[Federal Register: May 30, 2008 (Volume 73, Number 105)]
[Notices]
[Page 31187-31190]
[DOCID:fr30my08-110]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2008-0108]

Quiet Cars Notice of Public Meeting and Request for Comments

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of public meeting, request for information.

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SUMMARY: NHTSA is having a public meeting to bring together government
policymakers, stakeholders from the blind community, industry
representatives and public interest groups to discuss the safety of
blind pedestrians encountering quiet cars including hybrids, all-
electric vehicles and quiet internal combustion engine vehicles. This
public meeting and the request for information, is an opportunity for
an exchange among interested parties, as well as the public, on the
technical and safety policy issues related to increasingly quieter cars
and blind pedestrians. The date, time, location, and framework for this
public meeting are announced in this notice.

DATES: Public Meeting: The public meeting will be held on June 23,
2008, from 9 a.m. to 3 p.m. at the Grand Hyatt Washington, Washington,
DC.
    Comments: Written comments may be submitted to the agency and must
be received no later than August 1, 2008.

FOR FURTHER INFORMATION CONTACT: Mrs. Debbie Ascone, Office of the
Senior Associate Administrator for Vehicle Safety, NHTSA, telephone
202-366-4383, e-mail<EMAIL_ADDRESS>She may also be reached at
1200 New Jersey Avenue, SE., Washington, DC 20590.

ADDRESSES: Public meeting: The public meeting will be held at the Grand
Hyatt

Washington, 1000 H Street, NW., Washington, DC 20001, telephone: 202-
637-4764.
    Written comments: Written comments on this meeting and topic must
refer to the docket number of this notice and be submitted by any of
the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., between 9 am and 5 pm Eastern Time, Monday
through Friday, except Federal holidays.
    Regardless of how you submit your comments, you should mention the
docket number of this document.
    You may call the Docket Management Facility at<PHONE_NUMBER>.
    Instructions: For detailed instructions on submitting comments, see
the Procedural Matters section of this document. Note that all comments
received will be posted without change to http://www.regulations.gov,
including any personal information provided.

SUPPLEMENTARY INFORMATION:

Background

    According to R.L. Polk & Co, registration for new hybrid vehicles
rose to 350,289 registrations in 2007.\1\ While hybrid vehicles remain
a small portion of new registered vehicles, registrations of hybrids
increased 38% from 2006 to 2007. A hybrid electric vehicle (HEV) is
more commonly defined as a vehicle which combines a conventional
propulsion system (such as a gasoline or diesel engine) with an
electric motor and has an on-board rechargeable energy storage system
(such as batteries) to achieve better fuel economy than a conventional
vehicle. HEVs prolong the charge on their batteries by capturing
kinetic energy via regenerative braking, and some HEVs can use the
combustion engine to generate electricity by spinning an electrical
generator (often a motor-generator) to either recharge the battery or
directly feed power to an electric motor that drives the vehicle. All
HEVs have a start/stop system which can turn off the engine at idle and
restart it when needed. Some hybrids are capable of being driven by
only the electric motor at lower speeds (generally up to 25 mph). As
such, these vehicles can be significantly quieter than conventional
gasoline powered vehicles.
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    \1\ http://usa.polk.com/news/latestnews/news--2008--0421--
hybrids.htm.
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    Deborah Kent Stein discusses an emerging problem with HEVs in the
following:

    ``When the hybrid is traveling at low speeds, the electric motor
is very quiet. The problem arises when a hybrid car, powered by its
electric motor, is traveling at slow to moderate speeds--as when it
moves along a side street, emerges from a driveway or parking lot,
or starts up after a red light or stop sign. Under these
circumstances the engine is silent, and there is little or no sound
from tire friction or wind resistance. In addition nearly all
hybrids come to a full stop at red lights or stop signs, shutting
off the engine completely. The engine does not idle, emitting a low,
telltale purr. It makes no sound at all. A blind traveler has no
indication that a car is present and preparing to move forward at
any moment.'' \2\
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    \2\ Stop, Look, and Listen: Quiet Vehicles and Pedestrian Safety
by Deborah Kent Stein; from: The Braille Monitor, June 2005.

    Mrs. Stein, chairman for the National Federation of the Blind
(NFB), Committee on Automobile and Pedestrian Safety/Quiet Cars made
this statement in the article ``Stop, Look and Listen: Quiet Vehicles
and Pedestrian Safety,'' in the June 2005 issue of The Braille Monitor.
NHTSA recognizes this is a potential safety problem and is responding
to the concern and investigating the hazard of quieter vehicles to
pedestrians, cyclists and others who need to be aware of approaching
cars that are out of their line of sight.
    While the size of the specific problem is currently unknown, the
total number of pedestrian crashes in 2006 was 65,404 resulting in
4,784 fatalities and an estimated 61,000 injuries.
    Since August 2007, NHTSA has been working through the Society of
Automotive Engineers International (SAE) to identify effective ways to
address the safety issue with quieter vehicles. The Alliance of
Automobile Manufacturers and the Association of International
Automobile Manufacturers, along with the SAE have formed the Vehicle
Sound for Pedestrians Subcommittee under the SAE Safety and Human
Factors Committee.\3\ This subcommittee, Vehicle Sounds for Pedestrians
(VSP), created the three following Task Forces to gather information to
assist in determining the technical approaches to address the problem:
Audience for specification, target sound level, and type of sound and
driving conditions for the sound. The VSP subcommittee is currently
working to both define the issue and understand the conditions in which
these types of incidents occur and expects to propose and evaluate
different methods to address the issues as these factors are better
understood.
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    \3\ http://www.sae.org/servlets/works/
committeeHome.do?comtID=TEITSSHF.
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    Further work of the VSP subcommittee will explore: who will benefit
from the establishment of a minimum sound level for motor vehicles,
what that sound level should be and the type of sound that will be
necessary to have the desired effect, and under what vehicle and
ambient conditions the sound is required to be heard and measured. The
subcommittee is currently in the data gathering stage: what incidents
have happened, where, and under what conditions. Different data sources
have been identified and approached. Concurrently, the task force on
sound measurement is preparing an outline for a test procedure to
measure vehicle operating sounds.
    Thus far, this group of human factors experts also includes a
member of the American Council for the Blind and a representative of
NHTSA. The group is regularly meeting at four-week intervals to study
possible ways of improving the detection of quiet cars by pedestrians
and to explore the feasibility of proposing an SAE Recommended
Practice. In addition to the SAE initiative, NFB has commissioned Dr.
Lawrence Rosenblum at the University of California-Riverside to
investigate the sound made by hybrids and people's ability to detect
them. At Stanford University, with financial help from the NFB,
researchers have developed a prototype sound generating device that
receives information about the vehicle function and transmits the
information to speakers placed on the vehicle. While this vehicle-based
system is one potential countermeasure for quieter vehicles, NHTSA, the
automotive industry and the SAE subcommittee will continue their
efforts to identify the most appropriate and effective countermeasures.
In the United States House of Representatives, a bill has been
introduced entitled the ``Pedestrian Safety Enhancement Act of 2008,''
which, if enacted, requires the Secretary of Transportation to study
and establish a motor vehicle safety standard that provides for a means
of alerting blind and other pedestrians of motor vehicle operation.\4\
Additionally, in December 2007, NHTSA met with representatives of the
NFB to discuss this issue.
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    \4\ http://thomas.loc.gov/cgi-bin/query/D?c110:1:./temp/
~c110LBBXF7::.

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Public Meeting

    NHTSA is having this public meeting to discuss the technical and
safety policy issues associated with the increasing presence of quieter
cars and the risks to blind pedestrians. The meeting will bring
together State and local government policy makers, stakeholders in the
blind community, industry representatives and public interest groups.
    The meeting will be open to the public, but presentations will be
by invitation only. Time will be designated for open floor discussion
by the general audience. Meeting participants and the public are also
invited to submit comments on this issue to the docket. All materials
to be presented are asked to be submitted to NHTSA in advance for
appropriate dissemination to visually impaired attendees.
    The sections below describe the discussion of topics for the
meeting.

Statement of Problem

    Representatives of the blind community will discuss the problem
facing blind pedestrians around quieter vehicles. The discussion should
include the explanation and known size of the problem. The
presentations should identify specific situations in which vehicles are
hard to hear, the sound cues that are necessary in detecting a vehicle
and which of those cues are absent in those problematic locations. To
gain a better understanding of the desired outcome to this problem,
representatives of the blind community should discuss general ways to
increase the safety of blind pedestrians and potential solutions--both
desirable and undesirable to the blind community.

Pedestrian Safety

    Pedestrian safety is a difficult but important issue both
nationally and internationally. Presentations should discuss pedestrian
safety in general as well as specifically related to the blind
community. Any known incidents with pedestrians, in general and
involving the blind, and quieter vehicles will be detailed. Data
collection challenges should also be discussed as well as the needs to
improve this data collection. There will also be discussion of current
technologies to aide the blind community in safer pedestrian travel. A
NHTSA representative will discuss ongoing and planned activities for
pedestrian safety, identifying potential activities that could be
enhanced for the blind. A representative from the international vehicle
safety community will present information about the problem globally as
well as work in other nations to address pedestrians and quieter
vehicles. The discussion should also include international standards
for pedestrian safety and any potential solutions for this problem that
have been researched internationally.

Sound Measurement and Mobility

    In developing a solution to assist blind pedestrians around quieter
cars, a few fundamental questions must be addressed. Presentations on
this topic should include discussions of which sounds of a vehicle
should be measured and the means by which to measure that sound. Any
studies into this area should also be included. Sound experts should
also describe average noise levels as reference points for the audience
as well as extreme noise levels--both low and high extremes. A mobility
expert should discuss sound cues for blind individuals and any
measurement studies related to the field. There should also be
discussion on mobility in rural areas and locations that lack the
infrastructure for technology.

Automotive Industry Perspective

    A representative from the automobile industry should speak about
how the industry is addressing the problem. The discussion should
include information on what current and future vehicles would qualify
as quiet cars as well as what features of the car cause the reduction
in sound. The automobile industry representative should also discuss
what the industry is willing to commit to, product development and lead
time for vehicle-based solutions.

SAE Work and Status

    As was discussed previously, SAE has a subcommittee dedicated to
this topic and has active working groups looking at specific details.
An SAE spokesperson will discuss the process in general and the current
status of this work. Additional details of the working groups should be
laid out at the meeting and the representative should describe the
needs of the subcommittee to continue work and expedite both the work
and the process.

Potential Solutions

    Research into potential ways to address this issue should include
vehicle-, person-, and infrastructure-based approaches. Presentations
should include current and past research into each of these areas,
literature and conclusions from such. Product development,
effectiveness, lead time, cost and public acceptance of solutions
should also be discussed. Any potential solution that is currently
marketed or planned for market would be included in this discussion as
well as the history of the development of the product.

Noise Abatement

    While the lower sound of vehicles presents a safety concern for
blind pedestrians, it also provides a solution to the health concern
arising from noise pollution. Presentations on this topic should
include federal and local perspective on noise pollution as well as the
jurisdiction of noise pollution laws. The discussion should also
include studies about what levels of sound are dangerous to health and
studies into the magnification of sound presented by large numbers of
vehicles or vehicles in confined spaces. Current or planned efforts to
reduce the sound emitted by vehicles should also be discussed along
with supporting research into determination of said maximum levels.

Procedural Matters

    The meeting will be open to the public with advanced registration
for seating on a space-available basis. Individuals wishing to register
to assure a seat in the public seating area should provide their name,
affiliation, phone number and e-mail address to Mrs. Debbie Ascone
using the contact information at the beginning of this notice. Should
it be necessary to cancel the meeting due to an emergency or some other
reason, NHTSA will take all available means to notify registered
participants by e-mail or telephone.
    The meeting will be held at a site accessible to individuals with
disabilities. Individuals who require accommodations such as sign
language interpreters should contact Ms. Debbie Ascone by June 16,
2008. All written materials to be presented at the meeting will be
available electronically on the day of the meeting to accommodate the
needs of the visually impaired. A transcript of the meeting and other
information received by NHTSA at the meeting will be placed in the
docket for this notice at a later date.

How can I submit comments on this subject?

    It is not necessary to attend or to speak at the public meeting to
be able to comment on the issues. NHTSA invites readers to submit
written comments which the agency will consider in its research and
proceedings with the safety of quiet cars and pedestrians.

How do I prepare and submit comments?

    Your comments must be written and in English. To ensure that your

comments are correctly filed in the Docket, please include the docket
number of this document in your comments.
    Your primary comments must not be more than 15 pages long (49 CFR
553.21). However, you may attach additional documents to your primary
comments. There is no limit on the length of the attachments.
    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://regulations.gov.

How can I be sure that my comments were received?

    If you wish Docket Management to notify you upon its receipt of
your comments, enclose a self-addressed, stamped postcard in the
envelope containing your comments. Upon receiving your comments, Docket
Management will return the postcard by mail.

How do I submit confidential business information?

    If you wish to submit any information under a claim of
confidentiality, send three copies of your complete submission,
including the information you claim to be confidential business
information, to the Chief Counsel, National Highway Traffic Safety
Administration, 1200 New Jersey Ave., SE., Washington, DC 20590.
Include a cover letter supplying the information specified in our
confidential business information regulation (49 CFR part 512).
    In addition, send two copies from which you have deleted the
claimed confidential business information to Docket Management, 1200
New Jersey Ave., SE., West Building, Room W12-140, Washington, DC
20590, or submit them electronically, in the manner described at the
beginning of this notice.

Will the agency consider late comments?

    We will consider all comments that Docket Management receives
before the close of business on the comment closing date indicated
above under DATES. To the extent possible, we will also consider
comments that Docket Management receives after that date.
    Please note that even after the comment closing date, we will
continue to file relevant information in the docket as it becomes
available. Further, some people may submit late comments. Accordingly,
we recommend that you periodically check the docket for new material.

How can I read the comments submitted by other people?

    You may read the materials placed in the docket for this document
(e.g., the comments submitted in response to this document by other
interested persons) at any time by going to http://www.regulations.gov.
Follow the online instructions for accessing the dockets. You may also
read the materials at the Docket Management Facility by going to the
street address given above under ADDRESSES. The Docket Management
Facility is open between 9 a.m. and 5 p.m. Eastern Time, Monday through
Friday, except Federal holidays.

    Authority: 49 U.S.C. 30111, 30168; delegation of authority at 49
CFR 1.50 and 501.8.

Ronald L. Medford,
Senior Associate Administrator, Vehicle Safety.
[FR Doc. E8-12041 Filed 5-29-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register: August 31, 2006 (Volume 71, Number 169)]
[Notices]
[Page 51867-51868]
[DOCID:fr31au06-99]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension: Rule 15a-5; SEC File No. 270-527; OMB Control No. 3235-
0587.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collections of information summarized below. The Commission plans to
submit these existing collections of information to the Office of
Management and Budget (``OMB'') for extension and approval.
    Section 15(a) of the Investment Company Act of 1940 (15 U.S.C. 80a-
15(a)) (the ``Investment Company Act'' or ``Act'') prohibits any person
from serving as an investment adviser (or a subadviser) to a fund
except under a written contract that the fund's shareholders have
approved. The Commission has granted exemptive relief, by order, to a
number of registered open-end management investment companies
(``funds'') whose investment advisers do not directly manage a
portfolio of securities, but instead supervise one or more subadvisers,
which are themselves responsible for the day-to-day management of the
funds' portfolios (``manager of managers funds'').\1\ Sponsors have
analogized subadvisers in a manager of managers arrangement to
portfolio managers employed by a fund adviser who may be hired and
fired without the consent of shareholders.
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    \1\ In this notice, we use the term ``subadviser'' to mean a
party that contracts with a fund's principal adviser to provide
investment advisory services to the fund, and the term ``principal
adviser'' to mean a party that contracts directly with a fund to
provide investment advisory services to the fund.
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    Proposed Rule 15a-5 (17 CFR 270.15a-5) and amendments to Form N-1A
(17 CFR 239.15A, 17 CFR 274.11A) together would codify the orders we
have issued for manager of managers funds, including many of their
conditions, allowing any fund that satisfies the conditions to enter
into or materially amend a subadvisory contract without shareholder
approval. To provide for the protection of fund shareholders, a fund
that relied on the proposed rule would have to satisfy a number of
conditions, some of which would result in information collection
requirements.
    For example, any fund that relied on the proposed rule would have
to include certain provisions in all its advisory and subadvisory
contracts. Specifically, all the fund's subadvisory contracts for which
shareholder approval is not sought would have to provide the principal
adviser with the authority to terminate the subadvisory contract at any
time, on no more than 60 days written notice, without payment of
penalty.\2\ In addition, the advisory contract between each principal
adviser and the fund would have to require that the principal adviser
supervise the activities of its subadvisers. These provisions are
intended to ensure that only manager of managers funds (in which
subadvisers resemble and perform the duties of a portfolio manager in a
typical fund) are eligible for relief under the proposed rule and to
allow the principal adviser to carry out its principal duties to the
fund, the selection and monitoring of subadvisers, in an efficient
manner.
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    \2\ Most subadvisory contracts already contain terms that allow
the principal adviser to terminate the contract at any time. We
therefore estimate there would be no burden hours or costs imposed
on funds by this requirement.
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    During the first year after adoption of the rule, Commission staff
estimates that each fund relying on the rule would incur an initial
one-time burden to modify its existing contract with the principal
adviser to require the principal adviser to supervise the activities of
its subadvisers. Staff estimates this burden would be 5 hours per fund
(4 hours by in-house counsel, 0.5 hours by fund directors, 0.5 hours by
support staff).\3\ Commission staff estimates that 149 funds would have
to modify their advisory contracts with their principal advisers to
comply with the proposed rule, which would result in an estimated total
of 745 burden hours and 149 responses.\4\
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    \3\ These estimates are based on discussions with fund
representatives.
    \4\ These 149 funds include 125 funds that currently rely on
exemptive orders, 14 funds that have filed an application for an
exemptive order and, as explained infra note 5, 10 additional funds
that we estimate would choose to rely on the proposed rule during
the first year.

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    Commission staff estimates that after the first year, approximately
10 funds \5\ would spend, on average, 5 hours annually (4 hours by in-
house counsel, 0.5 hours by fund directors, 0.5 hours by support staff)
to modify their advisory contracts with their principal advisers to
comply with the proposed rule. Thus, the Commission estimates these
modifications would result in a total of 50 burden hours and 10
responses.
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    \5\ Based on the number of manager of managers applications
submitted since 1995, the staff estimates that 20 additional funds
would seek to rely on the proposed rule each year. Approximately 10
of those funds would be funds whose securities have already been
publicly offered, and therefore would need to modify their advisory
contracts with principal advisers. We estimate that the 10 new funds
that would rely on the proposed rule would incur no additional
burden or costs to include these provisions in the initial advisory
contract.
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    The proposed rule also would require funds to provide shareholders
(and file with the Commission) an information statement within 90 days
after entry into the subadvisory contract or after making a material
change to a wholly-owned subsidiary's existing subadvisory contract.
The information statement must describe the agreement and contain all
of the information that shareholders would have received in a proxy
statement had a shareholder vote been held. This information collection
is needed to ensure that shareholders are aware of the identity of the
subadvisers that would be making investment decisions for the fund and
the terms of each subadvisory contract.
    During the first 3 years after adoption of the proposed rule,
Commission staff estimates that 179 funds \6\ would each spend 20 hours
\7\ annually in preparing and distributing information statements. The
total annual estimate for complying with the third party disclosure
requirement of rule 15a-5 would be 3580 burden hours and 358 responses.
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    \6\ Commission staff estimates that 159 funds (including 125
funds that currently rely on exemptive orders, 14 funds that have
filed an application for an exemptive order, and 20 additional funds
that would have filed for exemptive relief during the first year
after the rule's adoption) would rely on the proposed rule during
the first year after its adoption. After the first year, the staff
estimates that each year 20 additional funds would rely on the
proposed rule.
    \7\ Based on discussions with fund representatives, the
Commission estimates that on average each fund would hire 2 new
subadvisers per year. Therefore, funds would be required to send to
shareholders 2 information statements per year. Based on discussions
with fund representatives, the Commission estimates that each fund
would spend 10 hours to prepare and mail each information statement.
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    To arrive at the total information collection burden, staff has
calculated a weighted average of the first year burden and the annual
burden thereafter. Using a three-year period, the estimated weighted
annual average information collection burden is 3862 hours \8\ and 414
responses.\9\
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    \8\ This estimate is based on the following calculation: (4325
hours (year 1) + 3630 hours (year 2) + 3630 hours (year 3)) / 3 =
3861.6 hours.
    \9\ This estimate is based on the following calculation: (507
responses (year 1) + 368 responses (year 2) + 368 responses (year
3)) / 3 = 414.3 responses.
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    The collections of information required by proposed rule 15a-5
would be voluntary because rule 15a-5 is an exemptive rule and,
therefore, funds may choose not to rely on the proposed rule. The
filings with the Commission required under the proposed rule would be
available to the public. An agency may not conduct or sponsor, and a
person is not required to respond to a collection of information unless
it displays a currently valid control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, C/O
Shirley Martinson, 6432 General Green Way, Alexandria, Virginia 22312
or send am e-mail to<EMAIL_ADDRESS>
    Dated: August 23, 2006.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 06-7300 Filed 8-30-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: August 8, 2007 (Volume 72, Number 152)]
[Rules and Regulations]
[Page 44384-44388]
[DOCID:fr08au07-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0165; FRL-8138-2]

Dimethenamid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
dimethenamid in or on grasses grown for seed. Interregional Research
Project No. 4 (IR-4) requested this tolerance under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 8, 2007. Objections and
requests for hearings must be received on or before October 9, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0165. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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 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 Docket Facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5639; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to
provide 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. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, any person may file an objection
to any aspect of this regulation and may also request a hearing on
those objections. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0165 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before October 9, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2006-0165, 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'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<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of March 22, 2006 (71 FR 14521) (FRL-7766-
7), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F6138) by Interregional Research Project No. 4 (IR-4), Technology
Center of New Jersey, Rutgers, the State of New Jersey, 681 U.S.
Highway 1 South, North Brunswick, NJ 08902-3390. The petition
requested that 40 CFR 180.464 be amended by establishing a tolerance
for residues of the herbicide dimethenamid in or on grass, forage at
0.05 parts per million (ppm); grass, hay at 0.30 ppm; grass, straw at
0.01 ppm; and grass, seed screenings at 0.01 ppm. That notice
referenced a summary of the petition prepared by BASF Corporation, the
registrant, which is available to the public in the docket, http://www.regulations.gov.
 There were no comments received in response to the

notice of filing. Based on review of the residue data, the EPA
determined that the tolerance for dimethenamid in or on grass, forage
at should be established at 0.15 ppm instead of 0.05 ppm requested by
the registrant, and the tolerance for grass, hay should be established
at 2.5 ppm instead of 0.30 ppm as requested by the registrant.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....'' These provisions were added to the FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for residues of dimethenamid in or on grass, forage at 0.15 parts per
million (ppm); grass, hay at 2.5 ppm; grass, straw at 0.01 ppm; and
grass, seed screenings at 0.01

ppm. EPA's assessment of exposures and risks associated with
establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by dimethenamid as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found in the
document ``Dimethenamid-P Human Health Risk Assessment for Proposed Use
on Grasses Grown for Seed, PC Codes: 120051 and 129051, Petition No:
0F6138, DP Num: 337887''. The document is available at http://www.regulations.gov.
 in the docket established by this action, which is

described under ADDRESSES, and is identified as EPA-HQ-OPP-2006-0165 in
that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UF) are
used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (``aPAD'') and chronic population adjusted
dose (``cPAD''). The aPAD and cPAD are calculated by dividing the LOC
by all applicable uncertainty/safety factors. Short-term, intermediate-
term, and long-term risks are evaluated by comparing aggregate exposure
to the LOC to ensure that the margin of exposure (``MOE'') called for
by the product of all applicable uncertainty/safety factors is not
exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for dimethenamid used for
human risk assessment can be found at http://www.regulations.gov in document

``Dimethenamid-P Human Health Risk Assessment for Proposed Use on
Grasses Grown for Seed, PC Codes: 120051 and 129051, Petition No:
0F6138, DP Num: 337887'' on page 16 in Docket ID EPA-HQ-OPP-2006-0165.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to dimethenamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing dimethenamid tolerances in (40
CFR 180.464). EPA assessed dietary exposures from (R,S)-2-chloro-N-[(1-
methyl-2-methoxy) ethyl]-N-(2,4-dimethylthien-3-yl)-acetamide in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. In estimating acute dietary
exposure, EPA used food consumption information from the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed all foods for which there are tolerances
were treated and contain tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Nationwide CSFII. As to residue levels in food, EPA assumed
all foods for which there are tolerances were treated and contain
tolerance-level residues.
    iii. Cancer. Dimethenamid was classified as Group C - possible
human carcinogen based on benign liver tumors (males) in rats. EPA
determined that the chronic Reference dose (cRfD) would be protective
of any cancer risk posed by dimethenamid because the cRfD of 0.05
milligrams/kilogram/day (mg/kg/day) used for risk assessment is based
on non-cancer precursor effects in the liver. In making this
determination, EPA also took into account that the tumor incidences
were only slightly above historical control levels, only showed
statistical significance as increased trends and not by pairwise
between control and treated animals, only evidenced a statistically
significant trend when benign and malignant tumors were combined, and
were only seen in one species. Therefore, the cRfD is considered
protective of both non-cancer and cancer effects.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for dimethenamid in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the environmental
fate characteristics of dimethenamid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the EPA's Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) and Screening Concentration in Ground
Water (SCI-GROW) models, the estimated drinking water concentrations
(EDWCs) of dimethenamid for acute exposures are estimated to be 9.0
parts per billion (ppb) for surface water and 0.34 ppb for ground
water. The EDWCs for chronic exposures are estimated to be 3.8 ppb for
surface water and 0.34 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. The EDWCs for use sites (other
than grasses grown for seed) with the highest values were used. For
acute dietary risk assessment, the water concentration value of 66.7
ppb was used to access the contribution to drinking water. For chronic
dietary risk assessment, the water concentration of value 20.2 ppb was
used to access the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Dimethenamid is not registered for use on any sites that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity.

Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to dimethenamid and any other
substances and dimethenamid does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that dimethenamid has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional (``10X'') tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA safety factor. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional uncertainty/safety
factors and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no concern for
increased qualitative and/or quantitative susceptibility following pre-
and post-natal exposure to the (RS) or (S) dimethenamid technical
products in rats and rabbits. In the developmental toxicity study in
rats there was an increased incidence of post-implantation loss and
minor skeletal variations. In the developmental toxicity study in
rabbits, late resorptions and minor skeletal variations were observed
at the highest dose tested. In the rabbit, the developmental effects
occurred at the same dose as maternal toxicity; whereas in the rat, the
developmental effects occurred at much higher doses than in the dams.
The reproduction study showed decreases in body weight in both pups and
parental animals at the same dose levels.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    i. The toxicity database for dimethenamid is complete.
    ii. The toxicity data showed no increase in qualitative and/or
quantitative susceptibility in fetuses and pups with in utero and pre-
and post-natal exposure.
    iii. There is no evidence that dimethenamid is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors to account for neurotoxicity.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment utilizes proposed
tolerance level residues and 100% crop treated information for all
commodities, which results in very high-end estimates of dietary
exposure. The dietary drinking water assessment utilizes values
generated by model and associated modeling parameters which are
designed to provide health protective, high-end estimates of water
concentrations.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. For linear
cancer risks, EPA calculates the probability of additional cancer cases
given aggregate exposure. Short-term, intermediate-term, and long-term
risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable
uncertainty/safety factors is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to dimethenamid will occupy < 1% of the aPAD for the population group
(women ages 13-49) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
dimethenamid from food and water will utilize 3% of the cPAD for the
population group (all infants (< 1 year)) receiving the greatest
exposure. There are no residential uses for dimethenamid that result in
chronic residential exposure to dimethenamid.
    3. Short-term risk. Dimethenamid is not registered for use on any
sites that would result in residential exposure. Therefore, the
aggregate risk is the sum of the risk from food and water.
    4. Intermediate-term risk. Dimethenamid is not registered for use
on any sites that would result in residential exposure. Therefore, the
aggregate risk is the sum of the risk from food and water, which do not
exceed the Agency's LOC.
    5. Aggregate cancer risk for U.S. population. The cRfD of 0.05 mg/
kg/day used for risk assessment is based on non-cancer precursor
effects. Therefore, the cRfD is considered protective of both non-
cancer and cancer effects. Consequently, a separate aggregate cancer
risk assessment was not conducted.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to dimethenamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with a
nitrogen phosphorus detector (GC/NPD) method (AM-0884-0193-1) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    An International Residue Limit (IRL) Status Sheet is appended to
the Dimethenamid-P Human Health Risk Assessment located in the docket
for this notice. Codex has established maximum residue limits (MRLs),
expressed in terms of dimethenamid-P and its enantiomer, for various
crop commodities but not for grass commodities. Canada and Mexico have
also established MRLs for dimethenamid-P and its enantiomer in/on
various crop commodities but not for grass, hay; grass, forage; grass,
straw; or grass, seed screenings.

V. Conclusion

    Therefore, the tolerance is established for residues of
dimethenamid, in or on grass, forage at 0.15 ppm; grass, hay at 2.5
ppm; grass, straw at 0.01 ppm; and grass, seed screenings at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994). Since tolerances and
exemptions that are established on the basis of a petition under
section 408(d) of the FFDCA, such as the tolerance in this final rule,
do not require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000) do not apply to this rule. In addition, This rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 23, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.464 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.464  Dimethenamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Grass, forage........................................               0.15
Grass, hay...........................................                2.5
Grass, seed screenings...............................               0.01
Grass, straw.........................................               0.01
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-15112 Filed 8-7-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: May 22, 2009 (Volume 74, Number 98)]
[Notices]
[Page 24061-24066]
[DOCID:fr22my09-108]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. OST-2009-0121]

Notice of Request for Information Collection Approval

AGENCY: Office of the Secretary.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, (44
U.S.C. 3501 et seq.) this notice announces the U.S. Department of
Transportation's (DOT) intention to renew the utilization of the
individual employment discrimination complaint form when processing
Equal Employment Opportunity (EEO) discrimination complaints filed by
applicants for employment with the Department. The Office of Management
and Budget (OMB) approved the form in 2006 with its renewal required by
July 31, 2009.

DATES: Comments on this notice must be received by July 21, 2009.

ADDRESSES: You may submit comments [identified by DOT Docket Number
OST-2009-0121] by any of the following methods:
     Web Site: http://www.regulations.gov. Follow the
instructions for submitting comments on the DOT electronic docket site.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building, Room W12-
140, Washington, DC 20590.
     Hand Delivery or Courier: West Building, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except on Federal holidays.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
    Instructions: All submissions must include the agency name (Office
of the Secretary, DOT) and docket number for this rulemaking. You
should provide two copies of your comments if you submit them by mail
or courier. Note that all comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided, and will be available to Internet users. You may
review DOT's complete Privacy Act Statement in the Federal Register
published on April 11, 2000 (65 FR 19477) or you may visit http://
DocketsInfo.dot.gov.
    Docket: For Internet access to the docket to read background
documents and comments received, go to http://www.regulations.gov.
Background documents and comments received may also be viewed at the
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., Docket
Operations, West Building, Room W12-140, Washington, DC 20590, between
9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays.

FOR FURTHER INFORMATION CONTACT: Tami Wright, Associate Director,
Compliance Operations Division (S-34), Departmental Office of Civil
Rights, Office of the Secretary, U.S. Department of Transportation,
1200 New Jersey Avenue, SE., Washington, DC 20590,<PHONE_NUMBER> or
(TTY)<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Form Title: Individual Complaint of Employment Discrimination.
    OMB Control Number: OMB 2105-0556.
    Type of Request: OMB renewal.
    Abstract: DOT will utilize the form to collect information
necessary to process EEO discrimination complaints filed by individuals
who are not Federal employees and are applicants for employment with
the Department. These complaints are processed in accordance with the
Equal Employment Opportunity Commission's regulations, 29 CFR part
1614, as amended. DOT will use the form to: (a) Request requisite
information from the applicant for processing his/her EEO employment
discrimination complaint; and (b) obtain information to identify an
individual or his or her attorney or other representative, if
appropriate. An applicant's filing of an EEO employment complaint is
solely voluntary. DOT estimates that it takes an applicant
approximately one hour to complete the form.
    Respondents: Job Applicants filing EEO employment discrimination
complaints.
    Estimated Number of Respondents: 10 per year.
    Estimated Total Burden on Respondents: 10 hours per year.
    Comments are invited on: (a) Whether the proposed collection of
information is reasonable for the proper performance of the EEO
functions of the Department, and (b) the accuracy of the Department's
estimate of the burden of the proposed information collection. All
responses to the notice will be summarized and included in the request
for Office of Management and Budget approval. All comments also will
become a matter of public record.

    Issued in Washington, DC, on May 15, 2009.
Mary N. Whigham Jones,
Acting Director, Departmental Office of Civil Rights.
BILLING CODE 4910-9X-P

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[FR Doc. E9-11988 Filed 5-21-09; 8:45 am]

BILLING CODE 4910-9X-C


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: April 3, 2002 SUBJECT: Tebuthiuron Acute and Chronic Dietary Exposure Assessments for the Tolerance Reassessment Eligibility Decision (TRED); PC codes 105501; DP Barcode D281821.

FROM: Sheila Piper, Chemist Chemistry and Exposure Branch Health Effects Division (7509C)

THROUGH: F. B. Suhre, Branch Senior Scientist Chemistry and Exposure Branch Health Effects Division (7509C)

and Sherrie Kinard, Chemist Douglas Dotson, Chemist Dietary Exposure Science Advisory Council (DeSAC) Health Effects Division (7509C)

TO: Paula Deschamp, Risk Assessor Reregistration Branch II Health Effects Division (7509C) and Wilhelmena Livingston, Chemical Review Manager Special Review Branch Special Review and Reregistration Division (7508C)

The purpose of this memorandum is to summarize the results of the dietary risk assessment for the general U. S. population (chronic only) and females 13 50 years (acute) resulting from exposure to tebuthiuron through food. This risk assessment is an updated risk analysis that has been conducted for tebuthiuron. The most recent dietary risk assessment was conducted by J. M. Winterseen (09/ 01/ 93). DP Barcode: D281821 Dietary exposure assessment / 1 Tebuthiuron / 105501 1 aPAD/ cPAD = acute/ chronic Population Adjusted Dose = Acute or Chronic RfD FQPA Safety Factor 1 EPA Reviewer: Sheila Piper , Date April 3, 2002 STUDY TYPE: Tebuthiuron Acute and Chronic Dietary Exposure Assessments for the Tolerance Reregistration Eligibility Decision (TRED) PC codes 105501; DP Barcode D281821.

ACTIVE INGREDIENT: Tebuthiuron SYNONYMS: Spike RESIDUE OF CONCERN: The residues of concern in livestock commodities are tebuthiuron and its metabolites 104, 106, 108, and 109; the terminal residues of concern in milk are tebuthiuron and metabolites 104, 104( OH), 106, 109 and 109( OH). Executive Summary A Tier 2 acute and a chronic dietary risk assessment were conducted for all supported currently registered tebuthiuron food uses. Dietary risk estimates are provided for the general U. S. population (chronic only) and females 13 50 (acute). This assessment concludes that for all included commodities, the acute risk estimates are below the Agency's level of concern (< 100% aPAD 1 ) at the 95 th exposure percentile for females 13 50 years (< 1% of the aPAD). This assessment also concludes that for all included commodities, the chronic risk estimates are below the Agency's level of concern (< 100% cPAD 1 ) for the general U. S. population (< 1% of the cPAD) and all population subgroups.

I. Introduction Exposure to pesticides can occur through food, water, residential and occupational means. Risk assessment incorporates both exposure and toxicity of a given pesticide. The risk is expressed as a percentage of a dose that could be expressed as a daily or a long term dose, that poses no unreasonable adverse effects. This is called the population adjusted dose (PAD), and is expressed as %PAD. References are available on the DP Barcode: D281821 Dietary exposure assessment / 2 Tebuthiuron / 105501 2 EPA/ pesticides web site which discuss the acute and chronic risk assessments in more detail: "Available Information on Assessing Exposure from Pesticides, A User's Guide", 6/ 21/ 2000, web link: http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2000/ July/ Day 12/ 6061. pdf ; or see SOP 99.6, 8/ 20/ 99.

The purpose of this memorandum is to summarize the results of the dietary risk assessment for the U. S. population (chronic only) and females 13 50 (acute) resulting from exposure to tebuthiuron through food. This risk assessment is an updated risk analysis that has been conducted for tebuthiuron. The most recent dietary exposure analysis was conducted by J. M. Winterseen (09/ 01/ 93).

II. Toxicological Information HED has completed the dietary risk assessment for tebuthiuron on the deliberations of the Hazard Identification Assessment Review Committee (HIARC) and hazard endpoints have been selected for both acute (one day) and chronic (long term) exposure intervals (Memorandum: R. Fricke dated February 5, 2002).

On December 13, 2001 and January 17, 2002 the HIARC evaluated the results of a rabbit developmental toxicity study and its impact on the Food Quality Protection Act (FQPA) assessment and toxicity endpoint selection for tebuthiuron. An appropriate endpoint attributable to a single dose was not available in the database for an acute reference dose (general population). An appropriate acute endpoint (females 13+) attributable to a single dose at 25 mg/ kg/ day was selected for risk assessment, since there was no dose response in the observed early resorptions. In addition, the selection of the 25 mg/ kg/ day dose for risk assessment is supported by the NOAEL of 50 mg/ kg/ day in a rabbit developmental range finding study with a structurally related urea. For chronic reference dose, the NOAEL is 14 mg/ kg/ day from the twogeneration reproduction study based on decreased body weight, body weight gain and food consumption in F1 females at 30 mg/ kg/ day. The acute and chronic hazard endpoints selected for dietary exposure to tebuthiuron are listed in Table 1.

In a meeting on February 4, 2002, the FQPA Safety Factor Committee recommended that the 10X FQPA Safety Factor (as required by the Food Quality Protection Act of August 3, 1996) be reduced to 3X for acute dietary exposure (females 13 50) and 1X for chronic dietary exposure (general population) when assessing the potential dietary risks posed by tebuthiuron use (C. Christensen, FQPA memo, 02/ 12/ 02). The basis and rationale for the 3x FQPA safety factor for females 13 50 years is due to a data gap for assessing susceptibility of fetuses DP Barcode: D281821 Dietary exposure assessment / 3 Tebuthiuron / 105501 3 following in utero exposure to tebuthiuron. For chronic dietary exposure to the general population, the FQPA safety factor will be reduced to 1x because there was no susceptibility identified in the 2 generation rat reproduction study (a long term study).

Table 1. Summary of Toxicological Dose and Endpoints for Tebuthiuron for Use in Dietary Exposure Assessment EXPOSURE SCENARIO DOSE (mg/ kg/ day) ENDPOINT STUDY Acute Dietary (Females 13 50) NOAEL= 25 UF = 100 FQPA= 3X Increased post implantation loss and fetal/ litter resorptions at 50 mg/ kg/ day (LOAEL). Developmental Toxicity Study in the Rabbit Acute RfD (Females 13 50 years old) = 0.25 mg/ kg/ day Acute PAD (females 13 50)= 0.083 mg/ kg/ day Acute Dietary (General Population) No appropriate effects attributed to a single exposure were identified.

Chronic Dietary NOAEL = 14 UF = 100 FQPA= 1X Decreased body weight and feed consumption in F1 females at 30 mg/ kg/ day (LOAEL) 2 Generation Reproduction Study in the Rat Chronic RfD = 0.14 mg/ kg/ day Chronic PAD (all population)= 0.14 mg/ kg/ day Cancer No endpoint for carcinogenicity due to inadequate carcinogenicity studies Category D or not classifiable as to human carcinogenicity Rat and mouse carcinogenicity studies III. Residue Information Tebuthiuron [N[ 5( 1,1 dimethylethyl) 1,3,4 thiadiazol 2 yl] N, N' dimethylurea] is a relatively nonselective, soil activated herbicide registered for use to control broadleaf, woody weeds, grasses and brush on terrestrial feed crop sites (pastures and rangeland). Pelleted/ tableted (P/ T) is the only tebuthiuron formulation class registered for use on food/ feed crops. This formulation may be applied preplant, preemergence, postemergence, or postharvest. The registered mode of DP Barcode: D281821 Dietary exposure assessment / 4 Tebuthiuron / 105501 4 application is broadcast using ground or aerial equipment.

Tolerances for residues of tebuthiuron have been established for grasses and livestock commodities (40 CFR §180.390). These tolerances are expressed in terms of the combined residues of N[ 5( 1,1 diemthylethyl) 1,3,4 thiadiazol 2 yl] N, N' dimethylurea and its metabolites containing the dimethylethyl thiadiazole moiety. Adequate enforcement methods are available for the determination of residues in/ on grasses and in animal tissues and milk.

Tebuthiuron is a List A FIFRA reregistration chemical that was the subject of a Reregistration Standard Guidance Document dated 7/ 87. The Residue Chemistry Chapter of the Tebuthiuron Tolerance Reregistration Eligibility Decision (TRED) is being completed in conjunction with this document and reflects the evaluation of all the submissions made in response to the earlier reregistration documents.

No monitoring data were available for tebuthiuron. An adequate method is available for the enforcement of plant commodity tolerances. A GLC with flame photometric detection is designated as Method II in PAM Vol. II. Tebuthiuron and metabolites 104 and 109 are thermally degraded on the GLC column and are determined as 104; metabolite 103( OH) is determined as 104( OH). A revised enforcement method for milk, to include hydrolysis steps and the determination of metabolites 104( OH) and 109( OH) is being requested. The stated detection limits are 0.1 ppm for tebuthiuron and metabolites 104 and 109, and 0.2 ppm for metabolite 103( OH).

Residues in meat and milk were estimated using livestock feeding studies. The order of preference for the purpose of refining dietary exposure assessment is usually: monitoring data> field trial data> tolerance. The registrant submitted all field trial data for registered uses of tebuthiuron on plant commodities which reflect maximum application rates and shortest PHIs (S. Funk, D187699, 8/ 93).

Metabolites C For dietary risk assessment, the Metabolism Committee concluded that the residues of concern in plants are the parent compound and its metabolites 103, 103( OH), 104, and 109. The residues of concern in livestock commodities (fat, meat, kidney, and liver) are tebuthiuron and its metabolites 104, 106, 108, and 109; the terminal residues of concern in milk are tebuthiuron and metabolites 104, 104( OH), 106, 109, and 109( OH). A poultry metabolism study is not required since grasses are not considered to be poultry feed items. DP Barcode: D281821 Dietary exposure assessment / 5 Tebuthiuron / 105501 5 Percent Crop Treated Information C An updated quantitative usage analysis for tebuthiuron was provided by BEAD based on data years 1996 99 (S. Smearman, Biological and Economic Analysis Division, 2/ 28/ 02). The percentage of the acres for each site treated in 1999, an average of less than 1 percent of rangeland/ pastureland acreage was treated up to an estimated maximum 2 percent of acres treated annually. For the miles of railroad rights of way and electric utility rights of way treated annually, the average percentage of miles treated was less than 1 percent, respectively. No information pertaining to the percent of area treated for industrial facilities or miles of pipeline rights of way was available, but based on the percentage of a. i. allocated to these sites it is assumed that the percent of area/ mileage treated also averages less than 1 percent.

Processing Information C Processing factors were taken from the DEEM default values.

Residue Estimates for Meat and Milk C The only source of dietary (food) exposure is the consumption of secondary residues in meat and milk from livestock fed tebuthiuron treated grass forage and hay. Tolerances in meat (2ppm) and milk (0.3 ppm) are established and in grass forage and hay at 10 ppm for residues of tebuthiuron and its metabolites containing the dimethyl thiadiazole moiety.

C The residues of concern in livestock commodities (fat, meat, kidney, and liver) are tebuthiuron and its metabolites 104, 106, 108, and 109; the terminal residues of concern in milk are tebuthiuron and metabolites 104, 104( OH), 106, 109, and 109( OH). A poultry metabolism study is not required since grasses are not considered to be poultry feed items.

C Feeding studies (S. Funk, Ruminant Feeding Study, D217379, 12/ 05/ 95) have demonstrated a transfer of tebuthiuron to animal tissue (meat, meat by products, etc.). The results of the ruminant feeding study conducted at a nominal 45 ppm tebuthiuron feeding level for 28 days show that the existing tolerances for milk and meat are inadequate and should be revised. The tolerances for meat (2 ppm) and fat (2 ppm) may DP Barcode: D281821 Dietary exposure assessment / 6 Tebuthiuron / 105501 6 be lowered to 1 ppm, but the tolerances for milk (0.3 ppm) and meat byproducts (2 ppm) must be increased to 0.8 ppm for milk and 5 ppm for meat byproducts.

C A dietary burden of tebuthiuron for beef cattle (extrapolating to goats, sheep and horses) is based on the feed items of grass forage. For dairy cattle, the residues used were the average residues from grass forage field trials while for beef cattle the highest average field trial (HAFT) residue values were used. See Table 2 below.

Table 2: Dietary Burden of Tebuthiuron to Beef and Dairy Cattle Commodity % DM a Beef Cattle Dairy Cattle Average Field Trial Data (ppm) b % Diet a Concentration (ppm) HAFT b (ppm) % Diet a Concentration c (ppm)

Grass Forage 25 1.97 60 2.56 2.56 60 6.14 Corn grain 88 0 40 0 0 40 0 TOTAL  100 2.56 100 6.14 a OPPTS Guideline 860.1000 b Beef cattle based on average field trial data; dairy cattle based on highest average field trial (HAFT) data c Ruminant contribution= [tolerance/ %DM] x %diet Dow Elanco dosed four groups of three dairy cows each for 28 days with gelatin capsules containing tebuthiuron at nominal dosage rates of 0 ppm, 45 ppm (9.5x), 135 ppm (28.5x), and 450 ppm (95x). Daily milk samples were collected, and within 24 hours of the last dosing the cows were sacrificed and tissues were collected.

For beef cattle, the nominal dosage rates of 0 ppm, 45 ppm (7.3x), 135 ppm (22x), and 450 ppm (73x) were determined based on the dietary burden for beef cattle. Tissue samples (5 grams) were analyzed by Method GRM 94.01, which determines tebuthiuron and metabolites 104, 106, 108 and 109. Liver, kidney, muscle, or fat was hydrolyzed with 6N HCl which converts metabolite 109 to 104. The maximum incurred residues in various tissues at the 45 ppm feeding level, expressed as the sum of tebuthiuron, 104 + 109 as 104, and 106 + 108 as 106. Results of the analyses of bovine tissues are summarized in Table 3. DP Barcode: D281821 Dietary exposure assessment / 7 Tebuthiuron / 105501 7 Table 3: Residues of Tebuthiuron and Metabolites in Tissues from the Oral Administration of Tebuthiuron for 28 Days Diet (ppm tebuthiuron) Tissue Analyte Concentration 1 (ppm) Range 2 (ppm) Average 3 (ppm)

0 liver tebuthiuron <0.1 4 <0.1 4 104 + 109 5 0.032  <0.05 4 0.039 + 0.010 6 106 + 108 7 0.104  0.368 0.201 + 0.14 kidney tebuthiuron 0.055  <0.1 4 0.075 + 0.023 104 + 109 5 0.108  <0.2 4 0.138 + 0.054 106 + 108 7 <0.1 4  0.19 0.248 + 0.19 muscle tebuthiuron <0.2 4 <0.2 4 104 + 109 5 <0.06 4 <0.06 4 106 + 108 7 <0.06 4 <0.06 4 fat tebuthiuron <0.01 4 0.01 4 104 + 109 5 0.006  <0.01 4 0.007 + 0.002 106 + 108 7 <0.01 <0.01 45 liver tebuthiuron <0.1 <0.1 104 + 109 5 0.94  2.13 1.73 + 0.68 106 + 108 7 1.50  1.80 1.65 + 0.15 kidney tebuthiuron <0.1 <0.1 104 + 109 5 0.355  0.907 0.679 + 0.29 106 + 108 7 0.756  1.06 0.873 + 0.16 muscle tebuthiuron <0.2 <0.2 104 + 109 5 0.214  0.560 0.418 + 0.18 106 + 108 7 0.196  0.230 0.216 + 0.018 fat tebuthiuron <0.01 <0.01 104 + 109 5 0.12  0.38 0.206 + 0.15 106 + 108 7 0.033  0.164 0.093 + 0.066 135 liver tebuthiuron 0.098  0.265 0.154 + 0.096 104 + 109 5 4.46  8.23 6.96 + 2.16 106 + 108 7 2.76  3.67 3.35 + 0.51 kidney tebuthiuron 0.050  0.069 0.059 + 0.01 104 + 109 5 1.58  2.72 2.27 + 0.60 106 + 108 7 1.44  3.20 2.22 + 0.90 muscle tebuthiuron 0.120  0.140 0.13 + 0.01 104 + 109 5 1.32  2.86 2.26 + 0.82 106 + 108 7 0.466  0.816 0.601 + 0.19 DP Barcode: D281821 Dietary exposure assessment / 8 Tebuthiuron / 105501 Table 3: Residues of Tebuthiuron and Metabolites in Tissues from the Oral Administration of Tebuthiuron for 28 Days Diet (ppm tebuthiuron) Tissue Analyte Concentration 1 (ppm) Range 2 (ppm) Average 3 (ppm)

8 fat tebuthiuron 0.01  0.074 0.036 + 0.03 104 + 109 5 0.52  2.00 1.33 + 0.75 106 + 108 7 0.158  0.428 0.250 + 0.15 450 liver tebuthiuron 0.359  1.20 0.666 + 0.46 104 + 109 5 28.4  41.6 33.3 + 7.2 106 + 108 7 11.2  18.0 14.6 + 3.4 kidney tebuthiuron 0.107  0.244 0.155 + 0.77 104 + 109 5 10.5  15.4 13.5 + 2.1 106 + 108 7 5.79  8.78 6.80 + 1.7 muscle tebuthiuron 0.210  0.370 0.280 + 0.082 104 + 109 5 8.96  13.6 11.2 + 2.3 106 +108 7 2.68  3.95 3.11 + 0.73 fat tebuthiuron 0.064  0.140 0.100 + 0.038 104 + 109 5 5.03  6.64 5.61 + 0.89 106 + 108 7 0.830  1.26 1.01 + 0.22 1 Not corrected for concurrent method recovery. 2 Range of average of duplicate determinations for three cows. 3 Average of duplicate determinations for three cows. 4 "<" values are estimated limits of detection. 5 Results are expressed as 104 equivalents. 6 <0.01 values were assigned 0.01. 7 Results are expressed as 106 equivalents.

Milk samples were analyzed for residues of tebuthiuron and metabolites 104, 106, 109, 104( OH), and 109( OH) using Method GRM 92.08. Metabolites 109 and 109( OH) were converted to metabolites 104 and 104( OH), respectively, in an initial acid hydrolysis. The hydrolysis product mixture was partitioned with ethyl acetate and purified on a neutral alumina solid phase extraction cartridge. A separate sample was required for metabolite 106. The maximum incurred residue in milk at the 45 ppm feeding level, expressed as the sum of tebuthiuron, 104 plus 109 as 104, 104( OH) plus 109( OH) as 104( OH), and 106. See Table 4.

Table 4: Residues of Tebuthiuron and Metabolites in Milk Diet (ppm) Day 1 Analyte Concentration 2 (ppm) DP Barcode: D281821 Dietary exposure assessment / 9 Tebuthiuron / 105501 9 0 25 Tebuthiuron <0.04 3 28 104 + 109 <0.02 28 104( OH) + 109( OH) <0.01 28 106 <0.01 45 6 12 4 Tebuthiuron 0.017; 0.023 (< 0.14) 5 104 + 109 0.550; 0.726 22 104( OH) + 109( OH) 0.063; 0.116 5 106 0.118; 0.132 135 7 22 Tebuthiuron 5 0.227; 0.480 5 104 + 109 3.03; 3.38 22 104( OH) + 109( OH) 0.143; 0.188 5 106 0.507; 0.626 450 8 22 Tebuthiuron 1.47; 3.18 25 104 + 109 23.0; 40.8 22 104( OH) + 109( OH) 1.15; 1.64 28 9 106 4.13; 5.25 1 Day of plateau of residue, unless otherwise indicated. 2 Not corrected for concurrent method recovery. First entry is average of three cows; second entry is maximum residue. For 104 + 109, results are expressed as 104 equivalents. For 104( OH) + 109( OH), results are expressed as 104( OH) equivalents. 3 "<" values are estimated limits of detection. 4 Residues were lower on subsequent days, except one cow (0.035 ppm) on day 13. 5 Results were variable among cows on a given days and among different days. The residue ranged from 0.148 to 0.288 ppm on day 25, 0.205 ppm average, 112% recovery. 6 Actual feeding levels were 71, 51, and 56 ppm. 7 Actual feeding levels were 192, 197, and 136 ppm. 8 Actual feeding levels were 903, 587, and 646 ppm. 9 Residue may not have plateaued, but low recovery (40%) obscures trends.

The average residues in various tissues at the 45 ppm (7.3x), 135 ppm (22x), and 450 ppm (73x) feeding levels, expressed as the sum of tebuthiuron, 104 + 109, and 106 + 108; and the total residues at 6.14 ppm tebuthiuron, assuming a linear regression relationship between diet intake and residues, are summarized in Table 5a.

Table 5a: Average Residues for Each Tissue Based on Linear Regression Beef Cattle Diet (ppm) Liver (ppm) Muscle (ppm) Kidney (ppm) Fat (ppm)

45ppm (7.3x) 3.43 0.80 1.6 0. 31 DP Barcode: D281821 Dietary exposure assessment / 10 Tebuthiuron / 105501 10 135ppm (22x) 10.44 2.96 4.53 1.62 450ppm (73x) 48.57 14.55 19.79 6.72 Calculated Maximum at 6.14 ppm (1x) 0.646 0.193 0.264 0.090 For milk, the average residues in milk at the 45 ppm (9.5x), 135 ppm (28.5x), and 450 ppm (95x) feeding levels, expressed as the sum of tebuthiuron, 104 + 109, and 104( OH) + 109( OH), and 106; and the total residues at 4.73 ppm tebuthiuron, assuming a linear regression relationship between diet intake and residues, are summarized in Table 5b.

Table 5b: Average Residues for Milk Based on Linear Regression Dairy Cattle Diet (ppm) Milk (ppm)

45ppm (9.5x) 0.748 135ppm (28.5x) 3.91 450ppm (95x) 29.75 Calculated Maximum at 4.73 ppm (1x) 0.296 Example: Calculation for Liver Step 1: The sum of the average of tebuthiuron residues, average 104 + 109 residues, and 106 + 108 residues are calculated from the feeding studies (see Table 4). Average refers to the average of duplicate analyses per each of the three cows. Please note the values using ½ LOD. 45 ppm: 0.05 ppm (parent) + 1.73 ppm (104 + 109) + 1.65 ppm (106 + 108)= 3.43 135 ppm: 0.129 ppm (parent) + 6.96 ppm (104 + 109) + 3.35 ppm (106 + 108)= 10.44 450 ppm: 0.668 ppm (parent) + 33.25 ppm (104 + 109) + 14.65 ppm (106 + 108)= 48.57 Step 2: The linear relationship (average residues versus beef cattle diets) for liver was derived from Table 5a using linear regression graph and equation to determine 1x.

Table 6. Summary of Tebuthiuron and its Metabolites in Meat and Milk DP Barcode: D281821 Dietary exposure assessment / 11 Tebuthiuron / 105501 11 RAC Anticipated Residues Chronic (ppm) Acute (RDF)

Liver 0. 006 (0.646 ppm x 1% CT) 0.013 (0.646 ppm x 2% CT)

Kidney 0. 003 (0.264 ppm x 1% CT) 0.005 (0.264 ppm x 2% CT)

Muscle 0.002 (0.193 ppm x 1% CT) 0.004 (0.193 ppm x 2% CT)

Fat 0. 001 (0.090 ppm x 1% CT) 0.002 (0.090 ppm x 2% CT)

Milk 0.003 (0.296 ppm x 1% CT) 0.006 (0.296 ppm x 2% CT)

I. DEEM™ Program and Consumption Information Tebuthiuron acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model (DEEM™) software Version 7.74, which incorporates consumption data from USDA's Continuing Surveys of Food Intake by Individuals (CSFII), 1989 1992. The 1989 92 data are based on the reported consumption of more than 10,000 individuals over three consecutive days, and therefore represent more than 30,000 unique "person days" of data. Foods "as consumed" (e. g., apple pie) are linked to raw agricultural commodities and their food forms (e. g., apples cooked/ canned or wheat flour) by recipe translation files internal to the DEEM software. Consumption data are averaged for the entire US population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment.

For chronic exposure and risk assessment, an estimate of the residue level in each food or food form (e. g., orange or orange juice) on the commodity residue list is multiplied by the average daily consumption estimate for that food/ food form. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total estimated exposure. Exposure estimates are expressed in mg/ kg body weight/ day and as a percent of the cPAD. This procedure is performed for each population subgroup. DP Barcode: D281821 Dietary exposure assessment / 12 Tebuthiuron / 105501 12 For acute exposure assessments, individual one day food consumption data are used on an individual by individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic (Tier 1 or Tier 2) exposure assessment, or "matched" in multiple random pairings with residue values and then summed in a probabilistic (Tier 3/ 4) assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i. e., those who reported eating relevant commodities/ food forms) and a per capita (i. e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis. However, for tiers 1 and 2, significant differences in user vs. per capita exposure and risk are identified and noted in the risk assessment.

II. Results/ Conclusions Acute Dietary Exposure Analysis A Tier 2 acute and chronic dietary risk assessments were conducted for all supported tebuthiuron food uses. Dietary risk estimates are provided for the general U. S. population (chronic only) and females 13 50 years (acute). This assessment concludes that for all included commodities, the acute risk estimates are below the Agency's level of concern (< 100% aPAD) at the 95 th exposure percentile for females 13 50 years (< 1% of the aPAD). This assessment also concludes that for all commodities, the chronic risk estimates are below the Agency's level of concern (< 100% cPAD) for the general U. S. population (< 1% of the cPAD) and all population subgroups. The results reported in Table 7 are for females 13 50 years only for acute dietary exposure analysis and Table 8 is the results of chronic dietary exposure analysis.

Table 7. Results of Acute Dietary Exposure Analysis Population Subgroup 95 th Percentile 99 th Percentile 99.9 th Percentile Exposure (mg/ kg/ day) % aPAD Exposure (mg/ kg/ day) % aPAD Exposure (mg/ kg/ day) % aPAD Females 13 50 years old 0.000078 <1 0.000121 <1 0.000207 <1 DP Barcode: D281821 Dietary exposure assessment / 13 Tebuthiuron / 105501 13 Chronic Dietary Exposure Analysis Table 8. Results of Chronic Dietary Exposure Analysis Population Subgroup Exposure (mg/ kg/ day) % cPAD U. S. Population (total) 0.000023 <1 All Infants (< 1 year) 0. 000036 <1 Children 1 6 years 0. 000083 <1 Children 7 12 years 0. 000043 <1 Females 13 50 0.000013 <1 Males 13 19 0.000025 <1 Males 20+ years 0. 000012 <1 Seniors 55+ 0.000012 <1 III. Discussion of Uncertainties C Residue Issues  The Agency notes that field trial data are generally considered by HED as an upper end or a worst case scenario of possible residues and are more suited to the requirements of tolerance setting, because it requires the highest rates of application and shortest PHI, than to the requirements of dietary exposure assessment (when the most realistic estimate is desired).

IV. List of Attachments Attachment 1: Acute Residue Input Data for DEEM Analysis for Tebuthiuron Attachment 2: Acute Residue Analysis for Tebuthiuron Attachment 3: Chronic Residue Input Data for DEEM Analysis for Tebuthiuron Attachment 4: Chronic Residue Analysis for Tebuthiuron DP Barcode: D281821 Dietary exposure assessment / 14 Tebuthiuron / 105501 14 cc: S. Piper (CEB), RF RDI: ChemSAC: 3/ 27/ 02; Secondary Reviewers: 4/ 1/ 02; FBSuhre 4/ 8/ 02 7509C: CEB: CM 2: RM 810F: 308 2717: Tebuthiuron

Attachment 1: Acute Residue Input Data for DEEM Analysis for Tebuthiuron U. S. Environmental Protection Agency Ver. 7.76 DEEM Acute analysis for TEBUTHIURON Residue file name: C:\ deem\ tebuthiruon\ tebuthiuronacute. RS7 Analysis Date 04 02 2002 Residue file dated: 04 02 2002/ 15: 58: 50/ 8 Reference dose: aRfD = 0.083 mg/ kg bw/ day NOEL = 25 mg/ kg bw/ day Comment: Assumes 3x factor for FQPA females 13 50 yrs only

Food Crop Food Name Def Res Adj. Factors RDL Code Grp (ppm) #1 #2 Ind        318 D Milk nonfat solids 0.296000 1.000 0.020 319 D Milk fat solids 0.296000 1.000 0.020 320 D Milk sugar (lactose) 0.296000 1.000 0.020 321 M Beef meat byproducts 0.646000 1.000 0.020 322 M Beef other organ meats 0.646000 1.000 0.020 323 M Beef dried 0.193000 1.920 0.020 324 M Beef fat w/ o bones 0.090000 1.000 0.020 325 M Beef kidney 0.264000 1.000 0.020 326 M Beef liver 0.646000 1.000 0.020 327 M Beef lean (fat/ free) w/ o bones 0.193000 1.000 0.020 328 M Goat meat byproducts 0.646000 1.000 0.020 329 M Goat other organ meats 0.646000 1.000 0.020 330 M Goat fat w/ o bone 0.090000 1.000 0.020 331 M Goat kidney 0.264000 1.000 0.020 332 M Goat liver 0.646000 1.000 0.020 333 M Goat lean (fat/ free) w/ o bone 0.193000 1.000 0.020 334 M Horsemeat 0.193000 1.000 0.020 336 M Sheep meat byproducts 0.646000 1.000 0.020 337 M Sheep other organ meats 0.646000 1.000 0.020 338 M Sheep fat w/ o bone 0.090000 1.000 0.020 339 M Sheep kidney 0.264000 1.000 0.020 340 M Sheep liver 0.646000 1.000 0.020 341 M Sheep lean (fat free) w/ o bone 0.193000 1.000 0.020 398 D Milk based water 0.296000 1.000 0.020 Attachment 2: Acute Residue Analysis for Tebuthiuron U. S. Environmental Protection Agency Ver. 7.76 DEEM ACUTE Analysis for TEBUTHIURON (1989 92 data) Residue file: tebuthiuronacute. RS7 Adjustment factor #2 used. Analysis Date: 04 02 2002/ 15: 54: 34 Residue file dated: 04 02 2002/ 15: 51: 52/ 8 NOEL (Acute) = 25.000000 mg/ kg body wt/ day Daily totals for food and foodform consumption used. Run Comment: "Assumes 3x factor for FQPA females 13 50 yrs" =============================================================================== DP Barcode: D281821 Dietary exposure assessment / 15 Tebuthiuron / 105501 15 Summary calculations (per capita):

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE          Females 13+ (preg/ not nursing): 0.000109 0.13 229030 0.000128 0.15 195001 0.000195 0.24 128105 Females 13+ (nursing): 0.000118 0.14 211948 0.000183 0.22 136354 0.000195 0.23 128528 Females 13 19 (not preg or nursing): 0.000098 0.12 255390 0.000175 0.21 142798 0.000235 0.28 106564 Females 13 50 yrs: 0.000078 0.09 319551 0.000121 0.15 206558 0.000207 0.25 120907 Attachment 3: Chronic Residue Input Data for DEEM Analysis for Tebuthiuron U. S. Environmental Protection Agency Ver. 7.76 DEEM Chronic analysis for TEBUTHIURON 1989 92 data Residue file: C:\ deem\ tebuthiruon\ tebuthirchronic. RS7 Adjust. #2 used Analysis Date 04 02 2002 Residue file dated: 04 02 2002/ 15: 52: 42/ 8 Reference dose (RfD) = 0.14 mg/ kg bw/ day Comment: Assumes 1x factor for FQPA  Food Crop RESIDUE Adj. Factors Code Grp Food Name (ppm) #1 #2       318 D Milk nonfat solids 0.296000 1.000 0.010 319 D Milk fat solids 0.296000 1.000 0.010 320 D Milk sugar (lactose) 0.296000 1.000 0.010 321 M Beef meat byproducts 0.646000 1.000 0.010 322 M Beef other organ meats 0.646000 1.000 0.010 323 M Beef dried 0.193000 1.920 0.010 324 M Beef fat w/ o bones 0.090000 1.000 0.010 325 M Beef kidney 0.264000 1.000 0.010 326 M Beef liver 0.646000 1.000 0.010 327 M Beef lean (fat/ free) w/ o bones 0.193000 1.000 0.010 328 M Goat meat byproducts 0.646000 1.000 0.010 329 M Goat other organ meats 0.646000 1.000 0.010 330 M Goat fat w/ o bone 0.090000 1.000 0.010 331 M Goat kidney 0.264000 1.000 0.010 332 M Goat liver 0.646000 1.000 0.010 333 M Goat lean (fat/ free) w/ o bone 0.193000 1.000 0.010 334 M Horsemeat 0.193000 1.000 0.010 336 M Sheep meat byproducts 0.646000 1.000 0.010 337 M Sheep other organ meats 0.646000 1.000 0.010 338 M Sheep fat w/ o bone 0.090000 1.000 0.010 339 M Sheep kidney 0.264000 1.000 0.010 340 M Sheep liver 0.646000 1.000 0.010 341 M Sheep lean (fat free) w/ o bone 0.193000 1.000 0.010 398 D Milk based water 0.296000 1.000 0.010 DP Barcode: D281821 Dietary exposure assessment / 16 Tebuthiuron / 105501 16 Attachment 4: Chronic Residue Analysis for Tebuthiuron U. S. Environmental Protection Agency Ver. 7.76 DEEM Chronic analysis for TEBUTHIURON (1989 92 data) Residue file name: C:\ deem\ tebuthiruon\ tebuthirchronic. RS7 Adjustment factor #2 used. Analysis Date 04 02 2002/ 16: 03: 16 Residue file dated: 04 02 2002/ 15: 52: 42/ 8 Reference dose (RfD, Chronic) = .14 mg/ kg bw/ day COMMENT 1: Assumes 1x factor for FQPA =============================================================================== Total exposure by population subgroup

Total Exposure  Population mg/ kg Percent of Subgroup body wt/ day Rfd    U. S. Population (total) 0.000023 0.0%

U. S. Population (spring season) 0.000023 0.0% U. S. Population (summer season) 0.000022 0.0% U. S. Population (autumn season) 0.000024 0.0% U. S. Population (winter season) 0.000023 0.0%

Northeast region 0.000023 0.0% Midwest region 0.000026 0.0% Southern region 0.000021 0.0% Western region 0.000023 0.0%

Hispanics 0.000025 0.0% Non hispanic whites 0.000023 0.0% Non hispanic blacks 0.000020 0.0% Non hisp/ non white/ non black 0.000024 0.0%

All infants (< 1 year) 0.000036 0.0% Nursing infants 0.000007 0.0% Non nursing infants 0.000048 0.0% Children 1 6 yrs 0.000083 0.1% Children 7 12 yrs 0.000043 0.0%

Females 13 19 (not preg or nursing) 0.000019 0.0% Females 20+ (not preg or nursing) 0.000011 0.0% Females 13 50 yrs 0.000013 0.0% Females 13+ (preg/ not nursing) 0.000022 0.0% Females 13+ (nursing) 0.000019 0.0%

Males 13 19 yrs 0.000025 0.0% Males 20+ yrs 0.000012 0.0% Seniors 55+ 0.000012 0.0% Pacific Region 0.000023 0.0%