Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Notices 51043 

bonds, and where applicable, sources of 

research support. 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 

website at http://epa.gov/scipoly/sap or 

may be obtained from the OPP 

Regulatory Public Docket 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, as 

amended by FQPA, 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 

Chlorpyrifos (0,0-diethyl-0-3,5,6- 

trichloro-2-pyridyl phosphorothioate) is 

a broad-spectrum, chlorinated 

organophosphate (OP) insecticide. In 

2000, nearly all residential uses were 

voluntarily canceled by Dow 

AgroSciences, but agricultural uses 

remain. The 2000 human health risk 

assessment was largely based on adult 

laboratory animal data (rat or dog) for 

cholinesterase inhibition and the 

application of default uncertainty 

factors to address inter- and intraspecies differences including 

susceptible populations. Currently, the 

Agency is developing a new human 

health risk assessment expected to be 

released in 2010. In 2008, the FIFRA 

SAP reviewed a draft science issue 

paper on the human health effects of 

chlorpyrifos. Since that time, Dow 

AgroSciences has undergone a research 

effort to improve the existing 

physiologically based pharmacokinetic/ 

pharmacodynamic model (PBPK/PD) 

developed by Dr. Charles Timchalk and 

co-workers at Pacific Northwest 

National Laboratory. Dow AgroSciences 

has also developed a proposed approach 

for linking this PBPK/PD model to the 

Cumulative and Aggregate Risk 

Evaluation System (CARES), see http:// 

www.ilsi.org/ResearchFoundation/ 

Pages/ CARES.aspx, a publically 

available probabilistic exposure model. 

The purpose of the October 2010 SAP 

meeting will be to review the PBPK/PD 

model and to evaluate the proposed 

approach for linking this model to 

CARES. 

The linking of the chlorpyrifos PBPK/ 

PD model to CARES may provide 

opportunities to integrate distributions 

of exposure to chlorpyrifos and its 

metabolites with cholinesterase 

inhibition levels across the U.S. 

population. In addition, this approach 

may allow estimation of data-derived 

uncertainty factors that consider use of 

toxicokinetic and toxicodynamic data to 

inform quantitative extrapolations for 

interspecies differences and human 

variability in dose response assessment. 

The topics to be covered in the October 

2010 SAP are consistent with EPA’s 

Office of Pesticide Programs continuing 

efforts to improve the scientific basis for 

risk assessment by broadening the 

application of probabilistic exposure 

techniques and PBPK models. The 

Agency has a conceptually similar effort 

on-going to link PBPK models for 

pyrethroids to the Stochastic Human 

Exposure and Dose Simulation model 

for multimedia and multipathway 

chemicals (SHEDS-Multimedia), a 

probabilistic exposure model developed 

by EPA’s Office of Research and 

Development, that was reviewed by the 

SAP in July 2010. The current effort by 

Dow AgroSciences is a research effort 

which may, if sufficiently robust, inform 

future risk assessments. The October 

meeting is a key milestone in this effort. 

The Agency will solicit feedback from 

the Panel on technical issues related to 

the PBPK/PD model, the proposed 

approach for linking the PBPK/PD 

model with CARES, and the use of such 

linked models in risk assessment. 

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 no later than 

September 20, 2010. 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 website or 

may be obtained from the OPP 

Regulatory Public Docket at http:// 

www.regulations.gov. 

List of Subjects 

Environmental protection, Pesticides 

and pests. 

Dated: August 9, 2010. 

Frank Sanders, 

Director, Office of Science Coordination and 

Policy. 

[FR Doc. 2010–20173 Filed 8–17–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2010–0628; FRL–8839–8] 

Pesticide Experimental Use Permit; 

Receipt of Application; Comment 

Request 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces EPA’s 

receipt of an application 524–EUP–RNR 

from Monsanto Company requesting an 

experimental use permit (EUP) for the 

plant-incorporated protectants (PIPs), 

Bacillus thuringiensis (Bt ) Vip3Aa19 


sroberts on DSKD5P82C1PROD with NOTICES
51044 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Notices 

protein and the genetic material 

necessary for its production (vector 

pCOT1) in event COT102 cotton, Bt 

Cry1Ac protein and the genetic material 

necessary for its production (vector PV– 

GHBK04) in event MON 15985 cotton, 

and Bt Cry2Ab2 protein and the genetic 

material necessary for its production 

(vector PV–GHBK11) in event MON 

15985 cotton. The Agency has 

determined that the permit may be of 

regional and national significance. 

Therefore, in accordance with 40 CFR 

172.11(a), the Agency is soliciting 

comments on this application. 

DATES: Comments must be received on 

or before September 17, 2010. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0628, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

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 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPP–2010– 

0628. EPA’s policy is that all comments 

received will be included in the docket 

without change and may be made 

available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or 

e-mail. The regulations.gov website is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the docket and made available 

on the Internet. If you submit an 

electronic comment, EPA recommends 

that you include your name and other 

contact information in the body of your 

comment and with any disk or CD-ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

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

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either in the 

electronic docket at http:// 

www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. 

S–4400, One Potomac Yard (South 

Bldg.), 2777 S. Crystal Dr., Arlington, 

VA. The hours of operation of this 

Docket Facility are from 8:30 a.m. to 4 

p.m., Monday through Friday, excluding 

legal holidays. The Docket Facility 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Denise Greenway, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8263; e-mail address: 

greenway.denise@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 those persons who are 

interested in agricultural biotechnology 

or may be required to conduct testing of 

pesticidal substances under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

or the Federal Insecticide, Fungicide, 

and Rodenticide Act (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. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

B. What Should I Consider as I Prepare 

My Comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD-ROM that 

you mail to EPA, mark the outside of the 

disk or CD-ROM as CBI and then 

identify electronically within the disk or 

CD-ROM the specific information that is 

claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. 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. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

3. Environmental justice. EPA seeks to 

achieve environmental justice, the fair 

treatment and meaningful involvement 

of any group, including minority and/or 

low income populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. To help 

address potential environmental justice 

issues, the Agency seeks information on 

any groups or segments of the 

population who, as a result of their 

location, cultural practices, or other 

factors, may have atypical or 

disproportionately high and adverse 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Notices 51045 

human health impacts or environmental 

effects from exposure to the pesticide(s) 

discussed in this document, compared 

to the general population. 

II. What Action is the Agency Taking? 

Under Section 5 of the Federal 

Insecticide, Fungicide and Rodenticide 

Act (FIFRA), 7 U.S.C. 136c, EPA can 

allow manufacturers to field test 

pesticides under development. 

Manufacturers are required to obtain an 

EUP before testing new pesticides or 

new uses of pesticides if they conduct 

experimental field tests on 10 acres or 

more of land or one acre or more of 

water. 

Pursuant to 40 CFR 172.11(a), the 

Agency has determined that the 

following EUP application may be of 

regional and national significance, and 

therefore is seeking public comment on 

the EUP application: 

Submitter: Monsanto Company, (524– 

EUP–RNR). 

Pesticide Chemical: Bacillus 

thuringiensis (Bt ) Vip3Aa19 protein 

and the genetic material necessary for 

its production (vector pCOT1) in event 

COT102 cotton, Bt Cry1Ac protein and 

the genetic material necessary for its 

production (vector PV–GHBK04) in 

event MON 15985 cotton, and Bt 

Cry2Ab2 protein and the genetic 

material necessary for its production 

(vector PV–GHBK11) in event MON 

15985 cotton. 

Summary of Request: The non-food 

524–EUP–RNR application is for 1897 

acres of PIP test materials, 909 acres of 

non-PIP materials, and 10857 acres of 

border plantings for a total of 13,663 

acres. Proposed shipment/use dates are 

December 1, 2010 to June 30, 2012. 

Eight trial protocols will be 

conducted: 

• Breeding and observation nursery. 

• Seed increase. 

• Yield and herbicide tolerance trials. 

• Insect efficacy trials. 

• Product characterization and 

performance trials. 

• Insect resistance management trials. 

• Benefit trials. 

• Seed treatment trials. 

States and Commonwealth involved 

are: Alabama, Arkansas, Arizona, 

California, Florida, Georgia, Hawaii, 

Kansas, Kentucky, Louisiana, Maryland, 

Missouri, Mississippi, New Mexico, 

North Carolina, Oklahoma Puerto Rico, 

South Carolina, Tennessee, Texas and 

Virginia. 

A copy of the application and any 

information submitted is available for 

public review in the docket established 

for this EUP application as described 

under ADDRESSES. 

Following the review of the 

application and any comments and data 

received in response to this solicitation, 

EPA will decide whether to issue or 

deny the EUP request, and if issued, the 

conditions under which it is to be 

conducted. Any issuance of an EUP will 

be announced in the Federal Register. 

List of Subjects 

Environmental protection, 

Experimental use permits. 

Dated: August 9, 2010. 

W. Michael McDavit, 

Acting Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

[FR Doc. 2010–20174 Filed 8–17–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2010–0008; FRL–8838–4] 

Pesticide Products; Registration 

Applications 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces receipt 

of 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 

applications, pursuant to section 3(c)(4) 

of FIFRA. 

DATES: Comments must be received on 

or before September 17, 2010. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number specified within Unit II., by one 

of the following methods: 

• Federal eRulemaking Portal: http:// 

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 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility’s telephone number is 

(703) 305–5805. 

Instructions: Direct your comments to 

the docket ID number specified for the 

pesticide of interest as shown in the 

registration application summaries. 

EPA’s policy is that all comments 

received will be included in the docket 

without change and may be made 

available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or 

e-mail. The regulations.gov website is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the docket and made available 

on the Internet. If you submit an 

electronic comment, EPA recommends 

that you include your name and other 

contact information in the body of your 

comment and with any disk or CD-ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

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

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either in the 

electronic docket at http:// 

www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. 

S–4400, One Potomac Yard (South 

Bldg.), 2777 S. Crystal Dr., Arlington, 

VA. The hours of operation of this 

Docket Facility are from 8:30 a.m. to 4 

p.m., Monday through Friday, excluding 

legal holidays. The Docket Facility’s 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: A 

contact person is listed at the end of 

each registration application summary 

and may be contacted by telephone or 


sroberts on DSKD5P82C1PROD with NOTICES