Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Notices 11873 

III. Conditional Approval Form 

EPA issued a notice, published in the 

Federal Register of February 15, 2006 

(71 FR 7954) (FRL–7761–5), which 

announced that Jabb of the Carolinas, 

P.O. Box 310, Pine Level, NC 27568, had 

submitted an application to 

conditionally register the pesticide 

products, Beauveria bassiana HF23 

Technical, insecticide (EPA File Symbol 

70787-1), containing the fungal active 

ingredient at 95 percent, an active 

ingredient not included in any 

previously registered product. 

Listed below are the applications 

conditionally approved on December 

27, 2006 for an end-use product and a 

technical. 

1. EPA File Symbol 70787-1: 

Beauveria bassiana HF23 Technical at 

95 percent for use as a Manufacturing 

product for insecticides. Manufacturer: 

Jabb of the Carolinas, P.O. Box 310, Pine 

Level, NC 27568. The registrant must 

provide analyses of five production 

batches of this Technical Grade Active 

Ingredient which is to be used for 

manufacture of other End-use Products. 

2. EPA File Symbol 70787-2: End-use 

Product (EP) balEnce containing 1.18 

percent of Beauveria bassiana HF23 

Technical for treatment of poultry 

houses to control house fly in chicken 

manure. 

List of Subjects 

Environmental protection, Chemicals, 

Pesticides and pests. 

Dated: February 28, 2007. 

Janet L. Andersen, 

Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

[FR Doc. E7–4275 Filed 3–13–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–ORD–2007–0212; FRL–8287–6] 

Notice of Availability of the External 

Review Draft of an Interim Guidance 

for Microarray-Based Assays 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of document availability 

for public comment. 

SUMMARY: The U.S. Environmental 

Protection Agency is announcing a 45 

day public comment period for the 

External Review Draft of the ‘‘Interim 

Guidance for Microarray-Based Assays: 

Data Submission, Quality, Analysis, 

Management and Training 

Considerations.’’ EPA is releasing this 

draft document solely for the purpose of 

seeking public comment prior to 

external peer review. The contractorlead external expert peer review will be 

conducted by letter and closed 

teleconference in the May 2007 

timeframe. All comments received, 

submitted in accordance with this 

notice, will be shared with the external 

peer review panel for their 

consideration. Comments received after 

the close of the comment period may be 

considered by EPA when it finalizes the 

document. This document has not been 

formally disseminated by EPA. This 

draft interim guidance does not 

represent and should not be construed 

to represent any EPA policy, viewpoint, 

or determination. Members of the public 

may obtain the draft interim guidance 

from www.regulations.gov; or 

www.epa.gov/osa/spc/ 

genomicsguidance.htm; or from Dr. 

Kathryn Gallagher via the contact 

information below. 

This draft Interim Guidance for 

Microarray-Based Assays outlines 

recommendations for: (1) What data to 

submit to the Agency for microarray 

studies, (2) performance approach 

considerations regarding quality 

assessment parameters, (3) data analysis 

approaches that should be considered; 

and (4) data management and storage 

issues for data submitted to or used by 

the Agency. The guidance applies to 

both human health and ecological DNA 

microarray data. The draft document 

was developed to provide information 

to the regulated community and other 

interested parties about submitting 

microarray data to the Agency and to 

provide guidance for EPA staff in 

evaluating such data and/or 

information. 

DATES: All comments received by April 

30, 2007 will be shared with the 

external peer review panel for their 

consideration. Comments received 

beyond that time may be considered by 

EPA when it finalizes the document. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ–

ORD–2007–0212, by one of the 

following methods: 

• www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

• E-mail: ORD.Docket@epa.gov. 

• Mail: ORD Docket, Environmental 

Protection Agency, Mailcode: 28221T, 

1200 Pennsylvania Ave., NW., 

Washington, DC 20460. 

• Hand Delivery: EPA Docket Center 

(EPA/DC), Room 3334, EPA West 

Building, 1301 Constitution Avenue, 

NW., Washington, DC 20460, Attention 

Docket ID No. EPA–HQ–ORD–2007–

0212. Deliveries are only accepted from 

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

Friday, excluding legal holidays. 

Special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–HQ–ORD–2007–

0212. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at 

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 by statute through 

www.regulations.gov or e-mail. The 

www.regulations.gov Web site 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 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public 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 www.regulations.gov 

index. 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, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in 

www.regulations.gov or in hard copy at 

the ORD Docket, EPA/DC, EPA West, 

Room 3334, 1301 Constitution Ave., 

NW., Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the ORD Docket is (202) 

566–1752. 


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11874 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Notices 

FOR FURTHER INFORMATION CONTACT: Dr. 

Kathryn Gallagher, Office of the Science 

Advisor, Mail Code 8105–R, U.S. 

Environmental Protection Agency, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460; telephone 

number: (202) 564–1398; fax number: 

(202) 564–2070, E-mail: 

Gallagher.kathryn@epa.gov. 

SUPPLEMENTARY INFORMATION: The 

mapping of diverse animal, plant, and 

microbial species genomes using 

molecular technologies has significantly 

affected research across all areas of the 

life sciences. The current understanding 

of biological systems is rapidly changing 

in ways previously unimagined and 

novel applications of this technology 

have already been commercialized. 

These advances in genomics are likely 

to have significant implications for risk 

assessment policies and regulatory 

decision making. In 2002, EPA issued 

its Interim Policy on Genomics 

(available at http://www.epa.gov/osa/ 

spc/genomics.htm) that communicated 

the Agency’s initial approach to using 

genomics information in risk assessment 

and decision making. The Interim 

Policy described genomics as the study 

of all the genes of a cell or tissue, at the 

DNA (genotype), mRNA (transcriptome), 

or protein (proteome) level. While 

noting that the understanding of 

genomics is far from established, the 

Agency stated that such data may be 

considered in the decision making 

process, but that these data alone were 

insufficient as a basis for decisions. 

Following the release of the Interim 

Policy, EPA’s Science Policy Council 

(SPC) created a cross-EPA Genomics 

Task Force and charged it with 

examining the broader implications 

genomics is likely to have on EPA 

programs and policies. The Genomics 

Task Force developed a Genomics 

White Paper entitled ‘‘Potential 

Implications of Genomics for Regulatory 

and Risk Assessment Applications at 

EPA’’ (available at http://www.epa.gov/ 

osa/genomics.htm). That document 

identified four areas likely to be 

influenced by the generation of 

genomics information within EPA and 

the submission of such information to 

EPA: (1) Prioritization of contaminants 

and contaminated sites; (2) monitoring; 

(3) reporting provisions; and (4) risk 

assessment. The Task Force identified 

the establishment of a framework for 

analysis and acceptance criteria for 

genomics information for scientific and 

regulatory purposes as a critical need. 

The Task Force recommended that the 

Agency charge a workgroup to establish 

such a framework and in doing so 

consider the performance of assays 

across genomic platforms (e.g., 

reproducibility, sensitivity, pathway 

analysis tools) and the criteria for 

accepting genomics data for use in a risk 

assessment (e.g., assay validity, 

biologically meaningful response). 

In 2004, EPA’s Genomics Technical 

Framework and Training Workgroups 

were formed with the responsibility to 

ensure that the technical framework and 

training activities build upon the 

Agency’s Interim Policy on Genomics 

while continuing to engage other 

interested parties. Information 

developed by these workgroups is 

intended for use by the EPA program 

offices and regions to determine the 

applicability of specific genomics 

information to the evaluation of risks 

under various statutes. 

To this end, EPA’s Genomics 

Technical Workgroup considered all of 

the ‘‘omics’’ technologies and 

applications and decided that an 

interim guidance document on the use 

of data generated by DNA microarray 

technology would be most beneficial to 

the Agency and regulated community at 

this time. Consequently, this document 

describes data submission, quality, 

analysis, management and training 

considerations for microarray-based 

assays. It is important to note that 

microarray technology is rapidly 

changing, such that methodologies for 

generating such data and ensuring its 

quality will likely change; however the 

need to ensure consistency and quality 

in generating, analyzing and using the 

data will not. As the state of the science 

develops, EPA plans to revisit this 

guidance as necessary. 

EPA will consider all peer review and 

public comments in finalizing its 

Interim Guidance for Microarray-Based 

Assays. To obtain additional 

information, visit: http://www.epa.gov/ 

osa/spc/genomicsguidance.htm 

Dated: March 9, 2007. 

Elizabeth Lee Hofmann, 

Acting Chief Scientist, Office of the Science 

Advisor. 

[FR Doc. E7–4650 Filed 3–13–07; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–8287–5] 

Notice of Approval of Revisions to 

Delaware’s National Pollutant 

Discharge Elimination System 

(NPDES) Program 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of approval. 

SUMMARY: Notice is hereby given of 

approval of the submittal by the State of 

Delaware of its new and revised NPDES 

regulations to maintain consistency 

with the requirements of the Clean 

Water Act and its implementing 

regulations at 40 CFR 122, 123 and 124, 

as amended. 

DATES: EPA’s approval is effective on 

March 14, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Evelyn MacKnight, U.S. EPA, Region 3, 

1650 Arch Street, Philadelphia, PA 

19103, or telephone her at (215) 814–

5717. Copies of materials considered by 

EPA in its decision are available for 

review by appointment at U.S. EPA, 

Region 3, 1650 Arch Street, 

Philadelphia, PA 19103. Appointments 

may be made by calling Ms. MacKnight. 

SUPPLEMENTARY INFORMATION: Section 

402 of the Federal Clean Water Act 

(CWA) created the NPDES program 

under which the Administrator of EPA 

may issue permits for the discharge of 

pollutants into waters of the United 

States when consistent with the CWA. 

Section 402(b) allows States to assume 

NPDES program responsibilities upon 

approval by EPA. On April 1, 1974, 

Delaware was authorized by EPA to 

administer the NPDES program; the 

State also received the authority to 

administer the General Permits program 

on October 23, 1992. 

EPA has established a regulation at 40 

CFR Part 123 that establishes the 

requirements for NPDES State Programs. 

Section 123.62 establishes procedures 

for the revision of authorized NPDES 

State Programs. Pursuant to § 123.62(a), 

a State may initiate a program revision 

and must keep EPA informed of any 

proposed modifications to its regulatory 

authority. On July 28, 2003, the State of 

Delaware submitted to EPA for review 

and approval revisions to the 

regulations implementing the State’s 

NPDES program. The State made 

significant revisions to sections 1 

through 8 and sections 10 through 14 of 

its Department of Natural Resources and 

Environmental Control’s (DNREC) 

March 15, 1974 Regulations Governing 

the Control of Water Pollution, which 

EPA has determined constituted a 

substantial revision to Delaware’s 

authorized NPDES program. EPA 

determined that the State’s submittal 

was complete on November 19, 2003, 

with the submittal of a statement from 

the State’s Attorney General’s office 

which certified that the regulations were 

duly adopted pursuant to State law. 

EPA solicited public comments as to 

whether it should approve or 

disapprove the revisions on February 

10, 2004 (69 FR 6289) pursuant to 


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