[Federal Register Volume 81, Number 133 (Tuesday, July 12, 2016)]
[Proposed Rules]
[Pages 45075-45079]
[FR Doc No: 2016-16322]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-7426; Directorate Identifier 2015-NM-199-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 737-100, -200, and -200C series
airplanes. This proposed AD is intended to complete certain mandated
programs intended to support the airplane reaching its limit of
validity (LOV) of the engineering data that support the established
structural maintenance program. This proposed AD would require
repetitive detailed, high frequency eddy current (HFEC), and ultrasonic
inspections of the center section rear spar upper clevis lugs and
horizontal stabilizer rear spar upper lugs, as applicable, for any
cracking, and related investigative and corrective actions if
necessary. For certain airplanes, this proposed AD would require
replacement of the center section rear spar upper chord with a new part
and a serviceable center section assembly. This proposed AD would also
require repetitive HFEC and fluorescent dye penetrant inspections of
the center section for cracking of the front and rear spar upper clevis
lugs or horizontal stabilizer front and rear spar upper lugs, and
related investigative and corrective actions if necessary. We are
proposing this AD to detect and correct cracking in the rear spar upper
clevis lugs of the center section, and in the rear spar upper lugs of
the horizontal stabilizer which could result in the loss of structural
integrity and controllability of the airplane.

DATES: We must receive comments on this proposed AD by August 26, 2016.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Data & Services Management, P. O. Box
3707, MC 2H-65, Seattle, WA 98124-2207; telephone:<PHONE_NUMBER>,
extension 1; fax:<PHONE_NUMBER>; Internet: https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 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-
7426.

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-2016-7426; 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 proposed AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Office (phone:<PHONE_NUMBER>) is in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Payman Soltani, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone:
562-627-5313; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2016-7426;
Directorate Identifier 2015-NM-199-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    As described in FAA Advisory Circular 120-104 (http://www.faa.gov/documentLibrary/media/Advisory_Circular/120-104.pdf), several programs
have been developed to support initiatives that will ensure the
continued airworthiness of aging airplane structure. The last element
of those initiatives is the requirement to establish a LOV of the
engineering data that support the structural maintenance program under
14 CFR 26.21. This proposed AD is the result of an assessment of the
previously established programs by the DAH during the process of
establishing the LOV for the affected airplanes. The actions specified
in this proposed AD are necessary to complete certain programs to
ensure the continued airworthiness of aging airplane structure and to
support an airplane reaching its LOV.
    This proposed AD is intended to complete certain mandated programs
intended to support the airplane reaching its LOV of the engineering
data that support the established structural maintenance program. An
operator detected a cracked center section at the rear spar upper chord
clevis lug. This condition, if not corrected, could result in cracking
in the rear spar clevis lugs of the horizontal stabilizer center
section, which could result in loss of structural integrity and
controllability of the airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 737-55A1033, Revision 2,
dated August 7, 2015. The service information describes procedures for
repetitive detailed, HFEC, and ultrasonic inspections of the center
section rear spar upper clevis lugs and rear spar upper lugs of the
horizontal stabilizer; HFEC and fluorescent dye penetrant inspections
for cracking in the front and rear spar upper clevis lugs of the center
section and the front and rear spar upper lugs of the horizontal
stabilizer. For certain airplanes, the service information describes
procedures for replacement of the center section rear spar upper chord
with a new part and replacing the center section with a serviceable
center section assembly, or installing bushings and sleeves as
applicable. 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.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between This Proposed AD and the Service
Information.'' For information on the procedures and compliance times,
see this service information at http://www.regulations.gov by searching
for and locating Docket No. FAA-2016-7426.
    The phrase ``related investigative actions'' is used in this NPRM.
Related investigative actions are follow-on actions that (1) are
related to the primary action, and (2) further investigate the nature
of any condition found. Related investigative actions in an AD could
include, for example, inspections.
    The phrase ``corrective actions'' is also used in this NPRM.
Corrective actions are actions that correct or address any condition
found. Corrective actions in an AD could include, for example, repairs.

Differences Between This Proposed AD and the Service Information

    Boeing Alert Service Bulletin 737-55A1033, Revision 2, dated August
7, 2015, specifies to contact the manufacturer for certain
instructions, but this proposed AD would require accomplishment of
repair methods, modification deviations, and alteration deviations in
one of the following ways:
     In accordance with a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by the Boeing Commercial
Airplanes Organization Designation Authorization (ODA) whom we have
authorized to make those findings.
    Where Boeing Alert Service Bulletin 737-55A1033, Revision 2, dated
August 7, 2015, specifies a compliance time or repeat interval as
``Horizontal Stabilizer Center Section flight cycles'' or ``Horizontal
Stabilizer flight cycles,'' this AD requires compliance for the
corresponding time or repeat interval in airplane flight cycles.

Costs of Compliance

    We estimate that this proposed AD affects 84 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                             Parts                              Cost on U.S.
              Action                      Labor cost          cost      Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Repetitive detailed, HFEC, and      9 work-hours x $85            $0  $765 per inspection   $64,260 per
 ultrasonic inspections.             per hour = $765 per               cycle.                inspection cycle.
                                     inspection cycle.

Repetitive HFEC and fluorescent     118 work-hours x $85           0  $10,030 per           $842,520 per
 dye penetrant inspections.          per hour = $10,030                inspection cycle.     inspection cycle.
                                     per inspection cycle.
Replacement.......................  Up to 252                 25,000  Up to $46,420 per     Up to $3,899,280 per
                                     work[dash]hours x                 inspection cycle.     inspection cycle.
                                     $85 per hour =
                                     $21,420 per
                                     inspection cycle.
----------------------------------------------------------------------------------------------------------------

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

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
               Action                      Labor cost        Parts cost              Cost per product
----------------------------------------------------------------------------------------------------------------
Bolt and Bushing Removal/            101 work-hours x $85            $0  $8,585.
 Inspection, Fabrication, and         per hour = $8,585.
 Installation.
Repair and replacement.............  Up to 252                   25,000  Up to $46,420 per inspection cycle.
                                      work[dash]hours x
                                      $85 per hour =
                                      $21,420 per
                                      inspection cycle.
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Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, 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.

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 adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2016-7426; Directorate Identifier
2015-NM-199-AD.

(a) Comments Due Date

    We must receive comments by August 26, 2016.

(b) Affected ADs

    This AD affects AD 84-23-05, Amendment 39-4949 (49 FR 45744,
November 20, 1984); and AD 86-12-05, Amendment 39-5321 (51 FR 18771,
May 22, 1986).

(c) Applicability

    This AD applies to The Boeing Company Model 737-100, -200, and -
200C series airplanes, certificated in any category, as identified
in Boeing Alert Service Bulletin 737-55A1033, Revision 2, dated
August 7, 2015.

(d) Subject

    Air Transport Association (ATA) of America Code 55, Stabilizers.

(e) Unsafe Condition

    This proposed AD is intended to complete certain mandated
programs intended to support the airplane reaching its limit of
validity (LOV) of the engineering data that support the established
structural maintenance program. We are issuing this AD to detect and
correct cracking in the rear spar upper clevis lugs of the center
section, and in the rear spar upper lugs of the horizontal
stabilizer which could result in the loss of structural integrity
and controllability of the airplane.

(f) Compliance

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

(g) Inspections, Related Investigative and Corrective Actions (Service
Information Tables 1 and 3)

    At the applicable time specified in table 1 or table 3 of
paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
737-55A1033, Revision 2, dated August 7, 2015, except as specified
in paragraph (o) of this AD: Do detailed, high frequency eddy
current (HFEC), and ultrasonic inspections of the center section
rear spar upper clevis lugs for any cracking, and do all applicable
related investigative and corrective actions, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
55A1033, Revision 2, dated August 7, 2015; except as specified in
paragraph (p) of this AD. Do all related investigative and
corrective actions before further flight. Repeat the inspections
thereafter at the applicable times specified in table 1 or table 3
of paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
737-55A1033, Revision 2, dated August 7, 2015.

(h) Replacement (Service Information Table 1)

    For airplanes identified as Group 1, Configuration 1, in Boeing
Alert Service

Bulletin 737-55A1033, Revision 2, dated August 7, 2015: At the
applicable time specified in table 1 of paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-55A1033,
Revision 2, dated August 7, 2015, except as specified in paragraph
(o) of this AD, replace the center section rear upper chord with a
new part or replace the center section with a serviceable center
section assembly, in accordance with the Accomplishment Instructions
of Boeing Alert Service Bulletin 737-55A1033, Revision 2, dated
August 7, 2015.

(i) Repetitive Post-Replacement Inspections, Related Investigative and
Corrective Actions (Service Information Table 2)

    For airplanes identified as Group 1, Configuration 1, in Boeing
Alert Service Bulletin 737-55A1033, Revision 2, dated August 7,
2015, with a new or serviceable 0.932-inch-thick center section rear
spar upper chord: At the applicable time specified in table 2 of
paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
737-55A1033, Revision 2, dated August 7, 2015, except as specified
in paragraph (o) of this AD, do detailed, HFEC, and ultrasonic
inspections of the center section rear spar upper chord clevis lugs
for any cracking, and do all applicable related investigative and
corrective actions, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-55A1033, Revision
2, dated August 7, 2015; except as specified in paragraph (p) of
this AD. Do all related investigative and corrective actions before
further flight. Repeat the inspections thereafter at the applicable
times specified in table 2 of paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 737-55A1033, Revision 2, dated August
7, 2015.

(j) Post-Replacement Inspections, Related Investigative and Corrective
Actions (Service Information Table 4)

    For airplanes on which the center section rear spar upper chord
was last replaced with a new part or serviceable part: Within the
applicable times specified in table 4 of paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-55A1033,
Revision 2, dated August 7, 2015, except as specified in paragraph
(o) of this AD, do detailed, HFEC, and ultrasonic inspections of the
center section rear spar upper chord clevis lugs for any cracking,
and do all applicable related investigative and corrective actions,
in accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 737-55A1033, Revision 2, dated August 7, 2015;
except as specified in paragraph (p) of this AD. Do all related
investigative and corrective actions before further flight. Repeat
the inspections thereafter at the applicable times specified in
table 4 of 1.E., ``Compliance'' of Boeing Alert Service Bulletin
737-55A1033, Revision 2, dated August 7, 2015.

(k) Repetitive Inspections, Related Investigative and Corrective
Actions of the Horizontal Stabilizer (Service Information Table 5)

    Within the applicable time specified in table 5 of paragraph
1.E., ``Compliance,'' of Boeing Alert Service Bulletin 737-55A1033,
Revision 2, dated August 7, 2015, except as specified in paragraph
(o) of this AD, do detailed, HFEC, and ultrasonic inspections of the
rear spar upper lugs of the horizontal stabilizer for any cracking,
and do all applicable related investigative and corrective actions,
in accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 737-55A1033, Revision 2, dated August 7, 2015;
except as specified in paragraph (p) of this AD. Do all related
investigative and corrective actions before further flight. Repeat
the inspections thereafter at the applicable times specified in
table 5 of 1.E., ``Compliance'' of Boeing Alert Service Bulletin
737-55A1033, Revision 2, dated August 7, 2015.

(l) Post Replacement Inspections, Related Investigative and Corrective
Actions (Service Information Table 6)

    For airplanes with a replaced horizontal stabilizer with a new
or serviceable part, within the applicable times specified in table
6 of 1.E., ``Compliance'' of Boeing Alert Service Bulletin 737-
55A1033, Revision 2, dated August 7, 2015, except as specified in
paragraph (o) of this AD: Do a detailed, HFEC, and ultrasonic
inspection of the rear spar upper lugs of the horizontal stabilizer
for any cracking, and do all applicable related investigative and
corrective actions, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-55A1033, Revision
2, dated August 7, 2015; except as specified in paragraph (p) of
this AD. Do all related investigative and corrective actions before
further flight. Repeat the inspections thereafter at the applicable
times specified in table 6 of 1.E., ``Compliance'' of Boeing Alert
Service Bulletin 737-55A1033, Revision 2, dated August 7, 2015.

(m) Scheduled Inspections, Related Investigative and Corrective Actions
(Service Information Table 7)

    Within the applicable times specified in table 7 of paragraph
1.E., ``Compliance,'' of Boeing Alert Service Bulletin 737-55A1033,
Revision 2, dated August 7, 2015, except as specified in paragraph
(o) of this AD: Do HFEC and fluorescent dye penetrant inspections
for cracking in the front and rear spar upper clevis lugs of the
center section and front and rear spar upper lugs of the horizontal
stabilizer, and do all applicable related investigative and
corrective actions, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-55A1033, Revision
2, dated August 7, 2015; except as specified in paragraph (p) of
this AD. Do all related investigative and corrective actions before
further flight. Repeat the inspections thereafter at the applicable
times specified in table 7 of paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 737-55A1033, Revision 2, dated August
7, 2015.

(n) Post Scheduled Inspections, Related Investigative and Corrective
Actions (Service Information Table 8)

    For airplanes on which the center section rear spar upper chord
or horizontal stabilizer rear spar upper chord has been replaced:
Within the applicable time specified in table 8 of paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-55A1033,
Revision 2, dated August 7, 2015, except as specified in paragraph
(o) of this AD: Do HFEC and fluorescent dye penetrant inspections
for cracking in the front and rear spar upper clevis lugs of the
center section or front and rear spar upper lugs of the horizontal
stabilizer, as applicable, and do all applicable related
investigative and corrective actions, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
55A1033, Revision 2, dated August 7, 2015; except as specified in
paragraph (p) of this AD. Do all related investigative and
corrective actions before further flight. Repeat the inspections
thereafter at the applicable times specified in table 8 of paragraph
1.E., ``Compliance,'' of Boeing Alert Service Bulletin 737-55A1033,
Revision 2, dated August 7, 2015.

(o) Exceptions to the Service Information: Compliance Times

    (1) Where Boeing Alert Service Bulletin 737-55A1033, Revision 2,
dated August 7, 2015, specifies a compliance time ``after the
Revision 2 date of this service bulletin,'' this AD requires
compliance within the specified compliance time after the effective
date of this AD.
    (2) Where Boeing Alert Service Bulletin 737-55A1033, Revision 2,
dated August 7, 2015, specifies a compliance time or repeat interval
as ``Horizontal Stabilizer Center Section flight cycles'' or
``Horizontal Stabilizer flight cycles,'' this AD requires compliance
for the corresponding time or repeat interval in airplane flight
cycles.

(p) Exception to the Service Information: Repair Compliance Method

    If any cracking of the lug is found during any inspection
required by this AD, and Boeing Alert Service Bulletin 737-55A1033,
Revision 2, dated August 7, 2015, specifies to contact Boeing for
appropriate action: Before further flight, repair the lug using a
method approved in accordance with the procedures specified in
paragraph (r) of this AD.

(q) Terminating Actions

    (1) For Model 737-100, -200, and -200C series airplanes:
Accomplishment of the inspections specified in paragraph (g) of this
AD terminates the requirements of paragraph A. of AD 84-23-05,
Amendment 39-4949 (49 FR 45744, November 20, 1984).
    (2) For Model 737-200 and -200C series airplanes: Accomplishment
of the inspections specified in paragraph (m) and (n) of this AD
terminates the requirements of paragraphs A. and B. of AD 86-12-05,
Amendment 39-5321 (51 FR 18771, May 22, 1986).

(r) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the

attention of the person identified in paragraph (s)(1) of this AD.
    (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, Los Angeles 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.

(s) Related Information

    (1) For more information about this AD, contact Payman Soltani,
Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles ACO,
3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-
5313; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-
5000, extension 1; fax:<PHONE_NUMBER>; Internet: https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on June 28, 2016.
John P. Piccola, Jr.,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.

[FR Doc. 2016-16322 Filed 7-11-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57450-57451]
[FR Doc No: 2019-23251]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-N-3163; FDA-2012-D-0429; FDA-2012-D-0049; FDA-
2018-N-3031; FDA-2011-D-0125; FDA-2018-N-4428; FDA-2012-N-0560; FDA-
2010-N-0414; FDA-2012-N-1203; and FDA-2019-N-0430]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
a list of information collections that have been approved by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of
1995 (PRA).

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at http://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Physician Interpretation of Information        0910-0875       9/30/2021
 About Prescription Drugs in Scientific
 Publications Versus Promotional Pieces.
Guidance on Meetings with Industry and         0910-0731       8/31/2022
 Investigators on the Research and
 Development of Tobacco Products........

Reporting Harmful and Potentially              0910-0732       8/31/2022
 Harmful Constituents in Tobacco
 Products and Tobacco Smoke Under the
 Federal Food, Drug, and Cosmetic Act...
Tobacco Products, User Fees,                   0910-0749       8/31/2022
 Requirements for the Submission of Data
 Needed to Calculate User Fees for
 Domestic Manufacturers and Importers of
 Tobacco................................
Guidance for Industry on Establishing          0910-0775       8/31/2022
 That a Tobacco Product Was Commercially
 Marketed in the United States as of....
February 15, 2007.......................
Medicated Feed Mill License Application.       0910-0337       9/30/2022
Guidance on Informed Consent for In            0910-0582       9/30/2022
 Vitro Diagnostic Studies Using Leftover
 Human Specimens That Are Not
 Individually Identifiable..............
Manufactured Food Regulatory Program           0910-0601       9/30/2022
 Standards..............................
Information to Accompany Humanitarian          0910-0661       9/30/2022
 Device Exemption Applications and
 Annual Distribution Number Reporting
 Requirements...........................
Generic Clearance for Quick Turnaround         0910-0876       9/30/2022
 Testing of Communication Effectiveness.
------------------------------------------------------------------------

    Dated: October 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23251 Filed 10-24-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: January 22, 2008 (Volume 73, Number 14)]
[Notices]
[Page 3800-3801]
[DOCID:fr22ja08-123]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

U.S. DOT Docket Number NHTSA-2008-0007 Reports, Forms, and Record
Keeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for public comment on proposed collection of
information.

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SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections.
    This document describes one collection of information for which
NHTSA intends to seek OMB approval.

DATES: Comments must be received on or before March 24, 2008.

ADDRESSES: You may submit comments identified by DOT Docket No. NHTSA-
2008-0007 by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the online instructions for submitting

comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200

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    Instructions: All submissions must include the agency name and
docket number for this proposed collection of information. Note that
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, including any personal information provided.

Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
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complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78), or you may visit http://DocketInfo.dot.gov
.

    Docket: For access to the docket to read background documents or
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address listed above. Follow the online instructions for accessing the
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FOR FURTHER INFORMATION CONTACT: Complete copies of each request for
collection of information may be obtained at no charge from Laurence
Long, NHTSA, 1200 New Jersey Avenue, SE., Rm. 48-220, NVS 211,
Washington, DC 20590. Mr. Long's telephone number is<PHONE_NUMBER>.
    Please identify the relevant collection of information by referring
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SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d), an agency must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) How to enhance the quality, utility, and clarity of the
information to be collected; and
    (iv) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collections of information:
    Title: Consumer Complaint Information.
    OMB Control Number: 2127-0008.
    Affected Public: Individuals and households.
    Abstract: Pursuant to Chapter 301 of Title 49 of the United States
Code, manufacturers of motor vehicles and items of motor vehicle
equipment must notify owners and provide a free remedy (i.e., a recall)
when it has been determined that a safety-related defect exists in the
manufacturer's product. NHTSA investigates possible safety defects and
may order recalls. NHTSA solicits information from vehicle owners,
which is used to identify and evaluate possible safety-related defects
and provide evidence of the existence of such defects.
    Consumer complaint information takes the form of a Vehicle Owner's
Questionnaire (VOQ), which is a paper, self-addressed mailer that
consumers complete. This mailer contains owner information, product
information, failed component information, and incident information. It
may also take the form of an electronic VOQ containing the same
information as identified above, which can be submitted via NHTSA's
Internet Web site or by calling the Department of Transportation's Auto
Safety Hotline. Or, it may take the form of a consumer letter. All
consumer complaint information, in addition to other sources of
available information, is entered into the agency's database and
reviewed by NHTSA staff to determine whether a safety-related defect
trend or catastrophic failure is developing that would warrant the
opening of a safety defect investigation.
    Estimated Annual Burden: 8,657 hours.
    Estimated Number of Respondents: 34,626.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

Kathleen Demeter,
Director, Office of Defects Investigation.
 [FR Doc. E8-990 Filed 1-18-08; 8:45 am]

BILLING CODE 4910-59-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF PREVENTION, PESTICIDES

                   AND TOXIC SUBSTANCES

July 10, 2009

MEMORANDUM

SUBJECT:	ChemSAC Review of the USDA IR-4 Crop Grouping Proposal to Amend
the Stone Fruit Crop Group 12, and Analysis of the USDA IR-4 Petition to
Amend the Crop Group Regulation 40 CFR § 180.41 (c) (12) and Commodity
Definitions [40 CFR § 180.1 (g)].

FROM:	Bernard A. Schneider, Ph.D., Senior Plant Physiologist

Chemistry and Exposure Branch

Health Effects Division (7509P)

TO:	William Donovan, Ph.D. and Michael Doherty, Ph.D.,

Chairpersons ChemSAC and Members

		Jennifer Selwyn, PMRA

		Marco Cotero, Mexico

	Barbara Madden, Minor Use Officer, RD (7505P)

		Rame Cromwell, FEAD (7506P)

BACKGROUND:

	The current Crop Group 12, Stone Fruits group published in 40 CFR
180.41 (13) includes eleven commodity entries in the botanical family of
Rosaceae.  Sweet or tart cherry, peach, and plum or fresh prune were
selected as representative commodities for this group.  There have been
54 group tolerances established on stone fruits crop group based on the
residue data generated from the representative crops.

	Since this crop group was established in 1995, more species and
varieties of stone fruits have become popular in commercial production
or trade and are currently “orphan” crops.  Jujube while not in the
Rosaceae family contains a single seed with a hard shell.  The
morphology of this crop resembles some stone fruits such as cherries and
small varieties of plums as it has large canopies shading the small
sized fruits, and should be similar to the stone fruits in terms of
residue exposure.  Some other “minor orphan” stone fruit commodities
have become more popular in some countries and areas today than they
were 10 years ago, such as the Klamath plum.  Increased globalization of
cooking in the United States has resulted in different fruits to be
enjoyed in everything from sorbets to salsas.  Adding these commodities
to the EPA stone fruits group will benefit the growers by enabling tools
for crop protection.  Some other species or varieties/cultivars of stone
fruits are also added in the proposed stone fruits group, including the
Japanese apricot.  The Japanese apricot is a popular fruit in Asia, and
its commercial products such as preserved Ume or Ume juice are already
being sold in American markets.  In the Japanese crop grouping system,
Japanese apricot (Ume) is grouped with Japanese plum (sumomo) and
apricot (andzu) as "small sized stone fruits."

The world total hectares for apricots, cherries, peaches, and plums have
increased from 3,583,597 hectares (ha) in 1997 to 4,717,647 ha in 2007,
and the total production of these fruits has increased from 23,525,883
metric tons in 1997 to 32,123,241 metric tons in 2007.  Some of these
fruits don’t have large commercial production, and thus have little
chance to develop an integrated pest control program (IPM) unless they
are added to pest control products labels and placed in the stone fruit
group.  Some of these “minor” stone fruits have great potential to
be grown on a larger scale in some areas in the future due to their
unique nutritional and medicinal values.  Being excluded from the crop
groups, means that tolerances requested for these commodities would have
to be established based on separate residue studies.  Without a doubt
the inclusion of these commodities in crop groups will benefit growers,
consumers, save time and tax payer’s money on residue studies, save
government agencies time in reviewing residue data, as well as
facilitating the establishment of import tolerances.

This petition proposes “Stone fruits Group 12” with 22 commodity
entries, among these 21 are in the botanical family of Rosaceae and one
in the family of Rhamnaceae.  Compared with many other crop groups, most
commodities in this group are closely related and all the commodities
share similar morphological and cultural characteristics.  The 11
commodities in the proposed crop group are temperate season perennial
trees grown for edible fruits.  The fact that these fruits are in the
same botanical family with similar biological and cultural aspects
suggests they should also encounter similar pest problems and hence have
similar needs for pest control products in similar use patterns.
Commodities and their varieties and/or hybrids proposed in this group
include all the commodities in the Codex Classification of Stone Fruits
Group and EU Crop List of Stone Fruits Group.  The representative
commodities in the existing EPA Stone Fruits Group, sweet or tart
cherry, peach, and plum or fresh prune have been recommended by the
Workgroup to continue to be representative commodities for the proposed
new group.  The new Stone Fruits Group and the representative
commodities proposed in this petition would facilitate the harmonization
of the U.S. and the Codex crop classification systems.

Currently there are two Commodity Definitions for stone fruits published
in the 40 CFR 180 (1) (g), for “Cherry and Peach.”  To facilitate
residue data generation and tolerance establishment on small and large
varieties of stone fruits, two subgroups are proposed in this proposal
for the stone fruits group, as the Peach subgroup and the Cherry
subgroup.  Peach subgroup includes medium to large fruits including
peaches, nectarines, plums, and jujube; and the Cherry subgroup includes
the smaller stone fruits, the cherries.  By proposing the two subgroups
the two commodity definitions could be deleted from the regulation.

The Crop Group 12 proposal was generated at the USDA/IR-4 Crop Grouping
Symposium in Washington, DC, October 2002 by the Temperate Tree and
Small Fruit Workgroup Chaired by Van Starner of USDA, IR-4 and
Co-Chaired by Craig Hunter, Canadian Horticultural Center, Rick
Melnicoe, University of California Department of Environmental
Toxicology, Dr. Richard Loranger and Chris Olinger, EPA, HED and John
Wise, Michigan State University.  It was further discussed and developed
within the Stone fruits Workgroup of the ICGCC.  This workgroup consists
of over 200 crop or regulatory experts from the US, and NAFTA, EU, Asia,
Middle East, and Latin America Regions representing over 40 countries.
The Workgroup discussed and validated each of the proposed commodities
and representative commodities.

Another important aspect is the harmonization with the Codex crop
classification.  The Codex Classification of foods and animal feeds for
Stone Fruit Group is also undergoing revision.  The IR-4/EPA Crop
Grouping Working Group and the International Crop Grouping Consulting
Committee (ICGCC) are making every effort to collaborate with the
revision of the Codex crop classification.  The expanded Stone Fruit
Group and the representative commodities proposed in this petition would
facilitate the harmonization of the U.S. and the Codex crop
classification systems.

	The classical definition of a stone fruit is a group of crops belonging
to the genus Prunus, which have the fruit type called a drupe such as
the peach, plum, cherry, and apricot.  Given this fact most commodities
included in this group are from the same botanical family and genus, and
that they are similar in plant morphology and cultural methods.  They
are widely grown in temperate and some in subtropical regions, and are
among the most popular fruits in the marketplace.

REQUEST:

	Dr Hong Chen, Crop Grouping Project Coordinator, USDA Interregional
Research Project No. 4 (IR-4), State Agricultural Experiment Station,
Rutgers University has submitted a petition (January 8, 2007) on behalf
of the IR-4 Project, and the Stone Fruits Workgroup of the International
Crop Grouping Consulting Committee (ICGCC) to amend the Crop Group
Regulation 40 CFR § 180.41 (c) (13) Crop Group 12, Stone Fruits Group,
and propose deletion of Commodity Definitions 40 CFR 180.1 (g) for
cherries and peaches.

	Four proposals to amend the Stone fruit group that were submitted by
USDA IR-4 were analyzed by Dr. Bernard A. Schneider, EPA and the
complete analysis and report is available as a separate attachment.  A
comparison of the current Stone fruit group with the proposed amended
group is shown in Table 1 of this memo and for the proposed crop
subgroups in Table 2.  Each of the specific proposals will be listed
below and HED recommendations and conclusions as well as other HED
recommendations on terminology, database development, and harmonization
with Codex.

HED ANALYSIS AND RECOMMENDATIONS:

	The EPA would like to commend the valuable and high quality input of
the ICGCC, all its members, and the Committee Chairperson Dr Hong Chen
and Bill Barney, USDA IR-4, as well as Dr. Yuen-Shaung Ng, Biologist,
HED, Doug Dotson, Chemist and Jessie Cordova, HED Information Technical
Specialist, Susan Stanton, Roger Chesser and Laura Nollen, Biologists,
RD, EPA for their input and development of various databases in this
report and Dr. Paul Schwartz, USDA, Office of Minor Use Pesticides for
his advice and peer review.

IR-4 Proposal 1:

1. “Amend the existing crop group in 40 CFR 180.41 (c) (12) that
consists of the following eleven commodity entries:

Apricot, Prunus armeniaca L. (Rosaceae)

Cherry, sweet, Prunus avium (L.) L. (Rosaceae)

Cherry, tart, Prunus cerasus L. (Rosaceae)

Nectarine, P. persica var. nucipersica (Suckow) C.K. Schneid. (Rosaceae)

Peach, Prunus persica (L.) Batsch var. persica (Rosaceae)

Plum, Prunus domestica L. ssp. domestica (Rosaceae)

Plum, Chickasaw, Prunus angustifolia Marshall (Rosaceae)

Plum, Damson, Prunus domestica spp. insititia (L.) C.K. Schneid.
(Rosaceae)

Plum, Japanese, Prunus salicina Lindl. (Rosaceae)

Plumcot, Prunus domestica L. x P. armeniaca L. (Rosaceae)

Prune (fresh), Prunus domestica L. ssp. Domestica (Rosaceae)

To an expanded crop group that consists of following 22 commodity
entries:

Apricot, Prunus armeniaca L. (Rosaceae)

Apricot, Japanese, Prunus mume Siebold & Zucc. (Rosaceae)

Capulin, Prunus serotina Ehrh. subsp. capuli (Cav.) McVaugh (Rosaceae)

Cherry, black, Prunus serotina Ehrh. ssp. serotina (Rosaceae)

Cherry, Nanking, Prunus tomentosa Thunb. (Rosaceae)

Cherry, sweet, Prunus avium (L.) L. (Rosaceae)

Cherry/tart, Prunus cerasus L. (Rosaceae)

Choke cherry, Prunus virginiana (Rosaceae)

Jujube, Ziziphus jujube Mill. (Rhamnaceae)

Plum, Klamath, Prunus subcordata Benth. (Rosaceae)

Nectarine, Prunus persica var. nucipersica (Suckow) C.K. Schneid.
(Rosaceae)

Peach, Prunus persica (L.) Batsch var. persica (Rosaceae)

Plum, Prunus domestica L. ssp. domestica (Rosaceae)

Plum, American, Prunus americana Marshall (Rosaceae)

Plum, beach, Prunus maritime Marshall (Rosaceae)

Plum, cherry, Prunus cerasifera Ehrh. (Rosaceae)

Plum, Chickasaw, Prunus angustifolia Marshall (Rosaceae)

Plum, Damson, Prunus domestica spp. insititia (L.) C.K. Schneid.
(Rosaceae)

Plum, Japanese, Prunus salicina Lindl. (Rosaceae)

Plumcot, Prunus domestica L. x P. armeniaca L. (Rosaceae)

Prune (fresh), Prunus domestica L. ssp. Domestica (Rosaceae)

Sloe, Prunus spinosa L. (Rosaceae)

And all edible varieties and/or hybrids of Prunus species and Ziziphus
species.”

HED Recommendation for IR-4 Proposal 1:

	Based on similarities and characteristics of the Rosaceae or Rose
family which includes all the proposed members to the Stone Fruit Crop
Group 12, as well as a comparison of stone fruits, cultural practices,
edible food and animal feed portions, residue levels, geographical
location, pest problems, established tolerances, and for international
harmonization purposes, I recommend that ChemSAC concur to amend the
Stone Fruit Crop Group 12 from eleven commodities to twenty-two
commodities.

	While USDA IR-4 also recommended adding jujube to the Stone fruit
group, however, after analysis of this crop, I recommend ChemSAC concur
not to add this commodity to this crop group.  Jujube is in a different
plant family (Rhamnaceae instead of Rosaceae) than all the other stone
fruits.  It is more adaptable to be added to a new proposed tropical
fruit edible peel crop group that IR-4 will be recommending later this
year.  Research into these commodities also showed that the Canada plum
(Prunus nigra) has had recent improved varieties for ornamental and
edible fruit use; therefore I am recommending including Canada plum as a
commodity in the revised Stone fruit group 12.  There were also two crop
subgroups proposed by IR-4 for this crop group which will be discussed
in IR-4 Proposal 3.

	The scientific names of the twenty-two commodities were also updated
and are listed below.

“HED Corrected Proposed Stone Fruit Crop Group 12 - 09”.

Commodities

Apricot, Prunus armeniaca L.

Apricot, Japanese, Prunus mume Siebold & Zucc.

Capulin, Prunus serotina Ehrh. subsp. capuli (Cav.) McVaugh

Cherry, black, Prunus serotina Ehrh. ssp. serotina

Cherry, Nanking, Prunus tomentosa Thunb

Cherry, sweet, Prunus avium (L.) L

Cherry, tart, Prunus cerasus L.

Chokecherry, Prunus virginiana L.

Nectarine, Prunus persica (L.) Batsch var. nucipersica (Suckow) C.K.
Schneid.

Peach, Prunus persica (L.) Batsch var. persica

Plum, Prunus domestica L. subsp. domestica

Plum, American, Prunus americana Marshall

Plum, beach, Prunus maritima Marshall

Plum, Canada, Prunus nigra Aiton

Plum, cherry, Prunus cerasifera Ehrh.

Plum, Chickasaw, Prunus angustifolia Marshall

Plum, Damson, Prunus domestica L. subsp. insititia (L.) C.K. Schneid.

Plum, Japanese, Prunus salicina Lindl.

Plum, Klamath, Prunus subcordata Benth

Plum, prune, Prunus domestica L. subsp. domestica

Plumcot, Prunus hybr.

Sloe, Prunus spinosa L

Cultivars, varieties, and hybrids of these commodities.

	Additional notes:

HED also recommends changing the preferred commodity name for Prune
(fresh) to Plum, prune, since this is the preferred tolerance commodity
term used in the EPA Food and Feed Commodity Vocabulary
(http://www.epa.gov/pesticides/foodfeed) for several years and is more
accurate description of the commodity.  The crop name is Prune plum.

HED also recommends that in the crop group table the term “varieties
and/or hybrids of these” should be changed to, “Cultivars,
varieties, and hybrids, of these commodities” to avoid all confusion
with terminology regarding whether they are cultivars, varieties, or
hybrids of the any stone fruit commodities.

IR-4 Proposal 2:

2. “The following commodities, Sweet or tart cherry, peach, and plum
or fresh prune, should remain as representative commodities for the
expanded group.”

HED Recommendation for Proposal 2:

	I recommend ChemSAC concur to retain Sweet or tart cherry, peach, and
plum or fresh prune, as representative commodities for the amended Stone
Fruit Crop Group 12.  These representative commodities account for > 99
% of the harvested acres for the members of the amended Stone Fruit
Group.  The representative commodities are based on similarities in
fruit and cultural practices and geographical locations, as well as
their high production (both acres and yield) and consumption.  A
comparison of established tolerances on stone fruit commodities also
supports that residue levels will be similar between members of the crop
group.  The commodity fresh prune will become prune plum to conform to
new EPA Food and Feed Commodity Vocabulary terminology.

IR-4 Proposal 3:

3. Establish two new subgroups under the Stone fruit crop group as
follows:”

1). Subgroup 12-A: Peach subgroup. Representative commodity: Peach, and
Plum or Fresh prune.

Sixteen commodities included in this subgroup are: American plum;
Apricot; Beach plum; Cherry plum; Chickasaw plum; Damson plum; Japanese
apricot; Japanese plum; Jujube; Klamath plum; Nectarine; Peach; Plum;
Plumcot; Prune (fresh), and Sloe.

2). Subgroup 12-B: Cherry subgroup. Representative commodity: Sweet or
Tart cherry.

Six commodities included in this subgroup are: Capulin; Cherry, black;
Cherry, Nanking; Cherry, sweet; Cherry, tart; and Chokecherry.

HED Recommendation for Proposal 3:

	I recommend that instead of the two subgroups proposed by IR-4 that a
third subgroup be established, in order to harmonize with Codex.  These
would be similar to the two proposed by IR-4 and a third which will
separate the proposed Peach subgroup into a Peach and a separate Plum
Subgroup.  The representative commodities for the proposed Peach
subgroup is peach and a plum or fresh prune.  Since we are recommending
a Plum subgroup the representative commodity for the Peach subgroup
would be peach and the representative commodity for the Plum subgroup
would be plum or prune plum.  Since hybrids between plums and apricots
have been produced recently which are said to have improved quality than
either parent it is logical to also place apricots in the Plum subgroup.

I also recommend that ChemSAC approve the Cherry subgroup; the Peach
subgroup; and the Plum subgroup.  The representative commodities for the
subgroups are the same as recommended for the Crop group.  Jujube will
not be a member of this crop group or subgroups and will be included in
a future Tropical fruit edible peel crop group, since it shares more
similarities to tropical and subtropical fruits.

The three recommended subgroups will be as follows:

Cherry subgroup 12A:  Representative commodity: Sweet cherry or Tart
cherry.

Six commodities proposed in this subgroup are: Black cherry; Capulin;
Nanking cherry; Sweet cherry; Tart cherry; and Chokecherry.

Peach subgroup 12B: Representative commodity: Peach.

Two commodities proposed in this subgroup are: Nectarine and Peach.

Plum subgroup 12C:  Representative commodity: Plum or Prune plum.

Fourteen commodities proposed in this subgroup are: American plum;
Apricot; Klamath plum; Beach plum; Canada plum; Cherry plum; Chickasaw
plum; Damson plum; Japanese apricot; Japanese plum; Plum; Plumcot; Prune
plum; and Sloe.

IR-4 Proposal 4:

4. “Deleting two Definitions, Cherries (tart or sour cherries and
sweet cherries) and Peaches (peaches, nectarines) from 40 CFR 180.1
(g).”

HED Recommendation for Proposal 4 Commodity Definition for Peaches and
Cherries:

	I also recommend at this time not to delete the Peach and Cherry
commodity definitions under 40 CFR Part 180.1(g) even though they will
be similar to the members in the proposed Peach subgroup 12A and the
Cherry subgroup 12B, respectively.  The reason is that under the current
commodity definition for peach it also covers nectarines and if the
definition were deleted there would be no tolerances for nectarines.
For several years we have been recommending for separate tolerances for
sweet and tart cherries, but there are still several established
tolerances just for cherry.  Therefore, we recommend not revising the
Peach and cherry commodity definitions.  They will however, appear in
the CFR not as Peaches or cherries but as peach and cherry.

Additional HED Recommendations/Conclusions:

HED Recommendation 5:

	Another important aspect of crop grouping is the harmonization effort
with the Codex Classification of Foods and Animal Feeds.  The current
EPA crop group for Stone fruit group 12 is very similar to the
corresponding Codex Stone fruits (Crop Group 003).  The Codex Group 003,
Stone Fruits, consists of twenty-one commodities including matches to
all the eleven commodities in the current EPA crop group 12.  The
differences are several of the Codex commodities refer to another
commodity such as “Plum, Japanese see Plums” whereas in the U.S.
system Plum, Japanese is a distinct commodity.  The twenty-three Codex
commodities really consist of ten distinct commodities with the rest
being multiple entries, or varieties of cultivar of other commodities
listed.  The U.S. is proposing to add the following commodities: Beach
plum; Black cherry; Capulin; Cherry plum; Chokecherry; Canada plum;
Japanese apricot; Klamath plum; and the Nanking cherry that are not yet
in the Codex system.  Several Codex names are equivalent to lookup terms
in the EPA Food and Feed Commodity Vocabulary like bullace is plum, and
morello is cherry, tart.  Jujube in the Codex system is placed in their
“Assorted tropical and subtropical fruit – edible peel” group and
EPA is also proposing to place jujube in a future Tropical fruit –
edible peel group.  Note that the current Codex crop group does not have
representative commodities.  A revision of the Codex Classification is
underway with consideration to include adding new commodities, creating
subgroups, and selecting representative commodities.

HED Recommendation 6:

Guidance for HED SOP 99.6 -  SEQ CHAPTER \h \r 1  “Classification of
Food Forms with Respect to Level of Blending” issued August 20, 1999,
and HED SOP 2000.1 – “  SEQ CHAPTER \h \r 1 Guidance for Translation
of Field Trial Data from Representative Commodities in the Crop Group
Regulation to Other Commodities in Each Crop Group/Subgroup” issued
September 12, 2000 can be updated to reflect the amendment to the Stone
fruit group 12.

HED Recommendation 7:

	The Health Effects Division Dry Matter Database prepared by Dr’s.
Yuen-Shaung NG and B. A. Schneider will be updated to include the
additional commodities for the Stone Fruit Group.

HED Recommendation 8:

Guidance on expressing tolerance terminology for the Stone fruit crop
group 12 is discussed under the “Tolerance expression guidance section
of this analysis.

HED Recommendation 9:

New lookup and preferred EPA terms for the members of the Stone Fruit
Crop Group are listed in the EPA Food and Feed Commodity Vocabulary
section of this report and these terms should be added to the updated
EPA Food and Feed Commodity Vocabulary website
(http://www.epa.gov/pesticides/foodfeed).

APPENDIX:

Table 1.  EPA Crop Group Proposals Comparison:  Current Established
Stone Fruits Crop Group 12 with the Proposed Amendments to the Stone
Fruit Group 12.

Regulation	Current Stone Fruits Crop Group 12

(May 17, 1995).	Proposed Stone Fruit Crop Group 12 for ChemSAC Approval
(8/09).

Name of the Crop Group	Stone Fruits Crop Group 12.	Stone Fruit Crop
Group 12-09 or 12-10.

Representative Crops	Three:

Sweet cherry or tart cherry

Peach and

Plum or fresh prune	Three:

Sweet cherry or tart cherry

Peach and

Plum or Prune plum

Subgroups	None	Three subgroups:

Cherry subgroup 12-09A;

Peach subgroup 12-09B;

Plum subgroup 12-09C.

Commodities included	(11) – Apricot; Cherry, sweet; Cherry, tart;
Nectarine; Peach; Plum; Plum, Chickasaw; Plum, Damson; Plum, Japanese;
Plumcot; Prune (fresh)	(22) – Apricot; Apricot, Japanese; Capulin;
Cherry, black; Cherry, Nanking; Cherry, sweet; Cherry/tart; Choke
cherry; Jujube*, Nectarine; Peach,; Plum; Plum, American; Plum, beach;
Plum, Canada**; Plum, cherry; Plum, Chickasaw; Plum, Damson; Plum,
Japanese; Plum, Klamath; Plumcot; Plum, prune; Sloe; and cultivars,
varieties, and/or hybrids of these.

Commodity Definitions 180.1(g).	Two:

Cherries;

Peaches	Two:

Cherry;

Peach

* Jujube was a proposed commodity by ICGCC rejected by EPA better to
place in the proposed Tropical fruit edible peel crop group.

** Canada plum added by EPA.

Table 2.  Comparison of Proposed and HED Recommendations for Crop
Subgroups 12A, 12B, and 12C.

.

IR-4 Proposed Crop Subgroup (Representative Commodity)	HED
Recommendation Crop Subgroup (Representative Commodity)	IR-4 Proposed
Members  of the Subgroup	HED Recommendation Crop Subgroup Members

Cherry subgroup 12A

(representative commodity: Cherry, sweet or Cherry, tart):	Cherry
subgroup 12A

(representative commodity: Cherry, sweet or Cherry, tart)	(6) Capulin;
Cherry, black; Cherry, Nanking; Cherry, sweet; Cherry/tart; and
Chokecherry. 	(6) Capulin; Cherry, black; Cherry, Nanking; Cherry,
sweet; Cherry, tart; and Chokecherry and cultivars, varieties, and/or
hybrids of these.

Peach subgroup 12B (representative commodity: Peach, and Plum or Fresh
prune.)	Peach subgroup 12B (representative commodity: Peach)	(16)
Apricot; Apricot, Japanese; Choke cherry; Jujube*, Nectarine; Peach,;
Plum; Plum, American; Plum, beach; Plum, cherry; Plum, Chickasaw; Plum,
Damson; Plum, Japanese; Plum, Klamath; Plumcot; Plum, prune; Sloe;	(2)
Peach, Nectarine, and cultivars, varieties, or hybrids of these.

	Plum subgroup 12C (representative commodity: Plum or Prune plum).	No
Plum subgroup was proposed in the USDA IR-4 petition.	(14) Apricot;
Apricot, Japanese; Plum; Plum, American; Plum, beach; Plum, Canada**;
Plum, cherry; Plum, Chickasaw; Plum, Damson; Plum, Japanese; Plum,
Klamath; Plumcot; Plum, prune; Sloe; and cultivars, varieties, and/or
hybrids of these.

* Jujube was a proposed commodity by ICGCC rejected by EPA better to
place in the proposed Tropical fruit edible peel crop group.

** Canada plum added by EPA.

 PAGE

 PAGE   2


[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Rules and Regulations]
[Page 23583]
[FR Doc No: 2018-10891]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2018-0350]

Safety Zones; Annual Events Requiring Safety Zones in the Captain
of the Port Lake Michigan Zone--Michigan City Summerfest Fireworks,
Lake Michigan

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zone in 33 CFR 165.929
for the Michigan City Summerfest Fireworks on a portion of Lake
Michigan on July 4, 2018. This action is necessary and intended to
ensure safety of life and property on navigable waters prior to,
during, and immediately after the fireworks display. During the
enforcement period listed below, entry into, transiting, or anchoring
within the safety zone is prohibited unless authorized by the Captain
of the Port Lake Michigan or a designated representative.

DATES: The regulation in 33 CFR 165.929 will be enforced for safety
zone listed as (e)(35) in Table 165.929 from 9 p.m. through 10 p.m. on
July 4, 2018.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email LT John Ramos, Waterways
Management Division, Marine Safety Unit Chicago, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Michigan
City Summerfest safety zone listed as item (e)(35) in Table 165.929 of
33 CFR 165.929 from 9 p.m. until 10 p.m. on July 4, 2018. This action
is being taken to provide for the safety of life on a navigable
waterway during the fireworks display. This safety zone encompasses all
waters of Michigan City Harbor and Lake Michigan within the arc of a
circle with a 1,000 foot radius from the launch site located in
position 41[deg]43.700' N, 086[deg]54.617' W. Entry into, transiting,
or anchoring within the safety zone is prohibited unless authorized by
the Captain of the Port Lake Michigan or a designated on-scene
representative.
    This notice of enforcement is issued under authority of 33 CFR
165.929, Safety Zones; Annual events requiring safety zones in the
Captain of the Port Lake Michigan zone and 5 U.S.C. 552 (a). In
addition to this notice in the Federal Register, the Coast Guard will
provide the maritime community with advance notification of this safety
zone enforcement period via Broadcast Notice to Mariners or Local
Notice to Mariners. The Captain of the Port Lake Michigan, or a
designated on-scene representative may be contacted via Channel 16,
VHF-FM or at<PHONE_NUMBER>.

    Dated: May 3, 2018.
Thomas J. Stuhlreyer,
Captain, U.S. Coast Guard, Captain of the Port Lake Michigan.
[FR Doc. 2018-10891 Filed 5-21-18; 8:45 am]
 BILLING CODE 9110-04-P