E7-22895. Endocrine Disruptor Screening Program; Workshop to Discuss Draft Policies and Procedures

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is convening a 1-day public workshop to discuss the Agency's draft administrative policies and procedures for completing the initial screening and testing under EPA's Endocrine Disruptor Screening Program (EDSP) and the burden and cost estimates for the related information collection activities. In two forthcoming notices in the Federal Register, EPA will announce the availability for public review and comment of: (1) The draft policies and procedures EPA is considering adopting for conducting the initial screening and testing under the EDSP and (2) the draft Information Collection Request (ICR) for the initial screening and testing. The purpose of the public workshop is to allow the public to ask questions and for EPA to provide further explanation about these aspects of the EDSP, which in turn may facilitate the preparation of comments.

DATES:

The meeting is on Monday, December 17, 2007, from 9 a.m. to 5 p.m.

Special accommodations: For information on access or services for individuals with disabilities, and to request accommodation of a disability, please contact the person listed under FOR FURTHER INFORMATION CONTACT 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, Conference Center—Lobby Level, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT:

William Wooge, Office of Science Coordination and Policy (OSCP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Who Should Attend?

You may be interested in attending this workshop if you produce, manufacture, use, or import pesticide/agricultural chemicals and other chemical substances; or if you are or may otherwise be involved in the testing of chemical substances for potential endocrine effects. To determine whether you or your business may have an interest in this workshop you should carefully examine section 408(p) of the Federal, Food, Drug, and Cosmetic Act (FFDCA). [21 U.S.C. 346a(p)]

II. What is the EDSP?

The EDSP was established in 1998 to carry out the mandate in section 408(p) of FFDCA [21 U.S.C. 346a et. seq.], which directed EPA “to develop a screening program . . . to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate.” If a substance is found to have an effect, FFDCA section 408(p)(6) directs the administrator to take action under available statutory authority to ensure protection of public health. That is, the ultimate purpose of the EDSP is to provide information to the Agency that will allow the Agency to evaluate the risks associated with the use of a chemical and take appropriate steps to mitigate any risks. The necessary information includes identifying any adverse effects that might result from the interaction of a substance with the endocrine system and establishing a dose-response curve. Section 1457 of the Safe Drinking Water Act (SDWA) also authorizes EPA to screen substances that may be found in sources of drinking water, and to which a substantial population may be exposed, for endocrine disruption potential. [42 U.S.C. 300j-17]

EPA currently is implementing its EDSP in three major parts that are being developed in parallel and with substantial work on each well underway. This document announces a public workshop related specifically to the third component of the EDSP (i.e., policies and procedures). The three parts are briefly summarized as follows:

1. Assay validation. Under FFDCA section 408(p), EPA is required to use “appropriate validated test systems and other scientifically relevant information” to determine whether substances may have estrogenic effects in humans. EPA is validating assays that are candidates for inclusion in the Tier 1 screening battery and Tier 2 tests, and will select the appropriate screening assays for the Tier 1 battery based on the validation data. Validation is defined as the process by which the reliability and relevance of test methods are evaluated for the purpose of supporting a specific use. The status of each assay can be viewed on the EDSP website in the Assay Status table: http://www.epa.gov/​scipoly/​oscpendo/​pubs/​assayvalidation/​status.htm. In addition, on July 13, 2007, EPA published a Federal Register document that outlined the approach EPA intends to take for conducting the peer reviews of the Tier 1 screening assays and Tier 2 testing assays and EPA's approach for conducting the peer review of the Tier 1 battery (72 FR 38577) (FRL-8138-4). EPA also announced the availability of a “list server” (Listserv) that will allow interested parties to sign up to receive e-mail notifications of EDSP peer review updates, including information on the availability of peer review materials to be posted on the EDSP website.

2. Priority setting. EPA described its priority setting approach to select pesticide chemicals for initial screening on September 27, 2005 (70 FR 567449) (FRL-7716-9), and announced the draft list of initial pesticide active ingredients and pesticide inerts to be considered for screening under FFDCA on June 18, 2007 (72 FR 33486) (FRL-8129-3). The Agency expects to finalize this initial list of chemicals before screening is initiated in 2008. More information on EPA's priority setting approach and the draft list of chemicals is available at http://www.epa.gov/​scipoly/​oscpendo/​prioritysetting. The first 73 pesticide chemicals to undergo screening is also referred to as “initial screening” in this document.

3. Policies and procedures. A forthcoming Federal Register document will describe EPA's draft policies relating to:

• The procedures that EPA is considering using to issue orders.
• How joint data development, cost sharing, data compensation, and data protection would be addressed.
• Procedures that order recipients would use to respond to an order.
• Other related procedures and/or policies.

In addition, EPA has developed an ICR to obtain the necessary approval under the Paperwork Reduction Act (PRA) for the related paperwork activities. The ICR document, which describes the information collection activities and related estimated paperwork burden and costs, will also be announced for public review and comment in a forthcoming Federal Register document.

III. Why Hold a Workshop?

EPA is holding this workshop to facilitate the public's comments on the draft policies and procedures that EPA is considering for conducting the initial screening and testing under the EDSP, as well as the Agency's estimated burden and costs for the related paperwork activities. The workshop is an opportunity for the public, stakeholders and the regulated community to discuss the draft EDSP policies and procedures and the draft ICR documents that are expected to be released for public comment shortly. Although the workshop is not intended to collect oral comments, the Agency intends to consider the discussion and will be documenting the discussion for the public docket.

In addition to attending this workshop, EPA invites you to provide comments on the draft policies and procedures and the draft ICR for initial EDSP screening and testing. The Federal Register documents announcing their availability will include a specific list of questions on which the Agency is specifically seeking comment, along with instructions for how to submit comments on those documents. This list, along with an agenda for the workshop, will be posted on the Agency's website and provided at the workshop. EPA will consider all comments received and EPA will announce the availability of the final versions of the policies and procedures and the ICR for the initial EDSP screening and testing in the Federal Register.

List of Subjects

• Environmental protection
• Chemicals
• Endocrine disruptors
• Pesticides and pests
• Reporting and recordkeeping

Dated: November 16, 2007.

James Jones,

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