Document ID: EPA-HQ-OPPT-2010-0497-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-08-06T04:00Z

SEQ CHAPTER \h \r 1 Supporting Statement for a Request for OMB Review
under

the Paperwork Reduction Act

IDENTIFICATION OF THE INFORMATION COLLECTION

	l(a)  	Title and Number of the Information Collection

	TITLE:	Correction of Misreported Chemical Substances on the Toxic
Substances Control Act (TSCA) Chemical Substance Inventory

	EPA ICR No.:  1741.06	OMB Control No.:  2070-0145

	l(b)	Short Characterization

	Section 8(b) of the Toxic Substances Control Act (TSCA), requires the
Environmental Protection 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. 
Individual 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 chemical industry uses 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 original submissions to the Inventory when the
Inventory was first established in 1979.

	Each year, OPPT receives a small number of such correction requests
from chemical companies or their legal representatives.  In almost all
cases, a submitter who wishes to 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.  This information allows OPPT to
establish a correct chemical identity that accurately 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.	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 by 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
promulgates 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 periodically
to update 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, respectively).

	The purpose of the Inventory is to define, for the 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 by reporting companies.  EPA determined that
reported substances may have been unintentionally misidentified as a
result of simple typographical errors, the misidentification of
substances, or the lack of sufficient technical or analytical
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 incorrectly 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
accurately identify those substances 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 correctly
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 was misidentified.  This would impose a much greater burden on
both EPA and the submitter than the existing correction mechanism.

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 rely on the
Inventory when making regulatory decisions.  Within OPPT, the Chemical
Control Division (CCD) and the Interagency Testing Committee (ITC)
frequently use the 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 misreported
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 year.  These letters are primarily requests for Chemical Abstracts
Service (CAS) Registry Numbers or Accession Numbers assigned to a
substance, although the Agency also 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 ensure 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 chemical
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 only be provided by the submitter
and no other government agency collects such information.

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

	Prior to submission to OMB, this ICR will be made available to the
public for comment through a Federal Register notice.  The public will
have 60 days to provide comments.  Any comments received will be given
consideration when completing the supporting statement that is submitted
to OMB.

	3(c)	Consultations

	  SEQ CHAPTER \h \r 1  Under 5 CFR 1320.8(d)(1) OMB requires agencies
to consult with potential ICR respondents and data users about specific
aspects of ICRs before submitting an original or renewal ICR to OMB for
review and approval.  In accordance with this regulation, EPA will
pursue additional consultations with interested parties during the
development of the renewal of this collection.

3(d)	Effects of Less Frequent Collection

	Not applicable, since the frequency of correction depends wholly on
industry.

3(e)	General Guidelines

	To the best of EPA’s knowledge, this collection does not exceed any
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 by
TSCA section 14.  A respondent may claim as confidential any information
submitted on the 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 claims 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 confidential 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 only persons
specifically authorized by EPA may access such information.  EPA further
restricts access to computer systems containing TSCA CBI to those who
have a need for access.  Such systems may be accessed only via special
computer terminals in restricted areas.  Furthermore, the procedures set
forth in 40 CFR Part 2, subpart B, strictly govern any transfer of TSCA
CBI from EPA to another agency, and the Agency receiving such
information must agree to comply fully with EPA procedures.

	Furthermore, this information collection fully complies with the
requirements of the Privacy Act of 1974 and OMB Circular A-108.

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 System (NAICS) codes, these persons are
typically classified under Chemical Manufacturing (NAICS 325) and
Petroleum and Coal Product Manufacturing (NAICS 324).

4(b)	Information Requested

		(i) 	Data Items

	The correction request form requires the submitter to include
information concerning the chemical substance’s identity, 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 business
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 presumably has already determined the new
chemical substance identity before he/she is able to conclude that the
substance was previously misidentified.  Therefore, the information
required to submit a correction request is readily available to the
submitter, who needs only to transpose the data to the form the Agency
provides.

	Furthermore, if, for whatever reason, the submitter is unable to
produce a suitable technical name for the corrected substance, he/she
need only provide the Agency with information concerning the reaction
mechanism, including all reactants.  In such a case, EPA will devise an
appropriate name for the chemical substance.

	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 EPA have an
obligation to provide a correction mechanism or to specify a reporting
format.  The 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 are generally familiar with the format and with the
information needed to complete the form.  Furthermore, use of the form
guards against delays due to incomplete submissions, as the form clearly
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
information 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 incorrectly reported substance will become a candidate 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 all of the submitted information, after processing, to an EPA
contractor, Chemical Abstracts Service (CAS), whereupon the contractor
enters the information to a computerized system.  The public is able to
access non-confidential data through commercial on-line systems, or on
compact discs (CDs) available from the National Technical Information
Service (NTIS).

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 correction process would fail to provide the
Agency with the pertinent information needed to make a correction.

5(d) 	Collection Schedule

	Not applicable since industry, not EPA, initiates corrections as
necessary.

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	6(a) 	Estimating Respondent Burden

	This ICR addresses an information collection effort that has been
undertaken in the same manner 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 years 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 to 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 ICR have been updated using the data
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 hourly 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 hourly 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

WORKSHEET 1: ANNUAL RESPONDENT BURDEN/COST ESTIMATES

Burden Hours and Costs per Respondent by Employee Category  SEQ CHAPTER
\h \r 1 

	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.  Hourly costs for
technical support personnel are based upon the salary for a GS-12, step
1 employee of $35.03. 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 payment.  These hourly estimates were then
multiplied by 1.6 to account for benefits (EPA Instructions for
Preparing Information Collection Requests, 1992).  Thus the hourly cost
estimate adjusted for benefits is $56.05 for technical workers. Assuming
the receipt of nine reports, the cost for EPA review is $504.45. 
Processing of the forms and entry of the data into EPA computer systems
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 $2,443.50.  The total Agency cost would be $2,947.95.  The
total Agency burden in 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 reports = 20 hours

		Costs:  $130.40/report x 9 reports = $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

	(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 currently 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 be 2.25 hour
per response.  According to the Paperwork Reduction Act, “burden”
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, or disclose or provide information to or
for a Federal agency.  For this collection it includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply
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
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, are listed in 40
CFR part 9 and included on the related collection instrument or form, if
applicable.

	  SEQ CHAPTER \h \r 1 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 has established a public docket for
this ICR under Docket ID No. EPA-HQ-OPPT-2010-0497.  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
holidays.  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 System
(FDMS) at     HYPERLINK "http://www.regulations.gov" 
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 those documents in the public docket that are available
electronically.  Once in the system, 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 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-2010-0497 and OMB control number 2070-0145 in any
correspondence.

 PAGE   

 PAGE   - 1 -