Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices 12311 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2013–0075; FRL–9378–8] 

FIFRA Scientific Advisory Panel; 

Notice of Public Meeting 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: There will be a 4-day meeting 

of the Federal Insecticide, Fungicide, 

and Rodenticide Act Scientific Advisory 

Panel (FIFRA SAP) to consider and 

review the Endocrine Disruptor 

Screening Program (EDSP) Tier 1 

Screening Assays and Battery 

Performance. 

DATES: The meeting will be held on May 

21–24, 2013, from approximately 9 a.m. 

to 5 p.m. 

Comments. The Agency encourages 

that written comments be submitted by 

May 7, 2013 and requests for oral 

comments be submitted by May 14, 

2013. However, written comments and 

requests to make oral comments may be 

submitted until the date of the meeting, 

but anyone submitting written 

comments after May 7, 2013 should 

contact the Designated Federal Official 

(DFO) listed under FOR FURTHER

INFORMATION CONTACT. For additional 

instructions, see Unit I.C. of the 

SUPPLEMENTARY INFORMATION. 

Nominations. Nominations of 

candidates to serve as ad hoc members 

of FIFRA SAP for this meeting should 

be provided on or before March 8, 2013. 

Webcast. This meeting may be 

webcast. Please refer to the FIFRA SAP’s 

Web site, http://www.epa.gov/scipoly/ 

sap for information on how to access the 

webcast. Please note that the webcast is 

a supplementary public process 

provided only for convenience. If 

difficulties arise resulting in webcasting 

outages, the meeting will continue as 

planned. 

Special accommodations. For 

information on access or services for 

individuals with disabilities, and to 

request accommodation of a disability, 

please contact the DFO 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 Bldg.), 2777 S. 

Crystal Dr., Arlington, VA 22202. 

Comments. Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0075, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave., 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

If your comments contain any 

information that you consider to be CBI 

or otherwise protected, please contact 

the DFO listed under FOR FURTHER

INFORMATION CONTACT to obtain special 

instructions before submitting your 

comments. 

Nominations, requests to present oral 

comments, and requests for special 

accommodations. Submit nominations 

to serve as ad hoc members of FIFRA 

SAP, requests for special seating 

accommodations, or requests to present 

oral comments to the DFO listed under 

FOR FURTHER INFORMATION CONTACT. 

FOR FURTHER INFORMATION CONTACT: Fred 

Jenkins Jr., DFO, Office of Science 

Coordination and Policy (7201M), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(202) 564–3327; fax number: (202) 564– 

8382; email address: 

jenkins.fred@epa.gov. 

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 interest to persons who are or may be 

required to conduct testing of chemical 

substances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA) and 

FIFRA. Since other entities may also be 

interested, the Agency has not 

attempted to describe all the specific 

entities that may be affected by this 

action. 

B. What should I consider as I prepare 

my comments for EPA? 

When submitting comments, 

remember to: 

1. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

2. 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. 

3. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

4. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

5. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

6. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

7. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

8. Make sure to submit your 

comments by the comment period 

deadline identified. 

C. How may I participate in this 

meeting? 

You may participate in this meeting 

by following the instructions in this 

unit. To ensure proper receipt by EPA, 

it is imperative that you identify docket 

ID number EPA–HQ–OPP–2013–0075 in 

the subject line on the first page of your 

request. 

1. Written comments. The Agency 

encourages that written comments be 

submitted, using the instructions in 

ADDRESSES, no later than May 7, 2013, 

to provide FIFRA SAP the time 

necessary to consider and review the 

written comments. Written comments 

are accepted until the date of the 

meeting, but anyone submitting written 

comments after May 7, 2013 should 

contact the DFO listed under FOR

FURTHER INFORMATION CONTACT. Anyone 

submitting written comments at the 

meeting should bring 25 copies for 

distribution to FIFRA SAP. 

2. Oral comments. The Agency 

encourages that each individual or 

group wishing to make brief oral 

comments to FIFRA SAP submit their 

request to the DFO listed under FOR

FURTHER INFORMATION CONTACT no later 

than May 14, 2013, in order to be 

included on the meeting agenda. 

Requests to present oral comments will 

be accepted until the date of the meeting 

and, to the extent that time permits, the 

Chair of FIFRA SAP may permit the 

presentation of oral comments at the 

meeting by interested persons who have 

not previously requested time. The 

request should identify the name of the 

individual making the presentation, the 

organization (if any) the individual will 


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represent, and any requirements for 

audiovisual equipment (e.g., overhead 

projector, 35 mm projector). Oral 

comments before FIFRA SAP are limited 

to approximately 5 minutes unless prior 

arrangements have been made. In 

addition, each speaker should bring 25 

copies of his or her comments and 

presentation slides for distribution to 

the FIFRA SAP at the meeting. 

3. Seating at the meeting. Seating at 

the meeting will be open and on a firstcome basis. 

4. Request for nominations to serve as 

ad hoc members of FIFRA SAP for this 

meeting. As part of a broader process for 

developing a pool of candidates for each 

meeting, FIFRA SAP staff routinely 

solicits the stakeholder community for 

nominations of prospective candidates 

for service as ad hoc members of FIFRA 

SAP. Any interested person or 

organization may nominate qualified 

individuals to be considered as 

prospective candidates for a specific 

meeting. Individuals nominated for this 

meeting should have expertise in one or 

more of the following areas: Regulatory 

toxicology/risk assessment, 

ecotoxicology (fish and amphibian 

toxicology), comparative endocrinology, 

reproductive physiology, developmental 

biology/toxicology, thyroid physiology, 

in vitro models, toxicological pathology, 

amphibian histopathology, 

morphometrics, quantitative ecology/ 

biostatistics, and systems biology. 

Nominees should be scientists who have 

sufficient professional qualifications, 

including training and experience, to be 

capable of providing expert comments 

on the scientific issues for this meeting. 

Nominees should be identified by name, 

occupation, position, address, and 

telephone number. Nominations should 

be provided to the DFO listed under FOR

FURTHER INFORMATION CONTACT on or 

before March 8, 2013. The Agency will 

consider all nominations of prospective 

candidates for this meeting that are 

received on or before this date. 

However, final selection of ad hoc 

members for this meeting is a 

discretionary function of the Agency. 

The selection of scientists to serve on 

FIFRA SAP is based on the function of 

the panel and the expertise needed to 

address the Agency’s charge to the 

panel. No interested scientists shall be 

ineligible to serve by reason of their 

membership on any other advisory 

committee to a Federal department or 

agency or their employment by a 

Federal department or agency except the 

EPA. Other factors considered during 

the selection process include 

availability of the potential panel 

member to fully participate in the 

panel’s reviews, absence of any conflicts 

of interest or appearance of lack of 

impartiality, independence with respect 

to the matters under review, and lack of 

bias. Although financial conflicts of 

interest, the appearance of lack of 

impartiality, lack of independence, and 

bias may result in disqualification, the 

absence of such concerns does not 

assure that a candidate will be selected 

to serve on FIFRA SAP. Numerous 

qualified candidates are identified for 

each panel. Therefore, selection 

decisions involve carefully weighing a 

number of factors including the 

candidates’ areas of expertise and 

professional qualifications and 

achieving an overall balance of different 

scientific perspectives on the panel. In 

order to have the collective breadth of 

experience needed to address the 

Agency’s charge for this meeting, the 

Agency anticipates selecting 

approximately 10 ad hoc scientists. 

FIFRA SAP members are subject to 

the provisions of 5 CFR part 2634, 

Executive Branch Financial Disclosure, 

as supplemented by the EPA in 5 CFR 

part 6401. In anticipation of this 

requirement, prospective candidates for 

service on the FIFRA SAP will be asked 

to submit confidential financial 

information which shall fully disclose, 

among other financial interests, the 

candidate’s employment, stocks and 

bonds, and where applicable, sources of 

research support. The EPA will evaluate 

the candidates financial disclosure form 

to assess whether there are financial 

conflicts of interest, appearance of a 

lack of impartiality or any prior 

involvement with the development of 

the documents under consideration 

(including previous scientific peer 

review) before the candidate is 

considered further for service on FIFRA 

SAP. Those who are selected from the 

pool of prospective candidates will be 

asked to attend the public meetings and 

to participate in the discussion of key 

issues and assumptions at these 

meetings. In addition, they will be asked 

to review and to help finalize the 

meeting minutes. The list of FIFRA SAP 

members participating at this meeting 

will be posted on the FIFRA SAP Web 

site at http://www.epa.gov/scipoly/sap 

or may be obtained from the OPP Docket 

or at http://www.regulations.gov. 

II. Background 

A. Purpose of FIFRA SAP 

FIFRA SAP serves as the primary 

scientific peer review mechanism of 

EPA’s Office of Chemical Safety and 

Pollution Prevention (OCSPP) and is 

structured to provide scientific advice, 

information and recommendations to 

the EPA Administrator on pesticides 

and pesticide-related issues as to the 

impact of regulatory actions on health 

and the environment. FIFRA SAP is a 

Federal advisory committee established 

in 1975 under FIFRA that operates in 

accordance with requirements of the 

Federal Advisory Committee Act. FIFRA 

SAP is composed of a permanent panel 

consisting of seven members who are 

appointed by the EPA Administrator 

from nominees provided by the National 

Institutes of Health and the National 

Science Foundation. FIFRA established 

a Science Review Board consisting of at 

least 60 scientists who are available to 

the SAP on an ad hoc basis to assist in 

reviews conducted by the SAP. As a 

peer review mechanism, FIFRA SAP 

provides comments, evaluations and 

recommendations to improve the 

effectiveness and quality of analyses 

made by Agency scientists. Members of 

FIFRA SAP are scientists who have 

sufficient professional qualifications, 

including training and experience, to 

provide expert advice and 

recommendation to the Agency. 

B. Public Meeting 

Under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), section 408(p) 

and the Safe Drinking Water Act 

(SDWA), section 1457, the EPA is 

required to screen all pesticide 

chemicals (active and inert ingredients) 

and those drinking water contaminants 

to which a ‘‘substantial population’’ is 

exposed for the potential to interact 

with the endocrine system. As 

recommended by a Federal Advisory 

Committee, (Endocrine Disruptor 

Screening and Testing Advisory 

Committee, EDSTAC), the EPA 

Endocrine Disruptor Screening Program 

(EDSP) established a two tiered 

screening and testing program to 

address the potential of chemicals to 

perturb the estrogen, androgen or 

thyroid (E,A or T) systems and elicit 

adverse human and ecological health 

outcomes. In 1999, following the 

EDSTAC recommendations, a joint 

subcommittee of the Agency’s Science 

Advisory Board (SAB) and FIFRA SAP 

recommended to the Agency, after 

review of the initial set of Tier 1 data, 

to subject that data to external scientific 

peer review for consideration to further 

optimize the Tier 1 screening battery. 

Tier 1 screening was recommended to 

include a diverse yet complementary 

suite of in vitro and in vivo assays 

covering multiple hormonal modes of 

action (MoA) across various taxa. To 

maximize sensitivity and reliability (i.e., 

minimizing false negatives) for 

determining the potential of a chemical 

to interact with E, A, or T, the suite of 

assays was to be conducted as a battery. 


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Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices 12313 

If the results of the Tier 1 battery 

indicated the potential for a chemical to 

interact with the endocrine system as 

determined through a weight of 

evidence (WoE) analysis, various Tier 2 

tests were to be considered for 

determining dose-response relationships 

and any potential adverse effects for risk 

assessment. The EDSP is mandated 

under FFDCA to use ‘‘validated’’ assays 

to screen for endocrine disrupting 

chemicals. Validation principles 

established by the Organization for 

Economic Co-Operation and 

Development (OECD) and Interagency 

Coordinating Committee on the 

Validation of Alternative Methods 

(ICCVAM) were followed to develop, 

standardize, and validate many of the 

initially proposed Tier 1 in vitro and in 

vivo screening assays as well as more 

novel screening assays that emerged 

after the EDSTAC final report in 1998. 

Subsequent to the validation process, an 

independent peer review of individual 

Tier 1 screening assays was conducted. 

Based on results of the validation 

process, comments from peer review, 

and recommendations from EDSTAC, 

the EDSP proposed a battery of 

screening assays that was founded on 

the strengths of one or more assays 

complimenting the limitations of other 

assays in the battery. Moreover, it was 

expected that the result(s) of each assay 

would not be considered in isolation but 

be inclusive of the results of all assays 

in the battery to support a WoE analysis. 

The FIFRA SAP reviewed the proposed 

Tier 1 screening battery and 

recommended a battery of 11 assays to 

EPA which the Panel indicated ‘‘* * * 

as an appropriate starting point to detect 

endocrine disrupting chemicals based 

on the current state of the science.’’ In 

addition, however, the SAP also 

expected the Agency to continue ‘‘* * * 

to develop, refine, and review the 

battery.’’ Notably, this latter statement 

concurs with a recommendation from 

the initial joint SAB/SAP who indicated 

EPA should review the initial data 

‘‘* * * with an eye towards revising the 

process and eliminating those methods 

that don’t work.’’ 

This FIFRA SAP review will be 

focused on a subset of the initial Tier 1 

screening data received by the Agency 

in response to test orders issued for the 

first list of chemicals in 2009. The SAP 

review will involve the performance of 

the 11 Tier 1 screening assays and 

performance of the assays as a battery 

that was designed to detect the potential 

of a test chemical to interact with the E, 

A or T hormonal pathways. The SAP 

will be asked to comment on factors that 

may impact interpretation of the assay/ 

battery results (e.g., variability) as well 

as suggestions for increasing the 

efficiency of the Tier 1 screening 

approach. To illustrate assay/battery 

performances, case examples of Tier 1 

data from the initial list of chemicals 

will be used. It should be noted that 

there will be a separate SAP meeting 

scheduled in the summer of 2013 to 

discuss the decision logic in a WoE 

approach to identify candidate 

chemicals for Tier 2 testing using EDSP 

Tier 1 screening results, other 

scientifically relevant information 

(OSRI), and health and ecological effects 

data from 40 CFR part 158 studies. 

C. FIFRA SAP Documents and Meeting 

Minutes 

EPA’s background paper, related 

supporting materials, charge/questions 

to FIFRA SAP, FIFRA SAP composition 

(i.e., members and ad hoc members for 

this meeting), and the meeting agenda 

will be available by approximately early 

May 2013. In addition, the Agency may 

provide additional background 

documents as the materials become 

available. You may obtain electronic 

copies of these documents, and certain 

other related documents that might be 

available electronically, at http:// 

www.regulations.gov and the FIFRA 

SAP homepage at http://www.epa.gov/ 

scipoly/sap. 

FIFRA SAP will prepare meeting 

minutes summarizing its 

recommendations to the Agency 

approximately 90 days after the 

meeting. The meeting minutes will be 

posted on the FIFRA SAP Web site or 

may be obtained from the OPP Docket 

or at http://www.regulations.gov. 

List of Subjects 

Environmental protection, Pesticides 

and pests, and Endocrine disruptors. 

Dated: February 13, 2013. 

Steven M. Knott, 

Acting, Director, Office of Science 

Coordination and Policy. 

[FR Doc. 2013–03977 Filed 2–21–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2010–0014; FRL–9378–7] 

Notice of Receipt of Requests To 

Voluntarily Cancel Certain Pesticide 

Registrations 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), EPA is issuing 

a notice of receipt of requests by 

registrants to voluntarily cancel certain 

pesticide registrations. EPA intends to 

grant these requests at the close of the 

comment period for this announcement 

unless the Agency receives substantive 

comments within the comment period 

that would merit its further review of 

the requests, or unless the registrants 

withdraw its requests. If these requests 

are granted, any sale, distribution, or 

use of products listed in this notice will 

be permitted after the registration has 

been cancelled only if such sale, 

distribution, or use is consistent with 

the terms as described in the final order. 

DATES: Comments must be received on 

or before August 21, 2013. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0014, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

Submit written withdrawal request by 

mail to: Pesticide Re-Evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001. ATTN: 

John W. Pates, Jr. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: John 

W. Pates, Jr., Pesticide Re-Evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8195; email address: 

pates.john@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

This action is directed to the public 

in general, and may be of interest to a 

wide range of stakeholders including 


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