[Federal Register: September 30, 2009 (Volume 74, Number 188)]
[Rules and Regulations]
[Page 50137-50145]
[DOCID:fr30se09-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0814; FRL-8436-5]

Thiamethoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of thiamethoxam (3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine) and its metabolite CGA-322704, [N-(2-
chloro-thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine, calculated as
the stoichiometric equivalent of thiamethoxam, in or on: avocado;
berry, low growing, subgroup 13-07G, except cranberry; black sapote;
bushberry subgroup 13-07B, except lingonberry and blueberry, lowbush;
caneberry subgroup 13-07A; canistel; fruit, small, vine climbing,
subgroup 13-07F, except fuzzy kiwifruit; mamey sapote; mango; papaya;
rice, grain; sapodilla; star apple; and vegetable, root, subgroup 1A.
Interregional Research Project Number 4 (IR-4) and Syngenta Crop
Protection, Inc., requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA). In addition, this regulation amends
existing tolerances for combined residues of thiamethoxam and its
metabolite CGA-322704 in or on: cattle, meat byproducts; goat, meat
byproducts; horse, meat byproducts; and sheep, meat byproducts.
Syngenta Crop Protection, Inc., requested these amended tolerances
under FFDCA.

DATES: This regulation is effective September 30, 2009. Objections and
requests for hearings must be received on or before November 30, 2009,
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-2008-0814. 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: Julie Chao, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at

http://www.epa.gov/fedrgstr. You may also access a frequently updated
electronic version of EPA's tolerance regulations at 40 CFR part 180
through the Government Printing Office's e-CFR cite at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2008-0814 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before November 30, 2009.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0814, 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. Petition for Tolerance

    In the Federal Registers of April 13, 2009 (74 FR 16866) (FRL-8396-
6) and August 19, 2009 (74 FR 41898) (FRL-8426-7), EPA issued notices
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide petitions PP 8E7411 and PP 8F7449 by
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W., Princeton, NJ 08540, and Syngenta Crop Protection, Inc.,
P.O. Box 18300, Greensboro, NC 27419-8300, respectively. The petitions
requested that 40 CFR 180.565 be amended by establishing tolerances for
combined residues of the insecticide thiamethoxam (3-[(2-chloro-5-
thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-oxadiazin-4-
imine) and its metabolite CGA-322704 [N-(2-chloro-thiazol-5-ylmethyl)-
N'-methyl-N'-nitro-guanidine], in or on the following commodities:
    PP 8E7411: Avocado at 0.2 parts per million (ppm); canistel at 0.2
ppm; mango at 0.2 ppm; papaya at 0.2 ppm; sapodilla at 0.2 ppm; sapote,
black at 0.2 ppm; sapote, mamey at 0.2 ppm; star apple at 0.2 ppm;
vegetable, root, subgroup 1A at 0.04 ppm.
    In addition, PP 8E7411 proposed to revise the tolerance expression
for the Berry Crop Group 13 to become the Berry and Small Fruit Crop
Group 13, per the Pesticide Tolerance Crop Grouping Program published
in the Federal Register of December 7, 2007 (72 FR 69150) (FRL-8343-1).
The proposed new tolerance expressions for the Berry and Small Fruit
Crop Group 13 for the tolerances in 40 CFR.565 for combined residues of
the insecticide thiamethoxam and its metabolite CGA-322704 are as
follows, in or on: Bushberry subgroup 13-07B at 0.20 ppm; caneberry
subgroup 13-07A at 0.35 ppm; fruit, small, vine climbing subgroup 13-
07F, except fuzzy kiwifruit at 0.20 ppm; low growing berry subgroup 13-
07G, except cranberry at 0.30 ppm. The existing tolerance on cranberry
at 0.02 ppm is retained.
    PP 8E7411 also requested that the following tolerances be deleted:
Bushberry subgroup 13B at 0.20 ppm; caneberry subgroup 13A at 0.35 ppm;
grape at 0.20 ppm; Juneberry at 0.20 ppm; lingonberry at 0.20 ppm;
salal at 0.20 ppm; strawberry at 0.30 ppm; and vegetable, root, except
sugar beet, subgroup 1B at 0.02 ppm.
    PP 8F7449: Rice, bran at 0.02 ppm; rice, grain at 0.02 ppm; rice,
hulls at 0.1 ppm; rice, polished at 0.02 ppm; rice, straw at 0.02 ppm.
    In addition, PP 8F7449 requested that 40 CFR 180.565 be amended by
increasing tolerances for combined residues of the insecticide
thiamethoxam and its metabolite CGA-322704 in or on the following:
Cattle, meat byproducts from 0.02 ppm to 0.04 ppm; goat, meat
byproducts from 0.02 ppm to 0.04 ppm; horse, meat byproducts from 0.02
ppm to 0.04 ppm; sheep, meat byproducts from 0.02 ppm to 0.04 ppm;
vegetable, root, except sugarbeet, subgroup 1B from 0.02 ppm to 0.05
ppm.
    The notices referenced summaries of the petitions prepared by
Syngenta Crop Protection, Inc., and Interregional Research Project
Number (IR-4), the registrants, which are available to the public in
the docket EPA-HQ-OPP-2008-0814, http://www.regulations.gov. There were
no comments received in response to the notices of filing.
    Based upon review of the data supporting the petition, EPA has
determined that the proposed tolerances for avocado; canistel; mango;
papaya; sapodilla; sapote, black; sapote, mamey; star apple; and
vegetable, root, subgroup 1A need to be raised. In addition, EPA has
determined that no tolerances are needed for rice, bran; rice, hulls;
rice, polished; and rice, straw. Finally, EPA is removing existing
tolerances that are no longer needed for bushberry subgroup 13B;
caneberry subgroup 13A; grape; Juneberry; lingonberry; salal;
strawberry; and vegetable, root, except sugar beet, subgroup 1B. 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 the petitioned-for
tolerances for combined residues of thiamethoxam (3-[(2-chloro-5-
thiazolyl)methyl]tetrahydro-5-methyl-N-

nitro-4H-1,3,5-oxadiazin-4-imine) and its metabolite CGA-322704 [N-(2-
chloro-thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine], calculated as
the stoichiometric equivalent of thiamethoxam, in or on avocado at 0.40
ppm; berry, low growing, subgroup 13-07G, except cranberry at 0.30 ppm;
bushberry subgroup 13-07B, except lingonberry and blueberry, lowbush at
0.20 ppm; caneberry subgroup 13-07A at 0.35 ppm; canistel at 0.40 ppm;
fruit, small, vine climbing, subgroup 13-07F, except fuzzy kiwifruit at
0.20 ppm; mango at 0.40 ppm; papaya at 0.40 ppm; sapodilla at 0.40 ppm;
sapote, black at 0.40 ppm; sapote, mamey at 0.40 ppm; star apple at
0.40 ppm; vegetable, root, subgroup 1A at 0.05 ppm; rice, grain at 0.02
ppm; cattle, meat byproducts at 0.04 ppm; goat, meat byproducts at 0.04
ppm; horse, meat byproducts at 0.04 ppm; sheep, meat byproducts at 0.04
ppm. EPA's assessment of exposures and risks associated with
establishing tolerances 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.
    Thiamethoxam shows toxicological effects primarily in the liver,
kidney, testes, and hematopoietic system. In addition, developmental
neurological effects were observed in rats. This developmental effect
is being used to assess risks associated with acute exposures to
thiamethoxam, and the liver and testicular effects are the bases for
assessing longer term exposures. Although thiamethoxam causes liver
tumors in mice, the Agency has classified thiamethoxam as ``not likely
to be carcinogenic to humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse
and that the carcinogenic effects are a result of a mode of action
dependent on sufficient amounts of a hepatotoxic metabolite produced
persistently. The non-cancer (chronic) assessment is sufficiently
protective of the key events (perturbation of liver metabolism,
hepatotoxicity/regenerative proliferation) in the animal mode of action
for cancer. Refer to the Federal Register of June 22, 2007 (72 FR
34401) (FRL-8133-6) for more information regarding the cancer
classification of thiamethoxam.
    Thiamethoxam produces a metabolite known as CGA-322704 (referred to
in the remainder of this rule as clothianidin). Clothianidin is also
registered as a pesticide. While some of the toxic effects observed
following testing with the thiamethoxam and clothianidin are similar,
the available information indicates that thiamethoxam and clothianidin
have different toxicological effects in mammals and should be assessed
separately. A separate risk assessment of clothianidin has been
completed in conjunction with the registration of clothianidin. The
most recent assessments, which provide details regarding the toxicology
of clothianidin, are available in the docket EPA-HQ-OPP- 2008-0814, at
http:///www.regulations.gov. Refer to the documents Clothianidin: Human
Health Risk Assessment for Proposed Uses on Berries (Group 13-07H),
Brassica Vegetables (Group 5), Cotton, Cucurbit Vegetables (Group 9),
Fig, Fruiting Vegetables (Group 8), Leafy Green Vegetables (Group 4A),
Peach, Pomegranate, Soybean, Tree Nuts (Group 14), and Tuberous and
Corm Vegetables (Group 1C); and Clothianidin: Human Health Risk
Assessment for Proposed Seed Treatment Uses on Root and Tuber
Vegetables (Group 1), Bulb Vegetables (Group 3), Leafy Green Vegetables
(Group 4A), Brassica Leafy Vegetables (Group 5), Fruiting Vegetables
(Group 8), Cucurbit Vegetables (Group 9), and Cereal Grains (Group 15,
except rice).
    Specific information on the studies received and the nature of the
adverse effects caused by thiamethoxam as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of June 22, 2007.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the level of concern (LOC).
    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
greater than that 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 thiamethoxam used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of June 22, 2007.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to thiamethoxam, EPA considered exposure under the petitioned-
for tolerances as well as all existing thiamethoxam tolerances in 40
CFR 180.565. EPA assessed dietary exposures from thiamethoxam in food
as follows:
    For both acute and chronic exposure assessments for thiamethoxam,
EPA combined residues of clothianidin coming from thiamethoxam with
residues of thiamethoxam per se. As discussed in this unit,
thiamethoxam's major metabolite is CGA-322704, which is also the
registered active ingredient clothianidin. Available information
indicates that thiamethoxam and clothianidin have different
toxicological effects in mammals and should be assessed separately;
however, these exposure assessments for this action incorporated the
total residue of thiamethoxam and clothianidin from use of thiamethoxam
because the total residue for each commodity for which thiamethoxam has
a tolerance has not been separated between thiamethoxam

and its clothianidin metabolite. The combining of these residues, as
was done in this assessment, results in highly conservative estimates
of dietary exposure and risk. A separate assessment was done for
clothianidin. The clothianidin assessment included clothianidin
residues from use of clothianidin as a pesticide and clothianidin
residues from use of thiamethoxam on those commodities for which the
pesticide clothianidin does not have a tolerance. As to these
commodities, EPA has separated total residues between thiamethoxam and
clothianidin.
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption
information from the U.S. Department of Agriculture (USDA) 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed tolerance-level
residues of thiamethoxam and clothianidin. It was also assumed that
100% of crops with registered or requested uses of thiamethoxam and
100% of crops with registered or requested uses of clothianidin are
treated.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance
level and/or anticipated residues from thiamethoxam field trials. It
was also assumed that 100% of crops with registered or requested uses
of thiamethoxam and 100% of crops with registered or requested uses of
clothianidin are treated.
    A complete listing of the inputs used in these assessments can be
found in the following documents: Thiamethoxam Acute and Chronic
Aggregate Dietary (Food and Drinking Water) Exposure and Risk
Assessments for the Section 3 Registration on Rice, Sugar Beets, and
Tropical Fruits; Clothianidin Acute and Chronic Aggregate Dietary (Food
and Drinking Water) Exposure and Risk Assessments. These documents are
available in the docket, EPA-HQ-OPP-2008-0814, at http://
www.regulations.gov.
    iii. Cancer. A quantitative cancer exposure assessment is not
necessary because EPA concluded that thiamethoxam is ``not likely to be
carcinogenic to humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse,
and that the carcinogenic effects are a result of a mode of action
dependent on sufficient amounts of a hepatotoxic metabolite produced
persistently. The non-cancer (chronic) assessment is sufficiently
protective of the key events (perturbation of liver metabolism,
hepatotoxicity/regenerative proliferation) in the animal mode of action
for cancer and thus a separate exposure assessment pertaining to cancer
risk is not necessary. Because clothianidin is not expected to pose a
cancer risk, a quantitative dietary exposure assessment for the
purposes of assessing cancer risk was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use PCT information in the dietary assessments for
thiamethoxam or clothianidin.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to section 408(f)(1) of FFDCA that data be provided 5 years
after the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such Data Call-Ins
as are required by section 408(b)(2)(E) of FFDCA and authorized under
section 408(f)(1) of FFDCA. Data will be required to be submitted no
later than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. Thiamethoxam is expected
to be persistent and mobile in terrestrial and aquatic environments.
These fate properties suggest that thiamethoxam has a potential to move
into surface water and shallow ground water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for thiamethoxam in drinking water.
Because the Agency does not have comprehensive monitoring data, the
Agency used screening level water exposure models in the dietary
exposure analysis and risk assessment for thiamethoxam in drinking
water. These simulation models take into account data on the physical,
chemical, and fate/transport characteristics of thiamethoxam. 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.
    A Tier I screening-level drinking water assessment was conducted
for the proposed rice seed treatment use. Because the proposed uses on
rice and cranberries (a registered use) involve flooding, for which
Pesticide Root Zone Model/Exposure/Analysis Modeling System (PRZM/
EXAMS) is not currently parameterized, these uses were assessed using
the modified Tier I Rice Model and the Provisional Cranberry Model. The
estimated drinking water concentrations (EDWCs) are based on
thiamethoxam concentrations in tail water from rice paddies and
cranberry bogs that drain into adjacent surface water bodies. Exposure
estimates were refined with a default percent cropped area factor of
87%. The Tier I Rice Model is expected to generate conservative EDWCs
that exceed peak measured concentrations of pesticides in water bodies
well downstream of rice paddies by less than one order of magnitude to
multiple orders of magnitude. Exposure in ground water due to leaching
was assessed with the Screening Concentration in Groundwater (SCI-GROW)
models.
    Based on the Tier I Rice Model and SCI-GROW models, the EDWCs of
thiamethoxam for acute exposures are 131.77 parts per billion (ppb) for
tail water and 2.93 ppb for ground water. The EDWCs for chronic
exposures for non-cancer assessments are 11.31 ppb for tail water and
2.93 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. The most conservative EDWCs in
both the acute and chronic exposure scenarios were for tail water, and
represent worst case scenarios. Therefore, for the acute dietary risk
assessments for thiamethoxam, the upper-bound EDWC value of 131.77 ppb
was used to assess the contribution to drinking water. For the chronic
dietary risk assessments for thiamethoxam, the upper-bound EDWC value
of 11.31 ppb was used to assess the contribution to drinking water.
    The registrant has conducted small-scale prospective ground water
studies in several locations in the United States to investigate the
mobility of thiamethoxam in a vulnerable hydrogeological setting. A
review of those data show that generally, residues of thiamethoxam, as
well as CGA-322704, are below the limit of quantification (0.05 ppb).
When quantifiable residues are found, they are sporadic and at low
levels. The maximum observed residue levels from any monitoring well
were 1.0 ppb for

thiamethoxam and 0.73 ppb for CGA-322704. These values are well below
the modeled estimates summarized in this unit, indicating that the
modeled estimates are, in fact, protective of what actual exposures are
likely to be.
    Clothianidin is not a significant degradate of thiamethoxam in
surface-or ground water sources of drinking water and, therefore, was
not included in the EDWCs used in the thiamethoxam dietary assessments.
For the clothianidin assessments, the acute EDWC value of 7.29 ppb for
clothianidin was incorporated into the acute dietary assessment and the
chronic EDWC value of 5.88 ppb for clothianidin was incorporated into
the chronic dietary assessment.
    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).
    Thiamethoxam is currently registered for the following uses that
could result in residential exposures: Turfgrass on golf courses,
residential lawns, commercial grounds, parks, playgrounds, athletic
fields, landscapes, interiorscapes, and sod farms; indoor crack and
crevice or spot treatments to control insects in residential settings.
EPA assessed residential exposure using the following assumptions:
    Thiamethoxam is registered for use on turfgrass (on golf courses,
residential lawns, commercial grounds, parks, playgrounds, athletic
fields, landscapes, interiorscapes and sod farms) and for indoor use to
control insects in residential settings. Thiamethoxam is applied by
commercial applicators only. Therefore, exposures resulting to
homeowners from applying thiamethoxam were not assessed. However,
entering areas previously treated with thiamethoxam could lead to
exposures for adults and children. As a result, risk assessments have
been completed for postapplication scenarios.
    Short-term exposures (1 to 30 days of continuous exposure) may
occur as a result of activities on treated turf. Short-term and
intermediate-term exposures (30 to 90 days of continuous exposure) may
occur as a result of entering indoor areas previously treated with a
thiamethoxam indoor crack and crevice product. The difference between
short- and intermediate-term aggregate risk is the frequency of hand-
to-mouth events for children. For short-term exposure there are 20
events per hour and for intermediate-term exposure there are 9.5 events
per hour. The doses and end-points for short- and intermediate-term
aggregate risk are the same.
    EPA combined all non-dietary sources of post application exposure
to obtain an estimate of potential combined exposure. These scenarios
consisted of adult and toddler dermal postapplication exposure and oral
(hand-to-mouth) exposures for toddlers. Since postapplication scenarios
for turf occur outdoors, the potential for inhalation exposure is
negligible and therefore does not require an inhalation exposure
assessment. Since thiamethoxam has a very low vapor pressure (6.6 x
10-9 @ 25[deg]C), inhalation exposure is also expected to be
negligible as a result of indoor crack and crevice use. Therefore, a
quantitative postapplication inhalation exposure assessment was not
performed.
    Thiamethoxam use on turf or as an indoor crack and crevice or spot
treatment does not result in significant residues of clothianidin. In
addition, clothianidin residential and aggregate risks are not of
concern. For further details, refer to the documents Clothianidin:
Human Health Risk Assessment for Proposed Uses on Berries (Group 13-
07H), Brassica Vegetables (Group 5), Cotton, Cucurbit Vegetables (Group
9), Fig, Fruiting Vegetables (Group 8), Leafy Green Vegetables (Group
4A), Peach, Pomegranate, Soybean, Tree Nuts (Group 14), and Tuberous
and Corm Vegetables (Group 1C); and Clothianidin: Human Health Risk
Assessment for Proposed Seed Treatment Uses on Root and Tuber
Vegetables (Group 1), Bulb Vegetables (Group 3), Leafy Green Vegetables
(Group 4A), Brassica Leafy Vegetables (Group 5), Fruiting Vegetables
(Group 8), Cucurbit Vegetables (Group 9), and Cereal Grains (Group 15,
except rice), available in the docket, EPA-HQ-OPP-2008-0814, at http://
/www.regulations.gov.
    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.''
    Thiamethoxam is a member of the neonicotinoid class of pesticides
and produces, as a metabolite, another neonicotinoid, clothianidin.
Structural similarities or common effects do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same sequence of
major biochemical events (EPA, 2002). Although clothianidin and
thiamethoxam bind selectively to insect nicotinic acetylcholine
receptors (nAChR), the specific binding site(s)/receptor(s) for
clothianidin, thiamethoxam, and the other neonicotinoids are unknown at
this time. Additionally, the commonality of the binding activity itself
is uncertain, as preliminary evidence suggests that clothianidin
operates by direct competitive inhibition, while thiamethoxam is a non-
competitive inhibitor. Furthermore, even if future research shows that
neonicotinoids share a common binding activity to a specific site on
insect nicotinic acetylcholine receptors, there is not necessarily a
relationship between this pesticidal action and a mechanism of toxicity
in mammals. Structural variations between the insect and mammalian
nAChRs produce quantitative differences in the binding affinity of the
neonicotinoids towards these receptors, which, in turn, confers the
notably greater selective toxicity of this class towards insects,
including aphids and leafhoppers, compared to mammals. While the
insecticidal action of the neonicotinoids is neurotoxic, the most
sensitive regulatory endpoint for thiamethoxam is based on unrelated
effects in mammals, including effects on the liver, kidney, testes, and
hematopoietic system. Additionally, the most sensitive toxicological
effect in mammals differs across the neonicotinoids (e.g., testicular
tubular atrophy with thiamethoxam; mineralized particles in thyroid
colloid with imidacloprid).
    Thus, EPA has not found thiamethoxam or clothianidin to share a
common mechanism of toxicity with any other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
thiamethoxam and clothianidin do 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 website 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 Food Quality
Protection Act (FQPA) safey factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional SF when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. In the developmental
studies, there is no evidence of increased quantitative or qualitative
susceptibility of rat or rabbit fetuses to in utero exposure to
thiamethoxam. The developmental NOAELs are either higher than or equal
to the maternal NOAELs. The toxicological effects in fetuses do not
appear to be any more severe than those in the dams or does. In the rat
developmental neurotoxicity study, there was no quantitative evidence
of increased susceptibility.
    There is evidence of increased quantitative susceptibility for male
pups in two 2-generation reproductive studies. In one study, there are
no toxicological effects in the dams whereas for the pups, reduced
bodyweights are observed at the highest dose level, starting on day 14
of lactation. This contributes to an overall decrease in bodyweight
gain during the entire lactation period. Additionally, reproductive
effects in males appear in the F1 generation in the form of increased
incidence and severity of testicular tubular atrophy. These data are
considered to be evidence of increased quantitative susceptibility for
male pups (increased incidence of testicular tubular atrophy at 1.8
milligrams/kilogram/day (mg/kg/day) when compared to the parents
(hyaline changes in renal tubules at 61 mg/kg/day; NOAEL is 1.8 mg/kg/
day).
    In a more recent 2-generation reproduction study, the most
sensitive effect was sperm abnormalities at 3 mg/kg/day (the NOAEL is
1.2 mg/kg/day) in the F1 males. This study also indicates increased
susceptibility for the offspring for this effect.
    Although there is evidence of increased quantitative susceptibility
for male pups in both reproductive studies, NOAELs and LOAELs were
established in these studies and the Agency selected the NOAEL for
testicular effects in F1 pups as the basis for risk assessment. The
Agency has confidence that the NOAEL selected for risk assessment is
protective of the most sensitive effect (testicular effects) for the
most sensitive subgroup (pups) observed in the toxicological database.
    3. Conclusion.In the final rule published in the Federal Register
of January 5, 2005 (70 FR 708) (FRL-7689-7), EPA had previously
determined that the FQPA SF should be retained at 10X for thiamethoxam,
based on the following factors: Effects on endocrine organs observed
across species; significant decrease in alanine amino transferase
levels in companion animal studies and in dog studies; the mode of
action of this chemical in insects (interferes with the nicotinic
acetylcholine receptors of the insect's nervous system); the transient
clinical signs of neurotoxicity in several studies across species; and
the suggestive evidence of increased quantitative susceptibility in the
rat reproduction study.
    Since that determination, EPA has received and reviewed a
developmental neurotoxicity (DNT) study in rats, and an additional
reproduction study in rats. Taking the results of these studies into
account, as well as the rest of the data on thiamethoxam, EPA has
determined that reliable data show the safety of infants and children
would be adequately protected if the FQPA SF for thiamethoxam were
reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for thiamethoxam is largely complete,
including acceptable/guideline developmental toxicity, 2-generation
reproduction, and DNT studies designed to detect adverse effects on the
developing organism, which could result from the mechanism that may
have produced the decreased alanine amino transferase levels. The
registrant must now submit, as a condition of registration, an
immunotoxicity study. This study is now required under 40 CFR part 158.
The available data for thiamethoxam show the potential for immunotoxic
effects, which are described in more detail below.
    ii. In the subchronic dog study, leukopenia (decreased white blood
cells) was observed in females only, at the highest dose tested (HDT)
of 50 mg/kg/day; the NOAEL for this effect was 34 mg/kg/day. The
overall study NOAEL was 9.3 mg/kg/day in females (8.2 mg/kg/day in
males) based on hematology and other clinical chemistry findings at the
LOAEL of 34 mg/kg/day (32 mg/kg/day in males).
    iii. In the subchronic mouse study, decreased spleen weights were
observed in females at 626 mg/kg/day; the NOAEL for this effect was the
next lowest dose of 231 mg/kg/day. The overall study NOAEL was 1.4 mg/
kg/day (males) based on increased hepatocyte hypertrophy observed at
the LOAEL of 14.3 mg/kg/day. The decreased absolute spleen weights were
considered to be treatment related, but were not statistically
significant at 626 mg/kg/day or at the HDT of 1,163 mg/kg/day. Since
spleen weights were not decreased relative to body weights, the
absolute decreases may have been related to the decreases in body
weight gain observed at higher doses.
    iv. Overall, the Agency has a low concern for the potential for
immunotoxicity related to these effects for the following reasons:
    a. In general, the Agency does not consider alterations in
hematology parameters alone to be a significant indication of potential
immunotoxicity. In the case of thiamethoxam, high-dose females in the
subchronic dog study had slight microcytic anemia as well as leukopenia
characterized by reductions in neutrophils, lymphocytes and monocytes;
the leukopenia was considered to be related to the anemic response to
exposure. Further, endpoints and doses selected for risk assessment are
protective of the observed effects on hematology.
    b. Spleen weight decreases, while considered treatment-related,
were associated with decreases in body weight gain, and were not
statistically significant. In addition, spleen weight changes occurred
only at very high doses, more than 70 times higher than the doses
selected for risk assessment. Therefore, an additional 10X safety
factor is not warranted for thiamethoxam at this time.
    v. For the reasons discussed in Unit III.D.2., there is low concern
for an increased susceptibility in the young.
    vi. Although there is evidence of neurotoxicity after acute
exposure to thiamethoxam at doses of 500 mg/kg/day including drooped
palpebral closure, decrease in rectal temperature and locomotor
activity and increase in forelimb grip strength, no evidence of
neuropathology was observed. These effects occurred at doses at least
fourteen-fold and 416-fold higher than the doses used for the acute,
and chronic risk assessments, respectively; thus, there is low concern
for these effects since it is expected that the doses used for
regulatory purposes would be protective of the effects noted at much
higher doses.
    vii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed using
tolerance-level and/or anticipated residues that are based on reliable
field trial data observed in the thiamethoxam field trials. Although
there is available information indicating that

thiamethoxam and clothianidin have different toxicological effects in
mammals and should be assessed separately, the residues of each have
been combined in these assessments to ensure that the estimated
exposures of thiamethoxam do not underestimate actual potential
thiamethoxam exposures. An assumption of 100 PCT was made for all foods
evaluated in the assessments. For the acute and chronic assessments,
the EDWCs of 131.77 ppb and 11.3 ppb, respectively, were used to
estimate exposure via drinking water. Compared to the results from
small-scale prospective ground water studies where the maximum observed
residue levels from any monitoring well were 1.0 ppb for thiamethoxam
and 0.73 ppb for CGA-322704, the modeled estimates are protective of
what actual exposures are likely to be. Similarly conservative
Residential SOPs as well as a chemical-specific turf transfer residue
(TTR) study were used to assess post-application exposure to children
and incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by thiamethoxam.
    viii. In the final rule published in the Federal Register of
February 6, 2008 (73 FR 6851) (FRL-8346-9), EPA had previously
determined that the FQPA SF for clothianidin should be retained at 10X
because EPA had required the submission of a developmental
immunotoxicity study to address the combination of evidence of
decreased absolute and adjusted organ weights of the thymus and spleen
in multiple studies in the clothianidin database, and evidence showing
that juvenile rats in the 2-generation reproduction study appear to be
more susceptible to these potential immunotoxic effects. In the absence
of a developmental immunotoxicity study, EPA concluded that there was
sufficient uncertainty regarding immunotoxic effects in the young that
the 10X FQPA factor should be retained as a database uncertainty
factor.
    Since that determination, EPA has received and reviewed an
acceptable/guideline developmental immunotoxicity study, which
demonstrated no treatment-related effects. Taking the results of this
study into account, as well as the rest of the data on clothianidin,
EPA has determined that reliable data show the safety of infants and
children would be adequately protected if the FQPA SF for clothianidin
were reduced to 1X. That decision is based on the following findings:
    a. The toxicity database for clothianidin is complete. As noted,
the prior data gap concerning developmental immunotoxicity has been
addressed by the submission of an acceptable developmental
immunotoxicity study.
    b. A rat developmental neurotoxicity study is available and shows
evidence of increased quantitative susceptibility of offspring.
However, EPA considers the degree of concern for the developmental
neurotoxicity study to be low for prenatal and postnatal toxicity
because the NOAEL and LOAEL were well characterized, and the doses and
endpoints selected for risk assessment are protective of the observed
susceptibility; therefore, there are no residual concerns regarding
effects in the young.
    c. While the rat multi-generation reproduction study showed
evidence of increased quantitative susceptibility of offspring compared
to adults, the degree of concern is low because the study NOAEL and
LOAEL have been selected for risk assessment purposes for relevant
exposure routes and durations. In addition, the potential immunotoxic
effects observed in the study have been further characterized with the
submission of a developmental immunotoxicity study that showed no
evidence of susceptibility. As a result, there are no concerns or
residual uncertainties for prenatal and postnatal toxicity after
establishing toxicity endpoints and traditional UFs to be used in the
risk assessment for clothianidin.
    d. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on assumptions that were judged to be highly conservative and health-
protective for all durations and population subgroups, including
tolerance-level residues, adjustment factors from metabolite data,
empirical processing factors, and 100 PCT for all commodities.
Additionally, EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to
clothianidin in drinking water. EPA used similarly conservative
assumptions to assess postapplication exposure of children and adults
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by clothianidin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to thiamethoxam will occupy 9.6% of the aPAD for children 1 to 2 years
old, the population group receiving the greatest exposure. Acute
dietary exposure from food and water to clothianidin is estimated to
occupy 23% of the aPAD for children 1 to 2 years old, the population
group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
thiamethoxam from food and water will utilize 42% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Chronic exposure to clothianidin from food and water will
occupy 19% of the cPAD for children 1 to 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 thiamethoxam and clothianidin 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).
    Thiamethoxam 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 thiamethoxam. The level of
concern for margins of exposure (MOEs) is 100 for aggregate short-term
exposures (i.e., MOEs less than 100 indicate potential risks of
concern).
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures aggregated result in aggregate MOEs of 370 to
500 for thiamethoxam and 380 to 2,200 for

clothianidin, for all exposure scenarios for infants, children, and
adults.
    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).
    Thiamethoxam 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 to thiamethoxam
through food and water with intermediate-term exposures for
thiamethoxam. The level of concern for MOEs is 100 for aggregate
intermediate-term exposures (i.e., MOEs less than 100 indicate
potential risks of concern).
    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 aggregated
result in aggregate MOEs of 370 to 540 for thiamethoxam, and 380 to
2,200 for clothianidin, for all exposure scenarios for infants,
children, and adults.
    5. Aggregate cancer risk for U.S. population. The Agency has
classified thiamethoxam as not likely to be a human carcinogen based on
convincing evidence that a non-genotoxic mode of action for liver
tumors was established in the mouse and that the carcinogenic effects
are a result of a mode of action dependent on sufficient amounts of a
hepatotoxic metabolite produced persistently. Thiamethoxam is not
expected to pose a cancer risk. Clothianidin has been classified as
``not likely to be a human carcinogen.'' It is not expected to pose a
cancer risk.
    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 thiamethoxam or clothianidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid
chromatography/ultraviolet (HPLC/UV) or mass spectrometry (MS)) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no CODEX or Mexican maximum residue limits (MRLs) for
thiamethoxam. A number of Canadian MRLs exist for this chemical and are
in accord with U.S. tolerances. The new/revised tolerances established
by this rule have been derived using the NAFTA Tolerance Harmonization
Spreadsheet.

C. Revisions to Petitioned-For Tolerances

    Available field trial data support tolerances for combined residues
of thiamethoxam and CGA-322704 in or on avocado, black sapote,
canistel, mamey sapote, mango, papaya, sapodilla, and star apple at
0.40 ppm. Therefore, the proposed tolerances of 0.20 ppm for each of
these commodities are being raised to 0.40 ppm.
    Available field trial data support tolerances for combined residues
of thiamethoxam and CGA-322704 in or on vegetable, root, subgroup 1A at
0.05 ppm. Therefore, the proposed tolerance of 0.04 ppm for this
subgroup is being raised to 0.05 ppm. In addition, because a group
tolerance for vegetable, root, subgroup 1A is being established, the
group tolerance for vegetable, root, except sugar beet, subgroup 1B is
no longer needed, and is therefore being removed.
    Based on the data submitted for rice bran and polished rice,
residues were shown not to concentrate in these processed commodities.
Therefore, EPA has determined that tolerances are not needed for these
commodities. Rice straw and rice hulls are no longer considered
significant animal feed items; therefore, the Agency is no longer
setting tolerances for these commodities.
    New crop group tolerances are being established for caneberry
subgroup 13-07A; bushberry subgroup 13-07B, except lingonberry and
blueberry, lowbush; fruit, small, vine climbing, subgroup 13-07F,
except fuzzy kiwifruit; and berry, low growing, subgroup 13-07G, except
cranberry. Therefore, the tolerances for caneberry subgroup 13A;
bushberry subgroup 13-07B; grape; Juneberry; lingonberry; salal; and
strawberry are no longer needed, and are being removed.
    Previously reviewed data support tolerances for combined residues
of thiamethoxam and CGA-322704 in or on cattle, goat, horse, and sheep
meat byproducts at 0.04 ppm. Therefore, the existing tolerances of 0.02
ppm for each of these commodities are being raised to 0.04 ppm.

V. Conclusion

    Therefore, tolerances are established for combined residues of
thiamethoxam (3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine) and its metabolite CGA-322704 [N-(2-
chloro-thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine], calculated as
the stoichiometric equivalent of thiamethoxam, in or on: avocado at
0.40 ppm; berry, low growing, subgroup 13-07G, except cranberry at 0.30
ppm; bushberry subgroup 13-07B, except lingonberry and blueberry,
lowbush at 0.20 ppm; caneberry subgroup 13-07A at 0.35 ppm; canistel at
0.40 ppm; fruit, small, vine climbing, subgroup 13-07F, except fuzzy
kiwifruit at 0.20 ppm; mango at 0.40 ppm; papaya at 0.40 ppm; sapodilla
at 0.40 ppm; sapote, black at 0.40 ppm; sapote, mamey at 0.40 ppm; star
apple at 0.40 ppm; vegetable, root, subgroup 1A at 0.05 ppm; rice,
grain at 0.02 ppm.
    In addition, revised tolerances are established in or on cattle,
meat byproducts at 0.04 ppm; goat, meat byproducts at 0.04 ppm; horse,
meat byproducts at 0.04 ppm; sheep, meat byproducts at 0.04 ppm.
    Tolerances are revoked and removed for bushberry subgroup 13B;
caneberry subgroup 13A; grape; Juneberry; lingonberry; salal;
strawberry; and vegetable, root, except sugarbeet, subgroup 1B. These
tolerances are no longer needed, since residues on these commodities
will be covered by the new crop group tolerances being established.

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) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 22, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.565 is amended by:
    a. Revising the introductory text in paragraph (a).
    b. Removing the entries for bushberry subgroup 13B; caneberry
subgroup 13A; grape; Juneberry; lingonberry; salal; strawberry; and
vegetable, root, except sugar beet, subgroup 1B from the table in
paragraph (a).
    c. Revising the existing entries for cattle, meat byproducts; goat,
meat byproducts; horse, meat byproducts; and sheep, meat byproducts in
the table in paragraph (a).
    d. By alphabetically adding entries for avocado; berry, low
growing, subgroup 13-07G, except cranberry; bushberry subgroup 13-07B,
except lingonberry and blueberry, lowbush; caneberry subgroup 13-07A;
canistel; fruit, small, vine climbing, subgroup 13-07F, except fuzzy
kiwifruit; mango; papaya; rice, grain; sapodilla; sapote, black;
sapote, mamey; star apple; vegetable, root, subgroup 1A; to the table
in paragraph (a) to read as follows:

Sec.  180.565  Thiamethoxam; tolerances for residues.

    (a) Tolerances are established for residues of the insecticide
thiamethoxam, including its metabolites and degradates, in or on the
following commodities. Compliance with the tolerance levels specified
below is to be determined by measuring only thiamethoxam (3-[(2-chloro-
5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-oxadiazin-4-
imine) and its metabolite CGA-322704 [N-(2-chloro-thiazol-5-ylmethyl)-
N'-methyl-N'-nitro-guanidine], calculated as the stoichiometric
equivalent of thiamethoxam, in or on the following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Avocado..............................................               0.40
                                * * * * *
Berry, low growing, subgroup 13-07G, except cranberry               0.30
                                * * * * *
Bushberry subgroup 13-07B, except lingonberry and                   0.20
 blueberry, lowbush..................................
Caneberry subgroup 13-07A............................               0.35
Canistel.............................................               0.40
                                * * * * *
Cattle, meat byproducts..............................               0.04
                                * * * * *
Fruit, small, vine climbing, subgroup 13-07F, except                0.20
 fuzzy kiwifruit.....................................
                                * * * * *
Goat, meat byproducts................................               0.04
                                * * * * *
Horse, meat byproducts...............................               0.04
                                * * * * *
Mango................................................               0.40
                                * * * * *
Papaya...............................................               0.40
                                * * * * *
Rice, grain..........................................               0.02
                                * * * * *
Sapodilla............................................               0.40
                                * * * * *
Sapote, black........................................               0.40
Sapote, mamey........................................               0.40
Sheep, meat byproducts...............................               0.04
                                * * * * *
Star apple...........................................               0.40
                                * * * * *
Vegetable, root, subgroup 1A.........................               0.05
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E9-23628 Filed 9-29-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Rules and Regulations]
[Pages 95857-95860]
[FR Doc No: 2016-30279]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-6898; Directorate Identifier 2016-NM-010-AD;
Amendment 39-18752; AD 2016-25-26]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model MD-90-30 airplanes. This AD was prompted by
reports of stick shaker activation at airspeeds that were above the
stall protection system's stick shaker schedule. This AD requires
installing angle-of-attack (AOA) sensor external case heaters on the
existing AOA sensors, installing additional wires, and doing a
functional test and applicable corrective actions. We are issuing this
AD to address the unsafe condition on these products.

DATES: This AD is effective February 2, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 2,
2017.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this 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>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6898.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6898; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Eric Igama, Aerospace Engineer,
Systems and Equipment Branch, ANM-130L, FAA, Los Angeles Aircraft
Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA
90712-4137; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all The Boeing Company
Model MD-90-30 airplanes. The NPRM published in the Federal Register on
June 13, 2016 (81 FR 38113) (``the NPRM''). The NPRM was prompted by
reports of stick shaker activation at airspeeds that were above the
stall protection system's stick shaker schedule. The NPRM proposed to
require installing AOA sensor external case heaters on the existing AOA
sensors, installing additional wires, and doing a functional test and
applicable corrective actions. We are issuing this AD to prevent ice
formation between the AOA sensor vane and face plate, which could cause
both vanes to become immobilized. If both vanes become immobilized, the
stall protection system could become unreliable or non-functional,
which could result in loss of control of the airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM and
the FAA's response to each comment.

Support of the NPRM

    The Air Line Pilots Association, International provided comments
that supported the intent of the NPRM.

Request To Change Boeing Address Identified in the NPRM

    Boeing asked that we change its mailing address for obtaining
copies of service information as specified in the NPRM to the
following: Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. Boeing stated that this address is valid for
this and all future ADs affecting Boeing airplanes.
    We agree with the commenter's request. We have updated the contact
information accordingly. However, we have corrected the telephone
number; it should be<PHONE_NUMBER>. We have changed this AD to include
this new mailing address for Boeing service information.

Request To Clarify Certain Language in the NPRM

    Boeing asked that we clarify the language specifying what prompted
the AD action, and the description of the unsafe condition, as
specified in the SUMMARY section. Boeing stated that the reported
incident occurred ``on Model 717-200 airplanes'' and included further
description of what prompted the AD action. Boeing also stated that
including this description clarifies the airplane model on which the
safety issue was identified. Boeing also asked that we revise the
description of the unsafe condition, which stated that ``the vane''
could become immobilized. Boeing noted that the safety issue is a
common cause failure (both vanes could become immobilized) due to an
external threat (i.e., weather).
    We agree to add ``both vanes'' to the Discussion section and
paragraph (e) of this AD for clarification. Information concerning the
origin of the safety issue on Model 717-200 airplanes was included in
the Discussion section of the NPRM. Since the information in the
Discussion section of the NPRM does not reappear in the final rule, we
have not changed this AD in this regard. In addition, we do not agree
that the requested changes are necessary in the SUMMARY section, which
merely provides a high-level description of the relevant information.
Details concerning the unsafe condition that appeared in the SUMMARY
section of the NPRM have been removed from this final rule in response
to new guidance from the Office of the Federal Register.
    Boeing also asked that we clarify the AD requirements by specifying
``installing additional wires'' in lieu of ``changing wires'' and
installing AOA sensor external case heaters ``on the AOA sensors'' in
lieu of ``and AOA sensors.'' Delta Air Lines (Delta) asked that we
change ``and AOA sensors'' to

``and existing AOA sensors'' since they are not new sensors.
    We agree to make the requested changes in the SUMMARY section, the
Discussion and the Related Service Information under 1 CFR part 51
sections of this final rule, and in paragraph (g) of this AD for
clarification.
    Delta asked that we remove the references to ``water intrusion''
from the NPRM related to the description of the unsafe condition. Delta
stated that the referenced service information does not address water
intrusion. Delta added that the installation of the external case
heater only prevents the existing water from freezing and rendering the
vane immobilized. UTC Aerospace Systems (UTC) also asked that we remove
the reference to moisture (water) intrusion since the referenced
service information does nothing to reduce or eliminate the problem; it
simply keeps the water from freezing. UTC also asked that we add to the
description of the unsafe condition that the AD is intended to reduce
or eliminate ice formation between the AOA sensor vane and face plate.
    We partially agree with the commenters' requests. Water intrusion
is addressed in the referenced service information since it contributes
to ice formation between the AOA sensor vane and face plate. However,
water intrusion is not corrected by this AD. Therefore, we have revised
the Discussion section and paragraph (e) of this AD to state ``We are
issuing this AD to prevent ice formation between the angle-of-attack
(AOA) sensor vane and face plate.''

Request To Clarify Corrective Actions

    UTC asked that we re-identify the corrective actions in the SUMMARY
and Discussion sections of the NPRM as removing and replacing the
existing AOA unit having part number (P/N) 0861EW1 with a certified
AOA, or installing a new AOA in accordance with the instructions
specified in Boeing Alert Service Bulletin MD90-30A029, dated November
25, 2015. UTC stated that this would clarify the potential cause of the
problem as related to the subject AOA and provide another choice for
operators to comply with the proposed AD. UTC added that this would
also define the AOA replacement as not including the existing AOA unit
having P/N 0861EW1.
    We agree that clarification is necessary; however, we do not agree
that this clarification should be included in the SUMMARY section and
the Discussion section of this final rule. The purpose of the language
in the SUMMARY section is to provide a high-level description of the
relevant information, and the information in the Discussion section of
the NPRM does not reappear in the final rule. Therefore, we have
revised the description of the required actions in the Related Service
Information under 1 CFR part 51 section of this final rule, as
specified by the commenter, to provide clarification to operators. We
have also included the correct part number for the existing AOA unit in
paragraph (g) of this AD.

Request To Update Referenced Service Information To Include the Correct
Part Number

    UTC asked that Boeing Alert Service Bulletin MD90-30A029, dated
November 25, 2015, be updated to correct the part number for the AOA
sensor identified therein. UTC stated that the service information
identifies replacing any AOA sensor having P/N ``081EW1,'' but the
correct part number is ``0861EW1.''
    We acknowledge the commenter's concern; however, Boeing Alert
Service Bulletin MD90-30A029, dated November 25, 2015, has not yet been
revised by the airplane manufacturer. We have confirmed that this part
number does not exist, and have clarified the correct part number for
the existing AOA sensor in paragraph (g) of this AD.

Request To Change the Costs of Compliance Section

    Boeing asked that we change the Costs of Compliance section of the
NPRM to include the parts cost for the external case heaters, as
provided by the supplier. Boeing stated that the supplier of these
heaters has received FAA parts manufacturer approval (PMA), which
allows operators to go directly to the supplier to procure the parts.
Boeing noted that the parts cost for two heaters is $2,389 each, for a
total of $4,778 (operators are required to purchase two external case
heaters for installation).
    We agree with the commenter's request for the reason provided. We
have changed the Costs of Compliance section in this final rule
accordingly.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin MD90-30A029, dated
November 25, 2015. The service information describes procedures for
installing AOA sensor external case heaters on the existing AOA
sensors, installing additional wires, and doing a functional test and
applicable corrective actions. The applicable corrective actions
include removing and replacing the existing AOA unit (P/N 0861EW1) with
a certified AOA, or installing a new AOA. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 95 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                   Labor cost          Parts cost       Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Installation of AOA sensor        Up to 44 work-      Up to $5,998        Up to $9,738        Up to $925,110
 external case heaters on the      hours (depending    (depending on the   (depending on the   (depending on the
 AOA sensors, installation of      on the group        group number).      group number).      group number).
 additional wires, and a           number) x $85 per
 functional test.                  hour = $3,740.
----------------------------------------------------------------------------------------------------------------

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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2016-25-26 The Boeing Company: Amendment 39-18752; Docket No. FAA-
2016-6898; Directorate Identifier 2016-NM-010-AD.

(a) Effective Date

    This AD is effective February 2, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model MD-90-30
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Unsafe Condition

    This AD was prompted by reports of stick shaker activation at
airspeeds that were above the stall protection system's stick shaker
schedule. We are issuing this AD to prevent ice formation between
the angle-of-attack (AOA) sensor vane and face plate, which could
cause both vanes to become immobilized. If both vanes become
immobilized, the stall protection system could become unreliable or
non-functional, which could result in loss of control of the
airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Installation of AOA Sensor External Case Heater

    Within 6 years after the effective date of this AD, install AOA
sensor external case heaters on the existing AOA sensors, install
additional wires, and do a functional test and applicable corrective
actions, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin MD90-30A029, dated November 25, 2015.
All applicable corrective actions must be done before further
flight. The correct part number for the existing AOA sensor is P/N
0861EW1.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), 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 manager of the ACO, send it to the
attention of the person identified in paragraph (i) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Los Angeles ACO, to
make those findings. For a repair method to be approved, the repair
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs
(h)(4)(i) and (h)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(i) Related Information

    For more information about this AD, contact Eric Igama,
Aerospace Engineer, Systems and Equipment Branch, ANM-130L, FAA, Los
Angeles ACO, 3960 Paramount Boulevard, Lakewood, CA 90712-4137;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin MD90-30A029, dated November
25, 2015.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this 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
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on December 7, 2016.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-30279 Filed 12-28-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Rules and Regulations]
[Pages 52190-52192]
[FR Doc No: 2014-20213]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0978; Directorate Identifier 2013-NM-120-AD;
Amendment 39-17958; AD 2014-17-05]
RIN 2120-AA64

Airworthiness Directives; the Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 767-400ER series airplanes. This AD was
prompted by reports of turbine wheel bursts in the air driven pump
(ADP) turbine gearbox assembly (TGA), which resulted in the release of
high energy fragments. This AD requires replacing the existing ADP TGA
with an improved ADP TGA. We are issuing this AD to prevent fragments
from an uncontained turbine wheel burst penetrating the fuselage and
striking passengers, or penetrating the wing-to-body fairing and
striking ground handling or maintenance personnel, causing serious
injury.

DATES: This AD is effective October 8, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 8,
2014.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management, P.
O. Box 3707, MC2H-65, Seattle, WA 98124-2207; telephone<PHONE_NUMBER>,
extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
You may review this 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 425-
227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for

and locating Docket No. FAA-2013-0978; or in person at the Docket
Management Facility between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this AD, the regulatory
evaluation, any comments received, and other information. The address
for the Docket Office (phone:<PHONE_NUMBER>) is Docket Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kenneth Frey, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain The Boeing Company
Model 767-400ER series airplanes. The NPRM published in the Federal
Register on December 6, 2013 (78 FR 73460). The NPRM was prompted by
reports of turbine wheel bursts in the ADP TGA, which resulted in the
release of high energy fragments. The NPRM proposed to require
replacing the existing ADP TGA with an improved ADP TGA. We are issuing
this AD to prevent fragments from an uncontained turbine wheel burst
penetrating the fuselage and striking passengers, or penetrating the
wing-to-body fairing and striking ground handling or maintenance
personnel, causing serious injury.

Revised Service Information

    In Note 1 to paragraph (g) of the NPRM (78 FR 73460, December 6,
2013), we referred to Fairchild Controls Service Bulletin N012000000-
29-03, Revision 2, dated January 29, 2013, as a source of guidance
information for modifying an existing ADP TGA. Since the NPRM was
published, Fairchild Controls has published Fairchild Controls Service
Bulletin N012000000-29-03, Revision 3, dated March 7, 2014. We have
revised Note 1 to paragraph (g) of this final rule to refer to
Fairchild Controls Service Bulletin N012000000-29-03, Revision 3, dated
March 7, 2014.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comment received on the proposal
(78 FR 73460, December 6, 2013) and the FAA's response to the comment.

Request to Clarify Compliance Time

    Boeing commented that the compliance time in paragraph (i) of the
proposed NPRM (78 FR 73460, December 6, 2013) was confusing and
requested clarification. Boeing stated that the compliance time in
Boeing Special Attention Service Bulletin 767-29-0113, dated May 29,
2013, is 36 months after the release date of that service bulletin,
which was May 29, 2013. Boeing asked if the NPRM's compliance time was
also 36 months after that service bulletin's release date, or if it was
36 months after the effective date of the final rule. Boeing suggested
that paragraph (i) of the proposed NPRM be revised to state ``36 months
after the effective date of the AD.''
    We agree to clarify the compliance time. Paragraph (i) of this AD
explains that where Boeing Special Attention Service Bulletin 767-29-
0113, dated May 29, 2013, specifies a compliance time ``after the
original issue date of this service bulletin,'' this AD requires
compliance within the specified compliance time ``after the effective
date of this AD. Boeing Special Attention Service Bulletin 767-29-0113,
dated May 29, 2013, specifies a compliance time of ``within 36 months
after the original issue date of this service bulletin.'' Therefore,
the compliance time for accomplishing the replacement required by this
AD is within 36 months after the effective date of this AD. No change
was made to this final rule regarding this issue.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting
this AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (78 FR 73460, December 6, 2013) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 73460, December 6, 2013).

Costs of Compliance

    We estimate that this AD affects 37 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators.
----------------------------------------------------------------------------------------------------------------
Replacement.........................  7 work-hours x $85 per         $114,705         $115,300       $4,266,100
                                       hour = $595.
----------------------------------------------------------------------------------------------------------------

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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:

    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2014-17-05 The Boeing Company: Amendment 39-17958; Docket No. FAA-
2013-0978; Directorate Identifier 2013-NM-120-AD.

(a) Effective Date

    This AD is effective October 8, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 767-400ER series
airplanes, certificated in any category, as identified in Boeing
Special Attention Service Bulletin 767-29-0113, dated May 29, 2013.

(d) Subject

    Air Transport Association (ATA) of America Code 29, Hydraulic
Power.

(e) Unsafe Condition

    This AD was prompted by reports of turbine wheel bursts in the
air driven pump (ADP) turbine gearbox assembly (TGA), which resulted
in the release of high energy fragments. We are issuing this AD to
prevent fragments from an uncontained turbine wheel burst
penetrating the fuselage and striking passengers, or penetrating the
wing-to-body fairing and striking ground handling or maintenance
personnel, causing serious injury.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Replacement of Turbine Gearbox Assembly

    Except as required by paragraph (i) of this AD: At the time
specified in paragraph 1.E., ``Compliance,'' of Boeing Special
Attention Service Bulletin 767-29-0113, dated May 29, 2013, replace
the existing ADP TGA having part number N012000000 or N012000000-1
with an improved ADP TGA having part number N012000000-2 or
N012000000-3, in accordance with the Accomplishment Instructions of
Boeing Special Attention Service Bulletin 767-29-0113, dated May 29,
2013.

    Note 1 to paragraph (g) of this AD:  Guidance on modifying an
existing ADP TGA so it can be re-identified as part number
N012000000-2 or N012000000-3 can be found in Fairchild Controls
Service Bulletin N012000000-29-03, Revision 3, dated March 7, 2014.

(h) Parts Installation Prohibition

    As of the effective date of this AD, no person may install an
ADP TGA having part number N012000000 or N012000000-1 on any
airplane.

(i) Exception to Service Information Specifications

    Where Boeing Special Attention Service Bulletin 767-29-0113,
dated May 29, 2013, specifies a compliance time ``after the original
issue date of this service bulletin,'' this AD requires compliance
within the specified compliance time ``after the effective date of
this AD.''

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
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 manager of the ACO, send it to the
attention of the person identified in paragraph (k) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane.

(k) Related Information

    For more information about this AD, contact Kenneth Frey,
Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA,
Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton,
WA 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Special Attention Service Bulletin 767-29-0113, dated
May 29, 2013.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington on August 15, 2014.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-20213 Filed 9-2-14; 8:45 am]
BILLING CODE 4910-13-P