[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Rules and Regulations]
[Page 24428-24434]
[DOCID:fr05my10-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0139; FRL-8820-4]

Spirodiclofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
spirodiclofen per se (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-
3-en-4-yl 2,2-dimethylbutanoate) in or on multiple commodities which
are identified and discussed later in this document. Bayer CropScience
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective May 5, 2010. Objections and
requests for hearings must be received on or before July 6, 2010, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0139. 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: Rita Kumar, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200

Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 308-8291; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR 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-2009-0139 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 6, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket 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-2009-0139, 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 Register of June 10, 2009 (74 FR 27538) (FRL-8915-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8F7500) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Dr.,
Research Triangle Park, N.C. 27709. The petition requested that 40 CFR
180.608 be amended by establishing tolerances for residues of the
insecticide spirodiclofen,(3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate), in or on avocado,
black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and
star apple at 1.3 parts per million (ppm). That notice referenced a
summary of the petition prepared by Bayer CropScience, the registrant,
which is available in the docket, http://www.regulations.gov. There
were no comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the proposed tolerances to 1.0 ppm; and changed the tolerance
expression to spirodiclofen per se (3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate). The reason for these
changes are explained in Unit IV.D.

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 spirodiclofen including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with spirodiclofen
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.
    Spirodiclofen has a low acute toxicity via the oral, dermal, and
inhalation routes. It is not an eye or dermal irritant. However, it is
a potential skin sensitizer. Following oral administration,
spirodiclofen is rapidly absorbed, metabolized, and excreted via urine
and feces. A rat whole body autoradiography study showed no
accumulation in any specific organs or tissues following oral
administration. Evidence of developmental toxicity was not observed in
the rabbit developmental toxicity study. The rat

developmental toxicity study resulted in an increased incidence of
slight dilatation of the renal pelvis 1,000 milligrams/kilograms/day
(mg/kg/day); highest dose tested (HDT) at a dose which did not cause
maternal toxicity. In the 2-generation reproductive toxicity study,
developmental effects were observed in F1 males (i.e., delayed sexual
maturation, decreased testicular spermatid and epididymal sperm counts
(oligospermia); and atrophy of the testes, epididymides, prostate, and
seminal vesicles) and F1 females (i.e., increased severity of ovarian
luteal cell vacuolation/degeneration) but at a higher dose (1,750 ppm)
than the systemic effects seen for parents and offspring (350 ppm).
Spirodiclofen did not show any evidence of neurotoxicity in the acute
and subchronic neurotoxicity studies. In a developmental neurotoxicity
study (DNT), a decrease in retention was observed in the memory phase
of the water maze for postnatal day (PND) 60 females at all doses. In
this DNT study, the morphometric measurements were not performed at the
low- and mid-doses; therefore, the registrant conducted a new study
using identical experimental conditions as the previous study. The
results of the new study demonstrated no treatment related maternal or
offspring toxicity at the HDT. Therefore, it can be concluded that
spirodiclofen is unlikely to be a neurotoxic or developmentally
neurotoxic compound.
    Spirodiclofen has been shown to have adverse effects on several
organs of the endocrine system at relatively low doses. Testicular
effects were observed in dogs, rats, and mice, manifested as Leydig
cell vacuolation in dogs, hypertrophy in dogs and mice, and hyperplasia
progressing to adenomas in rats, following chronic exposure. In female
rats, increased incidence of uterine nodules and uterine adenocarcinoma
were observed at terminal sacrifice in the chronic toxicity study.
Cytoplasmic vacuolation in the adrenal cortex, accompanied by increased
adrenal weight, was consistently observed in rats, dogs, and mice of
both sexes.
    Chronic toxicity and carcinogenicity studies showed increased
incidence of uterine adenocarcinoma in female rats, Leydig cell adenoma
in male rats, and liver tumors in mice. EPA classified spirodiclofen as
``likely to be carcinogenic to humans'' by the oral route based on
evidence of testes Leydig cell adenomas in male rats, uterine adenomas
and/or adenocarcinoma in female rats, and liver tumors in mice.
Mutagenicity studies conducted with the technical spirodiclofen
formulation and its major metabolites did not demonstrate any mutagenic
potential. EPA has determined that quantification of human cancer risk
using a linear low-dose extrapolation approach is appropriate.
     Specific information on the studies received and the nature of the
adverse effects caused by spirodiclofen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document ``Human Health Risk Assessment
Associated with the Section 3 Registration Application for Avocado,
Black Sapote, Canistel, Mamey Sapote, Mango, Papaya, Sapodilla, and
Star Apple,'' p.10 in docket ID number EPA-HQ-OPP-2009-0139.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level - generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for spirodiclofen used for
human risk assessment can be found at http://www.regulations.gov in
document ``Human Health Risk Assessment Associated with the Section 3
Registration Application for Avocado, Black Sapote, Canistel, Mamey
Sapote, Mango, Papaya, Sapodilla, and Star Apple,'' p. 12 in docket ID
number EPA-HQ-OPP-2009-0139.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spirodiclofen, EPA considered exposure under the
petitioned-for tolerances as well as all existing spirodiclofen
tolerances in 40 CFR 180.608. EPA assessed dietary exposures from
spirodiclofen in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
spirodiclofen; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Continuing Survey of Food Intake (CSFII). As to residue levels
in food, EPA assumed the following:
    a. Average field trial residues;
    b. Experimentally determined processing factors for apple and grape
processed commodities and for citrus oil, peeled citrus, and citrus
peel (DEEM (ver 7.81) defaults assumed for the remaining processed
commodities); and
    c. Maximum reasonably balanced livestock diets.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or non-linear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or non-linear approach is used and a cancer RfD is
calculated based on an earlier non-cancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has classified spirodiclofen as ``Likely to be Carcinogenic
to Humans'' and used a linear approach to quantify cancer risk.
Exposure for evaluating cancer risk was assessed using the same
estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and percent crop treated (PCT) information.
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 FFDCA section 408(f)(1) 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 FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances. Average
field trial residues were assumed for chronic and cancer analysis.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition A: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition B: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition C: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows: Hop
(92%), pome fruit (15%), stone fruit (10%), grape (7%), and citrus
(14%).
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition A, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions B and C, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which spirodiclofen may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spirodiclofen in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of spirodiclofen. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the PRZM/EXAMS and Screening Concentration in Ground Water
(SCI-GROW) models, the estimated drinking water concentrations (EDWCs)
of spirodiclofen for chronic exposures for non-cancer assessments are
estimated to be 4.99 ppb for surface water and 0.44 ppb for ground
water. The EDWCs of spirodiclofen for chronic exposures for cancer
assessments are estimated to be 1.67 ppb for surface water and 0.44 ppb
for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
    For chronic dietary risk assessment, the water concentration of
value 4.99 ppb was used to assess the contribution to drinking water.
    For cancer dietary risk assessment, the water concentration of
value 1.67 ppb was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Spirodiclofen is not registered for any specific use patterns that
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
     EPA has not found spirodiclofen to share a common mechanism of
toxicity with any other substances, and spirodiclofen does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
spirodiclofen does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's 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 FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The spirodiclofen toxicity
database is adequate to evaluate the potential increased susceptibility
of infants and children. In 2004, the Agency determined that there is
no evidence (qualitative or quantitative) of increased

susceptibility in the rabbit developmental toxicity study or in the rat
reproduction toxicity study following in utero and/or pre-/post-natal
exposure of spirodiclofen. However, evidence for quantitative
susceptibility was observed in a rat developmental toxicity study where
an increased incidence of slight dilatation of the renal pelvis was
observed at a dose (1,000 mg/kg/day; the limit dose) which did not
cause any maternal toxicity. Two rat developmental neurotoxicity (DNT)
studies were submitted to EPA following the assessment in 2004. The
first study demonstrated increased susceptibility in the offspring
based on the observed decreased retention in the memory phase of the
water maze for postnatal day 60 females at all doses (LOAEL 6.5 mg/kg/
day) and changes in brain morphometric parameters at the HDT (135.9 mg/
kg/day; caudate putamen, parietal cortex, hippocampal gyrus, and
dentate gyrus); there was no maternal toxicity at doses up to and
including 135.9 mg/kg/day HDT. EPA requested information concerning the
brain morphometric parameters in the low and mid doses with the
petitioner indicating that the brain tissues were not appropriately
preserved and analysis was therefore not possible. As a result, a
second rat DNT study was submitted which also indicated increased
susceptibility in offspring based on decreased pre-weaning body weight
and body weight gain in males and females and decreased post-weaning
body weights in males (LOAEL = 119.2 mg/kg/day; NOAEL = 28.6 mg/kg/
day). Neurotoxicity was not observed in offspring in the second DNT
study, and there was no maternal toxicity observed at doses up to and
including 119.2 mg/kg/day.
    EPA determined that the degree of concern is low for the
quantitative susceptibility seen in the developmental toxicity study in
rats. The increased incidence of slight renal pelvic dilation was
observed at the limit-dose only without statistical significance and
dose response. Renal pelvic dilation was considered to be a
developmental delay and not a severe effect for developmental toxicity.
The low background incidences in this study may be idiosyncratic to the
strain of rats tested (Wistar), since renal pelvis dilations are
commonly seen at higher incidences in other strains (Sprague-Dawley or
Fisher) of rats. In addition, doses selected for risk assessment of
spirodiclofen are much lower than the dose that caused these
developmental delays. The two DNT studies suggest increased
susceptibility of offspring due to exposure to spirodiclofen. However,
there is no concern for the increased susceptibility seen in the first
DNT study because the results were not reproduced in the second DNT
study conducted using the identical doses and experimental conditions.
The concern for increased susceptibility in the second DNT study is low
because there is a well established NOAEL, marginal toxicity (slight
changes in body weights), and all developmental/functional parameters
were comparable to controls. In addition, doses selected for risk
assessment of spirodiclofen are much lower than the dose that caused
these marginal changes in the body weights of offspring in the second
DNT study. There was no evidence of increased susceptibility in the
developmental toxicity study in rabbits or the 2-generation
reproduction study in rats.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for spirodiclofen is complete except for
an immunotoxicity study which is required as a part of new data
requirements in the 40 CFR part 158. However, the Agency does not
believe that conducting a functional immunotoxicity study will result
in a lower POD than that currently used for overall risk assessment.
The toxicology database for spirodiclofen does not show any evidence of
treatment-related effects on the immune system. The overall weight of
evidence suggests that this chemical does not target the immune system.
Therefore, a database uncertainty factor (UFDB) is not needed to
account for the lack of this study.
    ii. Based on the results of acute, subchronic and developmental
neurotoxicity studies in rats (see Units III.A. and III.D.2.), EPA has
concluded that there is no indication that spirodiclofen is a
neurotoxic chemical.
    iii. There is no evidence (qualitative or quantitative) of
increased susceptibility in the rabbit developmental toxicity study or
in the rat reproduction toxicity study following in utero and/or pre-/
post-natal exposure of spirodiclofen. However, evidence for
quantitative susceptibility was observed in a rat developmental
toxicity study and the second DNT study. See Unit III.D.2. for a
detailed discussion of why EPA determined that the degree of concern is
low for the quantitative susceptibility seen in this studies.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed using
reliable PCT information and anticipated residue values calculated from
residue field trial results. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to spirodiclofen in drinking water. Residential exposures are
not expected. These assessments will not underestimate the exposure and
risks posed by spirodiclofen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
spirodiclofen is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
spirodiclofen from food and water will utilize 3.3% of the cPAD for all
infants < 1 year old the population group receiving the greatest
exposure. There are no residential uses for spirodiclofen.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure take into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Spirodiclofen is not registered for any uses that would result in
residential exposure. Therefore the short-term/intermediate-term
aggregate risk is the sum of the risk from exposure to spirodiclofen
through food and water and will not be greater than the chronic
aggregate risk.
    4. Aggregate cancer risk for U.S. population. Using the exposure
assumptions described in Unit III.C.1.iii. for cancer, EPA has
concluded that exposure to spirodiclofen to cancer from

food and water will result in a life-time cancer risk of 3 x
10-6. EPA generally considers cancer risks in the range of
10-6 or less to be negligible. The precision which can be
assumed for cancer risk estimates is best described by rounding to the
nearest integral order of magnitude on the log scale; for example,
risks falling between 3 x 10-7 and 3 x 10-6 are
expressed as risks in the range of 10-6. Considering the
precision with which cancer hazard can be estimated, the
conservativeness of low-dose linear extrapolation, and the rounding
procedure described above in this Unit, cancer risk should generally
not be assumed to exceed the benchmark level of concern of the range of
10-6 until the calculated risk exceeds approximately 3 x
10-6. This is particularly the case where some conservatism
is maintained in the exposure assessment. For the reasons explained
below in this Unit, EPA concludes that there are significant
conservatisms in the spirodiclofen exposure assessment. First, residue
values are based on average field trial levels and not monitoring data.
Monitoring data tends to be significantly lower than field trial data
and the spirodiclofen monitoring data confirms this (all less than the
limit of detection (LOD); LOD = 0.001-0.05 ppm; 2.5-23x lower than the
residue used in the cancer assessment). Second, based on a critical
commodity analysis conducted in DEEM-FCID, the major contributors to
the cancer risk were hops (40% of the total exposure), water (19% of
the total exposure), and orange juice (16% of the total exposure) and
conservative residue estimates were used for these three commodities as
follows:
    i. Hops. Dietary exposure from hops is the result of beer
consumption. DEEM-FCID assumes that 100% of the residue in hops are
transferred to beer during the brewing process (no residue remain in/on
the spent hops). Since spirodiclofen has low water solubility, this is
a conservative assumption;
    ii. Drinking water. The water residue estimate assumed 87% of the
basin is cropped with 100% of the crops treated. Spirodiclofen is
proposed/registered for application to orchard crops (pome fruit,
citrus fruit, stone fruit, tree nuts, grape, and tropical fruits) which
are unlikely to occupy 87% of a water basin. In addition, it is
unlikely that spirodiclofen will capture the entire market within a
water basin.
    iii. Orange juice. Pending the submission of a new orange
processing study, default grapefruit (2.1x), lemon (2.0x), lime (2.0x),
orange (1.8x), and tangerine (2.3x) juice processing factors were
assumed. In all likelihood this exaggerates exposure estimates given
that grape and apple processing studies with spirodiclofen resulted in
a reduction in residues in juice.
    5. 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 spirodiclofen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a liquid chromatography (LC)/mass
spectrometry (MS)/(MS) method) 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, Canadian, or Mexican maximum residue limits
(MRLs) in/on these crops.

C. Response to Comments

    There were no comments received in response to the notice of filing
of the pesticide petition 8F7500.

D. Revisions to Petitioned-For Tolerances

    EPA has revised the proposed tolerance levels and tolerance
expression of spirodiclofen in/on the following commodities: Avocado
from 1.3 ppm to 1.0 ppm; black sapote from 1.3 ppm to 1.0 ppm; canistel
from 1.3 ppm to 1.0 ppm; mamey sapote from 1.3 ppm to 1.0 ppm; mango
from 1.3 ppm to 1.0 ppm; papaya from 1.3 ppm to 1.0 ppm; sapodilla from
1.3 ppm to 1.0 ppm; and star apple from 1.3 ppm to 1.0 ppm. Based on
review of the residue chemistry data submitted in support of this
petition, EPA concluded that 1.0 ppm tolerance for residues of
spirodiclofen per se in/on these crops is appropriate.

V. Conclusion

    Therefore, tolerances are established for residues of spirodiclofen
per se, (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-
dimethylbutanoate), in or on avocado, black sapote, canistel, mamey
sapote, mango, papaya, sapodilla, and star apple at 1.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the

Unfunded Mandates Reform Act of 1995 (UMRA) (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: April 20, 2010.
G. Jeffrey Herndon,
Acting 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. In Sec.  180.608, alphabetically add the following commodities to
the table in paragraph (a)(1) to read as follows:

Sec.  180.608  Spirodiclofen; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Avocado...................................  1.0
Black sapote..............................  1.0
Canistel..................................  1.0
                                * * * * *
Mamey sapote..............................  1.0
Mango.....................................  1.0
                                * * * * *
Papaya....................................  1.0
                                * * * * *
Sapodilla.................................  1.0
Star apple................................  1.0
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-10129 Filed 5-4-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Rules and Regulations]
[Page 49193]
[FR Doc No: 2019-20330]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2019-0735]

Special Local Regulations; Ironman Triathlon, Augusta, GA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce special local regulations for the
Ironman Triathlon in Augusta, Georgia on September 29, 2019, to provide
for the safety of life on navigable waterways during this event. Our
regulation for marine events within the Seventh Coast Guard District
identifies the regulated area for this event in Augusta, GA. During the
enforcement periods, the operator of any vessel in the regulated area
must comply with directions from the Patrol Commander or any Official
Patrol displaying a Coast Guard ensign.

DATES: The regulation in 33 CFR 100.701, Table to Sec.  100.701(f)(3)
will be enforced from 6:30 a.m. until 11:30 a.m. on September 29, 2019.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email MST1 Rachel Crowe, Marine Safety
Unit Savannah Office of Waterways Management, U.S. Coast Guard;
telephone<PHONE_NUMBER>, extension 243, or email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce special local
regulations in 33 CFR 100.701 for the Ironman Triathlon regulated area
listed in Table to Sec.  100.701(f)(3)from 6:30 a.m. until 11:30 a.m.
on September 29, 2019.
    This action is being taken to provide for the safety of life on
navigable waterways during this event. Our regulation for marine events
within the Seventh Coast Guard District, Sec.  100.701, specifies the
location of the regulated area for the Ironman Triathlon which
encompasses portions of the Savannah River and its branches in
Savannah, GA. During the enforcement periods, as reflected in 33 CFR
100.701(c), if you are the operator of a vessel in the regulated area
you must comply with directions from the Patrol Commander or any
Official Patrol displaying a Coast Guard ensign. The Coast Guard may be
assisted by other Federal, State, or local law enforcement agencies in
enforcing this regulation.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard will provide notice of the regulated area via Local
Notice to Mariners, Broadcast Notice to Mariners, and on-scene
designated representatives.

    Dated: September 16, 2019.
J.A. Coleman,
Lieutenant Commander, U.S. Coast Guard, Acting Captain of the Port
Savannah.
[FR Doc. 2019-20330 Filed 9-18-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 48 (Tuesday, March 12, 2019)]
[Rules and Regulations]
[Pages 8799-8802]
[FR Doc No: 2019-04394]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0056; Product Identifier 2017-NE-29-AD; Amendment
39-19584; AD 2019-05-02]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are superseding airworthiness directive (AD) 2017-22-13 for
certain Rolls-Royce plc (RR) RB211-Trent 900 turbofan engine models. AD
2017-22-13 required an inspection of the drains mast and the
replacement or repair of the drains mast if a crack is found. This AD
retains this requirement, but adds repetitive inspections and expands
the population of affected RR RB211-Trent 900 turbofan engine models.
This AD was prompted by RR in-service findings that indicated a need to
include part number (P/N) FW29847 drains mast and additional RR RB211-
Trent 900 turbofan engines to the affected population. We are issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective March 27, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 27,
2019.
    We must receive any comments on this AD by April 26, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Rolls-Royce
plc, Corporate Communications, P.O. Box 31, Derby, DE24 8BJ, United
Kingdom; phone: +44 (0)1332 242424; fax: 011-44-1332-249936; email:
http://www.rolls-royce.com/contact/civil_team.jsp; internet: https://customers.rolls-royce.com/public/rollsroycecare. You may view this
service information at the FAA, Engine & Propeller Standards Branch,
1200 District Avenue, Burlington, MA 01803. 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-2019-0056.

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-2019-
0056; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the mandatory continuing airworthiness information, regulatory
evaluation, any comments received, and other information. The street
address for Docket Operations (phone:<PHONE_NUMBER>) is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Besian Luga, Aerospace Engineer, ECO
Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-
238-7750; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued AD 2017-22-13, Amendment 39-19093 (82 FR 51550, November
7, 2017), (``AD 2017-22-13''), for certain RR RB211-Trent 970-84 and
RB211-Trent 972-84 turbofan engines. AD 2017-22-13 required an
inspection of the drains mast and the replacement or repair of the
drains mast if a crack is found. AD 2017-22-13 resulted from cracks
found in the transition duct area

of the drains mast. We issued AD 2017-22-13 to visually inspect the
external areas of the transition duct area of the drains mast for a
crack, and if a crack is found, to replace the drains mast or seal the
crack.

Actions Since AD 2017-22-13 Was Issued

    Since we issued AD 2017-22-13, RR in-service investigations found
cracks in the transition duct area of the drains mast. The RR
investigation originally highlighted that engines that have installed
the sub-idle ejector system introduced in RR Service Bulletin (SB)
RB.211-80-H632, Revision 2, dated August 11, 2015, were most at risk of
cracking. As a result, RR published Rolls-Royce Alert Non-Modification
Service Bulletin (NMSB) No. RB.211-71-AJ576, Revision 1, dated July 11,
2018, to add engines with a drains mast, P/N KH31996, installed that
have installed the sub-idle ejector system introduced in RR SB RB.211-
80-H632, Revision 2, dated August 11, 2015, and engines with a drains
mast, P/N FW29847, installed or have a drains mast, P/N KH31996, that
have not installed the sub-idle ejector system introduced in RR SB
RB.211-80-H632, Revision 2, dated August 11, 2015. Also since we issued
AD 2017-22-13, the European Union Aviation Safety Agency (EASA) has
issued EASA AD 2018-0185, dated August 29, 2018, which retains the
requirements of EASA AD 2017-0075R1, dated May 5, 2017, but adds
repetitive inspections and expands the population of affected RR RB211-
Trent 900 turbofan engine models. We are issuing this AD to address the
unsafe condition on these products.

Related Service Information Under 1 CFR Part 51

    We reviewed Rolls-Royce Alert NMSB No. RB.211-71-AJ576, Revision 1,
dated July 11, 2018. The Alert NMSB describes procedures for
inspection, repair, and replacement of the drains mast. 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.

Other Related Service Information

    We reviewed Rolls-Royce SB RB.211-80-H632, Revision 2, dated August
11, 2015. The SB describes procedures for installing a new sub-idle
ejector system on the low-pressure compressor case.

FAA's Determination

    This product has been approved by EASA, and is approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Community, EASA has notified us of the unsafe
condition described in the MCAI and service information referenced
above. We are issuing this AD because we evaluated all the relevant
information provided by EASA and determined the unsafe condition
described previously is likely to exist or develop in other products of
the same type design.

AD Requirements

    This AD requires visual inspections of the external areas of the
transition duct area of the drains mast for a crack. This AD also
requires, if a crack is found, replacement of the drains mast with a
part eligible for installation or sealing of the crack.

FAA's Justification and Determination of the Effective Date

    No domestic operators use this product. Therefore, we find that
notice and opportunity for prior public comment are unnecessary and
that good cause exists for making this amendment effective in less than
30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this final
rule. Send your comments to an address listed under the ADDRESSES
section. Include the docket number FAA-2019-0056 and product identifier
2017-NE-29-AD at the beginning of your comments. We specifically invite
comments on the overall regulatory, economic, environmental, and energy
aspects of this final rule. We will consider all comments received by
the closing date and may amend this final rule because of those
comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this final rule.

Costs of Compliance

    We estimate that this AD affects zero engines installed on
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
----------------------------------------------------------------------------------------------------------------
Inspect the drains mast...............  2 work-hours x $85 per                $0            $170              $0
                                         hour = $170.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the proposed inspection.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace the drains mast.......................  1 work-hour x $85 per hour = $85         $72,000         $72,085
Seal the drains mast..........................  1 work-hour x $85 per hour = $85               0              85
----------------------------------------------------------------------------------------------------------------

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

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 part 39 of the Federal Aviation
Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2017-22-13, Amendment 39-19093 (82 FR 51550, November 7, 2017), and
adding the following new AD:

2019-05-02 Rolls-Royce plc: Amendment 39-19584; Docket No. FAA-2019-
0056; Product Identifier 2017-NE-29-AD.

(a) Effective Date

    This AD is effective March 27, 2019.

(b) Affected ADs

    This AD replaces AD 2017-22-13, Amendment 39-19093 (82 FR 51550,
November 7, 2017).

(c) Applicability

    This AD applies to all Rolls-Royce plc (RR) RB211-Trent 970-84
and RB211-Trent 972-84 turbofan engines with a drains mast, part
number (P/N) KH31996 or FW29847, installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7170, Powerplant/
Engine Drains.

(e) Unsafe Condition

    This AD was prompted by RR in-service findings that indicated a
need to include part number (P/N) FW29847 drains mast and additional
RR RB211-Trent 900 turbofan engines to the affected population. We
are issuing this AD to prevent failure of the drains mast. The
unsafe condition, if not addressed, could result in engine fire and
damage to the airplane.

(f) Compliance

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

(g) Required Actions

    (1) For Group 1 engines, within 24 months after November 22,
2017 (the effective date of AD 2017-22-13), or within 24 months time
since new, whichever occurs later, and thereafter, at intervals not
to exceed 24 months since previous inspection, visually inspect the
external areas of the transition duct area of the drains mast for a
crack using Accomplishment Instructions, paragraph 3.A.(1), of RR
Alert Non-Modification Service Bulletin (NMSB) RB.211-71-AJ576,
Revision 1, dated July 11, 2018.
    If a crack is found, do one of the following before further
flight:
    (i) Remove and replace the drains mast with a part eligible for
installation, or
    (ii) Seal the crack using the Accomplishment Instructions,
paragraph 3.A.(1).(c).(ii).(2), of RR Alert NMSB RB.211-71-AJ576,
Revision 1, dated July 11, 2018, and within 100 flight cycles after
sealing the crack, remove and replace the drains mast with a part
eligible for installation.
    (2) For Group 2 engines, within 24 months after the effective
date of this AD, and thereafter, at intervals not to exceed 24
months since previous inspection, visually inspect the external
areas of the transition duct area of the drains mast for a crack
using Accomplishment Instructions, paragraph 3.A.(1), of RR Alert
NMSB RB.211-71-AJ576, Revision 1, dated July 11, 2018.
    If a crack is found, do one of the following before further
flight:
    (i) Remove and replace the drains mast with a part eligible for
installation, or
    (ii) Seal the crack using the Accomplishment Instructions,
paragraph 3.A.(1).(c).(ii).(2), of RR Alert NMSB RB.211-71-AJ576,
Revision 1, dated July 11, 2018, and within 100 flight cycles after
sealing the crack, remove and replace the drains mast with a part
eligible for installation.

(h) Definition

    (1) For the purposes of this AD, ``Group 1'' engines are those
with a drains mast, P/N KH31996, installed that have installed the
sub-idle ejector system introduced in RR SB RB.211-80-H632, Revision
2, dated August 11, 2015. ``Group 2'' engines are those engines with
a drains mast, P/N FW29847, installed or have a drains mast, P/N
KH31996, that have not installed the sub-idle ejector system
introduced in RR SB RB.211-80-H632, Revision 2, dated August 11,
2015.
    (2) For the purposes of this AD, a part eligible for
installation is a drains mast with a part number not listed in this
AD or a part that has passed the inspection required by this AD.
    (3) For the purposes of this AD, a flight cycle is a take-off
and landing.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, 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
certification office, send it to the attention of the person
identified in paragraph (j)(1) of this AD. You may email your
request 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.

(j) Related Information

    (1) For more information about this AD, contact Besian Luga,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to MCAI European Union Aviation Safety Agency (EASA)
AD 2018-0185, dated August 29, 2018, for more information. You may
examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2019-0056.

(k) 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) Rolls-Royce Alert Non-Modification Service Bulletin No.
RB.211-71-AJ576, Revision 1, dated July 11, 2018.
    (ii) [Reserved]
    (3) For Rolls-Royce plc service information identified in this
AD, contact Rolls-Royce plc, Corporate Communications, P.O. Box 31,
Derby, DE24 8BJ, United Kingdom; phone: +44 (0)1332 242424; fax:
011-44-1332-249936; email: http://www.rolls-royce.com/contact/civil_team.jsp; internet: https://customers.rolls-royce.com/public/rollsroycecare.
    (4) You may view this service information at FAA, Engine &
Propeller Standards Branch, 1200 District Avenue, Burlington, MA
01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.
    (5) You may view this service information 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 Burlington, Massachusetts, on March 6, 2019.
Karen M. Grant,
Acting Manager, Engine & Propeller Standards Branch, Aircraft
Certification Service.
[FR Doc. 2019-04394 Filed 3-11-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Rules and Regulations]
[Pages 58351-58354]
[FR Doc No: 2015-24256]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0503; Directorate Identifier 2011-SW-032-AD
Amendment 39-18276; AD 2015-19-14]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
(formerly Eurocopter Deutschland GmbH) (Airbus Helicopters) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Airbus
Helicopters Model BO-105A, BO-105C,

and BO-105S helicopters. This AD requires inspections to detect oil
contamination in the main gearbox (MGB). This AD was prompted by
initial findings from an accident investigation of a Model BO-105
helicopter, which indicated deterioration of the MGB caused by a
contaminated oil supply. The actions of this AD are intended to detect
oil contamination in the MGB, which could result in MGB deterioration,
MGB failure, and subsequent loss of control of the helicopter.

DATES: This AD is effective November 3, 2015.

ADDRESSES: For service information identified in this AD, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.airbushelicopters.com/techpub.
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2012-
0503; or in person at the Docket Operations Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the European Aviation Safety Agency (EASA)
AD, the economic evaluation, any comments received, and other
information. The street address for the Docket Operations Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.
    For service information identified in this proposed AD, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.airbushelicopters.com/techpub.
    You may review the referenced service information at the FAA,
Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, Texas 76177.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the EASA AD, the economic
evaluation, any comments received, and other information. The street
address for the Docket Operations Office (phone:<PHONE_NUMBER>) is U.S.
Department of Transportation, Docket Operations Office, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, Senior Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101
Hillwood Pkwy., Fort Worth, Texas 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On May 11, 2012, at 77 FR 27659, the Federal Register published our
notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR
part 39 to add an AD that would apply to Eurocopter Deutschland GmbH
(now Airbus Helicopters) Model BO-105A, BO-105C, and BO-105S
helicopters. The NPRM proposed to require inspecting the MGB oil filter
and MGB magnetic plug and, if the MGB oil filter or magnetic plug
contained metallic fuzz, cleaning the magnetic plug, flushing the main
transmission, changing the oil, and performing a ground run. If there
was a chip in the MGB oil filter or MGB magnetic plug, the NPRM
proposed replacing the main transmission with an airworthy main
transmission and cleaning the oil cooler and oil lines. The NPRM
proposed repeating the MGB magnetic plug inspection every 10 hours
time-in-service (TIS) and repeating the MGB oil filter inspection every
100 hours TIS.
    The NPRM was prompted by AD No. 2011-0091, dated May 18, 2011,
issued by EASA, which is the Technical Agent for the Member States of
the European Union, to correct an unsafe condition for Model BO105 A,
BO105 C, BO105 D, and BO105S helicopters. EASA AD No. 2011-0091
requires an inspection of the MGB magnetic plug every 10 flight hours
and an inspection of the Mann oil filter every 100 flight hours.

Actions Since NPRM Was Issued

    Since we issued the NPRM, EASA superseded AD No. 2011-0091 and
issued AD No. 2014-0230, dated October 21, 2014, to provide different
inspection intervals if an improved Purolator oil filter is installed.
After reviewing the EASA AD, we have determined that the actions should
address installation of a Purolator oil filter and that the AD should
only apply if a certain part-numbered Mann or Purolator oil filter is
installed. The AD also increases the inspection interval if a Purolator
oil filter is installed.

Comments

    We gave the public the opportunity to comment on the NPRM. The
following presents the one comment received on the NPRM and the FAA's
response to the comment.

Request

    The commenter, Timberland Logging, requested that the wording be
clarified so that the AD would require an inspection of the magnetic
plug only and not the chip detector. The commenter noted that the term
``magnetic plug/chip detector'' in the NPRM implies that the 10-hour
inspection applies to both the magnetic plug and the chip detector. The
commenter stated that the chip detector will activate a warning light
on the pilot's caution panel with any accumulation of fuzz or chips.
    We agree that the wording ``magnetic plug/chip detector'' is
confusing; therefore, we have revised the wording to remove ``chip
detector'' and only refer to the ``magnetic plug.''

FAA's Determination

    These helicopters have been approved by the aviation authority of
Germany and are approved for operation in the United States. Pursuant
to our bilateral agreement with Germany, EASA, its technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of these same
type designs and that air safety and the public interest require
adopting the AD requirements as proposed except for the changes
previously described. These changes are consistent with the intent of
the proposals in the NPRM, and will not increase the economic burden on
any operator nor increase the scope of this AD.

Differences Between This AD and the EASA AD

    The EASA AD applies to Model BO105D helicopters; this AD does not
because this model is not type

certificated in the U.S. The EASA AD allows for a grace period between
checking the magnetic plug by +10 hours TIS. This AD does not allow the
grace period.

Related Service Information

    Airbus Helicopters issued Alert Service Bulletin (ASB) No. ASB
B0105-10-125, Revision 3, dated May 27, 2014 (ASB BO105-10-125), to
specify repetitive inspections of the magnetic plug and oil filter with
different inspection intervals based upon what type of oil filter is
installed. Eurocopter (now Airbus Helicopters) Service Bulletin B0105-
10-126, Revision 1, dated August 6, 2013 (ASB B0105-10-126), introduces
an improved oil filter, Purolator part number (P/N) 1740001-13.
Eurocopter states that Mann oil filter P/N<PHONE_NUMBER> will not be
available in the future and will be replaced by a new oil filter
provided by Purolator. Installation of the Purolator oil filter
increases the inspection interval of the magnetic plug from 10 flight
hours to 50 flight hours and increases the inspection interval of the
oil filter from 100 flight hours to 600 flight hours.

Costs of Compliance

    We estimate that this AD will affect 68 helicopters of U.S.
Registry.
    We estimate that operators may incur the following costs in order
to comply with this AD. Labor costs are estimated at $85 per work hour.
We estimate 2 work hours to inspect the oil filter and chip detector at
an estimated $170 per helicopter and $11,560 for the fleet per
inspection cycle. We estimate 40 hours to replace a transmission with a
required parts cost of $225,000 for a total cost of $228,400.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

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):

2015-19-14 Airbus Helicopters Deutschland GmbH (AHD) (formerly
Eurocopter Deutschland GmbH) Helicopters: Amendment 39-18276; Docket
No. FAA-2012-0503; Directorate Identifier 2011-SW-032-AD.

(a) Applicability

    This AD applies to Model BO-105A, BO-105C, and BO-105S
helicopters with a Mann oil filter part number (P/N)<PHONE_NUMBER> or a
Purolator oil filter P/N 1740001-13, installed, certificated in any
category.

(b) Unsafe Condition

    This AD defines the unsafe condition as deterioration of the
main gearbox (MGB) caused by oil contamination. This condition could
result in MGB failure and subsequent loss of control of the
helicopter.

(c) Effective Date

    This AD becomes effective November 3, 2015.

(d) Compliance

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

(e) Required Actions

    (1) Within 100 hours time-in-service (TIS) or at the next MGB
magnetic plug or chip detector inspection, whichever occurs first,
and thereafter at intervals not to exceed 100 hours TIS if a Mann
oil filter is installed or 600 hours TIS if a Purolator oil filter
is installed, clean and inspect the MGB oil filter for chips and the
MGB magnetic plug for fine particles (metallic fuzz) or chips. A
``chip'' is a solid piece of metal but not metallic fuzz.
    (i) If there are no chips on the MGB oil filter or on the
magnetic plug, and the metallic fuzz covers less than 25% of the
magnetic plug, clean the magnetic plug.
    (ii) If there are no chips on the MBG oil filter or on the
magnetic plug, but the metallic fuzz covers 25% or more of the
magnetic plug, flush the main transmission, change the oil, perform
a ground run for 15 minutes at the flight-idle power setting, and
then re-inspect the MGB oil filter and magnetic plug for a chip and
the quantity of metallic fuzz on the metallic plug.
    (iii) If there is a chip on the MGB oil filter or on the
magnetic plug, or, after complying with paragraph (e)(1)(ii) of this
AD, metallic fuzz covers 25% or more of the magnetic plug, replace
the main transmission with an airworthy main transmission and clean
the oil cooler and oil lines.
    (2) At intervals not to exceed 10 hours TIS if a Mann oil filter
is installed and 50 hours TIS if a Purolator oil filter, inspect the
magnetic plug for a chip or metallic fuzz in accordance with the
requirements of paragraph (e)(1) of this AD.
    (3) If a Purolator oil filter has been installed on a
helicopter, do not install a Mann oil filter on that helicopter.

(f) Special Flight Permit

    A special flight permit will be permitted for up to 10 hours TIS
for the purpose of operating the aircraft to a maintenance facility
only.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Matt Fuller, Senior Aviation
Safety Engineer, Safety Management Group, Rotorcraft Directorate,
FAA, 10101 Hillwood Pkwy., Fort Worth, Texas 76177; telephone (817)
222-5110; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under

14 CFR part 91, subpart K, we suggest that you notify your principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office or certificate holding
district office before operating any aircraft complying with this AD
through an AMOC.

(h) Additional Information

    (1) Airbus Helicopters Alert Service Bulletin No. ASB BO105-10-
125, Revision 3, dated May 27, 2014, and Eurocopter Service Bulletin
B0105-10-126, Revision 1, dated August 6, 2013, which are not
incorporated by reference, contain additional information about the
subject of this AD. For service information identified in this AD,
contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (972) 641-
3775; or at http://www.airbushelicopters.com/techpub.You may review
a copy of the service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort
Worth, Texas 76177.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) AD 2014-0230, dated October 21, 2014. You may
view the EASA AD on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2012-0503.

 (i) Subject

    Joint Aircraft Service Component (JASC) Code: 6320 Main Gear
Box.

    Issued in Fort Worth, Texas, on September 17, 2015.
James A. Grigg,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2015-24256 Filed 9-28-15; 8:45 am]
 BILLING CODE 4910-13-P