[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Rules and Regulations]
[Pages 60162-60164]
[FR Doc No: 2021-23656]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0613; Project Identifier MCAI-2020-01431-T;
Amendment 39-21801; AD 2021-23-03]
RIN 2120-AA64

Airworthiness Directives; De Havilland Aircraft of Canada Limited
(Type Certificate Previously Held by Bombardier, Inc.) Airplanes

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

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain De Havilland Aircraft of Canada Limited Model DHC-8-400, -401,
and -402 airplanes. This AD was prompted by a report of cracking found
on a main landing gear (MLG) drag strut assembly. This AD requires a
records review to determine if an affected MLG drag strut assembly is
installed, repetitive detailed inspections for cracking of affected
strut assemblies, a one-time magnetic particle inspection for cracking,
and on-condition actions if necessary. The FAA is issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective December 6, 2021.

ADDRESSES:

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0613; 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 final rule, any comments received, and other information. The
address for Docket Operations is 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: Aziz Ahmed, Aerospace Engineer,
Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax 516-
794-5531; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued TCCA AD CF-2020-43, dated October 21,
2020 (referred to after this as the Mandatory Continuing Airworthiness
Information, or ``the MCAI''), to correct an unsafe condition for
certain De Havilland Aircraft of Canada Limited Model DHC-8-400, -401,
and -402 airplanes. You may examine the MCAI in the AD docket at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2021-0613.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain De Havilland
Aircraft of Canada Limited Model DHC-8-400, -401, and -402 airplanes.
The NPRM published in the Federal Register on August 3, 2021 (86 FR
41794). The NPRM was prompted by a report of cracking found on an MLG
drag strut assembly. The NPRM proposed to require a records review to
determine if an affected MLG drag strut assembly is installed,
repetitive detailed inspections for cracking of affected strut
assemblies, a one-time magnetic particle inspection for cracking, and
on-condition actions if necessary. The FAA is issuing this AD to
address cracking of the MLG drag strut assembly and possible failure
under compression loads during landing or ground operations, which
could result in asymmetric MLG configuration and potential runway
excursion. See the MCAI for additional background information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA has considered the comment
received. The Air Line Pilots Association, International (ALPA)
indicated its support for the NPRM.

Conclusion

    The FAA reviewed the relevant data, considered the comment
received, and determined that air safety and the public interest
require adopting this final rule as proposed, except for minor
editorial changes. The FAA has determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Costs of Compliance

    The FAA estimates that this AD will affect 34 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
               Labor cost                   Parts cost         Cost per product         Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 11 work-hours x $85 per hour = Up               $0  Up to $935................  Up to $31,790.
 to $935.
----------------------------------------------------------------------------------------------------------------

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

                                     Estimated Costs of On-Condition Actions
----------------------------------------------------------------------------------------------------------------
               Labor cost                   Parts cost         Cost per product         Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 10 work-hours x $85 per hour = Up              * $  Up to $850................  Up to $850.
 to $850.
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data that would enable the agency to provide parts cost estimates for the
  actions specified in this AD.

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

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

    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) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

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:

2021-23-03 De Havilland Aircraft of Canada Limited (Type Certificate
Previously Held by Bombardier, Inc.): Amendment 39-21801; Docket No.
FAA-2021-0613; Project Identifier MCAI-2020-01431-T.

(a) Effective Date

    This airworthiness directive (AD) is effective December 6, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to De Havilland Aircraft of Canada Limited Model
DHC-8-400, -401, and -402 airplanes, certificated in any category,
serial numbers 4001, 4003, and subsequent.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
Gear.

(e) Unsafe Condition

    This AD was prompted by a report of cracking found on a main
landing gear (MLG) drag strut assembly. The FAA is issuing this AD
to address cracking of the MLG drag strut assembly and possible
failure under compression loads during landing or ground operations,
which could result in asymmetric MLG configuration and potential
runway excursion.

(f) Compliance

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

(g) Records Review, Repetitive Inspections, and On-Condition Actions

    Within 30 days after the effective date of this AD: Review the
applicable airplane maintenance records to determine if any affected
MLG drag strut assembly identified in figure 1 to the introductory
text of paragraph (g) of this AD is installed. If any affected MLG
drag strut assembly is installed, do the actions specified in
paragraphs (g)(1) and (2) of this AD.

  Figure 1 to the Introductory Text of Paragraph (g)--Affected MLG Drag
                             Strut Assembly
------------------------------------------------------------------------
                 Part No.                            Serial No.
------------------------------------------------------------------------
46301-13..................................  MBM0056
                                            MBM0073
                                            MBM0076
                                            MBM0130
                                            MBM0136
                                            MBM0145
                                            MBM0179
                                            MBM0204
                                            MBM0208
                                            MBM0302
                                            MBM0303
                                            MBM0324
                                            MBM0405
                                            MBM0408
                                            MBM0412
                                            MBM0417
                                            MBM0423
------------------------------------------------------------------------

    (1) Within 80 flight hours after accomplishing the records
review required by paragraph (g) of this AD, do a detailed
inspection for cracking of the affected MLG drag strut assembly, and
do all applicable on-condition actions before further flight, in
accordance with a method approved by the Manager, New York ACO
Branch, FAA. Repeat the inspection thereafter at intervals not to
exceed 80 flight hours until the magnetic particle inspection
required by paragraph (g)(2) of this AD is done.
    Note 1 to paragraph (g)(1): Guidance on the inspections and on-
condition actions required by this AD can be found in Transport
Canada Civil Aviation (TCCA) AD CF-2020-43, dated October 21, 2020.
    (2) Within 1,600 flight hours or 12 months after the effective
date of this AD, whichever occurs first, perform a magnetic particle
inspection for cracks of the entire tubular section of the affected
MLG drag strut assembly, and do all on-condition actions before
further flight, in accordance with a method approved by the Manager,
New York ACO Branch, FAA. Performing the magnetic particle
inspection required by this paragraph terminates the repetitive
detailed inspections required by paragraph (g)(1) of this AD.

(h) Parts Installation Prohibition

    As of the effective date of this AD, no person may install an
affected MLG drag strut assembly identified in figure 1 to the
introductory text of paragraph (g) of this AD on any airplane unless
the inspections and applicable on-conditions specified in paragraphs
(g)(1) and (2) of this AD are done before further flight.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or De
Havilland Aircraft of Canada Limited's TCCA Design Approval
Organization (DAO). If approved by the DAO, the approval must
include the DAO-authorized signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) TCCA AD CF-2020-43, dated October 21, 2020, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2021-0613.
    (2) For more information about this AD, contact Aziz Ahmed,
Aerospace Engineer, Airframe and Propulsion Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email [email protected].
    (3) For information about TCCA AD CF-2020-43, dated October 21,
2020, contact TCCA, Transport Canada National Aircraft
Certification, 159 Cleopatra Drive, Nepean, Ontario K1A 0N5, Canada;
telephone<PHONE_NUMBER>; email [email protected]; internet https://tc.canada.ca/en/aviation. You may view this service information at
the FAA, Airworthiness Products Section, Operational Safety Branch,
2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

(k) Material Incorporated by Reference

    None.

    Issued on October 26, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-23656 Filed 10-29-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 65 (Wednesday, April 7, 2021)]
[Rules and Regulations]
[Pages 17910-17914]
[FR Doc No: 2021-07185]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0525; FRL-10020-23]

Spinosad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
spinosad in or on multiple commodities that are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective April 7, 2021. Objections and
requests for hearings must be received on or before June 7, 2021, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0525, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0525 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
June 7, 2021. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0525, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 11, 2020 (85 FR 7708) (FRL-
10005-02), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E8779) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the insecticide
spinosad, including its metabolites and degradates in or on the raw
agricultural commodities dragon fruit at 1.5 ppm; vegetable, Brassica,
head and stem, group 5-16 at 2.0 ppm; kohlrabi at 2.0 ppm; vegetable,
leafy, group 4-16 at 10.0 ppm; celtuce at 10.0 ppm; fennel, Florence,
fresh leaves and stalk at 10.0 ppm; leaf petiole vegetable subgroup 22B
at 10.0 ppm; and berry, low growing, except strawberry, subgroup 13-07H
at 0.01 ppm. The petition also requested to amend 40 CFR 180.495 by
removing the following spinosad tolerances: Brassica, head and stem,
subgroup 5A at 2.0 ppm; Brassica, leafy greens, subgroup 5B at 10 ppm;
vegetable, leafy, except Brassica, group 4 at 8 ppm; and cranberry at
0.01 ppm. That document referenced a summary of the petition prepared
by Dow AgroSciences, the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    Based upon review of the data supporting the petition, EPA is
establishing several tolerances at different levels than requested. The
reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in

support of this action. EPA has sufficient data to assess the hazards
of and to make a determination on aggregate exposure for spinosad
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
spinosad follows.
    In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and republishing the same sections is
unnecessary. EPA considers referral back to those sections as
sufficient to provide an explanation of the information EPA considered
in making its safety determination for the new rulemaking.
    EPA has previously published tolerance rulemakings for spinosad, in
which EPA concluded, based on the available information, that there is
a reasonable certainty that no harm would result from aggregate
exposure to spinosad and established tolerances for residues of that
chemical. EPA is incorporating previously published sections that
remain unchanged from those rulemakings as described further in this
rulemaking.
    Toxicological Profile. For a discussion of the Toxicological
Profile of spinosad, see Unit III.A. of the September 19, 2019
rulemaking (84 FR 49195) (FRL-9995-90).
    Toxicological Points of Departure/Levels of Concern. For a summary
of the Toxicological Points of Departure/Levels of Concern used for the
safety assessment, see Unit III.B. of the September 29, 2019
rulemaking.
    Exposure Assessment. Much of the exposure assessment remains
unchanged from the previous rulemaking, although the new exposure
assessment incorporates the additional dietary exposure from the
petitioned-for tolerances. The residue levels, percent crop treated,
and estimated drinking water concentrations used in the exposure
assessment remain the same and are discussed in Unit III.C. of the
September 29, 2019 rulemaking. Moreover, there have been no changes to
residential exposures, so the Agency's approach for assessing
residential (non-occupational, non-dietary exposures) is also discussed
in that same Unit. Finally, the Agency's conclusions about cumulative
effects remain the same as in that Unit.
    Safety Factor for Infants and Children. EPA continues to conclude
that there is reliable data showing that the safety of infants and
children would be adequately protected if the FQPA SF were reduced from
to 1X. The reasons for that decision are articulated in Unit III.D. of
the August 8, 2018 rulemaking.
    Aggregate Risks and Determination of Safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population adjusted dose
(aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate points of departure (PODs)
to ensure that an adequate margin of exposure (MOE) exists. For linear
cancer risks, EPA calculates the lifetime probability of acquiring
cancer given the estimated aggregate exposure.
    An acute analysis was not conducted as toxicological effects
attributable to a single dose were not identified. Chronic dietary
risks are below the Agency's level of concern of 100% of the cPAD:
Children 1 to 2 years old are the population subgroup with the highest
exposure estimate at 72% of the cPAD. The short-term aggregate MOE
(food, water, and residential) is 200 for children 1 to less than 2
years old and 780 for adults. These MOEs do not exceed the target level
of concern of 100. The short-term aggregate risk assessment is
protective of intermediate-term exposure as the short-term and
intermediate-term PODs are identical. EPA has also concluded that
spinosad is not expected to pose a cancer risk to humans based on the
lack of evidence of carcinogenicity in the database.
    Determination of Safety. Based on the risk assessments and
information described above, EPA concludes there is a reasonable
certainty that no harm will result to the general population, or to
infants and children, from aggregate exposure to spinosad residues.
More detailed information about the Agency's analysis can be found at
http://www.regulations.gov in the document titled ``Spinosad. Summary
of Residue Chemistry Data and Human Health Risk Assessment for the
Establishment of a Tolerance Without U.S. Registration on Tea.'' dated
March 6, 2019 in docket ID EPA-HQ-OPP-2018-0525 and the document titled
``Spinosad and Spinetoram. Human Health Risk Assessment for Proposed
Use on Dragon Fruit (Pitaya); Crop Group Expansion for Berry, Low
Growing, Except Strawberry, Subgroup 13-07H; and Crop Group Conversions
for Vegetable, Brassica, Head and Stem, Group 5-16; Brassica, Leafy
Greens, Subgroup 4-16B; Leaf Petiole Vegetable Subgroup 22B; Leafy
Greens Subgroup 4-16A; Celtuce; Fennel, Florence, Fresh Leaves and
Stalk; and Kohlrabi.'' dated February 12, 2021 in docket ID number EPA-
HQ-OPP-2019-0525.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method,
see Unit IV.A. of the September 29, 2019 rulemaking.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are no Codex MRLs established for dragon fruit, celtuce, and
fennel, Florence, fresh leaves and stalk.
    The U.S. tolerances for kohlrabi; vegetable, Brassica, head and
stem, group 5-16; and vegetable, leafy, group 4-16 are harmonized with
the Codex MRLs.
    The Codex MRL for the leaf petiole vegetable subgroup 22B is 2 ppm
while the U.S. tolerance is 8 ppm. Harmonization is not possible
because decreasing the U.S. tolerance to harmonize with the Codex MRL
would put U.S. growers at risk of having violative residues despite
legal use of the pesticide according to the label.
    The U.S. tolerance on the berry, low growing, except strawberry,
subgroup 13-07H is 0.04 ppm, and the Codex MRL is 0.02 ppm. EPA is not
harmonizing this tolerance with Codex because EPA's spinosad tolerance
is based on available residue data for the toxicologically equivalent
spinetoram, which supports the higher tolerance.

C. Revisions to Tolerances

    Based upon review of the data supporting the petition, EPA is
establishing tolerance levels consistent with Organization for Economic
Cooperation and Development (OECD) Rounding Class Practice.
    The tolerance for berry, low growing, except strawberry, subgroup
13-07H is being established at 0.04 instead of 0.01 as proposed. Due to
the toxicological equivalence and similar use patterns of spinosad and
spinetoram, EPA allows for the bridging of field trial residue data
between the two chemicals when consistent with the application rates.
The available data supports establishing the higher tolerance for this
subgroup.
    The tolerances for the leaf petiole vegetable subgroup 22B,
celtuce, and fennel, Florence, fresh leaves and stalk are being
established at 8 ppm rather than 10 ppm as proposed. This is so the
tolerance stays harmonized with Canada, which is a major export market
for these commodities.

V. Conclusion

    Therefore, tolerances are established for residues of spinosad in
or on berry, low growing, except strawberry, subgroup 13-07H at 0.04
ppm; celtuce at 8 ppm; dragon fruit at 1.5 ppm; fennel, Florence, fresh
leaves and stalk at 8 ppm; kohlrabi at 2 ppm; leaf petiole vegetable
subgroup 22B at 8 ppm; vegetable, Brassica, head and stem, group 5-16
at 2 ppm; and vegetable, leafy, group 4-16 at 10 ppm.
    Additionally, the following tolerances are removed as unnecessary
due to the establishment of the above tolerances: Brassica, head and
stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; cranberry; and
vegetable, leafy, except Brassica, group 4.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances and
modifications in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 5, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.495, amend the table in paragraph (a) as follows:
0
i. Add a heading to the table;
0
ii. Add alphabetically an entry for ``Berry, low growing, except
strawberry, subgroup 13-07H'';
0
iii. Remove the entries for ``Brassica, head and stem, subgroup 5A'';
and ``Brassica, leafy greens, subgroup 5B'';
0
iv. Add alphabetically an entry for ``Celtuce'';
0
v. Remove the entry for ``Cranberry'';
0
vi. Add alphabetically entries for ``Dragon fruit''; ``Fennel,
Florence, fresh leaves and stalk''; ``Kohlrabi''; ``Leaf petiole
vegetable subgroup 22B''; and ``Vegetable, Brassica, head and stem,
group 5-16'';
0
vii. Remove the entry for ``Vegetable, leafy, except Brassica, group
4''; and
0
viii. Add alphabetically an entry for ``Vegetable, leafy, group 4-16''.
    The additions read as follows:

Sec.  180.495  Spinosad; tolerances for residue.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Berry, low growing, except strawberry, subgroup 13-07H......        0.04

                                * * * * *
Celtuce.....................................................           8

                                * * * * *
Dragon fruit................................................         1.5
Fennel, Florence, fresh leaves and stalk....................           8

                                * * * * *
Kohlrabi....................................................           2
Leaf petiole vegetable subgroup 22B.........................           8

                                * * * * *
Vegetable, Brassica, head and stem, group 5-16..............           2
Vegetable, leafy, group 4-16................................          10

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-07185 Filed 4-6-21; 8:45 am]
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