[Federal Register Volume 82, Number 128 (Thursday, July 6, 2017)]
[Notices]
[Pages 31319-31320]
[FR Doc No: 2017-14201]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0222; FRL-9662-00]

CACI/Emergent and Arctic Slope Mission Services, LLC; Transfer of
Data

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces that pesticide related information
submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (FFDCA), including information
that may have been claimed as Confidential Business Information (CBI)
by the submitter, will be transferred to CACI/Emergent and its
subcontractor, Arctic Slope Mission Services, LLC, in accordance with
the CBI regulations. CACI/Emergent and its subcontractor, Arctic Slope
Mission Services, LLC, have been awarded a contract to perform work for
OPP, and access to this information will enable CACI/Emergent and its
subcontractor, Arctic Slope Mission Services, LLC, to fulfill the
obligations of the contract.

DATES: CACI/Emergent and its subcontractor, Arctic Slope Mission
Services, LLC, will be given access to this information on or before
July 11, 2017.

FOR FURTHER INFORMATION CONTACT: Mario Steadman, Information Technology
and Resources Management Division (7502P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action applies to the public in general. As such, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2017-0222, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. Contractor Requirements

    Under Contract No. EP-W-17-011, CACI/Emergent and its
subcontractor, Arctic Slope Mission Services, LLC, will provide program
management support, including, but not limited to: Development and
updating of Agency tools used for managing and locating materials,
automating and streamlining work flow processes, tracking of
performance and other related efforts. This plan shall meet Agency
requirements and initiatives as well as other requirements specified
herein. The Contractor shall be required to assess and provide a report
on current

tracking, information, and records management systems being utilized by
the Anti-Microbial Division (AD). This task will be requested of the
Contractor as directed by the TOCOR/ATOCOR when workload increases or
changes (e.g., moving from paper-based to computer-automated
recordkeeping and processes), and as more sophisticated records
management systems emerge. Prior to conducting such an assessment, the
TOCOR/ATOCOR must approve the specific assessment execution steps
proposed by the Contractor. This assessment should aim at identifying
inefficiencies and obstacles impacting AD's systems. Once the
assessment has been conducted, the Contractor shall provide an
Assessment Report. This Report shall describe in detail the process
being assessed, identify shortcomings of the AD process or system
assessed, and provide specific recommendations including an action plan
for addressing these ``shortcomings.'' The Contractor shall assist in
the development of records management systems and maintenance of
existing systems with software such as Microsoft Access and Excel to
improve reevaluation records management processes as specified by the
TOCOR/ATOCOR.
    OPP has determined that access by CACI/Emergent and its
subcontractor, Arctic Slope Mission Services, LLC, to information on
all pesticide chemicals is necessary for the performance of this
contract.
    Some of this information may be entitled to confidential treatment.
The information has been submitted to EPA under FIFRA sections 3, 4, 6,
and 7 and under FFDCA sections 408 and 409.
    In accordance with the requirements of 40 CFR 2.307(h)(2), the
contract with CACI/Emergent and its subcontractor, Arctic Slope Mission
Services, LLC, prohibits use of the information for any purpose not
specified in the contract; prohibits disclosure of the information to a
third party without prior written approval from the Agency; and
requires that each official and employee of the contractor sign an
agreement to protect the information from unauthorized release and to
handle it in accordance with the FIFRA Information Security Manual. In
addition, CACI/Emergent and its subcontractor, Arctic Slope Mission
Services, LLC, are required to submit for EPA approval a security plan
under which any CBI will be secured and protected against unauthorized
release or compromise. No information will be provided to CACI/Emergent
and its subcontractor, Arctic Slope Mission Services, LLC, until the
requirements in this document have been fully satisfied. Records of
information provided to CACI/Emergent and its subcontractor, Arctic
Slope Mission Services, LLC, will be maintained by EPA Project Officers
for this contract. All information supplied to CACI/Emergent and its
subcontractor, Arctic Slope Mission Services, LLC, by EPA for use in
connection with this contract will be returned to EPA when CACI/
Emergent and its subcontractor, Arctic Slope Mission Services, LLC,
have completed their work.

    Authority:  7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq.

    Dated: May 1, 2017.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2017-14201 Filed 7-5-17; 8:45 am]
 BILLING CODE 6560-50-P


Special Report 2006:

Local Movement of Sterile Pink Bollworm Moths In The San Joaquin Valley
of California

Dan Keaveny , Jim Hessler , Jim Rudig, California Department of Food and
Agriculture  and Robert Staten ,Consultant ,University of Arizona

Introduction:    Many attributes of the climate in the San Joaquin
Valley are extremely conducive to Pink Boll Worm (Pectinophora
gossypiella)  population development .  No sustainable population has
ever been found.  This has correctly been attributed to a continuous 36
year program relying almost exclusively on detection and sterile
release. The fundamental processes and procedures have remained
unchanged throughout this time. Sterile moths are released on all
sections (square mile) during the beginning of a current season where
native, non sterile moths were detected in the previous season.  As the
current crop is accurately mapped any section without a current cotton
crop is removed from a release zone.  As non sterile moths are detected
in a current season in non released sections a release zone is expanded
to include that new section. This results in a period during July and
August when releases are relatively stagnant or  constant. This offers
an ideal place and time to use programmatic data to asses dispersal away
from the targeted section of release. It is important to note that error
in aircraft is rare or nearly non existent . All aircraft flights are
guided ,monitored and recorded using a global positioning system (
Trimble 170 field computer ag. GPS Trimflight 3 System).  The flight
pattern is north to south using five “swaths” starting at the west
edge, ¼ mile, ½ mile, ¾ mile and the eastern edge of a release
section.  Releases are made on these lines three times a week.

Methods and Materials:  Adult Pink Bollworm populations are monitored
using a program wide standard  PBW delta trap and a standard 2 mg
concept lure. Traps are placed in the southern part of this zone at 1
trap per 60 acres and in the remainder on the area used in this study at
1 trap per 80 acres. The release area used in this study was in Kern
County. No other release section could be within 6 miles of the closest
release study section. Trap data was then sorted for all traps as 4
distinct capture zones. These are the area within the section of release
(release zone), all traps in an area from the zone boundary to an outer
boundary of 1 mi (zone 1), all traps from the 1 mile boundary to a 2
mile boundary (zone 2), and all traps from the 2 mile boundary to a 3
mile boundary (zone3).  All data was manipulated in Map Info.  The
number of acres in each band and the actual data including total moths
per week could be used as all trap locations and all field boundaries
are obtained with GPS units.

 Results:   The field arrangement and spatial relationships of each data
zone is shown in the attached map (Attachment 1). Sections which
actually contain fields are marked on this map. All traps are then
placed in fields. This gives a frame of reference as to where the data
actually comes from. All trap date are based on numbers of sterile moths
per week. Attachment 2 provides a summary of total moth capture in each
zone over all times that the study is conducted.  The zone or band
covering the mile adjacent had almost as high a number of a total moth
capture as the targeted sections.  Moth activity is still readily
apparent over the next two bands even though it is reduced as expected.
This study is conducted during the time when the pink bollworm moth is
the least mobile and is most prone to remain in favorable habitat.
Attachments 3 gives more detailed data including total recapture over
seven weeks and the number of positive traps i.e. traps with one or more
sterile moths in each zone.  This table also provides basic acres in
each zone and total traps used in each zone.  All data is then expressed
in percentage points for comparative purposes.

Conclusions:   The most important and simple conclusion is that almost
as many moths reside in the mile zone around a release zone as within
it.  This is not surprising as release is at 500 feet to ensure moth
flight before their fall to the ground can be completed.

VOLUME 2

DOCUMENT 1

Page   PAGE  1  of   NUMPAGES  4


[Federal Register Volume 87, Number 66 (Wednesday, April 6, 2022)]
[Proposed Rules]
[Pages 19818-19821]
[FR Doc No: 2022-07157]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0395; Project Identifier MCAI-2021-01048-T]
RIN 2120-AA64

Airworthiness Directives; ATR-GIE Avions de Transport
R[eacute]gional Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2018-18-05, which applies to all ATR-GIE Avions de Transport
R[eacute]gional Model ATR42-200, -300, and -320 airplanes; and AD 2020-
09-16, which applies to all ATR-GIE Avions de Transport R[eacute]gional
Model ATR42-200, -300, and -320 airplanes. AD 2018-18-05 and AD 2020-
09-16 require revising the existing maintenance or inspection program,
as applicable, to incorporate new or more restrictive airworthiness
limitations. Since the FAA issued AD 2018-18-05 and AD 2020-09-16, the
FAA has determined that new or more restrictive airworthiness
limitations are necessary. This proposed AD would retain the
requirements of AD 2020-09-16. This proposed AD would also require
revising the existing maintenance or inspection program, as applicable,
to incorporate new or more restrictive airworthiness limitations, as
specified in a European Union Aviation Safety Agency (EASA) AD, which
is proposed for incorporation by reference. The FAA is proposing this
AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by May 23,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov Follow the instructions for submitting comments..
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available in
the AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0395.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0395; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0395; Project Identifier
MCAI-2021-01048-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Shahram Daneshmandi, Aerospace Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des Moines,
WA 98198; telephone<PHONE_NUMBER>; email [email protected].
Any commentary that the FAA receives which is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Background

    The FAA issued AD 2018-18-05, Amendment 39-19384 (83 FR 44463,
August 31, 2018) (AD 2018-18-05), which applies to certain ATR-GIE
Avions de Transport R[eacute]gional Model ATR42-200, -300, and -320
airplanes. AD 2018-18-05 requires revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive maintenance requirements and airworthiness limitations. The
FAA issued AD 2018-18-05 to prevent reduced structural integrity of the
airplane.
    The FAA also issued AD 2020-09-16, Amendment 39-19912 (85 FR 29596,
May 18, 2020) (AD 2020-09-16), which applies to all ATR-GIE Avions de
Transport R[eacute]gional Model ATR42-200, -300, and -320 airplanes. AD
2020-09-

16 requires revising the existing maintenance or inspection program, as
applicable, to incorporate new or more restrictive airworthiness
limitations. The FAA issued AD 2020-09-16 to address reduced structural
integrity of the airplane. AD 2020-09-16 also specifies that
accomplishing the revision required by paragraph (g) of that AD
terminates all requirements of AD 2018-18-05, but AD 2020-09-16 did not
supersede AD 2018-18-05.

Actions Since AD 2018-18-05 and AD 2020-09-16 Were Issued

    Since the FAA issued AD 2018-18-05 and AD 2020-09-16, the FAA has
determined that new or more restrictive airworthiness limitations are
necessary.
    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0211, dated September 17, 2021
(EASA AD 2021-0211) (also referred to as the MCAI), to correct an
unsafe condition for all ATR-GIE Avions de Transport R[eacute]gional
Model ATR42-200, -300, and -320 airplanes.
    This proposed AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
proposing this AD to prevent reduced structural integrity of the
airplane. See the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0211 describes new or more restrictive airworthiness
limitations for airplane structures and components.
    This AD would also require EASA AD 2019-0256, dated October 17,
2019, which the Director of the Federal Register approved for
incorporation by reference as of June 22, 2020 (85 FR 29596, May 18,
2020).
    This material 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.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this NPRM after determining that
the unsafe condition described previously is likely to exist or develop
in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would retain the requirements of AD 2020-09-16.
This proposed AD would also require revising the existing maintenance
or inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations, which are specified in EASA AD
2021-0211 described previously, as proposed for incorporation by
reference. Revising the existing maintenance or inspection program, as
specified in EASA AD 2021-0211, would terminate the retained
requirements from AD 2020-09-16. Any differences with EASA AD 2021-0211
are identified as exceptions in the regulatory text of this proposed
AD.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections) and
Critical Design Configuration Control Limitations (CDCCLs). Compliance
with these actions and CDCCLs is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance (AMOC) according to
paragraph (m)(1) of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2021-0211 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2021-0211 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2021-0211 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0211. Service information required by EASA AD 2021-0211 for compliance
will be available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0395 after the FAA final rule is
published.

Airworthiness Limitation ADs Using the New Process

    The FAA's process of incorporating by reference MCAI ADs as the
primary source of information for compliance with corresponding FAA ADs
has been limited to certain MCAI ADs (primarily those with service
bulletins as the primary source of information for accomplishing the
actions required by the FAA AD). However, the FAA is now expanding the
process to include MCAI ADs that require a change to airworthiness
limitation documents, such as airworthiness limitation sections.
    For these ADs that incorporate by reference an MCAI AD that changes
airworthiness limitations, the FAA requirements are unchanged.
Operators must revise the existing maintenance or inspection program,
as applicable, to incorporate the information specified in the new
airworthiness limitation document. The airworthiness limitations must
be followed according to 14 CFR 91.403(c) and 91.409(e).
    The previous format of the airworthiness limitation ADs included a
paragraph that specified that no alternative actions (e.g.,
inspections), intervals, or CDCCLs may be used unless the actions,
intervals, and CDCCLs are approved as an AMOC in accordance with the
procedures specified in the AMOCs paragraph under ``Additional FAA AD
Provisions.'' This new format includes a ``New Provisions for
Alternative Actions, Intervals, and CDCCLs'' paragraph that does not
specifically refer to AMOCs, but operators may still request an AMOC to
use an alternative action, interval, or CDCCL.

Costs of Compliance

    The FAA estimates that this proposed AD affects 26 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2020-09-16 to be $7,650 (90 work-hours x $85 per work-
hour).
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since

operators incorporate maintenance or inspection program changes for
their affected fleet(s), the FAA has determined that a per-operator
estimate is more accurate than a per-airplane estimate.
    The FAA estimates the total cost per operator for the new proposed
actions to be $7,650 (90 work-hours x $85 per work-hour).

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.
    The FAA is 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

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would 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.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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:
0
a. Removing Airworthiness Directive (AD) 2018-18-05, Amendment 39-19384
(83 FR 44463, August 31, 2018); and AD 2020-09-16, Amendment 39-19912
(85 FR 29596, May 18, 2020); and
0
b. Adding the following new AD:

ATR-GIE Avions de Transport R[eacute]gional: Docket No. FAA-2022-
0395; Project Identifier MCAI-2021-01048-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by May 23, 2022.

(b) Affected ADs

    This AD replaces AD 2018-18-05, Amendment 39-19384 (83 FR 44463,
August 31, 2018); and AD 2020-09-16, Amendment 39-19912 (85 FR
29596, May 18, 2020) (AD 2020-09-16).

(c) Applicability

    This AD applies to all ATR-GIE Avions de Transport
R[eacute]gional Model ATR42-200, -300, and -320 airplanes,
certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to prevent reduced structural integrity of the
airplane.

(f) Compliance

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

(g) Retained Revision of the Existing Maintenance or Inspection
Program, With New Terminating Action

    This paragraph restates the requirements of paragraph (g) of AD
2020-09-16, with a new terminating action. Except as specified in
paragraph (h) of this AD: Comply with all required actions and
compliance times specified in, and in accordance with, European
Union Aviation Safety Agency (EASA) AD 2019-0256, dated October 17,
2019 (EASA AD 2019-0256). Accomplishing the revision of the existing
maintenance or inspection program required by paragraph (j) of this
AD terminates the requirements of this paragraph.

(h) Retained Exceptions to EASA AD 2019-0256, With No Changes

    This paragraph restates the exceptions specified in paragraph
(h) of AD 2020-09-16, with no changes.
    (1) The requirements specified in paragraphs (1) and (3) of EASA
AD 2019-0256 do not apply to this AD.
    (2) Where paragraph (2) of EASA AD 2019-0256 refers to its
effective date, this AD requires using June 22, 2020 (the effective
date of AD 2020-09-16).
    (3) Paragraph (4) of EASA AD 2019-0256 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, to incorporate the ``limitations, tasks and
associated thresholds and intervals'' specified in paragraph (4) of
EASA AD 2019-0256 within 90 days after June 22, 2020 (the effective
date of AD 2020-09-16).
    (4) The initial compliance time for doing the tasks specified in
paragraph (4) of EASA AD 2019-0256 is at the applicable ``associated
thresholds'' specified in paragraph (4) of EASA AD 2019-0256, or
within 90 days after June 22, 2020 (the effective date of AD 2020-
09-16), whichever occurs later.
    (5) The provisions specified in paragraphs (5) and (6) of EASA
AD 2019-0256 do not apply to this AD.
    (6) The ``Remarks'' section of EASA AD 2019-0256 does not apply
to this AD.

(i) Retained Restrictions on Alternative Actions, Intervals, and
Critical Design Configuration Control Limitations (CDCCLs), With New
Exception

    This paragraph restates the requirements of paragraph (i) of AD
2020-09-16, with a new exception. Except as required by paragraphs
(j) and (l) of this AD, after the existing maintenance or inspection
program has been revised as required by paragraph (g) of this AD, no
alternative actions (e.g., inspections), intervals, and CDCCLs are
allowed unless they are approved as specified in the provisions of
the ``Ref. Publications'' section of EASA AD 2019-0256.

(j) New Revision of the Existing Maintenance or Inspection Program

    Except as specified in paragraph (k) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2021-0211, dated September 17, 2021 (EASA
AD 2021-0211). Accomplishing the revision of the existing
maintenance or inspection program required by this paragraph
terminates the requirements of paragraph (g) of this AD.

(k) Exceptions to EASA AD 2021-0211

    (1) Where EASA AD 2021-0211 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The requirements specified in paragraphs (1) and (2) of EASA
AD 2021-0211 do not apply to this AD.
    (3) Paragraph (3) of EASA AD 2021-0211 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after the effective date of this AD.
    (4) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2021-0211 is at the applicable
``limitations'' and ``associated thresholds'' as

incorporated by the requirements of paragraph (3) of EASA AD 2021-
0211, or within 90 days after the effective date of this AD,
whichever occurs later.
    (5) The provisions specified in paragraphs (4) and (5) of EASA
AD 2021-0211 do not apply to this AD.
    (6) The ``Remarks'' section of EASA AD 2021-0211 does not apply
to this AD.

(l) New Provisions for Alternative Actions, Intervals, and CDCCLs

    After the existing maintenance or inspection program has been
revised as required by paragraph (j) of this AD, no alternative
actions (e.g., inspections), intervals, and CDCCLs are allowed
unless they are approved as specified in the provisions of the
``Ref. Publications'' section of EASA AD 2021-0211.

(m) Additional FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (n)(2) of
this AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or ATR-GIE
Avions de Transport R[eacute]gional's EASA Design Organization
Approval (DOA). If approved by the DOA, the approval must include
the DOA-authorized signature.

(n) Related Information

    (1) For information about EASA AD 2019-0256 and EASA AD 2021-
0211, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find these EASA ADs on the EASA website
at https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket at https://www.regulations.gov by searching
for and locating Docket No. FAA-2022-0395.
    (2) For more information about this AD, contact Shahram
Daneshmandi, Aerospace Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des
Moines, WA 98198; telephone206-231-3220; email
[email protected].

    Issued on March 31, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.

[FR Doc. 2022-07157 Filed 4-5-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 19, 2008 (Volume 73, Number 161)]
[Rules and Regulations]
[Page 48288-48290]
[DOCID:fr19au08-3]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-29174; Directorate Identifier 2007-NM-125-AD;
Amendment 39-15641; AD 2008-17-03]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-100, -200, -200C, -
300, -400, and -500 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Boeing Model 737-100, -200, -200C, -300, -400, and -500 series
airplanes. This AD requires repetitive inspections to detect cracking
of the body station 303.9 frame, and corrective action if necessary.
This AD also provides for optional terminating action for the
repetitive inspections. This AD results from reports of cracks found at
the cutout in the web of body station frame 303.9 inboard of stringer
16L. We are issuing this AD to detect and correct such cracking, which
could prevent the left forward entry door from sealing correctly, and
could cause in-flight decompression of the airplane.

DATES: This AD is effective September 23, 2008.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of September 23,
2008.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-
2207.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Howard Hall, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6430; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
certain Boeing Model 737-100, -200, -200C, -300, -400, and -500 series
airplanes. That NPRM was published in the Federal Register on September
13, 2007 (72 FR 52314). That NPRM proposed to require repetitive
inspections to detect cracking of the body station 303.9 frame, and
corrective action if necessary. That NPRM also proposed optional
terminating action for the repetitive inspections.

Comments

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

Support for the NPRM

    Boeing concurs with the NPRM.

Request To Delay Final Rule

    The Air Transport Association (ATA), on behalf of its member United
Airlines, requests that we delay issuing the final rule until kits (to
repair cracks or to terminate the repetitive inspections) are readily
available from Boeing. Only Boeing kits are specified; Boeing kit
65C37763-8 is under parts management control by Boeing.
    We disagree with the request to delay issuing the final rule. To
delay this action would be inappropriate, since we have determined that
an unsafe condition exists, and that inspections must be conducted in a
timely manner to ensure continued safety. Boeing is aware of the
pending AD. We have been advised that kits are currently available from
Boeing Spares, and that Boeing has already made forecasts to ensure
continued kit availability. Operators that order out-of-stock kits from
Boeing can request permission from Boeing Spares to manufacture the
kits. We have been advised that Boeing Spares will provide the drawings
and specifications required to make kits. The kits related to this AD
are made up of simple parts that should be easy for operators to
fabricate. We have not changed the final rule regarding this issue.

Request To Allow Existing Repairs as Terminating Action

    Continental requests that we revise the NPRM to allow existing FAA-
approved repairs (in the inspection area specified in the NPRM) as
terminating action for the proposed repetitive inspections. The
commenter notes that the service bulletin has no provisions for
inspecting existing FAA-approved repairs.
    While certain previously installed repairs might be acceptable as a
terminating action for the AD inspections, we cannot classify all
previously installed repairs--even ones approved by the FAA--as
terminating action unless the repair is properly evaluated in light of
the requirements of this AD. Paragraph (j) of the final rule provides
operators the opportunity to request approval of specific repair
configurations as terminating action. Such a request should include
data/rationale to show that the repair configuration provides an
acceptable level of safety without continued inspections. We have not
changed the final rule regarding this issue.

Request To Extend Grace Period

    Continental Airlines requests that we revise the NPRM to extend the
grace period for the initial inspection (for airplanes that have
exceeded the specified flight-cycle threshold). The commenter requests
an extension from 2,250 flight cycles to 4,500 flight cycles to
coincide with a scheduled heavy maintenance check. The commenter
asserts that the proposed grace period would not give operators
adequate time to comply with the AD without added financial and
logistical burden on the airlines. The commenter refers to AD 2005-20-
03, amendment 39-14296 (70 FR 56361, September 27, 2005). That AD also
applies to Boeing Model 737-100, -200, -200C, -300, -400, and -500
series airplanes. That AD requires repetitive inspections of the
intercostal webs, attachment clips, and stringer splice channels for
cracks; and corrective action if necessary. The commenter states that
the inspection area is the same for AD 2005-20-03 and the subject NPRM.
The grace period for that AD is 4,500 flight cycles, so extending the
grace period in the NPRM to 4,500 flight cycles will provide an
acceptable safety level in this AD.
    We agree with the commenter's request and rationale. We have
revised paragraph (h) in this final rule accordingly. We have
coordinated this change with Boeing.

Request To Relax Dimensional Tolerances

    Continental requests that the dimensional requirements be specified
to a maximum of two decimal places with a tolerance of
0.03 inch. Figure 11, detail A, of Boeing Alert Service Bulletin 737-
53A1188, Revision 2, dated May 9, 2007, specifies enlarging the slotted
hole to dimensions of three decimal places. (Boeing Alert Service
Bulletin 737-53A1197, dated August 25, 2006, contains similar
specifications.) The commenter asserts that a tight (three-decimal-
place) tolerance is virtually impossible to attain with this particular
modification.
    We agree that the noted dimension in the service bulletin is shown
to three decimal places. But we disagree that the actual ``build to''
or ``measure to'' dimensions must be controlled to three decimal
places. According to paragraph 3.A. of the Accomplishment Instructions
of the service bulletin, the tolerance for linear dimensions is  0.03 inch. Given the two-decimal-place accuracy of this
tolerance, the corresponding final dimension will require only two-
decimal-place accuracy. So, for example, for a specified dimension of
1.29900  0.03, the final ``build to'' and ``measure to''
dimensions, when appropriately rounded to the 2-decimal-place tolerance
accuracy, are 1.27-1.33. We have not changed the final rule regarding
this issue.

Clarification of Required Service Information

    We have revised the final rule to clarify that Revision 2 of Boeing
Alert Service Bulletin 737-53A1188 must be used for the requirements of
paragraph (f) of this AD.

Conclusion

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

Costs of Compliance

    There are about 2,765 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs,
depending on airplane configuration, for U.S. operators to comply with
this AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of U.S.-
             Action                    Work hours        Average labor         Parts          Cost per airplane       registered          Fleet cost
                                                         rate per hour                                                airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection......................  1 to 4..............             $80  None...............  $80 to $320, per    1,154..............  $92,320 to
                                                                                inspection cycle.                        $369,280, per
                                                                                inspection cycle.
Repair/preventive change, if      12 to 30............              80  $564 to $2,236.....  $1,524 to $4,636..  Up to 1,154........  Up to $5,349,944.
 done.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2008-17-03 Boeing: Amendment 39-15641. Docket No. FAA-2007-29174;
Directorate Identifier 2007-NM-125-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective September 23,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the airplanes, certificated in any
category, identified in Table 1 of this AD.

                         Table 1--Applicability
------------------------------------------------------------------------
                                          As identified in Boeing Alert
             Boeing model--                     Service Bulletin--
------------------------------------------------------------------------
737-100, -200, and -200C series          737-53A1197, dated August 25,
 airplanes.                               2006.
737-300, -400, and -500 series           737-53A1188, Revision 2, dated
 airplanes.                               May 9, 2007, or 737-53A1197,
                                          dated August 25, 2006.
------------------------------------------------------------------------

Unsafe Condition

    (d) This AD results from reports of cracks found at the cutout
in the web of body station frame 303.9 inboard of stringer 16L. We
are issuing this AD to detect and correct such cracking, which could
prevent the left forward entry door from sealing correctly, and
could cause in-flight decompression of the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Repetitive Inspections: Service Bulletin 737-53A1188

    (f) For airplanes identified in Boeing Alert Service Bulletin
737-53A1188, Revision 2, dated May 9, 2007, including airplanes
modified by the repair/preventive change specified in the original
version, dated April 9, 1998; or Revision 1, dated March 18, 1999;
of the service bulletin: Do detailed and high frequency eddy current
(HFEC) inspections in the web and doubler around the slotted holes
in the frame web at stringers 15L and 16L, in accordance with the
Accomplishment Instructions of Revision 2 of the service bulletin.
Do the inspections at the applicable time specified in paragraph
1.E. of Revision 2 of the service bulletin, except as provided by
paragraph (h) of this AD. Do all applicable corrective actions
before further flight in accordance with Revision 2 of the service
bulletin, except as provided by paragraph (i) of this AD. Repeat the
inspections at intervals not to exceed 4,500 flight cycles until
accomplishment of the repair/preventive change in accordance with
Revision 2 of the service bulletin, which terminates the repetitive
inspection requirements. A repair/preventive change done in
accordance with the original version or Revision 1 of the service
bulletin does not terminate the repetitive inspections, but the
repetitive inspections may be terminated after the existing kit is
replaced with a new kit in accordance with paragraph 3.B., Part II,
step 3, or Part III, step 3, of Revision 2 of the service bulletin.

Repetitive Inspections: Service Bulletin 737-53A1197

    (g) For airplanes identified in Boeing Alert Service Bulletin
737-53A1197, dated August 25, 2006: Do an ultrasound inspection of
the slot-shaped cutout in the web for the door stop strap at
stringer 16L, an HFEC inspection of the web along the upper and
lower edges of the doubler around the doorstop strap at stringer
16L, and a detailed inspection of the web around the doubler for the
cutout at stringer 16L, in accordance with the Accomplishment
Instructions of the service bulletin. Do the inspections at the
applicable time specified in paragraph 1.E. of the service bulletin,
except as provided by paragraph (h) of this AD. Do all applicable
corrective actions before further flight in accordance with the
service bulletin, except as provided by paragraph (i) of this AD.
Repeat the inspections at intervals not to exceed 4,500 flight
cycles, until accomplishment of the repair/preventive change in
accordance with the service bulletin, which terminates the
repetitive inspections.

Exceptions to Service Bulletin Specifications

    (h) Where Boeing Alert Service Bulletin 737-53A1188, Revision 2,
dated May 9, 2007, and Boeing Alert Service Bulletin 737-53A1197,
dated August 25, 2006, specify a compliance time after release of
the service bulletin, this AD requires compliance within the
specified time after the effective date of this AD. For the initial
inspection, the grace period for airplanes that have exceeded the
specified threshold is extended to 4,500 flight cycles after the
effective date of this AD.
    (i) Where Boeing Alert Service Bulletin 737-53A1188, Revision 2,
dated May 9, 2007, and Boeing Alert Service Bulletin 737-53A1197,
dated August 25, 2006, specify to contact Boeing for appropriate
action, including repair of damage outside the scope of the service
bulletin, repair using a method approved in accordance with the
procedures specified in paragraph (j) of this AD.

Alternative Methods of Compliance (AMOCs)

    (j)(1) The Manager, Seattle Aircraft Certification Office, FAA,
ATTN: Howard Hall, Aerospace Engineer, Airframe Branch, ANM-120S;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to be approved, the repair must meet the certification basis
of the airplane, and the approval must specifically refer to this
AD.

Material Incorporated by Reference

    (k) You must use Boeing Alert Service Bulletin 737-53A1188,
Revision 2, dated May 9, 2007; or Boeing Alert Service Bulletin 737-
53A1197, dated August 25, 2006; as applicable; to do the actions
required by this AD; unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington
98124-2207.
    (3) You may review copies of the service information
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on August 6, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-18812 Filed 8-18-08; 8:45 am]

BILLING CODE 4910-13-P


              OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460
              OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

MEMORANDUM

DATE:		July 30, 2019

SUBJECT:	Federal Food, Drug, and Cosmetic Act (FFDCA) Safety Assessment for Exemption from the Requirement of a Tolerance for Residues of Lipochitooligosaccharide (LCO) MOR116

				Docket ID Number: EPA-HQ-OPP-2018-0244

FROM:		Gina Burnett, Senior Regulatory Advisor
            Biochemical Pesticides Branch
            Biopesticides & Pollution Prevention Division (7511P)

THROUGH:	Linda Hollis, Chief
            Biochemical Pesticides Branch
				Biopesticides & Pollution Prevention Division (7511P)

TO:			Robert McNally
				Division Director
				Biopesticides & Pollution Prevention Division (7511P)

This memorandum provides the rationale for establishing an exemption from the requirement of a tolerance for residues of Lipochitooligosaccharide (LCO) MOR116 in or on all food commodities.
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) and (D), including exposure of infants and children as well as other noted factors.
This document summarizes the analyses of the Biopesticides and Pollution Prevention Division (BPPD) Risk Assessment and Biochemical Pesticide Branches (RAB and BPB) to assess the risks from aggregate exposure to residues of the pesticide LCO MOR116. This document summarizes the toxicity of the pesticide and any reasonably expected exposure to the pesticide through food, drinking water, and other non-occupational exposures. The safety of the reasonably expected aggregate exposure is assessed relative to the toxicity of the pesticide.
Based on this assessment, BPB recommends the establishment of an exemption from the requirement of a tolerance for residues of LCO MOR116 in or on all food commodities due to the lack of any risks of concern from exposure when used as a pesticide in accordance with label directions and good agricultural practices.

I.  Summary of Petitioned-for Establishment of an Exemption from the Requirement of a Tolerance

In the Federal Register of July 24, 2018 (83 FR 34968) (FRL-9980-31), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 8F8670) by Monsanto Company (now known as Bayer Crop Science LP), 800 N. Lindbergh Blvd., St. Louis, MO 63167. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of LCO MOR116 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner, Monsanto Company (now known as Bayer Crop Science LP), which is available in the docket via http://www.regulations.gov. There were no comments received in response to the notice of filing.

II.  Toxicological Profile

Consistent with FFDCA section 408(b)(2)(D) of FFDCA, RAB and BPB reviewed the available scientific data and other relevant information on LCO MOR116, and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. RAB and BPB also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
A.  Overview of LCO MOR116 Toxicity
LCO MOR116 is a synthetically derived member of the lipochitooligosaccharide (LCO) chemical class, that are signaling molecules involved in the initiation of plant-microbe endosymbioses in an estimated 70-80% of land plants (Reference 1, below). As a biopesticide, the compound is considered a plant growth regulator (PGR) and is intended for use to increase growth and decrease stress in growing crops. Typical of a PGR, LCO MOR116 should be applied at low concentrations because use at high concentrations can result in detrimental effects to the plant.  LCO MOR116 is not expected to be applied above 5.89 X 10[-][11] lb ai/lb seed. Further, exemptions from the requirement of a tolerance have already been established for the closely related compound MP LCO SP104 (PC Code 006388) due to its structural similarity, and for rhizobial inoculants (food use) in pesticide formulations per 40 CFR §180.1353 and §180.910, respectively. Rhizobial inoculants are generally known for their ability to produce LCOs (Reference 2).

According to the Tier I mammalian toxicology acute toxicity studies on a manufacturing-use product containing LCO MOR116, this compound is not considered to be acutely toxic, is minimally irritating to the eye and skin, is not a dermal sensitizer, and is not a mutagen. Based on a weight of evidence (WOE) approach, considering all the available hazard data and proposed application rates and use pattern, EPA's Hazard and Science Policy Council (HASPOC) concluded that subchronic toxicity data for LCO MOR116 are not required to support the LCO MOR116 tolerance exemption (Reference 3).

 Acute Toxicity

To satisfy the Tier I mammalian acute toxicology data requirements for biochemical pesticides (listed at 40 CFR 158.2050, OCSPP Guideline numbers 870.1100, 870.1200, 870.1300, 870.2400, 870.2500, and 870.2600), acute toxicology studies on an LCO MOR116 manufacturing-use product (MP), as presented in Table 1, below, were submitted. According to this information, LCO MOR116 is not considered to be acutely toxic. The chemical is classified as Toxicity Category IV for acute oral, dermal and inhalation toxicity and dermal and eye irritation. The substance is not considered to be a dermal sensitizer.

Table 1. Acute Mammalian Toxicology Data for LCO MOR116 MP (40 CFR § 158.2050)
                           Study/OCSPP Guideline No.
                                    Results
                              Toxicity Category/
                                  Description
                                     MRID
Acute oral toxicity
(870.1100)
                          LD50 > 5,000 mg/kg (rat)

                                      IV
                                   50464807
Acute dermal toxicity
(870.1200)
                          LD50 > 5,000 mg/kg (rat)
                                      IV
                              50738202, 50464808
Acute inhalation toxicity
(870.1300)
                           LC50 > 5.14 mg/L (rat)

                                      IV
                              50738202, 50464809
Primary eye irritation
(870.2400)
Minimally irritating (rabbit): minimal irritation observed at one-hour post instillation of the test substance with clearance by 24 hours
                                      IV
                                   50738202
Primary dermal irritation
(870.2500)
Nonirritating (rabbit): no irritation noted at any point throughout the 72-hour study.
                                      IV
                         50464810, 50738202, 50464811
Dermal sensitization (Buehler)
(870.2600)
                         Not a sensitizer (guinea pig)
                                      N/A
                                   50738202

 Subchronic Toxicity

To satisfy the subchronic toxicity data requirements for LCO, in lieu of guideline studies, the applicant has requested waivers and cited information (eight studies) from the open scientific literature. These eight studies (2-28-day, 4-90-day, a 1-year, and a 2-year oral toxicity) are available for structurally similar compounds related to LCO's and are adequate for use in the risk assessment. The studies indicate a lack of adverse effects. These structurally-similar compounds are chitooligomers (LCO degradation product), chitosan oligosaccharide (also an LCO degradation product), chitin-glucan, chitin, N-acetylglucosamine, and oligo-N-acetylglucosamine. Summaries of the eight studies are provided below in Table 2, below.

From these studies, no endpoints appropriate for risk assessment were identified. The full supporting basis for the acceptance of the waiver rationales, guideline-by-guideline, is described below. In summary, based on the available data and information, LCO MOR116 is not subchronically toxic.
 Table 2: Subchronic Toxicity information taken from the Open Literature for Compounds Structurally Similar to LCO MOR116

 Chemical
 Study Type
 NOAELs
 (mg/kg/day)
 LOAELs
 (mg/kg/day)
 Effects at LOAEL
 Reference
 Chitooligomers
 28-day rat
 3,000
                                       -
 No adverse effects at HDT
 (Qin et. al., 2006)
 COS
 28-day rat
 2,000
                                       -
 No adverse effects at HDT
 (Kim et. al., 2001)
 Chitin-glucan
 90-day rat
 6,600 M
 7,000 F
                                       -
 No adverse effects at HDT
 (Jonker et. al., 2010)
 Chitin
 90-day rat
 3,500
                                       -
 No adverse effects at HDT
 (Niho et. al., 1999)
 GlcNAc
 90-day rat
 2,476 M
 2,834 F
                                       -
 No adverse effects at HDT
 (Lee et. al., 2004)

 OAG

 90-day rat
 641 M
 3,640 F
 3,640 M

 M: decreased weight of submaxillary salivary gland[1]
 (Tago et. al., 2007)
 GlcNAc
 1 yr rat
 2,323 M
 2,545 F
                                       -
 No adverse effects at HDT
 (Takahashi et. al., 2009)

 GlcNAc

 2 yr rat
 2,323 M
 2,545 F

                                       -
 No adverse effects at HDT
 (not carcinogenic)

 (Takahashi et. al., 2009)
 F = female; M = male; HDT = highest dose tested; LOAEL = lowest-observed-adverse-effect-level; NOAEL = no-observed-adverse-effect-level

90-Day Oral

Based on a weight of evidence (WOE) approach, considering all the available LCO MOR116 hazard and other data on similar compounds, a 90-day oral study on LCO MOR116 is not required at this time. This approach included the following considerations: 1) several oral toxicity studies conducted on similar compounds to LCO MOR116 showed no adverse effects at the highest dose tested; 2) the acute toxicology studies for an LCO MOR116 MP demonstrate Toxicology Category IV, suggesting that the compound has low toxicity on an acute basis; 3) LCO MOR116 is structurally similar to LCO naturally occurring compounds that have long been part of the normal diet (seafood and plants); 4) prior data waivers for all subchronic toxicity requirements were granted by the Agency for use of chitin and chitosan as food additives and plant growth regulators, respectively; 5) mode of action is not relevant outside the plant kingdom; 6) there is an existing U.S. EPA tolerance exemption for chitin and chitosan; 7) ubiquity of LCOs in the environment; 8) due to low toxicity, a qualitative assessment will be performed; 9) the anticipated low application rates of LCO MOR116; and 10) worst case exposures fall well below generally accepted Threshold of Toxicological Concern (TTCs) for corn and canola, which is 1800 μg/chemical/person/day for Cramer Class I (Ref. 2).

90-Day Dermal

Based on a WOE approach, considering all the available LCO MOR116 hazard and other data on similar compounds, the HASPOC recommends that a 90-day dermal toxicity study on LCO MOR116 is not required at this time.

90-Day Inhalation

Based on a WOE approach, considering all the available LCO MOR116 hazard and other data on similar compounds, the HASPOC recommends that a 90-day inhalation toxicity study on LCO MOR116 is not required at this time.

 Mutagenicity

Based on a WOE approach, considering all the available LCO MOR116 hazard and exposure data, genetic toxicity (mutagenicity) testing on LCO MOR116 is not required at this time. This requirement has been satisfied with a WOE approach. This approach included the following considerations: 1) available literature studies demonstrated a lack of genotoxicity for LCOs; 2) structure-activity relationships demonstrating a lack of genotoxic potential; 3) prior genotoxicity data waivers granted by the agency for use of (structurally similar) chitin and chitosan as food additives and plant growth regulators, respectively; 4) U.S. EPA has established a tolerance exemption for chitin and chitosan; 5) ubiquitous nature of LCOs in the environment; 6) a History of Safe Use (HOSU) of LCO's; 7) the maximum predicted exposure levels of LCO MOR116 are orders of magnitude lower than generally recognized Thresholds of Toxicological Concern (TTCs) (Refs 2 and 3).

 Developmental Toxicity

Based on a WOE approach, considering all the available hazard and exposure data on LCO MOR116, a Prenatal Developmental Study is not required at this time. This approach included the following considerations: 1) LCO MOR116 is structurally similar to LCO naturally occurring compounds that have long been part of the normal diet (seafood and plants); 2) the acute toxicology studies are classified as Toxicity Category IV, indicating low acute toxicity for LCO MOR116; 90-day oral toxicity studies of similarly-structured compounds (chitin-glucan, chitin, N-acetylglucosamine, and oligo-N-acetylglucosamine) have found NOAEL's greater than 2000 mg/kg in rats; 3) prior data waivers for all subchronic toxicity requirements were granted by the Agency for use of chitin and chitosan as food additives and plant growth regulators, respectively; 4) mode of action is not relevant outside the plant kingdom; 5) there is an existing U.S. EPA tolerance exemption for the related compounds, chitin and chitosan; 6) ubiquity of LCOs in the environment; 7) due to the low toxicity for this chemical, a qualitative assessment was performed; 8) the low application rates of LCO MOR116; and 9) worst-case exposures that fall well below the rabbit developmental Threshold of Toxicological Concern (TTCs) for corn and canola of 280 μg/chemical/person/day (Refs 2 and 3).

III.  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).

Food Exposure: There is potential for dietary exposure to LCO MOR116 as a pesticide, however, exposure is anticipated to be negligible compared to (naturally found) background levels. LCOs are present in the roots of food crops and in bacteria and fungi that are associated with the roots of food crops. Molecules identical to LCO breakdown products (such as chitin, vaccenic acid, and N-acetyl-D-glucosamine) are also present in insects, crustaceans, fungi, bacteria, and humans, and are regularly consumed as part of a normal diet. The chitin backbone can be broken down by the human gut into GlcNAc, which is naturally present in human tissues, human breastmilk, and is also commonly consumed as a dietary supplement. Pesticidal use of LCO MOR116 is unlikely to contribute significantly to overall human exposure due to its anticipated low application rate, high water solubility and because it is expected to degrade relatively rapidly once applied (and, therefore, is not likely to bioconcentrate).

Drinking Water Exposure: Residues of LCO MOR116 in drinking water are not anticipated when products are used according to label instructions. The active ingredient is applied at low concentrations, is very soluble in water, and will dissociate within minutes once applied. Therefore, residues of LCO MOR116 in drinking water are unlikely.

Other Non-occupational Exposure: LCO MOR116 is not currently registered for use in residential settings. It is intended for agricultural use only. Therefore, a residential assessment is not required and was not conducted.

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

LCO MOR116 is not toxic and does not produce toxic metabolites; therefore, it does not have a common mechanism of toxicity with other substances and cumulative effects are not expected.

V.  Determination of Safety for the U.S. Population, Infants and Children

A.  U.S. Population

Due to the lack of toxicity, EPA concludes that there is reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of LCO MOR116. This includes all anticipated dietary exposures and all other exposures for which there is reliable information.

B. Infants and Children

FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure, unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor. In applying this provision, EPA either retains the default value of 10X or uses a different safety factor when reliable data available to EPA support the choice of a different factor.

As discussed above, EPA has not identified any toxicity with LCO MOR116. Because there are no threshold levels of concern to infants, children, or adults, EPA conducted a qualitative assessment without safety factors; therefore, no additional margin of safety is necessary to protect infants and children.

VI.  Conclusions
The available data support a determination 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 LCO MOR116. Therefore, BPB recommends that an exemption from the requirement of a tolerance be established for residues of LCO MOR116 in or on all food, when used in accordance with label directions and good agricultural practices.

VII.  References

 Gough and Cullimore, 2011. Lipo-chitooligosaccharide Signaling in Endosymbiotic Plant-Microbe Interactions. Molecular Plant-Microbe Interactions 24:867-878.

 EPA, 2019a. Revised Final Human Health Risk Assessment: In Support of the Registration of LCO MOR116 MP Containing 0.013% Lipochitooligosaccharide (LCO) MOR116 (EPA File Symbol No. 524-ALU and Petition No. 8F8670) as its Active Ingredient and the End-Use Product LCO Liquid Additive (EPA File Symbol No 524-ALG) Containing 0.0000266% LCO MOR116 as its Active Ingredient. July 8, 2019.

 EPA, 2019b. Lipochitooligosaccharide (LCO) MOR116: Summary of Hazard and Science Policy Council (HASPOC) Meeting on May 2, 2019:  Recommendations on the Need for the Following Subchronic Studies: 90-Day Oral Study (OCSPP 870.3000), 90-Day Dermal (OCSPP 870.3250), 90-Day Inhalation (OCSPP 870.3465), Prenatal Developmental Study (OCSPP 870.3700), and Genetic Toxicity Testing (OCSPP 870.5100, 870.5300, 870.5375). May 3, 2019.


June 14   17, 2002 Episode ° Plots provide ozone concentration and wind vectors ID Description AP Apex JN Jean JO Joe Neal MQ Mesquite PL Hendersen PV Palo Verde School LV Las Vegas Airport NE Nellis Air Force CAL CalWash 3 Monitoring Stations