[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Rules and Regulations]
[Pages 44504-44509]
[FR Doc No: 2017-20114]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9301; Product Identifier 2015-NM-193-AD; Amendment
39-19056; AD 2017-19-26]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2008-12-04,
which applied to certain The Boeing Company Model 737-600, -700, -700C,
-800, and -900 series airplanes. AD 2008-12-04 required various
repetitive inspections to detect cracks along the chem-milled steps of
the fuselage skin, and to detect missing or loose fasteners in the area
of a certain preventive modification or repairs; replacement of the
time-limited repair with a permanent repair, if applicable; and
applicable corrective actions which would end certain repetitive
inspections. This AD reduces the post-modification inspection
compliance times, limits installation of the preventive modification to
airplanes with fewer than 30,000 total flight cycles, and adds
repetitive inspections for modified airplanes. This AD was prompted by
an evaluation by the design approval holder (DAH) that indicated that
the upper skin panel at the chem-milled step above the lap joint is
subject to widespread fatigue damage (WFD) if the modification was
installed after 30,000 total flight cycles. We are issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective October 30, 2017.

    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 30,
2017.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
You may view this referenced service information at the FAA, Transport
Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>. It is
also available on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2016-9301.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9301; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Alan Pohl, Aerospace Engineer,
Airframe Section, FAA, Seattle ACO Branch, 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 supersede AD 2008-12-04, Amendment 39-15547 (73 FR 32991,
June 11, 2008) (``AD 2008-12-04''). AD 2008-12-04 applied to certain
The Boeing Company Model 737-600, -700, -700C, -800, and -900 series
airplanes. The NPRM published in the Federal Register on November 22,
2016 (81 FR 83745) (``the NPRM''). The NPRM was prompted by an
evaluation by the DAH that indicated that the upper skin panel at the
chem-milled step above the lap joint is subject to WFD if the
modification was installed after 30,000 total flight cycles. The NPRM
proposed to continue to require various repetitive inspections to
detect cracks along the chem-milled steps of the fuselage skin, and to
detect missing or loose fasteners in the area of the preventive
modification or repairs; replacement of the time-limited repair with a
permanent repair, if applicable; and applicable corrective actions
which would end certain repetitive inspections. The NPRM also proposed
to reduce the post-modification inspection compliance times, limit
installation of the preventive modification to airplanes with fewer
than 30,000 total flight cycles, and add repetitive inspections for
modified airplanes. We are issuing this AD to detect and correct
cracking of the upper skin panel at the chem-milled step above the lap
joint, which could result in reduced structural integrity of the
airplane.

Comments

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

Support for the NPRM

    Boeing and United Airlines supported the NPRM.

Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that installation of winglets, as
provided in Supplemental Type Certificate (STC) ST00830SE, does not
affect the ability to accomplish the actions proposed in the NPRM.
    We agree with the commenter. We have redesignated paragraph (c) of
the proposed AD as (c)(1) and added paragraph (c)(2) to this AD to
state that installation of STC 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.

Request To Revise Certain Compliance Time Provisions

    Southwest Airlines (SWA) asked that we revise certain compliance
language in paragraph (p)(4) of the proposed AD, which stipulated that
post-repair or post-mod inspections be done at the time specified in
the service information or at the time specified in the previously
approved AMOC, ``whichever occurs first.'' SWA stated that previously
approved AMOCs for post-repair or post-modification supplemental
inspections that comply with certain regulations may contain unique
damage tolerance inspection programs that demonstrate a level of safety
equivalent to that of AD 2008-12-04. SWA added that altering those
supplemental inspections to post-repair or post-modification
inspections as specified in Boeing Alert Service Bulletin 737-53A1232,
Revision 3, dated July 27, 2015, when those are done first, could
result in incorrect inspection methods to geometrical structure that
does not conform to the repair or modification definitions specified in
Revisions 1 and 3 of that service information.
    We partially agree with the commenter's request. We have determined
that repairs and preventive modifications should be handled separately.
Fleet experience and subsequent analysis of Model 737-200, -200C, -300,
-400, and -500 airplanes, which have similar chem-milled step details,
have shown that certain post-preventative modification inspection
programs may not adequately address the unsafe condition. Therefore,
paragraph (p)(4) of this AD has been changed to remove the language
``preventative modifications'' and remove the reference to the service
information and ``whichever occurs first'' from the compliance time
specified. In addition, we have added paragraph (p)(5) to this AD to
address only the preventive modifications without change to the service
information and ``whichever occurs first'' language.

Request To Retain Certain Exceptions

    Additionally, SWA asked that paragraphs (j) and (k) of AD 2008-12-
04 be included in the proposed AD. Paragraph (j) of AD 2008-12-04
provides an allowance for repairs that are FAA-approved and that have a
minimum of three rows of fasteners above and below the chem-milled
step. SWA stated that paragraph (k) of AD 2008-12-04 provides a means
of inspections without an AMOC when an external repair is covering the
chem-milled step, but that the doubler does not span the step by a
minimum of three rows of fasteners above and below the chem-milled
step. SWA added that both paragraphs (j) and (k) of AD 2008-12-04 are
missing from the proposed AD and should be added, with certain
clarifications, to paragraph (j) of the proposed AD. First, the repair
is an external doubler repair. Second, in lieu of the doing the post-
repair supplemental inspections in accordance with table 2 of paragraph
1.E.,

``Compliance,'' of Boeing Alert Service Bulletin 737-53A1232, Revision
3, dated July 27, 2015, the inspections should be done in accordance
with 14 CFR 121.1109(c)(2) or 14 CFR 129.109(b)(2) supplemental
inspection requirements, or in accordance with FAA-approved damage
tolerance inspection requirements.
    SWA also stated that if paragraphs (j) and (k) of AD 2008-12-04 are
not restated for compliance with existing FAA-approved repairs,
operators will be required to seek AMOC approvals for such existing
repairs prior to the inspection threshold or repeat interval of table 1
of paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
737-53A1232, Revision 3, dated July 27, 2015. SWA stated that not
including the exceptions in paragraphs (j) and (k) of AD 2008-12-04
could potentially lead to disruption of operations if it is necessary
to request AMOC approvals during repair discovery, or could burden
operators with records research to identify these repairs for AMOC
approvals prior to the required compliance times.
    We agree that an allowance can be made for repairs that meet the
criteria specified in paragraph (j) of AD 2008-12-04. These repairs
address the unsafe condition identified in this AD. Therefore, we have
added paragraph (l)(3) to this AD to include the provision of paragraph
(j) of AD 2008-12-04 for repairs that were accomplished before the
effective date of this AD.
    We disagree that post-repair inspections for these repairs should
be done in accordance with 14 CFR 121.1109(c)(2) or 14 CFR
129.109(b)(2) supplemental inspection requirements. Post-repair
inspections for repairs that meet the criteria of paragraph (j) of this
AD are to be accomplished in accordance with table 2 of paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-53A1232, Revision
3, dated July 27, 2015. This is consistent with the DAH's current
recommendation as well as the requirements of paragraph (j) of AD 2008-
12-04. Paragraph (l)(3) of this AD reflects these provisions.
    We also disagree with the commenter's request to change the word
``repair'' to ``external doubler repair'' in paragraph (l)(3) of this
AD because we are retaining the provisions of paragraph (j) of AD 2008-
12-04.
    We also agree to add certain provisions of paragraph (k) of AD
2008-12-04 to this AD. We have added paragraph (l)(4) to this AD to
address certain repairs as defined in paragraph (k) of AD 2008-12-04.
However, paragraph (l)(4) of this AD does not include a reference to
Boeing Model 737 Non-destructive Test (NDT) Manual, Part 6, Subject 53-
30-20, and instead requires that the inspection be done using FAA-
approved procedures. We have also added Note 1 to paragraph (l)(4) of
this AD to specify that guidance on the inspection specified in
paragraph (l)(4) of this AD can be found in Boeing Model 737 NDT
Manual, Part 6, Subject 53-30-20.

Clarification of Paragraph (i)(1) of This AD

    We have revised the language in paragraph (i)(1) of this AD to
clarify which modifications are exempt from the actions required by
paragraph (i)(1) of this AD.

Conclusion

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

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 737-53A1232, Revision 3,
dated July 27, 2015. This service information describes procedures for
an external detailed inspection and an external nondestructive
inspection (NDI) for cracks in the fuselage skin at chem-milled steps.
Corrective actions include a permanent or time-limited repair, a
preventive modification, and replacement of loose and missing
fasteners. Related investigative actions include internal and external
detailed inspections of the repair area. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 376 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
----------------------------------------------------------------------------------------------------------------
Inspections.................  Up to 25 work-hours x              $0  Up to $2,125 per       Up to $799,000 per
                               $85 per hour =                         inspection cycle.      inspection cycle.
                               $2,125 per
                               inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary repairs and
replacements that would be required based on the results of the
inspections. We have no way of determining the number of aircraft that
might need these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                Action                            Labor cost                   Parts cost             product
----------------------------------------------------------------------------------------------------------------
Fastener replacement..................  Up to 1 work-hour x $85 per    Minimal..................             $85
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the related investigative actions, certain repairs,
and other applicable 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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

    We have determined that 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 removing Airworthiness Directive (AD)
2008-12-04, Amendment 39-15547 (73 FR 32991, June 11, 2008), and adding
the following new AD:

2017-19-26 The Boeing Company: Amendment 39-19056; Docket No. FAA-
2016-9301; Product Identifier 2015-NM-193-AD.

(a) Effective Date

    This AD is effective October 30, 2017.

(b) Affected ADs

    This AD replaces AD 2008-12-04, Amendment 39-15547 (73 FR 32991,
June 11, 2008) (``AD 2008-12-04'').

(c) Applicability

    (1) This AD applies to The Boeing Company Model 737-600, -700, -
700C, -800, and -900 series airplanes, certificated in any category,
as identified in Boeing Alert Service Bulletin 737-53A1232, Revision
3, dated July 27, 2015.
    (2) Installation of Supplemental Type Certificate (STC)
ST00830SE [http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/184DE9A71EC3FA5586257EAE00707DA6?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

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by a fatigue test that revealed numerous
cracks in the upper skin panel at the chem-milled step above the lap
joint, followed by an evaluation by the design approval holder (DAH)
that indicated that location is subject to widespread fatigue damage
(WFD) on airplanes on which a certain modification was installed
after 30,000 total flight cycles. We are issuing this AD to detect
and correct cracking of the upper skin panel at the chem-milled step
above the lap joint, which could result in reduced structural
integrity of the airplane.

(f) Compliance

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

(g) Inspections at Locations Without the Preventive Modification, Time-
Limited Repair, or Permanent Repair Installed

    At locations where a preventive modification, time-limited
repair, or permanent repair has not been installed as specified in
Boeing Service Bulletin 737-53A1232: At the applicable time
specified in paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 737-53A1232, Revision 3, dated July 27, 2015, do an
external detailed inspection and an inspection specified in either
paragraph (g)(1) or (g)(2) of this AD, for any crack in the fuselage
skin at the chem-milled steps at specified locations, in accordance
with Accomplishment Instructions of Boeing Alert Service Bulletin
737-53A1232, Revision 3, dated July 27, 2015. Do all applicable
related investigative and corrective actions before further flight
in accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015,
except as required by paragraph (l)(1) of this AD, and except as
provided in paragraphs (l)(3) and (l)(4) of this AD. Repeat the
inspections thereafter at the applicable time specified in paragraph
1.E., ``Compliance,'' of Boeing Alert Service Bulletin 737-53A1232,
Revision 3, dated July 27, 2015.
    (1) Do an external medium frequency eddy current (MFEC), or
magneto optic imager (MOI), or C-Scan inspection.
    (2) Do an external ultrasonic phased array (UTPA) inspection.

(h) Repetitive Post-Modification Inspections and Repair at Any Location
With the Preventive Modification But No Time-Limited or Permanent
Repair

    At any location with a preventive modification installed as
specified in Boeing Service Bulletin 737-53A1232: At the applicable
time specified in paragraph 1.E., ``Compliance,'' of Boeing Alert
Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015,
except as required by paragraph (l)(2) of this AD, do the actions
specified in paragraphs (h)(1) and (h)(2) of this AD.
    (1) Do external detailed and external high frequency and medium
frequency eddy current inspections for any crack, in accordance with
Part 7 of the Accomplishment Instructions of Boeing Alert Service
Bulletin 737-53A1232, Revision 3, dated July 27, 2015. If no crack
is found during the inspection, repeat the inspections thereafter at
the applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015. If any crack is found during any inspection required by
this paragraph, repair before further flight, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
53A1232, Revision 3, dated July 27,

2015, except as required by paragraph (l)(1) of this AD.
    (2) Do a detailed inspection for any crack and any loose or
missing fasteners, in accordance with Part 7 of the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-53A1232, Revision
3, dated July 27, 2015. Repeat the inspections thereafter at
applicable time specified in paragraph 1.E, ``Compliance,'' of
Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015. If any crack is found during any inspection, or any loose
or missing fastener is found, before further flight, do all
applicable corrective actions, in accordance with Part V of the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
53A1232, Revision 3, dated July 27, 2015, except as specified in
paragraph (l)(1) of this AD.

(i) Additional Actions for Modified Airplanes

    (1) At any location where a preventive modification as specified
in Boeing Service Bulletin 737-53A1232 was installed after the
accumulation of 30,000 total flight cycles, at the applicable time
specified in paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 737-53A1232, Revision 3, dated July 27, 2015, except as
required by paragraph (l)(2) of this AD, do all applicable
investigative and corrective actions using a method approved in
accordance with the procedures specified in paragraph (p) of this
AD. For preventive modifications installed on airplanes listed in
Appendix A of Boeing Alert Service Bulletin 737-53A1232, Revision 3,
dated July 27, 2015, at the specified total flight cycles: The
actions specified in this paragraph are not required.
    (2) For airplanes which have installed STC ST01697SE (http://
rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/
0812969a86af879b8625766400600105/$FILE/ST01697SE.pdf) and the
preventive modification has been installed after 15,000 total flight
cycles: Before the accumulation of 25,000 total flight cycles, do
all applicable investigative and corrective actions using a method
approved in accordance with the procedures specified in paragraph
(p) of this AD.

(j) Inspections and Repair at Locations With the Permanent Chem-Milled
Step Repair Installed

    At any location where a permanent repair has been installed as
specified in Boeing Service Bulletin 737-53A1232: At the applicable
time specified in paragraph 1.E., ``Compliance,'' of Boeing Alert
Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015, do
the inspections specified in paragraph (j)(1) or (j)(2) of this AD,
in accordance with Accomplishment Instructions of Boeing Alert
Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015.
Repeat the inspections thereafter at the applicable time specified
in paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
737-53A1232, Revision 3, dated July 27, 2015. Do all applicable
related investigative and corrective actions before further flight
in accordance with Boeing Alert Service Bulletin 737-53A1232,
Revision 3, dated July 27, 2015, except as required by paragraph
(l)(1) of this AD.
    (1) Do an external low frequency eddy current (LFEC) inspection
for any crack, and doubler external LFEC and external detailed
inspections for any crack and loose or missing fasteners.
    (2) Do an external LFEC inspection for any crack, a doubler
external LFEC and external detailed inspections for any crack and
loose or missing fasteners, and an internal MFEC for any crack.

(k) Inspection and Replacement at Locations With a Chem-Milled Time-
Limited Repair Installed

    At any location where a chem-milled time-limited repair is
installed, do the actions specified in paragraphs (k)(1) and (k)(2)
of this AD, at the applicable time specified in 1.E. ``Compliance,''
of Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015.
    (1) Do internal and external detailed inspections of the time-
limited repair for any crack, or loose or missing fasteners, in
accordance with Part IV of the Accomplishment Instructions of Boeing
Alert Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015.
Repeat the inspections thereafter at the applicable time specified
in paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
737-53A1232, Revision 3, dated July 27, 2015. If any crack is found
during any inspection, or if any loose or missing fastener is found,
before further flight, do all applicable corrective actions, in
accordance with Part IV of the Accomplishment Instructions of Boeing
Alert Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015,
except as specified in paragraph (l)(1) of this AD.
    (2) Replace the time-limited repair with the permanent repair,
in accordance with Part IV of the Accomplishment Instructions of
Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015.

(l) Exceptions to Service Information Specifications

    (1) Where Boeing Alert Service Bulletin 737-53A1232, Revision 3,
dated July 27, 2015, specifies to contact Boeing for repair
instructions, this AD requires repair before further flight using a
method approved in accordance with the procedures specified in
paragraph (p) of this AD.
    (2) Where paragraph 1.E., ``Compliance,'' of Boeing Alert
Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015,
specifies a compliance time ``after the date of Revision 2 of this
service bulletin,'' this AD requires compliance within the specified
compliance time after the effective date of this AD.
    (3) For airplanes on which the actions specified in paragraph
(g) of this AD are required: Inspections specified in table 1 of
paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
737-53A1232, Revision 3, dated July 27, 2015, are not required in
areas that are spanned by an FAA-approved repair that has a minimum
of 3 rows of fasteners above and below the chem-milled step,
provided that the repair was installed before the effective date of
this AD. Operators must accomplish post-repair inspections at the
applicable time specified in table 2 of paragraph 1.E,
``Compliance,'' of Boeing Alert Service Bulletin 737-53A1232,
Revision 3, dated July 27, 2015.
    (4) For any airplane that has an external doubler covering the
chem-milled step, but the doubler does not span the step by a
minimum of 3 rows of fasteners above and below the chem-milled step
and the doubler was installed before the effective date of this AD:
One method of compliance with the inspection requirement of
paragraph (g) of this AD is to inspect all chem-milled steps covered
by the repair using non-destructive test (NDT) methods approved in
accordance with the procedures specified in paragraph (p) of this
AD. These repairs are to be considered time-limited and are subject
to the post-repair supplemental inspections and replacement at the
times specified in table 3 of paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015.
    Note 1 to paragraph (l)(4) of this AD: Guidance for the
procedures for the alternative inspection specified in paragraph
(l)(4) of this AD can be found in the Boeing 737 NDT Manual, Part 6,
Subject 53-30-20.

(m) Optional Terminating Action

    (1) For airplanes that have accumulated 30,000 total flight
cycles or fewer, or for airplanes on which STC ST01697SE was
installed and that have accumulated 15,000 total flight cycles or
fewer, accomplishment of the preventive modification specified in
Part V of Boeing Alert Service Bulletin 737-53A1232, Revision 3,
dated July 27, 2015, terminates the inspections required by
paragraph (g) of this AD in the modified areas only.
    (2) Installation of a permanent repair as specified in Part III
of Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015, or a time-limited repair as specified in Part IV of Boeing
Alert Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015,
terminates the inspections required by paragraph (g) of this AD in
the repaired areas only.

(n) Installation Limitations of Preventive Modification

    As of the effective date of this AD, installation of the
preventive modification specified in Boeing Service Bulletin 737-
53A1232 is prohibited on the airplanes identified in paragraphs
(n)(1) and (n)(2) of this AD.
    (1) Airplanes that have accumulated more than 30,000 total
flight cycles.
    (2) Airplanes which have installed STC ST01697SE and that have
accumulated more than 15,000 total flight cycles.

(o) Credit for Previous Actions

    This paragraph provides credit for the corresponding actions
specified in paragraphs (g), (h), (i), (j), (k), and (m) of this AD,
if those actions were performed before the effective date of this AD
using the service information identified in paragraph (o)(1),
(o)(2), or (o)(3) of this AD.
    (1) Boeing Special Attention Service Bulletin 737-53A1232, dated
April 2, 2007.

    (2) Boeing Special Attention Service Bulletin 737-53A1232,
Revision 1, dated May 18, 2012.
    (3) Boeing Special Attention Service Bulletin 737-53A1232,
Revision 2, dated July 26, 2013.

(p) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (q)(1) 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, modification, or alteration 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. To be approved, the
repair method, modification deviation, or alteration deviation must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) AMOCs approved previously for repairs for AD 2008-12-04 are
approved as AMOCs for the installation of the repair specified in
this AD, provided all post-repair inspections are done at the
applicable times specified in the AMOC.
    (5) AMOCs approved previously for preventive modifications for
AD 2008-12-04 are approved as AMOCs for the installation of the
preventive modification specified in this AD, provided all post-
modification inspections are done at the applicable times specified
in the AMOC, or in tables 1a and 1b of paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-53A1232,
Revision 3, dated July 27, 2015, whichever occurs first. The AMOC
must include all of the inspections specified in Tables 1a and 1b of
Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015.

(q) Related Information

    (1) For more information about this AD, contact Alan Pohl,
Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 1601
Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:
425-917-6450; email<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (r)(3) and (r)(4) of this AD.

(r) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated
July 27, 2015.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740;
telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
    (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 September 14, 2017.
Jeffrey E. Duven,
Director, System Oversight Division, Aircraft Certification Service.
[FR Doc. 2017-20114 Filed 9-22-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 3, 2008 (Volume 73, Number 42)]
[Notices]
[Page 11407-11408]
[DOCID:fr03mr08-53]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

February 25, 2008.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC06-78-002; EC07-37-002.
    Applicants: Entegra Power Group LLC, Gila River Power, L.P., Union
Power Partners, L.P., EPG LLC, Entegra TC LLC.
    Description: Application for order extending blanket authorizations
and amending reporting requirements for certain future transfers and
acquisitions of equity interests etc re Entrega Power Group LLC et al.
    Filed Date: 02/12/2008.
    Accession Number: 20080221-0041.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 04, 2008.

    Docket Numbers: EC08-42-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Application for authorization to acquire an existing
generation facility re Puget Sound Energy Inc.
    Filed Date: 02/07/2008.
    Accession Number: 20080212-0108.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 28, 2008.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG08-39-000.
    Applicants: Providence Heights Wind, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Providence Heights Wind, LLC.
    Filed Date: 02/20/2008.
    Accession Number: 20080220-5030.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 12, 2008.

    Docket Numbers: EG08-40-000.
    Applicants: Ocotillo Windpower, LP.
    Description: Notice of Self-Certification of Ocotillo Windpower, LP
as an Exempt Wholesale Generator.
    Filed Date: 02/21/2008.
    Accession Number: 20080221-5024.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 13, 2008.

    Docket Numbers: EG08-41-000.
    Applicants: Goat Wind, LP.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Goat Wind, LP.
    Filed Date: 02/21/2008.
    Accession Number: 20080221-5038.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 13, 2008.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER08-389-001.
    Applicants: San Diego Gas & Electric Company.
    Description: Waiver of 30 day notice period in SDG&E's Transmission
Owner Tariff.
    Filed Date: 02/25/2008.
    Accession Number: 20080225-5028.

    Comment Date: 5 p.m. Eastern Time on Monday, March 17, 2008.

    Docket Numbers: ER08-582-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection LLC submits a notice of
cancellation of an interconnection service agreement for an
interconnection project that has been withdrawn from the PJM generation
interconnection queue.
    Filed Date: 02/20/2008.
    Accession Number: 20080222-0113.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 12, 2008.
    Docket Numbers: ER08-583-000.
    Applicants: American Electric Power Service Corp.
    Description: AEP Operating Companies requests acceptance of the
Second Revised Interconnection and Local Delivery Service Agreement
with the City of Olive Hill, KT et al.
    Filed Date: 02/20/2008.
    Accession Number: 20080222-0114.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 12, 2008.

    Docket Numbers: ER08-584-000; ER02-298-004.
    Applicants: Thompson River Co-Gen, LLC.
    Description: Thompson River Power LLC informs the Commission that
it has succeeded to the market-based rate tariff of Thompson River Co-
Gen, LLC and submits non-material change in status etc.
    Filed Date: 02/21/2008.
    Accession Number: 20080225-0187.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 13, 2008.

    Docket Numbers: ER08-585-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits revisions to it Grid Management Charge rate formula.
    Filed Date: 02/20/2008.
    Accession Number: 20080225-0087.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 12, 2008.

    Docket Numbers: ER08-586-000.
    Applicants: Consolidated Edison Company of New York.
    Description: Consolidated Edison Company of New York Inc submits a
Revised and Restated Interconnection Agreement by and between Con
Edison, KIAC Partners and the Port Authority of New York and New Jersy,
dated as of 1/7/08.
    Filed Date: 02/21/2008.
    Accession Number: 20080225-0058.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 13, 2008.

    Docket Numbers: ER08-587-000.
    Applicants: Northeast Utilities Service Company.
    Description: Connecticut Light and Power Company submits executed
Preliminary Design Services Agreement, Schedule 22 of its Transmission,
Markets and Services Tariff FERC Electric 3.
    Filed Date: 02/21/2008.
    Accession Number: 20080222-0152.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 13, 2008.

    Docket Numbers: ER08-588-000.
    Applicants: Northeast Utilities Service Company.
    Description: The Connecticut Light and Power Company submits the
executed Design, Engineering, & Permitting Agreement with Waterbury
Generation, LLC.
    Filed Date: 02/21/2008.
    Accession Number: 20080222-0153.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 13, 2008.

    Docket Numbers: ER08-589-000.
    Applicants: Midwest Generation Energy Services, LLC.
    Description: Notice of Succession of Midwest Generation Energy
Services, LLC informing of name change to Edison Mission Solutions, LLC
effective 1/24/08.
    Filed Date: 02/22/2008.
    Accession Number: 20080222-5055.
    Comment Date: 5 p.m. Eastern Time on Friday, March 14, 2008.

    Take notice that the Commission received the following electric
reliability filings:

    Docket Numbers: RR07-16-002.
    Applicants: North American Electric Reliability Corp.
    Description: Request of North American Electric Reliability
Corporation for Approval of Amendment to 2008.
    Filed Date: 02/15/2008.
    Accession Number: 20080215-5036.
    Comment Date: 5 p.m. Eastern Time on Monday, March 17, 2008.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and Sec.
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-3983 Filed 2-29-08; 8:45 am]

BILLING CODE 6717-01-P


                                     Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Natamycin

                 Docket ID Number: EPA-HQ-OPP-2015-0811 (NOF)
                              Date: June 16, 2016

Section 408(c)(2)(A)(i) of FFDCA allows the U.S. Environmental Protection Agency (EPA or the Agency) to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if the EPA determines that the exemption is "safe." Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B),
in establishing or maintaining in effect an exemption from the requirement of a tolerance, the EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require the EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption, 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...." Additionally, FFDCA section 408(b)(2)(D) requires that the EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."

The EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, the EPA determines the toxicity of pesticides. Second, the EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

 Summary of Petitioned-for Tolerance Exemption

In the Federal Register of April 25, 2016 (81 FR 24044) (FRL-9944-86), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 5F8407) by Keller and Heckman, LLP, 1001 G Street, NW, Washington, DC, 20001 on behalf of DSM Food Specialties (the Petitioner) B.V., P.O. Box 1, 2600 MA Delft, The Netherlands. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of natamycin in or on  citrus, pome and stone fruit crop groups, avocado, kiwi, mango and pomegranates when used as a fungistat and used as a dip drench, flood or spray in enclosed packing house facilities. The notice referenced a summary of the petition prepared by the Petitioner, which is available in Docket ID Number EPA-HQ-OPP-2015-0811 via http://www.regulations.gov.

     Toxicological Profile

Consistent with section 408(b)(2)(D) of FFDCA, the EPA reviewed the available scientific data and other relevant information on natamycin, and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. The EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

 Overview of Natamycin

Natamycin is a naturally occurring antifungal agent produced during fermentation by the common soil microorganisms Streptomyces natalensis, Streptomyces lydicus, and Streptomyces chattanoogensis. Natamycin has a non-toxic mode of action. As an antifungal it binds to ergosterol, a sterol found in plants, fish liver oil, egg yolk, dairy products and in the cell membranes of many strains of fungi. In fungi, ergosterol helps regulate fluidity, permeability, stability, and resistance to physical stress of cell membranes similar to the function of cholesterol in animal cells. By binding to ergosterol, natamycin alters the cell membrane of the targeted fungus to the degree that the cell cannot grow, thus preventing germination of fungal spores. Natamycin is active against a broad variety of yeast and molds. However, natamycin  has no antibacterial properties and therefore is not expected to cause resistance by human pathogenic bacteria.
Natamycin has been used as a food preservative worldwide for over 40 years and is approved as a food additive/preservative by the European Union, the World Health Organization, and by 70 individual countries including New Zealand and Australia for use as a fungistat to suppress mold on cheese, meats and sausage. In the United States, natamycin is approved by the Food and Drug Administration (FDA) as a direct food additive/preservative for the inhibition of mold and yeast on the surface of cheeses (21CFR 172.155) and as an additive to the feed and drinking water of broiler chickens to retard the growth of specific molds (21CFR 573.685). Natamycin is also FDA approved for use as a treatment to suppress fungal eye infections such as blepharitis, conjunctivitis, and keratitis (21CFR 449.40). In 2012, the EPA and Health Canada's Pesticide Management Regulatory Agency (PMRA) jointly established a tolerance exemption for natamycin when used as a fungistat to prevent the germination of fungal spores on mushrooms produced in enclosed production facilities (FR vol. 77, no. 97, p. 29543). PMRA has also registered natamycin under the active ingredient name "pimaricin" for use in laboratories for preserving milk samples (PMRA Reg. Nos. 22612 and 28530). On December 17, 2014, the EPA amended the tolerance by extending use to post-harvest pineapples when used as a fungistat in enclosed packinghouse facilities to prevent certain fungal diseases. (FR 79, no 242, p. 75065). Three products are currently registered containing natamycin for use as a biopesticide fungistat (87485-1, Natamycin TGAI; 87485-2 Natamycin L, (mushrooms), and 87485-3 Zivion P (pineapples)).

     Biochemical Pesticide Toxicology Data Requirements

      All applicable mammalian toxicology data requirements supporting the petition to amend the existing tolerance exemption for natamycin to include use on citrus, pome, stone fruit crop groups, avocado, kiwi, mango and pomegranate as a post harvest use have been fulfilled by bridging from existing data on file that supported the tolerance exemption for natamycin on pineapples.   No significant toxicological effects were observed in the acute toxicity studies, the Tier I subchronic toxicity studies, or other information that was used to address the toxicity data requirements. Natamycin is not a contact dermal sensitizer and does not cause chromosomal aberration and is not a mutagen. Relative to Natamycin use, non-occupational exposure will be primarily dietary (consumption of treated citrus, pome, and stone fruit crop groups, avocado, kiwi, mango, and pomegranates).  The following is a summary of EPA's review of the toxicity profile of this biochemical.

Acute Toxicity: Natamycin has a non-toxic mode of action as is categorized as follows: Acute Oral LD50 > 3,000 mg/kg (Toxicology Category III); Acute Dermal LD50 > 5,050 mg/kg (Toxicology Category IV); Acute Inhalation LC50 > 2.39 mg/L (Toxicology Category IV); Primary Eye Irritation was severely irritating but no positive effects after 24 hours (Toxicology Category III); Primary Dermal Irritation was slightly irritating (Toxicology Category IV); and natamycin is not a contact dermal sensitizer.

The acute toxicity studies on natamycin (98.17% and 98.27% pure), confirm a low toxicity profile. The acute toxicity data show virtual nontoxicity for all routes of exposure. Therefore, it can be concluded that any dietary risks associated with this biochemical would be negligible.

 Acute Oral Toxicity OSCPP 870.1100) Natamycin was evaluated for acute oral toxicity to albino female rats with the administration via gavage dose at a level of 2,000 mg/kg. There were no clinical signs of toxicity in survivors (one rat died, polyuria was observed). There were no effects on body weight gain in animals surviving to termination. The acute oral LD50 was estimated at greater than 2,000 mg/kg. (MRID 48105505).

 Acute Dermal Toxicity (OCSPP 870.1200) An acute dermal toxicity test was conducted with rats to determine the potential for natamycin to produce toxicity from a single topical application. Under the conditions of this study, the single dose acute dermal LD50 of the test substance is greater than 5,050 mg/kg of body weight in male and female rats. There were no clinical signs of toxicity or signs of dermal irritation at any time throughout the study. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded prior to application and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice (MRID 48105506).

 Acute Inhalation Toxicity (OCSPP 870.1300) Natamycin, was evaluated for its acute inhalation toxicity potential in albino rats where five males and five females were exposed for four hours to an aerosol generated from the test substance (dry powder) at a level of 2.39 mg/L. There was no mortality during the study. Clinical signs included activity decrease and piloerection, which were no longer evident by Day 3. Animal body weight was unaffected. The gross necropsy revealed no observable abnormalities. As indicated by the data, the acute inhalation LC50 is greater than 2.39 mg/L (MRID 48105507).

 Primary Eye Irritation (OCSPP 870.2400) An acute eye irritation study was conducted on three albino rabbits using test substance natamycin. The undiluted test substance (O.1 mL) was placed into the conjunctival sac of the right eye of each test animal. All treated eyes were washed with room temperature deionized water for one minute immediately after recording the 24-hour observation. The number of animals testing "positive" for each parameter (Table 1.0) over the number of animals tested is presented below.

          Table 1.0. Results of Primary Eye Irritation Test (870.2400) for Natamycin

                             Time After Treatment

                                     1hr.
                                     24hr.
                                     48hr.
                                     72hr.
Cornea
Opacity
                                      3/3
                                      0/3
                                      0/3
                                      0/3
Iritis
                                      3/3
                                      0/3
                                      0/3
                                      0/3
Conjunctivae
Redness
Chemosis

                                      3/3
                                      3/3

                                      0/3
                                      0/3

                                      0/3
                                      0/3

                                      0/3
                                      0/3

      There were no positive effects exhibited in any eyes at 24 hours after treatment. The test substance is rated severely irritating and assigned to Toxicity Category III (MRID 48105508).

 Primary Skin Irritation (OCSPP 870.2500) A primary dermal irritation study was conducted on three albino rabbits using test substance natamycin. There was one intact test site per animal. Each test site was treated with 500 mg of test substance and covered with a semi-permeable dressing. The test substance was maintained in contact with the skin for 4 hours. Observations for dermal irritation and defects were made at 1, 24, 48, and 72 hours after removal of the dressings. Irritation scores derived from the respective erythema and edema scores through the 72-hour observations for each animal are presented in Table 2.0.

Table 2.0. Results of Primary Skin Irritation Test for Natamycin

Erythema
Edema
Irritation Scores

Hours after unwrap
Hours after unwrap

1
24
48
72
1
24
48
72

5082-M
0
0
0
0
0
0
0
0
0.00
5084-M
1
0
0
0
0
0
0
0
0.25
5071-F
0
0
0
0
0
0
0
0
0.00

      Based on the PII of 0.1, the test substance is rated slightly irritating. Based on the scores at the 72-hour observation, the test substance is assigned to Toxicity Category IV (MRID 48105509).

 Dermal Sensitization: (OCSPP 870.2600) A skin sensitization study was conducted on 3 groups of 5 female mice to determine if test substance Natamycin produced a sensitizing reaction. Five females were assigned to each of three groups, I-III. Naive control group animals remained untreated during the induction phase of the study. Test group animals were treated with 25 ul on the dorsum of the ear. Test animals were treated once daily for three days. The test substance produced a stimulation index of <3 in all groups of test animals and is not considered a sensitizing agent in mice (MRID 48105510).

Subchronic Toxicity: : In a subchronic oral toxicity study using natamycin (98.17% and 98.27% pure) as the test substance, doses of 125 and 500 mg/kg/day showed no treatment related findings. The highest concentration level, 2,000 mg/kg/day, showed reduced weight for both male and female rats (MRID 48105511). The Agency does not consider the temporary decrease in body weight or food intake observed in the 2,000 mg/kg bw/day test group to be an adverse effect, as this is likely due to the palatability of the food containing this high dose of test substance. Therefore, the Agency establishes the NOAEL (No Observed Adverse Effect Level) for this study as 2,000 mg/kg bw/day. A LOAEL (Lowest Observed Adverse Effect Level) was not identified, suggesting that the test animals could have tolerated a higher dose.

90-day Oral Toxicity (OCSPP 870.3100) Dose levels were 0, 125, 500, and 2000 ppm. Test substance was administered daily via diet for at least 90 days. One control group and three treatment groups were tested, each consisting of 10 males and 10 females Wistar rats. The following parameters were evaluated: clinical signs daily; body weight weekly and on the day preceding the first necropsy date, food consumption weekly, food scattered daily in weeks 4,7,8,10 and 12, functional observations during week 12-13, ophthalmoscopic examination at pretest and in week 13, clinical pathology, macroscopic examination and organ weight at termination. At concentrations 125 and 500 mg/kg/day there were no treatment related findings. The highest concentration level, 2000 mg/kg/day showed reduced weight for both male and female rats. Alanine aminotransferase activity increased in individual cases (males), urea and inorganic phosphate values increased for both male and female rats, potassium values increased for males, cholesterol and total protein values reduced (females) (MRID 48105511).

Developmental Toxicity: A developmental toxicity study using natamycin (98.17% and 98.27% pure) as the test substance (MRID 48105512) showed no discernable effects on growth, reproduction, teratological or mutagenic responses, or on gross and microscopic pathology, at concentration levels 0, 5, 15 and 50 mg/kg bw/day.

Prenatal Developmental Toxicity (OCSPP 870.3700; 870.3800; 870.5450; 870.5915) Natamycin dosages of 5, 15, and 50 mg/kg per day administered by diet had no discernable effect on growth, reproduction, teratological or mutagenic response, or on gross and microscopic pathology (MRID 48105512).

Mutagenicity:  Two mutagenicity studies, using natamycin (98.17% and 98.27% pure) as the test substance, were performed. These studies are sufficient to confirm that there are no expected dietary or non-occupational risks of mutagenicity with regard to food use of natamycin.
Bacterial Reverse Mutation Test (OCSPP 870.5100) Natamycin was tested in the Salmonella typhimurium reverse mutation assay with four histidine-required strains (TA1535, TA1537, TA100, and TA96) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain (WP2uvrA). The test was performed in two independent experiments in the presence and absence of S9-mix (Aroclor-1254 induced rat liver S9-mix). All bacterial strains showed negative responses over the entire dose range, i.e. no dose-related, two-fold, increase in the number of revertants in two independently repeated experiments. Based on the results of this study, Natamycin is not a mutagen in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay (MRID 48105513)

In Vitro Mammalian Cell Gene Mutation (OCSPP 870.5300) This test reported the effects of Natamycin on the number of chromosome aberrations in cultured peripheral human lymphocytes in the presence and absence of a metabolic activation system (Aroclor-1254 induced rat liver S9-mix). Positive control chemicals, mitomycin C and cyclophosphamide, both produced a statistically significant increase in the incidence of cell with chromosome aberrations, indicating that the test conditions were adequate and that the metabolic activation system (S9-mix) functioned properly. Natamycin did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and in the presence of S9-mix, in two independently repeated experiments (MRID 48105514).

	Table 3.0. Toxicological Data for Natamycin
                                  Guideline #
                                     Test
                           Results/Toxicity Category
                                     MRIDs
                               Study Conclusion
Acute Oral Toxicity
OCSPP 870.1100
                             LD50 >3,000 mg/kg
                                      III
48105505
Kuhn, (2008)
                                  Acceptable
Acute Dermal Toxicity
OCSPP 870.1200
                             LD50 > 5,050 mg/kg
                                      IV
48105506
Kuhn, (2008)
                                  Acceptable
Acute Inhalation Toxicity
OCSPP 870.1300
                              LC50 > 2.39 mg/L
                                      IV
[48105507]
[Crutchfield, (2008)]
                                  Acceptable

Primary Eye Irritation
OCSPP 870.2400
            Severely irritating no positive effects after 24 hours.
                                      III
48105508
Kuhn, (2008)
                                  Acceptable
Primary Dermal Irritation
OCSPP 870.2500
                              Slightly irritating
                                      IV
48105509
Kuhn, (2008)
                                  Acceptable
Dermal Sensitization
OCSPP 870.2600
Not a dermal sensitizer
48105510
Kuhn, (2008)
                                  Acceptable

90 day Oral Toxicity-Rat
OCSPP 870.3100
At 125 and 500 mg/kg/day no treatment related findings. At 2000 mg/kg/day showed reduced weight.
48105511
Otterdijk, (2003)
                                  Acceptable
870.3700, 3800, 5450, 5915.
Prenatal Developmental Toxicity Study - Rat
Dosages of 5, 15 and 50 mg/kg/day administered by diet had no effect on growth, reproduction, teratology or mutagenic response.
48105512
Knickerbocker and Re, (1979)
                                  Acceptable
870.5100
Bacterial Reverse Mutation Test
Not a mutagen
48105513
Verspeek-Rip, (2002)
                                  Acceptable
 870.5375
In Vitro Mammalian Chromosome Aberration Tests
No chromosomal aberrations
48105514
Meerts, (2002)

                                  Acceptable

 Aggregate Exposure

In examining aggregate exposure, FFDCA section 408 directs the EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

  Dietary Exposure: Dietary exposure to residues of natamycin are expected to be insignificant, even in the event of exposure. Furthermore, the active ingredient is of low acute toxicity and is not a developmental toxicant, a mutagen, or toxic via repeat oral exposure.

Drinking Water Exposure
Exposure of humans to natamycin in drinking water is not expected because natamycin is approved for application indoors only.

Other Non-occupational Exposure: Non-occupational exposure is not expected because natamycin is not approved for residential uses. The active ingredient is applied directly to commodities and degrades rapidly.

 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 EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."

The EPA has not found natamycin to share a common mechanism of toxicity with any other substances, and natamycin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, the EPA has assumed that natamycin does not have a common mechanism of toxicity with other substances. Following from this, the EPA concludes that there are no cumulative effects associated with natamycin that need to be considered. For information regarding the EPA's efforts to determine chemicals that have a common mechanism of toxicity and to evaluate the cumulative effects of su   ch chemicals, see the EPA's website at http://www.epa.gov/pesticides/cumulative.

     Determination of Safety for the United States Population, Infants and Children

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, the EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that the 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 the EPA determines that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor. In applying this provision, the EPA either retains the default value of 10X, or uses a different additional or no safety factor when reliable data are available to support a different additional or no safety factor.

Because there are no threshold effects associated with this biochemical, an additional margin of safety for infants and children is not necessary.

EPA has determined that there are no foreseeable dietary risks to the U.S. population, including infants and children, from the use of natamycin as a pesticide (fungstat) on mushrooms in enclosed mushroom facilities, pineapples, citrus, pome, stone fruit crop groups, avocado, kiwi, mango and pomegranates when label instructions and good agricultural practices are followed. The available data and information indicate that the chemical is of low toxicity and not a developmental toxicant. Therefore, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues of natamycin when it is used as labeled and in accordance with good agricultural practices. Such exposure includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA has arrived at this conclusion because the data and information available on natamycin do not demonstrate significant toxic potential to mammals, including infants and children.

      Conclusions

EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of natamycin. Therefore, the tolerance exemption is amended for residues of the biochemical pesticide natamycin when used on citrus, pome, stone fruit crop groups, avocado, kiwi, mango and pomegranates when used in accordance with label directions and good agricultural practices.

References

 Crutchfield, V. (2008) Natamycin TGAI: Acute Inhalation Toxicity Study in Rats: Final Report. Project Number: 11405/07. Unpublished study prepared by Stillmeadow, Inc. 19 p. (MRID 48105507)

 Devine, J.; Maryann C. (2013) Magnitude of Residues of Natamycin in Post-Harvest Treated Pineapples (Decline, Processing). Project Number: 197SRUS12R/1, 029653/1, 029653. Unpublished study prepared by SynTech Research. 204p. (MRID 49292403)

  Knickerbocker, M. (1979) Natamycin TGAI: Teratological Evaluation of Pimaricin in Dutch-Belted Rabbits. Project Number: 5906. Unpublished study prepared by Food & Drug Research Laboratories, Inc. 290 p. (MRID 48105512)

 Kuhn, J. (2008) Natamycin TGAI: Acute Oral Toxicity Study (UDP) in Rats: Final Report. Project Number: 11403/07. Unpublished study prepared by Stillmeadow, Inc. 12 p (MRID 48105505)

 Kuhn, J. (2008) Natamycin TGAI: Acute Dermal Toxicity Study in Rat: Final Report. Project Number: 11404/07. Unpublished study prepared by Stillmeadow, Inc. 13 p. (MRID 448105506)

 Kuhn, J. (2008) Natamycin TGAI: Acute Eye Irritation Study in Rabbits: Final Report. Project Number: 11406/07. Unpublished study prepared by Stillmeadow, Inc. 18 p. (MRID 48105508)

 Kuhn, J. (2008) Natamycin TGAI: Acute Dermal Irritation Study in Rabbits: Final Report. Project Number: 11407/07. Unpublished study prepared by Stillmeadow, Inc. 13 p. (MRID 48105509)

 Kuhn, J. (2008) Natamycin TGAI: Skin Sensitization: Local Lymph Node Assay in Mice: Final Report. Project Number: 11408/07. Unpublished study prepared by Stillmeadow, Inc. 13 p. (MRID 48105510)

 Meerts, I. (2002) Natamycin TGAI: Evaluation of the Ability of Natamycin to Induce Chromosome Aberrations in Cultured Peripheral Human Lymphocytes. Project Number: NOTOX/PROJECT/339356. Unpublished study prepared by Notox B.V. 28 p. (MRID 48105514).
 Otterdijk, F. (2003) Natamycin TGAI: 90 Day Oral Toxicity Study with Natamycin in the Rat. Project Number: NOTOX/PROJECT/339323, 002019. Unpublished study prepared by Notox B.V. 220 p. (MRID 48105511)

 Van der Lee, J, and Jovanovich, A. 2011. 18-month Final Report for Storage Stability and Corrosion Characteristics; Natamycin L. Project No. STAB/SLD/09/008. (MRID 48544501).

 Verspeek, C. (2002) Natamycin TGAI: Evaluation of the Mutagenic Activity of Natamycin in the Salmonella typhimurium Reverse Mutation Assay and the Escherichia coli Reverse Mutation Assay (with Independent Rat). Project Number: NOTOX/PROJECT/339345. Unpublished study prepared by Notox B.V. 29 p. (MRID 48105513).