- 1

- Supporting Statement for a Request for OMB Review under

the Paperwork Reduction Act

1. IDENTIFICATION OF THE INFORMATION COLLECTION l(a) Title and Number of the Information Collection TITLE: Correction of Misreported Chemical Sub stances on the Toxic

Substances Control Act (TSCA) Chemical Substance Inventory EPA ICR No.: 1741.06 OMB Control No.: 2070
- 0145 l(b) Short Characterization Sec tion 8(b) of the Toxic Substances Control Act (TSCA), requires the Environmental Protecti on Agency

(EPA) to compile and keep current an Inventory of Chemical Substances in Commerce (hereinafter “the Inventory”), which is a listing of chemical substances manufactured, imported and processed for commercial purposes in the United States. Individ ual plant or factory sites producing chemicals submit the required information. This information collection request pertains to the use of the TSCA Chemical Substance Inventory Reporting Form C (EPA Form 7710

- 3C ; see Attachment 4 below), which the chemic al industry use s exclusively in submitting requests to EPA’s Office of Pollution Prevention and Toxics (OPPT) for correcting misreported chemical identities of substances listed on the Inventory . Such requests pertain only to errors discovered in the orig inal submissions to the Inventory when the Inventory

was first established in 1979. Each ye ar, OPPT receives a small number of such correction requests from chemical companies or their legal representatives. In almost all cases, a submitter who wishes t o correct the chemical identity of a substance that was previously misreported for the Inventory initiates these requests for correction . The correction mechanism allows the submitter to add the correct substance to the Inventory without having to file a Premanufacture Notice (PMN) under TSCA section 5. In submitting a request for correction, the submitter provides certain basic information to EPA on Form C. This information is stored in one of EPA’s mainframe computers. T his information allows OPPT to establish a correct chemical identity that accuratel y reflects the substance the submitter manufactures. Since the Inventory performs a regulatory

function by distinguishing between an existing chemical and a new chemical, it is imperative that the Inventory be accurate. A correct Inventory also ensures the accuracy of EPA’s chemical screening and risk assessment activities.- 2

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2. NEED FOR AND USE OF THE COLLECTION 2(a) Need/Authority for the Collection TSCA requires EPA to identify , assess and control risks of injury to human health and the environment posed b y commercial chemicals. TSCA section 8(b) requires EPA to compile and keep current a complete list of chemical substances manufactured or processed in, or imported into, the United States. Under TSCA section 8(a) the Administrator of EPA promulgate s rules to provide for the maintenance and collection of records from manufacturers, importers and processors of commercial chemicals. The Inventory Update Rule (IUR), which EPA uses periodicall y to up date the TSCA section 8(b) Inventory , is codified at 40 CFR 710. Copies of the relevant sections of TSCA and of the Code of Federal Regulations are attached below (see Attachments 1 and 2, respectivel y). The purpose of the Inventory is to define, for th e purpose of TSCA, what chemical substances exist in U.S. commerce. Substances not included on the Inventory are considered to be new substances that are subject to the Premanufacture Notification (PMN) requirements stipulated under section 5(a) of TSCA. The need for correcting chemical identities listed on the Inventory arose following the initial Inventory

reporting period, when both EPA and the chemical industry recognized that substances submitted for inclusion in the initial Inventory could be, for various reasons, incorrectly

described b y reporting companies. EPA determined that reported substances may have been unintentionally misidentified as a result of simple ty pographical errors, the misidentification of substances, or the lack of sufficient t echnical or anal yt ical capabilities fully to characterize the exact chemical substances. Although not required to do so under TSCA, EPA developed guidelines, at the request of industry , under which industry could correct the chemical identities of incorre ctly

described substances listed in the Inventory

. EPA published these guidelines in the Federal Register on July 29, 1980 (45 FR 50544); see Attachment 3. For the Inventory

to perform its regulatory function, it must accuratel y identify those substance s that exist in U.S. commerce. Otherwise the Inventory will not be able to provide reliable information that EPA needs in performing chemical screening and risk assessment activities under TSCA. The submitter, on the other hand, must be certain that the substance he/she manufactures or imports is correctl y identified on the Inventory, so that he/she will be in full compliance with TSCA reporting requirements. The correction mechanism ensures the accuracy of the Inventory

without imposing an unreasonable burden on the chemical industry

. Without the Inventory

correction mechanism, a submitter would have to file a PMN to place the correct chemical substance on the Inventory whenever finding that the previously reported substance wa s misidentified. This wou ld impose a much greater burden on both EPA and the submitter than the existing correction mechanism.- 3

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2(b) Practical Utility/Users of the Data OPPT will use the data contained in the correction request to alter the incorrect chemical identities in the Inventory so that the information is complete and accurate. Many branches of the Agency

rel y on the Inventory when making regulatory decisions. Within OPPT, the Chemical Control Division (CCD) and the Interagency Testing Committee (ITC) frequentl y use th e Inventory . Both CCD and the ITC rely on the accuracy

of the Inventory

for screening chemical substances for further attention or testing. If the Inventory data were inaccurate, CCD or the ITC could inadvertently screen a fictitious chemical, i.e., a mi sreported substance not yet corrected on the Inventory

. As well as providing vital government service, the Inventory provides information necessary to members of industry . Correspondence between the private and public sectors of the U.S. concerning the Inventory is ceaseless. OPPT receives hundreds of inquiries regarding the Inventory each ye ar. These letters are primarily requests for Chemical Abstracts Service (CAS) Registry Numbers or Accession Numbers assigned to a substance, although the Agency al so receives a variety of other requests regarding TSCA. One such request expresses a bona fide intent to manufacture a chemical substance. A “bona fide” letter requests a formal search of the Inventory for a particular chemical substance. If the substance is included on the Inventory , the potential manufacturer need not submit a PMN. Since failure to submit a PMN for a substance not included on the Inventory, i.e., a new chemical, would constitute a violation of TSCA, the Inventory must be correct to e nsure that only substances that are actually manufactured are included. An Inventory correction letter requests a change in the Inventory to correct a previously

misreported substance. This correction mechanism allows the Inventory to be kept accurately , thus ensuring that the Agency ’s responses to industry

inquiries, e.g., bona fide, Accession Number and CAS Registry Number requests, are accurate. Furthermore, an accurate Inventory also ensures that the Agency performs risk assessments on the correct ch emical substance and that industry will not need to submit unnecessary

PMNs.

3. NON
- DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3(a) Non
- Duplication Not applicable: the required data can onl y be provided by the submitter and no other go vernment agency

collects such information. 3(b) Public Notice Required Prior to ICR Submission to OMB Prior to submission to OMB, this I CR will be made available to the public for comment through a Federal Register notice. The public will have 60 day s to provide comments. Any- 4

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comments received will be given consideration when completing the supporting statement that is submitted to OMB. 3(c) Consultations Under 5 CFR 1320.8(d)(1) OMB requires agencies to consult with potenti al I CR respondents and data users about specific aspects of I CRs before submitting an original or renewal I CR to OMB for review and approval. In accordance with this regulation, EPA will pursue additional consultations with interested parties during the d evelopment of the renewal of this collection. 3(d) Effects of Less Frequent Collection Not applicable, since the frequency of correction depends wholl y on industry. 3(e) General Guidelines To the best of EPA’s knowledge, this collection does not exce ed an y of the Paperwork Reduction Act guidelines at 5 CFR 1320.6. 3(f) Confidentiality Respondents may

claim information submitted to EPA on the correction form as confidential if release of such information would reveal the submitter’s trade secrets or proprietary

information, as defined b y TSCA section 14. A r espondent may claim as confidential any

information submitted on th e reporting form, except the identity of a chemical substance that the respondent has not claimed as confidential in the existing Inventory data base. Respondents must assert c laims of confidentiality at the time they submit the information to EPA and only in the manner specified by EPA. EPA has established procedures for handling, storing, processing, and disposing of TSCA conf idential business information (CBI), in accordance with stipulations set forth at 40 CFR Part 2, subpart B. In general, EPA houses confidential information in secured areas and onl y persons specificall y authorized by EPA may access such information

. EPA further restricts a ccess to computer s ys tems containing TSCA CBI to those who have a need for access

. S uch sy stems m ay be accessed onl y via special computer terminals in restricted area s . Furthermore, the procedures set forth in 40 CFR Part 2, subpart B, strictly govern an y transfer of TSCA CBI from EPA to another agency , and the Agency receiving such information must agree to compl y full y with EPA procedures. Furthermore, this information collection fully complies with the requirements of the Privacy A ct of 1974 and OMB Circular A

- 108.- 5

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3(g) Sensitive Questions Not applicable; this information collection does not include questions of a sensitive nature.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4(a) Respondents/NAICS Codes The respondent community consists of persons manufacturing or importing chemicals listed on the Inventory

and regulated under TSCA section 8. In general, the industry segments that compose the respondent community for this information collection are those that produce or import organic chemicals, who have already reported to the initial Inventory effort, and who need to make a correction to that submission. Using North American Industry Classification Sy stem (NAI CS) codes, these persons are t ypically classified under C hemical Manufacturing (NAICS 325) and Petroleum and Coal Product Manufacturing (NAI CS 324). 4(b) Information Requested (i) Data Items The correction request form requires the submitter to include information concerning the chemical substance ’s ident ity , plant site, production volume, site limitations, and import/export of the substance, if applicable.

(ii) Respondent Activities Most of the information contained on the Form C reporting form is readily accessible to the submitter as “customary bu siness practices,” such as production and site

- limitation data. The remaining information is equally apparent, e.g., plant site location and whether the submitter imports or manufactures. With regard to the chemical substance identity requirement, such data should be predetermined before the time of an Inventory correction submission. Since industry almost exclusively

initiates corrections to the Inventory , the submitter presumabl y has already determined the new chemical substance identity before he/she is able to conclude that the substance was previousl y misidentified. Therefore, the information required to submit a correction request is readily available to the submitter, who needs onl y to transpose the data to the form the Agency provide s . Further more, if, for whatever reason, the submitter is unable to produce a suitable technical name for the corrected substance, he/she need onl y provide the Agency with information concerning the reaction mechanism, including all reactants. In such a case, EPA w ill devise an appropriate name for the chemical substance.- 6

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It is significant to note that in almost all cases it is industry , not EPA, that initiates correction requests. The Agency does not require industry to provide correction information nor does EP A have an obligation to provide a correction mechanism or to specify a reporting format. Th e correction mechanism exists at the request of industry and the EPA form is used because it reduces the burden on both the Agency and industry

by providing a clear format for the data. Because the Form C has been in use since the initial Inventory reporting period, submitters ar e generall y familiar with the format and with the information needed to complete the form. Furthermore, use of the form guards against del ay s due to incomplete submissions, as the form clearl y outlines the required information.

5. THE INFORMATION COLLECTED
-- AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5(a) Agency Activities As a result of the correction mechanism, the Agency must review the original submissions to determine whether a correction is needed. Once EPA confirms the validity of the correction, the Agency

will process the correction information. EPA will maintain the confidentiality

of the informat ion at the request of the submitter, and will forward the results to the Chemical Abstracts Service (CAS) where the data are stored. EPA will add the corrected chemical substance to the Inventory while the incorrectl y reported substance will become a cand idate for deletion from the Inventory , if no other person has reported the same substance, through notice and comment rulemaking. 5(b) Collection Methodology and Management EPA sends a ll of the submitted information, after processing, to an EPA contrac tor, Chemical Abstracts Service (CAS), whereupon the contractor enter s the information to a computerized sy stem. The public is able to access non

- confidential data through commercial on

line sy stems, or o n compact discs (CD s ) available from the National T echnical Information Service (NT IS ). 5(c) Small Entity Flexibility No small entity

exemption exists. A small entity exemption would be meaningless or counterproductive to the interests of small entities who may wish to submit corrections. In addition , the amount of information required to complete a correction request is minimal. Furthermore, the correction cannot be processed without each piece of information requested, as only essential data are solicited. Any small entity simplification of the co rrection process would fail to provide the Agency with the pertinent information needed to make a correction.- 7

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5(d) Collection Schedule Not applicable since industry , not EPA, initiates corrections as necessary

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6. ESTIMATING THE BURDEN AND COST OF T HE COLLECTION 6(a) Estimating Respondent Burden This I CR addresses an information collection effort that has been undertaken in the same m anner since 1980. As time goes by , the need for correcting the initial Inventory entries diminishes as most of the corrections needed presumably would have been discovered and made by now, after 30 ye ars and several Inventory Update Rule (IUR) reporting cycles. At this time EPA estimates the number of respondents to be no more than nine per year, based on recent experience. It is anticipated that these respondents will incur a minimal reporting burden in providing information to the Agency , estimated at 2.0 hours per report, and a recordkeeping burden estimated at 0.25 hours per report , for a total estimated burden of 2.25 hours per report

. Worksheet 1, below, illustrates the estimated burden per respondent for responding to this information collection. 6(b) Estimating Respondent Cost Worksheet 1 illustrates the estimated costs per respondent for responding t o this information collection. This information is derived from information provided by submitters, individuals involved in the processing of the forms received, and previous experience. Respondent hourly

costs in this I CR have been updated using the d ata sources that have been used for this purpose in the past. The underlying data come from the Bureau of Labor Statistics’ Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006

– December 2008 , US Bureau of Labor Statistics, March 12, 2009. These hourl y cost estimates include wages, fringe benefits, and overhead. The wage and fringe benefit numbers are from the BLS data, and the overhead allowance is calculated at 17% of the hourl y wage. Category Hourly wage Fringe benefits Overhead Total hourly cost Managerial $43.22 $19.46 $7.35 $70.03 Technical $35.29 $17.55 $6.00 $58.84 Clerical $17.22 $8.33 $2.93 $28.48- 8

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WORKSHEET 1: ANNUAL RESPONDENT BURDEN/COST ESTIMATES Burden Hours and Costs per Respondent b y Employee Category Managerial @ $ 70.03 Technical

@ $ 58.84 Clerical

@$ 28.48 Total

Hours Total Costs Create and gather information 1.50 1.50 $ 88.26 Review and report information 0.50 0.50 $ 35.02 Recordkeeping 0.25 0.25 $ 7

. 12 Subtotal 0.50 1.50 0.25 2.25 $ 130.40 6(c) Estimating Agency Burden and Cost Costs associated with this collection include the printing and distributing of reporting forms, providing reporting assistance, reviewing and processing of the report forms and entry of data into the Inventory

databases. The time to review a correction request by an EPA employee is estimated from experience at two hours. Hourl y costs for technical support personnel are based upon the salary

for a GS

- 12, step 1 employee of $3 5.03

. The hourly rates were taken from the U.S. Office of Personnel Management’s 2009 General Schedule for workers with the Washington , D

. C

. locality pay ment. These hourl y estimates were then multiplied by 1.6 to account for benefits (EPA Instructions for Preparing Information Collection Requests, 1 992). Thus th e hourly

cost estimate adju sted for benefits is $56.05 for technical workers

. Assuming the receipt of nine reports , the cost for EPA review is $ 504

. 4 5 . Processing of the forms and entry of the dat a into EPA computer sy stems is estimated at $271.50 per form (based on contractor’s fee and estimate of 0.5 hours non

- exempt time and 1.5 hours of exempt time), for a total of $2, 443

. 5 0. The total Agency cost would be $ 2,947

. 95 . The total Agency burden i n reviewing and processing the forms, based on two hours of review and two hours of processing time, would be 36 hours. 6(d) Bottom Line Burden Hours and Cost (i) Respondent Burden The simple collection (see Worksheet 1) Burden: 2. 25 hours /report x 9 repo rts = 20 hours Costs: $ 130.40 /report x 9 repo rts = $1, 173

. 60 (ii) Agency

Burden The total Agency

burden is estimated to be 36 hours. The total Agency

cost is estimated to be $ 2,947.95- 9

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(iii) The complex collection

- Not applicable. (iv ) Variations in the annual bottom line

- Not applicable. 6(e) Reasons for Change in Burden This request reflects no net change in the total estimated respondent burden from that currentl y in the OMB inventory. 6(f) Burden Statement The annual public burden for this collection of information, which is approved under OMB Control No. 2070

- 0145, is estimated to b e 2. 25 hour per response. According to the Paperwork Reduction Act, “burden” means the total time, effort, or financial resources expended by p ersons to generate, maintain, retain, or disclose or provide information to or for a Federal agency . For this collection it includes the time needed to review instructions; develop, acquire, install, and utilize technology and s ys tems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing way s to compl y with any previously

applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a col lection of information unless it displays a currentl y 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 Reg ister, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable. To comment on the Agency ’s need for this information, the accuracy of the provided burden estimates, and any suggested meth ods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this I CR under Docket ID No. EPA

- HQ

- OPPT

- 20 1 0

- 0 497 . The docket is available for public viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC). The EPA/DC Public Reading Room is located in the EPA West Building, Room 3334, 1301 Constitution Ave., N

. W., Washington, D

. C. The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday , excluding legal holiday s. The telephone number for the EPA/DC Public Reading Room is (202) 566

- 1744, and the telephone number for the Pollution Prevention and Toxics Docket is (202) 566

- 0280. An electronic version of the public docket is available through the Federal Docket Management S ys tem (FDMS) at www.regulations.gov . Use FDMS to submit or view public comments, access the index listing of the contents of the public docket, and to access th ose documents in the public docket that are available electronically . Once in the sy stem, select “search,” then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Manag ement and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. EPA

- HQ

- OPPT

- 20 1 0

- 0 497 and OMB control number 2070

- 0145 in any

correspondence.