-IURweb reporting softwa re as part of the CDX registration process,

as described in section 4 of this document.

As proposed, EPA will receive all IUR subm issions electronically. The CDX registration process, required for all res pondents, would provide a case numb er which the respondent would use to identify its submission and which th e Agency would use to track any additional information or changes related to that submissi on. EPA believes this is an improvement over the 2006 IUR, which resulted in the generation of several identifying nu mbers by either the respondent or EPA.

Information quality and validation begins w ith the e-IURweb reporting tool, which will be programmed to help the respondent provide the information required, in the correct format as required by the IUR rule. Use of e-IURweb will el iminate many of the problems with incorrect chemical identifications experi enced in the past by providing a current listing of the TSCA Inventory chemicals and their associated iden tification numbers. Othe r respondent-generated errors, such as incorrect codes, will also be eliminated due to the use of techniques such as dropdown menus, restrictions on the sp ecific information that can be entered, and error-checking algorithms.

Mandatory IUR reporting via the Internet is the most efficient collection method for respondents and EPA. Respondents 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 re ceipt 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 will be programmed into the data-entry system

to further ensure the quality of the data.

To aid persons subject to this informa tion collection, the Agency’s TSCA and CDX Hotlines are available to answer questions regarding the IUR requirements or submission process. When Hotline staff are unable to answer questions, the respondent is referred to OPPT’s Information Management Division (IMD) or Chem ical Control Division (CCD), as appropriate.

Other Divisions within OPPT or OEI are used as necessary.

(ii) Data Management

This section describes the Agency tasks re quired for efficiently processing submissions under the IUR. The tasks for which the Agency is responsible are presented under four main categories: database systems development, gui dance 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 re viewers to search or e xport into their various analytical modeling systems and databases. Th e IUR database is also available for quickPage 17 of 48

screening and other direct uses. The Agency ma kes 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 collectio ns. 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, stor ing it in a larger Mana ge Toxic Substances (MTS) database. In addition, IUR data ar e tracked via the correspondence tracking system utilized by the Confidential Business Information Tracking System (CBITS)

located within the Confidential Bu siness Information Center (CBIC).

 Guidance Document Development -- The Agency is responsible for developing guidance to assist respondents in complying with IUR requirements. The guidance documents usually are developed by a contractor with oversig ht by Agency personnel.

 Form U Processing -- The Agency is responsible for processing IUR Form U submissions. This includes developing sta ndard operating procedures and documentation for all stages in the IUR document life cycle, document receipt and tracking, data input, quality control, file and database maintena nce, information security, CBI aggregation policy, data dissemination, and staff trai ning. For the 2011 IUR submission period, EPA will develop new processes to receive IUR submissions over the Internet, using CDX.

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

5(c) Small Entity Flexibility

The current IUR regulation pr ovides ample flexibility to sm all entities. This regulation affects only businesses -- governmental jurisdic tions and not-for-profit organizations are not required to take any action. Small manufacturer s (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 recordk eeping requirements. A ma nufacturer (including importer) is considered a small business if (1) th e firm’s total annual sales when combined with those of its parent company (if any) are less than $40 million for the submission period and (2) its total production and/or importation of the ch emical substances, mixture or category, for the reporting period, does not exceed 100,000 pounds (45,000 ki lograms) at an individual site owned and controlled by the firm. The Economic Analysis for the Proposed Inventory Update Reporting Modifications Rule determined that the impact on these co mpanies is, on average, significantly less than one percent of revenues (EPA 2009).

5(d) Collection SchedulePage 18 of 48

The submission period shall be from June 1, 2011 to September 30, 2011. This submission period/schedule follows the re quirements of 40 CFR 710.53 (proposed 40 CFR 711.13).

6. Estimating the Burden and Cost of the Collection

This section presents the burde n and costs estimates incurred by all affected entities as a result of the proposed IUR rule amendments. Th is addendum to the supporting statement covers the years 2011, 2012, and 2013. Therefore, it provides burden and cost estimates for the information collection correspondin g to the 2011 reporting cycle (w hich is the first submission after the proposed amendments to the IUR rule are finalized), and also for the information collection corresponding to the next reporting cy cle, for which respondents will be preparing during 2012 and 2013. Even though reporting occurs only once per reporting cycle (once every five years for the 2011 cycle and, as proposed, every four years in the future), EPA believes that rule compliance and data collection activities, an d thus, costs and burdens , are incurred over the course of the reporting cycle. Therefore, for pur poses of this analysis, the burden and cost for one reporting cycle are averaged over the numbe r of years in the re porting cycle and are presented here as average annual figures. All co sts are presented in ye ar 2008 dollars. The IUR requires reporting on a “per site” basi s rather than a “per company” basis. Therefore, each site is considered a respondent and is likely to subm it one Form U containing one or more chemicalspecific reports. EPA estimates that a total of 4,085 respondents will respond to this information collection in the 2011 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 29,253 full reports and 618 partial reports during the first reporting cycle, and 30,716 full reports and 649 partial report s in future reporting cycles. Each report is for a single chemical/site combination. Each site is expected to submit an average of 7.16 full reports and 0.15 partial reports. The average burd en per respondent, which is one site, is estimated to be 792 hours for the 2011 reporting cycle, or 158 hours annually over a five-year cycle. For future fouryear reporting cycles, the averag e burden per respondent is estim ated to be 615 hours per cycle, or 154 hours annually, over a four-year cycle. Given that this ICR addendum covers a time period that spans both the first and a future re porting cycle, the aver age annual burden over the three year period of 2011 through 2013 is 155 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 2011 reporting cycle, each manufactur ing site (including im porters) must submit

a Form U if the site meets or exceeds the 25,000 lb. threshold for at least one chemical in the 2010 principal reporting year. In future cycl es, this reporting threshold will apply for any calendar year since the last pr incipal reporting year. For purpose s of the ICR, one manufacturing site is equivalent to one res pondent. Form U contains four Part s. 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, which also must be completed by all sites.Page 19 of 48

Together, Part I and Part II are considered a “partia l report.” Part III contains processing and use information. Under the proposed amendments, Part III would be completed for all chemicals unless the chemical is specifically exempted from the requirement to do so. Part IV contains secondary company identification information a nd specific information identifying a chemical substance. Part IV is completed only by a second ary respondent (see Sec tion 2(b)). For purposes of this analysis, burden and costs associated with Part IV are cons idered part of the burden and costs estimates of Part I (respondent identificat ion) and the beginning of Part II (chemical identification), and therefore we re not separately calculated. Together, Parts I, II, and III (and Part IV, when applicable) are considered a “f ull report.” Each report is submitted for a unique chemical/site combination; that is, a site must complete a separate report for each applicable chemical, but Part I of Form U is completed on ly once per site. EPA antic ipates that it will be completed when respondents register with CDX. To comply with the regulation, manufacturers (including importers) must complete the following activities in Table 2. Table 2 also provides a

cross-walk of the related Information Co llection that corresponds to each activity.

Table 2: Cross-Walk between Industry Activiti es and Related Information Collections (ICs)
Activity Description Related IC(s) Compliance

Determination Site staff must determine whether reporting is required for a chemical manufactured (including imported) at a particular site, based on the chemical’s production volume and the applicability of certain reporting exemptions. This involves determining whether the production volume of a

chemical substance met or exceeded the 25,000 lb. threshold in the 2010 principal reporting year for the 2011 submission period. In future reporting cycles, site staff must determine whether the production

volume met or exceeded the threshold in the associated principal reporting cycle and in any calendar year since the last principal reporting year in future reporting cycles. 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 Si gnature Agreement form, which is signed, dated, and notarized; complete a Verification of Company Authorizing Official form, which is signed by an immediate supervisor or witnessing official; and mail both forms 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 chemicals at that site. The information must be reviewed, and submitted to EPA. This task involves any research Prepare and Submit Report, and

Maintain RecordsPartial Report

Prepare and Submit Report, andPage 20 of 48

necessary to identify the correct information to report, the act of completing Form U (technical and clerical burden), and mana gerial review. Once Form U is completed, company staff must submit it electronically to EPA via CDX. 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 RecordsFull Report

Burden estimates were derived originally from a survey conducted by EPA in 1996 (under OMB Control No. 2070-0034) to assess the poten tial 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 current propos al were derived as described in the Economic Analysis for the Proposed Inventory Update Reporting (IUR) Modifications Rule (EPA, 2010b).

Table 3 and Table 4 illustrate the burden fo r a typical respondent on a per-activity basis, including time required to complete each sec tion of Form U. Because IUR reporting for all respondents occurs within a re quired timeframe, which EPA is proposing to change from once every five years to once every four years, the Agency expects only one collection to occur, in 2001, during the three-year period covered by th is ICR addendum. Th erefore, burden hour estimates for 2011 (Table 3) are based on the first reporting cycle burdens in the Economic Analysis for the Proposed Inventory U pdate Reporting (IUR) Modifications Rule (EPA, 2010b). Burden hour estimates for 2012 and 2013 (Table 4) are based on the future reporting cycle burdens as also described in the economic analysis (EPA, 2010b). 4 The section-by-section industry burden estimates for report prepara tion also include the burden of compliance

determination and rule familiarization. EPA estim ates the total industry burden for completing and submitting one partial report to be 57.36 hours, and the estimated burden for completing and submitting one full report, to be 140.38 hours in the firs t reporting cycle. Each site is expected to submit an average of 7.16 full re ports and 0.15 partial reports.

EPA calculated burden estimates for each elem ent of Form U individually using the 1996 survey results, economic analyses for other rules with similar requi rements (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 IUR EA (EPA, 2010b).

3 The economic analysis for the 2005 Amendments assumed a 15 percent reduc tion 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 futu re reporting cycles will be reduced becau se of efficiencies achieved through the establishment of compliance processes; as described in the IUR EA (EPA, 2010b). 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.Page 21 of 48Table 3: Total Industry Burden, by Activity, First Reporting CycleClerical Burden(hours)Technical Burden(hours)ManagerialBurden(hours)Total Burden(hours)Activity(a) (b) (c) (d) = (a)+(b)+(c)PREPARATION OF REPORT (Includes rule familiarization associated with each data element)Part I.Site Identification InformationCertification 0.00 0.85 1.01 1.86Company Information (ParentCompany Name, D&B Number,Mailing Address, Technical Contact, Technical Contact MailingAddress)0.00 0.04 0.02 0.06Plant Site Identification (Site Name, D&B Number, Mailing Address) 0.00 0.06 0.02 0.08Total for Part I 0.00 0.95 1.05 2.00Part II.Manufacturing InformationSite-Limited, Activity, Production Volume (lb.) 0.00 2.28 0.56 2.84Chemical Identification Upfront CBI Substantiation 0.00 1.45 0.77 2.22Plant Site Upfront Substantiation 0.00 0.83 0.51 1.34Total Number of Workers 0.00 1.43 0.59 2.02Maximum Concentration, PhysicalForm, Percent Volume ofProduction0.00 2.79 1.07 3.86Production Volume for Each ofthe Years since Last PrincipalReporting Year0.00 4.10 1.01 5.11Production Volume Used On-Site 0.00 0.20 0.05 0.25Whether Imported Chemical is Physically at Reporting Site 0.00 0.11 0.03 0.14Volume Exported 0.00 1.03 0.25 1.28Whether a Chemical is to be Recycled, Remanufactured,Reprocessed, Reused, or Reworked0.00 0.11 0.03 0.14Total for Part II 0.00 14.34 4.85 19.19Part III. Processing and Use InformationUpfront Substantiation for Processing and Use InformationCBI Claims0.00 0.43 0.26 0.69Industrial Processing andUse Exposure-Related DataDetermination of Applicability 0.00 1.01 0.28 1.29Industrial Function Category 0.00 4.67 2.07 6.73Sector 0.00 0.94 0.40 1.33Page 22 of 48Clerical Burden(hours)Technical Burden(hours)ManagerialBurden(hours)Total Burden(hours)Activity(a) (b) (c) (d) = (a)+(b)+(c)Percent of Production Volume 0.00 10.00 5.27 15.27Total Number of Processing and Use Sites 0.00 9.14 3.52 12.67Total Number of Potentially Exposed Workers 0.00 15.43 3.83 19.26Consumer and Commercial Use Exposure-Related DataDetermination of Applicability 0.00 0.94 0.25 1.19Identification of Production Category/Use by Children 0.00 1.68 0.25 1.92Percent of Production Volume 0.00 1.26 0.45 1.71Maximum Concentration by Category 0.00 1.36 0.34 1.70Number of Commercial Workers Reasonably Likely to beExposed0.00 15.43 3.83 19.26Total for Part III0.00 62.26 20.76 83.02COMPLIANCE DETERMINATIONCompliance Determination0.002.500.002.50RULE FAMILIARIZATIONRule Familiarization0.0019.009.0028.00CDX REGISTRATION ACTIVITIESCDX Registration 0.00 0.73 0.18 0.92CDX Electronic Signature Agreement 0.00 1.00 0.75 1.75Total for CDX Registration Activities 0.001,730.932.67RECORDKEEPINGRecordkeeping0.75 1.50 0.75 3.00TOTAL BURDENBurden for one PartialReport (Parts I, II, Compliance Determination,Rule Familiarization, Recordkeepingand CDX Registration Activities)0.75 38.29 15.65 57.36Burden for one FullReport (Parts I, II, III, Compliance Determination,Rule Familiarization, Recordkeepingand CDX Registration Activities)0.75 100.55 36.41 140.38Note:Totals may not sum due to rounding.Source:Economic Analysis for the Proposed InventoryUpdate Reporting (IUR) Modifications Rule(EPA, 2010b).Page 23 of 48Table 4: Total Industry Burden, by Activity, Future Reporting CyclesClerical Burden(hours)Technical Burden(hours)ManagerialBurden(hours)Total Burden(hours)Activity(a) (b) (c) (d) = (a)+(b)+(c)PREPARATION OF REPORT (Includes rule familiarization associated with each data element)Part I.Site Identification InformationCertification 0.00 0.85 1.01 1.86Company Information (ParentCompany Name,, D&B Number,Mailing Address, Technical Contact, Technical Contact MailingAddress)0.00 0.01 0.00 0.01Plant Site Identification (Site Name, D&B Number, Mailing Address) 0.00 0.01 0.00 0.02Total for Part I 0.00 0.95 1.05 2.00Part II.Manufacturing InformationSite-Limited, Activity, Production Volume (lb.) 0.00 1.82 0.45 2.27Chemical Identification Upfront CBI Substantiation 0.00 1.16 0.61 1.77Plant Site Upfront Substantiation 0.00 0.66 0.41 1.07Total Number of Workers 0.00 1.14 0.47 1.61Maximum Concentration, PhysicalForm, Percent Volume ofProduction0.00 2.23 0.86 3.09Production Volume for Each ofthe Years since Last PrincipalReporting Year0.00 3.28 0.81 4.09Production Volume Used On-Site 0.00 0.16 0.04 0.20Whether Imported Chemical is Physically at Reporting Site 0.00 0.09 0.02 0.11Volume Exported 0.00 0.82 0.20 1.02Whether a Chemical is to be Recycled, Remanufactured,Reprocessed, Reused, or Reworked0.00 0.09 0.02 0.11Total for Part II 0.00 11.47 3.88 15.35Part III. Processing and Use InformationUpfront Substantiation for Processing and Use InformationCBI Claims0.00 0.43 0.21 0.64Industrial Processing andUse Exposure-Related DataDetermination of Applicability 0.00 0.81 0.23 1.03Industrial Function Category 0.00 3.53 1.65 5.18Sector 0.00 0.75 0.32 1.06Page 24 of 48Clerical Burden(hours)Technical Burden(hours)ManagerialBurden(hours)Total Burden(hours)Activity(a) (b) (c) (d) = (a)+(b)+(c)Percent of Production Volume 0.00 8.00 4.22 12.22Total Number of Processing and Use Sites 0.00 7.31 2.82 10.13Total Number of Potentially Exposed Workers 0.00 12.34 3.06 15.41Consumer and Commercial Use Exposure-Related DataDetermination of Applicability 0.00 0.75 0.20 0.95Identification of Production Category/Use by Children 0.00 0.67 0.20 0.87Percent of Production Volume 0.00 1.01 0.36 1.37Maximum Concentration by Category 0.00 1.09 0.28 1.36Number of Commercial Workers Reasonably Likely to beExposed0.00 12.34 3.06 15.41Total for Part III0.00 49.03 16.60 65.63COMPLIANCE DETERMINATIONCompliance Determination0.002.500.002.50RULE FAMILIARIZATIONRule Familiarization0.002.002.004.00CDX REGISTRATION ACTIVITIESCDX Registration 0.00 0.73 0.18 0.92CDX Electronic Signature Agreement 0.00 1.00 0.75 1.75Total for CDX Registration Activities 0.001.730.932.67RECORDKEEPINGRecordkeeping0.75 1.50 0.75 3.00TOTAL BURDENBurden for one PartialReport (Parts I, II, Compliance Determination,Rule Familiarization, Recordkeepingand CDX Registration Activities)0.75 18.34 7.65 29.41Burden for one FullReport (Parts I, II, III, Compliance Determination,Rule Familiarization, Recordkeepingand CDX Registration Activities)0.75 67.37 24.26 95.04Note:Totals may not sum due to rounding.Source:Economic Analysis for the Proposed InventoryUpdate Reporting (IUR) Modifications Rule(EPA, 2010b).Page 25 of 48

6(b) Estimating Cost

EPA multiplied burden estimates by standard wa ge rates for managerial, technical, and clerical levels developed from information pub lished 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. Fo llowing the methodology outlined in (EPA, 2002b), fringe benefits are calculated as a percenta ge of total wages for each category. EPA added 17 percent to the wages in each category to accoun t 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. Tabl e 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$

Wage 1 Fringe

Benefits 1 Fringes as % of Wage Overhead % of Wage 2 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 Employ ee Compensation Supplem entary 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 pe r 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 $3,538 and the cost for completing and submitting one full report is $8,655. More information on the deriva tion of these costs is found in the IUR EA (EPA, 2010b).

Similarly, Table 7 contains the cost per activ ity of completing Form U for one respondent in future reporting cycles. Burden hours pr esented in Table 4 were multiplied by the corresponding loaded wage rage in Table 5. EP A estimates the total cost for completing and submitting one partial report in future reporting cycles is $1,636 and the cost for completing and submitting one full report is $5,684. More informati on on the derivation of these costs is found in the IUR EA (EPA, 2010b).Page 26 of 48Table 6: Total Industry Cost, by Activity, First Reporting CycleClerical Cost(2008$)Technical Cost(2008$)ManagerialCost(2008)Total Cost(2008$)Activity(a) (b) (c) (d) = (a)+(b)+(c)PREPARATION OF REPORT (Includes rule familiarization associated with each data element)Part I.Site Identification InformationCertification $0.00 $50.01 $70.73 $120.74Company Information (ParentCompany Name, D&B Number,Mailing Address, Technical Contact, Technical Contact MailingAddress)$0.00 $2.35 $1.40 $3.75Plant Site Identification (Site Name, D&B Number, Mailing Address) $0.00 $3.53 $1.40 $4.93Total for Part I $0.00 $55.90 $73.53 $129.43Part II.Manufacturing InformationSite-Limited, Activity, Production Volume (lbs) $0.00 $134.15 $32.95 $167.10Chemical Identification Upfront CBI Substantiation $0.00 $85.32 $45.01 $130.33Plant Site Upfront Substantiation $0.00 $48.84 $30.01 $78.84Total Number of Workers $0.00 $84.14 $34.42 $118.56Maximum Concentration, Physical Form, Percent Volume ofProduction$0.00 $164.16 $62.96 $227.12Production Volume for Each ofthe Years since Last PrincipalReporting Year$0.00 $241.48 $59.31 $300.79Production Volume Used On-Site $0.00 $11.71 $2.88 $14.59Whether Imported Chemical is Physically at Reporting Site $0.00 $6.71 $1.65 $8.36Volume Exported $0.00 $60.37 $14.83 $75.20Whether a Chemical is to be Recycled, Remanufactured,Reprocessed, Reused, or Reworked$0.00 $6.71 $1.65 $8.36Total for Part II $0.00 $843.58 $339.98 $1,183.56Part III. Processing and Use InformationUpfront Substantiation for Processing and Use InformationCBI Claims$0.00 $25.12 $18.37 $43.49Industrial Processing andUse Exposure-Related DataDetermination of Applicability $0.00 $59.27 $19.94 $79.21Industrial Function Category $0.00 $274.49 $144.64 $419.13Sector $0.00 $55.01 $27.68 $82.69Page 27 of 48Clerical Cost(2008$)Technical Cost(2008$)ManagerialCost(2008)Total Cost(2008$)Activity(a) (b) (c) (d) = (a)+(b)+(c)Percent of Production Volume $0.00 $588.41 $369.34 $957.75Total Number of Processing and Use Sites $0.00 $537.89 $246.72 $784.62Total Number of Potentially Exposed Workers $0.00 $907.74 $268.15 $1,175.90Consumer and Commercial Use Exposure-Related DataDetermination of Applicability $0.00 $55.01 $17.56 $72.57Identification of Production Category/Use by Children $0.00 $98.73 $17.26 $116.00Percent of Production Volume $0.00 $74.02 $31.55 $105.57Maximum Concentration by Category $0.00 $80.02 $24.11 $104.13Number of Commercial Workers Reasonably Likely to beExposed$0.00 $907.74 $268.15 $1,175.90Total for Part III$0.00 $3,663.47 $1,453.48 $5,116.95COMPLIANCE DETERMINATIONCompliance Determination$0.00$147.10$0.00$147.10RULE FAMILIARIZATIONRule Familiarization$0.00$1,117.95$630.25$1,748.19CDX REGISTRATION ACTIVITIESCDX Registration$0.00$43.15$12.84$55.99CDX Electronic Signature Agreement$0.00$58.84$52.52$111.36Total for CDX Registration Activities $0.00$101.99 $65.36 $167.35RECORDKEEPINGRecordkeeping$21.36 $88.26 $52.52 $162.14TOTAL COSTCost for one PartialReport (Parts I, II, Compliance Determination,Rule Familiarization, Recordkeepingand CDX Registration Activities)$21.36 $2,354.77 $1,161.63 $3,537.76Cost for one FullReport (Parts I, II, III, Compliance Determination,Rule Familiarization, Recordkeepingand CDX Registration Activities)$21.36 $6,018.24 $2,615.11 $8,654.71Note:Totals may not sum due to rounding.Source:Economic Analysis for the Proposed InventoryUpdate Reporting (IUR) Modifications Rule(EPA, 2010b).Page 28 of 48Table 7: Total Industry Cost, by Activity, Future Reporting CyclesClerical Cost(2008$)Technical Cost(2008$)ManagerialCost(2008)Total Cost(2008$)Activity(a) (b) (c) (d) = (a)+(b)+(c)PREPARATION OF REPORT (Includes rule familiarization associated with each data element)Part I.Site Identification InformationCertification $0.00 $50.01 $70.73 $120.74Company Information (ParentCompany Name, D&B Number,Mailing Address, Technical Contact, Technical Contact MailingAddress)$0.00 $0.47 $0.28 $0.75Plant Site Identification (Site Name, D&B Number, Mailing Address) $0.00 $0.71 $0.28 $0.99Total for Part I $0.00 $51.19 $71.29 $122.48Part II.Manufacturing InformationSite-Limited, Activity, Production Volume (lbs) $0.00 $107.32 $31.37 $138.70Chemical Identification Upfront CBI Substantiation $0.00 $68.25 $42.86 $111.11Plant Site Upfront Substantiation $0.00 $39.07 $28.57 $67.64Total Number of Workers $0.00 $67.31 $32.77 $100.08Maximum Concentration, Physical Form, Percent Volume ofProduction$0.00 $131.33 $59.94 $191.27Production Volume for Each ofthe Years since Last PrincipalReporting Year$0.00 $193.18 $56.47 $249.65Production Volume Used On-Site $0.00 $9.37 $2.74 $12.11Whether Imported Chemical is Physically at Reporting Site $0.00 $5.37 $1.57 $6.93Volume Exported $0.00 $48.30 $14.12 $62.41Whether a Chemical is to be Recycled, Remanufactured,Reprocessed, Reused, or Reworked$0.00 $5.37 $1.57 $6.93Total for Part II $0.00 $674.87 $271.98 $946.85Part III. Processing and Use InformationUpfront Substantiation for Processing and Use InformationCBI Claims$0.00 $25.12 $14.70 $39.82Industrial Processing andUse Exposure-Related DataDetermination of Applicability $0.00 $25.12 $15.95 $41.07Industrial Function Category $0.00 $0.00 $115.71 $115.71Sector $0.00 $47.41 $22.14 $69.56Page 29 of 48Clerical Cost(2008$)Technical Cost(2008$)ManagerialCost(2008)Total Cost(2008$)Activity(a) (b) (c) (d) = (a)+(b)+(c)Percent of Production Volume $0.00 $207.82 $295.47 $503.30Total Number of Processing and Use Sites $0.00 $44.01 $197.38 $241.39Total Number of Potentially Exposed Workers $0.00 $470.73 $214.52 $685.25Consumer and Commercial Use Exposure-Related DataDetermination of Applicability $0.00 $47.41 $14.05 $61.46Identification of Production Category/Use by Children $0.00 $207.82 $13.81 $221.63Percent of Production Volume $0.00 $44.01 $25.24 $69.25Maximum Concentration by Category $0.00 $470.73 $19.29 $490.01Number of Commercial Workers Reasonably Likely to beExposed$0.00 $430.32 $214.52 $644.84Total for Part III$0.00 $2,884.62 $1,162.78 $4,047.40COMPLIANCE DETERMINATIONCompliance Determination$0.00$147.10$0.00$147.10RULE FAMILIARIZATIONRule Familiarization$0.00$117.68$140.05$257.73CDX REGISTRATION ACTIVITIESCDX Registration $0.00$43.15$12.84$55.99CDX Electronic Signature Agreement $0.00$58.84$52.52$111.36Total for CDX Registration Activities $0.00 $101.99 $65.36 $167.35RECORDKEEPINGRecordkeeping$21.36 $88.26 $52.52 $162.14TOTAL COSTCost for one PartialReport (Parts I, II, Compliance Determination,Rule Familiarization, Recordkeepingand CDX Registration Activities)$21.36 $1,079.09 $535.84 $1,636.29Cost for one FullReport (Parts I, II, III, Compliance Determination,Rule Familiarization, Recordkeepingand CDX Registration Activities)$21.36 $3,963.71 $1,698.63 $5,683.70Note:Totals may not sum due to rounding.Source:Economic Analysis for the Proposed InventoryUpdate Reporting (IUR) Modifications Rule(EPA, 2010b).Page 30 of 48

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 activit ies that involve using the data are not included.

EPA Staff Activities

Of the tasks listed above, Agency personnel are responsible for 1) qual ity control of data entry; and 2) data processing, systems developm ent, and contract oversight and management. Contractors perform the other ac tivities, as described below.

EPA estimates the total burden of completing Ag ency tasks to be one full-time equivalent at the GS 13 level for data processing, syst ems development, and contract oversight and management, per-reporting cycle. An estimated 0.181 FTEs are needed at the GS 12 level for quality control of data entry. Calculations of the Agency burden are presented in Economic Analysis for the Proposed Inventory U pdate Reporting (IUR) Modifications Rule (EPA, 2010b).

EPA labor costs are based on annual federa l wage rates published by the Office of Personnel Management for the Washington-Balt imore-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 Ag ency staff at the GS-12 Step 3, and GS-13 Step 3 levels.Page 31 of 48

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 contains the burden and cost per report for all EPA staff activities. 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. 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 0.000054 FTE per report and the total cost per-report is approximately $0.81. The burden and cost of pr ocessing each data element in Form U are

derived in the Economic Analysis for the Proposed Inventory Update Reporting (IUR) Modifications Rule (EPA, 2010b). EPA multiplied the burdens by the number of data elements in

each section to estimate the total cost and burde n of processing each Form U. For more detail on the derivation of these burdens, see the IUR EA (EPA, 2010b).

Table 9: EPA Staff Burden and Cost of Processing One Report

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 0.0000009 0.0019 $0.11
Quality Control of Data for Part II 0.0000027 0.0056 $0.33
Quality Control of Data for Part III 0.0000030 0.0063 $0.37

Total GS-12 Burd en, per report 0.0000066 0.0138 $0.81 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 extr amural tasks completed by contractors (this category includes costs to EPA, but not burden h ours). Contractor activit ies include document receipt, tracking, data entry, maintaining bac kup systems, printing and publishing forms and materials, and managing the TSCA hotline, as presented in Table 10. With the exception of document receipt, tracking, and data entry, all cont ractor costs are fixed and are not dependent on the number of reports received. All fixed costs ar e taken from the last published ICR and were

inflated from 2007 to 2008 dollars with an inflati on factor calculated using the Employment Cost Index (ECI), seasonally adjusted, for white-colla r occupations in privat e industry (BLS, 2009).Page 32 of 48

EPA calculated the cost estimate per report for document receipt, tracking, and data entry, $0.63, by starting with the cost estimated in the 2007 ICR, and updating it to reflect the

new data elements and the electronic submissi on requirement in the proposed 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 decreas e in EPA processing burden as a result of using the CDX system. For more information, see the Economic Analysis for the Proposed Inventory Update Reporting (IUR) Modifications Rule (EPA, 2010b).

Table 10: Cost of Contractor Activities

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 $0.29

Total Cost of Document receipt, tracking, and data entry, per full
report $5.14 n/a $0.63

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

6(d) Bottom-Line Industry Bu rden and Cost Estimates

This section describes the estimated total so cial paperwork burden and cost of the IUR rule, including the proposed amendments. The next IUR submission period will occur in 2011 for chemicals manufactured (including impor ted) during the calendar year 2010. Even though reporting occurs only once per re porting cycle (once every five years for the 2011 cycle and, as proposed, once every four years in the future), EPA believes rule compliance and data collection activities, and thus, costs and burdens, are incurred over the c ourse of the reporting cycle. Therefore, for purposes of this analysis, the burd en and cost for one reporting cycle are averaged over the number of years in the re porting cycle and are presented he re as average annual figures. This ICR addendum supporting statement is fo r 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 th e IUR database, which includes data from thePage 33 of 48

most recent (2006) IUR collection. The EPA IUR da tabase contains information collected under the IUR for previous submission periods and was us ed to generate estimates of expected reports for the 2011 reporting cycle. In the 2011 reporting year, EPA expects a total of 4,085 sites to submit 29,253 full reports (98 percent of all reports) and 618 partial report s (two percent of all reports) for a total of 29,871 reports. In futu re reporting cycles, EPA expects 4,289 sites to submit 30,716 full reports and 649 partial reports for a total of 31,365 reports (98 percent and two percent of all re ports, 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 proposed amendments, to be 3.24 million hours. Gi ven that this data collection is part of a five-yea r reporting cycle, EPA estimates the annual industry burden for 2011 to be 647,016 hours. As presented in Table 11, EPA estimates the total cost to industry would be $199 million, or an annual cost of $39.7 million.

Table 11: Estimated Respondent Burden and Cost Associated with the First Reporting Cycle (2011)

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 (hours)

Compliance

Determination (per Site) 2.50 4,085 Sites $147.10 10,213 $600,896 2,043 $120,179

Rule

Familiarization (per Site) 28.00 4,085 Sites $1,748.19 114,380 $7,141,370 22,876 $1,428,274

CDX Registration Activities (per Site) 2.67 4,085 Sites $111.36 10,893 $454,905 2,179 $90,981

Part I Preparation (per site) 2.00 4,085 Sites $129.43 8,170 $528,706 1,634 $105,741

Partial Report Preparation (Part II, per Report) 19.19 618 Partial Reports $1,183.56 11,861 $731,438 2,372 $146,288

Full Report Preparation (Part II and Part III, per Report) 102.21 29,253 Full Reports $6,300.50 2,989,951 $184,308,643 597,990 $36,861,729

Recordkeeping (per Report) 3.00 29,871 Reports $162.14 89,613 $4,843,211 17,923 $968,642

Total Industry Burden and Co st for the First Reporting Cycle 3,235,080 $198,609,168 647,016 $39,721,834Page 34 of 48

Total Industry Burden and Cost for Future Reporting Cycles . EPA estimates the total industry burden for future reporting cycles, in cluding both current ba seline burden and the burden resulting from the proposed amendments, to be 2.64 million hours. Gi ven that this data collection will occur every four years, EPA estimat es the annual industry burden for future years to be 659,742 hours. As presented in Table 12, EPA es timates the total cost to industry would be $162 million, or an annual cost of $40.5 million.

Table 12: Estimated Annual Respondent Burden and Cost Associated with Future Reporting Cycles

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) 15.35 649 Partial Reports $946.85 9,964 $614,503 2,491 $153,626

Full Report Preparation (Part II and Part III, per Report) 80.98 30,716 Full Reports $4,994.25 2,487,494 $153,403,359 621,873 $38,350,840

Recordkeeping (per Report) 3.00 31,365 Reports $162.14 94,095 $5,085,444 23,524 $1,271,361

Total Industry Burden and Cost for Future Reporting Cycles 2,638,966 $162,082,689 659,742 $40,520,672Page 35 of 48

Annual Industry Burden and Cost for 2011 to 2013. As shown in Table 13, EPA

calculated the estimated total a nnual 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, sp ans two reporting cycles with different

burdens and costs. The total a nnual burden associated with th is ICR addendum is 655,500 hours. The total annual cost is $40.3 million.

Table 13: Estimated Annual Average Burden an d Cost Associated with this ICR Addendum

2011 2012 2013 2011-2013 Average

Activity 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) 2,043 $120,179 2,681 $157,726 2,681 $157,726 2,468 $145,210

Rule

Familiarization (per Site) 22,876 $1,428,274 4,289 $276,355 4,289 $276,355 10,485 $660,328

CDX Registration

Activities (per Site) 2,179 $90,981 2,859 $179,438 2,859 $179,438 2,632 $149,952

Part I Preparation (per Site) 1,634 $105,741 2,024 $131,327 2,024 $131,327 1,894 $122,798

Partial Report Preparation (Part II, per Report) 2,372 $146,288 2,491 $153,626 2,491 $153,626 2,451 $151,180

Full Report Preparation (Part II and Part III, per Report) 597,990 $36,861,729 621,873 $38,350,840 621,873 $38,350,840 613,912 $37,854,469

Recordkeeping (per Report) 17,923 $968,642 23,524 $1,271,361 23,524 $1,271,361 21,657 $1,170,455

Total 655,500 $40,254,393Page 36 of 48

Average Burden and Cost per Site. As shown in Table 14, the Agency estimates the typical respondent burden for this information collection activity to be 792 hours in the first reporting cycle and 615 hours in futu re reporting cycles. Given that the 2011 (first) collection is based on a five-year reporting cycle, the average annual burde n for the first reporting cycle

would be 158 hours. Given that a collection would occur once every four years under the proposed rule, the average annual burden for fu ture cycles would be 154 hours. These burden

estimates assume each site will submit an aver age of 7.16 full reports and 0.15 partial reports in both the next, and future, reporting cy cle. This is a decrease of 2.01 partial reports per site and an increase of 2.98 full reports per site compared to the average number of reports completed per site presented in the currently ap proved ICR (EPA ICR No. 1884.04) .

Table 14: Average Burden per Site

Burden Hours

Activity Managerial Technical Clerical Total

Hours

per Activity Reports

per Average

Site Total

Burden (hours

per

average

site) Annual

Burden (hours

per

average

site) First Reporting Cycle

Rule Familiarization. Compliance Determination, CDX Registration Activities and Part I Preparation (per Site) 10.98 24.18 0.00 35.17 1.00 35.17 7.03

Partial Report Preparation (Part II, per Report) 4.85 14.34 0.00 19.19 0.15 2.90 0.58

Full Report Preparation (Part II and Part III, per Report) 25.61 76.60 0.00 102.21 7.16 732 146

Recordkeeping (per Report) 0.75 1.50 0.75 3.00 7.31 21.9 4.39

Total Hours 792 158
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) 3.88 11.47 0.00 15.35 0.15 2.32 0.58

Full Report Preparation (Part II and Part III, per Report) 20.49 60.50 0.00 80.98 7.16 580 145

Recordkeeping (per Report) 0.75 1.50 0.75 3.00 7.31 21.9 5.48

Total Hours 615 154Page 37 of 48

Table 15 presents the average cost per s ite, by activity, for an IUR respondent. EPA estimates the average site will submit 7.16 full repor ts and 0.15 partial reports and incur a total cost of $48,678 during the first reporting cycl e ($9,736 annually), and $37,790 during future reporting cycles ($9,448 annually) for Form U completion and submission.

Table 15: Average Cost per Site

Cost (2008$)

Activity Managerial Technical Clerical Total

Cost

per Activity Reports

per Average

Site Total

Cost (2008$

per

average

site) Annual

Cost (2008$

per

average

site)

First Reporting Cycle

Rule Familiarization. Compliance Determination, CDX Registration Activities and Part I Preparation (per site) $769.13 $1,423 $0.00 $2,192.

06 1.00 $2,192 $438

Partial Report Preparation (Part II, per Report) $339.98 $843.58 $0.00 $1,183.

56 0.15 $179 $35.82

Full Report Preparation (Part II and Part III, per Report) $1,793.45 $4,507 $0.00 $6,300.

50 7.16 $45,122 $9,024

Recordkeeping (per Report) $52.52 $88.26 $21.36 $162.14 7.31 $1,186 $237

Total Cost $48,678 $9,736
Future Reporting Cycles

Rule Familiarization. Compliance Determination, CDX Registration Activities and Part I Preparation (per site) $276.70 $417.96 $0.00 $694.66 $1.00 $695 $174

Partial Report Preparation (Part II, per Report) $271.98 $674.87 $0.00 $946.85 $0.15 $143 $35.82

Full Report Preparation (Part II and Part III, per Report) $1,434.76 $3,559.49 $0.00 $4,994.

25 $7.16 $35,767 $8,942

Recordkeeping (per Report) $52.52 $88.26 $21.36 $162.14 $7.31 $1,186 $296

Total Cost $37,790 $9,448Page 38 of 48

As shown in Table 16, EPA calculated the estim ated burden and cost per site associated with this ICR addendum by taking a weighted averag e of the first and future reporting cycles to reflect that the period cove red by this ICR addendum, 2011 through 2013, spans two reporting cycles with different burdens and costs. The av erage annual burden per site is 155 hours and the average annual cost per site is $9,544.

Table 16: Estimated Annual Burden and Cost p er Site Associated with this ICR Addendum

2011 2012 2013 2011-2013 Average

Activity 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) 7.03 $438 2.76 $174 2.76 $174 4.19 $262

Partial Report Preparation (Part II, per Report) 0.58 $35.82 0.58 $36 0.58 $36 0.58 $36

Full Report Preparation (Part II and Part III, per Report) 146 $9,024 145 $8,942 145 $8,942 145 $8,969

Recordkeeping (per Report) 4.39 $237 5.48 $296 5.48 $296 5.12 $277

Total 155 $9,544

Table 17 presents the 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.Page 39 of 48

Table 17: Information Collection Tally for First and Future Reporting Cycles

Information Collection No. of Respondents No. of Responses / Respondent Responses

Subtotal Burden

Hours

per Response Burden Hours

Subtotal

First Reporting Cycle Compliance Determination 4,085 1 4,085 2.50 10,213
Rule Familiarization 4,085 1 4,085 28.00 114,380 CDX Registration Activities 4,085 1 4,085 4.67 19,063

 CDX Registration 4,085 1 4,085 0.92 3,745

 ESA 4,085 1 4,085 1.75 7,149

 Part I of Form U 4,085 1 4,085 2.00 8,170 Prepare and Submit Report, and Maintain Records – Partial Report 4,085 0.15 618 22.19 13,718

 Part II of Form U 4,085 0.15 618 19.19 11,863

 Recordkeeping 4,085 0.15 618 3.00 1,854 Prepare and Submit Report, and Maintain Records - Full Report 4,085 7.16 29,255 105.21 3,077,924

 Part II and III of Form U 4,085 7.16 29,255 102.21 2,990,159

 Recordkeeping 4,085 7.16 29,255 3.00 87,765 Future Reporting Cycles Compliance Determination 4,289 1 4,289 2.50 10,723
Rule Familiarization 4,289 1 4,289 4.00 17,156 CDX Registration Activities 4,289 1 4,289 4.55 19,535

 CDX Registration 4,289 1 4,289 0.92 3,932

 ESA 4,289 1 4,289 1.75 7,506

 Part I of Form U 4,289 1 4,289 1.89 8,098 Prepare and Submit Report, and Maintain Records – Partial Report 4,289 0.15 649 18.35 11,911

 Part II of Form U 4,289 0.15 649 15.35 9,964

 Recordkeeping 4,289 0.15 649 3.00 1,947 Prepare and Submit Report, and Maintain Records - Full Report 4,289 7.16 30,716 83.98 2,579,642

 Part II and III of Form U 4,289 7.16 30,716 80.98 2,487,494

 Recordkeeping 4,289 7.16 30,716 3.00 92,148 Average for ICR Addendum Period

Compliance Determination 4,221 1 4,221 2.50 10,553

Rule Familiarization 4,221 1 4,221 12.00 49,564 CDX Registration Activities 4,221 1 4,221 4.59 19,378 Prepare and Submit Report,

and Maintain Records – Partial Report 4,221 0.15 639 19.63 12,513

-- Part II of Form U 4, 22 1 0.15 639 16.63 10,597 -- Recordkeeping 4, 22 1 0.15 639 3.00 1,916 Prepare and Submit Report, and Maintain Records - Full Report 4,221 7.16 30,229 91.05 2,745,736

--Part II and III of Form U 4, 22 1 7.16 30,229 88.06 2,655,049 --Recordkeeping 4, 22 1 7.16 30,229 3.00 90,687
Some burden estimate subtotals may not calcula te due to rounding of unit burden estimatesPage 40 of 48

Agency Tally

Table 18 presents the Agency costs associated with the IUR rule for the first reporting cycle. EPA multiplied the costs per report by the to tal number of Parts I, II, and III to calculate

the total burden and cost associated with the nu mber of reports EPA expects to be submitted. The

total burden is 0.172 FTEs and the total cost is $37,396 in the first reporting cycle, for variable

cost activities. The burden and cost of the fixe d 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 1.181 FTEs. Th e estimated total co st incurred by the Agency for the first reporting cycle, $286,580, wa s calculated by summing the Agency staff and

contractor activities.

Table 18: Total Cost and Burden of Agen cy 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

Part I N/A 4,085 Sites $0.09 N/A $360

Part II N/A 29,871 Part

IIs $0.25 N/A $7,550 Document receipt, tracking, and data

entry Contractor

Part III N/A 29,253 Part

IIIs $0.29 N/A $8,402

Part I 0.0000009 4,085 Sites $0.11 0.004 $465

Part II 0.0000027 29,871 Part

IIs $0.32 0.080 $9.759 Quality Control of

Data EPA Employee

(GS-12 Step 3) Part III 0.0000030 29,253 Part

IIIs $0.37 0.089 $10.860

Total Variable Cost and Burden 0.172 $37,396

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 1.000 $249,184 Total Agency Cost and Burden 1.172 $286,580Page 41 of 48

6(e) Reasons for Change in Burden

EPA estimates industry will incur an increase of 223,026 hours in annual burden compared to the estimate in the information collection request most recently approved by OMB (from 432,274 hours currently approved as reported in the currently approved ICR (EPA ICR No. 1884.04) (EPA, 2008a), to 655,500 hours as estimated in Section 6(d) above). This increase is due to both program changes and an adjustme nt in reporting requirementcriteria. Several of the proposed IUR amendments change the number of partial and/or full reports EPA expects to be submitted, based on the specific chemicals th e amendments affect. Details on the proposed amendments and the burden and cost impacts of each amendment when taken individually and considered together (i.e., one proposed amendm ent may change the impact of another), are

described in the Economic Analysis for the Proposed Inventory Update Reporting (IUR) Modifications Rule (EPA, 2010b).

6(f) Burden Statement

The annual public burden for this collection of information is estimated to average 155 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. Fo r this collection it includes the time needed to determine whether a site is subject to the rule (Compliance Determination); review and understand instructions; prepare a nd submit reports (including sear ching data sources); complete

and review the collection of in formation; transmit the inform ation; 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 di splayed either by publication in the Federal Register or by other appropriate means, such as on the related colle ction instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR Part 9.

To comment on the Agency’s need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA ha s 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., M onday 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 Toxi cs Docket is (202) 566-0280.

An electronic version of th is docket is available at http://www.regulations.gov/ . Use the federal government wide electronic docket and comment system at www.regulations.gov to submit or view public comments, access the inde x listing of the docket contents, and to access

those documents in the docket that are availa ble electronically. Once in the system, selectPage 42 of 48

“advance search,” then key in the docket ID number identified above. Also, you can send

comments to the Office of Information and Re gulatory Affairs, Offi ce of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. EPA-HQ- OPPT-2009-0187 and OMB control number 2070- 0162 in any correspondence.

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 Pr evention 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 Modifica tions Final Rule (EPA-HQ OPPT 2004-0106-

0055 ). July 2005

.

EPA, 2006. US EPA, Office of Po llution Prevention and Toxics, Instructions for Reporting for the 2006 Partial Updating of the TS CA 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-HQOPPT-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.Page 43 of 48

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

EPA, 2010b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch . Economic Analysis for the Propos ed Inventory Update Reporting (IUR) Modifications Rule . July 2010.

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.Attachment A - Page 1 of 4 Attachment A: 2011 IUR Form UAttachment A - Page 2 of 4Attachment A - Page 3 of 4Attachment A - Page 4 of 4