Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Notices 4381 

methodologies and protocols that are 

intended to provide data to inform 

regulatory decisions under TSCA, 

FIFRA, and/or FFDCA. The test 

guidelines provide guidance for 

conducting the test, and are also used by 

EPA, the public, and the companies that 

are subject to data submission 

requirements under TSCA, FIFRA, and/ 

or the FFDCA. 

As a guidance document, the test 

guidelines are not binding on either 

EPA or any outside parties, and the EPA 

may depart from the test guidelines 

where circumstances warrant and 

without prior notice. The procedures 

contained in the test guidelines are 

recommended for generating the data 

that are the subject of the test guideline, 

but EPA recognizes that departures may 

be appropriate in specific situations. 

You may propose alternatives to the 

recommendations described in the test 

guidelines, and the Agency will assess 

them for appropriateness on a case-bycase basis. 

II. General Information 

A. Does this Action Apply to Me? 

This action is directed to the public 

in general. Although this action may be 

of particular interest to those persons 

who are or may be required to conduct 

testing of pesticides and chemical 

substances for submission to EPA under 

FIFRA and/or FFDCA, 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 

technical 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 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 the 

estimate. 

vi. Provide specific examples to 

illustrate your concerns and suggested 

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. 

III. Overview 

A. What Action is EPA Taking? 

EPA is announcing the availability for 

public review and comment of the 

following four draft test guidelines 

under Series 810–Product Performance 

Test Guidelines for Public Health Uses 

of Antimicrobial Agents: 

• OPPTS 810.2000 - General Considerations 

for Public Health Uses of Antimicrobial 

Agents. 

• OPPTS 810.2100 – Sterilants - Efficacy 

Data Recommendations. 

• OPPTS 810.2200 - Disinfectants for Use 

on Hard Surfaces—Efficacy Data 

Recommendations. 

• OPPTS 810.2300 - Sanitizers for Use on 

Hard Surfaces—Efficacy Data 

Recommendations. 

These guidelines address efficacy 

testing for antimicrobial agents intended 

to be used on hard, inanimate, 

environmental surfaces, and which bear 

label claims as sterilants, disinfectants, 

and/or sanitizers. Data from these 

studies are used to support the labeling 

claims for public health related 

antimicrobial agents. 

B. How Were These Test Guidelines 

Developed? 

The product performance use 

guidelines for antimicrobial agents were 

last updated in 1982 under the 

‘‘Pesticide Assessment Guidelines - 

Subdivision G, Product Performance.’’ 

Since then, the Agency has presented 

several issues at two separate meetings 

of the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) Scientific 

Advisory Panel (SAP) (one in September 

1997 and the other in July 2007) related 

to the conduct of studies for 

antimicrobial agents. In addition to 

formatting changes to incorporate the 

guidelines into the OPPTS guidelines 

series 810, EPA has added sections that 

incorporate the recommendations from 

the two SAPs, new guidelines and 

clarifications from other guidance 

documents, and comments from the 

regulated industry. In particular, a new 

section has been added that describes 

the data to be submitted to support 

labeling claims against two spore 

forming bacteria, Bacillus anthracis and 

Clostridium difficile. Altogether, these 

revised guidelines, once final, will 

represent the Agency’s current 

recommendations for conducting 

studies to support antimicrobial 

pesticide label claims. 

On October 8, 2008, EPA published in 

the Federal Register a proposed rule 

entitled ‘‘Data Requirements for 

Antimicrobial Pesticides’’ (73 FR 59382). 

Proposed § 158.2220 (40 CFR part 158) 

contains a table entitled ‘‘Antimicrobial 

Product Performance Data 

Requirements,’’ which referenced under 

the Guidelines Number column the 91 

series of guidelines. EPA’s intention is 

to replace the 91 series designations 

with the appropriate reference to the 

810 series designations under 810.2000. 

Therefore, at the time of the publication 

of the final rule, appropriate references 

to the OPPTS test guideline numbers 

and names will be incorporated into the 

final data requirement regulations. 

List of Subjects 

Environmental protection, Chemical 

testing, Test guidelines. 

Dated: January 15, 2010. 

Stephen A. Owens, 

Assistant Administrator, Office of Prevention, 

Pesticides and Toxic Substances. 

[FR Doc. 2010–1323 Filed 1–26–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2009–0091; FRL–8807–3] 

Pesticide Experimental Use Permit; 

Receipt of Amendment and Extension 

Application; Comment Request 

AGENCY: Environmental Protection 

Agency (EPA). 


srobinson on DSKHWCL6B1PROD with NOTICES
4382 Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Notices 

ACTION: Notice. 

SUMMARY: This notice announces EPA’s 

receipt of an application 29964-EUP-6 

from Pioneer Hi-Bred International, 

Incorporated requesting to amend and 

extend an existing experimental use 

permit (EUP) for the following plantincorporated protectants (PIPs) and their 

associated combined-trait hybrids. 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 February 26, 2010. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2009–0091, 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–2009– 

0091. 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 email. 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: 

Jeannine Kausch, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8920; e-mail address: 

kausch.jeannine@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 interested in 

agricultural biotechnology or those who 

are or may be required to conduct 

testing of chemical 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 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Notices 4383 

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. 

In accordance with 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: Pioneer Hi-Bred 

International, Incorporated, (29964- 

EUP-6). 

Pesticide Chemicals: Bacillus 

thuringiensis Cry1F protein and the 

genetic material necessary (vector 

PHP8999) for its production in corn 

event TC1507 (Organization for 

Economic Cooperation and 

Development (OECD) Unique Identifier: 

DAS-01507-1), Bacillus thuringiensis 

Cry34Ab1 and Cry35Ab1 proteins and 

the genetic material necessary (vector 

PHP17662) for their production in corn 

event DAS-59122-7 (OECD Unique 

Identifier: DAS-59122-7), Bacillus 

thuringiensis Cry1Ab delta-endotoxin 

protein and the genetic material 

necessary (vector pZO1502) for its 

production in corn event Bt11 (OECD 

Unique Identifier: SYN-BT011-1), 

Bacillus thuringiensis Cry1Ab deltaendotoxin protein and the genetic 

material necessary (vector PV-ZMCT01) 

for its production in corn event MON 

810 (OECD Unique Identifier: MON00810-6), Bacillus thuringiensis 

Vip3Aa20 insecticidal protein and the 

genetic material necessary (vector 

pNOV1300) in corn event MIR162 

(OECD Unique Identifier: SYN-IR162-4), 

and Bacillus thuringiensis mCry3A 

protein and the genetic material 

necessary (vector pZM26) in corn event 

MIR604 (OECD Unique Identifier: SYNIR604-5). 

Summary of Request: Pioneer Hi-Bred 

International, Incorporated has 

requested an amendment and extension 

of experimental use permit 29964-EUP6, which was first granted on April 22, 

2009. Under the existing EUP, plantings 

are permitted through March 31, 2010. 

Pioneer Hi-Bred International, 

Incorporated is now proposing to extend 

the experimental program until June 30, 

2011 and to amend it by conducting 

testing with up to 1.52 pounds of Cry1F 

protein, 19.52 pounds of Cry34Ab1 and 

Cry35Ab1 proteins, 0.16 pounds of 

Cry1Ab protein (MON 810), 14.51 

pounds of Vip3Aa20 protein, 0.47 

pounds of mCry3A protein, and 0.16 

pounds of Cry1Ab protein (Bt11) on 

33,311 acres (1,414 acres of non-PIP and 

border corn plants are also proposed for 

a total of 34,725 acres). The proposed 

program will be conducted in the 

Commonwealth of Puerto Rico and 

States of Arkansas, California, Colorado, 

Georgia, Hawaii, Iowa, Illinois, Indiana, 

Kansas, Louisiana, Michigan, 

Minnesota, Missouri, Mississippi, North 

Carolina, Nebraska, Oklahoma, Oregon, 

Pennsylvania, South Dakota, Tennessee, 

Texas, Washington, and Wisconsin. 

Trial protocols will concentrate on 

nursery/breeding observation, yield and 

agronomic evaluation, efficacy, insect 

resistance management, inbred and 

hybrid seed production, and regulatory 

studies. 

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: January 14, 2010. 

Keith A. Matthews, 

Acting Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

[FR Doc. 2010–1356 Filed 1–26–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2009–0930; FRL–8806-5] 

Pesticide Products: Registration 

Applications 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces receipt 

of applications to register pesticide 

products containing a new active 

ingredient not included in any currently 

registered products pursuant to the 

provisions of section 3(c)(4) of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), as amended. 

DATES: Comments must be received on 

or before February 26, 2010. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2009–0930, 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–2009– 

0930. 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 email. 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. 


srobinson on DSKHWCL6B1PROD with NOTICES