[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Rules and Regulations]
[Page 25528-25533]
[DOCID:fr07my08-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2004-0306; FRL-8361-4]

Pyridalyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
pyridalyl in or on vegetables, leafy, except Brassica, group 4;
Brassica, head and stem, subgroup 5A; vegetables, fruiting, group 8;
mustard greens; and turnip greens. Valent U.S.A. Corporation and the
International Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 7, 2008. Objections and
requests for hearings must be received on or before July 7, 2008, 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-2004-0306. 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: Olga Odiott, Registration Division
(7505P),

Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 308-9369; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

    In addition to accessing 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-2004-0306 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 July 7, 2008.
    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-2004-0306, 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 Tolerance

    In the Federal Register of December 5, 2003 (68 FR 68044) (FRL-
7344-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
2F6459 and 3E6592) (petition 3E6592 was inadvertently referred to as
2E6592 in the December, 2003 FR notice) by Valent U.S.A. Corporation,
1600 Riviera Ave., Suite 200, Walnut Creek, California 94596-8025 and
the International Research Project Number 4 (IR-4), 681 U.S Highway
1 South, North Brunswick, NJ, 08902-3390. Petition 2F6459
requested that 40 CFR 180 be amended by establishing tolerances for
residues of the insecticide pyridalyl, (pyridine, 2-[3-[2,6-dichloro-4-
[(3,3-dichloro-2-propenyl)oxy]phenoxy]propoxy]-5-(trifluoromethyl), in
or on vegetables, leafy, except Brassica, group 4, at 20.0 parts per
million (ppm); vegetables, fruiting, group 8, at 1.1 ppm; Brassica,
head and stem, subgroup 5A, at 5.0 ppm; cotton seed at 0.4 ppm; meat at
0.04 ppm; meat by-products at 0.05 ppm; animal fat at 1.0 ppm; and
whole milk at 0.1 ppm; and to establish tolerances for residues of
pyridalyl plus the metabolite 3,5-dichloro-4-[3-(5-trifluoromethyl-2-
pyridyloxy)]propoxy phenol (S-1812-DP) in or on the raw agricultural
commodity cotton, gin byproducts at 23.0 ppm. Petition 3E6592 requested
that 40 CFR 180 Part be amended by establishing tolerances for residues
of pyridalyl in or on the raw agricultural commodities: Brassica, leafy
greens, subgroup 5B, at 30 ppm; and turnip greens at 30 ppm. That
notice referenced a summary of the petition prepared by Valent U.S.A.
Corporation, the registrant, which is available to the public 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 petitions, EPA has
determined that the proposed tolerances for Brassica, head and stem,
subgroup 5A, and vegetables, fruiting, group 8, should be reduced to
3.5 ppm; and 1.0 ppm respectively; that a tolerance for mustard greens
at 30 ppm; should be proposed; and that the proposed tolerance for
Brassica, leafy greens, subgroup 5B should be deleted. The reasons for
these changes are explained in Unit IV.C. The Agency is evaluating
additional environmental fate data and has not yet made a decision to
register the outdoor uses associated with the proposed tolerances for
cotton and related commodities. A decision to establish these
tolerances will be made at such time when the Agency makes the
determination to register these outdoor uses.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a

reasonable certainty that no harm will result to infants and children
from aggregate exposure to the pesticide chemical residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the following
petitioned-for tolerances for residues of pyridalyl per se in or on
vegetables, leafy, except Brassica, group 4, at 20 ppm; Brassica, head
and stem, subgroup 5A at 3.5 ppm; vegetables, fruiting, group 8, at 1.0
ppm; mustard greens at 30 ppm; and turnip greens at 30 ppm. EPA's
assessment of exposures and risks associated with establishing
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Pyridalyl has low acute toxicity via the oral, dermal and
inhalation routes of exposure but is a dermal sensitizer. There was no
evidence of neurotoxicity seen in either the sub-chronic and chronic
toxicity studies or the developmental and reproductive studies. There
is low concern for prenatal and/or postnatal toxicity resulting from
exposure to pyridalyl. Pyridalyl is classified as ``Not Likely to be
Carcinogenic to Humans'' based on lack of carcinogenicity in mice and
rats and overall negative findings in various mutagenicity studies.
    Specific information on the studies received and the nature of the
adverse effects caused by pyridalyl 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 pyridalyl in/on cotton, fruiting
vegetables, leafy vegetables, head and stem Brassica vegetables,
Brassica leafy greens, and turnip greens, shrubs, ornamentals and non-
bearing trees. HED Risk Assessment on page number 26 in docket ID
number EPA-HQ-OPP-2004-0306.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed 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 or a Benchmark Dose (BMD) approach is sometimes used for
risk assessment. Uncertainty/safety factors (UFs) are used in
conjunction with the POD to take into account uncertainties inherent in
the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. Safety is assessed for acute and chronic dietary
risks by comparing aggregate food and water exposure to the pesticide
to the acute population adjusted dose (aPAD) and chronic population
adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the
POD by all applicable UFs. Aggregate short-term, intermediate-term, and
chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for pyridalyl used for
human risk assessment is shown in Table 1 of this unit.

      Table 1.--Summary of Toxicological Doses and Endpoints for Pyridalyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of    An effect of concern attributable to a single exposure (dose) was not
 age)                                    identified from the oral toxicity studies, including the developmental
Acute dietary (general population                         toxicity studies in rats and rabbits.
 including infants and children).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)      NOAEL= 3.4 mg/kg/day     cPAD = 0.034 mg/kg/day          Combined chronic
                                       UFA = 10x..............                                         toxicity/
                                       UFH = 10x..............                            carcinogenicity study-
                                       FQPA SF = 1x...........                                              rats
                                                                                LOAEL = 17.1 miligrams/
                                                                                kilogram/day (mg/kg/
                                                                                day) on males and 21.1
                                                                                mg/kg/day on females
                                                                                based on decreased body
                                                                                weights, weight gain,
                                                                                and food efficiency.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)              Classified as ``Not likely to be Carcinogenic to Humans''
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a =
  acute, c = chronic). RfD = reference dose. LOC = level of concern.

C. Exposure Assessment

    Pyridalyl residues of concern for tolerance expression and risk
assessment were determined to be: 3,5-dichloro-4-[3-(5-trifluoromethyl-
2-pyridyloxy)]propoxy phenol (S-1812-DP), 2-hydroxy-5-
trifluoromethylpyridine (HTFP), and 3-hydroxy-5-trifluoromethylpyridone
(HPDO).
    Pyridalyl is the predominant residue in crops and livestock. S-
1812-DP is the only major metabolite observed in any of the metabolism
studies and is found at significant levels in the cotton gin byproduct
field trials. The toxicity of S-1812-DP is assumed to be comparable to
the parent compound.
    Rotational crops did not take up parent pyridalyl or its metabolite
S-1812-DP from the soil, but did take up metabolite HTFP. HTFP was then
metabolized in rotational crops via oxidation to HPDO. Metabolites HTFP
and HPDO are assumed to be of equivalent toxicity to the parent
compound and are included as residues of concern.
    Pyridalyl is expected to be persistent in both soil and aquatic
environments. However, S-1812-DP and HTFP, the major metabolites in the
terrestrial field-dissipation studies, are expected to be more soluble
and mobile than the parent compound, and therefore are included in the
drinking water assessment.
    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyridalyl, EPA considered exposure under the petitioned-for
tolerances for pyridalyl. EPA assessed dietary exposures from pyridalyl
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
pyridalyl; 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 United States
Department of Agricuulture (USDA) 1994-1996 and 1998 Continuing Surveys
of Food Intake by Individuals (CSFII). As to residue levels in food,
EPA used tolerance level residues and 100 percent crop treated (PCT)
information for all commodities. In addition, Dietary Exposure
Evaluation (DEEM/TM) (version 7.76) default processing
factors were used for all processed commodities.
    iii. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for pyridalyl.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for pyridalyl in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of pyridalyl. 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.
    The Agency used estimated environmental concentrations (EECs),
which are the model estimates of a pesticide's concentration in water,
to quantify pyridalyl drinking water exposure and risk as a Percent
Reference Dose (%RfD) or %PAD. Drinking water levels of comparison
(DWLOCs) were calculated and used as a point of comparison against the
model estimates of the pesticide's concentration in water. DWLOCs are
theoretical upper limits on a pesticide's concentration in drinking
water in light of total aggregate exposure to a pesticide in food, and
from residential uses. Since DWLOCs address total aggregate exposure to
pyridalyl they are further discussed in the aggregate risk sections in
Unit E.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models the EECs of pyridalyl for chronic exposures are estimated
to be 1.64 parts per billion (ppb) for surface water and 3.4 ppb for
ground 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).
    Pyridalyl 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 pyridalyl to share a common mechanism of toxicity
with any other substances, and pyridalyl does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that pyridalyl 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. There was low concern for
the quantitative susceptibility in the 2-generation reproduction study,
since there was clear NOAEL for the offspring toxicity, the effects of
concern were well defined and used for risk assessment. Therefore,
there are no concerns and no residual uncertainties with regard to
prenatal and/or postnatal toxicity.
    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 pyridalyl is complete.
    ii. There is no indication that pyridalyl is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There are no concerns and no residual uncertainties with
regard to prenatal and/or postnatal toxicity.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground water and surface water modeling
used to assess exposure to pyridalyl in drinking water. These

assessments will not underestimate the exposure and risks posed by
pyridalyl.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to pyridalyl from food,
drinking water, and residential uses, the Agency calculated DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)]. This allowable exposure
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic term, and cancer.
    When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute 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,
pyridalyl 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 exposure to pyridalyl
from food will utilize 35% of the cPAD for the U.S. population, 20% of
the cPAD for all infants, and 59% of the cPAD for children 1-2 years
old, the children subpopulation at greatest exposure. There are no
residential uses for pyridalyl. There is potential for chronic dietary
exposure to pyridalyl and its metabolites in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface water and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table:

                                   Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyridalyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Surface       Ground
            Population Subgroup                                  cPAD mg/kg/day                          %cPAD        Water        Water       Chronic
                                                                                (Food)     EECa(ppb)    EECb(ppb)   DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                                                0.034           35         1.64          3.4          780
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (< 1 yr)                                                                           0.034           20         1.64          3.4          270
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 yrs.                                                                              0.034           59         1.64          3.4          140
--------------------------------------------------------------------------------------------------------------------------------------------------------
a Tier II PRZM-EXAMS - Index reservoir model, pyridalyl plus HTFP and S-1812-DP.
b Tier 1 SCI-GROW model, HTFP (highest value).

    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Pyridalyl is not registered for any use patterns that would result
in residential exposure. Therefore, the short-term aggregate risk is
the sum of the risk from exposure to pyridalyl through food and water
and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Pyridalyl is not registered for any use patterns that would result
in intermediate-term residential exposure. Therefore, the intermediate-
term aggregate risk is the sum of the risk from exposure to pyridalyl
through food and water, which has already been addressed, and will not
be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Pyridalyl is
classified as ``not likely to be carcinogenic to humans'' by all
relevant routes of exposure based on adequate studies in mice and rats
and overall negative findings in various mutagenicity assays.
Therefore, pyridalyl is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to pyridalyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/nitrogen-
phosphorus detector (GC/NPD) methods RM-38P-1-1, RM-38M-1, and RM-38M-
1-1 for plant commodities; and RM-38P-2 and RM-38P-3-1 for livestock
commodities) is available to enforce the tolerance expression. The
methods 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>FDA multiresidue methods (protocols B, D, E,
and F) are also available for enforcement of the tolerances (PAM Vol.I,
Appendix II, 1/94).

B. International Residue Limits

    There are currently no U.S. or international Codex tolerances
established for pyridalyl.

C. Revisions to Petitioned-For Tolerances

    Based on its review of submitted crop field trial data, EPA
determined that the proposed tolerances for Brassica head and stem,
subgroup 5A; and for fruiting vegetables, group 8 should be reduced to
3.5 and 1.0 ppm, respectively. The Agency determined also that the data
were not sufficient to support the proposed tolerance for Brassica
leafy greens, subgroup 5B; although a mustard green tolerance at 30 ppm
was supported by the data.

V. Conclusion

    Therefore, tolerances are established for residues of pyridalyl per
se, in or on vegetables, leafy, except Brassica, group 4 at 20 ppm;
Brassica, head and stem, subgroup 5A at 3.5 ppm; vegetables, fruiting,
group 8 at 1.0 ppm; mustard greens at 30 ppm; and turnip greens at 30
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, 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 23, 2008.
Debra Edwards,
Director, 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 180.640 is added to read as follows:

180.640  Pyridalyl; tolerances for residues.

    (a) General. Tolerances are established for residues of pyridalyl,
pyridine,2-[3-[2,6-dichloro-4-[(3,3-dichloro-2-
propenyl)oxy]phenoxy]propoxy]-5-(trifluoromethyl, in or on the
following raw agricultural commodities:)

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A.................                3.5
Mustard greens.......................................                 30
Turnip greens........................................                 30
Vegetable, fruiting, group 8.........................                1.0
Vegetables, leafy, except Brassica, group 4                           20
------------------------------------------------------------------------

    (b) Section 18 emergency exemption. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E8-9823Filed 5-6-08; 8:45 am]


[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Rules and Regulations]
[Pages 30713-30716]
[FR Doc No: 2014-12158]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 748

[Docket No. 140506409-4409-01]
RIN 0694-AG15

Amendments to Existing Validated End-User Authorizations in the
People's Republic of China: Samsung China Semiconductor Co. Ltd and
Semiconductor Manufacturing International Corporation

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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

SUMMARY: In this rule, the Bureau of Industry and Security (BIS) amends
the Export Administration Regulations (EAR) to revise existing
authorizations for Validated End-Users (VEUs) Samsung China
Semiconductor Co. Ltd. (Samsung China) and Semiconductor Manufacturing
International Corporation (SMIC) in the People's Republic of China
(PRC). Specifically, BIS amends Supplement No. 7 to part 748 of the EAR
to change the address of the facility used by Samsung China. In
addition, BIS adds a facility to the list of eligible destinations and
an item to the list of eligible items for SMIC.

DATES: This rule is effective May 29, 2014.

FOR FURTHER INFORMATION CONTACT: Karen Nies-Vogel, Chair, End-User
Review Committee, Bureau of Industry and Security, U.S. Department of
Commerce, 14th Street & Pennsylvania Avenue NW., Washington, DC 20230;
by telephone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>, or email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

Authorization Validated End-User

    Validated End-Users (VEUs) are designated entities located in
eligible destinations to which eligible items may be exported,
reexported, or transferred (in-country) under a general authorization
instead of a license. The names of the VEUs, as well as the dates they
were so designated, and their respective eligible destinations and
items are identified in Supplement No. 7 to part 748 of the Export
Administration Regulations (EAR). Under the terms described in that
supplement, VEUs may obtain eligible items without an export license
from the Bureau of Industry and Security (BIS), in conformity with
Section 748.15 of the EAR. Eligible items vary between VEUs, but may
include commodities, software, and technology, except those controlled
for missile technology or crime control reasons on the Commerce Control
List (CCL) (part 774 of the EAR).
    VEUs are reviewed and approved by the U.S. Government in accordance
with the provisions of Section 748.15 and Supplement Nos. 8 and 9 to
part 748 of the EAR. The End-User Review Committee (ERC), composed of
representatives from the Departments of State, Defense, Energy, and
Commerce, and other agencies, as appropriate, is responsible for
administering the VEU program. BIS amended the EAR in a final rule
published on June 19, 2007 (72 FR 33646) to create Authorization VEU.

Amendments to Existing Validated End-User Authorizations in the
People's Republic of China (PRC)

Revision to the List of ``Eligible Items (By ECCN)'' for Validated End-
User Samsung China Semiconductor Co. Ltd (Samsung China)

    This final rule amends Supplement No. 7 to part 748 of the EAR to
change the address of the Samsung China facility to which eligible
items may be exported, reexported or transferred (in-country) using
Authorization VEU. BIS makes this change pursuant to a request from
Samsung China advising BIS that Samsung China received verification of
the final address of its facility from the Chinese government. Samsung
China's VEU-eligible facility, which is located in an area being newly
developed for corporate use, has not moved. The list of eligible items
for Samsung China remains the same. BIS added Samsung China as a VEU in
Supplement No. 7 to part 748 in a rule published in the Federal
Register on July 10, 2013 (78 FR 41291).

Prior Address of Samsung China Destination:

Samsung China Semiconductor Co. Ltd., Xinglong Street, Chang'an
District, Xi'an, People's Republic of China 710065.

New Address for Samsung China:

Samsung China Semiconductor Co. Ltd., No. 1999, North Xiaohe Road,
Xi'an, China 710119.

Revisions to the List of ``Eligible Destinations'' and ``Eligible Items
(By ECCN)'' for Validated End-User Semiconductor Manufacturing
International Corporation (SMIC)

    This final rule also amends Supplement No. 7 to part 748 of the EAR
to add a facility to the list of SMIC facilities to which eligible
items may be exported, reexported or transferred (in-country) using
Authorization VEU, bringing the number of SMIC's VEU-authorized
facilities in the PRC to a total of five. BIS also adds an ECCN to
SMIC's list of eligible items that may be sent to the five facilities.
The ECCN added in this rule to SMIC's VEU authorization is ECCN 3A233
(certain types of mass spectrometers). BIS makes these changes pursuant
to requests from SMIC. SMIC requested the addition of the new VEU-
eligible destination in order to facilitate shipments to its new
business venture.

Additional SMIC Destination:

Semiconductor Manufacturing North China (Beijing) Corporation, No. 18
Wen Chang Road, Building 9, Beijing Economic-Technological Development
Area, Beijing, China 100176.

Eligible Items (by ECCN) That May Be Exported, Reexported or
Transferred (In-Country) to the Eligible Destination Identified Under
Semiconductor Manufacturing International Corporation Validated End-
User Authorization

    ECCNs 1C350.c.3, 1C350.d.7, 2B006.b.1, 2B230, 2B350.d.2,
2B350.d.3, 2B350.g.3, 2B350.i.3, 3A233, 3B001.a, 3B001.b, 3B001.c,
3B001.e, 3B001.f, 3C001, 3C002, 3C003, 3C004, 5B002, and 5E002
(limited to ``technology'' according to the General Technology Note
for the ``production'' of integrated circuits controlled by ECCN
5A002 that have been classified by BIS as eligible for License
Exception ENC under paragraph (b)(2) or (b)(3) of Section 740.17 of
the EAR, or classified by BIS as a mass market item under paragraph
(b)(3) of Section 748.15 of the EAR).

    Authorization VEU eliminates the burden on exporters and
reexporters of preparing individual license applications because the
export, reexport and transfer (in-country) of the eligible items
specified for each VEU may be made under general authorization instead
of under individual licenses.

Export Administration Act

    Since August 21, 2001, the Export Administration Act has been in
lapse and the President, through Executive Order 13222 of August 17,
2001 (3 CFR, 2001 Comp., p. 783 (2002)), as amended by Executive Order
13637 of March 8, 2013, 78 FR 16129 (March 13, 2013), and as extended
most recently by the Notice of August 8, 2013, 78 FR 49107 (August 12,
2013), has continued the EAR in effect under the International
Emergency Economic Powers Act. BIS continues to carry out the
provisions of the Export Administration Act, as appropriate and to the
extent permitted by law, pursuant to Executive Order 13222, as amended
by Executive Order 13637.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
This rule has been determined to be not significant for purposes of
Executive Order 12866.
    2. This rule involves collections previously approved by the Office
of Management and Budget (OMB) under Control Number 0694-0088, ``Multi-
Purpose Application,'' which carries a burden hour estimate of 43.8
minutes to prepare and submit form BIS-748; and for recordkeeping,
reporting and review requirements in connection with Authorization VEU,
which carries an estimated burden of 30 minutes per submission. This
rule is expected to result in a decrease in license applications
submitted to BIS. Total burden hours associated with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA) and OMB Control
Number 0694-0088 are not expected to increase significantly as a result
of this rule.
    Notwithstanding any other provisions of law, no person is required
to respond to, nor be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the PRA,
unless that collection of information displays a currently valid OMB
Control Number.
    3. This rule does not contain policies with Federalism implications
as that term is defined under Executive Order 13132.
    4. Pursuant to the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(B), BIS finds good cause to waive requirements that this rule be
subject to notice and the opportunity for public comment because they
are unnecessary. In determining whether to grant VEU designations, a
committee of U.S. Government agencies evaluates information about and
commitments made by candidate companies, the nature and terms of which
are set forth in 15 CFR part 748, Supplement No. 8. The criteria for
evaluation by the committee are set forth in 15 CFR 748.15(a)(2).
    The information, commitments, and criteria for this extensive
review were all established through the notice of proposed rulemaking
and public comment process (71 FR 38313 (July 6, 2006) (proposed rule),
and 72 FR 33646 (June 19, 2007) (final rule)). Given the similarities
between the authorizations provided under the VEU program and export
licenses (as discussed further below), the publication of this
information does not establish new policy. In publishing this final
rule, BIS updates the address of an existing VEU and adds an eligible
destination and an item to a second existing VEU. These changes have
been made within the established regulatory framework of the
Authorization VEU program. Further, this rule does not abridge the
rights of the public or eliminate the public's option to export under
any of the forms of authorization set forth in the EAR.
    Publication of this rule in other than final form is unnecessary
because the authorizations granted in the rule are consistent with the
authorizations granted to exporters for individual licenses (and
amendments or revisions thereof), which do not undergo public review.
In addition, as with license applications, VEU authorization
applications contain confidential business information, which is
necessary for the extensive review conducted by the U.S. Government in
assessing such applications. This information is extensively reviewed
according to the criteria for VEU authorizations, as set out in 15 CFR
748.15(a)(2). Additionally, just as the interagency reviews license
applications, the authorizations granted under the VEU program involve
interagency deliberation and result from review of public and non-
public sources, including licensing data, and

the measurement of such information against the VEU authorization
criteria. Given the nature of the review, and in light of the parallels
between the VEU application review process and the review of license
applications, public comment on this authorization and subsequent
amendments prior to publication is unnecessary. Moreover, because, as
noted above, the criteria and process for authorizing and administering
VEUs were developed with public comments, allowing additional public
comment on this amendment to individual VEU authorizations, which was
determined according to those criteria, is unnecessary.
    Section 553(d) of the APA generally provides that rules may not
take effect earlier than thirty (30) days after they are published in
the Federal Register. BIS finds good cause to waive the 30-day delay in
effectiveness under 5 U.S.C. 553(d)(3) because the delay would be
contrary to the public interest. BIS is simply amending the list of VEU
authorizations by adding a new end user, consistent with established
objectives and parameters administered and enforced by the responsible
designated departmental representatives to the End-User Review
Committee. Delaying this action's effectiveness could cause confusion
regarding which facilitates and items are authorized by the U.S.
Government and in turn stifle the purpose of the VEU Program.
Accordingly, it is contrary to the public interest to delay this rule's
effectiveness.
    No other law requires that a notice of proposed rulemaking and an
opportunity for public comment be given for this final rule. Because a
notice of proposed rulemaking and an opportunity for public comment are
not required under the APA or by any other law, the analytical
requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)
are not applicable. As a result, no final regulatory flexibility
analysis is required and none has been prepared.

List of Subjects in 15 CFR Part 748

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

    Dated: May 21, 2014.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
    Accordingly, part 748 of the EAR (15 CFR parts 730-774) is amended
as follows:

PART 748--[AMENDED]

0
1. The authority citation for 15 CFR part 748 continues to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 8, 2013, 78 FR
49107 (August 12, 2013).

0
2. Amend Supplement No. 7 to part 748 by:
0
a. Revising the the entry for ``Samsung China Semiconductor Co. Ltd.''
in ``China (People's Republic of)''; and
0
b. Revising the entry for ``Semiconductor Manufacturing International
Corporation'' in ``China (People's Republic of)'' to read as follows:

  Supplement No. 7 to Part 748--Authorization Validated End-User (VEU): List of Validated End-Users, Respective
                   Items Eligible for Export, Reexport and Transfer, and Eligible Destinations
----------------------------------------------------------------------------------------------------------------
                                                                                Federal Register
    Country      Validated end-user    Eligible items (By ECCN)     Eligible destination          citation
----------------------------------------------------------------------------------------------------------------
 Nothing in this Supplement shall be deemed to supersede other provisions in the EAR, including but not limited
                                              to Sec.   748.15(c).
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
                Samsung China         1C350.c.3, 1C350.d.7,      Samsung China              78 FR 41291, 7/10/
                 Semiconductor Co.     2B230, 2B350.d.2,          Semiconductor Co. Ltd.,    13.
                 Ltd                   2B350.g.3, 2B350.i.3,      No. 1999, North Xiaohe    78 FR 69535, 11/20/
                                       3A233, 3B001.a.1,          Road, Xi'an, China         13.
                                       3B001.b, 3B001.c,          710119.                   79 FR [INSERT PAGE
                                       3B001.e, 3B001.f,                                     NUMBER], 5/29/14.
                                       3B001.h, 3C002, 3C004,
                                       3D002, and 3E001
                                       (limited to
                                       ``technology'' for items
                                       classified under 3C002
                                       and 3C004 and
                                       ``technology'' for use
                                       consistent with the
                                       International Technology
                                       Roadmap for
                                       Semiconductors process
                                       for items classified
                                       under ECCNs 3B001 and
                                       3B002).
                Semiconductor         1C350.c.3, 1C350.d.7,      Semiconductor              72 FR 59164, 10/19/
                 Manufacturing         2B006.b.1, 2B230,          Manufacturing              07.
                 International         2B350.d.2, 2B350.d.3,      International (Shanghai)  75 FR 67029, 11/1/
                 Corporation.          2B350.g.3, 2B350.i.3,      Corporation, 18 Zhang      10.
                                       3A233, 3B001.a, 3B001.b,   Jiang Rd., Pudong New     77 FR 10953, 2/24/
                                       3B001.c, 3B001.e,          Area, Shanghai, China      12.
                                       3B001.f, 3C001, 3C002,     201203.                   78 FR 69535, 11/20/
                                       3C003, 3C004, 5B002, and  Semiconductor               13.
                                       5E002 (limited to          Manufacturing             79 FR [INSERT PAGE
                                       ``technology'' according   International (Tianjin)    NUMBER], 5/29/14.
                                       to the General             Corporation, 19 Xing Hua
                                       Technology Note for the    Avenue, Xi Qing Economic
                                       ``production'' of          Development Area,
                                       integrated circuits        Tianjin, China 300385..
                                       controlled by ECCN 5A002  Semiconductor
                                       that have been             Manufacturing
                                       classified by BIS as       International (Beijing)
                                       eligible for License       Corporation, No. 18 Wen
                                       Exception ENC under        Chang Road, Beijing
                                       paragraph (b)(2) or        Economic-Technological
                                       (b)(3) of Section 740.17   Development Area,
                                       of the EAR, or             Beijing, China 100176..
                                       classified by BIS as a    Semiconductor
                                       mass market item under     Manufacturing
                                       paragraph (b)(3) of        International (Shenzhen)
                                       Section 748.15 of the      Corporation, Qier Road,
                                       EAR).                      Export Processing Zone,
                                                                  Pingshan New Area,
                                                                  Shenzhen, China 518118..
----------------------------------------------------------------------------------------------------------------
                                                                 Semiconductor
                                                                  Manufacturing North
                                                                  China (Beijing)
                                                                  Corporation, No. 18 Wen
                                                                  Chang Road, Building 9,
                                                                  Beijing Economic-
                                                                  Technological
                                                                  Development Area,
                                                                  Beijing, China 100176.

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

[FR Doc. 2014-12158 Filed 5-28-14; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Rules and Regulations]
[Pages 25369-25372]
[FR Doc No: 2013-09114]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0936; Directorate Identifier 2011-NM-269-AD;
Amendment 39-17433; AD 2013-08-16]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 737-700 and -700C series airplanes. This AD
was prompted by reports of early fatigue cracks at chem-mill areas on
the crown skin panels. This AD requires repetitive inspections for
cracking of the fuselage skin at certain locations at chem-mill areas,
and repair if necessary. We are issuing this AD to detect and correct
fatigue cracking of the skin panel at the specified chem-mill step
locations, which could result in rapid decompression of the airplane.

DATES: This AD is effective June 5, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of June 5, 2013.

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

www.myboeingfleet.com. You may review copies of the referenced 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>.

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 (phone:<PHONE_NUMBER>) is 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: Wayne Lockett, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM published in the Federal Register on September 18, 2012 (77
FR 57536). That NPRM proposed to require repetitive inspections for
cracking of the fuselage skin at certain locations at chem-mill areas,
and repair if necessary.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(77 FR 57536, September 18, 2012) and the FAA's response to each
comment.

Request To Revise Federal Aviation Regulations Citations

    Boeing stated that references to section 129.109(c)(2) of the
Federal Aviation Regulations (14 CFR 129.109(c)(2)) are incorrect,
since that paragraph does not exist in the current revision of the
Federal Aviation Regulations, and that the correct paragraph reference
is section 129.109(b)(2). Boeing noted that this error occurred in the
second paragraph of the ``Differences Between the Proposed AD and the
Service Information'' section, and in Note 1 to paragraph (k) of the
proposed AD (77 FR 57536, September 18, 2012).
    We agree that the specified references are incorrect. We agree that
the citation in the proposed AD (77 FR 57536, September 18, 2012) is
inaccurate, but since that section of the preamble does not reappear in
this AD, no corresponding change to this AD is necessary. We have
corrected the citation in Note 1 to paragraph (k) of this AD.

Winglet Supplemental Type Certificate (STC) Comment

    Aviation Partners Boeing stated that the installation of winglets
per STC ST00830SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/408E012E008616A7862578880060456C?OpenDocument&Highlight=st00830se) does
not affect the actions specified in the NPRM (77 FR 57536, September
18, 2012).
    We concur. We have added paragraph (c)(2) to this AD to state that
installation of STC ST00830SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/408E012E008616A7862578880060456C?OpenDocument&Highlight=st00830se) does
not affect the ability to accomplish the actions required by this AD.
Therefore, for airplanes on which STC ST00830SE is installed, a
``change in product'' alternative method of compliance (AMOC) approval
request is not necessary to comply with the requirements of 14 CFR
39.17.

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 and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 57536, September 18, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 57536, September 18, 2012).
    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 545 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                    Labor cost         Parts cost       Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection of chem-mill step      37 work-hours x $85  None............  $3,145, per          $1,714,025, per
 locations.                        per hour = $3,145,                     inspection cycle.    inspection cycle.
                                   per inspection
                                   cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national

government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2013-08-16 The Boeing Company: Amendment 39-17433; Docket No. FAA-
2012-0936; Directorate Identifier 2011-NM-269-AD.

(a) Effective Date

    This AD is effective June 5, 2013.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to The Boeing Company Model 737-700 and -
700C series airplanes, certificated in any category, as identified
in Boeing Service Bulletin 737-53-1310, dated October 20, 2011.
    (2) Installation of Supplemental Type Certificate (STC)
ST00830SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/408E012E008616A7862578880060456C?OpenDocument&Highlight=st00830se)
does not affect the ability to accomplish the actions required by
this AD. Therefore, for airplanes on which STC ST00830SE is
installed, a ``change in product'' alternative method of compliance
(AMOC) approval request is not necessary to comply with the
requirements of 14 CFR 39.17.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by reports of early fatigue cracks at chem-
mill areas on the crown skin panels. We are issuing this AD to
detect and correct fatigue cracking of the skin panel at the
specified chem-mill step locations, which could result in rapid
decompression of the airplane.

(f) Compliance

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

(g) Inspections

    At the applicable time specified in paragraph 1.E.,
``Compliance,'' of Boeing Service Bulletin 737-53-1310, dated
October 20, 2011, except as required by paragraph (j) of this AD: Do
an external detailed inspection and an external nondestructive
inspection (a medium frequency eddy current (MFEC), magneto optic
imager (MOI), C-scan, or ultrasonic phased array (UTPA) inspection)
for cracking in the fuselage skin along the chem-mill steps at
certain locations specified in, and in accordance with, the
Accomplishment Instructions of Boeing Service Bulletin 737-53-1310,
dated October 20, 2011. Repeat the inspections thereafter at the
applicable times specified in paragraph 1.E., ``Compliance,'' of
Boeing Service Bulletin 737-53-1310, dated October 20, 2011.

(h) Repair

    If any cracking is found during any inspection required by
paragraph (g) of this AD, before further flight, repair the cracking
using a method approved in accordance with the procedures specified
in paragraph (l) of this AD. Accomplishing the repair approved in
accordance with the procedures specified in paragraph (l) of this AD
terminates the repetitive inspection requirement for that area under
the repair only.

(i) Optional Terminating Modification

    Modification of an inspection area, including an external
detailed inspection and an external nondestructive inspection (MFEC,
MOI, C-scan, or UTPA) for cracking of the area to be modified, and a
high frequency eddy current inspection of all existing holes for
cracking as applicable, in accordance with the Accomplishment
Instructions of Boeing Service Bulletin 737-53-1310, dated October
20, 2011, terminates the repetitive inspections required by
paragraph (g) of this AD for that modified area only. If any
cracking is found during any inspection described by this paragraph,
before further flight, repair the cracking using a method approved
in accordance with the procedures specified in paragraph (l) of this
AD.

(j) Service Bulletin Exception

    Boeing Service Bulletin 737-53-1310, dated October 20, 2011,
specifies compliance times ``after the original issue date of this
service bulletin.'' However, this AD requires compliance within the
specified compliance times ``after the effective date of this AD.''

(k) Post-Modification Inspections

    The post-modification inspections specified in Tables 2 through
7 of paragraph 1.E., ``Compliance,'' of Boeing Service Bulletin 737-
53-1310, dated October 20, 2011, are not required by this AD.

    Note 1 to paragraph (k) of this AD: The damage tolerance
inspections specified in Tables 2 through 7 of paragraph 1.E.,
``Compliance,'' of Boeing Service Bulletin 737-53-1310, dated
October 20, 2011, may be used in support of compliance with section
121.1109(c)(2) or 129.109(b)(2) of the Federal Aviation Regulations
(14 CFR 121.1109(c)(2) or 14 CFR 129.109(b)(2)). The actions
specified in Part 5 of the Accomplishment Instructions and
corresponding figures of Boeing Service Bulletin 737-53-1310, dated
October 20, 2011, are not required by this AD.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(m) Related Information

    For more information about this AD, contact Wayne Lockett,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Service Bulletin 737-53-1310, dated October 20, 2011.
    (ii) Reserved.

    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on April 4, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-09114 Filed 4-30-13; 8:45 am]
BILLING CODE 4910-13-P