[Federal Register: August 22, 2007 (Volume 72, Number 162)]
[Rules and Regulations]
[Page 46906-46914]
[DOCID:fr22au07-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0206; FRL-8142-6]

Fipronil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of fipronil and its two metabolites and one photodegradate in or on
potato and potato, wet peel, and indirect or inadvertent residues of
fipronil and its two metabolites and one photodegradate in or on wheat,
forage; wheat, grain;

wheat, hay; and wheat, straw. BASF Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). In
addition, this establishes time-limited tolerances for combined
residues of fipronil in or on turnip and rutabaga. This action is in
response to EPA's granting of emergency exemptions under section 18 of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on turnip and rutabaga. This
regulation establishes maximum permissible levels for combined residues
of fipronil in these food commodities. The tolerances for rutabaga and
turnip expire and are revoked on December 31, 2010.

DATES: This regulation is effective August 22, 2007. Objections and
requests for hearings must be received on or before October 22, 2007,
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-2005-0206. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ann Sibold, 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), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    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 an electronic copy of this Federal
Register document through the electronic docket 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 pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2005-0206 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 October 22, 2007.
    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-2005-0206, 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'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 Tolerances

    In the Federal Register of August 24, 2005 (70 FR 49599) (FRL-7726-
3), 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
5F6948) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.517 be amended by
establishing tolerances for combined residues of the insecticide
fipronil, 5-amino-1-(2,6-dichloro-4-(trifluoromethyl) phenyl)-4-
((1,R,S)-trifluoromethyl)sulfinyl)-1-H-pyrazole-3-carbonitrile and its
2 metabolites, MB45950 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)thio]-1H-pyrazole-3-
carbonitrile) and MB46136 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-

[(trifluoromethyl)sulfonyl]-1H-pyrazole-3-carbonitrile), and
photodegradate MB46513 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-
carbonitrile), in or on vegetable, tuberous , corm, subgroup 1C at 0.04
parts per million (ppm) and potato, wet peel at 0.4 ppm and indirect or
inadvertent residues of the insecticide fipronil, 5-amino-1-(2,6-
dichloro-4-(trifluoromethyl) phenyl)-4-((1,R,S)-
trifluoromethyl)sulfinyl)-1-H-pyrazole-3-carbonitrile and its 2
metabolites MB45950 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)thio]-1H-pyrazole-3-
carbonitrile) and MB46136 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)sulfonyl]-1H-pyrazole-3-
carbonitrile) and its photodegradate MB46513 (5-amino-1-(2,6-dichloro-
4-(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-
carbonitrile), in or on wheat, forage at 0.04 ppm, wheat, grain at 0.04
ppm, wheat, hay at 0.04 ppm, and wheat, straw at 0.04 ppm. That notice
referenced a summary of the petition prepared by BASF Corporation, the
registrant, which is available to the public in the docket, http://www.regulations.gov.
 One comment was received on the notice of filing.

EPA's response to this comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
revised the tolerance for vegetable tuberous corm crop subgroup 1C to
limit it to potato. The reason for these changes is explained in Unit
V.
    EPA is also establishing time-limited tolerances for combined
residues of the insecticide fipronil, in or on turnip and rutabaga at
1.0 ppm. These tolerances expire and are revoked on December 31, 2010.
The tolerances are being established in response to EPA's authorization
to the Oregon Department of Agriculture, for the emergency use of
fipronil to control the cabbage maggot, a highly damaging pest to root
crops, in these crops, under a FIFRA section 18 specific exemption. The
request was based upon three factors:
    1. A recent severe increase in cabbage maggot populations.
    2. The apparent increasing resistance of the maggot to the
organophosphate registered alternative.
    3. Phytotoxicity of the organophosphate alternative to the emerging
seedlings.
    The Applicant stated that significant economic losses would occur
without the requested use of fipronil under an emergency exemption.
After having reviewed the submission, EPA concurs that emergency
conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of fipronil in or on rutabaga
and turnip. In doing so, EPA considered the safety standard in section
408(b)(2) of FFDCA, and EPA decided that the necessary tolerances under
section 408(l)(6) of FFDCA would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing these tolerances without notice and opportunity for public
comment as provided in section 408(l)(6) of the FFDCA. Although the
tolerances expire and are revoked on December 31, 2010, under section
408(l)(5) of FFDCA, residues of the pesticide not in excess of the
amounts specified in the tolerances remaining in or on rutabaga and
turnip after that date will not be unlawful, provided the pesticide is
applied in a manner that was lawful under FIFRA, and the residues do
not exceed levels that were authorized by these tolerances at the time
of that application. EPA will take action to revoke these tolerances
earlier if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
    Because the rutabaga and turnip tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
fipronil meets EPA's registration requirements for use on rutabaga and
turnip or whether permanent tolerances for these uses would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of fipronil by a State for
special local needs under FIFRA section 24(c). Nor do these tolerances
serve as the basis for any State other than Oregon to use this
pesticide on these crops under section 18 of FIFRA without following
all provisions of EPA's regulations implementing FIFRA section 18 as
identified in 40 CFR part 166. For additional information regarding the
emergency exemptions for fipronil, contact the Agency's Registration
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

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. . .
.'' These provisions were added to FFDCA by the Food Quality Protection
Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerances
for combined residues of fipronil and its metabolites and its degradate
on potato at 0.03 ppm and potato, wet peel at 0.10 ppm and indirect or
inadvertent residues of fipronil and its metabolites and its degradate
on wheat, forage at 0.02 ppm, wheat, grain at 0.005 ppm, wheat, hay at
0.03 ppm, and wheat, straw at 0.03 ppm, and the tolerances to support
authorization of an emergency exemption on turnip at 1.0 ppm and
rutabaga at 1.0 ppm. EPA's assessment of exposures and risks associated
with establishing the 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. Specific information on the studies received and the nature
of the adverse effects caused by fipronil 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.
 The referenced document, ``Fipronil:

Third Reevaluation--Report of the Hazard Identification Assessment
Review Committee, December 6, 2000,'' is available in the docket
established by this action, which is described under ADDRESSES, and is
identified as EPA-HQ-OPP-2005-0206 in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from 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) is
sometimes used for risk assessment. Uncertainty/safety factors (UF) are
used in conjunction with the LOC 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
risks by comparing aggregate 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 LOC by all
applicable uncertainty/safety factors. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the margin of exposure (MOE) called for by the
product of all applicable uncertainty/safety factors is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for fipronil used for
human risk assessment is shown in Table 1 of this unit.

       Table 1.--Summary of Toxicological Dose and Endpoints for Fipronil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF and Endpoint   Study and Toxicological
          Exposure Scenario                 Assessment, UF        for Risk Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL= 2.5 milligrams/   FQPA SF = 1              Acute neurotoxicity--
(All populations including infants      kilograms (mg/kg)       aPAD = acute RfD/FQPA     rat
 and children).                        UF = 100...............   SF = 0.025 mg/kg.       LOAEL = 7.0 mg/kg based
                                       acute RfD = 0.025 mg/kg                            on: Decreased hind leg
                                                                                splay in males at 7
                                                                                hours
Chronic dietary                        NOAEL= 0.019 mg/kg/day   FQPA SF = 1              Chronic/carcinogenicity
(All populations)....................  UF = 100...............  cPAD = chr RfD/FQPA SF    study --rat
                                       chronic RfD = 0.0002 mg/  = 0.0002 mg/kg/day.     LOAEL = 0.059 mg/kg/day
                                        kg/day.                                           based on: Increased
                                                                                incidence of seizures
                                                                                and death, alterations
                                                                                in clinical chemistry
                                                                                (protein), increased
                                                                                thyroid stimulating
                                                                                hormone (TSH), and
                                                                                decreased T4
Short-term oral (1-7 days)             Oral study maternal      LOC for MOE = 300        Developmental toxicity
(Residential)........................   LOAEL < 0.1 mg/kg/day    (Residential, includes    study--rabbit
                                        UF of 3 for no NOAEL,    the FQPA SF).           maternal LOAEL = 0.1 mg/
                                        100 for interspecies                              kg/day based on:
                                        extrapolation and                                 Maternal toxicity of
                                        intraspecies variation                            decreased body weight
                                                                                gain, decreased food
                                                                                consumption, and
                                                                                decreased food
                                                                                efficiency
Intermediate-term oral (1 week--       Oral study LOAEL < 0.1    LOC for MOE = 300        Developmental toxicity
 several months)                        mg/kg/day UF of 3 for   (Residential, includes    study--rabbit
(Residential)........................   no NOAEL, 100 for        the FQPA SF).           LOAEL = 0.1 mg/kg/day
                                        interspecies                                      based on: Maternal
                                        extrapolation and                                 toxicity of decreased
                                        intraspecies variation                            body weight gain,
                                                                                decreased food
                                                                                consumption, and
                                                                                decreased food
                                                                                efficiency
Short-termdermal (1-7 days)            Dermal study NOAEL= 5    LOC for MOE = 100        21-Day dermal toxicity
(Residential)........................   mg/kg/day                (Occupational)           study--rabbit
                                                                LOC for MOE = 100        LOAEL = 10.0 mg/kg/day
                                                                 (Residential, includes   based on: Decreased
                                                                 FQPA SF).                body weight gain, and
                                                                                food consumption in
                                                                                both sexes
Intermediate-term dermal (1 week--     Dermal study NOAEL = 5   LOC for MOE = 100        21-Day dermal toxicity
 several months)                        mg/kg/day                (Occupational)           study-- rabbit
(Residential)........................                           LOC for MOE = 100        LOAEL = 10.0 mg/kg/day
                                                                 (Residential, includes   based on: Decreased
                                                                 FQPA SF).                body weight gain, and
                                                                                food consumption in
                                                                                both sexes
Long-term dermal (several months--     Oral study NOAEL =       acceptable MOE = 100     Chronic/carcinogenicity
 lifetime)                              0.019 mg/kg/day(dermal   (Occupational)           study --rat
(Residential)........................   absorption rate = 1%)   acceptable MOE = 100     LOAEL = 0.059 mg/kg/day
                                                                 (Residential, includes   based on: Increased
                                                                 FQPA SF).                incidence of seizures
                                                                                and death, alterations
                                                                                in clinical chemistry
                                                                                (protein), increased
                                                                                TSH, and decreased T4
Short-term inhalation (1-7 days)       Oral study NOAEL = 0.05  LOC for MOE = 100        Developmental
(Residential)........................   mg/kg/day(inhalation     (Occupational)           neurotoxicity-- rat
                                        absorption rate =       LOC for MOE = 100        LOAEL = 0.90 mg/kg/day
                                        100%)                    (Residential, includes   based on: Decrease in
                                                                 FQPA SF).                group mean pup weights
                                                                                during lactation, and
                                                                                significant increase
                                                                                in time of preputial
                                                                                separation in males
                                                                                (dietary)
Intermediate-term inhalation (1 week-- Oral study NOAEL = 0.05  LOC for MOE = 100        Developmental
 several months)                        mg/kg/day (inhalation    (Occupational) LOC for   neurotoxicity-- rat
(Residential)........................   absorption rate =        MOE = 100               LOAEL = 0.90 mg/kg/day
                                        100%)                    (Residential, includes   based on: Decrease in
                                                                 FQPA SF)                 group mean pup weights
                                                                                during lactation, and
                                                                                significant increase
                                                                                in time of preputial
                                                                                separation in males
                                                                                (dietary)

Long-term inhalation (several months-- O ral study NOAEL=       acceptable MOE = 100     Chronic/carcinogenicity
 lifetime)                              0.019 mg/kg/day          (Occupational)           rat study
(Residential)........................   (inhalation absorption  acceptable MOE = 100     LOAEL = 0.059 mg/kg/day
                                        rate = 100%)             (Residential, includes   based on: Increased
                                                                 FQPA SF).                incidence of seizures
                                                                                and death, alterations
                                                                                in clinical chemistry
                                                                                (protein), increased
                                                                                TSH, and decreased T4
Cancer                                 Group C--possible human  Use chronic RfD to       Increases in thyroid
(Oral, dermal, inhalation)...........   carcinogen               estimate human risk      follicular cell tumors
                                                                                with fipronil (male/
                                                                                female)
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = FQPA Safety Factor, NOAEL = no observed adverse effect level, LOAEL = lowest
  observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference dose,
  LOC = level of concern, MOE = margin of exposure.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fipronil, EPA considered exposure under the petitioned-for
tolerances, as well as the turnip and rutabaga tolerances to support
the authorized section 18s, and all existing fipronil tolerances in (40
CFR 180.517). EPA assessed dietary exposures from fipronil 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 one-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 all foods for which there are tolerances
were treated and contain tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Nationwide CSFII. As to residue levels in food, EPA relied
upon anticipated residues and percent crop treated information for some
commodities A partially refined analysis was performed using
anticipated residues from field trial data for existing uses for which
data were available. Anticipated residues were also used for potato
commodities. Processing factors were used for existing uses. Percent
crop treated was not used.
    iii. Cancer. Fipronil has been classified as a Group C--Possible
Human Carcinogen, based on increases in thyroid follicular cell tumors
in both sexes of the rat, which were statistically significant by both
pair-wise and trend analyses. There is no apparent concern for
mutagenicity (no mutagenic activity). The RfD methodology should be
used to estimate human risk for the following reasons: The thyroid
tumors appear to be related to a disruption in the thyroid-pituitary
status, and fipronil is not likely to be carcinogenic to humans at
doses that do not alter rat thyroid hormone homeostasis. In addition,
the cRfD is based on the NOAEL from the combined chronic/
carcinogenicity study in rats. The NOAEL is based on increased
incidence of seizures and death, alterations in clinical chemistry
(protein) and thyroid toxicity (increase in TSH), decrease in thyroxine
(T4)). Therefore, the cRfD is considered to be protective of both
cancer and non-cancer effects of fipronil.
    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 pursuant
to FFDCA section 408(f)(1) require 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.
    2. Dietary exposure from drinking water.The Agency lacks sufficient
monitoring data to complete a comprehensive dietary exposure analysis
and risk assessment for fipronil in drinking water. Because the Agency
does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate characteristics of
fipronil. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
fipronil for acute exposures are estimated to be 2.654 parts per
billion (ppb) for surface water and 0.021 ppb for ground water. The
EECs for chronic exposures are estimated to be 0.3179 ppb for surface
water and 0.021 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 2.654 ppb was used to
access the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 0.3179 ppb was used to
access 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).
    Fipronil is currently registered for the following residential non-
dietary sites: For use on cats and dogs for flea control and on turf to
control fire ants. These products may be applied by homeowners. EPA
assessed residential exposure using the following assumptions: The
probability of applying fipronil to dogs and cats to control fleas and
ticks and applying fipronil to control turf pests on the same day is
considered to be negligible for the following reasons: Use on turf
application is limited to application one per year. For the pet care
products, fipronil is applied as a Ready-to-Use (RTU) pump spray to the
fur of the animal or as a RTU, pour-on, spot

treatment made on the back of the animal between the shoulder blades.
Repeated applications if necessary may be made once every one to three
months during flea or tick season. Therefore, since these applications
are infrequent, for aggregate risk assessment, exposure from pet and
turf treatments were not combined. Based on the existing and proposed
uses, the pet uses result in the highest estimated handler exposure.
Since more exposure is expected from the pet care spray product,
exposure to the spray product represents the worst case for all
residential scenarios. For post-application risk, the use on pets is
used to estimate exposure to toddlers. Adult post-application exposure
is considered negligible.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to fipronil and any other
substances and fipronil does not appear to produce a toxic metabolite
produced by other substances. For the purposes of these tolerance
actions, therefore, EPA has not assumed that fipronil has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the 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. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional uncertainty/safety
factors and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. EPA concluded that there is
no indication of increased susceptibility of rats or rabbits to in
utero and/or postnatal exposure to fipronil. In the prenatal
developmental toxicity studies in rats and rabbits and in the 2-
generation reproduction study in rats, developmental toxicity occurred
at the same or greater doses than those that caused maternal toxicity.
In particular, the toxicity endpoint used for the short term oral
exposure scenario was based on maternal effects seen in the
developmental toxicity study. However, because no maternal NOAEL was
established, an additional 3X safety factor was added to the maternal
LOAEL. The developmental or offspring NOAEL was 10x greater than the
maternal LOAEL. In addition, the combined chronic/carcinogenicity study
in rats is based on increased incidence of seizures and deaths,
alterations in clinical chemistry (protein) and an increase in TSH and
a decrease in T4 at the LOAEL of 0.059 mg/kg/day. No effects on body
weights and body weigh gains were observed at the LOAEL in the chronic
toxicity study. For this reason EPA believes that the additional 3X
safety factor is protective of infants and children.
    However, the developmental neurotoxicity study identified a
developmental NOAEL (0.05 mg/kg/day) which is less than the maternal
NOAEL of 0.9 mg/kg/day, indicating an apparent susceptibility issue.
EPA determined that the evidence regarding appearance of susceptibility
was not convincing for several reasons. First, the findings at 0.9 mg/
kg/day in the developmental neurotoxicity study (decrease in offspring
body weight and delayed time to preputial separation) were equivocal.
EPA, using a conservative approach, established the LOAEL for offspring
developmental toxicity at 0.9 mg/kg/day with the understanding that
these effects, although statistically significant, were marginal and
appeared to define a threshold response level. This conservative
approach resulted in the NOAEL for offspring developmental toxicity
(0.05 mg/kg/day) being lower than the NOAEL for maternal toxicity (0.9
mg/kg/day) giving an appearance of increased susceptibility. Second,
the findings in the developmental neurotoxicity study were not
supported by the overall weight-of-the-evidence from the fipronil
database. Evaluation of the database indicated that:
     The offspring body weight findings in the developmental
neurotoxicity study are not supported by the results of the 2-
generation reproduction study in rats at similar treatment levels.
     Increased susceptibility to the offspring was not
demonstrated following prenatal and/or postnatal dosing in the prenatal
developmental toxicity study nor the 2-generation reproduction study in
rats.
     No increased susceptibility was seen in the prenatal
developmental toxicity study in rats following in utero exposure to the
photodegradate, MB46513.
More specific information may be found in the referenced document,
``Fipronil: Third Reevaluation--Report of the Hazard Identification
Assessment Review Committee, December 6, 2000,'' available in the
docket established by this action, as noted in this unit.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    i. The toxicity database for fipronil is complete for food use.
    ii. The weight of the evidence does not indicate that there is
increased sensitivity in young animals. In any event, there is a clear
NOAEL identified in the one study where there was an appearance of
sensitivity in the young. The degree of concern for prenatal and/or
postnatal toxicity is low.
    iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% crop treated (CT) and anticipated residues were used as
described in this unit. They are based in reliable data and will not
underestimate the exposure and risk. Conservative ground and surface
water modeling estimates were used. Similarly conservative Residential
Standard Operating Procedures (SOPs) were used to assess post-
application exposure to children as well as incidental oral exposure of
toddlers. These assessments will not underestimate the exposure and
risks posed by fipronil.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the (``aPAD'') and (``cPAD'').
The aPAD and cPAD are calculated by dividing the level of concern (LOC)
by all applicable uncertainty/safety factors. For linear

cancer risks, EPA calculates the probability of additional cancer cases
given aggregate exposure. Short-term, intermediate-term, and long-term
risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable
uncertainty/safety factors 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 fipronil will occupy 25% of the aPAD for the population group
(children 1-2 years old) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to fipronil
from food and water will utilize 96% of the cPAD for the population
group (children (1-2 years old). Based the use pattern, chronic
residential exposure to residues of fipronil is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Fipronil is currently registered for use that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for fipronil.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential
exposures aggregated result in aggregate MOEs as follows: The short-
term aggregate risk assessment takes into account average exposure
estimates from dietary consumption of fipronil (food and drinking
water) and non-occupational exposures (pet uses). Postapplication
exposure from the use on pets is considered short-term. Therefore, a
short-term aggregate risk assessment was conducted, using children with
combined dermal and oral exposures from pet uses as a worst case. Table
3 of this unit summarizes the results. Since the LOC is different for
oral and dermal exposures, 300 and 100, respectively, the Aggregate
Risk Index (ARI) method was used to determine short-term aggregate
risk. The aggregate ARI from food, water, and non-occupational
exposures is 1.5. Therefore, short-term aggregate risk estimates do not
exceed the Agency's level of concern (i.e. ARIs greater than or equal
to 1). Adult post-application risk is considered negligible and so an
aggregate risk assessment for adults is not considered necessary.

                                                             Table 3.--Aggregate Short-Term
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Food + Water                  Oral                     Dermal
                    Population                    ------------------------------------------------------------------------------   ARI \3\Aggregate \4\
                                                     LOC \1\      MOE \2\        LOC          MOE          LOC          MOE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                   300          532          300        3,300          100        5,000                      1.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ LOC=Level of Concern
\2\ MOE= NOAEL (or LOAEL)/exposure
\3\ ARI=MOE Calculated/MOELOC
\4\ARI=Aggregate= 1/((1/ARIfood)+(1/ARIoral)+(1/ARIdermal)).

    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Fipronil is currently registered for use(s) that could result in
intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for fipronil.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food, water, and
residential exposures aggregated result in aggregate MOEs as follows:
Intermediate-term risk to children is not expected to be higher than
short-term risk due to the lack of inhalation exposure and a soil
ingestion MOE of 1 million.
    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 fipronil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method EC-95-303) 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) established for fipronil + metabolites MB46136 and MB45950 +
photodegradate MB46513 on the commodities included in this request.

C. Response to Comments

    One comment was received from a private citizen who opposes the
approval of any pesticide that leaves a residue on food. The comment
contained no specific information pertaining to fipronil but was
limited to general claims such as EPA was providing inadequate
protection for Americans. The Agency has received the same comment from
this commenter on numerous previous occasions and rejects it for the
reasons previously stated in the Federal Registers of January 7, 2005
(70 FR 1349) (FRL-7691-4), June 30, 2005 (70 FR 37686) (FRL-7718-3),
and October 29, 2004 (69 FR 63096) (FRL-7681-9).

V. Conclusion

    Therefore, the tolerances are established for combined residues of
fipronil (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-4-
[(trifluoromethyl)sulfinyl]-1H-pyrazole-3-carbonitrile) and its two
metabolites MB45950 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)thio]-1H-pyrazole-3-
carbonitrile) and MB46136 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)sulfonyl]-1H-pyrazole-3-
carbonitrile) and its photodegradate MB46513 (5-amino-1-(2,6-dichloro-
4-(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-
carbonitrile), in or on potato at 0.03 ppm, potato, wet peel at 0.1 ppm
and indirect or inadvertent residues of fipronil and its metabolites
and its degradate on wheat, forage at 0.02 ppm, wheat, grain at 0.005
ppm, wheat, hay at 0.03 ppm, and wheat, straw at 0.03 ppm. Time-limited
tolerances are also

established for combined residues of fipronil and its metabolites and
degradate on turnip at 1.0 ppm and rutabaga at 1.0 ppm.
    The registrant petitioned for tolerances on vegetable, tuberous
corm, subgroup 1C. In evaluating this petition, the Agency determined
that planting methods associated with the different members of crop
subgroup vegetable, tuberous corm, subgroup 1C result in different
amounts of fipronil and its metabolites and degradate being loaded into
the environment. Further, because of the planting depth of potatoes,
the environmental loading of fipronil and its metabolites and degradate
is expected to be lower for potatoes than other members of vegetable
tuberous corm crop group 1C and is expected to be below levels of
concern. For this reason, the Agency is establishing tolerances only
for potato and the rotational crop wheat at this time. The Agency is
working to resolve these issues as they relate to other members of
vegetable tuberous corm crop group 1C.

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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) 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, or are established under
section 408(l)(6) of FFDCA, such as the tolerances 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 6,
2000) do not apply to this rule. In addition, This 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: August 3, 2007.
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. 517 is amended by alphabetically adding commodities to
the table in paragraph (a) and by adding text to paragraphs (b) and (d)
to read as follows:

Sec.  180.517  Fipronil; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Potato.........................................                     0.03
Potato, wet peel...............................                     0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are
established for combined residues of the insecticide, fipronil, 5-
amino-1-(2,6-dichloro-4-(trifluoromethyl) phenyl)-4-((1,R,S)-
trifluoromethyl)sulfinyl)-1-H-pyrazole-3-carbonitrile and its 2
metabolites MB45950 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)thio]-1H-pyrazole-3-
carbonitrile) and MB46136 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)sulfonyl]-1H-pyrazole-3-
carbonitrile) and its photodegradate MB46513 (5-amino-1-(2,6-dichloro-
4-(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-
carbonitrile), in connection with use of the pesticide under Section 18
emergency exemptions granted by EPA. The tolerances expire and are
revoked on the dates specified in the table for this paragraph.

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Rutabaga......................................          1.0     12/31/10
Turnip........................................          1.0     12/31/10
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established
for combined indirect or inadvertent residues of the insecticide
fipronil and its metabolites and photodegradate in or on food
commodities when present therein as a result of the application of
fipronil to growing crops listed in paragraphs (a) and (b) of this
section and other nonfood crops to read as follows:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Wheat, forage..................................                     0.02
Wheat, grain...................................                    0.005
Wheat, hay.....................................                     0.03
Wheat, straw...................................                     0.03
------------------------------------------------------------------------

[FR Doc. E7-16621 Filed 8-21-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: October 1, 2009 (Volume 74, Number 189)]
[Rules and Regulations]
[Page 50692-50695]
[DOCID:fr01oc09-7]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1363; Directorate Identifier 2008-NM-104-AD;
Amendment 39-16032; AD 2009-20-09]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 767-200, -300, and -300F
Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Boeing Model 767-200, -300, and -300F series airplanes. This AD
requires repetitive inspections for fatigue cracking and corrosion of
the upper link

fuse pin of the nacelle struts, and related investigative and
corrective actions if necessary. This AD also provides terminating
action for the repetitive inspections. This AD results from two reports
of cracked upper link fuse pins. We are issuing this AD to prevent
fatigue cracking or corrosion of the upper link fuse pin, which could
result in failure of the fuse pin and consequent reduced structural
integrity of the nacelle strut and possible separation of the strut and
engine from the airplane during flight.

DATES: This AD is effective November 5, 2009.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of November 5,
2009.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1, fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; 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 (telephone<PHONE_NUMBER>) is the Document 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: Berhane Alazar, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6577; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
certain Boeing Model 767-200, -300, and -300F series airplanes. That
NPRM was published in the Federal Register on January 12, 2009 (74 FR
1155). That NPRM proposed to require repetitive inspections for fatigue
cracking and corrosion of the upper link fuse pin of the nacelle
struts, and related investigative and corrective actions if necessary.
That NPRM also proposed to provide terminating action for the
repetitive inspections.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received.

Support for the AD

    Boeing concurs with the content of the NPRM. Air Transport
Association (ATA) on behalf of its members Delta Airlines and United
Airlines (UAL) agrees with the intent of the NRPM, and provides the
following recommendations from its members.

Request to Add a Note of Clarification

    Delta asks that we revise the NPRM to include a note in the AD
which specifies that the upper link inspections can be done with the
pylon and/or engine in any position. Delta states that Boeing Alert
Service Bulletin 767-54A0074, Revision 1, dated April 24, 2008,
specifies doing a visual inspection with ``the fuse pin in place,
without engine removal and strut removal.'' Delta notes that there are
times when engines or pylons are removed for other reasons, and it
would prefer not to wait until the engine and strut are reinstalled.
Delta states that the procedures specified in Boeing Alert Service
Bulletin 767-54A0074, Revision 1, dated April 24, 2008, allow fuse pin
inspections with the engines and pylons in any position. Delta adds
that related service information, Boeing Telex 1-1154785301, dated
January 21, 2009 (released after the NPRM was issued), specifies that
the upper link inspections can be done with the pylon and/or engine in
any position.
    We agree with the commenter's request. For the reasons provided by
Delta, we have included a new Note 1 after paragraph (f) of this AD to
specify that the upper link inspections can be done with the pylon and/
or engine in any position.

Request to Define ``References''

    Delta asks that we revise the NPRM to include a note to clarify
that the ``References'' column in the table in Figure 2 of Boeing Alert
Service Bulletin 767-54A0074, Revision 1, dated April 24, 2008, should
be treated as ``refer to'' material (which is information that provides
guidance for using related procedures), as defined in Note 9 of
paragraph 3.A. of that service bulletin. Delta points out that the
procedures in Boeing Telex 1-1154785301, dated January 21, 2009,
specify that the airplane maintenance manual (AMM) and standard
operating procedures manual (SOPM) are identified in the ``References''
column of that table as ``refer to'' material so that operator
equivalent procedures may be used.
    We agree that the material in the ``References'' column in the
table in Figure 2 of Boeing Alert Service Bulletin 767-54A0074,
Revision 1, dated April 24, 2008, refers to the procedures in the
specified manuals and should be treated as guidance for using related
procedures. However, to add a note to this AD could be confusing
because none of the paragraphs in the AD refer to the procedures in
those manuals. Therefore, we have made no change to the AD in this
regard.

Request to Add a Note Clarifying Application of Primer

    Delta asks that we revise the NPRM to include a note to clarify
that re-application of primer in accordance with Steps 4.b.(1) and
4.b.(2) of the Accomplishment Instructions of Boeing Alert Service
Bulletin 767-54A0074, Revision 1, dated April 24, 2008, is necessary
only to touch up bare areas of the fuse pin. Delta states that
paragraph 3.B, Step 4.b., of the Accomplishment Instructions of Boeing
Alert Service Bulletin 767-54A0074, Revision 1, dated April 24, 2008,
specifies applying two coats of Boeing Material Specification (BMS) 10-
11 primer after each inspection if no cracks are found during the
inspection. Delta notes that the procedure does not specify ``touching
up primer'' but rather applying two coats each time. Delta adds that
since the repeat inspection interval is much shorter, the fuse pin will
have ten coats of primer built up over the next ten years, and asserts
that the inspection cannot be done through ten coats of primer. Delta
points out that Boeing has confirmed in Boeing Telex 1-1154785301,
dated January 21, 2009, that two coats of primer are required only to
touch up bare areas on the fuse pin.
    We agree that clarification is necessary for the reasons provided
by Delta. We have included a new Note 2 after paragraph (f) of this AD
to specify that two coats of primer are necessary only to touch up bare
areas of the fuse pin.

Request to Provide Credit for Inspections Done Using Previous Service
Information

    UAL asks that operators be given credit for inspections done before
the effective date of the AD in accordance with Boeing Service Bulletin
767-54-0074, dated March 27, 1997. UAL notes

that paragraph (h) of the NPRM provides credit for the replacement of
fuse pins done in accordance with Boeing Service Bulletin 767-54-0074,
dated March 27, 1997, but does not provide credit for the inspections,
even though the procedures in the original issue and Revision 1 of the
service bulletin are the same.
    We agree with the commenter. We have confirmed that inspections
done before the effective date of this AD in accordance with Boeing
Service Bulletin 767-54-0074, dated March 27, 1997, are acceptable for
compliance with the inspection requirements of paragraph (f) of this
AD. However, we point out that Boeing Service Bulletin 767-54-0074,
dated March 27, 1997, allows the use of operator's equivalent
procedures, which Boeing Service Bulletin 767-54-0074, Revision 1,
dated April 24, 2008, does not allow. Therefore, we have revised
paragraph (h) of this AD to give credit for inspections done before the
effective date of this AD in accordance with Boeing Service Bulletin
767-54-0074, dated March 27, 1997, provided that the inspection was not
done using operator's equivalent procedures.

Request to Clarify Certain Language in Paragraph (h) of the NPRM

    UAL suggests that paragraph (h) of the NPRM be revised to clarify
the meaning of ``corresponding requirements.'' UAL states that
paragraph (h) of the NPRM specifies that replacement of the fuse pins
in accordance with Boeing Service Bulletin 767-54-0074, dated March 27,
1997, is acceptable for compliance with the ``corresponding
requirements'' of this AD. UAL notes that the phrase ``for compliance
with the `corresponding requirements' of this AD'' is very vague.
    We agree that clarification is necessary for the reasons provided
by the commenter. We have changed paragraph (h) of this AD to refer to
paragraph (f) of this AD for the inspections and paragraph (g) of this
AD for the modification.

Request to Extend Grace Period

    Aeroflot asks that we increase the grace period for the inspections
so that operators can prepare for accomplishment of the requirements in
the AD. Aeroflot states that it is convenient to plan the work with
common access SC-Checks, and adds that the NPRM gives a simple C-Check
preparation period. Aeroflot states that this work has an economic
impact with the time used in preparation and gaining access.
    We do not agree with the commenter's request. In developing an
appropriate compliance time for this AD, we considered not only the
safety implications, but the manufacturer's recommendations, and the
practical aspect of accomplishing the actions within an interval of
time that corresponds to typical scheduled maintenance for affected
operators. However, under the provisions of paragraph (i) of this AD,
we may consider requests for adjustments to the compliance time if data
are submitted to substantiate that such an adjustment would provide an
acceptable level of safety. We have made no change to the AD in this
regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously. We also determined that
these changes will not increase the economic burden on any operator or
increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 354 airplanes of U.S. registry. We
also estimate that it will take 4 work-hours per product to comply with
this AD. The average labor rate is $80 per work-hour. Based on these
figures, we estimate the cost of this AD to the U.S. operators to be
$113,280, or $320 per product.

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), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance 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

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2009-20-09 Boeing: Amendment 39-16032. Docket No. FAA-2008-1363;
Directorate Identifier 2008-NM-104-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective November 5,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 767-200, -300, and -300F
series airplanes, certificated in any category; as identified in
Boeing Alert Service Bulletin 767-54A0074, Revision 1, dated April
24, 2008.

Unsafe Condition

    (d) This AD results from two reports of cracked upper link fuse
pins. We are issuing this AD to prevent fatigue cracking or
corrosion of the upper link fuse pin, which could result in failure
of the fuse pin and consequent reduced structural integrity of the
nacelle strut and possible separation of the strut and engine from
the airplane during flight.

Compliance

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

Initial and Repetitive Inspections/Investigative and Corrective Actions

    (f) Inspect the upper link fuse pin of the nacelle struts for
fatigue cracking and corrosion at the applicable time specified in
Table 1 of this AD. Do the applicable inspection by doing all the
applicable actions specified in the Accomplishment Instructions of
Boeing Alert Service Bulletin 767-54A0074, Revision 1, dated April
24, 2008; and do all applicable related investigative and corrective
actions before further flight. Repeat the applicable inspection at
intervals not to exceed 3,000 flight cycles or 24 months, whichever
is first, until the requirements of paragraph (g) of this AD have
been done.

                        Table 1--Compliance Times
------------------------------------------------------------------------
                                At the later of:
         Engine type           initial inspection       Grace period
                                    threshold
------------------------------------------------------------------------
JT9D........................  14,000 total flight   Within 3,000 flight
                               cycles.               cycles or 18 months
                                                     after the effective
                                                     date of this AD,
                                                     whichever is first.
CF6-80A.....................  24,000 total flight   Within 3,000 flight
                               cycles.               cycles or 18 months
                                                     after the effective
                                                     date of this AD,
                                                     whichever is first.
PW4000......................  8,000 total flight    Within 3,000 flight
                               cycles.               cycles or 18 months
                                                     after the effective
                                                     date of this AD,
                                                     whichever is first.
CF6-80C2....................  10,000 total flight   Within 3,000 flight
                               cycles.               cycles or 18 months
                                                     after the effective
                                                     date of this AD,
                                                     whichever is first.
RB211.......................  24,000 total flight   Within 3,000 flight
                               cycles.               cycles or 18 months
                                                     after the effective
                                                     date of this AD,
                                                     whichever is first.
------------------------------------------------------------------------

    Note 1: The upper link inspections can be done with the pylon
and/or engine in any position.

    Note 2: In paragraph 3.B, Steps 4.b.(1)(a) and
4.b.(2)(b)2){a{time}  of the Accomplishment Instructions of Boeing
Alert Service Bulletin 767-54A0074, Revision 1, dated April 24,
2008, the procedures specify to apply two layers of Boeing Material
Specification (BMS) 10-11 primer to the inside surface of the fuse
pin if no crack indication is found. However, two layers of primer
are only necessary to touch up bare areas on the fuse pin if no
crack indication is found.

Terminating Action in AD 2000-19-09, Amendment 39-11910, and AD 2004-
16-12, Amendment 39-13768

    (g) Accomplishment of the modification specified in paragraph
(g)(1) or (g)(2) of this AD, as applicable, terminates the
inspections required by paragraph (f) of this AD.
    (1) For Model 767 series airplanes powered by Rolls-Royce RB211
series engines, as identified in AD 2000-19-09: Modification of the
nacelle strut and wing structure, as required by paragraphs (a) and
(b) of AD 2000-19-09.
    (2) For Model 767-200, -300, and -300F series airplanes powered
by Pratt & Whitney and General Electric engines, as identified in AD
2004-16-12: Modification of the nacelle strut and wing structure, as
required by paragraphs (a), (b), (d), and (e) of AD 2004-16-12.

Credit for Actions Done Using Previous Service Information

    (h) Inspection of the fuse pins before the effective date of
this AD in accordance with Boeing Service Bulletin 767-54-0074,
dated March 27, 1997, is acceptable for compliance with the
inspections required by paragraph (f) of this AD if the inspections
are accomplished without using an operator's equivalent procedure.
Replacement of the fuse pins with new fuse pins before the effective
date of this AD in accordance with Boeing Service Bulletin 767-54-
0074, dated March 27, 1997, is acceptable for compliance with the
modification required by paragraph (g) of this AD.

Alternative Methods of Compliance (AMOCs)

    (i)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, ATTN: Berhane Alazar, Aerospace Engineer, Airframe Branch, ANM-
120S, FAA, Seattle ACO, 1601 Lind Avenue, SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Or, e-mail information to 9-ANM-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (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 an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who 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, and the approval must specifically refer to this
AD.

Material Incorporated by Reference

    (j) You must use Boeing Alert Service Bulletin 767-54A0074,
Revision 1, dated April 24, 2008; to do the actions required by this
AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1, fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on September 18, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-23506 Filed 9-30-09; 8:45 am]

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