E8-14528. Modification of the Voluntary Children's Chemical Evaluation Program; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA will hold a public meeting to give the stakeholders in the Voluntary Childrens Chemical Evaluation Program (VCCEP) and interested members of the public an opportunity to comment on the modifications the Agency intends to make to VCCEP. The modifications are based on the responses the Agency received to its request for comment on the implementation of the VCCEP pilot. The modifications will primarily address the timeliness and efficiency issues of the program in order to increase its productivity and ability to provide information to the public on the potential risks to children of exposure to certain chemicals. The meeting will also provide the public with an opportunity to comment on the use of the modified VCCEP approach to address certain data and assessment needs identified in EPA's review of high production volume (HPV) and mid production volume (MPV) chemicals under its Chemical Assessment and Management Program (ChAMP).

DATES:

The meeting will be held on Tuesday, July 22, 2008, from 9 a.m. to 11 a.m.

Requests to participate in the meeting must be received on or before July 17, 2008.

To request accommodation of a disability, please contact the person listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

ADDRESSES:

The meeting will be held at the Environmental Protection Agency, 1201 Constitution Ave., NW., Rm. 1153, Washington, DC 20460.

Requests to participate in the meeting, identified by docket identification (ID) number EPA-HQ-OPPT-2006-0341, may be submitted to the technical person listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Colby Lintner, 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 of 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), in particular those chemical manufacturers (including importers) that are sponsoring chemicals in VCCEP, individuals or groups concerned with chemical testing and childrens 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. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established a docket for this action under docket ID number EPA-HQ-OPPT-2006-0341. All documents in the docket are listed in the docket's index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (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. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone]. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr.

II. Background

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 December 2000 (Ref. 1) and requested chemical manufacturers and importers to participate in a pilot of the program by voluntarily sponsoring their chemical if it were among those selected by EPA. The pilot began in 2001 when companies volunteered to sponsor their chemicals in response to EPAs request.

In 2006, at what was approximately the midpoint in the implementation of the pilot phase of VCCEP, EPA sought to evaluate how well the pilot was meeting the objectives of VCCEP. To that end, EPA requested that the public submit comments on their experience with the pilot phase of VCCEP and its opinions on the progress of the pilot phase to date (Ref. 2). Additionally, EPA developed a list of questions in order to focus comments on certain features of the VCCEP pilot on which the Agency particularly wanted input. The comments EPA received were summarized and made available to the public on the VCCEP website (http://www.epa.gov/​oppt/​vccep). Some of the main comments concerned the timeliness and efficiency of the program, the chemicals selected for the pilot program, the use of a tiered approach to testing, and the use of a Peer Consultation process to review chemical assessments. Based on those comments and also internal Agency discussions, EPA has developed a list of modifications that it believes will improve the future performance of VCCEP. Although the VCCEP program will continue to operate primarily as described in the Federal Register notice launching the program (Ref. 1), certain modifications to address the main concerns of the Agency, stakeholders and the public are being contemplated by EPA. EPA wants to share and discuss the contemplated modifications with the VCCEP stakeholders and the public and listen to any additional comments. Therefore, EPA will hold a public meeting on July 22, 2008, at EPA headquarters in Washington, DC. The modifications which will be the basis for the discussions at the public meeting are as follows:

1. Chemical selection. To address the concern that the chemicals covered in the VCCEP Pilot were a set of particularly well-studied chemicals for which, in most cases, little additional assessment was needed, future VCCEP chemicals will primarily be selected from chemicals that, when assessed as part of ChAMP, are identified as being of special concern and as presenting hazard/exposure data needs that are relevant to characterizing risks to children. (A more detailed description of ChAMP is provided in this unit as well as at (http://www.epa.gov/​ChAMP). Chemicals that also meet the original VCCEP chemical selection criteria which were evidence of presence in human tissues and in relevant environmental media (e.g., indoor air, drinking water, and food) will be a particular focus of future VCCEP activity.

2. Changes to the assessment approach.

• To ensure timely completion of chemical assessments, specific due dates for sponsor assessment submissions and peer consultations will be established in sponsor commitments, including timelines for responding to follow-up actions/requests.
• To bring concerns for potential chemical risks to prompt resolution, EPA will indicate in its Tier 1 Data Needs Decision when it believes it is reasonable to combine Tiers 2 and 3 as used in the VCCEP Pilot into a single tier. EPA recognizes that a three tier approach may be acceptable when the sponsor can demonstrate that it is sound scientifically and that a delay in the public availability of Tier 3 data would not have potential public health impacts.

3. Peer consultation modifications. Under the modified approach envisioned by EPA, the following points would be agreed to in advance by EPA and the sponsoring company or the VCCEP approach will not be used for purposes of obtaining needed information.

• The peer consultation process will remain the mechanism to review sponsor-generated assessments and the sponsor will be responsible for contracting with an independent third party to manage the peer consultation and will bear the associated financial burdens.
• Distinguishing between “data needs” and “data gaps,” which was a useful outcome of the VCCEP Pilot, will be used in VCCEP peer consultations.
• So that sponsors can better address concerns identified in the peer consultation before EPA develops a Data Needs Decision, the sponsor will promptly develop revised assessments that respond to issues identified in the Peer Consultation Meeting Report and make them publicly available. The sponsor will amend its assessments within 90 days after the Peer Consultation Meeting Report is made available to them. EPA will use the amended assessments and the Peer Consultation Meeting Report to make its Data Needs Decision within 90 days of receipt of the revised assessments. The sponsor will then have 4 months after the receipt of the Data Needs Decision, as is current practice in the VCCEP Pilot, to decide whether to commit to the next tier of assessment, if necessary.

The meeting on July 22, 2008, will also provide the public with an opportunity to comment on the use of the modified VCCEP approach to address certain data and assessment needs identified in EPA's review of HPV and MPV chemicals under ChAMP, including environmental toxicity, environmental fate, and aspects that may go beyond mammalian toxicity. ChAMP was established by EPA as a mechanism to partially address the Security and Prosperity Partnership (SPP) commitments announced by the United States, Canada, and Mexico in Montebello, Canada in August 2007. These commitments included a number of national and regional commitments to trilateral cooperation in the assessment and management of chemicals in North America. The United States has committed, by 2012, to assess and initiate needed actions on chemicals produced above 25,000 pounds per year (lb./yr.) in the country. High production volume (HPV) chemicals are manufactured and imported in quantities greater than 1,000,000 lb./yr. and moderate production volume (MPV) chemicals are manufactured and imported in quantities greater than 25,000 lb./yr. but less than 1,000,000 lb./yr. EPA's ongoing efforts under ChAMP to screen and prioritize the risks of chemicals will be a major component of EPA's efforts to meet its SPP commitments.

EPA believes that an adaptation of the modified VCCEP approach could provide a flexible framework to further evaluate certain chemicals identified by EPA in its ChAMP screening-level assessments as presenting special concerns and associated follow-up action involving hazard/exposure data development or assessment.

EPA believes that in most instances, the detailed evaluation of SPP follow-up cases under the modified VCCEP approach should generally begin at Tier 1. Sponsor-developed assessments should build on EPA's SPP screening-level assessments, consider EPA recommended follow-up actions (including conducting higher tier tests specifically identified as priorities by EPA on the basis of its initial assessment), and include a more highly developed quantification of exposures.

III. How Can I Request to Participate in this Meeting?

You may submit a request to participate in this meeting to the technical person listed under FOR FURTHER INFORMATION CONTACT. Do not submit any information in your request that is considered CBI. Requests to participate in the meeting, identified by docket ID number EPA-HQ-OPPT-2006-0341, must be received on or before July 17, 2008.

IV. References

1. EPA. Voluntary Children's Chemical Evaluation Program; Notice. Federal Register (65 FR 81699, December 26, 2000) (FRL-6758-5). Available on-line at: http://www.epa.gov/​fedrgstr.

2. EPA. Implementation of the Pilot Voluntary Children's ChemicalEvaluation Program; Request for Comment; Notice. Federal Register (71 FR 67121, November 20, 2006) (FRL-8057-1). Available on-line at: http://www.epa.gov/​fedrgstr.

List of Subjects

• Environmental protection
• Chemicals
• Child Health

Dated: June 20, 2008.

James B. Gulliford

Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances