 [Federal Register: August 26, 2008 (Volume 73, Number 166)] [ Notices]                [Page 50398] [DOCID:fr26au08-121]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

  Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations

(CFR), notice is hereby given that the Federal Railroad Administration

(FRA) received a request for a waiver of compliance with certain

requirements of its safety standards. The individual petition is

described below, including the party seeking relief, the regulatory

provisions involved, the nature of the relief being requested, and the

petitioner's arguments in favor of relief.

Port Authority Trans-Hudson Corporation

[Docket Number FRA-2008-0085]

    The Port Authority Trans-Hudson Corporation (PATH), seeks a waiver

of compliance from certain provisions of Safety Appliance Standards, 49

CFR Part 231, that requires a sill step, side, and end handhold on each

side and each end of a passenger car. Specifically, the PATH request is

to use an alternate location of the sill step and side handhold and not

install end handholds for the production of PATH's new fleet of

passenger cars in passenger train service.

    PATH operates on 13.8 miles of an interstate rail transit system

between five major terminals and eight intermediate stations linking

New Jersey and New York. The PATH system is a closed system, does not

interchange and has other railroads with no highway rail crossings.

Currently, PATH operates 326 vehicles of similar comparable design with

relatively short headways and high platforms over a system that one-

half of which is located in tunnels below ground level carrying 250,000

passengers in a 24-hour period. There is no interchange of car

equipment between PATH and any rapid transit system or railroad.

Because of the unique characteristics of PATH that is more

representative of an inter-urban rapid transit system, PATH requests a

waiver of certain provisions of FRA requirements, which they believe

are not totally applicable. PATH also believes that in the past, FRA,

while asserting jurisdiction over PATH, has acknowledged that PATH's

operations are analogous to that of an inter-urban rapid transit

system.

    Interested parties are invited to participate in these proceedings

by submitting written views, data, or comments. FRA does not anticipate

scheduling a public hearing in connection with these proceedings since

the facts do not appear to warrant a hearing. If any interested party

desires an opportunity for oral comment, they should notify FRA, in

writing, before the end of the comment period and specify the basis for

their request.

    All communications concerning these proceedings should identify the

appropriate docket number (e.g., Waiver Petition Docket Number 2008-

0085) and may be submitted by any of the following methods:

     Web site: http://www.regulations.gov. Follow the online

instructions for submitting comments.

     Fax:<PHONE_NUMBER>.

     Mail: Docket Operations Facility, U.S. Department of

Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC

20590.

     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,

Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,

except Federal holidays.

    Communications received within 45 days of the date of this notice

will be considered by FRA before final action is taken. Comments

received after that date will be considered as far as practicable. All

written communications concerning these proceedings are available for

examination during regular business hours (9 a.m.-5 p.m.) at the above

facility. All documents in the public docket are also available for

inspection and copying on the Internet at the docket facility's Web

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

    Anyone is able to search the electronic form of any written

communications and 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).

    Issued in Washington, DC on August 20, 2008.

Grady C. Cothen, Jr.,

Deputy Associate Administrator for Safety Standards and Program

Development.

[FR Doc. E8-19673 Filed 8-25-08; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Rules and Regulations]
[Pages 20493-20496]
[FR Doc No: 2011-7743]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0262; Directorate Identifier 2010-NM-215-AD;
Amendment 39-16649; AD 2011-07-12]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Model F.27 Mark
050 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    * * * [T]he Federal Aviation Administration (FAA) has published
Special Federal Aviation Regulation (SFAR) 88, and the Joint
Aviation Authorities (JAA) has published Interim Policy INT/POL/25/
12. The review conducted by Fokker Services on the Fokker 50 and
Fokker 60 type design, in response to these regulations, revealed
that the clearance between parts of the main landing gear (MLG) and
the fuel pipes may be insufficient.
    This condition, if not detected and corrected, could lead to
chafing, possibly resulting in fuel leakage and, in combination with
other factors, a fuel fire.

This AD requires actions that are intended to address the unsafe
condition described in the MCAI.

DATES: This AD becomes effective April 28, 2011.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of April 28,
2011.
    We must receive comments on this AD by May 31, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; phone: 425-227-
1137; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2010-0197, dated October 1, 2010 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    * * * [T]he Federal Aviation Administration (FAA) has published
Special Federal Aviation Regulation (SFAR) 88, and the Joint
Aviation Authorities (JAA) has published Interim Policy INT/POL/25/
12. The review conducted by Fokker Services on the Fokker 50 and
Fokker 60 type design, in response to these regulations, revealed
that the clearance between parts of the main landing gear (MLG) and
the fuel pipes may be insufficient.
    This condition, if not detected and corrected, could lead to
chafing, possibly resulting in fuel leakage and, in combination with
other factors, a fuel fire.
    EASA issued AD 2010-0182 to require actions to ensure that a
minimum clearance is maintained between the parts of the MLG and the
fuel pipes in both nacelles.
    Since that AD was issued, it was discovered that aeroplane
serial numbers 20133 through 20142 were erroneously omitted in the
original Fokker Service Bulletins (SB) and consequently the AD did
not apply to those aeroplanes. The two SB's (some typographical
errors in part numbers were also found) have now been revised to
correct this omission.
    For the reasons described above, this new AD retains the
requirements of AD 2010-0182, which is superseded, and expands the
Applicability to add the 10 missing serial numbers.

    The required actions include an inspection to determine fuel pipe
part numbers, a general visual inspection to determine the clearance
between certain fuel pipes and parts of the main landing gear, and
replacement of certain pipes with insufficient main landing gear
clearance. The required actions also include revising the maintenance
program to incorporate a fuel limitation and a critical design
configuration control limitation (CDCCL). You may obtain further
information by examining the MCAI in the AD docket.
    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).

    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    The Joint Aviation Authorities (JAA) has issued a regulation that
is similar to SFAR 88. (The JAA is an associated body of the European
Civil Aviation Conference (ECAC) representing the civil aviation
regulatory authorities of a number of European States who have agreed
to co-operate in developing and implementing common safety regulatory
standards and procedures.) Under this regulation, the JAA stated that
all members of the ECAC that hold type certificates for transport
category airplanes are required to conduct a design review against
explosion risks.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.

Relevant Service Information

    Fokker Services B.V. has issued Service Bulletin SBF50-28-028,
Revision 1, dated September 15, 2010; and Service Bulletin SBF50-28-
031, Revision 1, dated September 15, 2010. The actions described in
this service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    There are no products of this type currently registered in the
United States. However, this rule is necessary to ensure that the
described unsafe condition is addressed if any of these products are
placed on the U.S. Register in the future.

Differences Between the AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

FAA's Determination of the Effective Date

    Since there are currently no domestic operators of this product,
notice and opportunity for public comment before issuing this AD are
unnecessary.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2011-0262; Directorate
Identifier 2010-NM-215-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator,

the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2011-07-12 Fokker Services B.V.: Amendment 39-16649. Docket No. FAA-
2011-0262; Directorate Identifier 2010-NM-215-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective April
28, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Fokker Services B.V. Model F.27 Mark 050
airplanes; certificated in any category; serial numbers 20133
through 20335 inclusive; except those with inboard fuel tanks
installed.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new actions (e.g., inspections)
and/or critical design configuration control limitations (CDCCLs).
Compliance with these actions and/or CDCCLs is required by 14 CFR
91.403(c). For airplanes that have been previously modified,
altered, or repaired in the areas addressed by this AD, the operator
may not be able to accomplish the actions described in the
revisions. In this situation, to comply with 14 CFR 91.403(c), the
operator must request approval of an alternative method of
compliance (AMOC) according to paragraph (n) of this AD. The request
should include a description of changes to the required actions that
will ensure the continued operational safety of the airplane.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Reason

    (e) The mandatory continued airworthiness information (MCAI)
states:

    * * * [T]he Federal Aviation Administration (FAA) has published
Special Federal Aviation Regulation (SFAR) 88, and the Joint
Aviation Authorities (JAA) has published Interim Policy INT/POL/25/
12. The review conducted by Fokker Services on the Fokker 50 and
Fokker 60 type design, in response to these regulations, revealed
that the clearance between parts of the main landing gear (MLG) and
the fuel pipes may be insufficient.
    This condition, if not detected and corrected, could lead to
chafing, possibly resulting in fuel leakage and, in combination with
other factors, a fuel fire.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Inspection

    (g) Within 6 months after the effective date of this AD: Inspect
the part numbers of each fuel pipe (two in each nacelle), in
accordance with Part 1 of the Accomplishment Instructions of Fokker
Service Bulletin SBF50-28-028, Revision 1, dated September 15, 2010.
    (h) If, as a result of the inspection required by paragraph (g)
of this AD, fuel pipe part numbers other than those specified in
Part 1 of the Accomplishment Instructions of Fokker Service Bulletin
SBF50-28-028, Revision 1, dated September 15, 2010, are found to be
installed: Before further flight, do a general visual inspection to
determine the clearance between the fuel pipes and the parts of the
main landing gear, and for chafing marks, in accordance with Part 2
of the Accomplishment Instructions of Fokker Service Bulletin SBF50-
28-028, Revision 1, dated September 15, 2010.

Fuel Pipe Replacement

    (i) If, during the inspection required by paragraph (h) of this
AD, the measured clearance is less than or equal to 3.0 mm and
greater than 1.5 mm for one or more fuel pipes, and no chafing marks
are found: Within 24 months after the effective date of this AD,
install new fuel pipes in both engine nacelles, in accordance with
the Accomplishment Instructions of Fokker Service Bulletin SBF50-28-
031, Revision 1, dated September 15, 2010.
    (j) If, during the inspection required by paragraph (h) of this
AD, the measured clearance is less than or equal to 1.5 mm for one
or more fuel pipes, or chafing marks are found on one or more fuel
pipes: Before further flight, install new fuel pipes in both engine
nacelles, in accordance with the Accomplishment Instructions of
Fokker's Service Bulletin SBF50-28-031, Revision 1, dated September
15, 2010.

Maintenance Program Revision To Add Fuel Airworthiness Limitation

    (k) Within 6 months after the effective date of this AD, revise
the airplane maintenance program by incorporating the limitations
specified in paragraphs (k)(1) and (k)(2) of this AD.
    (1) The CDCCL specified in paragraph 1.L.(1)(c) of Fokker
Service Bulletin SBF50-28-031, Revision 1, dated September 15, 2010.
    (2) The fuel airworthiness limitation specified in paragraph
1.L.(1)(c) of Fokker Service Bulletin SBF50-28-028, Revision 1,
dated September 15, 2010. The initial compliance time for doing the
inspection is within 4,800 flight hours after doing the inspection
required by paragraph (h) of this AD.

No Alternative Actions, Intervals, and/or CDCCLs

    (l) After accomplishing the revision required by paragraph (k)
of this AD, no alternative actions (e.g., inspection, interval) and/
or CDCCLs may be used unless the actions, intervals, and/or CDCCLs
are approved as an AMOC in accordance with the procedures specified
in paragraph (n) of this AD.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (m) Actions accomplished prior to the effective date of this AD,
in accordance with Fokker Service Bulletin SBF50-28-028, dated May
20, 2010; or Service Bulletin SBF50-28-031, dated May 20, 2010; as
applicable; are acceptable to comply with the corresponding
requirements of this AD.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows:
    Although EASA Airworthiness Directive 2010-0197, dated October
1, 2010, specifies both revising the maintenance program to include
airworthiness limitations, and doing certain repetitive actions
(e.g., inspections) and/or maintaining CDCCLs, this AD only requires
the revision. Requiring a revision of the maintenance program,
rather than requiring individual repetitive actions and/or
maintaining CDCCLs, requires operators to record AD compliance only
at the time the revision is made. Repetitive actions and/or
maintaining CDCCLs specified in the airworthiness limitations must
be complied with in accordance with 14 CFR 91.403(c).

 Other FAA AD Provisions

    (n) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Information may be e-mailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (o) Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2010-0197, dated October 01, 2010; Fokker
Service Bulletin SBF50-28-028, Revision 1, dated September 15, 2010;
and Fokker Service Bulletin SBF50-28-031,

Revision 1, dated September 15, 2010; for related information.

Material Incorporated by Reference

    (p) You must use Fokker Service Bulletin SBF50-28-028, Revision
1, dated September 15, 2010; and Fokker Service Bulletin SBF50-28-
031, Revision 1, dated September 15, 2010; as applicable; to do the
actions required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 231, 2150
AE Nieuw-Vennep, the Netherlands; phone: +31 (0)252-627-350; fax:
+31 (0)252-627-211; e-mail:
<EMAIL_ADDRESS>Internet: http://www.myfokkerfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on March 22, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-7743 Filed 4-12-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 249 (Wednesday, December 29, 2010)]
[Rules and Regulations]
[Pages 81878-81885]
[FR Doc No: 2010-32451]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2009-0205; FRL-8857-4]

Imazosulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
imazosulfuron in or on pepper, bell; pepper, non-bell; rice, grain; and
tomato. Valent USA Corporation requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 29, 2010. Objections and
requests for hearings must be received on or before February 28, 2011,
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-2009-0205. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., 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 (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; 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).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To
access the harmonized test guidelines referenced in this document
electronically, please go http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2009-0205 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
February 28, 2011. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0205, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 6, 2009 (74 FR 20947) (FRL-8412-7),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 9F7535)
by Valent USA Corporation, 1600 Riviera Ave., Suite 200, Walnut Creek,
CA 94596. The petition requested that 40 CFR part 180 be amended by
adding a section for the herbicide imazosulfuron and establishing
tolerances therein for residues of imazosulfuron, 2-chloro-N-[[(4,6-
dimethoxy-2-pyrimidinyl)amino]carbonyl] imidazo-[1,2-a]pyridine-3-
sulfonamide, in or on pepper, bell, fruit; pepper, non-bell, fruit;
rice, grain; and tomato, fruit; each at 0.02 parts per million (ppm).
That notice referenced a summary of the petition prepared by Valent USA
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    EPA has modified the proposed commodity terms for pepper and tomato
commodities and revised the requested tolerance expression in
accordance with current policy. The reasons for these changes are
explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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 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 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. * *
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 imazosulfuron including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with imazosulfuron 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.
    The toxicology data for imazosulfuron suggest that this herbicide
possesses relatively low toxicity. Many of the effects of single or
repeated dosing were observed near or beyond the respective limit
doses.
    Imazosulfuron is of low acute toxicity by the oral, dermal, and
inhalation routes of exposure; it is not a skin or eye irritant or a
dermal sensitizer. The primary target organ of imazosulfuron in
repeated-dose studies was the liver in all species tested. Mild to
moderate thyroid effects were apparent only in the chronic toxicity
study in dogs. Dramatic eye effects (retinal degeneration, lens
vascularization, cataracts and corneal scarring) were observed in rats
fed > 1,000 mg/kg/day beginning at 3 months in the chronic toxicity/
carcinogenicity study. Ocular effects (increased incidence of eye
opacity, corneal edema, inflammation and neovascularization) were also
observed in the high-dose males (4,577 mg/kg/day) in the 90-day feeding
toxicity study in rats. Decreased body weight and body weight gain
compared to control were frequent findings throughout the toxicology
database for imazosulfuron.
    Clinical signs (decreased motor activity, abnormal gait, upward
curvature of the spine and piloerection) were observed in males at the
limit dose of the acute neurotoxicity study; however, these effects can
be attributed to generalized toxicity and were resolved by Day 2 of the
study. No neurotoxic effects were observed during the subchronic
screening battery or noted as clinical signs in any other repeated-dose
study.
    No developmental effects were observed at the highest dose tested
(HDT) (125 mg/kg/day) in the rabbit developmental toxicity study. No
developmental or reproductive toxicity was observed in the 1-generation
rat study. Decreased pup viability was observed in the rat 2-generation
reproduction study at a dose approaching the limit dose (LOAEL = 892
mg/kg/day) in both the F1 and F2 offspring generations. Mortality was
also observed in the parental generation at this dose. No increased
qualitative or quantitative offspring susceptibility was apparent in
any of the submitted studies for imazosulfuron.
    There was no evidence of carcinogenicity in rats and mice up to the
limit dose at 24 and 18 months, respectively. Imazosulfuron was
determined to be non-mutagenic in bacteria and negative in an in vivo
mammalian cytogenetics assay. Overall, there was no evidence that
imazosulfuron was either mutagenic or clastogenic in either in vivo or
in vitro assays. The cancer classification is ``not likely to be
carcinogenic to humans,'' based on the absence of significant tumor
increases in the carcinogenicity studies.
    Specific information on the studies received and the nature of the
adverse effects caused by imazosulfuron 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 at http://www.regulations.gov in the document ``Imazosulfuron: Human Health Risk
Assessment for Proposed Uses on Rice, Peppers and Tomatoes,'' p. 45 in
docket ID number EPA-HQ-OPP-2009-0205.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. 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/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for imazosulfuron used for human risk assessment is shown in
the Table of this unit.

  Table--Summary of Toxicological Doses and Endpoints for Imazosulfuron for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                      Point of departure and
         Exposure/Scenario              uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years    An acute reference dose specific to females age 13-49 was not identified,
 of age).                              because there was no prenatal or fetal toxicity observed in developmental
                                             or reproductive animal studies following a single oral dose.
Acute dietary (General population    NOAEL = 400 mg/kg/day    Acute RfD = 4 mg/kg/    Acute neurotoxicity
 including females 13-49 years of     UFA = 10x.               day.                    screening battery.
 age and infants and children).                                                       LOAEL = 2,000 mg/kg/day
                                                                                based on the following
                                                                                clinical signs: Abnormal
                                                                                gait, decreased activity,
                                                                                piloerection and upward
                                                                                curvature of the spine;
                                                                                and incidents of
                                                                                irregular breathing,
                                                                                reduced righting reflex,
                                                                                tremors, decreased visual
                                                                                placement response in
                                                                                males and increased
                                                                                response to sound in one
                                                                                female.

                                     UFH = 10x..............  aPAD = 4 mg/kg/day
                                     FQPA SF = 1x...........
Chronic dietary (All populations)..  NOAEL= 75 mg/kg/day UFA  Chronic RfD = 0.75 mg/  Chronic toxicity in the
                                      = 10x.                   kg/day.                 dog.
                                                                                LOAEL = 150 mg/kg/day
                                                                                based on moderate thyroid
                                                                                hypertrophy (males at mid-
                                                                                and high-dose; mild
                                                                                hypertrophy in females at
                                                                                high-dose).
                                     UFH = 10x..............  cPAD = 0.75 mg/kg/day.
                                     FQPA SF = 1x...........
Incidental oral short-term (1 to 30  NOAEL= 235 mg/kg/day     LOC for MOE = 100.....  Reproduction, 2-generation
 days) and intermediate-term (1 to    UFA = 10x.                                       (rat).
 6 months).                                                                           LOAEL = 892 mg/kg/day
                                                                                based on mortality,
                                                                                clinical signs, decreased
                                                                                body weights, body weight
                                                                                gains and food
                                                                                consumption in parents.
                                                                                90-day oral toxicity
                                                                                (rat).
                                                                                LOAEL = 956 mg/kg/day
                                                                                based on decreased body
                                                                                weight gains and food
                                                                                efficiency.
                                     UFH = 10x..............
                                     FQPA SF = 1x...........
Dermal short-term (1 to 30 days)        No systemic toxicity occurred at the limit dose and the primary toxic
 and intermediate-term (1 to 6           effects of concern (liver, eye) were adequately assessed in a 21-day
 months).                               dermal toxicity study. It is concluded that this compound is not or is
                                         poorly absorbed through the skin and, therefore, a quantitative risk
                                         assessment for this route and duration of exposure is not necessary.
Inhalation short-term (1 to 30       Inhalation (or oral)     LOC for MOE = 100.....  Reproduction, 2-generation
 days) and intermediate-term (1 to    study NOAEL = 235 mg/                            (rat).
 6 months).                           kg/day (inhalation                              LOAEL = 892 mg/kg/day
                                      absorption rate =                                based on mortality,
                                      100%).                                           clinical signs, decreased
                                                                                body weights, body weight
                                                                                gains and food
                                                                                consumption in parents.
                                     UFA = 10x..............
                                     UFH = 10x..............
                                     FQPA SF = 1x...........  ......................  90-day oral toxicity
                                                                                (rat). LOAEL = 956 mg/kg/
                                                                                day based on decreased
                                                                                body weight gains and
                                                                                food efficiency.
Cancer (Oral, dermal, inhalation)..    Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                             absence of significant tumor increases in two adequate rodent
                                                               carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to imazosulfuron, EPA considered exposure under the
petitioned-for tolerances. There are no tolerances currently
established for imazosulfuron. EPA assessed dietary exposures from
imazosulfuron 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. Such effects were identified
for imazosulfuron. 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 Intakes by Individuals (CSFII). As to residue levels in food, EPA
assumed that residues are present in all commodities at the tolerance
level and that 100% of commodities are treated with imazosulfuron.
DEEMTM 7.81 default concentration factors were used to
estimate residues of imazosulfuron in processed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed that residues
are present in all commodities at the tolerance level and that 100% of
commodities are treated with imazosulfuron. DEEMTM 7.81
default concentration factors were used to estimate residues of
imazosulfuron in processed commodities.
    iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA classified imazosulfuron as ``Not likely to be
Carcinogenic to Humans''; therefore, a dietary exposure assessment for
the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for imazosulfuron. Tolerance level residues and 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The residues of concern in
drinking water include imazosulfuron and its degradates HMS, IPSN,
UDPM, ADPM, and SDPM. The Agency used screening level water exposure
models in the dietary exposure analysis and risk assessment for
imazosulfuron and its degradates in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of imazosulfuron and its degradates. 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 First Index Reservoir Screening Tool (FIRST), Tier 1
Rice Model, and Screening Concentration in Ground Water (SCI-GROW)
models, the estimated drinking water concentrations (EDWCs) of
imazosulfuron and its degradates for both acute exposures and chronic
exposures for non-cancer assessments are estimated to be 278.9 parts
per billion (ppb) for surface water (based on the Tier 1 Rice Model
results) and 4.8 ppb for ground water (based on the SCI-GROW model
results).
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute and chronic dietary
risk assessment, the water concentration value of 278.9 ppb was used to
assess 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). Imazosulfuron is
currently registered for the following uses that could result in
residential exposures: Residential turfgrass and recreational areas.
EPA assessed residential exposure using the following assumptions:
There is a potential for exposure of homeowners applying products
containing imazosulfuron on home lawns. There is also a potential for
post-application exposure of adults and children entering turf areas
that have been treated with imazosulfuron and for bystander exposure of
adults and children in areas adjacent to pesticide applications.
    Residential handlers may receive short-term dermal and inhalation
exposure to imazosulfuron when mixing, loading and applying the
pesticide on home lawns. Since a dermal endpoint of concern was not
identified for imazosulfuron, only short-term inhalation exposure of
residential handlers was assessed.
    Adults and children may receive short-term inhalation and dermal
exposures from entering turf areas treated with imazosulfuron.
Volatilization of imazosulfuron may also be a source of short-term
post-application inhalation exposure of bystanders nearby application
sites. Finally, children may receive short-term incidental oral
exposure (i.e., hand-to-mouth, object-to-mouth and soil ingestion
exposure) during post-application activities on treated turf. EPA did
not identify any dermal endpoints of concern for imazosulfuron; and a
quantitative post-application inhalation exposure assessment was not
performed for imazosulfuron due to its low acute inhalation toxicity,
low vapor pressure (< 3.5 x 10-6 Pa), low proposed use rate
(0.3 lb ai/A), and the soil-directed application method (i.e., it is
not applied using equipment, such as air blast sprayers, that would
result in higher post-application inhalation exposures). Therefore, EPA
assessed only short-term post-application incidental oral exposure of
children (toddlers).
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
    EPA has not found imazosulfuron to share a common mechanism of
toxicity with any other substances, and imazosulfuron does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
imazosulfuron does not have 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 Web site at  http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The pre- and postnatal
toxicity database for imazosulfuron includes guideline rat and rabbit
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. No developmental effects were observed at the HDT in the
rabbit developmental toxicity study, and no developmental or
reproductive toxicity was observed in the developmental (1-generation)
rat study. In the 2-generation rat reproduction study, both decreased
pup viability and parental mortality were observed, but only at a dose
approaching the limit dose.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for imazosulfuron is largely complete,
lacking only an immunotoxicity study. EPA has evaluated the available
toxicity data for imazosulfuron and determined that an additional
database uncertainty factor is not needed to account for potential
immunotoxicity. The most sensitive endpoint in the database is moderate
thyroid hypertrophy. Liver toxicity accompanied by body weight and food
consumption effects is seen throughout the toxicology database. No
treatment-related changes indicative of potential immunotoxicity were
seen in hematology parameters, organ weights (thymus, spleen), gross
necropsy (enlarged lymph nodes) or histopathology (spleen, thymus,
lymph nodes) when tested up to the limit dose in mice and rats.
Therefore, EPA does not believe that conducting a special series
870.7800 immunotoxicity study will result in a NOAEL less than 75 mg/
kg/day, which is presently used as the point of departure for chronic
risk assessment.
    ii. No neurotoxic effects were observed during the subchronic
screening battery or noted as clinical signs in any other repeated-dose
study. Although untoward clinical signs were observed in the acute
neurotoxicity study, these effects can be attributed to generalized
toxicity and were resolved by Day 2 of the study. Based on these
considerations, there is no need for a developmental neurotoxicity
study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that imazosulfuron results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.

    iv. There are no significant residual uncertainties in the exposure
databases. Data have been requested to confirm the stability of
imazosulfuron during frozen storage and the metabolic profile of
pyrimidine-labeled imazosulfuron in rice grain in the confined
rotational crop trial. A field rotational crop study is also required
for grain (wheat); however, as explained in Unit III.D.3.iv.c., EPA
does not expect these studies to have a measurable impact on exposure
estimates for imazosulfuron.
    a. Storage stability. The final reports of the storage stability
studies must be submitted, reflecting frozen storage intervals of up to
11.8 months for peppers, up to 34.5 months for rice grain, and up to
17.3 months for tomatoes. Interim data suggest that imazosulfuron is
stable in frozen storage, and similar sulfonylurea chemicals are known
to be stable. Therefore, EPA expects imazosulfuron to be stable in
frozen storage but is requiring the final study reports as
confirmation.
    b. Metabolic profile. The HPLC profile for the pyrimidinyl (Py)-
label grain storage stability analysis must be submitted to confirm
that the metabolite profile was stable in Py-label grain. Grain samples
from the confined rotational crop study were stored for a relatively
long interval (9 months) prior to completion of the analyses. Analysis
of an imidozolyl (Im)-label sample after the 9-month period yielded a
metabolic profile similar to that of a sample analyzed at the start of
the period. A similar comparison must be made for the Py-label sample
of grain. This is of no practical consequence for risk assessment
because total residue levels on grain were small (<0.01 ppm at a 365-
day plantback interval), imazosulfuron was not present, and no
metabolites/degradates were considered toxicologically significant.
    c. Field accumulation in rotational crops (grain). The grain
(wheat) rotational crop study is needed to identify maximum levels of
residues in grain and livestock feed items (forage, straw) as a
function of the plantback interval. On an interim basis, a plantback
interval of 12 months is being required for grains and soybeans. The
results of the rotational crop study may allow a shorter plantback
interval. The confined rotational crop study showed that imazosulfuron
and metabolites will be negligible (<0.01 ppm) on forage, hay, straw,
stover, and grain at a 365-day plantback interval and will, therefore,
make no contribution to dietary exposure.
    The dietary food exposure assessments were performed assuming
tolerance-level residues and 100 PCT for all commodities. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to imazosulfuron in drinking water.
EPA used similarly conservative assumptions to assess postapplication
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by imazosulfuron.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
imazosulfuron will occupy 1.4% of the aPAD for infants less than 1 year
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
imazosulfuron from food and water will utilize 2.7% of the cPAD for
infants less than 1 year old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
imazosulfuron is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Imazosulfuron
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to imazosulfuron.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 40,000 for adults
and 7,000 for children. For adults, the aggregate MOE includes short-
term residential handler inhalation exposure plus chronic dietary
exposure to imazosulfuron from food and water. For children, the
aggregate MOE includes short-term incidental oral residential exposure
plus chronic dietary exposure to imazosulfuron from food and water.
Because EPA's level of concern for imazosulfuron is a MOE of 100 or
below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
imazosulfuron is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
imazosulfuron.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, imazosulfuron is not expected to pose a cancer risk to humans.
    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 imazosulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry (LC/MS/MS) Method RM-42C-3) 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

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for imazosulfuron.

C. Revisions to Petitioned-For Tolerances

    EPA is revising the proposed commodity terms for ``pepper, bell,
fruit''; ``pepper, non-bell, fruit''; and ``tomato, fruit''; to read
``pepper, bell''; ``pepper, non-bell''; and ``tomato''. The commodity
terms have been changed in accordance with the guidance in the Agency's
Food and Feed Commodity Vocabulary.
    EPA is also revising the requested tolerance expression to clarify
the chemical moieties that are covered by the tolerances and specify
how compliance with the tolerances is to be measured. The revised
tolerance expression makes clear that the tolerances cover residues of
the herbicide imazosulfuron, including its metabolites and degradates,
but that compliance with the tolerance levels is to be determined by
measuring only imazosulfuron, 2-chloro-N-[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl]imidazo-[1,2-[alpha]]pyridine-3-sulfonamide,
in or on the commodities.

 V. Conclusion

    Therefore, tolerances are established for residues of
imazosulfuron, including its metabolites and degradates, in or on
pepper, bell at 0.02 ppm; pepper, non-bell at 0.02 ppm; rice, grain at
0.02 ppm; and tomato at 0.02 ppm. Compliance with the tolerance levels
is to be determined by measuring only imazosulfuron, 2-chloro-N-[[(4,6-
dimethoxy-2-pyrimidinyl)amino]carbonyl]imidazo-[1,2-[alpha]]pyridine-3-
sulfonamide, in or on the commodities.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled 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 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 9, 2000) do not apply to this final rule. In addition,
this final 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) (Pub. L. 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: December 13, 2010.
Steven Bradbury,
Director, 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 180.651 is added to read as follows:

Sec.  180.651  Imazosulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide imazosulfuron, including its metabolites and degradates, in
or on the following commodities. Compliance with the tolerance levels
specified in the following table below is to be determined by measuring
only imazosulfuron, 2-chloro-N-[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl]imidazo-[1,2-[alpha]]pyridine-3-sulfonamide,
in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Pepper, bell...............................................         0.02
Pepper, non-bell...........................................         0.02
Rice, grain................................................         0.02
Tomato.....................................................         0.02
------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2010-32451 Filed 12-28-10; 8:45 am]
BILLING CODE 6560-50-P