E6-9458. Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Data Submissions for the Voluntary Children's Chemical Evaluation Program (VCCEP); EPA ICR No. 2055.02, OMB No. 2070-0165

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that the following Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval: Data Submissions for the Voluntary Children's Chemical Evaluation Program (VCCEP); EPA ICR No. 2055.02, OMB No. 2070-0165. The ICR, which is abstracted below, describes the nature of the information collection activity and its expected burden and costs.

DATES:

Additional comments may be submitted on or before July 17, 2006.

ADDRESSES:

Submit your comments, referencing docket ID Number EPA-HQ-OPPT-2005-0061 to (1) EPA online using www.regulations.gov (our preferred method), by e-mail to [e-mail] or by mail to: Document Control Office (DCO), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, Mailcode: 7408-M, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-554-1404; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On December 13, 2005 (70 FR 73741), EPA sought comments on this renewal ICR. EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments during the comment period. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice.

EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OPPT-2005-0061, 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), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is 202-566-1744, and the telephone number for the Pollution Prevention and Toxics 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, key in the docket ID number identified above and click submit.

EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in www.regulations.gov as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in www.regulations.gov. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in www.regulations.gov. For further information about the electronic docket, go to www.regulations.gov.

Title: Data Submissions for the Voluntary Children's Chemical Evaluation Program (VCCEP).

ICR Numbers: EPA ICR No. 2055.02, OMB Control No. 2070-0165

ICR Status: This is a request to renew an existing approved collection. This ICR is scheduled to expire on September 30, 2006. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB.

Abstract: VCCEP is a voluntary program intended to provide data to enable the public to understand the potential health risks to children associated with certain chemical exposures. EPA has asked companies that manufacture and/or import 23 chemicals that have been found in human tissues and the environment to volunteer to sponsor their evaluation in VCCEP. VCCEP consists of three tiers which a sponsor may commit to separately. Thus far, EPA has received Tier 1 commitments for 20 chemicals. As part of their sponsorship, companies will submit commitment letters, collect and/or develop health effects and exposure information on their chemical(s), integrate that information in a risk assessment, and develop a “Data Needs Assessment.” The Data Needs Assessment will discuss the need for additional data, which could be provided by the next tier, to fully characterize the risks the chemical may pose to children.

The information submitted by the sponsor will be evaluated by a group of scientific experts with extensive, relevant experience in toxicity testing and exposure evaluations, a Peer Consultation Group. This Group will forward its opinions to EPA and the sponsor(s) concerning the adequacy of the assessments and the need for development of any additional information to fully assess risks to children. EPA will consider the opinions of the Peer Consultation Group and announce whether additional higher tier information is needed. Sponsors and the public will have an opportunity to comment on EPA's decision concerning data needs. EPA will consider these comments and issue a final decision. If the final decision is that additional information is needed, sponsors will be asked to volunteer to provide the next tier of information. If additional information is not needed, the risk communication and, if necessary, risk management phases of the program will be initiated.

Responses to the collection of information are voluntary. Respondents may claim all or part of a notice as CBI. EPA will disclose information that is covered by a CBI claim only to the extent permitted by, and in accordance with, the procedures in 40 CFR part 2.

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 numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 231.4 hours per response. 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. This includes the time needed to review instructions; develop, acquire, install and utilize technology and systems for the purposes of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: Manufacturers, processors, importers, or distributors in commerce of certain chemical substances or mixtures who have volunteered to sponsor a chemical under the VCCEP.

Frequency of Collection: On occasion.

Estimated average number of responses for each respondent: 3.5.

Estimated No. of Respondents: 20.

Estimated Total Annual Burden on Respondents: 106,256 hours.

Estimated Total Annual Costs: $8,973,067.

Changes in Burden Estimates: There is a decrease of 48,076 hours (from 154,332 hours to 106,256 hours) in the total estimated respondent burden compared with that identified in the information collection most recently approved by OMB. This decrease represents the net effect of several changes in estimates and assumptions made from the previous VCCEP ICR, based on recent experiences with the VCCEP pilot. First, the estimated number of chemicals participating in the program was reduced from 23 to 20, based on actual participation. Second, because the Tier 1 Peer Consultation Documents submitted thus far to EPA have been so comprehensive (e.g., many have contained information on Tier 2- and Tier 3-level tests), EPA is estimating that fewer chemicals will advance to the higher tiers. This decrease is an adjustment.

Dated: June 9, 2006.

Oscar Morales,

Director, Collection Strategies Division.