Endocrine Disruptor Screening Program; Weight-of-Evidence Guidance Document; Notice of Availability, 60022-60023 [2011-24893]

Download as PDF 60022 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Notices ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2010–0877; FRL–8890–7] Endocrine Disruptor Screening Program; Weight-of-Evidence Guidance Document; Notice of Availability Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: EPA’s Endocrine Disruptor Screening Program (EDSP) is announcing the availability of a final guidance document titled, ‘‘Weight-ofEvidence: Evaluating Results of EDSP Tier 1 Screening to Identify the Need for Tier 2 Testing.’’ This weight-of-evidence (WoE) guidance document was revised based on public and peer review comments and existing peer-reviewed EPA guidelines. This guidance document provides basic principles and criteria for application of a WoE approach to evaluate results from the battery of Tier 1 screening assays along with other scientific and technical information relevant to Tier 1 screening to determine whether or not a chemical has the potential to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal pathways of the endocrine system. The combined results and information will also be used to identify which tests and information may be needed for Tier 2 testing. FOR FURTHER INFORMATION CONTACT: For technical information contact: Don Bergfelt, Office of Science Coordination and Policy (7203M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; telephone number: (202) 564– 8472; e-mail address: bergfelt.don@epa.gov. For general information contact: The TSCA–Hotline, ABVI–Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; e-mail address: TSCAHotline@epa.gov. SUPPLEMENTARY INFORMATION: SUMMARY: sroberts on DSK5SPTVN1PROD with NOTICES I. General Information A. Does this action apply to me? This action is directed to the public in general. You may be potentially affected by this action if you produce, manufacture, use, consume, work with, or import pesticide chemicals. To determine whether you or your business may be affected by this action, you should carefully examine section 408(p) of FFDCA, 21 U.S.C. 346a(p). Potentially affected entities may include, but are not limited to: VerDate Mar<15>2010 18:20 Sep 27, 2011 Jkt 223001 • Chemical manufacturers, importers and processors (NAICS code 325), e.g., persons who manufacture, import or process chemical substances. • Pesticide, fertilizer, and other agricultural chemical manufacturers (NAICS code 3253), e.g., persons who manufacture, import or process pesticide, fertilizer and agricultural chemicals. • Scientific research and development services (NAICS code 5417), e.g., persons who conduct testing of chemical substances for endocrine effects. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. 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 a copy of this document and other related information? EPA has established a docket for this action under docket identification (ID) number EPA–HQ–OPPT–2010–0877; FRL–8890–7. All documents in the docket are listed in the docket index available at https://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 https:// 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 legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. 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 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 provided an EPA/DC badge that must be visible at all times in the building and returned upon departure. II. Overview of Revision Process The Agency submitted a draft WoE guidance document for evaluating the results of EDSP Tier 1 screening for public review and comment as described in a Federal Register notice issued November 4, 2010 (75 FR 67963) (FRL–8849–8). Initially the commenting period was for 60 days, but was extended for an additional 30 days following a request from the chemical industry. Public comments were compiled and grouped according to the commonality among individual submissions so that they could be more readily and fully considered by EPA during revision of the WoE document. Comments were provided to the Agency from 13 different affiliations that mostly included the chemical industry as well as research organizations, and environmental and animal welfare advocates. In general, there were four main categories of comments considered relevant to the WoE guidance document that requested additional detail and clarification of the following: 1. Tier 1 battery of assays. 2. Assay endpoints. 3. Other scientifically relevant information. 4. WoE analysis. The Agency considered specific comments within these categories and revised respective sections in the document. The Agency also considered peer review comments received from senior scientists across EPA with expertise in toxicology, reproductive physiology, and endocrinology encompassing health and ecological effects and made revisions. Also incorporated into the revised document are the fundamental principles and criteria for weighing and integrating different lines of evidence in a WoE evaluation articulated in existing peerreviewed EPA guidelines. The Agency acknowledges the contribution that public and peer review comments have had in helping to expand the quantity and enhance the quality of guidance provided in this final version of the WoE document that will assist in evaluating the results of EDSP Tier 1 screening to identify the need for Tier 2 testing. List of Subjects Environmental protection, Endocrine disruptors, Screening assays, Weight-ofevidence. E:\FR\FM\28SEN1.SGM 28SEN1 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Notices Dated: September 22, 2011. Stephen A. Owens, Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2011–24893 Filed 9–27–11; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–9472–7] National Environmental Justice Advisory Council; Notification of Public Meeting and Public Comment Environmental Protection Agency. ACTION: Notification of public meeting. AGENCY: Pursuant to the Federal Advisory Committee Act (FACA), Public Law 92–463, the U.S. Environmental Protection Agency (EPA) hereby provides notice that the National Environmental Justice Advisory Council (NEJAC) will meet on the dates and times described below. All meetings are open to the public. Members of the public are encouraged to provide comments relevant to the specific issues being considered by the NEJAC. For additional information about registering for public comment, please see SUPPLEMENTARY INFORMATION. Due to limited space, seating at the NEJAC meeting will be on a first-come, firstserved basis. DATES: The NEJAC meeting will convene Tuesday, October 25, 2011, from 9 a.m. until 10 p.m.; and will reconvene on Wednesday, October 26, 2011, from 9 a.m. to 5 p.m. All noted times are in Mountain Time. One public comment period relevant to the specific issues being considered by the NEJAC (see SUPPLEMENTARY INFORMATION) is scheduled for Tuesday, October 25, 2011, from 4 p.m. to 5:15 p.m., and 6:30 p.m. to 10 p.m. Mountain Time. Members of the public who wish to participate during the public comment period are highly encouraged to pre-register by Noon, Mountain Time, Friday, October 7, 2011. ADDRESSES: The NEJAC meeting will be held at The Albuquerque Marriott Hotel located at 2101 Louisiana Boulevard, NE., Albuquerque, New Mexico 87110. Telephone: 505–881–6800 or 1–800– 334–2086; Fax: 505–888–2982. FOR FURTHER INFORMATION CONTACT: Questions concerning the meeting should be directed to Mr. Aaron Bell, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., (MC2201A), Washington, DC 20460; by telephone at 202–564–1044, via e-mail sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:20 Sep 27, 2011 Jkt 223001 at Bell.Aaron@epa.gov; or by fax at 202– 501–0936. Additional information about the meeting is available at the following Web site address: https://www.epa.gov/ environmentaljustice/nejac/ meetings.html. Registration is required for all participants. Pre-registration by Noon Mountain Time, Friday, October 7, 2011, for all attendees is highly recommended. To register online, visit the Web site address above. Registration forms should be faxed to Ms. Estela Rosas, EPA Contractor, APEX Direct, Inc., at 877–773–0779, or e-mailed to Meetings@AlwaysPursuingExcellence. com. Please remember to specify which meeting you are registering to attend (e.g., NEJAC October 2011). Please also state whether you would like to be put on the list to provide public comment, and whether you are submitting written comments before the October 7, 2011, deadline. Non-English speaking attendees wishing to arrange for a foreign language interpreter may make appropriate arrangements in writing using the above telephone number. SUPPLEMENTARY INFORMATION: The Charter of the NEJAC states that the advisory committee shall provide independent advice to the EPA Administrator about areas that may include, among other things, ‘‘advice about broad, cross-cutting issues related to environmental justice, including environment-related strategic, scientific, technological, regulatory, and economic issues related to environmental justice.’’ The meeting shall be used to receive comments, and discuss and provide recommendations regarding these primary areas: (1) Implementation of EPA Plan EJ 2014; (2) EPA’s tribal program; (3) EPA’s hazardous waste rules, and (4) the U.S.-Mexico Environmental Program (Border 2020). A. Public Comment: Individuals or groups making oral presentations during the public comment periods will be limited to a total time of five minutes. To accommodate the large number of people who want to address the NEJAC, only one representative of a community, organization, or group will be allowed to speak. The suggested format for written public comments is as follows: Name of Speaker; Name of Organization/Community; City and State; E-mail address; and a brief description of the concern and what you want the NEJAC to advise EPA to do. Written comments received by Noon Mountain Time, Friday, October 7, 2011, will be included in the materials distributed to the members of the NEJAC. Written comments received after that date and time will be provided PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 60023 to the NEJAC as time allows. All information should be sent to the mailing address, e-mail address, or fax number listed in the FOR FURTHER INFORMATION, CONTACT section above. B. Information about Services for Individuals with Disabilities: For information about access or services for individuals with disabilities, please contact Ms. Estela Rosas, EPA Contractor, APEX Direct, Inc., at 877– 773–0779 or Meetings@AlwaysPursuing Excellence.com. To request special accommodations for a disability, please contact Ms. Rosas at least seven (7) working days prior to the meeting, to give EPA sufficient time to process your request. All other requests specifically related to the meeting should be sent to the mailing address, e-mail address, or fax number listed in the FOR FURTHER INFORMATION CONTACT section above. Dated: September 21, 2011. Victoria J. Robinson, Designated Federal Officer, National Environmental Justice Advisory Council. [FR Doc. 2011–24982 Filed 9–27–11; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2011–0005; FRL–8888–5] Pesticide Products; Receipt of Applications To Register New Uses Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: This notice announces receipt of an applications to register new uses for pesticide products containing currently registered active ingredients, pursuant to the provisions of section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. EPA is publishing this notice of such application, pursuant to section 3(c)(4) of FIFRA. DATES: Comments must be received on or before October 28, 2011. ADDRESSES: Submit your comments, identified by the docket identification (ID) number specified in Unit II., by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One SUMMARY: E:\FR\FM\28SEN1.SGM 28SEN1

Agencies

[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Notices]
[Pages 60022-60023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24893]



[[Page 60022]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2010-0877; FRL-8890-7]


Endocrine Disruptor Screening Program; Weight-of-Evidence 
Guidance Document; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA's Endocrine Disruptor Screening Program (EDSP) is 
announcing the availability of a final guidance document titled, 
``Weight-of-Evidence: Evaluating Results of EDSP Tier 1 Screening to 
Identify the Need for Tier 2 Testing.'' This weight-of-evidence (WoE) 
guidance document was revised based on public and peer review comments 
and existing peer-reviewed EPA guidelines. This guidance document 
provides basic principles and criteria for application of a WoE 
approach to evaluate results from the battery of Tier 1 screening 
assays along with other scientific and technical information relevant 
to Tier 1 screening to determine whether or not a chemical has the 
potential to interact with the estrogen, androgen, or thyroid (E, A, or 
T) hormonal pathways of the endocrine system. The combined results and 
information will also be used to identify which tests and information 
may be needed for Tier 2 testing.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Don 
Bergfelt, Office of Science Coordination and Policy (7203M), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8472; e-mail 
address: bergfelt.don@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. You may be 
potentially affected by this action if you produce, manufacture, use, 
consume, work with, or import pesticide chemicals. To determine whether 
you or your business may be affected by this action, you should 
carefully examine section 408(p) of FFDCA, 21 U.S.C. 346a(p).
    Potentially affected entities may include, but are not limited to:
     Chemical manufacturers, importers and processors (NAICS 
code 325), e.g., persons who manufacture, import or process chemical 
substances.
     Pesticide, fertilizer, and other agricultural chemical 
manufacturers (NAICS code 3253), e.g., persons who manufacture, import 
or process pesticide, fertilizer and agricultural chemicals.
     Scientific research and development services (NAICS code 
5417), e.g., persons who conduct testing of chemical substances for 
endocrine effects.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. 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 a copy of this document and other related information?

    EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2010-0877; FRL-8890-7. All 
documents in the docket are listed in the docket index available at 
https://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 https://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 legal holidays. The telephone number of the 
EPA/DC Public Reading Room is (202) 566-1744, and the telephone number 
for the OPPT Docket is (202) 566-0280. 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.

II. Overview of Revision Process

    The Agency submitted a draft WoE guidance document for evaluating 
the results of EDSP Tier 1 screening for public review and comment as 
described in a Federal Register notice issued November 4, 2010 (75 FR 
67963) (FRL-8849-8). Initially the commenting period was for 60 days, 
but was extended for an additional 30 days following a request from the 
chemical industry. Public comments were compiled and grouped according 
to the commonality among individual submissions so that they could be 
more readily and fully considered by EPA during revision of the WoE 
document. Comments were provided to the Agency from 13 different 
affiliations that mostly included the chemical industry as well as 
research organizations, and environmental and animal welfare advocates. 
In general, there were four main categories of comments considered 
relevant to the WoE guidance document that requested additional detail 
and clarification of the following:
    1. Tier 1 battery of assays.
    2. Assay endpoints.
    3. Other scientifically relevant information.
    4. WoE analysis.

The Agency considered specific comments within these categories and 
revised respective sections in the document. The Agency also considered 
peer review comments received from senior scientists across EPA with 
expertise in toxicology, reproductive physiology, and endocrinology 
encompassing health and ecological effects and made revisions. Also 
incorporated into the revised document are the fundamental principles 
and criteria for weighing and integrating different lines of evidence 
in a WoE evaluation articulated in existing peer-reviewed EPA 
guidelines. The Agency acknowledges the contribution that public and 
peer review comments have had in helping to expand the quantity and 
enhance the quality of guidance provided in this final version of the 
WoE document that will assist in evaluating the results of EDSP Tier 1 
screening to identify the need for Tier 2 testing.

List of Subjects

    Environmental protection, Endocrine disruptors, Screening assays, 
Weight-of-evidence.


[[Page 60023]]


    Dated: September 22, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2011-24893 Filed 9-27-11; 8:45 am]
BILLING CODE 6560-50-P
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