[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Pages 40063-40064]
[FR Doc No: 2021-15775]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2149]

Jonathan Doyle: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Jonathan Doyle for a period of 5 years from importing articles of food
or offering such articles for importation into the United States. FDA
bases this order on a finding that Mr. Doyle was convicted of a felony
count under Federal law for conduct relating to the importation into
the United States of an article of food. Mr. Doyle was given notice of
the proposed debarment and an opportunity to request a hearing within
the timeframe prescribed by regulation. As of April 8, 2021 (30 days
after receipt of the notice), Mr. Doyle has not responded. Mr. Doyle's
failure to respond and request a hearing constitutes a waiver of his
right to a hearing concerning this matter.

DATES: This order is applicable July 26, 2021.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>, or at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar an individual from importing an article of food or
offering such an article for import into the United States if FDA
finds, as required by section 306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a felony for conduct relating to the
importation into the United States of any food.
    On October 15, 2020, Mr. Doyle was convicted as defined in section
306(l)(1)(A) of the FD&C Act, in the U.S. District Court for the
Northern District of Texas-Dallas Division, when the court accepted Mr.
Doyle's plea of guilty and entered judgment against him for the offense
of conspiracy to introduce misbranded food into interstate commerce
with an intent to defraud and mislead in violation of 18 U.S.C. 371 (21
U.S.C. 331(a) and 21 U.S.C. 333(a)(2)).
    FDA's finding that the debarment is appropriate is based on the
felony conviction referenced herein. The factual basis for this
conviction is as follows: As contained in the factual
r[eacute]sum[eacute], dated February 15, 2019, in Mr. Doyle's case, he
was the President of USPlabs, LLC (USP Labs), and owned 45 percent of
the company. USP Labs sold dietary supplements. Beginning in or around
October 2008 and continuing until at least in or around August 2014,
Mr. Doyle engaged in a conspiracy with others to import and ship in
interstate commerce a variety of chemicals for use and prospective use
in dietary supplements with false labeling. To further this conspiracy,
Mr. Doyle's coconspirators ordered chemicals from Chinese chemical
sellers to be used as ingredients in dietary supplements and had them
labeled falsely as other food substances. USP Labs sold dietary
supplements called Jack3d and OxyElite Pro, both of which originally
contained a substance called 1,3-dimethylamylamine (DMAA), which is
also known as methylhexaneamine. USP Labs imported numerous substances
intended for human consumption, including DMAA, using false and
fraudulent Certificates of Analysis (COA) and other false and
fraudulent documentation and labeling. At least some of the false COAs
that USP Labs

caused to be created for their DMAA shipments stated falsely that the
substance in the shipments had been extracted from the geranium plant.
Further, on or about December 8, 2011, Mr. Doyle's coconspirator
instructed a Chinese chemical seller via email to misbrand a shipment
of nine different chemicals sent from China to USP Labs in Texas. One
of those synthetic chemicals was called ``aegeline.'' The first
aegeline-containing version of OxyElite Pro, which was called OxyElite
``New Formula,'' went on sale in December 2012. In summer 2013, USP
Labs reformulated the product again to contain aegeline and powder
derived from a Chinese herb called cynanchum auriculatum. On or about
June 15, 2013, Mr. Doyle's coconspirator instructed a Chinese chemical
seller to have two metric tons of ground cynanchum auriculatum root
powder shipped internationally to SK Laboratories in California for
inclusion in USP Labs' products, using the false name ``cynanchum
auriculatum root extract.'' USP Labs sent false labels listing
``cynanchum auriculatum (root) extract'' as an ingredient in its
OxyElite Pro ``Advanced Formula'' supplement, even though that
ingredient was not present in the product. The conspirators collected
millions in revenue that they would not have obtained, absent the
conspiracy.
    As a result of this conviction FDA sent Mr. Doyle, by certified
mail on March 4, 2021, a notice proposing to debar him for a period of
5 years from importing articles of food or offering such articles for
import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Mr. Doyle's felony
conviction of conspiracy to introduce misbranded food into interstate
commerce with an intent to defraud and mislead in violation of 18
U.S.C. 371 (21 U.S.C. 331(a) and 21 U.S.C. 333(a)(2)), constitutes
conduct relating to the importation into the United States of an
article of food because the offense involved a conspiracy to import a
variety of chemicals with false labeling in order to either use those
chemicals in dietary supplements which would themselves also contain
false labeling or to determine whether those chemicals could be used in
new dietary supplements.
    The proposal was also based on a determination, after consideration
of the relevant factors set forth in section 306(c)(3) of the FD&C Act,
that Mr. Doyle should be subject to a 5-year period of debarment. The
proposal also offered Mr. Doyle an opportunity to request a hearing,
providing Mr. Doyle 30 days from the date of receipt of the letter in
which to file the request, and advised Mr. Doyle that failure to
request a hearing constituted a waiver of the opportunity for a hearing
and of any contentions concerning this action. Mr. Doyle failed to
respond within the timeframe prescribed by regulation and has,
therefore, waived his opportunity for a hearing and waived any
contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(1)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Jonathan Doyle has been convicted of a felony count under Federal law
for conduct relating to the importation into the United States of an
article of food and that he is subject to a 5-year period of debarment.
    As a result of the foregoing finding, Mr. Doyle is debarred for a
period of 5 years from importing articles of food or offering such
articles for import into the United States, effective July 26, 2021.
Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the United States of an article
of food by, with the assistance of, or at the direction of Jonathan
Doyle is a prohibited act.
    Any application by Mr. Doyle for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2020-N-2149 and sent to the Dockets Management Staff (ADDRESSES).
The public availability of information in these submissions is governed
by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.

    Dated: July 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15775 Filed 7-23-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Rules and Regulations]
[Pages 48361-48362]
[FR Doc No: 2023-15589]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0430; Airspace Docket No. 19-AAL-75]
RIN 2120-AA66

Amendment of United States Area Navigation (RNAV) Route T-277;
Point Lay, AK.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends RNAV route T-277 in the vicinity of Point
Lay, AK, due to the planned decommissioning of the Point Lay, AK (PIZ),
Nondirectional Radio Beacon (NDB). The Point Lay, AK, NDB will be
decommissioned as part of a large and comprehensive T-route
modernization project for the state of Alaska.

DATES: Effective date 0901 UTC, October 5, 2023. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: A copy of the Notice of Proposed Rulemaking (NPRM), all
comments received, this final rule, and all background material may be
viewed online at www.regulations.gov using the FAA Docket number.
Electronic retrieval help and guidelines are available on the website.
It is available 24 hours each day, 365 days each year.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Steven Roff, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would expand the availability of RNAV in Alaska and
improve the efficient flow of air traffic within the National Airspace
System (NAS) by lessoning the dependency on ground-based navigation.

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA 2022-0430 in the Federal Register (87 FR 26705; May 5, 2022),
proposing to amend RNAV route T-277. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. One comment was received regarding procedural
aspects of how to transition between ground-based and satellite-based
airway structures. Specifically, the commenter referenced Colored
Airways B-2, G-16, and G-18 no longer intersecting with RNAV route T-
277 because the colored airways use the Point Lay, AK, NDB and T-277,
as amended, uses the JODGU waypoint. The commenter also stated that
they are supportive of the proposed rule and encouraged its adoption.
    The FAA is transitioning the NAS away from Low-Frequency NDB-based
navigational airways, including the area around the Point Lay, AK
(PIZ), NDB. PIZ is planned for decommissioning in the fall of 2024. The
colored airways associated with PIZ are B-2, G-16, and G-18. On
December 2, 2022, the FAA published a final rule in the Federal
Register (87 FR 73928) revoking G18 and on January 17, 2023, published
an NPRM in the Federal Register (88 FR 2561) proposing to revoke B-2.
Additionally, the FAA plans to propose to revoke G-16. The FAA
acknowledges there is no current guidance explaining how to transition
between ground-based and satellite-based airway structures; however,
the proposed action for T-277, collectively with existing RNAV routes
T-267 and T-366, provide replacement routing options in the Point Lay,
AK, area and negate the need for transitions between ground-based and
satellite-based enroute structures.

Incorporation by Reference

    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11, Airspace Designations and Reporting
Points, which is incorporated by reference in 14 CFR 71.1 on an annual
basis. This document amends the current version of that order, FAA
Order JO 7400.11G, dated August 19, 2022 and effective September 15,
2022. FAA Order JO 7400.11G is publicly available as listed in the
ADDRESSES section of this document. These amendments will be published
in the next update to FAA Order JO 7400.11.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Rule

    This action amends 14 CFR part 71 by amending RNAV route T-277 in
the vicinity of Point Lay, AK in support of a large and comprehensive
T-route modernization project in the state of Alaska. The route
amendment replaces the Point Lay, AK, NDB with the JODGU waypoint. The
RNAV T-route amendment action is described below.
    T-277: T-277 This action amends T-277 to extend between the
Bettles, AK, (BTT) very high frequency (VHF) omnidirectional range
(VOR) distance measuring equipment (VOR/DME) and the JODGU, AK,
waypoint. Previously, T-277 extended between the Bettles, AK, (BTT)
VOR/DME and the Point Lay, AK (PIZ) NBD.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (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) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action of establishing RNAV route
T-277, in the vicinity of Point Lay, AK qualifies for categorical
exclusion under the National Environmental Policy Act (42 U.S.C. 4321
et seq.) and its implementing regulations at 40 CFR part 1500, and in
accordance with FAA Order 1050.1F, Environmental Impacts: Policies and
Procedures, paragraph 5-6.5a, which categorically excludes from further
environmental impact review rulemaking actions that designate or modify
classes of airspace areas, airways, routes, and reporting points (see
14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas;
Air Traffic Service Routes; and Reporting Points); and paragraph 5-
6.5.i., which categorically excludes from further environmental impact
review the establishment of new or revised air traffic control
procedures conducted at 3,000 feet or more above ground level (AGL);
procedures conducted below 3,000 feet AGL that do not cause traffic to
be routinely routed over noise sensitive areas; modifications to
currently approved procedures conducted below 3,000 feet AGL that do
not significantly increase noise over noise sensitive areas; and
increases in minimum altitudes and landing minima. As such, this action
is not expected to result in any potentially significant environmental
impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding
Extraordinary Circumstances, the FAA has reviewed this action for
factors and circumstances in which a normally categorically excluded
action may have a significant environmental impact requiring further
analysis. Accordingly, the FAA has determined that no extraordinary
circumstances exist that warrant preparation of an environmental
assessment or environmental impact study.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p.389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-277 Bettles, AK (BTT) to JODGU, AK [Amended]

Bettles, AK (BTT)                               VOR/DME                        (Lat. 66[deg]54'18.03'' N, long. 151[deg]32'09.18'' W)
JODGU, AK                                       WP                             (Lat. 69[deg]44'11.47'' N, long. 163[deg]00'04.08'' W)

* * * * *

    Issued in Washington, DC, on July 18, 2023.
Karen L. Chiodini,
Acting Manager, Airspace Rules and Regulations.
[FR Doc. 2023-15589 Filed 7-26-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Rules and Regulations]
[Pages 24010-24013]
[FR Doc No: 2017-10267]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0123; Directorate Identifier 2016-NM-033-AD;
Amendment 39-18889; AD 2017-10-15]
RIN 2120-AA64

Airworthiness Directives; Airbus Defense and Space S.A. (Formerly
Known as Construcciones Aeronauticas, S.A.) Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, CN-
235-300, and C-295 airplanes. This AD was prompted by a reported
inability to extend the external handle of the emergency door from its
recess due to a jammed spring mechanism. This AD requires a one-time
functional check of each emergency door handle, and corrective actions
if necessary. We are issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective June 29, 2017.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of June 29,
2017.

ADDRESSES: For service information identified in this final rule,
contact EADS-CASA, Military Transport Aircraft Division (MTAD),
Integrated Customer Services (ICS), Technical Services, Avenida de
Arag[oacute]n 404, 28022 Madrid, Spain; telephone: +34 91 585 55 84;
fax: +34 91 585 55 05; email<EMAIL_ADDRESS>
Internet: http://www.eads.net. 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-2017-0123.

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-2017-
0123; 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 street address for the Docket Office (telephone:
800-647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Airbus Defense and
Space S.A. Model CN-235, CN-235-100, CN-235-200, CN-235-300, and C-295
airplanes. The NPRM published in the Federal Register on February 28,
2017 (82 FR 12074) (``the NPRM''). The NPRM was prompted by a reported
inability to extend the external handle of the emergency door from its
recess due to a jammed spring mechanism. The NPRM proposed to require a
one-time functional check of each emergency door handle, and corrective
actions if necessary. We are issuing this AD to detect and correct
jamming of the door spring mechanism, which could lead to the inability
to push out the emergency door external handle from its position
normally aligned with the door skin. This condition could result in the
inability to open the emergency door from outside during an emergency.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2016-0051, dated March 11, 2016 (referred to after this as the
Mandatory Continuing

Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Airbus Defense and Space S.A. Model CN-235, CN-235-
100, CN-235-200, CN-235-300, and C-295 airplanes. The MCAI states:

    Failure to extend the external handle of emergency door from its
recess was reported. As a consequence, it was impossible to open the
rear emergency door from outside. Subsequent investigation
determined that jamming of the door spring mechanism led to failure
pushing out the emergency door external handle from its position
normally aligned with the door skin.
    This condition, if not detected and corrected, could lead to
failure to open the emergency door from outside in an emergency.
    To address this potential unsafe condition, Airbus Defence&Space
(D&S) issued Alert Operators Transmission (AOT) AOT-CN235-52-0001
and AOT-C295-52-0001 to provide inspection instructions [and
corrective actions if necessary].
    For the reasons described above, this [EASA] AD requires a one-
time functional check of [each of] the affected emergency door
external handle[s] and, depending on findings, [detailed visual
inspection for damage or unexpected material and] corrective action
[repair]. This [EASA] AD also requires reporting the check result.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0123.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    We reviewed the following Airbus Defense and Space service
information.
     Airbus Defense and Space Alert Operators Transmission AOT-
CN235-52-0001, dated September 4, 2014.
     Airbus Defense and Space Alert Operators Transmission AOT-
C295-52-0001, dated September 4, 2014.
    The service information describes procedures for a one-time
functional check of each emergency door handle and corrective actions
if necessary. These documents are distinct since they apply to
different airplane models. This service information is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 27 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Functional Check:..................  1 work-hour x $85 per hour               $0             $85          $2,295
                                      = $85.
Reporting..........................  1 work-hour x $85 per hour                0              85           2,295
                                      = $85.
----------------------------------------------------------------------------------------------------------------

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

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to the FAA
at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information
Collection Clearance Officer, AES-200.

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 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 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.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator,

the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2017-10-15 Airbus Defense and Space S.A. (Formerly Known as
Construcciones Aeronauticas, S.A.): Amendment 39-18889; Docket No.
FAA-2017-0123; Directorate Identifier 2016-NM-033-AD.

(a) Effective Date

    This AD is effective June 29, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Defense and Space S.A. (Formerly Known
as Construcciones Aeronauticas, S.A.) Model CN-235, CN-235-100, CN-
235-200, CN-235-300, and C-295 airplanes, certificated in any
category, all manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

(e) Reason

    This AD was prompted by a reported inability to extend the
external handle of the emergency door from its recess due to a
jammed spring mechanism. We are issuing this AD to detect and
correct jamming of the door spring mechanism, which could lead to
the inability to push out the emergency door external handle from
its position normally aligned with the door skin. This condition
could result in the inability to open the emergency door from
outside during an emergency.

(f) Compliance

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

(g) One Time Functional Check

    Within 30 days after the effective date of this AD, do a one-
time functional check of each emergency door handle in accordance
with Airbus Defense and Space Alert Operators Transmission AOT-
CN235-52-0001, dated September 4, 2014; or Airbus Defense and Space
Alert Operators Transmission AOT-C295-52-0001, dated September 4,
2014; as applicable.

(h) Additional Actions for Discrepancies

    If any discrepancy (non-working emergency door handle) is found
during the functional check required by paragraph (g) of this AD,
before further flight, do the actions required by paragraphs (h)(1)
and (h)(2) of this AD.
    (1) Accomplish a detailed visual inspection for damage and
unexpected material in accordance with Airbus Defense and Space
Alert Operators Transmission AOT-CN235-52-0001, dated September 4,
2014; or Airbus Defense and Space Alert Operators Transmission AOT-
C295-52-0001, dated September 4, 2014; as applicable.
    (2) Repair using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus Defense and Space
S.A.'s EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.

(i) Reporting

    Submit a report of the findings (both positive and negative)
from the functional test required by paragraph (g) of this AD and
the inspection required by paragraph (h)(1) of this AD to Airbus
Defense and Space in accordance with the instructions of Airbus
Defense and Space Alert Operators Transmission AOT-CN235-52-0001,
dated September 4, 2014; or Airbus Defense and Space Alert Operators
Transmission AOT-C295-52-0001, dated September 4, 2014; as
applicable; at the applicable time specified in paragraph (i)(1) or
(i)(2) of this AD.
    (1) If the functional test or inspection was done on or after
the effective date of this AD: Submit the report within 30 days
after the functional test or inspection.
    (2) If the functional test or inspection was done before the
effective date of this AD: Submit the report within 30 days after
the effective date of this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to the attention of
the person identified in paragraph (k)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>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.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or
Airbus Defense and Space S.A.'s EASA DOA. If approved by the DOA,
the approval must include the DOA-authorized signature.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
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for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2016-0051, dated March 11, 2016, for related
information. This MCAI may be found in the AD docket on the Internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2017-0123.
    (2) For more information about this AD, contact Shahram
Daneshmandi, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus Defense and Space Alert Operators Transmission AOT-
CN235-52-0001, dated September 4, 2014.
    (ii) Airbus Defense and Space Alert Operators Transmission AOT-
C295-52-0001, dated September 4, 2014.
    (3) For service information identified in this AD, contact EADS-
CASA, Military Transport Aircraft Division (MTAD), Integrated
Customer Services (ICS), Technical Services, Avenida de
Arag[oacute]n 404, 28022 Madrid, Spain; telephone: +34 91 585 55 84;
fax: +34 91 585 55 05; email<EMAIL_ADDRESS>
Internet: http://www.eads.net.
    (4) You may view this 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
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on May 8, 2017.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-10267 Filed 5-24-17; 8:45 am]
 BILLING CODE 4910-13-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ANN ARBOR, MI 48105 June 23, 2005 OFFICE OF AIR AND RADIATION MEMORANDUM SUBJECT: Exhaust Emission Testing of Two High Performance SD/ I Marine Engines FROM: Mike Samulski and Matt Spears Assessment and Standards Division TO: Docket OAR 2004 0008 This memorandum describes exhaust emission testing of two " high performance" marine engines. The two engines were a carbureted 738 horsepower and a supercharged and fuel injected 1040 horsepower sterndrive/ inboard ( SD/ I) marine engine. The engines were operated on a dynamometer over a five mode steady state marine duty cycle. Gaseous hydrocarbon ( HC), carbon monoxide ( CO), and oxides of nitrogen ( NOx) were measured using a portable emissions measurement sampling unit ( PEMS).

At the time of this testing, no data was available on emission rates from high performance SD/ I engines. The purpose of this testing was to help determine baseline emissions for these engines. We measured emissions of 21.6 g/ kW hr HC+ NOx and 253 g/ kW hr CO for the carbureted engine and 12.5 g/ kW hr HC+ NOx and 349 g/ kW hr CO for the supercharged and fuel injected engine. For reasons discussed later in this memo, the measured HC emissions for the carbureted engine are probably understated.

Background Typical gasoline powered sterndrive/ inboard marine engines are marinized using automotive engine blocks. Sterndrive engines are those that are mounted at the rear of the vessel with a drive unit, attached directly to the engine, that passes through the hull of the vessel. These engines are also known as " inboard/ outboard" engines. Inboard engines are similar to sterndrive engines except that they may be located away from the stern and are connected to the propeller by a propeller shaft that passes through the hull.

Marinization refers to making modifications and adding components to the basic engine block to create an engine that is suitable for use in marine applications. These modifications include choosing and optimizing the fuel management system, configuring a marine cooling system, adding 1 Samulski, M., " Sensitivity of Test Cycle and Fuel Type on a Spark Ignition Four Stroke Inboard Marine Engine," SAE Paper 941782, 1994.

 2 intake and exhaust manifolds, and adding associated accessory drives and units. In traditional SD/ I engine designs, these engines are not modified to produce significantly more power than the base automotive engine.

A small subset of SD/ I engines are designed to produce much higher power than an automotive engine of the same engine displacement. These engines are referred to as highperformance or racing engines. These engines are often used in racing applications which would be exempt from exhaust emissions under the Clean Air Act. However, these engines are also commonly used for recreation. Typical high performance vessels are powered by two or three of these engines. Because of the short time between rebuilds of these engines, it is common practice for boat owners to own to sets of engines so that one set can be used while the other is being rebuilt.

High performance marine engines are typically built up from custom engine blocks that are the same as or similar to engine blocks used in race cars. These engine blocks typically have larger bores than comparable automotive engines and are more robust so to be able to withstand higher forces. Increased horsepower is achieved in three ways: higher fuel rates, better air management, and higher engine speeds. These higher engine speeds require engine components to be machined with precise tolerances. Otherwise, the high speed flexing of the parts can cause them to fail. In addition, these engines typically run rich to help protect the engine against high temperatures.

Engines and Fuel Specifications We tested two high performance engines as a part of this effort. The first was a carbureted 738 horsepower engine manufactured by Sterling Performance. The second was a supercharged and fuel injected 1040 horsepower engine manufactured by Baker Engineering. We chose these engines to provide examples of two widely different styles of high performance engines. Both of these engines had been operated in boats, but it was not possible to determine the hours of use on these engines. Table 1 presents a side by side comparison of the two engines which are shown in Figures 1 and 2. Note that both manufacturers have diverse product lines and this comparison is not intended to be representative of the capabilities of each company.

The fuel used for this testing was 93 octane Sunoco gasoline purchased at a nearby gas station in Milford, MI. Through a visit to the gas station after the testing, it was determined that this fuel contained 10% ethanol. Because the ethanol in the fuel contains oxygen, it would be expected that the HC and CO emissions on this fuel would be somewhat lower than on straight gasoline. Previous testing on a carbureted 5.7 liter engine showed a 10 percent reduction in HC and 25% reduction in CO on E10 compared to gasoline. 1 The oxygen in the fuel would also be expected to increase NOx emissions which may offset the HC reduction in the combined HC+ NOx measurement. The fuel consumption calculations were made using a specific gravity of 0.77 which was based on the known specific gravity for other Sunoco fuels. Sterling Performance reported that they observed a peak power of 1200 hp on the supercharged engine when operated on high octane racing fuel.  3 Figure 2: Fuel Injected, Supercharged, and Intercooled 1040 hp Engine Figure 1: Carbureted and Naturally Aspirated 738 hp Engine Table 1: Engine Specifications Sterling Performance Baker Engineering Block Configuration Displacement Rated Power Rated Speed Air Induction Oil System V8 588 cubic inches 738 hp ( 550 kW) 5800 rpm naturally aspirated dry sump V8 632 cubic inches 1040 hp ( 778 kW) 5800 rpm supercharged, intercooled dry sump Fuel system 4 Barrel Holley Carburetor throttle body injection ( 2 throttle bodies) 8 fuel injectors batch fire per bank electronic fuel pump Electronic control distributer with electronic control of ignition system Fuel Air Spark Technology open loop 2 Morgan, E., Lincoln, R., " Duty Cycle for Recreational Marine Engines," SAE Paper 901596, 1990.

 4 Figure 3: Sample Probe Location Test Methodology Testing was performed at Sterling Performance. Although Sterling Performance is equipped to test engines for power and fuel consumption, they are not equipped to perform exhaust emission measurements. Exhaust emission measurements were made with a portable emission sampling system provided by EPA.

Testing was performed over the E4 duty cycle adopted by the International Standards Organization to represent operation of pleasurecraft with spark ignition marine engines. This is the same duty cycle that is currently used to certify outboard and personal watercraft marine engines to EPA standards. The E4 duty cycle contains five test modes including idle, full power, and three intermediate modes along a theoretical propeller curve. 2 Table 2 presents this duty cycle.

Table 2: Modal Duty Cycle for SI Marine Engines Mode % of Maximum Test Speed ( MES) % of Maximum Torque at MES % of Maximum Power* at MES Weighting Factor 1 2 3 4 5 100 80 60 40 idle 100 71.6 46.5 25.0 0 100 57.2 27.9 10.1 0 0.06 0.14 0.15 0.25 0.40 * % power = (% speed) × (% torque).

To create resistance ( load) on the engine during testing, the engine was connected with a drive shaft to a water brake dynamometer. Fuel consumption was measured through the use of a small fuel reservoir and two turbine flow meters. Overflow fuel from the fuel injectors was returned to the reservoir to allow for an accurate measurement of fuel consumption. During engine operation, the test cell heated due to engine operation. However, constant temperature air was drawn from outside the test cell and routed to a hood above the air intake on the engines.

In a typical boat application, cooling water is drawn from the ambient water and routed through the engine and cooling system. This water is then dumped into the exhaust stream. In this testing, cooling water was routed through the engine to a heat exchanger which cooled the water and  5 Figure 4: Oil Reservoir, Intake Air Hood, and Cooling Fan returned it to the engine. Because no water was mixed into the exhaust, a dry sample could be taken. Emission measurements were made by inserting a sample probe into the exhaust manifold on the left bank of the engine downstream of where the exhaust gases from the four left bank cylinders mix. Exhaust concentration was then based on the sample from the left bank and total emissions were determined using the total fuel consumption. We first considered sampling downstream of where the exhaust pipes from the two banks are joined. However, there were friction fittings ( joining the exhaust manifold and corrugated piping) upstream of this point where air may have been drawn into the exhaust stream. This air flow, which could not be measured, would likely have diluted the measured exhaust concentration if we had sampled at that point.

Both of the engines had external oil tanks with a dry sump in the oil pan. A cooling fan was directed at the oil reservoir and the engine during testing. As discussed above, the air in the test cell increased in temperature during testing. In addition, especially at high power modes, the water temperature and oil temperature increased during testing. This increase in temperature was larger than would be seen in an in use application because of the efficiency of the cooling systems in boats which have the potential to draw large amounts of ambient water through the engine. Therefore, we used short sample times, especially at the peak power mode, to prevent engine overheating At wide open throttle, we sampled for 30 seconds. At the remaining modes we sampled for two minutes each.

Portable Emissions Measurement System We used a portable emissions measurement system ( PEMS) to measure engine emissions. The PEMS we used was a Semtech D manufactured by Sensors, Inc., Saline, MI. Semtech D. Table 3 presents the emissions measurement technology to analyze hydrocarbons, oxides of nitrogen, carbon monoxide, and carbon dioxide. All of these analyzers are specifically allowed by EPA for conducting any emissions certification and compliance testing. To ensure that all of the EPArequired emissions calculations were properly conducted, Semtech D also measured atmospheric pressure and intake air temperature and humidity.  6 Table 3: Emissions Measurement Technology Emission Analyzer technology Comments Nitric oxide, NO Nondispersive Ultraviolet, NDUV NO and NO 2 are added to determine total oxides of nitrogen, NOx Nitrogen dioxide, NO 2 Nondispersive Ultraviolet, NDUV Carbon Monoxide, CO Nondispersive Infrared, NDIR Carbon Dioxide, CO 2 Nondispersive Infrared, NDIR Total hydrocarbons, THC Heated Flame Ionization Detector, HFID HFID and all sample lines heated to 191 ° C The Semtech D is normally equipped with an averaging Pitot tube exhaust flow meter, which is used along with the emissions concentration measurements to determine emissions rates in grams per second. However, to facilitate rapid installation, the flow meter was not used. Instead, Semtech D calculated grams of emissions per grams of fuel consumed based on summing CO, CO 2 and THC concentrations and factoring in certain molecular weights and the hydrogen to carbon ratio of the fuel. To determine emissions flow rates in grams per second, the fuel specific emissions data from Semtech D were multiplied by fuel consumption data provided by a fuel flow meter that was already installed at the Sterling Performance Marine laboratory. Brake specific emissions were determined by dividing the emissions rates by the power developed by the engine.

The emissions test procedure was conducted as follows:

1. Semtech D was started, warmed up, and the automated leak check was performed. 2. Each gas analyzer within the Semtech D was zeroed and spanned, and then audited with mid span calibration gases both prior to testing and after testing to ensure that EPA certification and compliance thresholds for analyzer drift ( i. e., ± 2% of span) were met for each test. 3. Emissions were stabilized at each steady state mode and a fixed amount of time was determined over which fuel specific emissions were averaged. A shorter amount of time was used during the full power mode to prevent engine damage. 4. Each test was validated by verifying acceptable emissions analyzer drift and by verifying that Semtech D did not report any errors such as any pressures or temperatures being out of EPA required limits. 3 " Draft Regulatory Support Document: Control of Emissions from Spark Ignition Marine Vessels and Highway Motorcycles," U. S. EPA, July 2002.

 7 Test Results and Discussion Carbureted Engine Table 4 presents the modal and weighted test results for the carbureted engine. The combined HC+ NOx value was measured to be 21.6 g/ kW hr and CO was measured to be 253 g/ kWhr These emissions are high compared to traditional SD/ I engines which have typically have exhaust emissions on the order of 14 18 g/ kW hr HC+ NOx and 100 200 g/ kW hr CO. 3 These higher emissions are likely due to the high fueling rate combined with rich air fuel ratios and low residence times in the cylinder.

Table 4: Exhaust Emission Test Results for 738 hp Naturally Aspirated and Carbureted Engine Speed, rpm Power, kW BSFC, kg/ hr HC, g/ hr NOx, g/ hr CO, kg/ hr 5802 4639 3481 2321 1345 550 316 153 60 1 164 99 59 30 9 8409 1593 1067 1195 838* 9610 2250 249 60 59 67 58 58 27 4 weighted result, g/ kW hr 376 13.2 8.4 253 * may be understated because exhaust concentration was above measurement range To protect against high temperatures, high performance engines are typically calibrated to operate very rich of stoichiometric. This reduces the combustion efficiency and lowers cylinder temperatures. In addition, liquid fuel helps absorb heat and lubricate the cylinders. Especially at idle, carbureted and throttle body injected engines are often calibrated rich to prevent the risk of misfire due to cylinder to cylinder variation in the air fuel ratio. This variation is due differences to the geometry of the air intake path for each cylinder and to the offsets in cylinder valve and spark timing. For naturally aspirated engines, the air fuel ratios for each cylinder are also sensitive to the pressure pulses created by the valve timing.

At idle, the hydrocarbon concentration in the exhaust was higher than what could be measured accurately using the PEMS unit. Therefore, the actual HC emission may be significantly higher than what is reported in Table 3. An investigation of the air fuel ratio at idle suggested that raw fuel may have been passing through one of the cylinders unburned. As a sensitivity analysis, we consider the scenario where the air fuel ratio in the exhaust at idle was the same as for the fuelinjected engine. As shown in the attachments, the exhaust air fuel ratio for these two engines is similar for the other test modes. Under this scenario, the actual hydrocarbon concentration at mode 5 would have been 50% higher than what was measured. Under this sensitivity analysis, the weighted hydrocarbon emissions were calculated to be 14.7 g/ kW hr.  8 We performed a second sensitivity analysis in which we looked what would happen if the idle mode were calibrated for low HC. To do this, we modeled the idle mode emissions based on those for the fuel injected engine ( adjusted for engine speed and displacement). Using a value of 282 g/ hr at idle, we get a weighted HC estimate of 11.3 g/ kW hr. Although the idle mode is the heaviest weighted mode in the duty cycle, the actual mass flow is relatively small. Therefore, even if this change were made at idle, the weighted HC emissions would still be higher than typical SD/ I engines.

The high NOx emissions at idle suggested that there is likely high cylinder to cylinder variation. These engines are typically calibrated for peak power. Air intake paths for the carbureted engine are designed to use pressure pulses to help ram the air into the cylinder at wide open throttle. Due to the cylinder to cylinder variation, one cylinder may be running much leaner than the others. It is for this reason that the engine is calibrated for such rich overall operation at idle. In addition, this engine is designed with a high compression ratio to increase power. High compression ratios also increase peak cylinder temperatures and NOx is formed at these high temperatures.

Fuel Injected Engine Table 5 presents the modal and weighted test results for the fuel injected and supercharged engine. The combined HC+ NOx value was measured to be 12.5 g/ kW hr and CO was measured to be 349 g/ kW hr. This HC+ NOx level is lower than most typical SD/ I engines on a brake specific basis. However, CO emissions are about twice as high.

Table 5: Exhaust Emission Test Results for 1040 hp Fuel Injected, Supercharged, and Intercooled Engine Speed, rpm Power, kW BSFC, kg/ hr HC, g/ hr NOx, g/ hr CO, kg/ hr 5785 4641 3485 2300 1725 778 453 225 76 5 262 159 97 54 17 3446 1519 2096 1374 384 7480 1842 351 84 34 115 105 100 66 9 weighted result, g/ kW hr 448 7.6 4.9 349 The relatively low HC+ NOx emissions are due to low NOx levels, probably due to a rich airfuel ratio and cooled charge air. HC emissions are high, but within the upper end of the range of hydrocarbon rates for typical SD/ I engines. Rich air fuel ratios likely contribute to the high HC and CO emissions.

This engine uses electronically controlled fuel injection which allows the engine to be better calibrated for more precise fuel management. However, the injectors are in the throttle body and they are batch fired, four at a time, for each bank. Therefore, the engine still must be calibrated rich, especially at idle, to avoid lean misfire due to cylinder to cylinder air fuel ratio variation. Because the intake air is supercharged, cylinder to cylinder variation due to pressure pulses is likely minimal.  9 Acknowledgments We would like to thank Jeff Burrill and Tim Cushing at Sterling Performance for supplying the engines and the testing facility as well as for their time and expertise.  10

Attachments Attachment 1: Detailed Test Data for Carbureted Engine Mode Statistic Engine Speed rpm Power hp Fuel Flow lbs/ hr Humidity grains / lb. dry air HC ppm NOx corrected ppm CO % CO 2 % Exhaust A/ F 1 average std. dev.

COV 5802 3.9 0% 738 1.6 0% 362 2.1 1% 32.5 0.4 1% 7585 1101.1 15% 2982 703.8 24% 3.37 1.1 31% 12.78 1.5 12% 12.8 0.6 5%

2 average std. dev.

COV 4639 4.0 0% 424 1.0 0% 218 3.4 2% 32.7 0.7 2% 2476 36.1 1% 1181 17.6 1% 5.09 0.1 1% 12.13 0.0 0% 12.5 0.0 0%

3 average std. dev.

COV 3481 2.0 0% 205 1.3 1% 129 1.7 1% 33.8 0.4 1% 3058 30.0 1% 235 1.6 1% 9.28 0.1 1% 9.48 0.0 0% 11.2 0.0 0%

4 average std. dev.

COV 2321 4.2 0% 81 0.7 1% 65 2.0 3% 34.6 0.4 1% 6623 888.6 13% 115 1.3 1% 8.32 0.1 1% 9.92 0.1 1% 11.3 0.1 0%

5* average std. dev.

COV 1345 9.9 1% 2 0.1 4% 19 1.3 7% 34.1 0.4 1% 11533 0.3 0% 269 1.2 0% 3.35 0.1 3% 8.45 0.1 2% 16.4 0.2 1%

* Note: The HC concentration at idle appeared to be above the highest range for the PEMS unit.  11

Attachment 2: Detailed Test Data for Fuel Injected, Supercharged Engine Mode Statistic Engine Speed rpm Power hp Fuel Flow lbs/ hr Humidity grains / lb. dry air HC ppm NOx corrected ppm CO % CO 2 % Exhaust A/ F 1 average std. dev.

COV 5785 4.3 0% 1044 2.3 0% 577 7.2 1% 45.6 1.2 3% 1890 84.2 4% 1403 122.1 9% 3.56 0.3 8% 12.68 0.1 1% 13.3 0.2 1%

2 average std. dev.

COV 4641 1.8 0% 607 1.2 0% 351 2.1 1% 46.1 0.9 2% 1445 58.7 4% 605 28.2 5% 5.67 0.2 3% 11.65 0.1 1% 12.4 0.1 1%

3 average std. dev.

COV 3485 2.9 0% 301 0.8 0% 214 2.2 1% 47.2 1.0 2% 3472 368.0 11% 202 4.9 2% 9.51 0.4 5% 8.81 0.6 7% 11.4 0.1 1%

4 average std. dev.

COV 2300 5.1 0% 101 0.9 1% 118 1.3 1% 47.7 1.3 3% 4100 94.7 2% 87 0.8 1% 11.21 0.1 1% 6.88 0.0 0% 11.4 0.0 0%

5 average std. dev.

COV 1725 13.7 1% 7 0.2 3% 38 2.2 6% 47.8 1.0 2% 2753 165.6 6% 82 0.8 1% 3.58 0.2 5% 9.97 0.1 1% 15.6 0.1 1%


MEMORANDUM

DATE:	26-JUL-2001

SUBJECT:	PP# 6E06209.  Dicamba (Distinct®, EPA Reg #7969-150) on Sweet Corn.  Evaluation of Residue Data and Analytical Methods.  MRID# 451540-01.  Chemical 029801.  Barcode D275611.  Case 293383.  Submission S590360.

FROM:	George F. Kramer, Ph.D., Chemist

Registration Action Branch 1 (RAB 1)

Health Effects Division (HED) (7509C)

THRU:	G. Jeffrey Herndon, Branch Senior Scientist

RAB1/HED (7509C)

TO:		Shaja Brothers/Robert Forrest, PM Team 5

Registration Division (RD) (7505C)

Interregional Research Project No. 4 (IR-4) has submitted a petition on behalf of the Agricultural Experiment Stations of MN, ND and WI proposing the following permanent tolerances for the combined residues of the herbicide dicamba (3,6-dichloro-o-anisic acid) and its 5-hydroxy (5-OH) metabolite (3,6-dichloro–5-hydroxy-o-anisic acid) in/on the following raw agricultural commodities (RACs):

Corn, sweet, forage

1.0 ppm

Corn, sweet, fresh

0.1 ppm

Corn, sweet, stover

1.0 ppm

Tolerances for residues of dicamba and its 5-OH metabolite have been established for corn grain, corn forage, corn fodder, wheat grain, wheat straw, barley grain, and barley straw at 0.5 ppm; and for field corn forage, field corn stover and popcorn stover at 3.0 ppm (40 CFR § 180.227(a)).  Tolerances for dicamba and its 2-OH metabolite (3,6-dichlorosalicylic acid (DCSA, or 3,6-dichloro-2-hydroxybenzoic acid) have been established at 0.05 ppm for soybeans; 0.1 ppm for soybean hay and soybean forage; and on cattle, goats, hogs, horses, and sheep meat, fat, and meat byproducts at 0.2 ppm, liver and kidney at 1.5 ppm, and milk at 0.3 ppm (40 CFR §180.227(b)).  Tolerances for dicamba and its 5-OH metabolite, resulting from the application of the sodium salt of dicamba, have been established for cottonseed at 3.0 ppm (40 CFR § 180.227(c)).

Concurrently, the petitioner has submitted a request for Section 3 registration of Distinct® Herbicide (EPA Reg. No. 7969-150), a multiple active ingredient water-dispersible granule (WDG) formulation containing 21.4% diflufenzopyr and 55% dicamba, for use on sweet corn for the control of various weeds.  This residue chemistry review deals only with the use of dicamba on sweet corn.  Issues pertaining to diflufenzopyr are addressed in a separate memo (J. Tyler, in preparation; D275619).

Dicamba Registration Standard was dated 12-AUG-1983, followed by a Dicamba Second Round Review on 24-MAY-1989.  Dicamba is a List A chemical.

Structural Formulae:

Executive Summary of Chemistry Deficiencies

• Additional field residue trials.

• Revised Section F.

CONCLUSIONS

OPPTS GLN 860.1200:  Proposed Uses

1. The petitioner has provided an adequate set of directions for the proposed use.

OPPTS GLN 860.1300:  Nature of the Residue - Plants

2. The nature of the residue in plants is adequately understood (F. Griffith, 02-MAY-1996, PP#6F4604, D220469).  The residues to be regulated in barley, corn, cotton, oats, wheat, and grasses are dicamba and its 5-OH metabolite; in asparagus the residues to be regulated are dicamba and DCSA; and in soybeans and aspirated grain fractions, the residues to be regulated are dicamba, 5-OH dicamba and DCSA.

OPPTS GLN 860.1300:  Nature of the Residue - Livestock

3. The nature of the residue in ruminants and poultry is adequately understood (L. Cheng, 07-MAR-1996, D204482).  The residues to be regulated in livestock are dicamba and its DCSA metabolite.

OPPTS GLN 860.1340:  Residue Analytical Methods

4. The petitioner has presented an adequately validated capillary GC/ECD residue analytical method to determine the magnitude of dicamba and 5-OH dicamba residues in plant commodities (barley, corn, cotton, cotton processed fractions, pasture grass, peanut, sorghum, soybean, sugar cane, tomato, tomato processed fractions, wheat and wheat processed fractions).  Pesticide Analytical Manual (PAM) Volume II lists Method I and II, GC methods with electron capture detection (GC/ECD), for the enforcement of tolerances on dicamba and its metabolite 5-OH dicamba in/on plant commodities and milk.

OPPTS GLN 860.1360:  Multiresidue Method

5. Documentation from the FDA, PAM Volume I, Appendix II and Table 201-D, shows that dicamba is partially recovered (71 - 76%) using Protocol B.

OPPTS GLN 860.1380:  Storage Stability Data

6. BASF submitted the results of a frozen storage stability study for dicamba and its metabolite 5-OH dicamba in the following field corn RACs:  forage, silage, grain, and fodder (S. Chun & W. Donovan, 16-JUL-1998, D228703).  The results of this study show dicamba to be stable for up to 3 years in frozen storage, and 5-OH dicamba to be stable for up to 2 years in frozen storage.  As the sweet corn samples were stored for a maximum of 24 months, storage stability is not an issue for this petition.

OPPTS GLN 860.1500:  Crop Field Trials

7a. A total of 9 field residue trials were conducted in Regions 1 (1 trial), 2 (1 trial), 3 (1 trial), 5 (3 trials), 6 (1 trial), 10 (1 trial) and 12 (1 trial).  The number and location does not match that required for sweet corn:  12 trials conducted in Regions 1 (2 trials), 2 (1 trial), 3 (1 trial), 5 (5 trials), 10 (1 trial), 11 (1 trial) and 12 (1 trial).  The petitioner previously submitted the results of 20 field corn residue trials.  HED can generally translate field corn forage and stover data to sweet corn.  However, in this case, translation is not appropriate as the application rate in the field corn trials was >10X the maximum sweet corn application rate.

7b. HED requests that the petitioner submit an additional 3 sweet corn residue trials conducted in Regions 1 (1 trial), 5 (1 trial) and 11 (1 trial).  Permanent tolerances and a conditional registration may be established while these trials are conducted.

7c. Based on the available data, the following tolerance for residues of the herbicide dicamba and its 5-OH metabolite are appropriate for this petition:

Corn, sweet, forage

0.50 ppm

Corn, sweet, kernel plus cob with husks removed

0.04 ppm

Corn, sweet, stover

0.50 ppm

A revised Section F is required.

OPPTS GLN:  860.1520:  Processed Food/Feed

8. As there are no processed commodities associated with sweet corn, processing studies not are required to support the subject petition.

OPPTS GLN 860.1480:  Meat, Milk, Poultry, Eggs

9. Given that there are already dicamba tolerances established on major livestock feed items at high levels (i.e., aspirated grain fractions at 5100 ppm, grass forage at 125 ppm and wheat forage at 20 ppm), HED concludes that the dietary burden to livestock will not be affected by the use of dicamba on sweet corn.

OPPTS GLN 860.1850 and 860.1900:  Confined/Field Accumulation in Rotational Crops

10. Based on the results of a confined rotational crop study (memo S. Chun & W. Donovan, 25-JUN-1998; D228694), HED has concluded that the plantback intervals specified on the Distinct® label (7 days for corn and 120 days for all other crops) are appropriate.

Other Considerations

11. There is neither a Codex proposal, nor Canadian or Mexican limits for residues of dicamba in/on sweet corn.  Therefore, a compatibility issue is not relevant to the proposed tolerance.  A copy of the IRLS (International Residue Limit Status) sheet is attached to this memorandum.

RECOMMENDATIONS

Provided Section F is revised as specified in Conclusion 7c, HED concludes there are no residue chemistry data requirements that would preclude the establishment of permanent tolerances for residues of dicamba and its 5-OH metabolite in/on sweet corn RACs.  Registration of Distinct® should be made conditional upon the submission of additional residue data as specified in Conclusion 7b.  A human-health risk assessment will be prepared as a separate document.

	DETAILED CONSIDERATIONS

OPPTS GLN 860.1200:  Proposed Uses

Distinct® is a selective postemergence herbicide.  The maximum application rate for sweet corn is 0.14 lbs. ai/A and a maximum of 2 applications are permitted per season.  The maximum seasonal use rate is 0.21 lbs. ai/A with a minimum retreatment interval of 2 weeks.  Surfactants (0.25% v/v) should be added to the postemergence finished spray.  The spray volume is 3-50 gal/A by ground equipment.  The PHI is 32 days for fresh corn and 72 days for stover.

The rotational crop restrictions listed on the label are 7 days for corn and 120 days for all other crops.

The petitioner has proposed an adequate set of directions for use of Distinct® on sweet corn.

Note:  The revised Distinct® label also contains directions for use on popcorn and grass.  Dicamba is already for use on these crops and the use rate on the Distinct® label is less than that which is already registered for dicamba alone.  Issues pertaining to dicamba in/on popcorn and grass are thus not relevant to this petition.

OPPTS GLN 860.1300:  Nature of the Residue - Plants

The nature of the residue in plants is adequately understood (F. Griffith, 02-MAY-1996, PP#6F4604, D220469).  In most plants there is oxidation on the ring at the 5 position to form the 5-OH metabolite.  In asparagus and soybeans there is demethylation on the ring at the 2 position to form the DCSA metabolite.  Thus, the residues to be regulated in barley, corn, cotton, oats, wheat, and grasses are dicamba and its 5-OH metabolite; in asparagus the residues to be regulated are dicamba and DCSA; and in soybeans and aspirated grain fractions, the residues to be regulated are dicamba, 5-OH dicamba and DCSA.

OPPTS GLN 860.1300:  Nature of the Residue - Livestock

The nature of the residue in ruminants and poultry is adequately understood (L. Cheng, 07-MAR-1996, D204482).  In ruminants the metabolic pathway is the same as in asparagus and soybeans which is demethylation and formation of the DCSA metabolite.  The same basic metabolic pathway exist in poultry; however there is a minor pathway producing a small amount of 2-amino-3,6-dichlorophenol found in poultry liver.  The residues to be regulated in livestock are dicamba and its DCSA metabolite.

OPPTS GLN 860.1340:  Residue Analytical Method - Plant Commodities

The petitioner has presented an adequately validated capillary GC/ECD residue analytical method to determine the magnitude of dicamba and 5-OH dicamba residues in plant commodities (barley, corn, cotton, cotton processed fractions, pasture grass, peanut, sorghum, soybean, sugar cane, tomato, tomato processed fractions, wheat and wheat processed fractions).  This method (AM-0691B-0593-3) underwent a successful independent laboratory validation (D. Miller, 13-DEC-1993) and a successful EPA method validation (J. Stokes, 24-JAN-1997).  This method was recently superceded by method AM-0691B-0297-4 (MRID 44394102), which consists of a more detailed step-by-step description of the procedures, GC-MS confirmatory tests, and additional recovery data.  The analytical method has not been changed from method AM-0691B-0593-3.  The limit of quantitation (LOQ) for dicamba and 5-OH dicamba is 0.02 ppm.  PAM Volume II lists Method I and II, GC methods with electron capture detection (GC/ECD), for the enforcement of tolerances on dicamba and its metabolite 5-OH dicamba in/on plant commodities and milk.

OPPTS GLN 860.1340:  Residue Analytical Methods - Livestock Commodities

The GC/EC method, AM-0685 (MRID 00079744) detects residues of dicamba and 3,6-dichloro-2-hydroxybenzoic acid (both as the methyl ester of dicamba) in milk, muscle, liver, kidney and fat.  The method has been successfully validated by the Agency using milk and ground beef samples (9/1/82, K. Zee, PP#1F2569).

OPPTS GLN 860.1360:  Multiresidue Method

Although the petitioner requested a waiver for dicamba multiresidue method testing (S. Knizner, 11-JUN-1993, D189393 and D189595), documentation from the FDA PAM, Volume I, Appendix II and Table 201-D, shows that dicamba is partially recovered (71 - 76%) using Protocol B.

OPPTS GLN 860.1380:  Storage Stability Data

BASF submitted the results of a frozen storage stability study for dicamba and its metabolite 5-OH dicamba in the following field corn RACs:  forage, silage, grain, and fodder (S. Chun & W. Donovan, 16-JUL-1998, D228703).  The results of this study show dicamba to be stable for up to 3 years in frozen storage, and 5-OH dicamba to be stable for up to 2 years in frozen storage.  As the sweet corn samples were stored for a maximum of 24 months, storage stability is not an issue for this petition.

OPPTS GLN 860.1500:  Crop Field Trials

Submitted with this petition:

Sweet Corn Residues of diflufenzopyr and Dicamba Resulting From Application of Distinct® (BAS 662 H)  MRID# 451540-01.

A total of 9 field residue trials were conducted in 1996.  These trials were located in Regions 1 (1 trial), 2 (1 trial), 3 (1 trial), 5 (3 trials), 6 (1 trial), 10 (1 trial) and 12 (1 trial).  Four plots were established at each site.  Treatment 1 was the untreated control.  Treatment 2 consisted of 2 applications of diflufenzopyr at a rate of 0.05 lbs. ai/A for a total of 0.10 lbs. ai/A.  Treatment 3 consisted of 2 applications of Distinct® at a rate of 0.125 lbs. dicamba/A for a total of 0.25 lbs. ai/A (1.2X).  Treatment 4 consisted of 2 applications of dicamba at a rate of 0.25 lbs. ai/A for a total of 0.50 lbs. ai/A (2.4X).  The first treatment was made when the corn was 12 inches tall; the second, when the corn was 24 inches tall.  Two replicate samples were harvested from each treated plot 4-7 weeks (forage and ears) and 5-16 weeks (stover) after application.  The samples were frozen and shipped to Sandoz.  Sample analysis for and 5-OH dicamba was performed using method AM-0691B-0593-3.  The method was validated over a range of 0.02-0.1 ppm.  The average recovery was 84 ± 13% for dicamba and 88 ± 11% for 5-OH dicamba.  Analyses of the treated samples (Tables 1 & 2) showed that the maximum total residues at 1.2X were 0.29 ppm in forage, 0.39 ppm in stover and <0.04 ppm in ears (kernel plus cob with husk removed).

Table 1. Residue levels of dicamba and 5-OH dicamba following Treatment 3 (0.25 a.i./A dicamba, 1.2X)

Trial Site

PHI

(Weeks)

Dicamba (ppm)

5-OH Dicamba (ppm)

Totalb (ppm)

Sweet Corn Forage

WI

7

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

MN

6

<0.02

 0.03

<0.05

<0.02

 0.05

<0.07

IN

7

<0.02

 0.06

<0.08

<0.02

 0.06

<0.08

OR

8

<0.02

 0.03

<0.05

<0.02

 0.04

<0.06

CA

6

 0.10

 0.11

 0.21

<0.02

 0.08

<0.10

WA

4

 0.05

 0.31

 0.26

 0.05

 0.24

 0.29

GA

6

<0.02

 0.07

<0.09

<0.02

 0.07

<0.09

FL

4

 0.03

 0.22

 0.25

<0.02

 0.13

<0.17

NY

4

 0.03

 0.13

 0.16

 0.04

 0.18

 0.22

Sweet Corn Stover

WI

10

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

MN

9

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

IN

11

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

OR

16

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

CA

13

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

WA

10

 0.05

 0.34

 0.39

 0.04

 0.24

 0.28

GA

NC a

-

-

-

-

-

--

FL

5

 0.05

 0.28

 0.33

 0.03

 0.21

 0.24

NY

10

<0.02

 0.03

<0.05

<0.02

 0.03

<0.05

Sweet Corn Ears

WI

7

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

MN

6

NA

NA

NA

NA

NA

NA

IN

7

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

OR

8

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

CA

6

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

WA

4

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

GA

6

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

FL

4

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

NY

4

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

a NC = Not Collected

b NA = Not Analyzed

Table 2. Residue levels of dicamba and 5-OH dicamba following Treatment 4 (0.50 a.i./A dicamba, 2.4X)

Trial Site

PHI

(Weeks)

Dicamba (ppm)

5-OH Dicamba (ppm)

Totalb (ppm)

Sweet Corn Forage

WI

7

 0.054

 0.15

 0.20

 0.042

 0.12

 0.16

MN

6

<0.02

 0.042

<0.06

<0.02

 0.058

<0.08

IN

7

<0.02

 0.10

<0.12

0.024

 0.16

 0.18

OR

8

 0.096

 0.30

 0.40

 0.042

 0.15

 0.19

CA

6

 0.087

 0.17

 0.26

 0.038

 0.26

 0.30

WA

4

 0.14

 0.92

 1.1

 0.10

 0.66

 0.76

GA

6

 0.043

 0.14

 0.18

 0.058

 0.24

 0.30

FL

4

 0.22

 1.5

 1.7

 0.20

 1.3

 1.5

NY

4

 0.099

 0.82

 0.92

 0.063

 0.50

 0.56

Sweet Corn Stover

WI

10

 0.047

 0.13

 0.18

 0.067

 0.17

 0.24

MN

9

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

IN

11

<0.02

<0.066

<0.09

<0.02

<0.051

<0.07

OR

16

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

CA

13

 0.026

 0.093

 0.12

 0.030

 0.068

 0.098

WA

10

 0.072

 0.57

 0.64

 0.083

 0.59

 0.67

GA

NC a

-

-

-

-

-

-

FL

5

 0.27

 1.5

 1.8

 0.18

 0.90

 1.1

NY

10

 0.028

 0.076

 0.10

 0.034

 0.093

 0.13

Sweet Corn Ears

WI

7

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

MN

6

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

IN

7

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

OR

8

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

CA

6

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

WA

4

 0.064

 0.034

 0.098

 0.081

 0.043

 0.12

GA

6

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

FL

4

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

NY

4

<0.02

<0.02

<0.04

<0.02

<0.02

<0.04

a NC = Not Collected

b NA = Not Analyzed

Conclusions:  A total of 9 field residue trials were conducted in Regions 1 (1 trial), 2 (1 trial), 3 (1 trial), 5 (3 trials), 6 (1 trial), 10 (1 trial) and 12 (1 trial).  The number and location does not match that required for sweet corn:  12 trials conducted in Regions 1 (2 trials), 2 (1 trial), 3 (1 trial), 5 (5 trials), 10 (1 trial), 11 (1 trial) and 12 (1 trial).  The petitioner previously submitted the results of 20 field corn residue trials.  HED can generally translate field corn forage and stover data to sweet corn.  However, in this case, translation is not appropriate as the application rate in the field corn trials was >10X the maximum sweet corn application rate.  HED thus requests that the petitioner submit an additional 3 sweet corn residue trials conducted in Regions 1 (1 trial), 5 (1 trial) and 11 (1 trial).  Permanent tolerances and a conditional registration may be established while these trials are conducted.  Based on the available data, the following tolerance for residues of the herbicide dicamba and its 5-OH metabolite are appropriate for this petition:

Corn, sweet, forage

0.50 ppm

Corn, sweet, kernel plus cob with husks removed

0.04 ppm

Corn, sweet, stover

0.50 ppm

A revised Section F is required.

OPPTS GLN 860.1520:  Processed Food/Feed

As there are no processed commodities associated with sweet corn, processing studies not are required to support the subject petition.

OPPTS GLN 860.1480:  Meat, Milk, Poultry, Eggs

Given that there are already dicamba tolerances established on major livestock feed items at high levels (i.e., aspirated grain fractions at 5100 ppm, grass forage at 125 ppm and wheat forage at 20 ppm), HED concludes that the dietary burden to livestock will not be affected by the use of dicamba on sweet corn.

OPPTS GLN 860.1850/1900:  Confined/Field Accumulation in Rotational Crops

Based on the results of a confined rotational crop study, HED has concluded that the following plantback restrictions are appropriate (memo S. Chun & W. Donovan, 25-JUN-1998; D228694):

Application Rate

Rotational Restrictions

0.75 or less lb a.i./A

After 120 days from time of application: no rotational cropping restrictions apply.

Planting within 120 days of application: only rotate to crops below.

0.75 to 2.0 lb a.i./A

Rotate to the following crops only:

corn, soybeans, cotton, wheat , barley, oats, grass pasture and hay or rangeland, sorghum, asparagus, sugarcane.

As the application for sweet corn is <0.75 lb a.i./A, the plantback intervals specified on the Distinct® label (7 days for corn and 120 days for all other crops) are appropriate.

Other Considerations:  There is neither a Codex proposal, nor Canadian or Mexican limits for residues of dicamba in/on sweet corn.  Therefore, a compatibility issue is not relevant to the proposed tolerance.  A copy of the IRLS sheet is attached to this memorandum.

Attachment 1- IRLS Sheet

cc:  Kramer

RDI: G. Herndon(7/19/01), RAB1 Chemists (7/19/01)

G.F. Kramer:806T:CM#2:(703)305-5079:7509C:RAB1

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:

3,6-dichloro-o-anisic acid

Common Name:

Dicamba

( Proposed tolerance

( Reevaluated tolerance

( Other

Date:

6/29/01

Codex Status (Maximum Residue Limits)

U. S. Tolerances

X No Codex proposal step 6 or above

( No Codex proposal step 6 or above for the crops requested

Petition Number:  6E06209

DP Barcode:  D271606

Other Identifier:

Residue definition: N/A

Reviewer/Branch:  G.F. Kramer

Residue definition:  parent + its 5-OH metabolite

Crop (s)

MRL (mg/kg)

Crop(s)

Tolerance (ppm)

Corn, sweet, forage

1.0

Corn, sweet, fresh

0.1

Corn, sweet, stover

1.0

Limits for Canada

Limits for Mexico

( No Limits

( No Limits for the crops requested

( No Limits

( No Limits for the crops requested

Residue definition:

dicamba

Residue definition:

dicamba

Crop(s)

MRL (mg/kg)

Crop(s)

MRL (mg/kg)

corn (field and sweet)

none (default)

corn

0.5

Notes/Special Instructions:.

S. Funk, 07/03/01.

Rev. 1998

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