Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 55469 

• Pesticide manufacturing (NAICS 

code 32532). 

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 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. 

II. What Action is the Agency Taking? 

EPA is printing a summary of each 

pesticide petition received under 

section 408 of the Federal Food, Drug, 

and Cosmetic Act (FFDCA), 21 U.S.C. 

346a, proposing the establishment or 

amendment of regulations in 40 CFR 

part 180 for residues of pesticide 

chemicals in or on various food 

commodities. EPA has determined that 

these pesticide petitions contains data 

or information regarding the elements 

set forth in FFDCA section 408(d)(2); 

however, EPA has not fully evaluated 

the sufficiency of the submitted data at 

this time or whether the data support 

granting of the pesticide petitions. 

Additional data may be needed before 

EPA rules on these pesticide petitions. 

Pursuant to 40 CFR 180.7(f), a 

summary of the petition included in this 

notice, prepared by the petitioner along 

with a description of the analytical 

method available for the detection and 

measurement of the pesticide chemical 

residues is available on EPA’s Electronic 

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

To locate this information on the home 

page of EPA’s Electronic Docket, select 

‘‘Quick Search’’ and type the OPP 

docket ID number. Once the search has 

located the docket, clicking on the 

‘‘Docket ID’’ will bring up a list of all 

documents in the docket for the 

pesticide including the petition 

summary. 

New Tolerances 

1. PP 4F6833. Nippon Soda Co., Ltd. 

c/o Nisso America Inc., 45 Broadway, 

Suite 2120, New York, NY, 10006, 

proposes to establish a tolerance for 

residues of the insecticide acetamiprid 

in or on food commodities cucurbit crop 

group at 0.5 parts per million (ppm); 

stone fruit crop group except plum, 

prune, fresh and dried at 1.2 ppm; 

plum, prune, fresh and dried at 0.3 

ppm; tree nut crop group except almond 

hulls at 0.1 ppm; almond hulls at 5.0 

ppm; and pistachios at 0.1 ppm. 

2. PP 6F7051. Nippon Soda Co., Ltd. 

c/o Nisso America Inc., 45 Broadway, , 

Suite 2120, New York, NY, 10006 

proposes to establish a tolerance for 

residues of the insecticide acetamiprid 

in or on food commodities in bulb 

vegetables crop group 3 at 3 ppm; edible 

podded legume vegetables, crop 

subgroup 6a at 0.5 ppm; succulent 

shelled pea and beans, crop group 6b, at 

0.5 ppm and berries, crop group 13 at 

1 ppm. 

For both petitions Liquid 

Chromatography/Mass Spectrometry 

(LC/MS/MS) methods is use to measure 

and evaluate the chemical residue(s). 

List of Subjects 

Environmental protection, 

Agricultural commodities, Feed 

additives, Food additives, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 12, 2006. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

[FR Doc. 06–7961 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–8221–9] 

Approaches for the Application of 

Physiologically Based 

Pharmacokinetic (PBPK) Models and 

Supporting Data in Risk Assessment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of availability. 

SUMMARY: EPA is announcing the 

availability of a final report titled, 

‘‘Approaches for the Application of 

Physiologically Based Pharmacokinetic 

(PBPK) Models and Supporting Data in 

Risk Assessment’’ (EPA/600/R–05/ 

043F), prepared by the National Center 

for Environmental Assessment (NCEA) 

within EPA’s Office of Research and 

Development (ORD). 

ADDRESSES: The document is available 

electronically through the NCEA Web 

site at http://www.epa.gov/ncea. A 

limited number of paper copies will be 

available from the EPAs National 

Service Center for Environmental 

Publications (NSCEP), P.O. Box 42419, 

Cincinnati, OH 45242; telephone: 1–

800–490–9198 or 513–489–8190; 

facsimile: 513–489–8695. Please provide 

your name, your mailing address, the 

title and the EPA number of the 

requested publication. 

FOR FURTHER INFORMATION CONTACT: The 

Technical Information Staff, National 

Center for Environmental Assessment/ 

Washington Office (8623D), U.S. 

Environmental Protection Agency, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460. Telephone: 

202–564–3261; fax: 202–565–0050; email: nceadc.comment@epa.gov. 

SUPPLEMENTARY INFORMATION: This final 

report highlights the benefits of using 

physiologically based pharmacokinetic 

(PBPK) modeling and it will be used as 

a learning tool for EPA scientists and 

health risk assessors. It describes 


sroberts on PROD1PC70 with NOTICES
55470 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 

principles of and the kind of data 

needed for PBPK modeling, and 

discusses some approaches for the 

evaluation and use of PBPK models in 

the health assessment of environmental 

agents. PBPK models represent an 

important class of dosimetry models 

that are useful for predicting internal 

doses to target organs. To predict 

internal dose level, PBPK models use 

physiological, biochemical, and 

physicochemical data to construct 

mathematical representations of 

processes associated with the 

absorption, distribution, metabolism, 

and elimination of compounds. With 

the appropriate data, these models can 

be used to extrapolate across species 

and exposure scenarios, and address 

various sources of uncertainty in health 

assessments. 

This report addresses the following 

questions: (1) Why do risk assessors 

need PBPK models; (2) How can these 

models be used in risk assessments; and 

(3) What are the considerations for 

evaluating whether a PBPK model can 

be used in a given health assessment of 

an environmental agent? 

The report is not intended to be used 

as Agency guidance on the use of PBPK 

modeling and does not specify when to 

use a PBPK model in health assessments 

of environmental agents. 

Dated: September 14, 2006. 

George W. Alapas, 

Acting Director, National Center for 

Environmental Assessment. 

[FR Doc. 06–8053 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–8221–8; Docket ID No. EPA–HQ–ORD–

2006–0756] 

Evaluation of the Carcinogenicity of 

Ethylene Oxide 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of public comment 

period. 

SUMMARY: EPA is announcing a 30-day 

public comment period for the draft 

document titled, ‘‘Evaluation of the 

Carcinogenicity of Ethylene Oxide’’

(EPA/635/R–06/003). The document 

was prepared by the National Center for 

Environmental Assessment within 

EPA’s Office of Research and 

Development. 

EPA is releasing this draft document 

solely for the purpose of seeking public 

comment and for review by the EPA 

Science Advisory Board (SAB) via a 

meeting to be held later in 2006 (time 

and place to be specified in a separate 

Federal Register notice). This document 

has not been formally disseminated by 

EPA. It does not represent and should 

not be construed to represent any 

Agency policy or determination. EPA 

will consider any public comments 

submitted in accordance with this 

notice when revising the document. 

DATES: The 30-day public comment 

period begins September 22, 2006, and 

ends October 23, 2006. Technical 

comments should be in writing and 

must be received by EPA by October 23, 

2006. 

ADDRESSES: The draft ‘‘Evaluation of the 

Carcinogenicity of Ethylene Oxide’’ is 

available primarily via the Internet on 

the National Center for Environmental 

Assessment’s home page under the 

Recent Additions and the Data and 

Publications menus at http:// 

www.epa.gov/ncea. A limited number of 

paper copies are available from the 

Technical Information Staff, NCEA–W; 

telephone: 202–564–3261; facsimile: 

202–565–0050. If you are requesting a 

paper copy, please provide your name, 

your mailing address, and the document 

title, ‘‘Evaluation of the Carcinogenicity 

of Ethylene Oxide.’’ Please provide your 

name, your mailing address, the title, 

and the EPA number of the requested 

publication. 

Comments may be submitted 

electronically via www.regulations.gov, 

by mail, by facsimile, or by hand 

delivery/courier. Please follow the 

detailed instructions provided in the 

SUPPLEMENTARY INFORMATION section of 

this notice. 

FOR FURTHER INFORMATION CONTACT: For 

information on the public comment 

period, contact the Office of 

Environmental Information Docket; 

telephone: 202–566–1752; facsimile: 

202–566–1753; or e-mail: 

ORD.Docket@epa.gov. 

For technical information, contact 

Henry D. Kahn, D.Sc., NCEA; telephone: 

202–564–3269; facsimile: 202–565–

0079; or e-mail: kahn.henry@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Information About the Project/ 

Document 

Ethylene oxide (EtO) is a gas at room 

temperature. It is manufactured from 

ethylene and used primarily as a 

chemical intermediate in the 

manufacture of ethylene glycol. It is also 

used as a sterilizing agent for medical 

equipment and as a fumigating agent for 

spices. The largest sources of human 

exposure are in occupations involving 

contact with the gas in production 

facilities and in hospitals that sterilize 

medical equipment. EtO can also be 

inhaled by residents living near 

production or sterilizing/fumigating 

facilities. 

This draft assessment document 

characterizes the potential for a 

carcinogenic health hazard from human 

inhalation exposure to EtO. This is 

accomplished by a weight-of-evidence 

evaluation as to how likely EtO is to be 

a human carcinogen, as well as an 

evaluation of related dose-response 

information which leads to the 

development of lifetime cancer risk 

estimates per unit of exposure. This 

assessment, when finalized, will be 

posted to EPA’s Integrated Risk 

Information System (IRIS) database. The 

document was prepared by EPA’s 

National Center for Environmental 

Assessment (NCEA). EPA last published 

a health assessment of the potential 

carcinogenicity of EtO in 1985 (U.S. 

EPA, 1985). 

The current assessment reviews the 

more recently developed database on 

the carcinogenicity of EtO, pertinent 

data from the 1985 assessment, and 

several reviews and assessments issued 

by other organizations (IARC, 1994; 

Health Canada, 2001; CalEPA, 1999; 

EOIC, 2001). 

II. How To Submit Technical Comments 

to the Docket at www.regulations.gov 

Submit your comments, identified by 

Docket ID No. EPA–HQ–ORD 2006–

0756 by one of the following methods: 

• www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

• E-mail: ORD.Docket@epa.gov. 

• Fax: 202–566–1753 

• Mail: Office of Environmental 

Information (OEI) Docket (Mail Code: 

2822T), U.S. Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460. The phone 

number is 202–566–1752. 

• Hand Delivery: The OEI Docket is 

located in the EPA Headquarters Docket 

Center, EPA West Building, Room B102, 

1301 Constitution Ave., NW., 

Washington, DC. The EPA Docket 

Center 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. 

Such deliveries are only accepted 

during the docket’s normal hours of 

operation, and special arrangements 

should be made for deliveries of boxed 

information. 

If you submit comments by mail or 

hand delivery, please submit one 

unbound original with pages numbered 

consecutively, and three copies of the 

comments. For attachments, provide an 


sroberts on PROD1PC70 with NOTICES