Icr-1780.04

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:

Voluntary Cover Sheet for TSCA Submissions

EPA ICR No.: 1780.04
1(b)

OMB Control No.: 2070-0156

Short Characterization

This Information Collection Request (ICR) pertains to the voluntary use of a cover sheet
that has been developed by industry and EPA to facilitate the processing of information that is
submitted to the Agency under sections 4 and 8 of the Toxic Substances Control Act (TSCA), or
under the Voluntary Children’s Chemical Evaluation Program (VCCEP). The cost and burdens
related to the submissions under TSCA sections 4 and 8 and VCCEP have already been approved
by the Office of Management and Budget (OMB) and are contained in the following ICRs:
(1)
(2)
(3)

(4)

TSCA section 4 submissions are addressed in “Section 4 Test Rules and Consent
Orders,” OMB Control No. 2070-0033, EPA ICR No. 1139.
TSCA section 8(d) submissions are addressed in “TSCA Section 8(d) Health and
Safety Data Reporting Rule,” OMB Control No. 2070-0004, EPA ICR No. 0575.
TSCA section 8(e) reporting requirements are addressed in “Notification of
Substantial Risk of Injury to Health and the Environment under TSCA Section
8(e),” OMB Control No. 2070-0046, EPA ICR No. 0794.
Certain voluntary reporting requirements are addressed in “Voluntary Children’s
Chemical Evaluation Program (VCCEP),” OMB Control No. 2070-0165, EPA
ICR No. 2055.

Under TSCA sections 4 and 8, industry is required to submit certain information and
studies for existing chemical substances. VCCEP is a voluntary reporting program. EPA
typically receives several thousand submissions each year, with each submission consisting of
three studies, on average. In addition, EPA may impose specific data call-ins on industry.
This ICR only applies to the burden and costs associated with the use of the voluntary
cover sheet for those submissions. The submissions EPA receives under these programs can be
numerous, lengthy and complex. For example, EPA received 10,000 submissions in FY 1992 in
response to the TSCA Section 8(e) Compliance Audit Program. Processing of these submissions
was not completed until FY 1995. In June 1994, EPA received 900 submissions, representing
approximately 3,500 studies, under a TSCA section 8(d) data call-in for siloxanes by the
Interagency Testing Committee (ITC).
Submissions/studies are received, logged, internally tracked, duplicated, distributed to
government scientists for review and analysis, indexed, microfiched and made publicly available

through the TSCA Test Submissions (TSCATS) database. However, TSCATS is only an online
index of, and pointer system to, the large volume of unpublished studies; the full texts are
available only in paper or on microfiche.
Under the auspices and funding of the Silicone Environmental Health and Safety Council
(SEHSC), industry, EPA, and the ITC developed a model software application for submitting
summary data for the section 8(d) siloxane data call-in. This model was designed around the
TSCATS data structure but expanded to include additional data elements deemed valuable by
industry. The objective was to capture comprehensively all submissions and studies from the ten
SEHSC member companies for EPA=s more efficient and effective receipt, tracking, processing,
identification, internal and external search and retrieval, and upload to TSCATS for public
availability. In addition, discussions were initiated and are ongoing for the electronic transfer by
electronic medium or EDI of full submissions.
OPPT initiated a voluntary pilot program to accept certain Health and Safety Data
submissions in an electronic format. Participating companies submit TSCA Health and Safety
Study Cover Sheet(s) with attached electronic copies of the studies over the Internet. The
studies are submitted in Portable Document Format (PDF) and digitally signed using the Public
Key Infrastructure (PKI) standard. Allowing industry to submit TSCA Health and Safety
Studies over the Web will reduce burden on Industry as well as the Agency by incorporating
standardization and indexing of data, on-line help and automatic processing. This will also assist
EPA in meeting goals established in the Paperwork Reduction Act (PRA) and the Government
Paperwork Elimination Act (GPEA).
As a follow-up to the experience with the TSCA section 8(d) siloxane data call-in, the
Chemical Manufacturers Association (CMA, now known as the American Chemical Council
[ACC] and so referred to in the rest of this document), the Specialty Organics Chemical
Manufacturers Association (SOCMA), and the Chemical Industry Data Exchange (CIDX), are
actively and cooperatively pursuing summary data transfer by software application and EDI. In
particular, ACC led the effort to develop the standardized cover sheet for voluntary use by
industry as a first step to an electronic future and to begin familiarizing companies with standard
requirements and concepts of electronic commerce. This form, entitled “TSCA Health and
Safety Study Cover Sheet,” was designed by ACC for voluntary use as a cover sheet for
submissions of information under TSCA sections 4, 8(d) and 8(e), and now under VCCEP as
well.
The voluntary use of a cover sheet facilitates the submission of information by displaying
certain basic data elements, permitting EPA more easily to identify, log, track, distribute, review
and index submissions, and makes information publicly available more rapidly and at reduced
cost via TSCATS, to the mutual benefit of both industry and EPA. It is this form/cover sheet
that is addressed in this information collection request.

The specific reporting form used by this information collection is known as the TSCA
Health & Safety Study Cover Sheet (EPA Form No. 7710-58), a copy of which, along with its

associated instructions, appears below as Attachment 1.

2.

NEED FOR AND USE OF THE COLLECTION

2(a)

Need/Authority for the Collection

The standardized cover sheet discussed in this ICR is used in conjunction with submissions of
information as required under TSCA sections 4, 8(d), 8(e) and VCCEP. The need and authority for these
reporting requirements are discussed in detail in the information collection requests associated with these
requirements and are not themselves relevant to the discussion of the use of the standardized cover sheet form
that follows.
ACC and member companies actively utilize electronic commerce in their daily business operations.
They recognize the future importance of electronic commerce for all their operations. This TSCA Cover Sheet
is a first step in standardizing data and terms to promote the acceptance and implementation of electronic TSCA
submissions to and communications with the Agency. ACC has determined that this TSCA Cover Sheet, as a
paper and near term electronic version, will achieve efficiencies through industry-industry and industry-EPA
cooperation, will engender more efficient systems, and will result in significant money and time savings.
2(b)

Use/Users of the Data

EPA staff members in the Office of Pollution Prevention and Toxics (OPPT) are the primary users of the
data found on the standardized cover sheet. OPPT employees use the information displayed on the cover sheet
to identify the submission when it reaches EPA without having to examine portions of a submission that may be
very lengthy and complex. OPPT staff members subsequently use information from the cover sheet to
distribute, locate and track the submission as the submission moves through Agency reviews and decision
points, to index the data, and to identify the data within the TSCATS database in making the data publicly
available.
OPPT and ACC expect that the use of the TSCA Cover Sheet by industry will provide EPA the
following benefits: expedited processing; reduced errors; improved data quality; more timely EPA access and
scientific review; improved communication between EPA and industry submitters; quicker public availability;
and overall time and money savings.
In addition, ACC and OPPT expect that the use of the TSCA Cover Sheet by industry will provide
industry the following benefits: improved internal company storage; more efficient preparation and submission;
standardized keywords; improved data quality; quicker decisions; improved understanding of EPA=s needs;
quicker access through TSCATS to relevant studies by industry toxicologists; and significant potential cost
savings from non-initiation/non-duplication of studies through rapid TSCATS availability.

3. NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA
3(a)

Non-Duplication

The use of the Voluntary TSCA Cover Sheet is not a separate collection activity; rather it simply offers
a cover form that may be used in conjunction with other submissions. These submissions still occur only once.
As such, there is no duplicative collection.
3(b)

Public Notice Required Prior to ICR Submission to OMB

In proposing to renew this ICR, EPA provided a 60-day public notice and comment period that ended on
October 17, 2006 (71 FR 47805, August 18, 2006). EPA received no comments during the comment period.
3(c)

Consultations

This effort developed from the cooperative effort among the Silicone Environmental Health and Safety
Council (SEHSC), the Interagency Testing Committee (ITC), and EPA for the SEHSC-developed data base
effort in response to the 30th ITC list/TSCA section 8(d) reporting. Out of this effort, ACC and SOCMA
initiated subsequent discussions with EPA for their design and pilot of the Voluntary TSCA Cover Sheet. ACC
and SOCMA are committed to encouraging member companies to use the cover sheet when submitting TSCA
studies under sections 4, 8(d), 8(e) and VCCEP to EPA.
Additionally, 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 ICR to OMB for review and
approval. EPA submitted questions to nine parties via email. The individuals contacted were:
Mr. Steven Russell
American Chemistry Council
steven_russell@americanchemistry.com
703-741-5178
Mr. James Cooper
Synthetic Organic Chemical Manufacturers Association (SOCMA)
cooperj@socma.com
202-721-4158
Dr. Susan Hearn
Dow Chemical Co.
shearn@dow.com
989-636-9192
Ms. Jessine Monaghan
GE Plastics
jessine.monaghan@ge.com
202-637-4003
Mr. Howard Feldman
American Petroleum

feldman@api.org
202-682-8344
Dr. Richard Denison
Environmental Defense
rdenison@environmentaldefense.org
202-387-3500
Mr. Thomas Neltner
National Center for Healthy Housing
tneltner@centerforhealthyhousing.org
410-992-0712
Ms. Janet McCabe
Improving Kids Environment
mccabe@ikecoalition.org
317-902-3610
Mr. Harry Gregori
Environmental Solutions, Inc.
harry.gregori@envirsol.com
804-740-5605
EPA received no responses to its solicitation for consultations. A copy of EPA’s consultation email to
the above nine potential respondents is included below as Attachment 2.
3(d)

Effects of Less Frequent Collection

Since the use of this cover sheet is strictly voluntary on the part of respondents, this is not applicable.
3(e)

General Guidelines

The use of this cover sheet does not exceed any of the PRA guidelines at 5 CFR 1320.6.
3(f)

Confidentiality

Any information included on the cover sheet may be claimed as confidential by the respondent. Claims
of confidentiality are handled according to EPA procedures described in 40 CFR Part 2 and in the TSCA
Confidential Business Information Security Manual, which call for careful protection of confidential, trade
secret or proprietary information.
3(g)

Sensitive Questions

This information collection does not include questions of a sensitive nature.

4.

THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)

Respondents and NAICS Codes

Respondents affected by this activity are found mainly under NAICS codes 324 - Petroleum and Coal
Products Manufacturing, and 325 - Chemical Manufacturing.
4(b)

Information Requested

(i)

Data Items

The Voluntary Cover Sheet simply captures certain information that is being submitted under another
approved ICR. The data items included on the Cover Sheet are already contained in the submission to which
the cover sheet is attached, and include the following:
Data Element

Description

1. Submission Type

Identifies the submission, including the type of submission
and whether it is the initial submission, a follow-up or a final
report.

2. Summary of Attachment

Allows the respondent to provide a summary or abstract of the
attached study or report, any internal company tracking
number, an EPA tracking number, and an indication of the
number of studies submitted.

3. Chemical Identification

Identifies the chemical(s) addressed in the submission.

4. Title of Attachment

Identifies the title of the attached study or report.

5. Indexing Terms

Allows the respondent to identify the proper terms to use for
indexing purposes, which facilitates the search and retrieval of
the information.

6. Study/Report Information
Provides specific information regarding the attached study or
report, including the source, date of the study or report,
sponsor(s), and the length of the document.
7. Submitter Information

Identifies the submitter and/or technical contact, including
name, title, company, mailing address, phone and e-mail
address.

8. Comments

Allows the submitter to provide any additional comments, so as
to avoid the need for or use of a separate cover letter.

9. Signature

A signature is required for submissions under section 8(e); the
cover form provides a place for the submitter=s signature,
thereby avoiding the need for or use of a separate cover letter.

10. Continuation

Allows the submitter to expand the response to any of the
previous items, if needed, without the need to use a separate
cover letter or additional forms.

A copy of the sample Voluntary Cover Sheet for TSCA Submissions is attached to this ICR, along with
the instructions provided to users. ACC designed the form to capture all data and information required under
“Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8(e),” and
determined there was significant value for standardized data presentation under TSCA sections 4, 8(d) and 8(e).
Additionally, TSCATS index codes to identify study type, subject organism (if appropriate), and route of
exposure (if appropriate) are included.
(ii)

Respondent Activities

After making the determination to submit information to EPA under TSCA sections 4 or 8, VCCEP, or
to otherwise submit TSCA-related chemical information to EPA, the submission of which is covered under
separate ICRs, the respondent will decide whether or not to use the TSCA Cover Sheet for that submission.
The use of the TSCA Cover Sheet for submissions under TSCA is completely voluntary. However, ACC and
SOCMA explicitly solicit and encourage their members to use it for all such submissions.
Once the respondent has decided to use the Voluntary TSCA Cover Sheet, the respondent simply
completes the form by transferring or summarizing the information that the respondent has already assembled
as part of its submission. In many cases the use of this cover sheet takes the place of a cover or transmittal
letter to EPA that the respondent might otherwise routinely prepare, containing much of the same information
as is found on the cover sheet. Respondents are not obliged to prepare or develop additional data or information
in order to use the cover sheet.
The completed cover sheet is then included as part of the submission to EPA. Please note, this ICR does
not include any burden or costs associated with the actual transmittal of the information to EPA, or that
associated with maintaining a copy of the submission in their records. The existing ICRs that address the
underlying submission already include the burden and costs associated with copying and mailing the
submission to the Agency, and with keeping a copy of the submission in their records.

5.

THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT
5(a)

Agency Activities

OPPT staff use the information found on the cover sheet to identify the type of submission or the type of
information contained in a submission, to route a submission to other EPA staff for review, evaluation or action,
to file or retrieve a submission, and to conduct other routine information-management tasks associated with the
receipt and processing of a submission. Since the information appears in a consistent, standardized format,
OPPT staff members are able to complete these tasks in a highly efficient manner.
OPPT staff members review and take action upon the submissions themselves in accordance with
procedures that are described in greater detail in the information collection requests associated with the specific
reporting requirements previously referenced.
5(b)

Collection Methodology and Management

Since this is a standardized cover sheet attached to a more detailed and lengthy submission, the

collection methodology and management of this cover sheet necessarily follow the collection methodology and
management associated with the specific information collections for which this cover sheet will be utilized.
These collections are described in greater detail in the information collection requests associated with the
specific reporting requirements previously referenced.
In general EPA enters the information found on the cover sheet into Agency information management
systems so as to identify, locate and track the submission as the submission moves through appropriate Agency
reviews and actions. EPA anticipates that the use of the cover sheet by respondents will result in cost and time
savings, greater data accuracy and quality, and more timely public availability of data.
5(c)

Small Entity Flexibility

The use of this voluntary cover sheet does not directly affect any existing small entity flexibility
applicable to respondents to the reporting requirements under TSCA sections 4, 8(d), 8(e) or VCCEP. Any
small entity flexibility associated with these collections is described in greater detail in the information
collection requests associated with these reporting requirements. (In general, reporting requirements under
TSCA sections 8(d) and 8(e) apply to all respondents, regardless of size. Small entities required to report under
TSCA section 4 have certain options available to them in responding to those requirements. Under VCCEP, no
company is required to participate.) For those respondents, whether large or small, that respond to these
information collections, the use of this cover sheet should provide a more efficient means of submitting required
information. However, since the use of this cover sheet is strictly voluntary (although the underlying reporting
requirement itself may be mandatory), a respondent may choose not to use the form at all.
5(d)

Collection Schedule

Since this is a standardized cover sheet attached to a more detailed and lengthy submission, the
collection schedule associated with this cover sheet necessarily follows the collection schedules associated with
the specific information collections for which this cover sheet will be utilized. In general, responses to
reporting requirements under TSCA sections 4, 8(d), 8(e) and VCCEP are “on-occasion” responses for which a
strict collection schedule does not apply.

6.

ESTIMATING THE BURDEN AND COST OF THE COLLECTION

In using this Voluntary TSCA Cover Sheet effort, respondents are not required to generate any new
data; rather they simply transfer information from the underlying submission to the cover sheet. Although the
information included in the cover sheet is often included in a cover letter, the Agency has not attempted to
estimate any burden adjustment to the underlying ICRs to reflect the use of the Voluntary TSCA Cover Sheet,
rather than a cover letter to the Agency. This ICR only estimates the burden and costs associated with the use
of the Voluntary TSCA Cover Sheet. As such, it estimates the burden and costs related to the respondent’s
review of the instructions, completion of the form, and the identification of the appropriate TSCATS study
index terms.

6(a)

Estimating Respondent Burden

Based on the industry estimates provided during the ACC-initiated pilot of the cover sheet in the spring

of 1996, which ranged from 15 minutes to an hour, EPA estimates that the average burden associated with the
use of the cover sheet is approximately 30 minutes (0.5 hour).
Using recent estimates of the yearly average number of potential submissions expected under the other
ICRs for submissions related to TSCA sections 4, 8(d), 8(e) and VCCEP, and assuming that respondents used
the Voluntary TSCA Cover Sheet for every submission, Table 1 illustrates the total potential burden related to
this ICR. This assumption effectively results in an overstatement of the total burden associated with the use of
the Voluntary TSCA Cover Sheet since not all respondents will choose to use the cover sheet. However, there
are no reliable data available to suggest a lesser level of use of the form that EPA could use to calculate the
burden associated with its use. The burden identified below should be considered the maximum upward bound
for the total burden rather than a precise estimate of the burden based on the actual real-life use of the form.
Table 1 B Total Potential Burden
Submission Type

TSCA Sec. 4 2

Total Average
Annual
Submissions

Burden Hours and
Cost per Submission
Burden Costs 1

Total Burden
Hours and Cost

1,425

0.5

$24.86

712.5

$35,426

36

0.5

$24.86

18.0

$895

TSCA Sec. 8(e) - initial 4

345

0.5

$24.86

172.5

$8,577

TSCA Sec. 8(e) - follow-up 4

108

0.5

$24.86

54.0

$2,685

VCCEP 4

209

0.5

$24.86

104.5

$5,196

2,123

0.5

$24.86

1,061.5

$52,779

TSCA Sec. 8(d) 3

Total Potential Burden

Since the Voluntary TSCA Cover Sheet is expected to be used in lieu of the letter that has been used in
the past to transmit submission to the Agency, this burden should not be considered additive to the existing
burden estimates provided in the underlying ICRs. Accounting for this separately in this ICR may also result in
the double counting of this particular burden. However, the Agency wishes to continue the voluntary use of this
cover sheet and will account for its burden separately until the form is more widely used.
6(b)

1

Estimating Respondent Cost

This is based on an estimated labor cost of $49.72/hour, as discussed in section 6(b).

2

Section 4 Test Rules and Consent Orders, including HPV Challenge Program Submissions; OMB No. 2070-0033; EPA ICR
No. 1139.06; February 2005.
3

TSCA Section 8(d) Health and Safety Data Reporting Rule; OMB No. 2070-0004; EPA ICR No. 0575.09; April 2005.

4

Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8(e); OMB No. 2070-0046;
EPA ICR No. 0794.10; September 2005.
5 Data Submissions for the Voluntary Children’s Chemical Evaluation Program (VCCEP); OMB No. 2070-0165; EPA ICR
No. 2055.02; December 2005.

Based on information provided by ACC, a technical level employee is expected to complete the
Voluntary TSCA Cover Sheet. For purposes of estimating the cost associated with completing this form, EPA
used the most current average industry labor costs for technical employees of $49.72 per hour (Source: Labor
rates are unpublished December 2004 data from BLS for all manufacturing industries, the most recent available.
The estimates include fringe benefits and 17% overhead). As shown in Table 1, the total potential cost
associated with completing the cover form is $52,779.
6(c)

Estimating Agency Burden and Cost

Industry use of the cover sheet does not increase Agency burden and cost over that currently associated
with these information collections. It is anticipated, in fact, that the Agency=s costs for data processing, system
support and storage and distribution may decrease. Currently EPA staff must extract cover sheet information
from the submission itself and any accompanying cover letter; this task will be eased by EPA staff being able to
obtain necessary information directly from the standardized form.
Current Agency burden and costs are:
Section 4: 5,911 hours / $327,883
(Source: Section 4 Test Rules and Consent Orders; OMB No. 2070-0033; EPA ICR No. 1139.07; June
2005)
Section 8(d): 5,720 hours / $233,908
(Source: TSCA Section 8(d) Health and Safety Data Reporting Rule; OMB No. 2070-0004; EPA ICR
No. 0575.09; February 2003)
Section 8(e): 6,431 hours / $50,685
(Source: Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section
8(e); OMB No. 2070-0046; EPA ICR No. 0794.10; June 2003)
VCCEP: 1,100 hours / $575,242
(Source: Data Submissions for the Voluntary Children’s Chemical Evaluation Program
(VCCEP); OMB No. 2070-0165; EPA ICR No. 2055.01; September 2003)
In addition, it should be noted that the time and costs for making publicly available TSCA data and
information in TSCATS is estimated to be reduced by approximately 25%-33% for studies/submissions
utilizing the voluntary cover sheet.
6(d)

Bottom Line Burden Hours and Costs

(i) Respondent Tally
Each use of the cover sheet is estimated to result in a burden of 0.5 hours, at a cost of $24.86.
The Agency estimates a total of 2,123 submissions each year, so the total potential burden associated
with this ICR is estimated to be 1,061.5 hours, at an estimated cost of $52,779.
(ii) Agency Tally
Industry use of the cover sheet does not increase Agency burden and cost over that currently associated
with the underlying information collections with which the cover sheet is used, which are covered by other

ICRs.
6(e)

Reasons for Change in Burden

There is a decrease of 8,074.5 hours (from 9,136 hours to 1,061.5 hours) in the total estimated
respondent burden compared with that identified in the information collection most recently approved
by OMB. This decrease reflects a decrease in the estimated number of submissions under TSCA
sections 4, 8(d) and 8(e), offset by the estimated number of submissions under VCCEP, for which the
Voluntary TSCA Cover Sheet could be used, in particular a substantial decrease in the estimated number
of TSCA section 4 submissions. (As discussed in the TSCA section 4 ICR identified elsewhere in this
document, this decrease results from a reduction in the estimated number of section 4 test rules and
Enforceable Consent Agreements EPA expects to issue, as well as a reduction in the estimated testing
remaining for the HPV Challenge Program. EPA also now estimates the VCCEP submissions in a
separate ICR.) Since the use of the Voluntary TSCA Cover Sheet is a direct reflection of the number of
submissions received under TSCA sections 4, 8(d), 8(e) and VCCEP, any change in the estimated
numbers of submissions under those requirements will result in a parallel change in the burden hours
associated with this information collection. The potential number of annual submissions may change
from year to year, but the Agency believes that the estimated number of submissions used in this ICR is
reasonable. In addition, EPA now uses more accurate BLS data for labor rates, resulting in lowered
respondent costs. This decrease represents an adjustment.

6(f)

Burden Statement

The annual public burden for this collection of information, which is approved under OMB Control No.
2070-0156, is estimated to average 0.5 hours per response. According to the Paperwork Reduction Act,
Aburden@ 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; train personnel to be able to respond to the 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 and on the form.
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-2006-0499,
which is available for online viewing at http://www.regulations.gov, or in person inspection at the OPPT
Docket in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW.,
Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is
(202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Use www.regulations.gov
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-2006-0499 and OMB control number 2070-0156 in any
correspondence.

ATTACHMENT LIST
All of the attachments listed below can be found in the docket for this ICR (unless otherwise noted);
accessible electronically through www.Regulations.gov . On the main page, select Advanced Search from
the menu bar at the top and select Docket Search. Enter the Docket ID Number, EPA-HQ-OPPT-20060156 in the Docket ID field. Click on the Submit button. From the results page, you will be able to link to
the docket view or directly open select documents found in the docket.

ATTACHMENT 1- TSCA Health & Safety Study Cover Sheet and Instructions (EPA Form 7710-58)
ATTACHMENT 2- Copy of EPA Consultation Request to Potential Respondents
ATTACHMENT 3- First Federal Register Notice – 71 FR 47805- Agency Information Collection Activities;
Proposed Collection; Comment Request; Voluntary Cover Sheet fro TSCA Submissions
(published August 18, 2006).

ATTACHMENT 1
TSCA Health & Safety Study Cover Sheet and Instructions
(EPA Form 7710-58)

Approved Under OMB Control # 2070-0156
Expiration Date: xx/xx/xxxx

TSCA HEALTH & SAFETY STUDY COVER SHEET
Use of this form is voluntary, but recommended by EPA as a cover sheet for TSCA section 4, 8(d), and 8(e) submssions
to expedite and improve the management, processing, quality, review, and public availability of data in TSCATS
TSCA CBI STATUS:

9

CHECK IF THIS PAGE CONTAINS CONFIDENTIAL BUSINESS INFORMATION (CBI)
Clearly mark the confidential information with bracketing and check the box in the appropriate section (9 Contains CBI).
Submit a sanitized cover sheet with CBI deleted. Mark the sanitized copy, "Public Display Copy" in the heading.

1.0 SUBMISSION TYPE 9 Contains CBI
9 8(d)
9 8(e)
9 FYI
9 4
9 OTHER: Specify____________________
9 Initial Submission
9 Follow-up Submission
9 Final Report Submission
Previous EPA Submission Number or Title if update or follow-up:
Docket Number, if any: #
ITC Submission 9 Yes 9 No
9 continuation sheet attached
2.3 FOR EPA USE ONLY
2.1 SUMMARY/ABSTRACT ATTACHED 2.2 SUBMITTER TRACKING
(may be required for 8(e): optional for '4,
NUMBER OR INTERNAL ID
8(d) & FYI) 9 YES 9 NO

2.4 Study ___
of ____

3.0 CHEMICAL/TEST SUBSTANCE IDENTITY 9 Contains CBI
Reported Chemical Name (specify nomenclature if other than CAS name):
CAS#__________-_____-___
Purity _______%
9 Single Ingredient
9 Commercial/Tech Grade
9 Mixture
Trade Name: ________________________ Common Name: __________________________
CAS Number
NAME
% WEIGHT
Other chemical(s) present
in tested mixture
9 continuation sheet attached
4.0 REPORT/STUDY TITLE

9 Contains CBI

9 continuation sheet attached
5.1 STUDY/TSCATS INDEXING TERMS
[CHECK ONE]
ENVIRONMENTAL EFFECTS (EE):
ENVIRONMENTAL FATE (EF):_____
HEALTH EFFECTS (HE):
5.2 STUDY/TSCATS INDEXING TERMS (see instructions for 4 digit codes)
STUDY
SUBJECT
ROUTE OF
VEHICLE OF
EXPOSURE (HE only):
EXPOSURE (HE only)_____
TYPE: ___________
ORGANISM (HE, EE only):
Other:____________
Other:_________________________ Other: ____________________ Other:__________________
6.0 REPORT/STUDY INFORMATION 9 Contains CBI 9 Study is GLP
Laboratory
Report/Study Date_______
Number of pages _________
Source of Data/Study Sponsor (if different than submitter)
9 continuation sheet attached
7.0 SUBMITTER INFORMATION 9 Contains CBI
Submitter: _____________________________________ Title: ________________________ Phone: ( )______________
Company Name: _________________________________Company Address:_____________________________________
_____________________________________________
________________________________________
_______________________________________________Submitter Address (if different):
_____________________________________
Technical Contact: ________________ ______________ Phone: ( )______________
e-mail address__________________________________________________________
9 continuation sheet attached
8.0 ADDITIONAL COMMENTS 9 Contains CBI

9 continuation sheet attached Submitter Signature:
EPA Form No. 7710-58 (Revised 6/25/96)

Date:
Page____of____

Approved Under OMB Control # 2070-0156

TSCA HEALTH & SAFETY STUDY COVER SHEET
9.0 CONTINUATION SHEET
TSCA CBI STATUS:

9

CHECK IF THIS PAGE CONTAINS CONFIDENTIAL BUSINESS INFORMATION (CBI)
Clearly mark the confidential information with bracketing and check the box in the appropriate section (9 Contains CBI). Submit a
sanitized cover sheet with CBI deleted. Mark the sanitized copy, "Public Display Copy" in the heading.
Submitter Tracking Number/Internal ID

CONTINUED FROM COVER SHEET SECTION # _______________
9 Contains CBI

EPA Form No. 7710-58 (Revised 6/25/96)

Page____of____

Approved under OMB Control # 2070-0156

TSCA HEALTH & SAFETY STUDY COVER SHEET - INSTRUCTIONS
(Note: Do not mail these instructions with your submission)
Paperwork Reduction Act Notice
The annual public burden for this collection of information is estimated to average 30 minutes per
response, including the time needed for reading the instructions and completing the necessary information
contained in this form. Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing the burden to: Director, Collection Strategies Division,
Environmental Protection Agency (2822T), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460.
Include OMB number 2070-0156 in any correspondence. Do not send the completed form to this address. The
actual information or form should be submitted in accordance with the instructions specified in the
corresponding regulations
General Instructions
$

This voluntary cover sheet was designed to serve as a tool for industry and EPA in the preparation,
processing, review, and availability of TSCA information, and as an alternative for cover letters to
TSCA submissions.

$

As with all EPA submissions, follow applicable EPA regulations and guidance in submitting the
information.

$

A check box at the top has been provided to indicate if there is confidential business information (CBI).
Check this box if the page contains information that is confidential. For information what can be
claimed confidential under TSCA refer to TSCA section 14, 40 CFR Part 2 Sub-Part B and other
applicable EPA and TSCA guidance. If the page contains CBI, clearly mark the information with
bracketing. Check the box "Contains CBI" in the appropriate section. Submit another cover sheet with
the CBI deleted and mark "Public Display Copy" in the heading.

$

Under TSCA reporting requirements, a submission may contain multiple studies. A cover sheet should
be completed for each study in the submission and go to box 2.4 and add Study 1 of 1 for a submission
having a single study, Study 1 of x, Study 2 of x, etc. (for a submission having multiple or x number of
studies).

$

A cover sheet is unnecessary for submissions containing no health and safety data. Examples of
submissions with no health and safety data include: section 4-related correspondence on issues of
different test protocols; section 8(e) or FYI voluntary actions of submitters to reduce exposures;
information on chemical use or commercial status; substantiation for submitting FYI vs. 8(e). If a
submission is related to a previous submission, please reference the EPA assigned Document ID for
PMN, 8(e) and FYI submissions (PMN, 8EHQ and FYI numbers). For other submissions, please
reference the EPA Document Control Number (DCN) or Study title with submission date. The EPA
will provide the Document ID as well as the DCN when acknowledging PMNs, 8(e)s and FYIs.
If additional space is needed in any of the sections of the Cover Sheet, please check the "continuation
sheet attached" box in the appropriate section and attach a Continuation Sheet (a standardized
continuation sheet has been provided; it is titled 9.0 Continuation Sheet).

INSTRUCTIONS - continued page 2
$

It is important to indicate if a study/submission is initial, follow-up or final. An initial submission is for
a given chemical/case identified or initiated by a company. A follow-up or a supplement is a
submission which contains information specifically requested by EPA (Follow-up) or information
related to a previous submission but not specifically requested by EPA (Supplement).

$

Please attach to the cover sheet package an abstract or summary for each study prepared by or for the
submitter, if available, and check the box "YES" under section 2.1. Otherwise check the box "NO".
[Note: a summary/abstract is required under 8(e).]

$

Space is provided in section 8.0 for the submitter to provide any additional study interpretation,
comments, etc which could immediately assist in EPA=s screening and review of the study/submission.
A continuation sheet may be attached.

$

If any information in the cover sheet is unknown, write "unknown." If it is not applicable write "N.A."
Provide written explanation if appropriate.
Detailed Instructions For Completing Cover Sheet

TSCA CBI (Confidential Business Information) Status - Check this box if the page contains information that
is confidential. For information what can be claimed confidential under TSCA refer to TSCA section 14, 40
CFR Part 2 Sub-Part B and other applicable EPA and TSCA guidance. If the page contains CBI, clearly mark
the information with bracketing. Check the box "Contains CBI" in the appropriate section. Submit another
cover sheet with the CBI deleted and mark "Public Display Copy" in the heading.
1.0 Submission Type - Check one of the boxes for the TSCA section that the submission is being made under8(d), 8(e), FYI, 4 or OTHER. Check the appropriate box to indicate if a study/submission is initial, follow-up
or final. An initial submission is for a given chemical/case identified or initiated by a company. A follow-up or
a supplement is a submission which contains information specifically requested by EPA (Follow-up) or
information related to a previous submission but not specifically requested by EPA (Supplement).
2.1 Summary/Abstract Attached - Please attach to the cover sheet package an abstract or summary for each
study prepared by or for the submitter, if available, and check the box "YES" under section 2.1. Otherwise
check the box "NO". [Note: a summary/abstract may be required under 8(e).]
2.2 Submitter Tracking Number or Internal ID - Enter an internal company id number; also, write this ID
on the complete submission for easy linkage to and retrieval of the entire study/submission for EPA processing,
review, and public availability.
2.3 For EPA Use Only - Please leave this section blank. This is for EPA purposes such as assignment of
submission tracking numbers.
2.4 Study

of

-

INSTRUCTIONS - continued page 3
3.0 Chemical/Test Substance Identity - If additional space is required for any chemical identity data element,
check the continuation box and attach a continuation sheet appropriately identifying the relevant specific data
element and referencing the study/submission. Enter the CAS# of the chemical for the specific study of the
cover sheet. Enter the chemical name; specify nomenclature if other than CAS name. Enter the % purity if
impurities are present, leave blank if unknown. Check one of three boxes indicating if the chemical is a single
ingredient (e.g., 100% NaCl), technical grade product (e.g., 50% NaOH solution), or mixture (e.g., perfume
formula with many ingredients). Enter the trade names and common names for the material if applicable. If the
test substance contains more than one chemical, list the components by CAS number, name, and % weight in
the mixture. Submitters are requested to provide informative generic chemical names for substances whose
chemical identity has been claimed TSCA confidential business information.
4.0 Report/Study Title - Provide the title of the entire submission, not the title of any specific study
subsection; if insufficient space, check the continuation box and attach a continuation sheet with the complete
title.
5.1 Study/TSCATS Indexing Terms - Check either Health Effects, Environmental Effects, or Environmental
Fate - check only one.
5.2 Study/TSCATS Indexing Terms - See the attached Study Indexing Terms Sheet. Find appropriate
(checked) Study Type and select relevant, detailed Study Type (for HE, EE, EF), Subject Organism (HE, EE
only), Route of Exposure (HE only), and Vehicle (HE only, if applicable); transfer the 4-letter TSCATS code to
the cover sheet. If an appropriate indexing term is not available, check other box and clearly print description.
6.0 Report/Study Information - If additional space is required for any study information data, check the
continuation box and attach a continuation sheet identifying the relevant specific data element and referencing
the study/submission. Enter the complete name of the contractor or laboratory which conducted the study.
Include the source of data or study sponsor, if different than the submitter. Enter the actual completion date of
the study/submission as dd/mm/yy. Check GLP box if existing Good Laboratory Practices were used in the
conduct of the study.
7.0 Submitter Information - If additional space is required for any submitter information, check the
continuation box and attach a continuation sheet identifying this data element and referencing the
study/submission (e.g. submitter tracking number). Enter submitter name, title, and phone. Enter company
name and address. Enter the address of the submitter if the submitters address is different than the company
address. Please provide a key technical contact name and telephone number of an individual who can discuss
the content/substance of the study/submission during the EPA scientific review process.
8.0 Additional Comments - This space is provided for the submitter to provide any additional study
interpretation, comments, etc., which could immediately assist in EPA=s screening and review of the
study/submission. A continuation sheet may be attached. For TSCA section 8(e) and FYI submissions state
rationale for submitting information as 8(e) versus FYI and voluntary actions taken by the submitter in response
to the new information.
Submitter Signature/Date - TSCA section 8(e) submissions must be signed by the submitter and dated. All
submissions should be submitted by certified mail with return receipt to demonstrate submission receipt by the
EPA.
9.0 Continuation Sheet - If additional space is needed in any of the sections of the cover sheet, please check
the "continuation sheet attached" box in the appropriate section and attach a Continuation Sheet, Section 9.0.

INSTRUCTIONS - continued page 4
STUDY INDEXING TERMS
FOR HEALTH EFFECT (HE)
STUDIES ONLY
Study Type
___ Acute Toxicity (ATOX)
___ Subchronic Toxicity (STOX)
___ Chronic Toxicity (CTOX)
___ Carcinogenicity (CARC)
___ Combined Chronic Toxicity/
Carcinogenicity (CTCA)
___ Cell Transformation (TRFM)
___ Biochemical Interactions and/or
Mechanism of Toxic Effects (BCHM)
___ Absorption, Distribution, Metabolism
Excretion (ADME)
___ Primary Dermal Sensitization
(DSEN)
___ Primary Dermal irritation (DIRR)
___ Primary Eye irritation (EIRR)
___ Reproduction/Fertility Effects
(RTOX)
Teratology (TERA)
___ Combined Teratology/Reproductive
Effects (TERE)
___ Epidemiology Study (EPID)
___ Case Report (CASE)
___ Genotoxicity (GTOX)
___ Gene Mutation (MUTA)
___ Chromosomal Effects (CHRM)
___ DNA Effects (DNAF)
___ Tissue Determination Concentration
(TCON)
___ Industrial Hygiene (HYGN)
___ Neurotoxicity (NEUR)
___ Immunotoxicity (ITOX)
___ Target Organ Toxicity: specify____
___ Other: specify_________________

Subject Organism/Test System
___ Mammals (MAMM)
___ Rats (RATS)
___ Mice (MICE)
___ Hamsters (HAMS)
___ Guinea Pigs (GUIN)
___ Rabbits (RABB)
___ Dogs (DOGS)
___ Cats (CATS)
___ Monkeys (MNKY)
___ Pigs (PIGS)
___ Cattle (COWS)
___ Sheep (SHEP)
___ Goats (GOAT)
___ Humans (HUMN)
___ Other Mammals (OTMA)
___ Bacteria (BACT)
___ Algae (ALGA)
___ Fungi (FUNG)
___ Yeast (YEST)
___ Plant (PLNT)
___ Insect (INSE)
___ Bird (BIRD)

FOR ENVIRONMENTAL
EFFECT (EE) STUDIES ONLY
Study Type
___ Acute Toxicity (ATOX)
___ Subchronic Toxicity (STOX)
___ Chronic Toxicity (CTOX)
___ Critical Life Stage Test (CLIF)
___ Seed Germination Test (SEED)
___ Plant Growth or Damage Test (PGRD)
___ Microbiological Function Test (MICR)
___ Ecosystem Modeling (ECOS)
___ Reproduction/Fertilization Test (RTOX)
___ Absorption, Distribution, Metabolism
Excretion (ADME)
___ Tissue Concentration (TCON)
___ Other Environmental Effects (OTEE)
specify __________________________

Route of Exposure
___ Oral (ORAL)
___ Gavage (GAVG)
___ Dermal (DERM)
___ Inhalation (INHL)
___ Intratracheal Instillation (INTR)
___ Parenteral (PARN)
___ Intravenous (INTV)
___ Intraperitoneal (INTP)
___ Intramuscular (INTM)
___ Subcutaneous (SUBC)
___ Implant (IMPL)
___ Transplacental (TRPL)
___ In Vitro (INVR)
----------------------------------------------------Vehicle of Exposure
(check only if applicable)
___
___
___
___

Water
Corn Oil
Food
Other: specify________________

FOR ENVIRONMENTAL FATE
(EF) STUDIES ONLY

Subject Organism
___ Bacteria (BACT)
___ Algae (ALGA)
___ Fungi (FUNG)
___ Yeast (YEST)
___ Plant (PLNT)
___ Amphibians (AMPH)
___ Mollusks (MOLL)
___ Fish - Freshwater (FFRE)
___ Fish - Marine (FMAR)
___ Reptiles (REPT)
___ Bird (BIRD)
___ Insect (INSE)
___ Invertebrates (INVE)
___ Other Wildlife (WILD)
specify ________________________

Study Type
___ Physical / Chemical Properties (PCHE)
___ Water Solubility (WSOL)
___ Vapor Pressure (VPRE)
___ Partition Coefficient (PART)
___ Dissociation Constant (DISS)
___ Henry's Law Constant (HLAW)
___ Transport Processes (TSPT)
___ Biodegradation (BDEG)
___ Bioconcentration /
Bioaccumulation (BIOC)
___ Photolysis (PHOT)
___ Hydrolysis (HYDR)
___ Monitoring Information (MONT)
___ Production and Process Info (PROD)
___ Other Studies (OTHR)
specify ____________________________

ATTACHMENT 2
Copy of EPA Consultation Request to Potential Respondents

Date:

09/18/2006 02:35 PM

From:

Ron Carlson/DC/USEPA/US

To:

[Addressees noted in Supporting Statement section 3(c)]

Subject:

Request for assistance; renewal of "Voluntary Cover Sheet for TSCA
Submissions" ICR

On August 18, 2006, EPA published a Notice in the Federal Register (71 FR
47805) titled Agency Information Collection Activities; Proposed
Collection; Comment Request; Voluntary Cover Sheet for TSCA Submissions;
EPA ICR No. 1780.04, OMB Control No. 2070-0156. This Notice refers to
EPA's intention to request renewed Office of Management and Budget (OMB)
clearance of an information collection involving the completion of a
voluntary cover form that enables the Agency more easily to collect,
identify, process, store, retrieve and disseminate certain information and
studies that industry submits under sections 4, 6 and 8 of the Toxic
Substances Control Act (TSCA).
In addition to public notice and comment requirement that the above Notice
initiates, OMB regulations at 5 CFR 1320.8(d)(1)) require agencies to
consult with potential respondents and data users about specific aspects
of an information collection request (ICR) before submitting it to OMB for
review and approval, regardless, in the case of ICR renewals, of whether
changes have or have not been made to the collection activity.
As part of this required consultation, I am contacting you to solicit your
input. I will also note that, if you take this opportunity to provide
input, your name, affiliation, e-mail address, phone number and any
information you provide (e.g., copies of e-mails) will be incorporated and
attached to the ICR supporting statement, which will be a public
document. In addition, the OMB Desk Examiner for the ICR in question may
contact you to verify the accuracy of any comments EPA identifies in the
ICR.
EPA solicits your input on the following questions:
Are the data EPA seeks under this ICR available from any public source, or
already collected by another EPA office or by another agency? If so,
where can the data be found?
Is it clear what is required for data submission?
suggestions for clarifying instructions?

If not, are there any

Would you be interested in an electronic/data submission option? What
type of alternative would you be most likely to utilize – web form,
diskette, CD-ROM?
For electronic submission, how should signature requirements be handled –
Private Key Infrastructure, PINS and passwords, signed paper cover sheet?
How does TSCA CBI affect your choice or use of an electronic medium?
Would you be more inclined to submit TSCA CBI on diskette than on paper
and what benefits would you realize (e.g., burden reduction, greater
efficiency in compiling information, etc).
Do you agree with EPA's estimated burden and costs (the ICR addresses only

the costs associated with paperwork)? Are the Bureau of Labor Statistics
(BLS) labor rates accurate? If you have any reason to consider the BLS
labor rates inaccurate or inappropriate as used by EPA, explain your
rationale.
You can access the Federal Register Notice, the ICR supporting document,
and any public comments received to date at:
http://www.regulations.gov/fdmspublic/component/main
- select Advanced Search link at the top of the page
- select Docket from drop-down menu
- select EPA in the Agency drop-down menu
- enter EPA-HQ-OPPT-2006-0499 in the Docket ID field
- scroll down to Submit
- then click on the Docket ID in the search results for a listing of the
documents within the docket
Your timely response will be greatly appreciated. If you have any
comments in response to the above questions, or with respect to any other
part of the information collection, please respond by return e-mail by
October 17, 2006. EPA will consider those responses, as well as any
public comment received in response to the Federal Register Notice
identified above, in preparing a final document for OMB review.
Thank you for your assistance.
Sincerely yours,
Ron Carlson, Environmental Protection Specialist
Information Management Division/Office of Pollution Prevention and
Toxics/Office of Prevention, Pesticides and Toxic Substances
Environmental Protection Agency
Washington, DC 20460
202-564-8631

ATTACHMENT 3
First Federal Register Notice – 71 FR 47805- Agency Information Collection Activities;
Proposed Collection; Comment Request; Voluntary Cover Sheet fro TSCA
Submissions (published August 18, 2006).