[Federal Register: December 7, 2007 (Volume 72, Number 235)]
[Rules and Regulations]
[Page 69144-69145]
[DOCID:fr07de07-5]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. CGD07-07-252]
RIN 1625-AA09

Drawbridge Operation Regulation; Atlantic Intracoastal Waterway,
Mile 1134, Key Largo, FL

AGENCY: Coast Guard, DHS.

ACTION: Temporary rule.

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SUMMARY: The Coast Guard is temporarily changing the operating
regulations governing the Jewfish Creek Bridge, Atlantic Intracoastal
Waterway mile 1134, Key Largo, Monroe County, Florida. This rule will
allow the Drawbridge to open on signal, except that from 7 a.m. until
sunset this bridge will open on the hour and half-hour. This action is
necessary for workers' safety.

DATES: This rule is effective 7 a.m. December 7, 2007 to April 30,
2008.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of the docket [Docket No. CGD07-07-252] and are
available for inspection or copying at Commander (dpb), Seventh Coast
Guard District, 909 S.E. 1st Avenue, Room 432, Miami, Florida 33131-
3028 between 8 a.m. and 4:30 p.m., Monday through Friday, except
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Mr. Michael Lieberum, Seventh Coast
Guard District, Bridge Administration Branch, telephone number 305-415-
6744.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    We did not publish a notice of proposed rulemaking (NRPM) for this
regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing an NPRM. An NPRM would be impracticable
and contrary to the public interest as a delay in the effective date
poses a risk to the construction workers and increases the risk of
traffic accidents.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective in less than 30 days after
publication in the Federal Register. The bridge owner had informed the
Coast Guard that there have been more vehicle accidents, resulting in
an increased risk to workers during normal operation of this bridge
then during the half-hour closure periods. Therefore, it is in the best
interest of safety to implement this regulation as soon as possible.

Background and Purpose

    The existing regulation of the draw requires that the Jewfish Creek
Bridge, mile 1134 at Key Largo, shall open on signal; except that, from
10 a.m. to Sunset, Thursday through Sunday and Federal holidays, the
draw need open only on the hour and half hour.
    The owner of the bridge notified the Coast Guard that there is a
noticeable difference in the vehicular delays and safety because of the
vehicles backed up due to the on-demand openings. This has created
additional accidents within the work zone and increases the potential
of serious injuries to construction workers in the work zone. For these
reasons the bridge owner has requested that the Coast Guard change the
current operation of the Jewfish Creek Bridge. The drawbridge will be
required to open twice an hour from 7 a.m. to sunset.
    In cases of emergency, the drawbridge will be opened as soon as
possible. This regulation is necessary for workers' safety.

Regulatory Evaluation

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    Although bridge openings will be restricted, vessel traffic will
still be able to transit the Atlantic Intracoastal Waterway pursuant to
the revised opening schedule.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule would affect the following entities, some of which
may be small entities: The owners or operators of vessels needing to
transit the Atlantic Intracoastal Waterway in the vicinity of the
Jewfish Creek Bridge, persons intending to drive over the bridge, and
nearby business owners. The revision to the openings schedule would not
have a significant impact on a substantial number of small entities,
although bridge openings will be restricted, vessel traffic will still
be able to transit the Atlantic Intracoastal Waterway pursuant to the
revised opening schedule.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding the rule so that they could better evaluate
its effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business

Regulatory Fairness Boards. The Ombudsman evaluates these actions
annually and rates each agency's responsiveness to small business. If
you wish to comment on actions by employees of the Coast Guard, call 1-
888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate
against small entities that question or complain about the rule or any
policy or action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not affect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and would not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD
which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have concluded that there are no factors in this case that would limit
the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (32)(e), of the Instruction, from further
environmental documentation.

List of Subjects in 33 CFR Part 117

    Bridges.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1(g); Department of
Homeland Security Delegation No. 0170.1

0
2. From 7 a.m. on December 7, 2007, through sunset on April 30, 2008,
Sec.  117.261(qq) is suspended and Sec.  117.261(uu) is added to read
as follows:

Sec.  117.261  Atlantic Intracoastal Waterway.

* * * * *
    (uu) Jewfish Creek Bridge, mile 1134, Key Largo. The draw shall
open on signal, except that from 7 a.m. to sunset, the bridge shall
open on the hour and half-hour.
* * * * *

    Dated: November 23, 2007.
William Lee,
Capt. USCG, District Commander, Seventh Coast Guard District, Acting.
[FR Doc. E7-23600 Filed 12-6-07; 8:45 am]

BILLING CODE 4910-15-P


                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                               WASHINGTON, D.C.  20460

	OFFICE OF CHEMICAL SAFETY
	AND POLLUTION PREVENTION

MEMORANDUM

DATE: 	01/23/14

SUBJECT: 	Zoxamide.  Petition for the Establishment of Permanent Tolerances for Use on Dry Onion Bulbs.  Summary of Analytical Chemistry and Residue Data.

PC Code: 101702
DP Barcode: D416653
Decision No.: 476622
Registration No.: 10163-6414
Petition No.: 3F8164
Regulatory Action: Section 3 Registration
Risk Assessment Type: NA
Case No.: NA
TXR No.: NA
CAS No.: 156052-68-5
MRID No.: 49067102
40 CFR: 180.567

FROM:	Meheret Negussie, Chemist
		Risk Assessment Branch III
		Health Effects Division (HED 7509P)

THROUGH:	Steve Funk, Senior Chemist
		Christine Olinger, Branch Chief
		Risk Assessment Branch III
		Health Effects Division (HED 7509P)

TO:		Marcel Howard/Hope Johnson, RM#21
		Fungicide Branch
		Registration Division (7505P)

Executive Summary

Zoxamide is a broad-spectrum protectant fungicide registered for use on potatoes, grapes, tomatoes, and cucurbit vegetables.

Tolerances for residues of zoxamide have been established under 40 CFR §180.567(a)(1) on  grapes at 3.0 ppm, grape raisins at 15.0 ppm, tomatoes at 2.0 ppm, and cucurbit vegetables at 1.0 ppm.  Tolerances are established under 40 CFR §180.567(a)(2) for the combined residues of zoxamide and its metabolites on potatoes at 0.06 ppm, potato flakes and chips at 0.30 ppm, and potato wet peel at 0.10 ppm.

Gowan Company (Gowan) has submitted a petition for the establishment of permanent tolerances for the residues of zoxamide [3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide and its metabolites 3,5-dichloro-4-hydromethylbenzoic acid (RH-1452) and 2,6-dichlorobenzene-1,4-dicarboxylic acid (RH-1453) in/on dry bulb onions. Section F of the current petition proposes the establishment of permanent tolerances for residues of zoxamide and its metabolites in/on:

      Dry bulb Onion (Crop Group 3, Bulb Vegetables) .........................0.7 ppm

In conjunction with this petition, Gowan is requesting amended registration of the 75% water dispersible granule (WDG) formulation of zoxamide (Gavel(R) 75DF Fungicide) (EPA Reg. No. 10163-6414), to add uses on dry bulb onions.  Gavel 75 DF agricultural fungicide is a mixture of 8.3% zoxamide and 66.7% mancozeb. Only zoxamide is evaluated in this assessment.  The product is proposed for up to eight foliar applications at 0.12 - 0.17 lb ai/A/application for a total seasonal application rate of 1.33 lb ai/A, with a preharvest interval (PHI) of 7 days.

Adequate metabolism studies on potatoes, grapes, cucumbers, and tomatoes are available.  The residue of concern for tolerance setting and risk assessment is zoxamide for grapes, grape processed commodities, tomatoes, and cucumbers.   The residue of concern for tolerance setting and risk assessment is zoxamide and its metabolites (RH-1452 and RH-1455) in/on potatoes and processed potatoes.

There are no livestock feed items associated with this petition.

Adequate analytical methods are available for enforcing zoxamide tolerances and collecting data on residues in plant commodities.  The analytical methods, gas chromatography with electron capture detection (GC/ECD) and GC with mass selective detection (GC/MSD) are available for tolerance enforcement for plant commodities as primary and confirmatory methods, respectively.  For the acid metabolites (RH-1452 and RH-1455), the GC/MSD is the primary method and the GC/ECD method is the confirmatory method.

The methods have been adequately validated for the determination of residues of zoxamide in plant commodities.

Samples from the submitted crop field trials were analyzed for residues of zoxamide and its metabolites using an acceptable GC/MSD method.  The method was adequately validated prior to and/or in conjunction with the analysis of the field trial samples. The validated limit of quantitation (LOQ) was 0.02 ppm for each analyte in dry bulb onion.

Adequate multiresidue methods testing data have been submitted.  The data indicate that the multiresidue methods are adequate for enforcement of tolerances for zoxamide only.

Adequate storage stability data are available to support storage conditions and intervals of samples from the onion bulb crop field trials.

The submitted crop field trial data for dry onion bulb reflect the proposed use pattern and are acceptable.  The submitted data will support the proposed tolerances for dry onion bulb of 0.7 ppm.  Using the Organization of Economic Cooperation and Development (OECD) statistical calculation procedure, the recommended tolerance for onion bulb is 0.7 ppm, which is the same as the proposed tolerance.  HED recommends submitting a revised Section F to propose a tolerance on onion, bulb, subgroup 3-07A.

The nature of the residue in rotational crops is understood based on adequate confined rotational crop studies.  HED has concluded that the residues of concern for rotational crops for risk assessment and tolerance setting purposes are the parent compound, and its metabolites RH-1455 and RH-1452.  The available data support the 30-day plant-back interval (PBI) specified on the label for rotated crops without primary uses of zoxamide.

There are no Codex or Canadian maximum residue limits (MRLs) established for residues of zoxamide in/on onion bulbs.  The US tolerance and Canadian MRL expressions are the same. The US and Canadian residue definitions include zoxamide for grapes and processed grapes and zoxamide and its metabolites for potatoes and processed potatoes.  The US and Codex residue definitions are not in harmony.  The Codex residue definition includes only zoxamide for all crops.  An International Residue Limit Status sheet is attached (Attachment II)

Regulatory Recommendations and Residue Chemistry Deficiencies

HED has examined the residue chemistry database for zoxamide.  Pending submission of revised Sections B and F and submittal of analytical standard, there are no residue chemistry issues that would preclude granting registration for the requested uses of zoxamide on dry bulb onion or establishment of the following tolerances for combined residues of zoxamide and its metabolites:
40 CFR §180.567 (a) (2):

            Onion, bulb, subgroup 3-07A	0.7 ppm

A human health risk assessment is forthcoming.

Note to PM:  According to HED's Interim Guidance on Tolerance Expressions (5/27/09, S. Knizner), the tolerance expressions for zoxamide should be revised as follow:

Under 40 CFR §180.567(a) (1):  "Tolerances are established for residues of zoxamide including is metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide).

Under 40 CFR §180.567 (a) (2):  "Tolerances are established for residues of zoxamide including is metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only the sum of zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated as the stoichiometric equivalent of zoxamide.

860.1200  Directions for Use

   * The proposed use directions for onions (dry bulb), garlic, and shallots should be revised to onions (dry bulb), garlic, and shallot bulbs.

860.1550 Proposed Tolerances

   * The proposed tolerance of 0.70 ppm for "Dry bulb Onion (Crop Group 3, Bulb Vegetables)" should be revised to Onion, bulb, subgroup 3-07A at 0.7 ppm.

860.1650 Submittal of Analytical Reference Standards

   * The analytical reference standard for zoxamide is depleted.  A 5g standard needs to be supplied to the repository.

Background

The chemical names and structures of zoxamide and the acid metabolites RH-1452 and RH-1455 are presented in Table 1. The physicochemical properties of the technical grade of zoxamide are presented in Table 2.

Table  1.	Zoxamide Nomenclature.
Chemical structure
--------------------------------------------------------------------------------

Common name
Zoxamide
Company experimental name
RH-7281
IUPAC name
(RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide
Molecular weight
336.64 g/mol
CAS name
3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide
CAS registry number
156052-68-5
End-use product (EP)
Gavel(R) 75DF Fungicide (EPA Reg. No. 10163-6414) (This product is a combination of zoxamide + mancozeb. Only zoxamide residues have been determined.)
Chemical structure

Common name
RH-141452
Company experimental name
RH-1452
Chemical name
3,5-dichloro-4-hydromethylbenzoic acid
Molecular weight
221.04 g/mol
CAS Name
Not available
Chemical structure

Common name
RH-141455
Company experimental name
RH-1455
Chemical name
2,6-dichlorobenzene-1,4-dicarboxylic acid
Molecular weight
235.02 g/mol
CAS Name
Not available

Table  2.	Physicochemical Properties of Zoxamide.
                                   Parameter
                                     Value
                                   Reference
Melting point/range
159.5 - 160.5 °C (98.8% purity)
MRID 49067102
pH

Density
Relative Density 1.38 at 20 °C

Water solubility (at 20°C)
0.681 +- 0.017 mg/L

Solvent solubility (at 20°C)
Ethyl acetate: 20.0 g/L
Acetone: 55.7 g/L
Xylene: 1.56 g/L
n-Octanol: 6.49 g/L
n-Heptane: 0.038 g/L
1,2-Dichloroethane: 12.5 g/L

Vapor pressure (at 25, 35, and 45°C)
<1.3 x 10[-5] Pa

Dissociation constant, pKa
Not measurable by spectrophotometry, titration or conductivity.  Absorbance did not change in acidic, neutral, or basic conditions; Solubility was too low for titration; with decrease in concentration, no increase in reading was observed.

Octanol/water partition coefficient, KOW
Log Kow 3.76 +- 0.04 at ambient temp

UV/visible absorption spectrum
212 nm. ε = 46330

860.1200  Directions for Use

Gowan has submitted proposed use directions (Section B) for the 75% water dispersible granule (WG) formulation of zoxamide (Gavel(R) 75DF Fungicide) (EPA Reg. No. 10163-6414) on  dry bulb onions. Gavel 75 DF agricultural fungicide is a mixture of 8.3% zoxamide and 66.7% mancozeb.

The proposed use directions for onion bulb are presented in Table 3.

Table  3.	Summary of Directions for Use of Zoxamide
Applic. Timing, Type, and Equip.
                                Formulation[1]
                                [EPA Reg. No.]
                                 Applic. Rate
                                   (lb ai/A)
                          Max. No. Applic. per Season
                          Max. Seasonal Applic. Rate
                                   (lb ai/A)
                                    PHI[1]
                                    (days)
                       Use Directions and Limitations[2]
                    Onions (dry bulb), garlic, and shallots
Broadcast, Foliar,
Ground, aerial, or chemigation
                     (Gavel(R) 75DF Fungicide [10163-6414]
                                   0.12-0.17

                                  1.5 to 2.0
                                   (product)
                                       8
                                     1.33
                                       7
Follow a protective spray schedule starting when diseases are first reported in the area and repeat at 7-day intervals throughout the season.
Do not allow spray or drift to contact bulbs after lifting from soil.
Do not apply to exposed bulb.
[1] PHI = Pre-harvest interval

For ground applications on potatoes, cucurbits, tomatoes, and dry bulb onions, the label recommends a spray volume of 2-3 gal/A; and 5 gal for vineyards.  The label specifies application in a minimum of 2 gallons of water per acre (GPA) using aerial equipment; in the state of CA a minimum of 5 GPA should be used.  Chemigation applications are to be made through sprinkler-type irrigation systems only.  The label recommends using agricultural surfactants and that zoxamide can be tank mixed with other registered fungicides.  The following crop restrictions appear on the registered label:  0-day PBI for any crop listed on the label and 30-day PBI for all other crops.

Note:  The Section B/label must be revised to indicate use on onions (dry bulb), garlic, and shallot, bulbs.

Conclusions.  The submitted use directions are adequate to allow evaluation of the residue data relative to the proposed use.  The submitted field trial data for onion bulb reflect the maximum proposed use rates, the minimum retreatment intervals (RTIs), and the proposed PHIs.

860.1300 Nature of the Residue - Plants

Residue Chemistry Memo DP# 237892, 1/10/2001, A. Acierto
Residue Chemistry Memo DP#s 266181, D268774, 4/02/2001, A. Acierto

Adequate metabolism studies on potatoes, grapes, cucumbers, and tomatoes are available.

The HED's Metabolism Assessment Review Committee (MARC) has determined that the residue of concern for tolerance setting and risk assessment is zoxamide for grapes and grape processed commodities and is zoxamide and its metabolites (RH-1452 and RH-1455) in/on potatoes (Memo, A.M. Acierto & W.D. Wassell, 12/18/2000, D270797).

The data concerning the metabolism of zoxamide in/on tomatoes and cucumbers were not presented to the MARC and HED had concluded the residue of concern in tomatoes and cucurbit vegetables for tolerances and risk assessment is zoxamide.

The nature of the residue of zoxamide on bulb onions is understood based on available metabolism studies.

860.1300 Nature of the Residue - Livestock

Residue Chemistry Memo DP# D277097, 12/18/2000, A. Acierto
Residue Chemistry Memo DP# 237892, 1/10/2001, W. Wassell, A. Acierto

An acceptable metabolism study on goats is available.  The MARC did not determine the residue of concern in ruminants since HED has concluded that livestock tolerances are not needed at this time.

HED has concluded that tolerances for secondary residues in milk and ruminant tissues are not required at this time and the uses can be considered category 3 of 40 CFR §180.6(a).  It is not possible to determine with certainty whether finite residues will be incurred, but there is no reasonable expectation of finite residues in milk and ruminant tissues.

Poultry:

A poultry metabolism study has not been submitted.  There are no poultry feed items associated with the registered/proposed uses of zoxamide.  Therefore, a poultry metabolism study is not required.  However, if any crops which have poultry feed items are added in the future, then a poultry metabolism study will be required.

860.1340 Residue Analytical Methods

Residue Chemistry Memo DP# 237892, 1/10/2001, A. Acierto
Residue Chemistry Memo DP#s 266181, D268774, 4/02/2001, A. Acierto

Plant commodity methods

Enforcement method: A gas chromatography using electron capture detection (GC/ECD) as the primary method and a GC with mass selective detection (GC/MSD) as the confirmatory method are available for tolerance enforcement for plant commodities.

Adequate method validation, radiovalidation, and independent method validation has been submitted for the primary and confirmatory methods.

For the two acid metabolites, RH-1452 and RH-1455, in/on potato tubers and potato processed fractions, the GC/MSD method is proposed as the primary method and the GC/ECD method as the confirmatory method.

The GC/ECD and GC/MSD methods were validated by the Analytical Chemistry Branch
(ACB)/Biological and Economic Analysis Division (BEAD).  After validation by ACB, the enforcement methods were forwarded to FDA. (DP# D284394, D284396, D284398, and
D28400).

 Data collection methods:  Samples of dry bulb onions from the submitted crop field trials were  analyzed for residues of zoxamide and its two acid metabolites (RH-1452 and RH-1455) using an acceptable GC/MSD method.  The method was adequately validated prior to and/or in conjunction with the analysis of the field trial.  The validated LOQs were 0.02 ppm for each analyte.

Briefly, residues in homogenized samples were extracted with acetonitrile (ACN): 2% sodium carbonate (80:20, v:v) and filtered.  The filtrates are combined and concentrated.  Residues in the concentrated extract are partitioned with 2% sodium carbonate solution and ethyl acetate (16:15, v:v).  The aqueous layer containing the sodium salts of RH-1452 and RH-1455 was re-partitioned with ethyl acetate.  The organic layers were combined and concentrated to dryness.  Residues were re-dissolved in hexane, sonicated, then subjected to Florisil solid phase extraction (SPE).  Residues of zoxamide were eluted with hexane:ethyl acetate (80:20, v:v), concentrated to dryness, and re-dissolved in hexane for further purification by Alumina-B SPE.  Zoxamide residues were eluted with hexane:ethyl acetate (80:20, v:v), concentrated to dryness, re-dissolved in ethyl acetate, and sonicated for analysis by GC/MSD.

For the aqueous layer, following liquid-liquid partitioning and after adjusting the pH to <=1, residues were partitioned with ethyl acetate.  The aqueous layer was re-partitioned with ethyl acetate; the remaining aqueous layer was discarded, and the organic layers were combined with sodium sulfate.  The solution was decanted, concentrated to dryness, re-dissolved in ethyl acetate, sonicated, and ethyl ether was added.  Residues of RH-1452 and RH-1455 were methylated with diazomethane.  The acid metabolites were esterified.  The methylated residues of RH-1452 (RH-7391) and RH-1455 (RH-7399) are concentrated to dryness and re-dissolved in hexane for further purification by Florisil column chromatography.  Residues were eluted with ethyl acetate, concentrated to dryness, and re-dissolved in ethyl acetate for analysis.  Residues of RH-7391 and RH-7399, methylated residue of the acid metabolites, were quantitated by GC/MSD.

Livestock commodity methods

The petitioner is not proposing tolerances for zoxamide residues in milk, eggs, and animal tissues.  Consequently, attempts to develop residue analytical methods for animal commodities were not pursued.  HED has concluded that, based on the proposed uses, residue analytical methods for animal commodities are not required for this petition.

Conclusions.  The residue analytical methods for plants are adequate.  Acceptable methods are available for tolerance enforcement purposes for the residues of concern in/on plant commodities, and samples of dry bulb onions from the submitted crop field trials were analyzed for residues of zoxamide and its metabolites using an acceptable data collection method.

860.1360 Multiresidue Methods

Residue Chemistry Memo DP# 237892, 1/10/2001, A. Acierto

The petitioner has previously submitted data pertaining to the multiresidue methods testing of zoxamide and its metabolites (RH-1452 and RH-1455) in conjunction with PP#9F05058.  The
multiresidue methods data indicate that zoxamide was successfully recovered using Protocols D and E, while none of the protocols successfully recovered either of the metabolites. The MRMs are adequate for enforcement of zoxamide tolerances. The submission has been forwarded to FDA for complete evaluation in conjunction with the earlier petition (D255783, N. Dodd, 7/20/99).

860.1380 Storage Stability

Residue Chemistry Memo DP# 237892, 1/10/2001, A. Acierto

Based upon available data, residues of zoxamide in/on potatoes are stable during frozen storage for a period of 11.3 months.  Based on the results of a successful radiovalidation study, residues of the acid metabolites in/on potato, tubers are stable under frozen storage conditions for up to 29 months.  Potato crop field trial samples were stored frozen for a period of 12 to 23 months prior to analysis and potato processed commodities were stored frozen for a period of 12 months prior to analysis.  Previously, adjustment of the potato processing data for storage degradation prior to analysis was not required.

The storage durations and conditions of samples from the submitted crop field trials are presented in Table 4.

            Table  4.	Summary of Storage Conditions and Durations of Samples from Crop Field Trial and Processing Studies.
Matrix
                                    Storage
                                  Temperature
                                     (°C)
                            Actual Storage Duration
                  Interval of Demonstrated Storage Stability
Dry bulb onions
~-25-10
40-343 days ( 1.3-11.4 months)
Residues of zoxamide are stable during frozen storage in/on potatoes for up to 11.3 months and its metabolites are stable up to 29 months.

Conclusions.  The available storage stability data for zoxamide on potatoes are adequate to support the storage durations and conditions of samples of dry bulb onion raw agricultural commodities from the submitted crop field trials.

860.1400 Water, Fish, and Irrigated Crops

This guideline requirement is not relevant to the current petitions as there are no aquatic uses currently proposed for zoxamide.

860.1460 Food Handling

This guideline requirement is not relevant to the current petitions as there are no food handling uses being proposed for zoxamide.

860.1480 Meat, Milk, Poultry, and Eggs

There are no livestock feedstuffs associated with the proposed use of zoxamide on onion bulbs.

860.1500 Crop Field Trials

DER References:	49067102.der.doc

Table  6.	Summary of Residue Data from Dry Bulb Onion Crop Field Trials with Zoxamide.
Commodity
                                    Analyte
                                  Total Rate
                                    lb ai/A
                                  (kg ai/ha)
                                      PHI
                                    (days)
                            Residue Levels (ppm)[1]

                                       n
                                  Sample Min.
                                  Sample Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                   Std. Dev.
Dry bulb onion
                                   Zoxamide
                                   1.32-1.34
                                  (1.48-1.51)
                                      6-7
                                      12
                                   <0.02
                                     0.443
                                   <0.020
                                     0.435
                                     0.172
                                     0.163
                                     0.115

                                    RH-1455

                                      12
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                     0.02
                                     0.02
                                      N/A

                                    RH-1452

                                      12
                                   <0.02
                                     0.053
                                   <0.02
                                     0.049
                                     0.023
                                     0.028
                                     0.010

                                   Combined

                                      12
                                   <0.062
                                   <0.483
                                   <0.063
                                   <0.475
                                     0.221
                                     0.211
                                     0.113
[1]  Except for sample min/max, values reflect per trial averages; n = no. of field trials.
[2]  LAFT = lowest average field trial; HAFT = highest average field trial.

Onion bulb

Gowan has submitted field trial data for zoxamide on dry bulb onion.  Twelve field trials were conducted in the United States and Canada during the 2011 and 2012 growing seasons in the North American Free Trade Agreement (NAFTA) Growing Zones 1 (NY; 1 trial), 5 (ON; 2 trials and MI, WI, and IA; 1 trial each), 6 (TX; 1 trial), 8 (KS; 1 trial), 10 (CA; 2 trials), 11 (ID; 1 trial), and 12 (OR; 1 trial).

Each trial consisted of one untreated plot and one treated plot.  At each trial location, the treated plot received eight foliar broadcast applications of a 75% water dispersible granule (WG) formulation of zoxamide (Gavel(R) 75DF Fungicide) at 0.160-0.174 lb ai/A/application (0.179-0.195 kg ai/ha/application) for a total seasonal rate of 1.32-1.34 lb ai/A (1.48-1.51 kg ai/ha).  Applications were made at 6- to 8-day retreatment intervals (RTIs).  Applications were made using ground equipment in spray volumes of 15-39 gal/A (140-365 L/ha).  A nonionic surfactant (NIS) was added to the spray mixtures at all trial sites.  Samples of dry bulb onions were harvested at a 6- to 7-day preharvest interval (PHI).  Additional dry bulb onion samples were harvested from one trial (MI; TCI-11-319-04) at PHIs of 0, 3, 10, and 14 days to assess residue decline.

Samples were analyzed for residues of zoxamide and its acid metabolites RH-1452 and RH-1455 using a gas chromatography method with mass selective detection (GC/MSD), entitled "Tolerance Enforcement Method for Parent RH-7281 and its Two Acid Metabolites, RH-1452 and RH-1455, in Potato Peel Waste," dated June 1, 2000, with Morse Laboratories method modifications dated June 25, 2012.  The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.02 ppm for each analyte in dry bulb onion.  The method was adequate for data collection based on acceptable method validation and concurrent recovery data.  The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels.  Quantifiable residues of RH-1455 and RH-1452 were converted to parent equivalents by the petitioner using molecular weight conversion factors of 1.43 for RH-1455 and 1.52 for RH-1452.

Dry bulb onion samples were stored frozen (frozen at the field sites and -25 to -10 °C at the analytical laboratory) from collection to analysis for 40-343 days (1.3-11.4 months).  Samples were analyzed within 0-9 days of extraction.  Adequate storage stability data are available to support the storage durations and conditions of samples from the submitted field trials.

Following eight foliar broadcast applications of the 75% WG formulation of zoxamide at 1.32-1.34 lb ai/A, residues (and per trial averages) of zoxamide, RH-1452, and combined residues, respectively, in/on bulb onions harvested at a 6- to 7-day PHI were <0.02-0.443 (<0.020-0.435), <0.02-0.053 (<0.02-0.049), and <0.062-<0.483 (<0.063-<0.475) ppm; residues of RH-1455 were <LOQ (0.02 ppm) in/on all samples of dry bulb onion.

In the residue decline trial, average residues of zoxamide were 0.333, 0.339, 0.264, 0.293, and 0.167 ppm at the 0-, 3-, 7-, 10-, and 14-day PHIs, respectively, indicating an overall decline in residues with increasing PHIs.  Average residues of RH-1452 as parent equivalents were 0.0266, 0.0309, 0.0263, <0.0260, and 0.0266 ppm at the 0-, 3-, 7-, 10-, and 14-day PHIs, respectively, indicating that residues were fairly stable over the sampling period.  Residues of RH-1455 were <LOQ in/on all samples; therefore, residue decline could not be assessed.  Average combined residues were <0.379, <0.390, <0.310, <0.338, and <0.213 ppm at the 0-, 3-, 7-, 10-, and 14-day PHIs, respectively, indicating a general overall decline in residues with increasing PHIs.

Conclusions.  Provided the directions for use and the proposed tolerances are revised, the submitted onion bulb field trial studies are acceptable and reflect the proposed use patterns.  Samples were analyzed for residues of zoxamide and it is metabolites using acceptable methods, and the studies are supported by adequate storage stability data.
The average field trial values for bulb onions were entered into the OECD spreadsheet to determine an appropriate tolerance level.  Refer to Appendix I for the tolerance calculations.  The OECD tolerance calculation procedure recommends a tolerance of 0.7 ppm for dry bulb onions.  The recommended tolerance level is the same as proposed by the petitioner.  HED recommends submitting a revised Section F to propose a tolerance on onion, bulb, subgroup 3-07A.

860.1520 Processed Food and Feed

HED does not require residue data for any processed commodities associated with dry onion bulbs.  Therefore, data requirements for processed food and feed are not relevant to this tolerance petition.

860.1650 Submittal of Analytical Reference Standards

The analytical reference standard for zoxamide is depleted.  A 5g standard needs to be supplied to the repository.  Metabolites of zoxamide are currently available in the EPA National Pesticide Standards Repository (personal communication with Theresa Cole, ACB, 12/12/13), with expiration dates of 03/01/2015 (RH-12452) and 02/07/2015 (RH-1455).

The new standard should be sent to the Analytical Chemistry Lab (located at Fort Meade), to the attention of Theresa Cole, at the following address:

	USEPA
	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP
	701 Mapes Road
	Fort George G. Meade, MD  20755-5350

(Please note that the mail will be returned if the extended zip code is not used.)

860.1850 Confined Accumulation in Rotational Crops

Residue Chemistry Memo DP# 237892, 1/10/2001, A. Acierto
Residue Chemistry Memo DP#s 266181, D268774, 4/02/20013, A. Acierto

Acceptable confined rotational crop studies were reviewed in conjunction with PP#9F05058 on representative crops of mustard greens (leafy vegetable), radishes and turnips (root vegetables), sorghum and wheat (cereal grains) and soybeans (legume/oil seed).

The parent compound was not identified in any rotational crop commodity at any plantback interval.  The metabolite RH-1452 was tentatively identified at <1-7% of TRR (ND-0.011 ppm) except in 30-day PBI soybean forage where it accounted for 25% of TRR (0.023 ppm).  Based on the results of the reviewed confined rotational crop study, it was concluded that there is no indication that zoxamide would be detected in rotational crops planted more than 30 days after the application of zoxamide.

A 30-day plant-back interval (PBI) specified on the label for rotated crops without primary uses of zoxamide is adequate.

860.1900 Field Accumulation in Rotational Crops

Residue Chemistry Memo DP# 237892, 1/10/2001, A. Acierto
Residue Chemistry Memo DP#s 266181, D268774, 4/02/2001, A. Acierto

Based on the results of the reviewed confined rotational crop study and the data requirements specified in OPPTS 860.1850, field accumulation studies are not required.

860.1550 Proposed Tolerances

Tolerances for residues of zoxamide have been established under 40 CFR §180.567(a)(1) on  grapes at 3.0 ppm, grape raisins at 15.0 ppm, tomatoes at 2.0 ppm, and cucurbit vegetables at 1.0 ppm.  Tolerances are established under 40 CFR §180.567(a)(2) for the combined residues of zoxamide and its metabolites on potatoes at 0.06 ppm, potato flakes and chips at 0.30 ppm, and potato wet peel at 0.10 ppm.

The OECD tolerance calculation procedure was utilized in determining appropriate tolerance levels for dry bulb onions.  Based on the tolerance spreadsheet, the proposed tolerance of 0.7 ppm for dry bulb onion is appropriate.  The tolerance proposed by Gowan is listed in Table 10, along with the tolerance levels and revised commodity definitions recommended by HED.

Pending submission of revised sections B and F, and submittal of analytical standard, adequate field trial data reflecting the proposed use patterns are available for purposes of establishing tolerances on dry bulb onions.

Note to PM:  According to HED's Interim Guidance on Tolerance Expressions (5/27/09, S. Knizner), the tolerance expressions for zoxamide should be revised as follow:

Under 40 CFR §180.567(a) (1):  "Tolerances are established for residues of zoxamide including is metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide).

Under 40 CFR §180.567 (a) (2):  "Tolerances are established for residues of zoxamide including is metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only the sum of zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated as the stoichiometric equivalent of zoxamide.

Table 10. 	Tolerance Summary for zoxamide.
Commodity
                                Tolerance (ppm)
Comments; Correct Commodity Definition

                                   Proposed
                                  Recommended

40 CFR §180.609(a)(2)
Onion, bulb
                                      0.7
                                      0.7
                          Onion, bulb, subgroup 3-07A

References
DP#:	277097
Subject:	PP#9F05058; Zoxamide in/on Potato and Grapes.  Conclusions of the 11/14/2000 Meeting of the Metabolism Assessment Review Committee.
From:	A. Acierto
To:	G. Kramer
Dated:	12/18/2000

DP#s:	237892
Subject:	 PP#9F05058.  Zoxamide in/on Grapes and Potatoes.  Review of Analytical Methods and Residue Data.  First Food Use Review.
From:	A. Acierto
To:	Rose Kearns/Cynthia Giles-Parker
Dated:	1/10/2001

DP#s:	266181 and 268774
Subject:	PP#0F06093.  Zoxamide in/onTomatoes and Cucurbits.  Review of Analytical Methods and Residue Data.
From:	A. Acierto
To:	Rose Kearns/Cynthia Giles-Parker
Dated:	4/2/2001
MRIDs:	45012103 to  45012118

DP#:	276323
Subject:	 PP# 9F05058. ID#<PHONE_NUMBER>1 & ID#<PHONE_NUMBER>2: Zoxamide in/on Grapes and Potatoes.
From:	A. Acierto
To:	Rose Kearns/Cynthia Giles-Parker
Dated:	5/10/2003
MRIDs:	45437802, 45499801, 45461402, and 45461403

Attachments:
International Residue Limit Status sheet
Appendix I - Tolerance Assessment Calculations

Template Version April 2008

International Residue Limits

                     Zoxamide (PC Code 101702; 12/04/2013)
Summary of US and International Tolerances and Maximum Residue Limits
Residue Definition:
US
Canada
Mexico[2]
Codex[3]
40 CFR 180. 567 (a)General

(1) 3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-
oxopropyl)-4-methylbenzamide
 (2) combined residues of zoxamide and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452)
Grapes and raisins: 3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-
oxopropyl)-4-methylbenzamide

Potatoes, potato processed fractions (chips, flakes and granules):
3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-
oxopropyl)-4-methylbenzamide, including the
metabolites 3,5-dichloro-1,4-benzene-dicarboxylic
acid and 3,5-dichloro-4-hydroxymethyl
benzoic acid

Zoxamide
Commodity[1]
Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US
Canada
Mexico[2]
Codex[3]
Onion, bulb, subgroup 3-07A
0.7

Completed:  M. Negussie; 12/04/2013
[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains.  PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.

Appendix I.  Tolerance Assessment Calculations.

The OECD statistical calculation procedure was used for calculating recommended tolerance on onion bulb.  As specified in the OECD document, the average residue value from each field trial was used.

Onion Bulb

The dataset used to establish tolerances for zoxamide and its metabolites consisted of field trial data representing application rates of 1.32-1.34 lb ai/A (8 applications at 0.16-0.17 lb ai/A/application) with a 6- to 8-day PHI.  The field trials reflect the proposed application rate and samples were collected at the proposed pre-harvest intervals.  The residue values entered into the tolerance spreadsheet are provided in Table I-1.

Using the OECD statistical calculation procedure the recommended tolerance for onion bulb is 0.7 ppm.

Table I-1.	Residue data used to calculate tolerances for zoxamide on onion bulb.
Regulator:
EPA
Chemical:
Zoxamide
Crop:
Onion bulb
PHI:
6-8 days
App. Rate:
1.32-1.34 lb ai/A
Submitter:
Gowan
MRID Citation:
MRID 49067102
               Combined residues of zoxamide and its metabolites

0.218

0.475

0.261

0.310

0.244

0.063

0.140

0.073

0.128

0.160

0.242

0.223

Figure I-1.  Tolerance spreadsheet summary of zoxamide field trial data for dry onion bulb.

                                   Zoxamide

                                Dry,onion bulb

                                      EPA

                               1.32-1.34 lb ai/A

Total number of data (n)
                                      12

Percentage of censored data
                                      0%

Number of non-censored data
                                      12

Lowest residue
                                     0.063

Highest residue
                                     0.475

Median residue
                                     0.221

Mean
                                     0.211

Standard deviation (SD)
                                     0.113

Correction factor for censoring (CF)
                                     1.000

Proposed MRL estimate

- Highest residue
                                     0.475

- Mean + 4 SD
                                     0.662

- CF x 3 Mean
                                     0.634

Unrounded MRL
                                     0.662

Rounded MRL
                                      0.7


[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Pages 25033-25035]
[FR Doc No: 2021-09771]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91764; File No. SR-GEMX-2021-04]

Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Extend the
Expiration Date of the Temporary Amendments Concerning Video Conference
Hearings

May 4, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 28, 2021, Nasdaq GEMX, LLC (``GEMX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I and II below, which
Items have been substantially prepared by the Exchange. The Exchange
has designated the proposed rule change as constituting a ``non-
controversial'' rule change under paragraph (f)(6) of Rule 19b-4 under
the Act,\3\ which renders the proposal effective upon receipt of this
filing by the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the expiration date of the
temporary amendments in SR-GEMX-2020-21 from April 30, 2021, to August
31, 2021.\4\ The proposed rule change would not make any changes to the
text of the Exchange rules.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 90755 (Dec. 21,
2020), 85 FR 85819 (Dec. 29, 2020) (SR-GEMX-2020-21). If the
Exchange seeks to provide additional temporary relief from the rule
requirements identified in this proposed rule change beyond August
31, 2021, the Exchange will submit a separate rule filing to further
extend the temporary extension of time. The amended Exchange rules
will revert to their original form at the conclusion of the
temporary relief period and any extension thereof.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/gemx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to continue to harmonize Exchange Rule
General 3, Section 2 with recent changes by the Financial Industry
Regulatory Authority, Inc. (``FINRA'') to its Rule 1015 in response to
the COVID-19 global health crisis and the corresponding need to
restrict in-person activities.\5\ The Exchange originally filed
proposed rule change SR-GEMX-2020-21, which allows the Exchange Review
Council (``ERC'') to conduct hearings in connection with appeals of
Membership Application Program decisions, on a temporary basis, by
video conference, if warranted by the current COVID-19-related public
health risks posed by an in-person hearing. While there are signs of
improvement, the COVID-19 conditions necessitating the temporary
amendments persist and, based on its assessment of current COVID-19
conditions and the lack of certainty as to when COVID-19-related health
concerns and corresponding restrictions will meaningfully subside, the
Exchange has determined that there is a continued need for this
temporary relief for several months beyond April 30, 2021. Accordingly,
the Exchange proposes to extend the expiration date of the temporary
rule amendments in

SR-GEMX-2020-21 from April 30, 2021, to August 31, 2021.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 91495 (April 7,
2021), 86 FR 19306 (April 13, 2021) (SR-FINRA-2021-006) (``FINRA
Filing''). The Exchange notes that the FINRA Filing also proposed to
temporarily amend FINRA Rules 9261, 9524, and 9830, which govern
hearings in connection with appeals of disciplinary actions,
eligibility proceedings, and temporary and permanent cease and
desist orders. The Exchange's Rules 9261, 9524, and 9830 incorporate
by reference The Nasdaq Stock Market LLC rules, which are the
subject of a separate filing. See SR-NASDAQ-2021-033 (April 28,
2021). Therefore, the Exchange is not proposing to adopt that aspect
of the FINRA Filing.
---------------------------------------------------------------------------

    As set forth in SR-GEMX-2020-21, the Exchange also relies on COVID-
19 data and criteria to determine whether the current public health
risks presented by an in-person hearing may warrant a hearing by video
conference. Based on that data and criteria, the Exchange does not
believe the COVID-19- related health concerns necessitating this relief
will meaningfully subside by April 30, 2021, and has determined that
there will be a continued need for this temporary relief for several
months beyond that date. Accordingly, the Exchange proposes to extend
the expiration date of the temporary rule amendments originally set
forth in SR-GEMX-2020-21 from April 30, 2021, to August 31, 2021. The
extension of the temporary amendments allowing for specified ERC
hearings to proceed by video conference will allow the Exchange's
critical adjudicatory functions to continue to operate effectively in
these extraordinary circumstances--enabling the Exchange to fulfill its
statutory obligations to protect investors and maintain fair and
orderly markets--while also protecting the health and safety of hearing
participants.
    The Exchange has filed the proposed rule change for immediate
effectiveness and has requested that the SEC waive the requirement that
the proposed rule change not become operative for 30 days after the
date of the filing, so the Exchange can implement the proposed rule
change immediately.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\6\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
by providing greater harmonization between the Exchange rules and FINRA
rules of similar purpose, resulting in less burdensome and more
efficient regulatory compliance.\8\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
    \8\ See supra note 5.
---------------------------------------------------------------------------

    The proposed rule change, which extends the expiration date of the
temporary amendments to the Exchange rules set forth in SR-GEMX-2020-
21, will continue to aid the Exchange's efforts to timely conduct
hearings in connection with its core adjudicatory functions. Given
current COVID-19 conditions and the uncertainty around when those
conditions will meaningfully improve, without this relief allowing ERC
hearings to continue to proceed by video conference, such hearings may
need to be postponed indefinitely. The Exchange must be able to perform
its critical adjudicatory functions in order to fulfill its statutory
obligations to protect investors and maintain fair and orderly markets.
As such, this relief is essential to the Exchange's ability to fulfill
its statutory obligations and allows hearing participants to avoid the
serious COVID-19-related health and safety risks associated with in-
person hearings.
    Among other things, this relief will allow the ERC to timely
provide members, disqualified individuals and other applicants an
approval or denial of their applications. As set forth in detail in SR-
GEMX-2020-21, this temporary relief allowing ERC hearings to proceed by
video conference accounts for fair process considerations and will
continue to provide fair process while avoiding the COVID-19-related
public health risks for hearing participants. Accordingly, the proposed
rule change extending this temporary relief is in the public interest
and consistent with the Act's purpose.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the temporary proposed rule
change will impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act. As set forth in
SR-GEMX-2020-21, the proposed rule change is intended solely to extend
temporary relief necessitated by the continued impacts of the COVID-19
outbreak and the related health and safety risks of conducting in-
person activities. The Exchange believes that the proposed rule change
will prevent unnecessary impediments to its operations, including its
critical adjudicatory processes, and its ability to fulfill its
statutory obligations to protect investors and maintain fair and
orderly markets that would otherwise result if the temporary amendments
were to expire on April 30, 2021.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \9\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\12\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange has
indicated that the proposed rule change to extend the expiration date
will continue to prevent unnecessary impediments to its operations,
including its critical adjudicatory processes, and its ability to
fulfill its statutory obligations to protect investors and maintain
fair and orderly markets that would otherwise result if the temporary
amendments were to expire on April 30, 2021.\13\ Importantly, extending
the relief provided in GEMX-2020-21 immediately upon filing and without
a 30-day operative delay will allow the Exchange to continue critical
adjudicatory and review processes in a reasonable and fair manner and
meet its critical investor protection goals, while also following best
practices with respect to the health and safety of its employees.\14\
The Commission also notes that this proposal extends without change the
temporary relief previously provided by GEMX-2020-21,\15\ and only
during the period in which the Exchange's operations are impacted by

COVID-19. As proposed, the changes would be in place through August 31,
2021 and the amended rules will revert back to their original state at
the conclusion of the temporary relief period and, if applicable, any
extension thereof.\16\ For these reasons, the Commission believes that
waiver of the 30-day operative delay for this proposal is consistent
with the protection of investors and the public interest. Accordingly,
the Commission hereby waives the 30-day operative delay and designates
the proposal operative upon filing.\17\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ See supra Item II.
    \14\ See FINRA Filing, 86 FR at 19308 (noting the same in
granting FINRA's request to waive the 30-day operative delay so that
SR-FINRA-2021-006 would become operative immediately upon filing).
    \15\ See supra note 4.
    \16\ See id. As noted above, the Exchange states that if it
requires temporary relief from the rule requirements identified in
this proposal beyond August 31, 2021, it may submit a separate rule
filing to extend the effectiveness of the temporary relief under
these rules.
    \17\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule change's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-GEMX-2021-04 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-GEMX-2021-04. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-GEMX-2021-04 and should be
submitted on or before June 1, 2021.
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    \18\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-09771 Filed 5-7-21; 8:45 am]
BILLING CODE 8011-01-P