Endocrine Disruptor Screening Program; Workshop to Discuss Draft Policies and Procedures, 65732-65733 [E7-22895]

Download as PDF 65732 Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Notices Rating EC2. EIS No. 20070445, ERP No. D–USN– E11063–00, Shock Trail of the MESA VERDE (LPD 19), San Antonio (LPD 17) Class Ship designated as the Shock Ship for Proposed Shock Trail, Possible Offshore Locations are Naval Station Norfolk, VA; Naval Station Mayport, FL; and Naval Air Station Pensacola, FL. Summary: EPA expressed environmental concerns about impacts to avian and marine species. Rating EC1. EIS No. 20070364, ERP No. DS–COE– E01013–FL, Rock Mining in the Lake Belt Region Plan, Continuance of Limestone Mining Construction, section 404 Permit, Miami-Dade County, FL. Summary: EPA expressed environmental concerns about water quality, wetland and mining-related seepage impacts, and requested additional mitigation and monitoring measures. Rating EC2. Dated: November 19, 2007. Robert W. Hargrove, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. E7–22851 Filed 11–21–07; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [ER–FRL–6693–2] mstockstill on PROD1PC66 with NOTICES Environmental Impact Statements; Notice of Availability Responsible Agency: Office of Federal Activities, General Information, (202) 564–7167 or http://www.epa.gov/ compliance/nepa/ Weekly receipt of Environmental Impact Statements Filed 11/12/2007 through 11/16/2007 Pursuant to 40 CFR 1506.9. EIS No. 20070495, Final Supplement, APH, 00, Importation of Solid Wood Packing Material, To Reevaluate and Refine Estimates of Methyl Bromide Usage in the Treatment, Implementation, United States. Wait Period Ends: 12/24/2007. Contact: David A. Bergston, 301–734–6103. EIS No. 20070496, Draft EIS, FRC, 00, Fayetteville/Greenville Expansion Project, Construction and Operation of the Natural Gas Pipeline Facilities in Arkansas and Mississippi. Comment Period Ends: 01/07/2008. Contact: Andy Black, 1–866–208– 3372. EIS No. 20070497, Draft EIS, FAA, CA, Horizon Air Service to Mammoth Yosemite Airport Project, Proposed Operations Specifications VerDate Aug<31>2005 16:16 Nov 21, 2007 Jkt 214001 Amendment to Provide Scheduled Air Service, Town of Mammoth Lakes, Mono County, CA. Comment Period Ends: 01/11/2008. Contact: Chuck Cox, 425–227–2243. EIS No. 20070498, Draft EIS, FHW, UT, I–15 Corridor Project, Transportation Improvement from Utah County to Salt Lake County, UT. Comment Period Ends: 01/11/2008. Contact: Carlos Machado, 801–963–0182. EIS No. 20070499, Final EIS, FRC, 00, Klamath Hydroelectric Project, Continued Operation for Hydropower License FERC No. 2082–27, Klamath River, Klamath County, OR and Siskiyou County, CA. Wait Period Ends: 12/24/2007. Contact: John Mudre, 202–502–8902. Amended Notices EIS No. 20070409, Draft EIS, AFS, MT, Beartooth Ranger District Travel Management Planning, Proposing to Designate Routes for Public Motorized Use, and Change Management of Pack and Saddle Stock on Certain Trail, Beartooth Ranger District, Custer National Forest, Carbon, Stillwater, Sweet Grass, and Park Counties, MT. Comment Period Ends: 12/19/2007. Contact: Doug Epperly, 406–657–6205 Ext 225. Revision for FR Notice Published 10/05/2007: Extending Comment Period from 11/19/2007 to 12/19/2007. EIS No. 20070478, Final EIS, AFS, AK, Helicopter Access to Conduct Forest Inventory and Analysis (FIA) in Wilderness, in Tongas and Kedgwick National Forest, AK. Wait Period Ends: 12/24/2007. Contact: Ken Post, 907–586–8796. Review to FR Notice Published 11/09/2007: Extending Wait Period from 12/10/2007 to 12/ 24/2007 and Correction to Title. Dated: November 19, 2007. Robert W. Hargrove, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. E7–22852 Filed 11–21–07; 8:45 am] 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: (202) 546–8476; e-mail address: wooge.william@epa.gov. SUPPLEMENTARY INFORMATION: AGENCY: 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)] SUMMARY: EPA is convening a 1–day public workshop to discuss the 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.], BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2007–1080; FRL–8341–3] Endocrine Disruptor Screening Program; Workshop to Discuss Draft Policies and Procedures Environmental Protection Agency (EPA). ACTION: Notice. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\23NON1.SGM 23NON1 mstockstill on PROD1PC66 with NOTICES Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Notices 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 VerDate Aug<31>2005 16:16 Nov 21, 2007 Jkt 214001 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. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 65733 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. [FR Doc. E7–22895 Filed 11–21–07; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OW–2007–1126; FRL–8498–8] Notice of Availability and Request for Comment on Draft Plan of Action for Reducing, Mitigating, and Controlling Hypoxia in the Northern Gulf of Mexico and Improving Water Quality in the Mississippi River Basin Environmental Protection Agency (EPA). ACTION: Notice of Availability and Request for Public Comment. AGENCY: SUMMARY: The Environmental Protection Agency (EPA), on behalf of the Mississippi River/Gulf of Mexico Watershed Nutrient Task Force (Task Force), invites public comments on the draft Gulf Hypoxia Action Plan 2008 for Reducing, Mitigating, and Controlling Hypoxia in the Northern Gulf of Mexico and Improving Water Quality in the Mississippi River Basin (2008 Action Plan). The Task Force is comprised of senior policymakers from eight Federal agencies, nine States, and two Tribal governments. The Action Plan is the result of several years of study and discussion by the members of the Task Force and many interested officials and E:\FR\FM\23NON1.SGM 23NON1

Agencies

[Federal Register Volume 72, Number 225 (Friday, November 23, 2007)]
[Notices]
[Pages 65732-65733]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22895]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-1080; FRL-8341-3]


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: 
(202) 546-8476; e-mail address: wooge.william@epa.gov.

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.],

[[Page 65733]]

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.

[FR Doc. E7-22895 Filed 11-21-07; 8:45 am]
BILLING CODE 6560-50-S