E6-19574. Implementation of the Pilot Voluntary Children's Chemical Evaluation Program; Request for Comment

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is requesting comment on the implementation of the pilot phase of the Voluntary Children's Chemical Evaluation Program (VCCEP). VCCEP was designed to collect health effects, exposure, and risk information on chemicals to which children are likely to be exposed, and to make that information available to the public so the public may better understand the potential health risks to children associated with certain chemical exposures. EPA announced the program in December 2000 and the pilot began in 2001 when companies volunteered to sponsor their chemicals under VCCEP. At what is approximately the midpoint in the implementation of the pilot phase of VCCEP, EPA is preparing to evaluate how well it is meeting its objectives for VCCEP. To this end, EPA is seeking comments from participants and observers about the operations and experience under the VCCEP pilot to this point. If requested, EPA will hold a public meeting to take comment on the implementation of the pilot phase of VCCEP.

DATES:

Comments must be received on or before January 19, 2007.

Requests for a public meeting must be received on or before December 11, 2006.

ADDRESSES:

To submit comments: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2006-0341, by one of the following methods.

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Hand Delivery: OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2006-0341. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is [phone]. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2006-0341. EPA's policy is that all comments received will be included in the public docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket, EPA Docket Center (EPA/DC). The EPA/DC suffered structural damage due to flooding in June 2006. Although the EPA/DC is continuing operations, there will be temporary changes to the EPA/DC during the clean-up. The EPA/DC Public Reading Room, which was temporarily closed due to flooding, has been relocated in the EPA Headquarters Library, Infoterra Room (Room Number 3334) in EPA West, located at 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone]. EPA visitors are required to show photographic identification and sign the EPA visitor log. Visitors to the EPA/DC Public Reading Room will be provided with an EPA/DC badge that must be visible at all times while in the EPA Building and returned to the guard upon departure. In addition, security personnel will escort visitors to and from the new EPA/DC Public Reading Room location. Up-to-date information about the EPA/DC is on the EPA website at http://www.epa.gov/​epahome/​dockets.htm.

To request a public meeting: Submit your request, identified by docket ID number EPA-HQ-OPPT-2006-0341, to Catherine Roman by one of the following methods:

• E-mail address: [e-mail].
• Mail: Chemical Control Division (7405M), Office Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, ATTN: Catherine Roman.
• Hand Delivery: 1201 Constitution Ave., NW., Washington, DC, EPA East, ATTN: Catherine Roman. Ask the reception desk to call [phone]. Such deliveries should be made during normal working hours, 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

For technical information contact: Catherine Roman, Chemical Control Division (7405M), Office Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. This action may, however, be of particular interest to those chemical manufacturers (including importers) who produce or import chemical substances that are subject to the Toxic Substances Control Act (TSCA), individuals or groups concerned with chemical testing and children's health, and animal welfare groups. Because other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at the estimate.

vi. Provide specific examples to illustrate your concerns, and suggested alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. Background

A. What Action is the Agency Taking?

EPA is requesting comment from stakeholders, interested parties, and the general public on the implementation of the VCCEP pilot and is also evaluating the progress of the VCCEP pilot toward meeting its objectives. VCCEP was designed to collect health effects, exposure, and risk information on chemicals to which children are likely to be exposed, and to make that information available to the public so the public may better understand the potential health risks to children associated with certain chemical exposures, and to allow EPA and others to evaluate the risks of these chemicals so that mitigation measures may be taken as appropriate.

EPA announced VCCEP in a December 26, 2000 Federal Register notice (Ref. 1) and requested chemical manufacturers and importers to participate in a VCCEP pilot by voluntarily committing to sponsor an information collection on 23 chemicals. The VCCEP pilot is intended to allow EPA to gain insight as to how best to design and implement VCCEP in order to effectively provide the Agency and the public with the means to understand the potential health risks to children associated with exposure to chemicals to which children may be exposed. EPA intends the VCCEP pilot to be the means of identifying efficiencies which can be applied to the subsequent implementation of VCCEP.

Several factors were considered in selecting the 23 chemicals for the VCCEP pilot; they included substantial production/importation (one million lbs. or more per year), presence in the environment, and biomonitoring evidence of presence in humans. A detailed description of the selection process used by EPA is in the document entitled Methodology for Selecting Chemicals for the Voluntary Children's Chemical Evaluation Program (VCCEP) Pilot (Ref. 2).

The requested commitment for the VCCEP pilot was for Tier 1 information, with the potential for EPA to request participants to make additional commitments to Tier 2 and Tier 3 information based on an evaluation of the Tier 1 submission. As part of their Tier 1 commitments, sponsors were asked to include an expected submission date that, as described in the December 2000 notice, is based on the amount of time EPA considered necessary to gather the information (or perform testing, if necessary) and prepare the assessments. Other guidance on timeliness provided in the December 2000 notice included the following:

• Within 6 months from the publication of the December 2000 notice was the recommended deadline to commit to Tier 1.
• Within 4 months after announcing EPA's Data Needs Decision was the recommended deadline to commit to upper tiers.
• Within 1 month after receiving a chemical assessment was EPA's goal to make it publicly available on the VCCEP website.

During 2001, 35 companies and 10 consortia voluntarily committed to sponsor 20 of the 23 chemicals in the VCCEP pilot. Three of the twenty-three chemicals were not sponsored and remain unsponsored. Also in 2001, EPA arranged for a third party, Toxicology for Excellence in Risk Assessment (TERA), to organize and facilitate public Peer Consultation meetings to evaluate the chemical assessments to be submitted by the chemical sponsors. At a Peer Consultation meeting, a panel of scientific experts with extensive and broad experience in toxicity testing, exposure evaluation, or the specific chemical discuss the chemical assessment and offer their opinions on its adequacy and possible additional data needs. This discussion is held at a public meeting where interested parties may also present comments. TERA prepares a report summarizing the opinions expressed at the public meeting and submits this report to EPA. EPA considers this report when it reviews the chemical assessment prior to forming its decision regarding additional data needs of the chemical.

In terms of progress, by the end of August 2006, the VCCEP pilot sponsors had submitted Tier 1 chemical assessments for 12 of the 20 chemicals; all 12 chemical assessments had been evaluated in public Peer Consultation meetings; summary reports of the Peer Consultation meetings for the 12 chemical assessments were made available; and EPA had reviewed the Peer Consultation reports and issued Data Needs Decisions for 6 of the 12 chemicals. EPA is in the process of developing Data Needs Decisions for the remaining 6 chemicals.

In its six Data Needs Decisions, EPA decided that additional data were needed for three chemicals. A consortium of three companies organized by the American Chemistry Council (ACC) has agreed to proceed to Tier 2 of the VCCEP pilot and sponsor the additional information collection for one of the chemicals. The Tier 1 sponsor of the other two chemicals with additional data needs informed the Agency that it will not commit to participate in Tier 2 for those chemicals. For the other three chemicals for which Data Needs Decisions have been issued, EPA concluded that the Tier 1 assessments provide sufficient information to adequately characterize the risk to children of exposure to those chemicals, and EPA considers the evaluation of these three chemicals to be completed for purposes of the VCCEP pilot. To summarize the activity and progress of the VCCEP pilot through August 2006, the table in this unit indicates how many chemicals have completed successive stages in the VCCEP pilot:

Stages in the VCCEP Process	Number of chemicals which have completed each stage
Sponsor commitment to provide Tier 1 information	20
Tier 1 chemical assessment submitted	12 *
Tier 1 chemical assessment has gone through Peer Consultation	12
Peer Consultation report available	12
EPA issued a Data Needs Decision (3 chemicals had Tier 2 data needs, 3 chemicals did not have Tier 2 data needs.)	6
Received a sponsor commitment to provide Tier 2 information	1
OR
Agency informed it will not receive sponsor commitment to provide Tier 2 information	2
* As noted on the VCCEP website, the submission of chemical assessments for four chemicals (ethylbenzene, ethylene dichloride, perchloroethylene, and trichloroethylene) has been delayed due to other commitments to develop the data as part of another effort or program.

The most recent information on the progress of specific chemicals in the VCCEP pilot is presented on the VCCEP website (http://www.epa.gov/​chemrtk/​vccep). Since the Fall of 2001, EPA has kept the public informed of activities in the VCCEP pilot through the VCCEP website. The website describes VCCEP and how it was developed. It also lists the chemicals and their sponsors, the date of sponsor commitments to each tier, the submission dates of chemical assessments, the dates of upcoming public Peer Consultation meetings, and the completion dates of Peer Consultation reports and EPA's Data Needs Decisions. Most importantly, the website makes the cited information available to the public by providing links to the chemical assessments, the Peer Consultation reports, and EPA's Data Needs Decisions.

In terms of timeliness for EPA, TERA, and the sponsors meeting the scheduled goals for the VCCEP pilot, the following observations are made:

• All sponsors committed to Tier 1 by the 6-month deadline.
• As part of their Tier 1 commitments, the sponsors for 5 of the 12 chemicals for which EPA has received a chemical assessment as of August 2006, provided a projected submission date for their Tier 1 chemical assessment. The chemical assessment for only one of the five chemicals (decabromodiphenyl ether) was received by EPA by the projected submission date.
• Some of the projected submission dates originally provided by the sponsors were subsequently revised at the request of the sponsor, or due to TERA scheduling of Peer Consultation meetings.
• EPA made all the chemical assessments available on the VCCEP website within 1 month of receipt.
• Although a recommended deadline for scheduling the Peer Consultation meetings was not specified in the December 2000 notice, the meetings for the 12 chemicals for which EPA has received a chemical assessment as of August 2006 were held within an average of 2.4 months of receiving the chemical assessment.
• Although a recommended deadline for TERA to issue its report summarizing a Peer Consultation meeting was not specified in the December 2000 notice, TERA issued its reports for the 12 chemicals for which EPA has received a chemical assessment as of August 2006, within an average of 4.1 months after each meeting.

The notice announcing VCCEP (Ref. 1, p. 81714) stated that EPA expected to evaluate the VCCEP pilot at 3 and 6 years after its initiation. EPA chose not to conduct an evaluation at 3 years because a sufficient number of chemicals had not gone through the public Peer Consultation process and, as a consequence of this, there was insufficient information to prepare a useful evaluation. Consequently, EPA decided to conduct a single evaluation at a point 5 years, approximately midway, into the program (i.e., 2006).

B. What is the Agency's Authority for Taking this Action?

Congress gave EPA the authority to implement TSCA for the purpose of protecting human health and the environment, in part, by requiring testing and, if necessary, by restricting the manufacture, processing, distribution in commerce, use, or disposal of certain chemical substances. VCCEP is a voluntary program which focuses on collecting information and developing data necessary to protect children from risks associated with chemical substances to which they are likely to be exposed. This notice seeks public involvement in a midpoint evaluation of how the VCCEP pilot is meeting its objectives and the overall objectives of VCCEP.

III. Request for Comment

EPA is requesting comment from stakeholders, interested parties, and the general public on the implementation of the VCCEP pilot, what modifications might be made to make the VCCEP pilot run more efficiently, and how well the VCCEP pilot is meeting the objectives of VCCEP. The main objectives of VCCEP are:

• To collect exposure, hazard, and risk information on chemicals to which children are likely to be exposed.
• To make the information available to the public so the public may better understand the potential health risks to children associated with certain chemical exposures.

The Agency is particularly interested in receiving your feedback with regard to the list of questions in this Unit III. Commenters should not feel that they must confine their comments to the following specific questions, nor should they feel they must respond to any or all of the questions. Commenters, however, should attempt to provide comments on the aspects of the VCCEP pilot with which they have had experience and/or have formed a definite opinion. To be most helpful in the Agency's evaluation, please provide enough detail to explain or illustrate conclusions that you have reached based on your experiences.

• Have the hazard, exposure, and risk assessments submitted by the sponsors provided sufficient information to enable the Peer Consultation panel to adequately evaluate these aspects as they relate to children from the chemicals in question? Have the Data Needs Assessments prepared by the sponsors been fair and unbiased?
• Has the Peer Consultation process been open, transparent, timely, and useful as a forum for scientists and experts from various stakeholder groups to exchange views on sponsors' assessments and recommended data needs? How might it be improved?
• Has the Peer Consultation process been efficient? If not, what improvements could be made?
• Has the Peer Consultation panel adequately considered both toxicology and exposure information in developing its results?
• Does the Peer Consultation process provide a scientifically rigorous and effective means for eliciting comments and opinions from the assembled experts on the Peer Consultation panel and those attending the public meeting, and for assisting EPA in developing decisions?
• Have the communications related to the Peer Consultation process, activities and outcomes been effective and have they facilitated public understanding and use of the information generated from this process?
• Should the time allowed for sponsor commitment remain the same, i.e., 6 months to commit to Tier 1, and 4 months to commit to subsequent Tiers? (The commitment period is the time for the sponsor to decide whether to participate in VCCEP, form a consortium, and notify the Agency.)
• How can the timeliness of activities under the VCCEP pilot be improved? Should specific due dates be established for each step in the process? If so, how should a missed due date be addressed?
• Should the sponsor be requested to commit to more than one tier at a time? Is it better to run the VCCEP pilot with commitments at each tier, i.e., three commitments, or to run the VCCEP pilot with two commitments, i.e., to Tier 1 and to Tiers 2/3?
• Are there any ways in which EPA's contributions to the VCCEP pilot's evaluation and data needs decision process could be improved or made more effective?
• Has the VCCEP pilot made significant progress with respect to its objectives?
• The VCCEP pilot was designed to ensure that health effects, exposure, and risk information are made available to the public to enable a better understanding of the potential health risks to children associated with certain chemical exposures. Does the VCCEP website provide easy access to and adequate explanation of the information generated by the VCCEP pilot?

Commenters should follow the guidance provided in Unit I.B. and under ADDRESSES when preparing and submitting their comments.

IV. Comments Document

EPA will prepare a Comments Document summarizing the comments received in response to this notice and at a public meeting, if held. The Comments Document will identify any common themes and will assist EPA in determining what modifications might be made to make the program run more efficiently and/or better meet the objectives of VCCEP. Significant program modifications which the Agency is considering as a result of this evaluation will be discussed with stakeholders before implementing.

At this time, once the Comments Document is complete, EPA expects to make the Comments Document available to the public on the VCCEP website. The Comments Document will not be published in the Federal Register, nor will a notice of availability be published in the Federal Register announcing its appearance on the VCCEP website. However, if you provide your e-mail address, EPA will notify you by e-mail when the Comments Document is available on the VCCEP website at http://www.epa.gov/​chemrtk/​vccep.

V. Public Meeting

If there are requests to do so, EPA will hold a public meeting to discuss and take comment on the implementation of the VCCEP pilot. To request a public meeting, follow the directions under ADDRESSES.

VI. Materials in the Docket

An official docket was established for this VCCEP pilot evaluation under docket ID number EPA-HQ-OPPT-2006-0341. The docket includes information considered by EPA in developing this notice such as the documents specifically referenced in this action, any public comments received, and other information related to this action. In addition, interested parties should consult documents that are referenced in the documents that EPA has placed in the public docket, regardless of whether these referenced documents are physically located in the public docket. For assistance in locating documents that are referenced in documents that EPA has placed in the public docket, but that are not physically located in the docket, please consult the technical contact listed under FOR FURTHER INFORMATION CONTACT. The public docket is available for review as specified under ADDRESSES.

1. EPA. Voluntary Children's Chemical Evaluation Program. Federal Register (65 FR 81700, December 26, 2000) (FRL-6758-5). Available on-line at: http://www.epa.gov/​chemrtk/​vccep/​pubs/​ts00274d.pdf.

2. EPA. Methodology for Selecting Chemicals for the Voluntary Children's Chemical Evaluation Program (VCCEP) Pilot. December 5, 2000. Available on-line at: http://www.epa.gov/​chemrtk/​vccep/​vccepmth.htm.

List of Subjects

• Environmental protection
• Chemicals
• Child health

Dated: November 9, 2006.

James B. Gulliford,

Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.