[Federal Register: July 6, 2010 (Volume 75, Number 128)]
[Rules and Regulations]
[Page 38745-38748]
[DOCID:fr06jy10-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2010-0156; FRL-9170-6]

Approval and Promulgation of Implementation Plans; State of Iowa

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The EPA is approving a revision to the Iowa State
Implementation Plan (SIP). The purpose of this revision is to update
the Polk County Board of Health Rules and Regulations, Chapter V, Air
Pollution. These revisions reflect updates to the Iowa statewide rules
previously approved by EPA and will ensure consistency between the
applicable local agency rules and Federally-approved rules. This
rulemaking also ensures Federal enforceability of the applicable parts
of the local agency's ``Air Pollution'' rules.

DATES: This direct final rule will be effective September 7, 2010,
without further notice, unless EPA receives adverse comment by August
5, 2010. If adverse comment is received, EPA will publish a timely
withdrawal of the direct final rule in the Federal Register informing
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2010-0156, by one of the following methods:
    1. http://www.regulations.gov. Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or Hand Delivery: Tracey Casburn, Environmental Protection
Agency, Air Planning and Development Branch, 901 North 5th Street,
Kansas City, Kansas 66101.
    Instructions: Direct your comments to Docket ID No. EPA-R07-OAR-
2010-0156. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit through http://
www.regulations.gov or e-mail information that you consider to be CBI
or otherwise protected. The http://www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 either electronically in http://
www.regulations.gov or in hard copy at the Environmental Protection
Agency, Air Planning and Development Branch, 901 North 5th Street,
Kansas City, Kansas 66101. The Regional Office's official hours of
business are Monday through Friday, 8 to 4:30 excluding Federal
holidays. The interested persons wanting to examine these documents
should make an appointment with the office at least 24 hours in
advance.

FOR FURTHER INFORMATION CONTACT: Tracey Casburn at<PHONE_NUMBER>, or
by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to EPA. This section provides additional information by
addressing the following questions:

I. What is being addressed in this document?
II. What revisions is EPA approving?
III. What action is EPA taking?
IV. What action is EPA not taking?
V. Statutory and Executive Order Reviews

I. What is being addressed in this document?

    The State requested EPA approval of the 2009 revisions to the local
agency's Rules and Regulations, Chapter V, ``Air Pollution,'' as a
revision to the SIP. In order for the local program's ``Air Pollution''
rules to be incorporated into the Federally-enforceable SIP, on behalf
of the local agency, the State must submit the formally adopted
regulations and control strategies, which are consistent with State and
Federal requirements, to EPA for inclusion in the SIP. The regulation
adoption process generally includes public notice of a public comment
period and a public hearing, and formal adoption of the rule by the
State authorized rulemaking body. In this case that rulemaking body is
the local agency. After the local agency formally adopts the rule, the
local agency submits the rulemaking to the State, and then the State
submits the rulemaking to EPA for consideration for formal action
(inclusion of the rulemaking into the SIP). EPA must provide public
notice and seek additional public comment regarding

the proposed Federal action on the State's submission.
    EPA received the request from the State to adopt the 2009 local air
agency rule revisions into the SIP on September 14, 2009. The revisions
were adopted by the local agency on July 28, 2009, and were effective
August 6, 2009. EPA is approving the requested revisions to the Iowa
SIP. The State's request specifically excluded Article VI, subsections
5-16 (n), (o), (p), and Article VIII from consideration by EPA.

II. What revisions is EPA approving?

    EPA is approving the 2009 revisions to the Polk County Board of
Health Rules and Regulations, Chapter V, ``Air Pollution.'' The local
agency routinely revises its ``Air Pollution'' regulations to be
consistent with the Federally-approved Iowa Administrative Code. The
local agency's ``Air Pollution'' rules were revised as follows:
    Article I, section 5-1 was revised to include cross references to
approved State rules. Section 5-2 of the same Article was revised to
include amended definitions of ``Allowable emissions,'' ``EPA reference
method,'' ``Disaster,'' ``Mobile Internal Combustion Engine,'' and
``Volatile Organic Compounds'' (VOCs). These revisions are consistent
with State and Federal regulations.
    Article II, section 5-4 was revised to include a cross reference to
the existing State rule, 567 IAC 23.1(2) which outlines New Source
Performance Standard data reporting requirements and responsibilities.
This revision is consistent with State and Federal regulations.
    Article III, section 5-7 was amended to include revisions to ``Open
Burning'' regulations. The revisions include the addition of a cross
reference to the existing State rules in 567 IAC Chapter 23 explaining
that the burning of any structure or demolished structure shall be in
accordance with 40 CFR 61.145, the National Emission Standards for
Hazardous Air Pollutants (NESHAPs) ``Standard for Demolition and
Renovation'' for asbestos control. This revision is consistent with
State and Federal regulations.
    Article IV, section 5-10 was revised to include a cross reference
to the existing State rule at 567 IAC 29.1, the Federal method for
visual determination of opacity of emissions. This revision is
consistent with State and Federal regulations.
    Article VII, subsections 5-18 (a)(3), 5-18(b)(5)(i) and 5-18(b)(7)
are revised to include cross references to existing State rules in 567
IAC Chapter 25. A revision to 5-18(b)(7) also includes the adoption
date of the most recent Federally promulgated Acid Rain continuous
emissions monitoring requirements. These revisions are consistent with
State and Federal regulations.
    Article IX, subsections 5-23(1), 5-23(2), and 5-23(3) were revised
to include methods for the containment and control of fugitive dust,
and subsections 5-23(7) and 5-23(8) were added to include methods for
the containment and control of fugitive dust. Changes to Section 5-25
clarify that no person shall cause, allow, or permit fugitive dust
material to become airborne in such quantities and concentrations that
it remains visible in the ambient air, or is deposited beyond the lot
line of the property on which it originates. These revisions are
consistent with State regulations and Federal requirements. The local
agency also added language to subsection 5-26(1) which explains
activities that are considered by the local agency as ``ordinary
travel'', which is exempted from the fugitive dust restrictions. This
is a clarification of the exemption and does not affect the stringency
of the restriction.
    Article X, section 5-33, and subsections 5-33(9) and 5-39(a)(4)
were revised to include cross references to approved State and Federal
regulations. Subsections 5-33(17) and 5-39(a)(11) were revised to
include a construction and operating permit exemption threshold for
retail gasoline and diesel fuel handling facilities. The local agency
revised the exemption to include only those facilities with a
throughput of less than 10,000 gallons per month (based on thirty-day
rolling average usage records). The local agency retained the right to
review project plans to substantiate the permit exemption to determine
that individual sources qualify for the exemption and would not
adversely impact air quality. The local agency made this revision as it
is more stringent than the existing SIP-approved exemption and is
aligned with 40 CFR part 63 subpart CCCCCC. The Iowa Administrative
Code currently does not provide for exemptions for retail gasoline
stations of any size so that all sources in the source category in Polk
County remain subject to the state permitting rule. In any event, the
revision addressed in this rulemaking in the county rule makes the
exemption more stringent, and is therefore approvable.
    Also in Article X, subsections 5-33(55) and 5-39(a)(48) were
revised to add a construction and operating permit exemption for cold
solvent cleaning machines that are not in-line cleaning machines.
Subsections 5-33(56) and 5-39(a)(49) were revised to add a construction
and operating permit exemption for emissions from mobile agricultural
and construction internal combustion engines that are operated only for
repair or maintenance purposes at equipment repair shops or equipment
dealerships. Subsection 5-35(d) was revised to reduce the amount of
time the owner or operator has to notify the local program prior to the
movement of portable equipment for which an operating permit has been
issued. The notification time was reduced from 30 to 14 days.
Subsections 5-36(1)(a) and 5-36(1)(a)(1) were revised to clarify what
the owner or operators' responsibilities are when applying for a
conditional operating permit. These revisions are consistent with SIP-
approved State regulations.
    Section 5-49 was added to Article X to allow for electric utilities
in Polk County to operate generators at a utility substation, with a
total combined capacity not to exceed 2 megawatts in capacity, for a
period of not longer than 10 days and only for the purpose of providing
electricity generation in the event of a sudden and unforeseen disaster
that has disabled standard transmission of electricity to the public.
EPA previously approved this allowance in a statewide rule after EPA
determined that this allowance would result in insignificant emissions
increases. We believe the Polk County revision is also approvable.

III. What action is EPA taking?

    EPA is approving these revisions to the Polk County Board of Health
Rules and Regulations, Chapter V, Air Pollution. These changes are
consistent with the Federally-approved Iowa SIP.
    The state submittal has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submittal also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
revisions meet the substantive SIP requirements of the Clean Air Act
(CAA), including section 110 and implementing regulations.
    EPA is processing this action as a direct final action because the
revisions make changes to the existing rules which are
noncontroversial. Therefore, we do not anticipate any adverse comments.
Please note that if EPA receives adverse comment on part of this rule
and if that part can be severed from the remainder of the rule, EPA may
adopt as final those parts of the rule that are not the subject of an
adverse comment.

IV. What action is EPA not taking?

    The State requested that EPA take action to approve the local
agency's revisions to Article XVI section 5-75. Section 5-75 outlines
the local agency's enforcement of criminal and civil penalties. As EPA
does not rely on the local agency's authority, but relies on its own
authority, to implement and enforce the requirements of the CAA, EPA is
not taking action on the requested revisions to Article XVI section 5-
75.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    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 action 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 the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 7, 2010. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: June 18, 2010.
Karl Brooks,
Regional Administrator, Region 7.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart Q--Iowa

0
2. In Sec.  52.820 the table in paragraph (c) is amended by revising
the entry for ``Chapter V'' under the heading ``Polk County'' to read
as follows:

Sec.  52.820  Identification of plan.

* * * * *
    (c) * * *

                                         EPA--Approved Iowa Regulations
----------------------------------------------------------------------------------------------------------------
                                                             State
          Iowa citation                   Title         effective date   EPA approval date       Explanation
----------------------------------------------------------------------------------------------------------------
                 Iowa Department of Natural Resources, Environmental Protection Commission [567]

                                                  * * * * * * *
                                                   Polk County

CHAPTER V........................  Polk County Board          08/06/09  07/06/10 [insert FR  Article I, Section
                                    of Health Rules                      page number where    5-2, definition of
                                    and Regulations                      the document         ``variance'';
                                    Air Pollution                        begins].             Article VI,
                                    Chapter V.                                                Sections 5-16(n),
                                                                                (o) and (p);
                                                                                Article VIII;
                                                                                Article IX,
                                                                                Sections 5-27(3)
                                                                                and (4); Article
                                                                                X, Section 5-28,
                                                                                subsections (a)
                                                                                through (c);
                                                                                Article XIII and
                                                                                Article XVI,
                                                                                Section 5-75 are
                                                                                not a part of the
                                                                                SIP.
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* * * * *
[FR Doc. 2010-16235 Filed 7-2-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 17 (Wednesday, January 26, 2011)]
[Rules and Regulations]
[Pages 4542-4548]
[FR Doc No: 2011-1655]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0713; FRL-8855-1]

Mefenoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
mefenoxam in or on multiple commodities which are identified and
discussed later in this document. This regulation additionally removes
the individual tolerance on lingonberry, as it will be superseded by
inclusion in bushberry subgroup 13-07B. Interregional Research Project
Number 4 (IR-4) requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 26, 2011. Objections and
requests for hearings must be received on or before March 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-2009-0713. 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: Laura Nollen, Registration Division
(7509P), 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.

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-2009-0713 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
March 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-2009-0713, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket 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 Tolerances

    In the Federal Register of October 7, 2009 (74 FR 51597) (FRL-8792-
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
9E7591) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ
08540. The petition requested that 40 CFR 180.546 be amended by
establishing tolerances for residues of the fungicide mefenoxam, (R)-
and (S)-2-[(2,6-dimethyl(phenyl)-methoxyacetylamine]-propionic acid
methyl ester, and its metabolites containing the 2,6 dimethylaniline
moiety, and N -(2-hydroxy methyl-6-methylphenyl)-N-(methoxyacetyl)-
alanine methyl ester, each expressed as mefenoxam equivalents, in or on
bean, snap, succulent at 0.35 parts per million (ppm); caneberry
subgroup 13-07A at 0.80 ppm; bushberry subgroup 13-07B at 2.0 ppm;
onion, bulb, subgroup 3-07A at 3.0 ppm; onion, green, subgroup 3-07B at
10.0 ppm; and spinach at 8.0 ppm. The notice additionally requested to
remove the individual tolerance for lingonberry at 2.0 ppm, as it will
be superseded by inclusion in bushberry subgroup 13-07B. That notice
referenced a summary of the petition prepared on behalf of IR-4 by
Syngenta Crop Protection, Inc., the registrant, which is available in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance levels for several commodities. EPA has
also revised the tolerance expression for all established commodities
to be consistent with current Agency 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 mefenoxam including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with mefenoxam
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.
    Mefenoxam, is the R-enantiomer of metalaxyl which is a racemic
mixture that contains approximately 50% each of the R- and S-
enantiomers. EPA conducted a side-by-side comparison of the available
toxicity data for mefenoxam and metalaxyl and concluded that mefenoxam
has similar toxicity to that of metalaxyl. Therefore, metalaxyl data
may be used to support the registration of mefenoxam.
    The database for mefenoxam/metalaxyl indicates that the liver is
the major target organ. Liver effects observed in oral studies in rats,
mice, and dogs include increased liver enzymes (alanine amino-
transferase, aspartate amino-transferase, and alkaline phosphatase),
increased incidence of pathological observations in the liver
(hepatocyte hypertrophy, vacuolation of hepatocytes, and fatty
infiltration) and increased relative and absolute liver weights. In
guideline studies, the dog appears to be the most sensitive species.
    The developmental toxicity studies in rat and rabbit and the
multigeneration reproduction study did not show metalaxyl/mefenoxam to
be a developmental or reproductive toxicant. There was no indication of
increased susceptibility in pups following prenatal and postnatal
exposures to mefenoxam. In the rat and rabbit developmental toxicity
studies, in which animals were administered metalaxyl by gavage at
relatively high doses, both rat and rabbit dams exhibited clinical
signs (ataxia, body tremors, reduced activity, and righting reflex).
These clinical signs are believed to result from metalaxyl/mefenoxam
induced bradycardia mediated through alpha-adrenoreceptors and not from
neurotoxicity.
    Metalaxyl has been classified as ``not likely to be carcinogenic to
humans'' based on the results of a carcinogenicity

study in mice and the combined chronic toxicity and carcinogenicity
studies in rats. Based on the classification of metalaxyl, mefenoxam is
also considered ``not likely to be carcinogenic to humans.''
Mutagenicity studies do not indicate increased mutagenic potential
following exposure to metalaxyl/mefenoxam.
    Specific information on the studies received and the nature of the
adverse effects caused by mefenoxam 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 document ``Mefenoxam. Human Health Risk
Assessment for Proposed Uses on Snap Beans and the Caneberry Subgroup,
Expanded Uses on the Bulb and Green Onion Subgroups and the Bushberry
Subgroup, and Amended Use on Spinach.'' at pages 51-53 in docket ID
number EPA-HQ-OPP-2009-0713.

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 mefenoxam used for
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Mefenoxam for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                      Point of departure and      RfD, PAD, LOC for     Study and toxicological
         Exposure/scenario          uncertainty/safety factors     risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years   None. No appropriate endpoint attributable to a single dose was identified.
 of age and the general population
 including infants and children).
                                   -----------------------------------------------------------------------------
Chronic dietary (All populations).  NOAEL = 7.41 mg/kg/day,     Chronic RfD = 0.074    6-Month Feeding
                                     UFA = 10x, UFH = 10x,       mg/kg/day.             (Metalaxyl) Study in
                                     FQPA SF = 1x.              cPAD = 0.074 mg/kg/     Dog, LOAEL = 39 mg/kg/
                                                                 day.                   day, based on increased
                                                                                liver weights and
                                                                                clinical chemistry
                                                                                (alkaline phosphatase).
Incidental oral short-term (1 to    NOAEL = 50 mg/kg/day, UFA   LOC for MOE = 100....  Developmental Toxicity in
 30 days).                           = 10x, UFH = 10x, FQPA SF                          Rat (Metalaxyl), LOAEL =
                                     = 1x.                                              250 mg/kg/day based on
                                                                                clinical signs of
                                                                                toxicity including post-
                                                                                dosing convulsions.
Incidental oral intermediate-term   NOAEL = 7.41 mg/kg/day,     LOC for MOE = 100....  6-Month Feeding
 (1 to 6 months).                    UFA = 10x, UFH = 10x,                              (Metalaxyl) Study in
                                     FQPA SF = 1x.                                      Dog, LOAEL = 39 mg/kg/
                                                                                day based on increased
                                                                                liver weights and
                                                                                clinical chemistry
                                                                                (alkaline phosphatase).
Inhalation short-term (1 to 30      Inhalation (or oral) study  LOC for MOE = 100....  Developmental Toxicity in
 days).                              NOAEL = 50 mg/kg/day                               Rat (Metalaxyl), LOAEL =
                                     (inhalation absorption                             250 mg/kg/day based on
                                     rate = 100%), UFA = 10x,                           clinical signs of
                                     UFH = 10x, FQPA SF = 1x.                           toxicity including post-
                                                                                dosing convulsions.
                                   -----------------------------------------------------------------------------
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).
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 mefenoxam, EPA considered exposure under the petitioned-for
tolerances as well as all existing mefenoxam tolerances in 40 CFR
180.546 and metalaxyl tolerances in 40 CFR 180.408. EPA assessed
dietary exposures from mefenoxam/metalaxyl 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. No such effects were
identified in the toxicological studies

for mefenoxam; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the U.S. Department
of Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys of Food
Intakes by Individuals (CSFII). As to residue levels in food, EPA
assumed tolerance-level residues for most commodities. Additional
factors derived from available residue chemistry data were applied to
the tolerance values for leafy vegetables, grain seed (including dried
beans), with the exception of flour cereal grains, nut commodities,
succulent snap beans, and caneberries to address concerns regarding the
adequacy of the residue analytical method to determine all metalaxyl/
mefenoxam residues of concern, including metabolites, in plant and
animal commodities. This was accomplished by calculating parent and
metabolite to parent ratios to residue levels of concern for risk
assessment purposes.
    Additionally, EPA used DEEM default processing factors except where
specific mefenoxam/metalaxyl tolerances exist for processed commodities
or where metabolism and processing data are available to establish
specific processing factors. Tolerances were used for dried apricot,
tomato paste, tomato puree, and potato processed commodities and a
data-derived processing factor was applied for fruit juices based on
available metabolism and processing data. Finally, the dietary
assessment incorporated average percent crop treated (PCT) information,
when available, for mefenoxam because it showed higher estimates than
metalaxyl. One hundred PCT was used for all other commodities,
including the proposed uses.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that mefenoxam does not pose a cancer risk 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.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on
the actual percent of food treated for assessing chronic dietary risk
only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows:

Almond, 1%                               Honeydew, 5%
Apple, 1% 5%                             Lemon, 5%
Artichoke; 5%                            Lettuce, 10%
Asparagus, 10%                           Onion, 30%
Avocado, 2.5%                            Orange, 5%
Blueberry, 1%                            Peach, 1%
Broccoli, 10%                            Peanut, 1%
Cabbage, 10%                             Pea, green, 2.5%
Cantaloupe, 10%                          Pepper, 15%
Tomato, 15%                              Potato, 20%
Carrot, 35%                              Pumpkin, 5%
Cauliflower, 5%                          Rice, 1%
Celery, 5%                               Soybean, 10%
Cherry, 1%                               Squash, 10%
Cotton, 5%                               Strawberry, 10%
Cucumber, 10%                            Sugar beet, 1%
Dry bean and pea, 1%                     Sweet corn, 1%
Garlic, 15%                              Tangerine, 10%
Grapefruit, 5%                           Walnut, 1%
Grape, 1%                                Watermelon, 15%

    In most cases, EPA uses available data from the USDA/National
Agricultural Statistics Service (USDA/NASS), proprietary market
surveys, and the National Pesticide Use Database for the chemical/crop
combination for the most recent 6-7 years. EPA uses an average PCT for
chronic dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than one. In those cases, 1% is used as the average PCT and 2.5%
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary
risk analysis. The maximum PCT figure is the highest observed maximum
value reported within the recent 6 years of available public and
private market survey data for the existing use and rounded up to the
nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which mefenoxam may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for metalaxyl/mefenoxam in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of mefenoxam. 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 Tier II Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) and Tier I Screening Concentration in
Ground Water (SCI-GROW) models, the estimated drinking water
concentrations (EDWCs) of mefenoxam for chronic exposures for non-
cancer assessments are estimated to be 36.7 parts per billion (ppb) for
surface water and 1.72 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 36.7 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). Mefenoxam is
currently registered for the following uses that could result in
residential exposures: Residential turf and ornamentals and
recreational turf,

such as golf courses and athletic fields. EPA assessed residential
exposure using the following assumptions: Exposure to adults may occur
from handling mefenoxam, and to children from postapplication contact
with treated areas. Therefore, adult handlers were assessed for short-
term inhalation exposure resulting from residential application of
mefenoxam; intermediate-term handler exposure is not expected. For
children, short- and intermediate-term postapplication oral exposures
(hand-to-mouth, object-to-mouth, and incidental ingestion of soil) were
assessed. Dermal toxicity endpoints were not identified for any
mefenoxam use pattern and chronic residential exposure is not expected;
therefore, these exposure scenarios were not assessed. It was also
determined that postapplication mefenoxam exposures to adults and
children at recreational use sites would be similar to those assessed
for residential use sites and, therefore, a separate recreational
exposure assessment is not necessary.
    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 mefenoxam to share a common mechanism of toxicity
with any other substances, and mefenoxam does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that mefenoxam 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. There is no evidence that
mefenoxam results in increased susceptibility from in utero exposure to
rats or rabbits in the prenatal developmental studies or exposure to
young rats in the 2-generation reproduction study.
    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 mefenoxam is complete except for
immunotoxicity, acute neurotoxicity, and subchronic neurotoxicity
testing. Recent changes to 40 CFR part 158 require acute and subchronic
neurotoxicity testing (OPPTS Guideline 870.6200), and immunotoxicity
testing (OPPTS Guideline 870.7800) for pesticide registration. However,
the existing data are sufficient for endpoint selection for exposure/
risk assessment scenarios, and for evaluation of the requirements under
the FQPA. The available studies do not indicate potential for
immunotoxicity, as evidenced by the lack of effects seen in the spleen,
thymus, or hematological parameters. Also, metalaxyl and mefenoxam do
not belong to a class of compounds (e.g., the organotins, heavy metals,
or halogenated aromatic hydrocarbons) that would be expected to be
toxic to the immune system.
    ii. With respect to neurotoxicity, clinical signs (ataxia, body
tremors, reduced activity, and righting reflex) were observed in
maternal animals in rat and rabbit developmental studies at relatively
high doses (>= 150 mg/kg/day), where metalaxyl was administered by
gavage only. These clinical signs were unlikely neurotoxically
mediated, but rather resulted from the bradycardia mediated through
alpha-adrenoreceptors. Therefore, there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that mefenoxam 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. Although one additional field trial with residue decline
measures is needed to complete the geographic distribution for
caneberry crops, there are no uncertainties in the exposure database
due to the fact that: (1) There is no significant difference in
residues in blackberry/raspberry samples from field trials conducted in
four regions including the major production region (~70%) and
relatively low production (6-15%) in the remaining regions; and (2)
existing decline data indicate that residues decline with increasing
sampling intervals.
    The chronic dietary food exposure assessment was somewhat refined,
using estimated average PCT data, when available, and 100 PCT for all
other commodities. The assessment was also performed based on
tolerance-level residues or additional factors to address concerns
regarding the adequacy of the residue analytical method in some
commodities and DEEM default processing factors unless specific
tolerances were established for processed commodities or metabolism and
processing data were available to establish specific processing
factors. These assumptions are based on reliable data which will not
underestimate potential dietary exposures. EPA made conservative
(protective) assumptions in the ground water and surface water modeling
used to assess exposure to mefenoxam 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
mefenoxam.

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. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was

selected. Therefore, mefenoxam is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
mefenoxam from food and water will utilize 60% of the cPAD for children
1-2 years 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 mefenoxam 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). Mefenoxam 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 mefenoxam.
    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 2,500 for the
general U.S. population; 920 for children 3-5 years old; and 880 for
children 1-2 years old. Because EPA's level of concern for mefenoxam 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). Mefenoxam is currently registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to mefenoxam.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 150 for children 3-5 years old and 140 for children
1-2 years old. Because EPA's level of concern for mefenoxam is a MOE of
100 or below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, mefenoxam 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 mefenoxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For the purposes of this tolerance action, adequate enforcement
methodologies including a gas-liquid chromatography with alkali flame-
ionization detection (GLC/AFID) (Method AG-348) and a GLC with
nitrogen-phosphorus detection (NPD) (Method AG-395) are available to
enforce the tolerance expression for plant commodities. However, the
Agency determined that the current residue analytical methods available
for tolerance enforcement will not adequately recover all of the
metalaxyl/mefenoxam residues of concern in the revised tolerance
expression. For this action, therefore, the Agency applied additional
factors derived from available residue chemistry data to certain
commodities to account for all residues of concern for dietary risk
assessments, as previously described in Unit III.C.ii.
    Neither Method AG-348 nor Method AG-395 distinguish between the R-
and S-enantiomers of metalaxyl/mefenoxam; however, a confirmatory high
performance liquid chromatography method with mass spectrometric
detection that utilizes a chiral column (chiral LC/MS), Method 456-98,
is available for the enantioselective determination of the D- and L-
enantiomers of metalaxyl in crops. Therefore, EPA has determined for
future actions that the multiresidue method Protocol D, which
completely recovers metalaxyl/mefenoxam per se, is an adequate
enforcement method for the determination of metalaxyl/mefenoxam per se
in plant and livestock commodities; and analysis using a 2,6-DMA common
moiety method, including recovery data for parent, CGA-62826, and CGA-
94689, can be used in order to refine dietary risk assessments.
    Method AG-;348 may be found in PAM Vol. II; Method AG-395 and
Method 456-98 have been submitted for inclusion in PAM Vol. II; and
Multiresidue method Protocol D may be found in PAM, Vol. I Section 302.
Methods not published in PAM 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.
    Pending revocation of Codex MRLs for metalaxyl, Codex MRLs for
metalaxyl-m (mefenoxam) have not been advanced to final status.
Therefore, there are currently no Codex MRLs established for residues
of mefenoxam in or on the commodities associated with this petition.
However, with the adoption of the revised tolerance expression, the
U.S. tolerance expression will be harmonized with the tolerance
expression for Codex.
    Canadian MRLs for mefenoxam (metalaxyl-m) are covered by MRLs
established for metalaxyl, and Canadian MRLs have been established for
residues of metalaxyl in or on spinach at 10 ppm, bulb onion at 3.0
ppm, green onion at 10 ppm, bean at 0.2 ppm, raspberry at 0.2 ppm, and
blueberry at 2.0 ppm. The Canadian MRLs are harmonized with U.S.
tolerance levels in or on the commodities associated with this
petition, with the exception of caneberry subgroup 13-07A, which is
being established at 0.70 ppm (the Canadian MRL for raspberry is 0.2
ppm). The U.S. tolerance on caneberry subgroup 13-07A cannot be
harmonized with the Canadian MRL on raspberry at this time because the
field trial data supporting the U.S. tolerance result in residues above
0.2 ppm. Additionally, with the adoption of the revised tolerance
expression for mefenoxam, the U.S. tolerance expression will not be in
harmonization with Canadian MRLs.

C. Revisions to Petitioned-for Tolerances

    Based on analysis of the residue field trial data supporting the
petition, EPA revised the proposed tolerances on bean, snap, succulent
from 0.35 ppm to

0.20 ppm; caneberry subgroup 13-07A from 0.80 ppm to 0.70 ppm; and
spinach from 8.0 ppm to 10 ppm. The Agency revised these tolerance
levels based on analysis of the residue field trial data using the
Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance
for Setting Pesticide Tolerances Based on Field Trial Data.
Additionally, EPA has revised the tolerance expression to clarify: (1)
That, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of mefenoxam not specifically mentioned; and
(2) that compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of mefenoxam,
including its metabolites and degradates, in or on bean, snap,
succulent at 0.20 ppm; caneberry subgroup 13-07A at 0.70 ppm; bushberry
subgroup 13-07B at 2.0 ppm; onion, bulb, subgroup 3-07A at 3.0 ppm;
onion, green, subgroup 3-07B at 10 ppm; and spinach at 10 ppm.
Compliance with the specified tolerance levels is to be determined by
measuring only metalaxyl (methyl N-(2,6-dimethylphenyl)-N-
(methoxyacetyl)-DL-alaninate). Additionally, this regulation deletes
the individual tolerance in or on lingonberry at 2.0 ppm.

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: January 13, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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 180.546 is amended by revising paragraph (a) introductory
text; removing the entry for ``Lingonberry'' from the table; and
alphabetically adding the following commodities to the table in
paragraph (a) to read as follows:

Sec.  180.546  Mefenoxam; tolerances for residues.

    (a) General. Tolerances are established for residues of mefenoxam,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only metalaxyl (methyl N-(2,6-
dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Bean, snap, succulent.....................................          0.20
Bushberry subgroup 13-07B.................................          2.0
Caneberry subgroup 13-07A.................................          0.70

                                * * * * *
Onion, bulb, subgroup 3-07A...............................          3.0
Onion, green, subgroup 3-07B..............................         10

                                * * * * *
Spinach...................................................         10

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-1655 Filed 1-25-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Notices]
[Pages 57110-57112]
[FR Doc No: 2014-22682]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1287]

Announcement of Requirements and Registration for the 2014 Food
and Drug Administration Food Safety Challenge

    Authority:  15 U.S.C. 3719.

AGENCY: Food and Drug Administration, HHS.
    Award Approving Official: Erik Mettler, Deputy Associate
Commissioner, Food and Drug Administration/Office of Foods and
Veterinary Medicine.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 2014
FDA Food Safety Challenge, a prize competition under the America
COMPETES Reauthorization Act of 2010. The 2014 FDA Food Safety
Challenge is an effort to advance breakthroughs in foodborne pathogen
detection, specifically with the goal of accelerating the detection of
Salmonella in fresh produce. As FDA's food safety program incorporates
preventive control measures through the implementation of the FDA Food
Safety Modernization Act, quicker detection of these harmful bacteria
will help to prevent foodborne illnesses.

DATES:
    1. Phase I submission period: September 23 to November 9, 2014.
    2. Phase II judging of submissions and selection of finalists:
November 10, 2014, to January 6, 2015.
    3. Phase III field accelerator, inclusive of finalist mentorship,
boot camp, and demo day: January 8 to March 5, 2015.
    4. Phase IV final judging: March 5 to March 11, 2015.
    5. Winner(s) announced: March 12, 2015.

FOR FURTHER INFORMATION CONTACT: Chad P. Nelson, Office of Foods and
Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    While the American food supply is among the safest in the world,
the Centers for Disease Control and Prevention (CDC) estimates that 1
in 6 Americans is sickened by foodborne illness annually, resulting in
about 3,000 deaths each year. It is estimated that the overall negative
economic impact of foodborne illness in the United States, including
medical costs, quality-of-life losses, lost productivity, and lost-life
expectancy, may be as high as $77 billion per year. Salmonella
represents the leading cause of deaths and of hospitalizations related
to foodborne illness. Contaminated produce is responsible for nearly
half of foodborne illnesses and almost a quarter of foodborne-related
deaths.
    The 2014 FDA Food Safety Challenge is a call to scientists,
academics, entrepreneurs, and innovators from all disciplines to submit
concepts applying novel and/or advanced methodologies to foster
revolutionary improvements in foodborne pathogen detection.

Specifically, concepts should apply cutting-edge techniques to achieve
significant improvements in the speed of the FDA's detection methods
for Salmonella with identification to the subtype/serovar level in
minimally processed fresh produce. FDA is most interested in concepts
that explore the acceleration or elimination of sample preparation and/
or enrichment in the testing process, and/or those that employ novel or
revolutionary techniques to achieve pathogen detection. Concepts may
combine new techniques with existing methodologies, such as polymerase
chain reaction, and must describe where time savings are achieved in
the testing process as well as the expected time from unprepared food
sample to verifiable result.
    The statutory authority for this challenge competition is section
105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-
358).

II. Subject of the Challenge Competition

    The primary goal of the challenge is to advance breakthroughs in
foodborne pathogen detection, specifically to significantly accelerate
detection of Salmonella in produce, in order to support FDA's effort to
ensure the safety of America's food supply.
    The secondary goals of the challenge are:
     To bring new innovators to FDA's foodborne pathogen
testing processes;
     To increase public awareness about food safety, foodborne
pathogen testing, and FDA's role in those areas; and
     To promote open government and citizen participation to
improve innovation in the Federal Government.
    This challenge is designed to solicit breakthrough solutions from
advanced scientific and research areas, such as, but not limited to
metagenomics (or other next-generation sequencing methods),
spectroscopy, application of nanotubes/nanotechnology, quantum
detection methods, and electrical detection methods. Although concepts
must specifically be able to address the detection of Salmonella, with
identification to the subtype/serovar level, in minimally processed
fresh produce, the ability of the solution to address testing for other
microbial pathogens and in other foods or complex matrices is
encouraged. Submissions must describe how the technique would increase
speed of pathogen detection efforts (starting from an unprepared food
sample, through verification of pathogen(s)) without sacrificing
specificity and sensitivity or comparability reference methods. FDA is
most interested in methods that would accelerate or eliminate sample
preparation and/or enrichment in the testing process. Submitted
concepts can be targeted at any point in the food system (i.e. harvest,
packaging, distribution, point of sale, etc.), however concepts should
specify which point(s) they are targeting and how the technique would
be implemented. Though submissions may be theoretical in terms of
application to food safety, all entries must be able to demonstrate a
path to practical development of their concept and a plan to move to
proof of concept over the course of the challenge. Submissions should
include relevant data with reference to use of the concept/technique,
such as any initial verification results, any available proof of
concept, or relevant data from the technique's use in adjacent
industries. During the field accelerator phase, which will include a
live boot camp, finalists will refine their submissions with the
assistance of FDA food safety and pathogen testing experts. Feedback
will focus on helping finalists to clarify their concepts and ensure
they are in line with FDA's needs and capabilities, maximize impact on
food safety, and can be reasonably executed. At the end of the field
accelerator phase, finalists will present their refined concepts to the
judges at a demo day and provide a final report describing how their
submission was modified based on the feedback from FDA subject matter
experts.

III. Eligibility Rules for Participating in the Competition

    To be eligible to win a prize under this challenge, an individual
or entity:
     Must have entered a submission on
www.foodsafetychallenge.com under the rules promulgated by FDA.
     Must have complied with all the requirements under this
section.
     Must be (1) an individual or team of U.S. citizens or
permanent residents of the United States each of whom are 18 years of
age and over or (2) an entity incorporated in and maintaining a primary
place of business in the United States. Foreign citizens can
participate as employees of an entity that is properly incorporated in
the United States and maintains a primary place of business in the
United States.
     May not be a Federal entity or Federal employee acting
within the scope of their employment. An individual or entity shall not
be deemed ineligible because the individual or entity used Federal
facilities or consulted with Federal employees during a competition if
the facilities and employees are made available to all individuals and
entities participating in the competition on an equitable basis.
    Federal grantees may not use Federal funds to develop COMPETES Act
challenge applications unless consistent with the purpose of their
grant award. Federal contractors may not use Federal funds from a
contract to develop COMPETES Act challenge applications or to fund
efforts in support of a COMPETES Act challenge submission.
    Employees of FDA, the U.S. Department of Agriculture's Food Safety
and Inspection Service, the CDC, Luminary Labs, LLC, each of their
affiliates, and/or any other individual or entity associated with the
development, evaluation, or administration of the challenge as well as
members of such persons' immediate families (spouses, children,
siblings, parents), and persons living in the same household as such
persons, whether or not related, are not eligible to participate in the
challenge.
    Entrants must agree to assume any and all risks and waive claims
against the Federal Government and its related entities, except in the
case of willful misconduct, for any injury, death, damage, or loss of
property, revenue, or profits, whether direct, indirect, or
consequential, arising from their participation in a competition,
whether the injury, death, damage, or loss arises through negligence or
otherwise.
    Entrants must also agree to indemnify the Federal Government
against third-party claims for damages arising from or related to
competition activities.
    Entrants are not required to obtain liability insurance or
demonstrate financial responsibility in order to participate in the
challenge.
    By participating in the challenge, each entrant who works with
pathogenic organisms such as Salmonella in support of its submission
agrees to follow the requirements for Biosafety Level II laboratory
operations, as outlined in the 5th edition of ``Biosafety in
Microbiological and Biomedical Laboratories,'' available at http://www.cdc.gov/biosafety/publications/bmbl5/.

IV. Registration Process for Participants

    To register for the 2014 FDA Food Safety Challenge, participants
can access http://foodsafetychallenge.com/ and click on Submission
Form.

V. Amount of the Prize

    The total prize pool for the 2014 FDA Food Safety Challenge is
$500,000. From the $500,000 prize pool, up to 5 finalists will be
awarded $20,000 each following the open submission phase and judging of
submissions. After the field accelerator phase and final

judging, the winner(s) will receive the remainder of the prize money.

VI. Payment of the Prize

    Prizes awarded under this competition will be paid by electronic
funds transfer and may be subject to Federal income taxes. FDA will
comply with the Internal Revenue Service withholding and reporting
requirements, where applicable.

VII. Basis Upon Which Winner(s) Will Be Selected

    A panel of expert judges will select up to five finalist teams from
the pool of eligible entries. These finalists will then refine their
concepts during the field accelerator phase and will present the
concept at demo day. The judging will be based and scored upon the
judges' own discretion as to the quality of each entry according to the
following finalist evaluation criteria, with equal weighting (i.e., 20
percent for each).

A. Finalist Evaluation Criteria

     Speed: Proposed reduction in time from unprepared food
sample to verified pathogen to subtype/serovar level for Salmonella in
fresh, minimally processed produce. The ability of the solution to also
address testing in other foods and other complex matrices is
encouraged. The ability of the technique to also address additional
pathogens such as Shiga toxin-producing Escherichia coli is encouraged.
     Improved detection and path to impact: Strength of
evidence, data, and/or argumentation regarding the application of
submission's technique to create impactful acceleration and improvement
of foodborne pathogen detection, inclusive of improvements in
specificity and sensitivity for Salmonella and possibly other
pathogens.
     Applicability: Applicability of solution to FDA testing
processes.
     Revolutionary: Whether the concept would be a
revolutionary improvement over the FDA's current testing procedures
with potential to make a major impact on food testing.
     Execution: Perceived ability of submitting team or
individual to execute and develop their concept.

B. Winner Selection Criteria

    Winner selection criteria will include finalist evaluation criteria
plus the following criterion: Demonstration of team's/individual's
ability to effectively iterate and improve their concept over the
course of the field accelerator phase.

VIII. Additional Information

    FDA reserves the right to suspend, postpone, terminate, or
otherwise modify the challenge, or any entrant's participation in the
challenge, at any time at FDA's discretion.

IX. Intellectual Property

    Entrants retain ownership of their concepts, including any
software, research, or other intellectual property that they develop in
connection therewith, subject to the license granted to FDA to use
publicly posted materials as set forth herein. By participating in the
challenge, each entrant hereby irrevocably grants to FDA and Luminary
Labs, LLC, a limited, non-exclusive, royalty free, worldwide license
and right to reproduce, publicly perform, publicly display, and use the
submission to the extent necessary to administer the challenge, and to
publicly perform and publicly display the submission abstract,
including, without limitation, for advertising and promotional purposes
relating to the challenge.
    Entrants retain all rights in the submission and any invention or
work, including any software, submitted as part of the submission,
subject to the following:
     A nonexclusive, nontransferrable, irrevocable, paid-up
license to practice or have practiced for or on behalf of the United
States any such invention or work throughout the world, should the
submission win; and
     A license in the submission or work submitted as part of
the submission for the United States to use, disclose, reproduce,
prepare derivative works, distribute copies to the public, and perform
publicly and display publicly, in any manner and for any purpose, and
to have or permit others to do so, should the submission win.

    Dated: September 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22682 Filed 9-23-14; 8:45 am]
BILLING CODE 4164-01-P


Janet Cakir/RTP/USEPA/US

03/13/2008 03:20 PM

To

Lydia Wegman/RTP/USEPA/US@EPA

cc

Tricia Crabtree/RTP/USEPA/US@EPA, Ron Evans/RTP/USEPA/US@EPA

Subject

Final set of electronic files for the March 2008 Ozone NAAQS RIA

copy of initial message......

Lydia,

    I am pleased to provide to you in this, and the following emails, a final set of electronic files for the March 2008 Ozone NAAQS Final RIA.  Within these files is the Regulatory Impact Analysis performed by the Air Benefit and Cost Group to support 2008 Ozone NAAQS Review.

Thank you,

Janet Cakir

_______________________________________

Janet F. Cakir, Ph.D.

Environmental Protection Specialist

Air Benefits Cost Group

109 TW Alexander Dr., (C439-02)

Research Triangle Park, NC 27711

Tel:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

email<EMAIL_ADDRESS>


[Federal Register Volume 78, Number 85 (Thursday, May 2, 2013)]
[Proposed Rules]
[Pages 25664-25666]
[FR Doc No: 2013-10366]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0335; Directorate Identifier 2012-NM-187-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A330-300, A340-200, and A340-300 series airplanes.
This proposed AD was prompted by a determination that ballscrew rupture
could occur on certain trimmable horizontal stabilizer actuators
(THSAs). This proposed AD would require repetitive THSA ballscrew shaft
integrity tests, and replacement if necessary. We are proposing this AD
to detect and correct ballscrew rupture, which, along with corrosion on
the ballscrew lower splines, may lead to loss of transmission of THSA
torque loads from the ballscrew to the tie-bar and consequent THSA
blowback, which could result in loss of control of the airplane.

DATES: We must receive comments on this proposed AD by June 17, 2013.

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 W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 45 80; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

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 regulatory
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 FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1138; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2013-0335;
Directorate Identifier 2012-NM-187-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on 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 proposed AD.

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 2012-0210, dated October 11, 2012 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the

MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    Since the issuance of EASA AD 2012-0061 which addresses the
corrosion identified in service on THSA [part number] P/N 47147-500
and P/N 47147-700 at the level of the ballscrew lower splines,
further analyses have been conducted to determine the need for any
additional action.
    The ballscrew lower splines are not loaded in normal operation,
only in case of ballscrew rupture. Analysis results have shown that
such rupture could happen during the current inspection interval
imposed by the Maintenance Review Board Report (MRBR), task 274000-
12.
    Corrosion on the lower splines, in case of ballscrew rupture,
may lead to loss of transmission of THSA torque loads from the
ballscrew to the tie-bar and consequent THSA blowback, which could
result in loss of control of the aeroplane.
    For the reasons described above, this [EASA] AD requires
reduction of the check interval of MRBR task 274000-12.

    Required actions include repetitive THSA ballscrew shaft integrity
tests. Corrective actions include replacement of the THSA. You may
obtain further information by examining the MCAI in the AD docket.

Relevant Service Information

    Airbus has issued the following service bulletins. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.
     Airbus Mandatory Service Bulletin A330-27-3191, dated June
7, 2012.
     Airbus Mandatory Service Bulletin A340-27-4186, dated June
7, 2012.

FAA's Determination and Requirements of This Proposed 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 proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 30 products of U.S. registry. We also estimate that
it would take about 7 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $17,850, or $595 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 8 work-hours and require parts costing up to $722,556, for a
cost of up to $723,236 per product. We have no way of determining the
number of products that may need these actions.

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 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 above, 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; 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 a regulatory 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 adding the following new AD:

Airbus: Docket No. FAA-2013-0335; Directorate Identifier 2012-NM-
187-AD.

(a) Comments Due Date

    We must receive comments by June 17, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A330-301, -302, -303, -321, -
322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212,
-213, -311, -312, and -313 airplanes; certificated in any category;
all manufacturer serial numbers; if fitted with a trimmable
horizontal stabilizer actuator (THSA) having part number (P/N)
47147-500 or P/N 47147-700.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
Controls.

(e) Reason

    This AD was prompted by a determination that ballscrew rupture
could occur on certain THSAs. We are issuing this AD to detect and
correct ballscrew rupture, which, along with corrosion on the
ballscrew lower splines, may lead to loss of transmission of THSA
torque loads from the ballscrew to the tie-bar and consequent THSA
blowback, which could result in loss of control of the airplane.

(f) Compliance

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

(g) Repetitive Integrity Tests

    At the later of the times specified in paragraph (g)(1) or
(g)(2) of this AD, as applicable, do a THSA ballscrew shaft
integrity test, in accordance with the Accomplishment Instructions
of Airbus Mandatory Service Bulletin A330-27-3191, dated June 7,
2012; or Airbus Mandatory Service Bulletin A340-27-4186, dated June
7, 2012; as applicable. Repeat the integrity test thereafter at
intervals not to exceed

12,000 flight hours or 4,400 flight cycles, whichever occurs first.
    (1) At the latest of the times specified in paragraph (g)(1)(i),
(g)(1)(ii), or (g)(1)(iii) of this AD.
    (i) Within 12,000 flight hours since the airplane's first
flight; or
    (ii) Within 12,000 flight hours since the most recent THSA
ballscrew shaft integrity test was done as specified in maintenance
review board report (MRBR) Task 274000-12; or
    (iii) Within 12,000 flight hours since the most recent THSA
ballscrew shaft integrity test was done, as specified in Airbus
Mandatory Service Bulletin A330-27-3179 or Airbus Mandatory Service
Bulletin A340-27-4175, as applicable. (These service bulletins
specify testing in case of type II or type III findings).
    (2) Within 1,000 flight hours after the effective date of this
AD, but without exceeding the latest of the times specified in
paragraphs (g)(2)(i), (g)(2)(ii), or (g)(2)(iii) of this AD.
    (i) 16,000 flight hours since the airplane's first flight.
    (ii) 16,000 flight hours since the most recent THSA ballscrew
shaft integrity test was done, as specified in MRBR task 274000-12.
    (iii) 16,000 flight hours since the most recent THSA ballscrew
shaft integrity test was done, as specified in Airbus Mandatory
Service Bulletin A330-27-3179, or Airbus Mandatory Service Bulletin
A340-27-4175, as applicable. (These service bulletins specify
testing in case of type II or type III findings).

(h) Replacement

    If the result from any test required by paragraph (g) of this AD
is not correct, as specified in the Accomplishment Instructions of
Airbus Mandatory Service Bulletin A330-27-3191, dated June 7, 2012;
or Airbus Mandatory Service Bulletin A340-27-4186, dated June 7,
2012; as applicable: Before further flight, replace the THSA with a
serviceable THSA, in accordance with the Accomplishment Instructions
of Airbus Mandatory Service Bulletin A330-27-3191, dated June 7,
2012; or Airbus Mandatory Service Bulletin A340-27-4186, dated June
7, 2012; as applicable. Replacement of a THSA, as required by this
paragraph, with a THSA having P/N 47147-500 or P/N 47147-700, is not
terminating action for the repetitive tests required by paragraph
(g) of this AD.

(i) Other FAA AD Provisions

    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. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed 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. The AMOC approval letter must specifically reference this
AD.
    (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.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) European Aviation Safety Agency Airworthiness Directive 2012-
0210, dated October 11, 2012, and the service bulletins specified in
paragraphs (j)(1)(i) and (j)(1)(ii) of this AD, for related
information.
    (i) Airbus Mandatory Service Bulletin A330-27-3191, dated June
7, 2012.
    (ii) Airbus Mandatory Service Bulletin A340-27-4186, dated June
7, 2012.
    (2) For service information identified in this AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on April 23, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-10366 Filed 5-1-13; 8:45 am]
BILLING CODE 4910-13-P