December 17, 2003 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.: 1780.03; OMB Control No.: 2070 0156 1( b) 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). The cost and burdens for those related submissions under TSCA sections 4 and 8 have already been approved by the Office of Management and Budget ( OMB) and are contained in the following ICRs:

( 1) The ICR for TSCA section 4 submissions are found in " Section 4 Test Rules and Consent Orders," OMB Control No. 2070 0033, EPA ICR No. 1139. ( 2) The ICR for TSCA section 8( d) submissions are found in " TSCA Section 8( d) Health and Safety Data Reporting Rule," OMB Control No. 2070 0004, EPA ICR No. 0575. ( 3) The ICR for TSCA section 8( e) reporting requirements are found 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.

This ICR, therefore, only applies to the burden and costs associated with the use of the voluntary cover sheet for those submissions.

Under TSCA sections 4 and 8, industry is required to submit certain information and studies for existing chemical substances. Under normal TSCA reporting conditions, EPA receives approximately 1,700 submissions each year; with each submission consisting of three studies, on average. In addition, specific data ( study) call ins may also be imposed on industry.

The submissions that EPA receives 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 completed in FY 1995. In June 1994, OPPT received 900 submissions, representing approximately 3,500 studies, under a TSCA section 8( d) data call in for siloxanes in support of the TSCA mandated Interagency Testing Committee ( ITC).  2  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 callin the Chemical Manufacturers Association ( CMA), 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. ( The Chemical Manufacturers Association is now known as the American Chemical Council [ ACC] and will be so referenced hereafter in this document.) In particular, ACC lead 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," is designed by ACC for voluntary use as a cover sheet for submissions of information under TSCA sections 4, 8( d) and 8( e).

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  3  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.

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) and 8( e). 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 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 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  4  cost savings from non initiation/ non duplication of studies through rapid TSCATS availability.  5  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, 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 June 17, 2003 ( 68 FR 19203, April 18, 2003). 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) and 8( e) to EPA.

ACC, in consultation and in cooperation with EPA, is pursuing development of an electronic version of this cover sheet for availability through the Internet. This electronic form could be interactively completed and immediately transmitted for even more efficient, timely and complete data. EPA intends actively to continue this effort in cooperation with ACC and any other interested parties.

In addition, in preparing this renewal, EPA initiated formal consultations with seven respondents ( both individual companies as well as industry associations) to this information collection. However, only one such respondent provided EPA with comments on the proposed renewal.

The one respondent was Mr. Mike Thelen, Dow Corning Corporation, Midland, MI 48686, telephone: 989 496 4168, fax: 989 496 5595. Mr. Thelen's comments ( dated May 14, 2003) were generally supportive of the Voluntary TSCA Cover Sheet in its current format. EPA made no changes to the ICR offered for public review based on Mr. Thelen's comments. Mr. Thelen's comments appear in Attachment 2 to this ICR.

3( d) Effects of Less Frequent Collection Since the use of this cover sheet is strictly voluntary on the part of respondents,  6  this is not applicable.

3( e) General Guidelines To the best of EPA's knowledge, the use of this cover sheet does not exceed any of the PRA guidelines at 5 CFR 1320.6. Since the use of this cover sheet is entirely voluntary, and the information collected on it is expected to remain unchanged in the future, EPA would like to omit the inclusion of a specific expiration date on the final form. Under the PRA, 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 EPA's regulations in 40 CFR, after initial display in the final rule, are listed in 40 CFR part 9. For forms, in addition to the required inclusion of the OMB control number for the ICR containing the form, EPA has traditionally included the expiration date of the ICR on the form. Since the ICR must be renewed every three years, inclusion of an expiration date on the form would require EPA to also amend the form every three years. Revising the form every three years creates unnecessary burdens for both EPA and those who wish to use the form. In addition, EPA intends for this voluntary cover sheet to serve as the data entry form for the electronic online submission system, TSCATS.

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 attached submission, and include the following:  7   8  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 This section on the form 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.  9  ( ii) Respondent Activities After making the determination to submit information to EPA under TSCA sections 4 or 8, 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 are able to complete these tasks in a highly efficient manner.

OPPT staff 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  10  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) or 8( e). 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). For those respondents, whether large or small, that are required to 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, 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 FYI 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, 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  11  terms.  12  6( a) Estimating Respondent Burden Based on the industry estimates provided during the ACC initiated twelve month pilot of the cover sheet in the spring of 1996, which ranged from 15 minutes to an hour, the Agency 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) and 8( e), and assuming that the Voluntary TSCA Cover Sheet was used for each and 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 herein 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. 1 Based on an estimated labor cost of $ 77/ hour, as discussed in section 6( b).

2 Section 4 Test Rules and Consent Orders; OMB No. 2070 0033; EPA ICR No. 1139.06; October 2001.

3 TSCA Section 8( d) Health and Safety Data Reporting Rule; OMB No. 2070 0004; EPA ICR No. 0575.09; February 2003.

4 Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8( e); OMB No. 2070 0046; EPA ICR No. 0794.09; January 2001.

5 Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8( e); OMB No. 2070 0046; EPA ICR No. 0794.09; January 2001.

6 Since FYI submissions are only submitted when the respondent wishes to do so, the annual potential submissions varies greatly and is highly unpredictable. The Agency believes that it is therefore reasonable to use 10 in this estimate.

 13  Table 1   Total Potential Burden Submission Type Total Average Annual Submissions Burden Hours and Cost per Submission Burden Costs1 Total Burden Cost Hours TSCA § 42 17,299 0.5 $ 38.50 8,649.5 $ 666,012 TSCA § 8( d) 3 495 0.5 $ 38.50 247.5 $ 19,058 TSCA § 8( e)  initial4 267 0.5 $ 38.50 133.5 $ 10,280 TSCA § 8( e)  follow up5 200 0.5 $ 38.50 100.0 $ 7,700 FYI Submissions6 10 0.5 $ 38.50 5.0 $ 385 Total Potential Burden 18,271 0.5 $ 38.50 9,135.5 $ 703,435 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) Estimating Respondent Cost 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 $ 77 per hour ( Source: Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8( e); OMB No. 2070 0046; EPA ICR No. 0794.09; January 2001). As shown in Table 1, the total potential cost associated with completing the cover form is $ 703,435.  14  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: 52,204 hours / $ 1,889,785 ( Source: Section 4 Test Rules and Consent Orders; OMB No. 2070 0033; EPA ICR No. 1139.06; October 2001)

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): $ 63,045 ( Source: Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8( e); OMB No. 2070 0046; EPA ICR No. 0794.09; January 2001)

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 $ 38.50. The Agency estimates a total of 18,271 submissions each year, so the total potential burden associated with this ICR is estimated to be 9,136 hours, at an estimated cost of $ 703,435.

( 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.  15   16  6( e) Reasons for Change in Burden The burden hours included in this request represents an increase of 8,221 hours in the annual burden, from 915 hours to 9,136 hours, from the request most recently approved by OMB. This increase reflects a net increase in the estimated number of submissions under TSCA sections 4, 8( d) and 8( e) for which the Voluntary TSCA Cover Sheet could be used, in particular a substantial increase in the estimated number of TSCA section 4 submissions. ( As discussed in the TSCA section 4 ICR identified elsewhere in this document, this increase results from the initiation of two new major voluntary testing agreement programs, the HPV Challenge Program and the Voluntary Children's Chemical Evaluation Program.) 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) and 8( e), 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. This increase 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, " 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; 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. In addition, the OMB control number for EPA's regulations, after initial display in the final rule, are listed in 40 CFR part 9.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OPPT 2003 0017, which is available for public viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1544 and the telephone number for the Pollution Prevention and Toxics  17  Docket is ( 202) 566 0280. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET 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. OPPT 2003 0017 and OMB control number 2070 0156 in any correspondence.

Attachments  18  ATTACHMENTS:

[ NOTE: Unless otherwise noted, an electronic copy of the attachment is available in the electronic version of the public docket available through EDOCKET at http:// www. epa. gov/ edocket. Once in the system, select " quick search," then indicate that you'd like to search by Docket and key in the following docket ID number: OPPT 2003 0017. Search the docket index for this document by the title provided below. If you have any difficulties, please contact the technical person listed in the Federal Register notice announcing the submission of this ICR to OMB for review and approval.]

Attachment Document # 1 TSCA Health and Safety Cover Sheet and Instructions [ The electronic copy for this attachment is available as part of the electronic copy of the ICR's Supporting Statement.]

# 2 Comment Received by EPA as a Result of Consultations with Respondents [ The electronic copy for this attachment is available as part of the electronic copy of the ICR's Supporting Statement.] ATTACHMENT 1 TSCA Health & Safety Study Cover Sheet and Instructions 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:

CHECK IF THIS PAGE CONTAINS CONFIDENTIAL BUSINESS INFORMATION ( CBI) Clearly mark the confidential information with bracketing and check the box in the appropriate section (

Contains CBI). Submit a sanitized cover sheet with CBI deleted. Mark the sanitized copy, " Public Display Copy" in the heading.

1.0 SUBMISSION TYPE

Contains CBI

8( d)

8( e)

FYI

4

OTHER: Specify____________________

Initial Submission

Follow up Submission

Final Report Submission Previous EPA Submission Number or Title if update or follow up: Docket Number, if any: # ITC Submission

Yes

No

continuation sheet attached 2.1 SUMMARY/ ABSTRACT ATTACHED ( may be required for 8( e): optional for § 4, 8( d) & FYI)

YES

NO 2.2 SUBMITTER TRACKING NUMBER OR INTERNAL ID 2.3 FOR EPA USE ONLY 2.4 Study ___ of ____

3.0 CHEMICAL/ TEST SUBSTANCE IDENTITY

Contains CBI Reported Chemical Name ( specify nomenclature if other than CAS name): CAS#__________________ Purity _______%

Single Ingredient

Commercial/ Tech Grade

Mixture Trade Name: ________________________ Common Name: __________________________ CAS Number NAME % WEIGHT Other chemical( s) present in tested mixture

continuation sheet attached 4.0 REPORT/ STUDY TITLE

Contains CBI

continuation sheet attached 5.1 STUDY/ TSCATS INDEXING TERMS [ CHECK ONE] HEALTH EFFECTS ( HE): ENVIRONMENTAL EFFECTS ( EE): ENVIRONMENTAL FATE ( EF):_____ 5.2 STUDY/ TSCATS INDEXING TERMS ( see instructions for 4 digit codes) STUDY SUBJECT ROUTE OF VEHICLE OF TYPE: ___________ ORGANISM ( HE, EE only): EXPOSURE ( HE only): EXPOSURE ( HE only)_____ Other:____________ Other:_________________________ Other: ____________________ Other:__________________ 6.0 REPORT/ STUDY INFORMATION

Contains CBI

Study is GLP Laboratory Report/ Study Date_______ Source of Data/ Study Sponsor ( if different than submitter) Number of pages _________

continuation sheet attached 7.0 SUBMITTER INFORMATION

Contains CBI Submitter: _____________________________________ Title: ________________________ Phone: ( )______________ Company Name: _________________________________ Company Address:_____________________________________ _____________________________________________ ________________________________________ _______________________________________________ Submitter Address ( if different): _____________________________________ Technical Contact: ________________ ______________ Phone: ( )______________

continuation sheet attached e mail address__________________________________________________________ 8.0 ADDITIONAL COMMENTS

Contains CBI

continuation sheet attached Submitter Signature: Date:

EPA Form No. 7710 58 ( Revised 6/ 25/ 96) Page____ of____ Approved Under OMB Control # 2070 0156 TSCA HEALTH & SAFETY STUDY COVER SHEET 9.0 CONTINUATION SHEET TSCA CBI STATUS:

CHECK IF THIS PAGE CONTAINS CONFIDENTIAL BUSINESS INFORMATION ( CBI) Clearly mark the confidential information with bracketing and check the box in the appropriate section (

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 # _______________

Contains CBI EPA Form No. 7710 58 C ( 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, U. S. Environmental Protection Agency ( Mail Code 2822T), 1200 Pennsylvania Avenue, NW, 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 that 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 brackets. 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 brackets. 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 under 8( 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 on 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) 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 EFFECT ( EE) STUDIES ONLY FOR ENVIRONMENTAL FATE ( EF) 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 __________________________ 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 Comments Received by EPA as a Result of Consultations with Respondents From: mike. thelen@ dowcorning. com To: Ron Carlson/ DC/ USEPA/ US@ EPA. gov Subject: RE: Renewal of " Voluntary Cover Sheet for TSCA Submissions" ICR Date: 05/ 14/ 03 09: 50 AM Attached is my feedback on the questions EPA has raised with respect to the Voluntary Cover Sheet for TSCA Submissions. I have indicated my response by beginning my feedback with ( Thelen). Please feel free to contact me if you have questions or need additional information.

( 1) In your opinion is this collection of information necessary for the proper performance of the functions of the EPA, including whether the information will have practical utility?

( Thelen) The collection of information through the " Voluntary Cover Sheet" is not necessary for the proper performance of functions within the EPA but does have practical utility in that EPA does not have to pay an outside contractor to develop this input and the indexing information is available realtime with the TSCA submission.

( 2) Please comment on how EPA could enhance the quality, utility and/ or clarity of the information to be collected.

( Thelen) I believe that the " Voluntary Cover Sheet" and document is understandable and clear. No proposed changes.

( 3) Are the data that EPA seeks available from any public source, or already collected by another office at EPA or by another agency? If yes, where can one find the data?

( Thelen) I do not believe that the information collected on the " Voluntary Cover Sheet" is available from any other source. This information must be developed from the content of the TSCA submission.

( 4) Consider how often EPA needs to collect these data. Can EPA collect the information less frequently and still produce the same outcome?

( Thelen) The appropriate time to collect this data is with the TSCA submission. By collecting the data on the cover sheet with the TSCA submission you avoid the lag time that is associated with developing this indexing information after EPA receives the submission. The ability to search for new information in TSCATS is enhanced with the submission of the Voluntary Cover Sheet with the TSCA submission.

( 5) The ICR is intended to explain to respondents that they are required to do certain things and provide certain data so that EPA can utilize them. Is it clear to you, based on the ICR, the form and its instructions, what you are required to do and what data to submit? If not, what suggestions do you have for clarifying the instructions? Is the format of the form clear, logical and easy to complete?

( Thelen) I have no problems following the Voluntary Cover Sheet form and the information required but I am not a good example of the norm based on my early involvement with the concept of the cover sheet through my involvement with the Silicones Environmental Health and Safety Councils submission of information to EPA and the Interagency Testing Committee on Siloxane TSCA submissions.

( 6) Please consider electronic alternatives to paper based data submissions. Are you interested in using, or are you currently utilizing, an electronic reporting/ data submission option for this or other EPA information submissions? ( Current electronic reporting alternatives include the use of web form/ XML based submissions via EPA's internet site and magnetic media based submissions, e. g., on diskette, CD ROM, etc.) Where a reporting requirement includes a signature requirement, should a secure electronic signature method ( such as Private Key Infrastructure) be required, or is a less secure method ( such as the use of PINs and passwords) adequate or more appropriate, or, if data are submitted on disk, is a signed cover sheet sufficient for the Agency's purposes? If you submit TSCA confidential business information ( CBI) for this or other EPA information submissions, would you be more inclined to submit CBI on diskette rather than on paper and what benefits would you realize ( e. g., burden reduction, greater efficiency in compiling information, etc.)?

( Thelen) There a number of points that are being addressed in this question; do I support electronic submissions, what type of electron submission do I currently use or support, what level of validation/ security is needed for the TSCA submission, if it is confidential business information ( CBI), what is my preference ( paper or electronic) and what are the benefits of electronic reporting. I support the use of electronic submissions and have used the cover sheet in beta testing. I have no preference to the use of the internet or electronic media ( eg. disk or CD ROM). I have provided Reports and presentations to OPPT on CD ROM to facilitate distribution of information. For non CBI submissions I believe that a PIN is adequate for TSCA submissions through EPA's website. The submitter has a copy of the submission if there was an issue with the submission. CBI presents a higher level of concern because the content of the submission is what needs to be protected from inadvertent disclosure. Electronic submissions would still be a preference but the issue to be addressed is the mechanism to get this electronic submission to EPA.

( 7) Please consider EPA's estimated burden and costs for responding to this information collection. Is the burden hour estimate reasonable? Are the costs, including labor rates, reasonable? ( Note that the labor rates include overhead costs, benefits, etc.) Please provide a explanation of how you arrived at your estimates of burden and cost if they are substantially different from EPA's estimates. Please offer any suggestions on how EPA could minimize the burden and cost of this information collection.

( Thelen) I agree with the estimate of .5 hours for completing the " Voluntary Cover Sheet" and the hourly rate. In order to complete the " Voluntary Cover Sheet" within the .5 hours you will need an Environmental Health and Safety professional who understands the content.

( 8) Please offer any other relevant suggestions, observations or criticisms that may occur to you that are not outlined above.

( Thelen) If EPA wants to promote the use of the " Voluntary Cover Sheet" it needs to be more visible and easy to find on EPA's website as an alternative to paper submissions. I tried to locate it and was not successful.

Michael E. Thelen Regulatory Affairs and Product Safety Environmental Health and Safety Dow Corning Corporation mike. thelen@ dowcorning. com 989 496 4168, fax 989 496 5595


/ Rich Leukroth To: pvoytek@ crosshnk. net cc: John Schaetfer/ DC/ USEPA/ US © EPA 04/ 28/ 2003 01: 16 PM Subject: TCE ECA Revised TabIel At the SOT Program Review Technical Consultation meeting last month, EPA discussed how the findings from Tier I and Tier I Program Review testing modify some of the original thinking about some of the Tier II activities. These changes impact the footnotes in the Tier II section of Table 1 in the ECA agreement. We agreed to incorporate these changes into the protocol developmenl aspect for TIER II.

I would appreciate your comments on the attached revised Table 1 for Tier II activities. Note: The testing and reporting mix stays the same but the footnotes for the route dosimetry extrapolations are changed to reflect new thinking as a result of Tier I study findings. Give me a call at 202 564 8167 if you have questions or need to discuss further.

revisedTbl 1 4_ 28_ 03. wpc **** * **** ******* ****** ****************** ****,

Richard W. Leukroth, Jr. Environmental Scientist / Toxicologist Chemical Control Division U. S. Environmental Protection Agency Mail Stop 7405; Room 4328 S 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 Phone: 202 564 8167 FAX: 202 564 4765 E mail: leukroth. rich@ epa. gov Deliveries: EPA East Building 1201 Constitution Avenue, NW Room 3166A ( 7401M) Washington, DC 20004 RECEIVED OPPT NCIC 2003 JUN24 8: 05AM OPPT 2002 0056 0065 Table 1. Required Testing, Test Standards, and Reporting Requirements for TCE

Modifications / Revisions (~) to Tier H Testing and Reporting Activities Testing Required testing Test standard Deadline for Segment final report~ ( Months)

Tier II Testing and/ or Extrapolation Reporting Developmental toxicity ( oral)

Developmental toxicity extrapolation of oral data to inhalation Reproductive toxicity ( oral)

Reproductive toxicity extrapolation of oral data to inhalation ~

Immunotoxicity extrapolation of extant oral data in ECA Appendix E. 2 to inhalation `~

Carcinogenicity extrapolation of extant oral data in ECA Appendix E. 3 to inhalation ~ 40 CFR § 799.9620 ( as annotated in ECA Appendix D. 3)

40 CFR § 799.9370 ( as annotated in ECA Appendix D. 4)

ECA Appendix C 40 CFR § 799.9380 ( as annotated in ECA Appendix D. 5)

ECA Appendix C ECA Appendix C ECA Appendix C Number of months after the effective date of this Federal Register Notice, which announces that EPA has concluded the EPA Program Review, when the final report is due. In addition, every 6 months from the effective date of the Order until the end of the ECA testing program, interim reports describing the status of all testing to be performed under the ECA for TCE must be submitted by the Companies to EPA. 40 CFR § 799.9620 ( as annotated in ECA Appendix D. 3)

ECA Appendix C Acute neurotoxicity ( oral)

Acute neurotoxicity extrapolation of oral data to inhalation Subchronic neurotoxicity ( oral)

Subchronic neurotoxicity extrapolation of oral data to inhalation 2 ECA Appendix C 12 15 18 21 24 27 30 33 9 6 I Number of months after the effective date of this Federal Register Notice, which announces that EPA has concluded the EPA Program Review, when the final report is due. In addition, every 6 months from the effective date of the Order until the end of the ECA testing program, interim reports describing the status of all testing to be performed under the Eca forTCE must be submitted by the Companies to EPA.

2 Quantitative route to route extrapolation documented graphically and with tabular data. Different dose metrics to be evaluated initially at the protocol development stage and then in the context of the final results. Dose metrics to consider include parent compound in venous blood or brain, as maximum concentration ( Cmax) or the area under the time concentration curve ( AUC), and metabolite, as amount metabolized in the liver or brain per day normalized to organ weight. Should mode of action data be available to support a dose metric other than Cmax or AUC for parent compound ( e. g. time above a critical concentration as is sometimes used in pharmaceutical applications) that dose metric will be derived and added to the overall evaluation. The choice of the final dose metric should be supported with mode ofaction information and adiscussion of the most health protective.

~ Quantitative route to route extrapolation documented graphically and with tabular data. Different dose metrics to be evaluated initially at the protocol development stage and then in the context of the final results. Dose metrics to consider include parent compound in venous blood, as maximum concentration ( Cmax) or the area under the time concentration curve ( AUC), and metabolite, as amount metabolized in the liver per day normalized to liver weight. The choice of the final dose metric should be supported with mode of action information and a discussion of the most health protective.

~ Quantitative route to route extrapolation based on the data of Sanders et al. ( 1985) documented graphically and with tabular data. Dose metrics to consider include parent compound in venous blood or spleen, as maximum concentration ( Cmax) or the area under the time concentration curve ( AUC), and metabolite, as amount metabolized in the liver or spleen per day normalized to organ weight. The choice of the final dose metric should be supported with mode of action information and a discussion of the most health protective.

~ Quantitative route to route extrapolation based on the data of NCI ( 1978) documented graphically and with tabular data. Dose metrics to consider include parent compound in venous blood or liver, as maximum concentration ( Cmax) or the area under the time concentration curve ( AUC), and metabolite, as amount metabolized in the liver per day normalized to liver weight. The choice of the final dose metric should be supported with mode of action information and a discussion of the most health protective. Dose response analysis to be performed using genotoxic assumption ( linear extrapolation) procedure.


[Federal Register: August 22, 2007 (Volume 72, Number 162)]
[Proposed Rules]
[Page 46939]
[DOCID:fr22au07-37]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2004-SC-0004-200706 (b); FRL-8457-1]

Approval and Promulgation of Implementation Plans South Carolina:
Revisions to Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing to approve the State Implementation Plan
(SIP) revisions submitted by the South Carolina Department of Health
and Environmental Control (SC DHEC) on November 19, 2004, for the
purpose of incorporating EPA's July 18, 1997, revisions to the National
Ambient Air Quality Standards and to ensure consistency between state
and Federal regulations. The proposed revisions consist of the
amendments published in the South Carolina State Register on September
24, 2004, revising Regulation 61-62.5, Standard Number 2, Ambient Air
Quality Standards. In the Final Rules Section of this Federal Register,
EPA is approving the State's SIP revision as a direct final rule
without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period on this document.
Any parties interested in commenting on this document should do so at
this time.

DATES: Written comments must be received on or before September 21,
2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2004-SC-0004, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2004-SC-0004'', Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier. Deliver your comments to: Nacosta C.
Ward, Regulatory Development Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia
30303-8960. Such deliveries are only accepted during the Regional
Office's normal hours of operation. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding federal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Nacosta C. Ward, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number
is<PHONE_NUMBER>. Ms. Ward can also be reached via electronic mail at
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: For additional information see the direct
final rule which is published in the Rules Section of this Federal
Register.

    Dated: July 31, 2007.
J.I. Palmer, Jr.,
Regional Administrator, Region 4.
[FR Doc. E7-16315 Filed 8-21-07; 8:45 am]

BILLING CODE 6560-50-P