[Federal Register Volume 79, Number 159 (Monday, August 18, 2014)]
[Proposed Rules]
[Pages 48698-48700]
[FR Doc No: 2014-19495]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0579; Directorate Identifier 2014-SW-020-AD]
RIN 2120-AA64

Airworthiness Directives; Agusta S.p.A. Helicopters (Type
Certificate Currently Held By AgustaWestland S.P.A) (AgustaWestland)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede airworthiness directive (AD) 2014-04-
14 for AgustaWestland Model A109S, AW109SP, A119, and AW119 MKII
helicopters. AD 2014-04-14 currently requires removing certain rod end
assemblies from service because of reports of fractures. Since we
issued AD 2014-04-14, additional fractured rod end assemblies have been
reported. This proposed AD would retain the requirements of AD 2014-04-
14 but expand the scope of applicable rod end assemblies. These
proposed actions are intended to prevent failure of a rod end assembly,
which could result in damage to the main rotor assembly and loss of
control of the helicopter.

DATES: We must receive comments on this proposed AD by October 17,
2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address 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 proposed AD, the European
Aviation Safety Agency (EASA) AD, the economic evaluation, any comments
received and other

information. The street address for the Docket Operations Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.
    For service information identified in this proposed AD, contact
AgustaWestland, Product Support Engineering, Via del Gregge, 100, 21015
Lonate Pozzolo (VA) Italy, ATTN: Maurizio D'Angelo; telephone 39-0331-
664757; fax 39-0331-664680; or at http://www.agustawestland.com/technical-bulletins. You may review service information at the FAA,
Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd.,
Room 663, Fort Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Robert Grant, Aviation Safety
Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort Worth,
Texas 76137; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    On March 3, 2014, we published AD 2014-04-14, Amendment 39-17773
(79 FR 11699) for AgustaWestland Model A109S, AW109SP, A119, and AW119
MKII helicopters with a main rotor lag damper assembly (lag damper),
part number (P/N) 109-0112-39-103, 109-0112-39-105, 109-0112-05-105, or
109-0112-05-107, installed with a rod end assembly, P/N M004-01H007-041
or P/N M004-01H007-045, with a serial number from 84 through 132 or
from 4964 through 5011. AD 2014-04-14 requires removing the applicable
rod end assemblies from service. AD 2014-04-14 was prompted by AD No.
2012-0208, dated October 5, 2012, issued by EASA, which is the
Technical Agent for the Member States of the European Union, to correct
an unsafe condition for AgustaWestland Model A109LUH, A109S, AW109SP,
A119, and AW119 MKII helicopters. EASA advises that cases of in-flight
fractures of rod end assembly, P/N M004-01H007-045, installed on main
rotor lag dampers have been reported on Model A109LUH and AW109SP
helicopters. An investigation revealed that two batches of rod end
assemblies, P/N M004-01H007-041 and M004-01H007-045, could have cracks,
according to EASA. EASA states that this condition, if not corrected,
could lead to main rotor damage, possibly resulting in loss of control
of the helicopter. The actions of AD 2014-04-14 were intended to
prevent such damage and loss of control of the helicopter.

Actions Since AD 2014-04-14 Was Issued

    Between the time we published the NPRM for AD 2014-04-14 (78 FR
44042, July 23, 2013) and the Final Rule for AD 2014-04-14 (79 FR
11699, March 3, 2014), EASA issued AD No. 2013-0290, dated December 9,
2013. EASA advises in AD No. 2013-0290 that a new case of a fractured
rod end assembly has been reported. According to EASA, an investigation
concluded that additional batches of rod end assembly P/N M004-01H007-
041 and P/N M004-01H007-045, as well as batches of P/N 109-0112-11-101
and P/N 109-0112-22-105, could be affected by cracks. EASA consequently
expanded the applicability of its AD to include the additional rod end
assemblies.
    This proposed AD would retain the requirements of AD 2014-04-14 but
expand the scope of applicable rod end assemblies. We also propose to
add a provision in the Required Actions section to clarify that the AD
must be complied with if the rod end assembly is removed during
maintenance before 25 hours time-in-service (TIS).

FAA's Determination

    These helicopters have been approved by the aviation authority of
Italy and are approved for operation in the United States. Pursuant to
our bilateral agreement with Italy, EASA, its technical representative,
has notified us of the unsafe condition described in its AD. We are
proposing this AD because we evaluated all known relevant information
and determined that an unsafe condition is likely to exist or develop
on other products of the same type design.

Related Service Information

    We reviewed AgustaWestland's Bollettino Tecnico (BT) No. 109S-49
for Model A109S helicopters, BT No. 109SP-052 for Model AW109SP
helicopters, and BT No. 119-50 for Model A119 and AW119 MKII
helicopters. All of the BTs are revision A, and dated December 3, 2013.
The BTs specify a one-time inspection of each rod end assembly to
determine its serial number. The BTs then require removal from service
of certain serial-numbered rod end assemblies because fractures had
been reported on rod ends in these batches. According to the BTs, no
one was injured in the helicopters, and no helicopters were damaged
because of these fractures.

Proposed AD Requirements

    This proposed AD would require removing the applicable rod end
assemblies from service within 25 hours TIS or the next time
maintenance of the helicopter involves removing the rod end assembly,
whichever occurs first. The proposed AD would also prohibit installing
the applicable rod end assemblies on any helicopter.

Differences Between This Proposed AD and the EASA AD

    The EASA AD calls for replacing certain rod end assemblies with
airworthy rod end assemblies within 25 hours TIS, 2 months, or the next
time maintenance of the applicable helicopters involves removing the
rod end assembly. This proposed AD would not have a calendar time
requirement. The EASA AD applies to AgustaWestland Model A109LUH
helicopters. This proposed AD would not apply to Model A109LUH
helicopters because that model does not have a U.S. type certificate.

Costs of Compliance

    We estimate that this proposed AD would affect 91 helicopters of
U.S. Registry and that labor costs average $85 a work-hour. Based on
these estimates, we expect the following costs:
     Replacing a rod end assembly would require 1.5 work-hours
for a labor cost of $128. Parts cost $3,918 for a total cost of $4,046
per helicopter, $368,186 for the U.S. fleet.

    According to the manufacturer's service information, costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. We do not control warranty coverage by
manufacturers. Accordingly, we have included all costs in our cost
estimate.

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 proposed 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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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, I certify this proposed regulation:
    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);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. 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 an economic evaluation of the estimated costs to comply
with this proposed 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.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 removing Airworthiness Directive (AD)
2014-04-14, Amendment 39-17773 (79 FR 11699, March 3, 2014), and adding
the following new AD:

Agusta S.p.A. Helicopters (Type Certificate Currently Held By
AgustaWestland S.p.A) (AgustaWestland): Docket No. FAA-2014-0579;
Directorate Identifier 2014-SW-020-AD.

(a) Applicability

    This AD applies to the following helicopters, certificated in
any category:
    (1) AgustaWestland Model A109S and AW109SP helicopters, with a
main rotor lag damper assembly (lag damper), part number (P/N) 109-
0112-39-103 or 109-0112-39-105, installed on rod end assembly, P/N
M004-01H007-041 with a serial number (S/N) 1 through 202; or rod end
assembly, P/N M004-01H007-045 with a S/N 1RW through 202RW or 4964
through 5011.
    (2) AgustaWestland Model A119 and AW119 MKII helicopters, with a
lag damper, P/N 109-0112-05-105 or 109-0112-05-107, installed on rod
end assembly, P/N 109-0112-11-101 with a S/N 1 through 78; or rod
end assembly, P/N 109-0112-11-105 with a S/N 1RW through 78RW; or
rod end assembly, P/N M004-01H007-045 with a S/N 1RW through 202RW
or 4964 through 5011.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack in a rod end
assembly, which could result in fracture of the rod end assembly,
damage to the main rotor, and subsequent loss of control of the
helicopter.

(c) Affected ADs

    This AD supersedes AD 2014-04-14, amendment 39-17773 (79 FR
11699, March 3, 2014).

(d) Comments Due Date

    We must receive comments by October 17, 2014.

(e) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(f) Required Actions

    (1) Within 25 hours time-in-service or the next time maintenance
of the helicopter involves removing the rod end assembly, whichever
occurs first, remove the rod end assembly from service.
    (2) Do not install a rod end assembly, P/N M004-01H007-041 with
a S/N 1 through 202; P/N M004-01H007-045 with a S/N 1RW through
202RW or 4964 through 5011; P/N 109-0112-11-101 with a S/N 1 through
78; or P/N 109-0112-11-105 with a S/N 1RW through 78RW, on any
helicopter.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Robert Grant, Aviation Safety
Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort
Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(h) Additional Information

    (1) AgustaWestland's Bollettino Tecnico (BT) No. 109S-49, BT No.
109SP-052, and BT No. 119-50, all Revision A, and all dated December
3, 2013, which are not incorporated by reference, contain additional
information about the subject of this AD. For service information
identified in this AD, contact AgustaWestland, Product Support
Engineering, Via del Gregge, 100, 21015 Lonate Pozzolo (VA) Italy,
ATTN: Maurizio D'Angelo; telephone 39-0331-664757; fax 39-0331-
664680; or at http://www.agustawestland.com/technical-bulletins. You
may review a copy of the service information at the FAA, Office of
the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room
663, Fort Worth, Texas 76137.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) AD No. 2013-0290, dated December 9, 2013. You
may view the EASA AD on the Internet at http://www.regulations.gov
in Docket No. FAA-2014-0579.

 (i) Subject

    Joint Aircraft Service Component (JASC) Code: 6200, Main Rotor
System.

     Issued in Fort Worth, Texas, on August 8, 2014.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2014-19495 Filed 8-15-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 1, 2005 (Volume 70, Number 210)]
[Notices]
[Page 65941-65942]
[DOCID:fr01no05-118]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52657; SR-Amex-2005-047; SR-BSE-2005-39; SR-CBOE-2005-
68; SR-ISE-2005-42; SR-PCX-2005-104; SR-Phlx-2005-27]

Self-Regulatory Organizations; Order Approving a Proposed Rule
Change and Amendment No. 1 by the American Stock Exchange LLC; a
Proposed Rule Change by the Boston Stock Exchange, Inc.; a Proposed
Rule Change by the Chicago Board Options Exchange, Incorporated; a
Proposed Rule Change and Amendment No. 1 by the International
Securities Exchange, Inc.; a Proposed Rule Change by the Pacific
Exchange, Inc.; and a Proposed Rule Change and Amendment No. 1 by the
Philadelphia Stock Exchange, Inc. Relating to the Definition of Firm
Customer Quote Size and Limitations on Sending Secondary P/A Orders

October 24, 2005.

I. Introduction

    On April 26, 2005, April 28, 2005, August 29, 2005, August 31,
2005, September 7, 2005, and September 13, 2005, the Philadelphia Stock
Exchange, Inc. (``Phlx''), the American Stock Exchange LLC (``Amex''),
the Chicago Board Options Exchange, Incorporated (``CBOE''), the
International Securities Exchange, Inc. (``ISE''), the Pacific
Exchange, Inc. (``PCX''), and the Boston Stock Exchange, Inc. (``BSE'')
(collectively, the ``Options Exchanges''), respectively, filed with the
Securities and Exchange Commission (``Commission''), pursuant to
section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ proposed rule changes to amend each of
their respective rules governing the operation of the intermarket
option linkage (``Linkage'') to conform with a proposed amendment \3\
to the Plan for the Purpose of Creating and Operating an Intermarket
Option Linkage (``Linkage Plan'').\4\ Each of the Exchanges is

proposing: (i) To amend the definition of ``Firm Customer Quote Size''
(``FCQS'') \5\ to provide automatic executions for Principal Acting as
Agent Orders (``P/A Orders'') \6\ sent via Linkage up to the full size
of an Options Exchange's disseminated quotation; and (ii) to eliminate
a 15-second waiting period between the sending of P/A Orders.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 52401 (September 9,
2005), 70 FR 54781 (September 16, 2005) (File No. 4-429)
(``Amendment No. 16'').
    \4\ On July 28, 2000, the Commission approved a national market
system plan for the purpose of creating and operating an intermarket
option market linkage proposed by the Amex, CBOE, and ISE. See
Securities Exchange Act Release No. 43086 (July 28, 2000), 65 FR
48023 (August 4, 2000). Subsequently, upon separate requests by the
Phlx, PCX, and BSE, the Commission issued orders to permit these
exchanges to participate in the Linkage Plan. See Securities
Exchange Act Release Nos. 43573 (November 16, 2000), 65 FR 70850
(November 28, 2000), 43574 (November 16, 2000), 65 FR 70851
(November 28, 2000) and 49198 (February 5, 2004), 69 FR 7029
(February 12, 2004).
    \5\ See Section 2(11) of the Linkage Plan; Amex Rule 940(b)(7);
Chapter XII; Section 1(g) of BOX's Rules; CBOE Rule 6.80(9); ISE
Rule 1900(7); PCX Rule 6.92(a)(10); and Phlx Rule 1083(g).
    \6\ See Section 2(16)(a) of the Linkage Plan; Amex Rule
940(b)(10)(i); Chapter XII; Section 1(j)(i) of BOX's Rules; CBOE
Rule 6.80(12)(i); ISE Rule 1900(10)(i); PCX Rule 6.92(a)(12)(i); and
Phlx Rule 1083(k)(i).
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    Phlx submitted Amendment No. 1 to its proposed rule change on
September 2, 2005.\7\ ISE submitted Amendment No. 1 to its proposed
rule change on September 7, 2005.\8\ Amex submitted Amendment No. 1 to
its proposed rule change on September 12, 2005.\9\
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    \7\ In its Amendment No. 1, the Phlx made clarifying changes to
the proposed rule text relating to the availability of Options
Exchanges' automatic execution systems.
    \8\ In its Amendment No. 1, the ISE made technical corrections
to the proposed rule change.
    \9\ In its Amendment No. 1, the Amex made clarifying changes to
the proposed rule text relating to the availability of Options
Exchanges' automatic execution systems.
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    Notice of: (i) Amex's proposed rule change, as amended; (ii) BSE's
proposed rule change; (iii) CBOE's proposed rule change; (iv) ISE's
proposed rule change, as amended; and (v) PCX's proposed rule change
were published in the Federal Register on September 20, 2005.\10\
Notice of Phlx's proposed rule change, as amended, was published in the
Federal Register on September 21, 2005.\11\ No comments were received
on the proposed rule changes. This order approves the proposed rule
changes, as amended.
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    \10\ Securities Exchange Act Release Nos. 52428 (September 14,
2005), 70 FR 55186 (September 20, 2005) (SR-Amex-2005-047); 52429
(September 14, 2005), 70 FR 55191 (September 20, 2005) (SR-BSE-2005-
39); 52424 (September 14, 2005), 70 FR 55193 (September 20, 2005)
(SR-CBOE-2005-68); 52410 (September 14, 2005), 70 FR 55198
(September 20, 2005) (SR-ISE-2005-42); and 52427 (September 14,
2005), 70 FR 55201 (September 20, 2005) (SR-PCX-2005-104).
    \11\ Securities Exchange Act Release No. 52425 (September 14,
2005), 70 FR 55443 (September 21, 2005) (SR-Phlx-2005-27).
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II. Description of the Proposals

    The purpose of the proposed rule changes is to amend each of the
Options Exchanges' rules governing the operation of the Linkage to
conform with Amendment No. 16 to the Linkage Plan.\12\ In general, the
proposed rule changes will modify the rules of each of the Options
Exchanges in two respects. First, the definition of FCQS will be
amended to reflect that all Options Exchanges disseminate dynamic
option quotes with size. Specifically, each of the Option Exchanges
proposes to amend its rules so that the FCQS is calculated based on the
size of the disseminated quotation of the Options Exchange receiving
the P/A Order. Secondly, the proposed rule changes will eliminate a 15-
second waiting period for sending a subsequent P/A Order currently
provided for in each of the Option Exchange's rules. Finally, the
proposed rule changes will clarify the conditions under which automatic
execution is required in response to P/A Orders.
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    \12\ Amendment No. 16 to the Linkage Plan is approved separately
today by the Commission. See Securities Exchange Act Release No.
52656 (October 24, 2005).
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III. Discussion

    After careful review, the Commission finds that the proposed rule
changes, as amended, are consistent with the requirements of the Act
and the rules and regulations thereunder applicable to national
securities exchanges.\13\ In particular, the Commission finds that the
proposed rule changes, as amended, are consistent with the provisions
of section 6(b)(5) of the Act,\14\ which requires, among other things,
that national securities exchanges' rules be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to remove impediments to and to perfect
the mechanism of a free and open market and a national market system
and, in general, to protect investors and the public interest.
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    \13\ In approving these proposals, the Commission has considered
the proposed rules' impact on efficiency, competition, and capital
formation. 15 U.S.C. 78c(f).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the proposed rule changes should
facilitate the conformity of the Options Exchanges' rules to Amendment
No. 16 to the Linkage Plan. Further, the Commission believes that the
Options Exchanges' proposal to calculate FCQS on the basis of the size
of the disseminated quotation of the Options Exchange receiving the P/A
Order is appropriate and should facilitate the use of the Linkage for
the Options Exchanges. This change proposed by the Options Exchanges,
coupled with the proposed elimination of the 15-second waiting period
for sending a subsequent P/A Order, should facilitate investors'
intermarket access to superior prices disseminated by Options Exchanges
other than the one to which the order was initially sent.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\15\ that the proposed rule changes (SR-Amex-2005-047; SR-BSE-2005-
39; SR-CBOE-2005-68; SR-ISE-2005-42; SR-PCX-2005-104; SR-Phlx-2005-27),
as amended, are approved.
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    \15\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Jonathan G. Katz,
Secretary.
 [FR Doc. E5-6028 Filed 10-31-05; 8:45 am]

BILLING CODE 8010-01-P


60152 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Rules and Regulations EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. '' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects 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. '' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications. '' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. '' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

XIII. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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: September 11, 2002. James Jones, Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[ AMENDED]

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

Authority: 21 U. S. C. 321( q), 346( a) and 371. 2. Section 180.1222 is added to subpart D to read as follows:

§ 180.1222 Sucrose octanoate esters; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of sucrose octanoate esters [( a Dglucopyranosyl b D fructofuranosyloctanoate mono, di, and triesters of sucrose octanoate] in or on all food commodities when used in accordance with good agricultural practices. [FR Doc. 02– 24224 Filed 9– 24– 02; 8: 45 am]

BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP– 2002– 0235; FRL– 7198– 4]

Clopyralid; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for residues of clopyralid in or on certain raw agricultural commodities. Interregional Research Project Number 4 (IR 4) and Dow Agro Sciences LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996. DATES: This regulation is effective September 25, 2002. Objections and requests for hearings, identified by docket control number OPP– 2002– 0235, must be received on or before November 25, 2002. ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP– 2002– 0235 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703 305– 6224; and e mail address: miller. joanne@ epamail. epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

Categories NAICS codes Examples of potentially affected entities Industry 111 112 311 32532 Crop production Animal production Food manufacturing Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have 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 Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations, '' `` Regulations and VerDate Sep< 04> 2002 14: 45 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25SER1. SGM 25SER1 60153 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Rules and Regulations Proposed Rules, '' and then look up the entry for this document under the `` Federal Register— Environmental Documents. '' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml 00/ Title 40/ 40cfr180 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. 2. In person. The Agency has established an official record for this action under docket control number OPP– 2002– 0235. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is ailable for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305– 5805.

II. Background and Statutory Findings In the Federal Register of August 14, 2002 (67 FR 52990) (FRL– 7191– 7), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U. S. C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104– 170), announcing the filing of pesticide petitions (PP 1E6227, 1E6241, 1E6283, 1E6291, 1E6320, 1E6329, 1E6333, 1E6334, 1E6335, 1E6399, and 1E6340 ) by the Interregional Research Project Number 4 (IR 4), P. O. Box 231, Rutgers University, New Brunswick, NJ 08903 and PP 4F4379 from Dow Agro Sciences LLC, Indianapolis, IN 46268. This notice included a summary of the petition prepared by Dow Agro Sciences LLC, the registrant. There were no comments received in response to the notice of filing. The petitions requested that 40 CFR 180.431 be amended by establishing tolerances for residues of the herbicide clopyralid, 3,6 dichloro 2 pyridinecarboxylic acid, in or on the following commodities: Flax seed at 3.0 part per million (ppm); strawberry at 1.0 ppm; hop, dried cones at 5.0 ppm; rapeseed seed, rapeseed forage, canola seed, mustard seed, and crambe seed at 3 ppm, and canola meat at 6.0 ppm; spinach at 5.0 ppm; stone fruit group at 0.5 ppm; garden beet tops at 3.0 ppm and garden beet roots at 4.0 ppm; mustard greens at 5.0 ppm; turnip roots at 1.0 ppm and turnip greens at 4.0 ppm; cranberry at 4 ppm; sweet corn, kernel plus cob with husks removed at 1.0 ppm, sweet corn forage at 7.0 ppm, sweet corn stover at 10.0 ppm, pop corn grain at 1.0 ppm, pop corn stover at 10.0 ppm, liver of cattle, goat, horse, and sheep at 3.0 ppm, meat byproducts, except liver, of cattle, goat, horse and sheep at 36.0 ppm, and milk at 0.2 ppm; and the brassica, head and stem, subgroup at 2.0 ppm. EPA is editorially correcting the tolerance expressions to read canola meal and turnip, tops. 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) 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) 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.... '' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL– 5754– 7).

III. Aggregate Risk Assessment and Determination of Safety Consistent with 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, consistent with section 408( b)( 2), for a tolerance for residues of clopyralid on strawberry at 1.0 ppm; hop, dried cones, at 5.0 ppm; rapeseed seed, rapeseed forage, mustard seed, and crambe seed at 3 ppm, canola meal and flax meal at 6.0 ppm; spinach at 5.0 ppm; stone fruit group at 0.5 ppm; prunes at 1.5 ppm, garden beet tops at 3.0 ppm and garden beet roots at 4.0 ppm; mustard greens at 5.0 ppm; turnip roots at 1.0 ppm and turnip tops at 4.0 ppm; cranberry at 4.0 ppm; sweet corn, kernel plus cob with husks removed at 1.0 ppm, sweet corn forage at 7.0 ppm, sweet corn stover at 10.0 ppm, pop corn grain at 1.0 ppm, pop corn stover at 10.0 ppm, liver of cattle, goat, horse, and sheep at 3.0 ppm, meat byproducts, except liver, of cattle, goat, horse and sheep at 36.0 ppm, and milk at 0.2 ppm; and the Brassica, head and stem, subgroup at 2.0 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. The nature of the toxic effects caused by clopyralid are discussed in the following Table 1 and Table 2 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

VerDate Sep< 04> 2002 14: 45 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25SER1. SGM 25SER1 60154 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Rules and Regulations TABLE 1.— SUBCHRONIC, CHRONIC, AND OTHER TOXICITY OF CLOPYRALID Guideline No. Study Type Results 870.3100 90– Day oral toxicity in mice NOAEL = 2,000 mg/ kg/ day in both sexes. LOAEL = 5,000 mg/ kg/ day in both sexes based on decreased body weight in both sexes.

870.3200 21/ 28– Day dermal toxicity in rabbits NOAEL = 1,000 mg/ kg/ day for both sexes.

870.3700 Prenatal developmental toxicity in rats Maternal NOAEL = 75 mg/ kg/ day LOAEL = 250 mg/ kg/ day based on mortality, reduced body weight gains and reduced food consumption. Developmental NOAEL = 250 mg/ kg/ day highest dose tested (HDT).

870.3700 Prenatal developmental toxicity in rabbits Maternal NOAEL = 110 mg/ kg/ day. LOAEL = 250 mg /kg/ day based on mortality, clinical signs, decreased body weight gains, and lesions of the gastric mucosa. Developmental NOAEL = 110 mg/ kg/ day. LOAEL = 250 mg/ kg/ day based on decreased fetal body weight and hydrocephalus.

870.3800 Reproduction and fertility effects in rats Systemic NOAEL = 500 mg/ kg/ day for males and females LOAEL = 1,500 mg/ kg/ day for males and females based on decreased body weights, decreased weight gain, and decreased food consumption in both sexes and slight focal hyperkeratotic changes in gastric squamous mucosa in males. Reproductive/ Offspring NOAEL = 500 mg/ kg/ day LOAEL = 1,500 mg/ kg/ day for males and females based on reduced pup weights in males and increased relative liver weight in pups of both sexes.

870.4100 Chronic toxicity dogs NOAEL = 100 mg/ kg/ day in males and females. LOAEL = 320 mg/ kg/ day based upon reduction in hematological parameters in both sexes, increased absolute liver weight in males, and vacuolated adrenal cortical cells in females.

870.4200 Carcinogenicity mice NOAEL = 500 mg/ kg/ day and   2,000 mg/ kg/ day in females. LOAEL = 2,000 mg/ kg/ day in males based on decreased body weight, body weight gains, and food efficiency. No evidence of carcinogenicity.

870.4300 Combined Chronic Toxicity/ Carcinogenicity in rats NOAEL = 15 mg/ kg/ day. LOAEL = 150 mg/ kg/ day based on epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes. No evidence of carcinogenicity.

870.5300 In vitro and in vivo host mediated assay in bacteria No evidence of induced mutant colonies over background in Salmonella strains TA 1,530 bacteria and G 46 and Saccharomyces strain D 3 870.5385 Bone marrow chromosome aberrations assay There was no significant increase in the frequency of chromosome aberrations in bone marrow at any dose tested.

870.5550 In vitro unscheduled DNA synthesis assay There was no evidence of unscheduled DNA synthesis in initial or supplementary assays

870.5450 Dominant lethal assay in rats. No evidence of treatment related resorptions up to 400 mg/ kg/ day for 5 days.

870.7485 Metabolism in rats Rapidly absorbed and excreted mainly in the urine. Parent compound only is detected in the excreta.

B. Toxicological Endpoints The dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect 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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences. For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/ UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor. For non dietary risk assessments (other than cancer) the UF is used to VerDate Sep< 04> 2002 14: 45 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25SER1. SGM 25SER1 60155 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Rules and Regulations determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/ exposure) is calculated and compared to the LOC. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e. g., risk is expressed as 1 x 10 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non linear approach, a `` point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/ exposures) is calculated. A summary of the toxicological endpoints for clopyralid used for human risk assessment is shown in the following Table 2:

TABLE 2.— SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CLOPYRALID FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose Used in Risk Assessment UF FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary (General population including infants and children) NOAEL = 75 mg/ kg/ day UF = 100 Acute RfD = 0.75 mg/ kg/ day FQPA SF = 1X aPAD = acute RfD/ FQPA SF = 0.75 mg/ kg/ day Developmental Toxicity Study  rat Maternal LOAEL = 250 mg ai/ kg/ day based on decreased weight gain during gestation days 6– 9 Chronic Dietary (All populations) NOAEL = 15 mg/ kg/ day UF = 100 Chronic RfD = 0.15 mg/ kg/ day FQPA SF = 1X cPAD = chronic RfD/ FQPA SF = 0.15 mg/ kg/ day 2– Year Chronic Toxicity/ Carcinogenicity Study  rat LOAEL = 150 mg ai/ kg/ day based on increased epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes Short Term Incidental Oral NOAEL = 75 mg/ kg/ day LOC for MOE = 100 Developmental Toxicity Study  rat Maternal LOAEL = 250 mg ai/ kg/ day based on decreased weight gain during gestation days 6– 9 Intermediate Term Incidental Oral NOAEL = 15 mg/ kg/ day LOC for MOE = 100 2– Year Chronic Toxicity/ Carcinogenicity Study  rat LOAEL = 150 mg ai/ kg/ day based on increased epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes Short– Term (1– 7 days) and Intermediate Term (1 week  several months) Dermal None No systemic toxicity was seen at the limit dose (1,000 mg/ kg/ day) in the 21– day dermal toxicity study in rabbits. This risk assessment is not required Not Applicable (N/ A)

Short– Term (1– 7 days) Inhalation NOAEL = 75 mg/ kg/ day inhalation absorption rate = 100%) LOC for MOE = 100 Developmental Toxicity Study  rat Maternal LOAEL = 250 mg ai/ kg/ day based on decreased body weight gain Cancer (Oral, dermal, inhalation) Not likely N/ A Acceptable oral rat and mouse carcinogenicity studies; no evidence of carcinogenic or mutagenic potential.

* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.431) for the residues of clopyralid, in or on a variety of raw agricultural commodities. Established, proposed and increased tolerances for clopyralid are adequate for any expected secondary residues in meat, milk, poultry and/ or eggs. Risk assessments were conducted by EPA to assess dietary exposures from clopyralid in food as follows: i. Acute exposure. Acute dietary risk assessments are performed for a fooduse pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. In conducting this acute dietary risk assessment the Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989– 1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments. Residue levels are at the recommended tolerances with the exception of sugar beets. The empirical processing factor of 0.1x was used for sugar beet representing the 10– fold reduction in residues for refined sugar. One hundred percent of all of the crops are treated with clopyralid. ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model VerDate Sep< 04> 2002 14: 45 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25SER1. SGM 25SER1 60156 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Rules and Regulations (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989– 1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments. Residue levels are at the recommended tolerances with the exception of sugar beets. The empirical processing factor of 0.1x was used for sugar beet representing the 10 fold reduction in residues for refined sugar. One hundred percent of all of the crops are treated with clopyralid. iii. Cancer. Acceptable oral rat and mouse carcinogenicity studies show no evidence of carcinogenic or mutagenic potential. Clopyralid is classified as not likely to be a human carcinogen. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for clopyralid 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 physical characteristics of clopyralid. The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone Model/ Exposure Analysis Modeling System (PRZM/ EXAMS) to estimate pesticide concentrations in surface water and SCI GROW, which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/ EXAMS (a tier 2 model) for a screening level assessment for surface water. The GENEEC model is a subset of the PRZM/ EXAMS model that uses a specific high end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/ EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/ EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to clopyralid they are further discussed in the aggregate risk sections in Unit III. E of this document. Based on the FIRST and SCI GROW models the estimated environmental concentrations (EECs) of clopyralid for acute exposures are estimated to be 46 parts per billion (ppb) for surface water and 9.7 ppb for ground water. The EECs for chronic exposures are estimated to be 18 ppb in surface water and 9.7 ppb for ground water. 3. From non dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non dietary exposure (e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Clopyralid is currently registered for use on the following residential nondietary sites: Turf and ornamentals (including golf courses). The risk assessment was conducted using the following residential exposure assumptions: the 75 mg/ kg/ day NOAEL was used in the short term inhalation, hand to mouth, and episodic granular ingestion risk assessments of the residential exposure. The intermediateterm assessment for children's hand tomouth exposure was based on the 15 mg/ kg/ day NOAEL chosen for incidental oral exposure. As no dermal endpoint was selected, a dermal risk assessment was not required for residential exposure. For residential oral and inhalation risk assessments, the target margin of exposure (MOE) was 100 which incorporates the removal of the FQPA Safety Factor. MOEs calculated for residential handler's inhalation exposure and children's oral exposures were well above the target of 100; and therefore, do not exceed the Agency's level of concern. 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) 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 does not have, at this time, available data to determine whether clopyralid has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, clopyralid 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 clopyralid 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 the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children 1. In general. FFDCA section 408 provides that EPA shall apply an additional 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 data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. Prenatal and postnatal sensitivity. No increased quantitative or qualitative susceptibility was seen following pre and/ or post natal exposures. In the developmental study with rats, no developmental toxicity was seen at the HDT (250 mg/ kg/ day) even in the presence of severe maternal toxicity which manifested as deaths, reduced body weight gain and decreased food consumption. In the two generation reproduction study, offspring toxicity, characterized as decreased pup weight and increased liver weights, occurred only at the HDT (1,500 mg/ kg/ day) which is higher than the Limit Dose (1,000 mg/ kg/ day). These changes occurred in the presence of severe VerDate Sep< 04> 2002 14: 45 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25SER1. SGM 25SER1 60157 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Rules and Regulations parental toxicity (decreased body weight, body weight gain, food consumption and slight focal hyper keratosis of the gastric mucosa). In the developmental rabbit study, hydrocephalus was seen in eight fetuses (3/ 15 litters) only at the highest dose tested (250 mg/ kg/ day) in the presence of severe maternal toxicity that manifested as death, decreases in mean body weight and lesions of the gastric mucosa; the developmental NOAEL was 110 mg/ kg/ day. The available data indicate that a developmental neurotoxicity study would have to be tested at dose levels higher than 250 mg/ kg/ day because no developmental toxicity was observed in rats at 250 mg/ kg/ day. In addition, the offspring NOAEL in the two generation reproduction study was 500 mg/ kg/ day with a LOAEL of 1,500 mg/ kg/ day. Therefore, it is anticipated that in order to elicit any fetal nervous system abnormalities in a developmental neurotoxicity study, the selected dose levels would have to be higher than 500 mg/ kg/ day. Since the dose level selections for the developmental neurotoxicity study will be greater than 500 mg/ kg/ day, the resultant NOAEL will be either comparable to, or higher than the doses currently used in the risk assessment. The NOAEL of 75 mg/ kg/ day selected for the acute RfD is seven times lower than the offspring NOAEL in the reproduction study. The NOAEL of 15 mg/ kg/ day selected for the chronic RfD and the residential exposure risk assessments is thirty three times lower than the offspring NOAEL in the reproduction study. Therefore, a developmental neurotoxicity study would not likely change the regulatory doses used for overall risk assessments. 3. Conclusion. EPA determined that an additional factor to protect infants and children was not appropriate. Several factors influenced this decision not to require a development neurotoxicity (DNT) study: i. Although hydrocephalus was observed at the high dose in the developmental rabbit study, it was seen in the presence of severe maternal toxicity; ii. No alterations to the fetal nervous system were seen in the developmental rat study at the same dose (250 mg/ kg/ day); iii. There was no quantitative or qualitative evidence of increased susceptibility in the two generation reproduction study; iv. There is no concern nor are there residual uncertainties for pre and/ or post natal toxicity; and v. Although there are no acute or subchronic neurotoxicity studies, there is no evidence of neurotoxicity or neuropathology in adult animals in any of the studies. EPA decided that the FQPA safety factor should be reduced to 1 rather than the statutory default factor of 10 because the existing toxicology database, which is complete, revealed no quantitative or qualitative evidence of increased susceptibility following in utero exposure to rats and rabbits and/ or following prenatal/ postnatal exposure to rats; and dietary (food and drinking water) and residential exposure assessments will not underestimate the potential exposures for infants, children, and/ or women of childbearing age from the use of clopyralid.

E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i. e., the PAD) is available for exposure through drinking water [e. g., allowable chronic water exposure (mg/ kg/ day) = cPAD  (average food + residential exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/ 70 kg (adult male), 2L/ 60 kg (adult female), and 1L/ 10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short term, intermediate term, chronic, and cancer. When EECs for surface water and ground water are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to clopyralid will occupy 4% of the aPAD for the U. S. population, 2% of the aPAD for females 13 years and older, 4% of the aPAD for all infants ( 1 year) and 7% of the aPAD for children 1– 6 years. In addition, there is potential for acute dietary exposure to clopyralid in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 3:

TABLE 3.— AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO CLOPYRALID Population Subgroup aPAD (mg/ kg) % aPAD (Food) Surface Water EEC (ppb) Ground Water EEC (ppb) Acute DWLOC (ppb)

General U. S. Population 0.75 4 46 9.7 25,000 All Infants ( 1 year) 0.75 4 46 9.7 7,200 Children 1– 6 years 0.75 7 46 9.7 7,000 Females 13– 50 0.75 2 46 9.7 22,000 VerDate Sep< 04> 2002 14: 45 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25SER1. SGM 25SER1 60158 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Rules and Regulations 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to clopyralid from food will utilize 7% of the cPAD for the U. S. population, 7% of the cPAD for all infants ( 1 year) and 17% of the cPAD for children 1– 6 years. Based on the use pattern, chronic residential exposure to residues of clopyralid is not expected. In addition, there is potential for chronic dietary exposure to clopyralid in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 4:

TABLE 4.— AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON CANCER) EXPOSURE TO CLOPYRALID Population Subgroup cPAD mg/ kg/ day % cPAD (Food) Surface Water EEC (ppb) Ground Water EEC (ppb) Chronic DWLOC (ppb)

U. S. Population 0.15 7 18 9.7 4,900 All Infants ( 1 year) 0.15 7 18 9.7 1,400 Children 1– 6 years 0.15 17 18 9.7 1,200 Females 13– 50 0.15 5 18 9.7 4,300 3. Short term risk. Short term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Clopyralid is currently registered for use that could result in short term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short term exposures for clopyralid. Using the exposure assumptions described in this unit for short term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 7,000 (U. S. population, food and residential), 9,600 (females 13– 50, food and residential) and 2,200 (children 1– 6 years old, food and residential). These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, shortterm DWLOCs were calculated and compared to the EECs for chronic exposure of clopyralid in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 5:

TABLE 5.— AGGREGATE RISK ASSESSMENT FOR SHORT TERM EXPOSURE TO CLOPYRALID Population Subgroup Aggregate MOE (Food + Residential Aggregate Level of Concern (LOC) Surface Water EEC (ppb) Ground Water EEC (ppb) Short– Term DWLOC (ppb)

U. S. Population 7,000 100 18 9.7 26,000 Children 1– 6 years 2,200 100 18 9.7 7,200 Females 13– 50 years 9,600 100 18 9.7 22,000 4. Intermediate term risk. Intermediate term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Clopyralid is currently registered for use( s) that could result in intermediateterm residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate term exposures for clopyralid. Using the exposure assumptions described in this unit for intermediateterm exposures, EPA has concluded that food and residential exposures aggregated result in an aggregate MOE of 530 (children 1– 6 years, food and residential). This aggregate MOE does not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, an intermediate term DWLOC was calculated and compared to the EECs for chronic exposure of clopyralid in ground and surface water. After calculating the DWLOC and comparing it to the EECs for surface and ground water, EPA does not expect intermediate term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 6:

TABLE 6.— AGGREGATE RISK ASSESSMENT FOR INTERMEDIATE TERM EXPOSURE TO CLOPYRALID Population Subgroup Aggregate MOE (Food + Residential Aggregate Level of Concern (LOC) Surface Water EEC (ppb) Ground Water + EEC (ppb) IntermediateTerm DWLOC (ppb)

Children 1– 6 years 530 100 18 9.7 1,200 VerDate Sep< 04> 2002 14: 45 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25SER1. SGM 25SER1 60159 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Rules and Regulations 5. Aggregate cancer risk for U. S. population. The Agency concluded that clopyralid was negative for carcinogenicity potential in rats and mice and classified clopyralid as `` not likely'' to be a human carcinogen according to EPA Draft Guidelines for Carcinogen Risk Assessment. 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, and to infants and children from aggregate exposure to clopyralid residues.

IV. Other Considerations A. Analytical Enforcement Methodology An adequate residue analytical method is available for enforcement of the proposed tolerances. This method, ACR 75.6, determines clopyralid as the methyl ester by gas chromatography using electron capture detection. This method has been successfully validated by EPA and has been published in FDA's Pesticide Analytical Manual, VolII (PAM II). An adequate residue analytical method is also available for the enforcement of the proposed tolerance on animal commodities. This method, ACR 86.1, determines clopyralid as the methyl ester by gas chromatography using electron capture detection. This method has been successfully validated by EPA and has been published in FDA's Pesticide Analytical Manual, VolII (PAM II).

B. International Residue Limits There are no Codex or Mexican maximum residue limits (MRLs). Canada has set maximum residue limits of 2.0 ppm for barley, oats, and wheat, 7.0 ppm for the milled fractions of barley, oats, and wheat (excluding flour), 1.0 ppm for strawberries and 0.2 ppm for flax.

V. Conclusion Therefore, tolerances are established for residues of clopyralid on strawberry at 1.0 ppm; hop, dried cones, at 5.0 ppm; rapeseed seed, rapeseed forage, mustard seed, and crambe seed at 3.0 ppm, canola meal and flax meal at 6.0 ppm; spinach at 5.0 ppm; stone fruit group at 0.5 ppm; prunes at 1.5 ppm, garden beet tops at 3.0 ppm and garden beet roots at 4.0 ppm; mustard greens at 5.0 ppm; turnip roots at 1.0 ppm and turnip tops at 4.0 ppm; cranberry at 4.0 ppm; sweet corn, kernel plus cob with husks removed at 1.0 ppm, sweet corn forage at 7.0 ppm, sweet corn stover at 10.0 ppm, pop corn grain at 1.0 ppm, pop corn stover at 10.0 ppm, liver of cattle, goat, horse, and sheep at 3.0 ppm, meat byproducts, except liver, of cattle, goat, horse and sheep at 36.0 ppm, and milk at 0.2 ppm; and the brassica, head and stem, subgroup at 2.0 ppm.

VI. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP– 2002– 0235 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 on or before November 25, 2002. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603– 0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees. '' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection. '' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305– 5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 2. Mail your copies, identified by docket control number OPP– 2002– 0235, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 2. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption.

VerDate Sep< 04> 2002 14: 45 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25SER1. SGM 25SER1 60160 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Rules and Regulations Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

VII. Regulatory Assessment Requirements This final rule establishes a tolerance under FFDCA section 408( d) 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 due to its lack of significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408( d), 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. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled Federalism( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. '' `` Policies that have federalism implications'' is defined in the Executive order to include regulations that have `` substantial direct effects 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. '' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications. '' `` Policies that have tribal implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. '' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

VIII. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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: September 16, 2002. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[ AMENDED]

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

Authority: 21 U. S. C. 321( q), 346( a) and 374. 2. Section 180.431 is amended as follows: i. By alphabetically adding commodities to the table in paragraph (a); ii. By removing tolerances for cattle, kidney; goat, kidney; horse, kidney and sheep, kidney in the table in paragraph (a); iii. By increasing tolerances for cattle, meat byproducts, except liver; goat, meat byproducts, except liver; horse, meat byproducts, except liver and sheep, meat byproducts, except liver; and milk in the table in paragraph (a); and iv. By removing the text from paragraph (b); and reserving paragraph (b) with the heading. The additions and revisions read as follows:

VerDate Sep< 04> 2002 14: 45 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25SER1. SGM 25SER1 60161 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Rules and Regulations § 180.431 Clopyralid; tolerances for residues. (a) General. Tolerances are established for residues of the herbicide clopyralid (3,6 dichloro 2 pyridinecarboxylic acid) in or on the following commodities:

Commodity Parts per million ***** Beet, garden, tops .......... 3.0 Beet, garden, roots ......... 4.0 Brassica, head and stem, subgroup ..................... 2.0 Canola, meal .................. 6.0 Canola, seed .................. 3.0 ***** Cattle, liver ...................... 3.0 ***** Cattle, meat byproducts, except liver .................. 36.0 ***** Corn, pop, grain .............. 1.0 Corn, pop, stover ............ 10.0 Corn, sweet, forage ........ 7.0 Corn, sweet, kernel plus cob with husks removed ......................... 1.0 Corn, sweet, stover ........ 10.0 Crambe, seed ................. 3.0 Cranberry ........................ 4.0 ***** Flax, meal ....................... 6.0 Flax, seed ....................... 3.0 Fruit, stone, group .......... 0.5 ***** Goat, liver ....................... 3.0 ***** Goat, meat byproducts, except liver .................. 36.0 ***** Hop, dried cones ............ 5.0 ***** Horse, liver ..................... 3.0 ***** Horse, meat byproducts, except liver .................. 36.0 Milk ................................. 0.2 ***** Mustard, greens .............. 5.0 Mustard, seed ................. 3.0 ***** Plum, prune, dried .......... 1.5 ***** Rapeseed, seed ............. 3.0 Rapeseed, forage ........... 3.0 ***** Sheep, liver ..................... 3.0 ***** Sheep, meat byproducts, except liver .................. 36.0 ***** Spinach ........................... 5.0 Strawberry ...................... 1.0 ***** Turnip, roots ................... 1.0 Turnip, tops ..................... 4.0 *****

(b) Section 18 emergency exemptions. [Reserved] * * * * *

[FR Doc. 02– 24232 Filed 9– 24– 02; 8: 45 am]

BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 281 [FRL– 7381– 6]

Hawaii; Final Approval of State Underground Storage Tank Program AGENCY: Environmental Protection Agency.

ACTION: Notice of final determination on the State of Hawaii's application for final approval.

SUMMARY: The State of Hawaii has applied for approval of its Underground Storage Tank Program for petroleum and hazardous substances under Subtitle I of the Resource Conservation and Recovery Act (RCRA). The Environmental Protection Agency (EPA) has reviewed Hawaii's application and has reached a final determination that Hawaii's Underground Storage Tank Program for petroleum and hazardous substances satisfies all of the requirements necessary to qualify for approval. Thus, the EPA is granting final approval to the State of Hawaii to operate its Underground Storage Tank Program for petroleum and hazardous substances.

EFFECTIVE DATE: Final approval for the State of Hawaii's Underground Storage Tanks Program shall be effective on September 30, 2002.

FOR FURTHER INFORMATION CONTACT: Mr. Norwood Scott, Underground Storage Tanks Program Office, U. S. EPA, Region 9, 75 Hawthorne Street (WST– 8), San Francisco, California 94105, Telephone: (415) 972– 3373.

SUPPLEMENTARY INFORMATION:

A. Background Section 9004 of the Resource Conservation and Recovery Act (RCRA) authorizes the Environmental Protection Agency (EPA) to approve state Underground Storage Tank Programs to operate in the State in lieu of the Federal Underground Storage Tank (UST) Program. To qualify for final authorization, a state's Program must: (1) Be `` no less stringent'' than the Federal Program for the seven elements set forth at RCRA Section 9004( a)( 1) through (7); and (2) provide for adequate enforcement of compliance with the UST standards of RCRA Section 9004( a). Note that RCRA Sections 9005 (on information gathering) and 9006 (on Federal enforcement) by their terms apply even in states with Programs approved by the EPA under RCRA Section 9004. Thus, the Agency retains its authority under RCRA Sections 9005 and 9006, 42 U. S. C. 6991d and 6991e, and other applicable statutory and regulatory provisions to undertake inspections and enforcement actions in approved states. With respect to such an enforcement action, the Agency will rely on Federal sanctions, Federal inspection authorities, and Federal procedures rather than the state authorized analogues to these provisions. Moreover, authorization of a state Program is a prospective action only and an authorized state Program only operates in lieu of the Federal Program as of the effective date of the authorization. The Agency may undertake enforcement of the Federal requirements for violations of those Federal requirements which occurred prior to the effective date of authorization of the state's Program. In this case, authorization of the Hawaii UST Program will be effective on September 30, 2002. On May 23, 2001, the State of Hawaii submitted an official application to obtain final program approval to administer the Underground Storage Tank Program for petroleum and hazardous substances. On October 5, 2001, the EPA published a tentative decision announcing its intent to grant Hawaii final approval. Further background on the tentative decision to grant approval appears at 66 FR 50963– 50966, October 5, 2001. Along with the tentative determination, the EPA announced the availability of the application for public comment and the date of a public hearing on the application. The EPA requested advance notice for testimony and reserved the right to cancel the public hearing for lack of public interest. The hearing was held at Kawananakoa Middle School in Honolulu, Hawaii on November 13, 2001.

B. Significant Public Comments and EPA's Responses Written comments regarding the EPA's approval of Hawaii's Underground Storage Tank Program were received during the comment period from EnviroWatch, Inc. Oral comments regarding the EPA's approval of Hawaii's Underground Storage Tank Program were received during the public hearing from Carroll Cox, President of EnviroWatch, Inc., and Joe Ryan, a resident of Waimanalo. Additionally, in April 2001, prior to publication of EPA's tentative decision to authorize Hawaii's Underground Storage Tank Program, EPA received a Petition To Withdraw Hawaii Certification and Title VI Complaint of Discriminatory Acts (Petition to VerDate Sep< 04> 2002 14: 45 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25SER1. SGM 25SER1