[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Proposed Rules]
[Pages 12627-12630]
[FR Doc No: 2022-04638]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0151; Project Identifier MCAI-2021-00521-A]
RIN 2120-AA64

Airworthiness Directives; Costruzioni Aeronautiche Tecnam S.P.A.
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Costruzioni Aeronautiche Tecnam S.P.A. Model P2012
Traveller airplanes. This proposed AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as free play
in the trim tab actuator and trim tab surface. This proposed AD would
require repetitively inspecting the trim tab trailing edge to determine
if free play exists and taking corrective actions as needed. The FAA is
proposing this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by April 21,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12 140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: 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
Costruzioni Aeronautiche Tecnam S.P.A., Airworthiness Office Via S.
D'acquisto 62, Boscotrecase, 80042, Italy; phone: +39 0823 997538;
email: [email protected]; website: https://www.Tecnam.com.
You may view this service information at the FAA, Airworthiness
Products Section, Operational Safety Branch, 901 Locust, Kansas City,
MO 64106. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0151; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the MCAI,
any comments received, and other information. The street address for
Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aviation Safety
Engineer, FAA, General Aviation & Rotorcraft Section, International
Validation Branch, 901 Locust, Room 301, Kansas City, MO 64106; phone:
(816) 329-4165; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2022-0151;
Project Identifier MCAI-2021-00521-A'' at the beginning of your
comments. The most helpful comments reference a specific portion of the
proposal, explain the reason for any recommended change, and include
supporting data. The FAA will consider all comments received by the
closing date and may amend this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Jim
Rutherford, Aviation Safety Engineer, FAA, General Aviation &
Rotorcraft Section, International Validation Branch, 901 Locust, Room
301, Kansas City, MO 64106. Any commentary that the FAA receives which
is not specifically designated as CBI will be placed in the public
docket for this rulemaking.

Background

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2021-0119, dated April 30, 2021 (referred to after this as
``the MCAI''), to address the unsafe condition on certain serial-
numbered Costruzioni Aeronautiche Tecnam S.P.A. Model P2012 Traveller
airplanes. The MCAI states:

    Occurrences have been reported of vibration in the horizontal
stabiliser control yoke and pedals, both sides. The subsequent
investigation identified free play in the trim tab actuator and trim
tab surface.
    This condition, if not detected and corrected, could lead to a
significant free play on the trim tab connection, with consequent
increase in dynamic loads and vibrations, possibly resulting in
reduced control of the aeroplane.
    To address this potential unsafe condition, TECNAM issued the
[Service Bulletin] SB to provide inspection instructions.
    For the reasons described above, this [EASA] AD requires
repetitive inspections of the trim tab trailing edge and, depending
on findings, accomplishment of applicable corrective action(s).

    You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-
0151.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Tecnam Service Bulletin 398-CS-Edition 2, Rev. 1,
dated August 17, 2020. The service information specifies procedures for
inspecting the trim tab trailing edge to determine if free play exists
and taking corrective actions as needed.
    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.

Other Related Service Information

    The FAA also reviewed Tecnam Service Bulletin 398-CS-Edition 2,
Rev. 0, dated August 5, 2020. The service information specifies
procedures for inspecting the trim tab trailing edge to determine if
free play exists and taking corrective actions as needed.
    In addition, the FAA reviewed Tecnam Job Card No. 1249 Ed.1, Rev.1,
dated May 5, 2021. The service information specifies procedures for
servicing free play of the mechanical trim actuator.

FAA's Determination

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

Proposed AD Requirements

    This AD requires accomplishing the actions specified in the service
information already described.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 21 products of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                  Labor cost           Parts cost         Cost per product      operators
----------------------------------------------------------------------------------------------------------------
Trim tab surface free play       1 work-hour x $85  Not applicable........  $85 per            $1,785 per
 inspection.                      per hour = $85.                            inspection cycle.  inspection
                                                                                cycle.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary actions
that would be required based on the results of the proposed inspection.
The FAA has no way of determining the number of airplanes that might
need these actions.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                Action                            Labor cost                   Parts cost             product
----------------------------------------------------------------------------------------------------------------
Trim actuator free play inspection....  2 work-hours x $85 per hour =   Not applicable..........            $170
                                         $170.
Trim actuator servicing...............  2 work-hours x $85 per hour =   $100....................             270
                                         $170.
Trim actuator replacement.............  1 work-hour x $85 per hour =    1,000...................           1,085
                                         $85.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:

    (1) Would not be a ``significant regulatory action'' under
Executive Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

Costruzioni Aeronautiche Tecnam S.P.A.: Docket No. FAA-2022-0151;
Project Identifier MCAI-2021-00521-A.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by April 21, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Costruzioni Aeronautiche Tecnam S.P.A. Model
P2012 Traveller airplanes, serial numbers 002 through 030 inclusive,
certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2731: Elevator Tab
Control System.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as free play in the
trim tab actuator and trim tab surface. The FAA is issuing this AD
to detect and correct free play in the trim tab connection, which
could lead to reduced airplane control.

(f) Compliance

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

(g) Trim Tab Surface Free Play Inspection and Maintenance

    Within 100 hours time-in-service (TIS) after the effective date
of this AD and thereafter at intervals not to exceed 100 hours TIS,
measure the trim tab surface for free play in accordance with
Appendix A, Accomplishment Instructions, section 2 (Step 1--Trim Tab
surface free play measurement) on pages 3 and 4 of Tecnam Service
Bulletin 398-CS-Edition 2, Rev. 1, dated August 17, 2020 (Tecnam SB
398-CS-Edition 2, Rev. 1). If there is free play that exceeds the
allowable tolerance, before further flight, measure the trim tab
actuator for free play and take any corrective actions in accordance
with Appendix A, Accomplishment Instructions, section 3 (Step 2--
Trim Actuator free play measurement) on page 5 of Tecnam SB 398-CS-
Edition 2, Rev 1.

(h) Credit for Previous Actions

    You may take credit for the initial inspection required by
paragraph (g) of this AD if you performed that action before the
effective date of this AD using Tecnam Service Bulletin 398-CS-
Edition 2, Rev. 0, dated August 5, 2020.

(i) Alternative Methods of Compliance (AMOCs)

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

Branch, send it to the attention of the person identified in
paragraph (j)(1) of this AD and email to: [email protected].
    (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.

(j) Related Information

    (1) For more information about this AD, contact Jim Rutherford,
Aviation Safety Engineer, FAA, General Aviation & Rotorcraft
Section, International Validation Branch, 901 Locust, Room 301,
Kansas City, MO 64106; phone:<PHONE_NUMBER>; email:
[email protected].
    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2021-0119, dated April 30, 2021, for more information. You may
examine the EASA AD in the AD docket at https://www.regulations.gov
by searching for and locating Docket No. FAA-2022-0151.
    (3) For service information identified in this AD, contact
Costruzioni Aeronautiche Tecnam S.P.A., Airworthiness Office, Via S.
D'acquisto 62, Boscotrecase, 80042, Italy; phone: +39 0823 997538;
email: [email protected]; website: https://www.Tecnam.com. You may view this referenced service information at
the FAA, Airworthiness Products Section, Operational Safety Branch,
901 Locust, Kansas City, MO 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued on February 25, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-04638 Filed 3-4-22; 8:45 am]
BILLING CODE 4910-13-P


  SEQ CHAPTER \h \r 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		July 16, 2009

Ingredient:  Fluopyram.  Report of the Residues of Concern Knowledgebase Subcommittee (ROCKS).

PC Code:  080302	DP Barcode:  D367115

Decision No.:  393949	Registration No.:  264-RNTI; 432-RUIL; 264-RNTT

Petition No.:  8F7358	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  658066-35-4

MRID No.:  NA	40 CFR:  180.xxx

From:		Edward Scollon, ROCKS Executive Secretary

		Health Effects Division (HED) (7509P)

Through:		Christine L. Olinger, ROCKS Co-Chair

		Mary Ko Manibusan, ROCKS Co-Chair

		HED (7509P)

To:		Fluopyram Risk Assessment Team

		Risk Assessment Branch III (RAB III)

		HED (7509P)

The ROCKS met on June 4, 2009 to discuss the residues of concern for the fungicide fluopyram in food and drinking water.  This was a joint meeting between the US EPA, EU (Germany), and PMRA (Canada).  As such, the residues of concern for risk assessment and tolerance expression for each party are reviewed in this document.

Team Members:

Leung Cheng, Myron Ottley, Sheila Healy, Steve Funk, Whang Phang, Paula Deschamp

ROCKS Members Attended:

Mary Manibusan, Christine Olinger, Rick Loranger, George Kramer, Edward Scollon, Ray Kent, Greg Orrick

EFED Attended:

Mohammed A. Ruhman, Mah Shamim

PMRA Attended (via teleconference):

Isabelle Pilote, Michael Honeyman, Minoli Silva

EU Attended (via teleconference):

Thomas Kuhl, Bernd Stein, Steffen Matezki

Material Reviewed:

Summary of toxicological data and residue chemistry

Summary of EU residue field trials

Environmental Degradates for Fluopyram, DP#365542, MA Ruhman, June 1, 2009

DEREK for Windows evaluations for fluopyram, lactame, AE C656948-7-hydroxy,  AE C656948-benzamide, AE C656948-E-olefine, and AE C656948-Z-olefine available upon request

Committee Recommendation:

Table 1.  Summary of Metabolites and Degradates to be included in the Risk Assessment.*

Matrix	Residues included in Risk Assessment	Residues included in Tolerance Expression

Plants	Primary Crops	fluopyram (fluopyram + benzamide (M25) for legumes and oil seed crops)	fluopyram

	Rotational Crops

Livestock	Ruminants	Fluopyram + benzamide (M25) +7-OH-fluopyram + olefins (E,Z) (M02, M03)	Fluopyram + benzamide (M25)

	Poultry	Fluopyram + benzamide (M25) + olefins (E,Z) (M02, M03)

	Drinking Water	fluopyram	Not Applicable

* Chemical names and abbreviations can be found in Table 1.

ROCKS Recommendation for Tolerance Expression Language

Section (a)(1) would be for plants; (a)(2) is for livestock

 (a)(1) General.  Tolerances are established for residues of the fungicide fluopyram, including its metabolites and degradates, in or on the commodities in the table.  Compliance with the tolerance levels specified below is to be determined by measuring only fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethy l)benzamide).

 (a)(2) General.  Tolerances are established for residues of the fungicide fluopyram, including its metabolites and degradates, in or on the commodities in the table.  Compliance with the tolerance levels specified below is to be determined by measuring only the sum of fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethy l)benzamide) and its benzamide metabolite [2-(trifluoromethyl)-benzamide], calculated as the stoichiometric equivalent of fluopyram, in or on the commodity.

Rationale:

Drinking Water Degradates (US only)

Environmental fate studies indicate that the parent fluopyram is stable under environmental conditions.  Reported half-lives range from 89 days in field and aqueous photolysis studies to >1000 days in aerobic/anaerobic water/sediment systems.  Fluopyram is mobile in soil and can therefore, be expected to occur in surface water runoff and/or in ground water leachate.

Four metabolites were identified in aerobic soil metabolism studies:  AE C656948-7-hydroxy, AE C656948-benzamide, AE C656948-pyridyl carboxylic acid (PCA), and lactame.  None of the metabolites exceeded 10% of applied nor were any of the metabolites considered more toxic than the parent.

AE C656948-7-hydroxy, AE C656948-benzamide, and AE C656948-PCA, were also tracked in field dissipation studies.  AE C656948-7-hydroxy, though structurally similar to the parent, was only found at 1-3% of the fluopyram levels.  AE C656948-PCA (1.2-18%) and AE C656948-benzamide (0.2-16.2%) were more abundant but showed rapid declines.  Lactame, a proposed metabolite of parent fluopyram, was present at low levels in the soil system (1.2%) and as a major metabolite in the aqueous photolysis study (13%).  Lactame is structurally dissimilar from parent fluopyram but would only be expected to form at significant levels in clear, shallow water.  Based upon the low abundance of the metabolites in the soil studies and their rapid dissipation in the field studies, minimal exposure is expected through drinking water.  Furthermore, none of the metabolites are considered more toxic than the parent.  Therefore, ROCKS concurs with the risk assessment team that the metabolites are not considered of concern.

Residues of Concern for Monitoring (Enforcement) and Risk Assessment

Primary and Rotational Crops

The metabolism in plants is relatively limited.  In plant metabolism studies, unchanged parent accounted for >90% of the residues in grapes, beans, and potatoes and 70% of the residue in red bell peppers.  While several metabolites were quantified (most <1% TRR), only AE C656948-benzamide exceeded 10% TRR in succulent and dry beans (52-64%).

Measureable quantities of parent and metabolites (AE C656948-pyridyl-acetic acid (PAA), AE C656948-pyridyl-carboxylic acid (PCA) and AE C656948-benzamide) were also found in succulent (at full maturity) and dry beans during European field trials.  These metabolites were not measured in US field trials.

Of the major metabolites, AE C656948-benzamide, PAA and PCA result from hydrolysis of the ethylene bridge; AE C656948-benzamide is a phenyl cleavage product and PPA and PCA are pyridyl cleavage products.   AE C656948-methyl-sulfoxide results from the substitution of the chlorine atom in PCA.  None of the metabolites, or their conjugates, are expected to be more toxic than the parent fluopyram.  Furthermore, inclusion of both phenyl and pyridyl metabolites as fluopyram equivalents for either risk assessment or tolerance expression, would overestimate total exposure to fluopyram.  Parent fluopyram by itself is expected to an adequate measure of misuse in primary crops.  In addition, parent fluopyram can be measured by some of the FDA multiresidue methods (MRM) while the benzamide metabolite does not lend itself to MRM analysis.  Therefore, ROCKS recommends fluopyram only for tolerance expression.  For risk assessment, ROCKS recommends fluopyram only, except for legumes and oil seeds.  For these commodities, ROCKS recommends fluopyram + AE C656948-benzamide due to the high levels of the latter in the bean metabolism studies.

In confined rotational crop studies, parent fluopyram also accounted for the majority of residue.  However, AE C656948-7-hydroxy (up to 39% TRR, plus its conjugate (up to 16% TRR)) was found in Swiss chard at all rotation intervals, and the methylsulfoxide metabolite was predominant in wheat grain at longer rotation intervals.  The latter metabolite was detected up to 0.10 ppm in field rotational wheat trials and the AE C656948-7-hydroxy compound was found only in wheat straw at 0.10 ppm level.  AE C656948-Benzamide (up to 39% TRR) was also present in Swiss chard.  Since the AE C656948-7-hydroxy and the benzamide were not significant residues in the field rotational studies, the ROCKS recommends that the residue of concern be parent only.  Although the methyl sulfoxide was found in wheat grain at higher levels than parent in the EU rotational field studies, there will be target uses of fluopyram on grains in the US that will drive risks from those crops.

International Harmonization

The EU and PMRA are in agreement with ROCKS’ recommended inclusion of fluopyram only for tolerance expression in primary and rotational crops.  The US and PMRA are in agreement to include fluopyram only for risk assessment, except for legumes and oil seeds, which include parent fluopyram + AE C656948-benzamide.  The EU recommends inclusion of fluopyram + AE C656948-benzamide + AE C656948-7-hydroxy + AE C656948-7-hydroxy conjugates, AE C656948-7-OH-GA and AE C656948-8-OH-GA, for risk assessment.  AE C656948-7-OH-GA and AE C656948-8-OH-GA are glucosylated conjugates of AE C656948-7-hydroxy.  At this meeting, the EU explained that they tend to include all quantifiable residues in dietary risk assessment, as opposed to US policy of including only those compounds which pose potential risk greater to or equal the parent chemical.  ROCKS determined these additional metabolites were not of concern.  The additional metabolites are not expected to be more toxic than the parent compound.  DEREK for Windows analysis of fluopyram, AE C656948-benzamide, AE C656948-7-hydroxy, and AE C656948 E- and Z-olefines did not indicate any alerts.  However, the lack of alerts for fluopyram indicates that DEREK may be of limited use for this chemical.  There are minimal toxicity concerns for the conjugates as these are likely to be more soluble in water, which would enhance in vivo clearance.  The residue levels of these metabolites are low relative to the parent fluopyram.

Refer to Table 2 for a comparison of residues of concern between the US, PMRA, and the EU recommended residues of concern.

Livestock Commodities

The metabolism in livestock is more extensive than was found in plant studies.  The major residues identified at varying sampling intervals include parent, AE C656948-benzamide, AE C656948-7-hydroxy, and AE C656948 E- and Z-olefines.  In the egg and poultry metabolism studies, AE C656948-benzamide (up to 99% TRR) accounted for the majority of residue in egg, muscle, fat, and liver.  Parent fluopyram (18%) was found in eggs and AE C656948 -olefines (14%) in the liver.  Similarly in the goat, AE C656948-benzamide accounted for the majority of residue (up to 99% TRR) in milk, muscle, fat, liver, and kidney.  Fluopyram (46%), AE C656948-7-hydroxy (22%), and AE C656948 -olefines (33%) were found at lower levels in milk, muscle, and fat.  The phenyl metabolite, AE C656948-benzamide, was a major metabolite in both plant and livestock metabolism studies.  However, the pyridyl metabolites, AE C656948-pyridyl-acetic acid (PAA) and AE C656948-pyridyl-carboxylic acid (PCA), were not present in the livestock studies.  While the fate of the pyridyl portion of the molecule is unknown, ROCKS determined tolerance expression and risk assessment decisions could be made without fully elucidating the livestock metabolic pathway.  Calculating the benzamide residues in terms of parent equivalents would likely account for the unknown pyridyl metabolites.  Feeding studies confirmed the rapid transformation of parent fluopyram; AE C656948-benzamide was the only major residue in edible poultry matrices while fluopyram, AE C656948-benzamide and AE C656948 -olefines were measured in the milk and meat of dairy cattle.  In the cattle study, the levels of benzamide metabolite were significantly higher than the parent in many samples.

Therefore, ROCKS recommends fluopyram + AE C656948-benzamide for tolerance enforcement in ruminant and poultry commodities; fluopyram + AE C656948-benzamide + AE C656948-7-hydroxy fluopyram + AE C656948 E- and Z-olefines for risk assessments in ruminant commodities; and fluopyram + AE C656948-benzamide + AE C656948 E- and Z-olefines for risk assessment in poultry.

EU/Canada

The US, EU, and Canada are in agreement on parent fluopyram + AE C656948-benzamide for purposes of tolerance enforcement in livestock.  The US, EU, and Canada are also in agreement regarding which compounds to include for risk assessment of poultry commodities.  However, consistent with their decisions for plants, the EU has proposed the inclusion of the conjugated metabolites, AE C656948-7-OH-GA and AE C656948-8-OH-GA, for risk assessments in ruminants.

Attachments:  Chemical Names and Structures

Attachment 1 – Plant and Livestock Metabolites and Degradates

Attachment 2 – Drinking Water Degradates

Table 2.  Summary of Metabolites and Degradates to be included in the Risk Assessment and Tolerance Expressions.

Matrix	US	EU	Canada

	RA	TOL	RA	TOL	RA	TOL

Plants	Primary Crop	Fluopyram

(Fluopyram + benzamide for legumes and oil seed crops)	Fluopyram Fluopyram + benzamide (M25) + 7-OH-fluopyram (M08) + 7-OH-Glc (M11) + 7-OH-Glc-MA(M12)	Fluopyram	Fluopyram +

(Fluopyram + benzamide for legumes and oil seed crops)	Fluopyram

	Rotational Crop	Fluopyram

(Fluopyram + benzamide for legumes and oil seed crops)	Fluopyram Fluopyram + benzamide (M25) + 7-OH-fluopyram (M08) + 7-OH-Glc (M11) + 7-OH-Glc-MA(M12)	Fluopyram	Fluopyram

(Fluopyram + benzamide for legumes and oil seed crops)	Fluopyram

Livestock	Ruminant	Fluopyram + benzamide + 7-OH-fluopyram + olefins (E, Z)	Fluopyram + benzamide	Fluopyram + benzamide + 7-OH-fluopyram (M08)+ olefins (E, Z) + 7-OH-CA(M09) + 7-OH-GA (M20b)	Fluopyram + benzamide Fluopyram + benzamide + 7-OH-fluopyram + olefins (E, Z)	Fluopyram + benzamide

	Poultry	Fluopyram + benzamide + olefins (E, Z)	Fluopyram + benzamide Fluopyram + benzamide + olefins (E, Z) 	Fluopyram + benzamide	Fluopyram + benzamide +  olefins (E, Z)	Fluopyram + benzamide

Drinking Water	Fluopyram	Not Applicable	Not Applicable	Not Applicable Not Applicable	Not Applicable

lAttachment 1:  Plant and Livestock Metabolites and Degradates

AE C656948-8-OH-GA; M20

AE C656948-di-OH-GA; M21

AE C656948-benzamide; AE F148815; BCS-AA10014; M25

AE C656948-hydroxyethyl-di-glc; M36

AE C656948-hydroxyethyl-GA; M37

AE C656948-pyridyl-acetic acid (PAA); M40

AE C656948-pyridyl-carboxylic acid (PCA); M43 3-chloro-5-(trifluoromethyl)pyridine-2-carboxylic acid

AE C656948-methyl-sulfoxide; M45	3-(methylsulfinyl)-5-(trifluoromethyl) pyridine-2-carboxylic acid

AE C656948-enol-GA; M04

 AE C656948-benzoyl-serine; M24 N-acetyl-O-[2-(trifluoromethyl)benzoyl]-serine

AE C656948-benzamide-N,O-GA; M32 1-O-{[2-(trifluoromethyl)-benzoyl]amino}-beta-D-glucopyranuronic acid

AE C656948-ethyl-diol; M38	1-[3-chloro-5-(trifluoromethyl)pyridin-2-yl] ethane-1,2-diol

AE C656948-hydroxy-PAA; M41 [3-chloro-5-(trifluoromethyl)pyridin-2-yl](hydroxy)acetic acid

AE C656948-pyridyl-methyl-cystein; M44 N-acetyl-S-{[3-chloro-5-(trifluoromethyl) pyridin-2-yl]methyl}cysteine

      Attachment 2:  Fluopyram and Its Major Environmental Degradates.

Code Name/ Synonym	Chemical Name	Chemical Structure

PARENT

fluopyram; AE C656948

	CAS: N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl )benzamide

CAS-no:

Formula: C17H17ClF4N4O5S

MW: 500.86 g/mol

METABOLITES

AE C656948-7-hydroxy; BCS-AA10065; M08

	N-{2-[3-chloro-5-(trifluoromethyl)pyridin-2-yl]-2-hydroxyethyl}-2-(trif luoromethyl)benzamide

Formula: C16H11ClF6N2O2

 Lactame 2,9-bis(trifluromethyl)-6,7-dihydropyridol[2,3-e][2]benza-zocin-8(5H)-on e

Formula: C16H10F6N2O

AE C656948-benzamide; AE F148815; BCS-AA10014; M25 2-(trifluoromethyl)benzamide

Formula: C8H6F3NO

AE C656948-pyridyl-carboxylic acid (PCA); M43

	3-chloro-5-(trifluoromethyl)pyridine-2-carboxylic acid

Formula: C7H3ClF3NO2

AE C656948-methyl-sulfoxide; M45

	3-(methylsulfinyl)-5-(trifluoromethyl) pyridine-2-carboxylic acid

Formula: C8H6F3NO3S

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