[Federal Register Volume 87, Number 47 (Thursday, March 10, 2022)]
[Rules and Regulations]
[Pages 13640-13644]
[FR Doc No: 2022-05065]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0235; FRL-9067-01-OCSPP]

Buprofezin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective March 10, 2022. Objections and
requests for hearings must be received on or before May 9, 2022, 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-2020-0235, is available at
https://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 and for the OPP Docket is<PHONE_NUMBER>.
    Due to the public emergency, 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, Acting Director,
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 protected].

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 Office of the
Federal Register's e-CFR site at https://www.ecfr.gov.

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-2020-0235 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
May 9, 2022. 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-2020-0235, by one of
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Registers of June 24, 2020 (85 FR 37806) (FRL-10010-
82), and August 5, 2020 (85 FR 47330) (FRL-10012-32), EPA issued
documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide petition (PP 0E8828) by IR-4,
North Carolina State University, 1730 Varsity Drive, Venture IV, Suite
210, Raleigh, NC 27606. These petitions requested that 40 CFR 180.511
be amended by establishing tolerances for residues of the insecticide
buprofezin, 2-[(1,1 dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-
phenyl-4H-1,3,5-thiadiazin-4-one, in or on asparagus bean, edible
podded at 0.02 parts per million (ppm); bushberry subgroup 13-07B at
0.08 ppm; catjang bean, edible podded at 0.02 ppm; Chinese longbean,
edible podded at 0.02 ppm; cowpea, edible podded at 0.02 ppm; french
bean, edible podded at 0.02 ppm; garden bean, edible podded at 0.02
ppm; green bean, edible podded at 0.02 ppm; goa bean, edible podded at
0.02 ppm; guar

bean, edible podded at 0.02 ppm; jackbean, edible podded at 0.02 ppm;
kidney bean, edible podded at 0.02 ppm; lablab bean, edible podded at
0.02 ppm; moth bean, edible podded at 0.02 ppm; mung bean, edible
podded at 0.02 ppm; navy bean, edible podded at 0.02 ppm; rice bean,
edible podded at 0.02 ppm; scarlet runner bean, edible podded at 0.02
ppm; snap bean, edible podded at 0.02 ppm; sword bean, edible podded at
0.02 ppm; urd bean, edible podded at 0.02 ppm; vegetable soybean,
edible podded at 0.02 ppm; velvet bean, edible podded at 0.02 ppm; wax
bean, edible podded at 0.02 ppm; winged pea, edible podded at 0.02 ppm;
and yardlong bean, edible podded at 0.02 ppm.
    In addition, IR-4 proposed, upon the approval of the aforementioned
tolerances, to remove the established tolerance for the residues of
buprofezin, including its metabolites and degradates in or on bean,
snap, succulent at 0.02 ppm.
    Three comments were received on the notices of filings. EPA's
responses to these comments are discussed 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 buprofezin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with buprofezin follows.
    In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections of the rule that would repeat
what has been previously published in tolerance rulemakings for the
same pesticide chemical. Where scientific information concerning a
particular pesticide chemical remains unchanged, the content of those
sections would not vary between tolerance rulemakings and republishing
the same sections is unnecessary and duplicative. 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 a number of tolerance rulemakings for
buprofezin, in which EPA concluded, based on the available information,
that there is a reasonable certainty that no harm would result from
aggregate exposure to buprofezin and established tolerances for
residues of that chemical. EPA is incorporating previously published
sections from those rulemakings as described further in this
rulemaking, as they remain unchanged.
    Toxicological profile. For a discussion of the Toxicological
Profile of buprofezin and aniline, a substance that may be formed as a
degradate in food from buprofezin and its aniline-containing
metabolites as a result of cooking, see Unit III.A. of the August 29,
2019 rulemaking (84 FR 45426) (FRL-9997-41). There is, however, a new
discussion of the non-cancer toxicity characterization of aniline in
Appendix F of the document titled ``Buprofezin. Human Health Risk
Assessment for Proposed New Use on Bushberry Crop Subgroup 13-07B and
Proposed Amendments to Expand Use on Succulent Beans to All Members of
Proposed Edible Podded Bean Legume Vegetable Subgroup 6-XXA and Use on
Greenhouse-Grown Tomatoes and Peppers to All Members of Fruiting
Vegetable Crop Group 8-10'' (hereinafter ``Buprofezin Human Health Risk
Assessment.'')
    Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern used for the
risk assessment, see Unit III.B. of the August 29, 2019 rulemaking.
    Exposure assessment. Much of the exposure assessment remains the
same, although the dietary exposure and risk assessments for buprofezin
and buprofezin-derived aniline were updated. These updates are
discussed in this section; for a description of the rest of EPA's
approach to and assumptions for the exposure assessment, see Unit
III.C. of the August 29, 2019 rulemaking.
    EPA's dietary exposure assessments have been updated to include the
additional exposures for the new uses of buprofezin. The assessment
used the same assumptions as the August 29, 2019 final rule concerning
tolerance level residues, default and empirical processing factors for
all processed commodities assumptions, and a conservative factor to
account for the presence of the BF4 Conjugate (2-(2-hydroxy-1,1-
dimethylethylimino)-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one). The
acute dietary exposure assessment assumed 100 percent crop treated
(PCT).
    Updated PCT estimates were used in the chronic dietary risk
assessment for crops that are currently registered for buprofezin:
Almond 1%, apple 2.5%, apricot 5%, broccoli 2.5%, cabbage 2.5%,
cantaloupe 15%, cauliflower 5%, celery 1%, cherry 10%, cotton 1%,
cucumber 1%, grapefruit 5%, raisin grape 5%, table grape 10%, wine
grape 2.5%, honeydew 75%, lemon 2.5%, lettuce 10%, nectarine 15%, olive
1%, orange 2.5%, peach 5%, pear 15%, pepper 1%, pistachio 15%, plum/
prune 2.5%, pumpkin 1%, spinach 1%, squash 2.5%, strawberry 15%,
tangerine 10%, tomato 1%, walnut 2.5%, and watermelon 1%. These average
PCT data were also used to refine the cancer dietary exposure analysis
for buprofezin-derived aniline. All other crops assumed 100% crop
treated.
    A cancer dietary exposure risk assessment for buprofezin was not
conducted because the only evidence of carcinogenicity was for benign
liver tumors in one sex (males) and one species (mouse); there was no
evidence of carcinogenicity in rats of either sex or in female mice. An
updated, highly refined cancer dietary exposure (cooked food forms
only) and risk assessment for buprofezin-derived aniline residues,
including those derived from aniline-containing metabolites of
buprofezin, was conducted. This assessment was conducted using (1)
buprofezin monitoring data for raw/uncooked agricultural commodities
(RACs) provided by the United States Department of Agriculture
Pesticide Data Program (PDP) to estimate average residues of
buprofezin; (2) buprofezin field trial data; (3) empirical and EPA's
2018 default processing factors; (4) average buprofezin PCT data; and
(5) the maximum conversion factor for buprofezin-derived aniline of
18.9%. The conversion factor of 18.9%, the highest found in a
previously submitted hydrolysis study, was applied to

estimate residues of buprofezin-derived aniline which may form in food
as a result of cooking. The highly refined estimated exposure of the
highest exposed adult population (adults 50 to 99 years old) to
buprofezin-derived aniline results in an upper bound cancer risk
estimate of 3 x 10-7.
    Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    In most cases, EPA uses available data from the United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the California Department
of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that Conditions a, b, and c discussed above
have been met. With respect to Condition a, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions b and c, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
reliable information on the regional consumption of food to which
buprofezin may be applied in a particular area.
    Drinking water, non-occupational, and cumulative exposures.
Drinking water and non-occupational exposures are not impacted by the
new uses, and thus have not changed since the last assessment. EPA's
conclusions concerning cumulative risk remain unchanged from Unit
III.C.2. of the August 29, 2019 rulemaking.
    Safety factor for infants and children. EPA continues to conclude
that a 10X FQPA SF must be retained for repeated exposure scenarios
because those assessments are based on a study that did not show a No
Observed Adverse Effect Level (NOAEL). EPA also 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
10X to 1X for single exposures. The reasons for these decisions are
articulated in Unit III.D. of the August 29, 2019 rulemaking.
    Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
dietary exposure estimates to the acute population adjusted dose (aPAD)
and the chronic population adjusted dose (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 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.
    Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are 5.8% of the aPAD for females 13-49 years old,
which is the only population subgroup with an acute dietary endpoint.
Chronic dietary risks are below the Agency's level of concern of 100%
of the cPAD; they are 42% of the cPAD for children 1 to 2 years old,
the most highly exposed subpopulation. Buprofezin is classified as
``Suggestive Evidence of Carcinogenicity, but not sufficient to assess
human carcinogenic potential.'' EPA has determined that the
quantification of risk using a non-linear (i.e., reference dose)
approach will adequately account for all chronic toxicity, including
carcinogenicity, that could result from exposure to buprofezin. Because
the chronic dietary risks are below the Agency's level of concern,
buprofezin is not expected to pose a cancer risk to humans.
    There are no data to determine an acute endpoint for aniline at
this time; hence, an acute dietary risk assessment was not conducted
for buprofezin-derived aniline. The highly refined estimated chronic
exposure of the most highly exposed adult subpopulation (adults 50 to
99 years old) to buprofezin-derived aniline is 0.000052 mg/kg/day.
Estimated chronic exposures to buprofezin-derived aniline are orders of
magnitude below any potential chronic non-cancer reference dose for
aniline. Therefore, a quantitative chronic non-cancer dietary risk
assessment for buprofezin-derived aniline is not necessary to conclude
with reasonable certainty that chronic exposures from buprofezin-
derived aniline do not pose a non-cancer dietary risk. The highly
refined estimated chronic exposure of the most highly exposed adult
subpopulation results in an upper bound cancer risk estimate of 3 x
10-7,

which is below the Agency's level of concern of 1 x 10-6.
    There are no residential uses of buprofezin; therefore, the
aggregate risk assessment is equivalent to the acute and chronic
dietary (food and drinking water) exposure and risk assessments to
buprofezin and buprofezin-derived aniline and are not of concern.
    Therefore, 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 buprofezin residues. More detailed information
about the Agency's analysis can be found at https://www.regulations.gov
in the document ``Buprofezin Human Health Risk Assessment'' in docket
ID number EPA-HQ-OPP-2020-0235.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available in Pesticide Analytical
Manual Volume I (PAM I) and PAM II for enforcement of buprofezin
tolerances, including gas chromatography methods with nitrogen
phosphorus detection (GC/NPD), and a GC/mass spectrometry (GC/MS)
method for confirmation of buprofezin residues in plant and livestock
commodities. The GC/MS method used for plant commodities utilizes three
ions for identification of buprofezin. The validated limit of
quantitation (LOQ) was 0.05 ppm. In addition, method BF/10/97 is an
adequate enforcement method for enforcement of buprofezin tolerances
in/on bean commodities. The LOQ is 0.02 ppm.

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).
    No Codex MRLs have been established for residues of buprofezin in/
on the proposed commodities in this action.

C. Response to Comments

    Although three comments were submitted to the docket in response to
the June 24, 2020, and August 5, 2020 notifications of filings, only
one specifically related to this tolerance action. This comment was
from a representative from the Republic of Ecuador. The commenter's
concern was that the proposed U.S. MRLs for buprofezin on beans at 0.02
ppm would prevent beans from Ecuador from being imported and marketed
in the U.S. because of buprofezin residues higher than 0.02 ppm. The
commenter was also concerned that the U.S. would reduce the tolerance
for residues in/on beans to be more restrictive. The commenter also
stated that it is essential for pesticide tolerances to be based on
scientific evidence, conclusive data and not under the precautionary
principle.
    The existing tolerance for residues in/on bean, snap, succulent is
based on previously submitted and reviewed field trial residue data
that demonstrate that residues of buprofezin in/on snap beans are less
than the limit of quantitation, which is 0.02 ppm. The petitioner
requested, and EPA agrees that it is appropriate, to extrapolate the
field trial data on succulent snap beans to support tolerances for
residues in/on the 25 specific edible podded bean commodities.
Therefore, this action is based on scientific evidence and conclusive
data and actually increases the tolerances for most of the edible
podded bean commodities from zero (not existent) to 0.02 ppm. Ecuador
has adopted the established European Union (EU) MRL of 0.01 ppm for
residues of buprofezin in/on beans (with pods) and beans (without
pods). The recommended U.S. tolerance of 0.02 ppm for residues of
buprofezin in/on individual edible podded bean commodities is not more
restrictive than this MRL. The U.S. tolerances are based on the use
pattern that is registered in the U.S. If the use pattern is different
in Ecuador, the bean growers or another organization could submit a
petition for an import tolerance for residues of buprofezin in/on
beans, with supporting field trial residue data based on the alternate
use pattern. EPA would review such a petition to determine if it meets
the statutory standard that there is a reasonable certainty that no
harm will result to the general population, or to infants and children,
from aggregate exposure to buprofezin residues.

D. Revisions to Petitioned-For Tolerances

    Most of the proposed commodity definitions have been modified to be
consistent with Agency nomenclature.

V. Conclusion

    Therefore, tolerances are established for residues of buprofezin,
2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4H-
1,3,5-thiadiazin-4-one, in or on Bean, asparagus, edible podded at 0.02
ppm; Bean, catjang, edible podded at 0.02 ppm; Bean, french, edible
podded at 0.02 ppm; Bean, garden, edible podded at 0.02 ppm; Bean, goa,
edible podded at 0.02 ppm; Bean, green, edible podded at 0.02 ppm;
Bean, guar, edible podded at 0.02 ppm; Bean, kidney, edible podded at
0.02 ppm; Bean, lablab, edible podded at 0.02 ppm; Bean, moth, edible
podded at 0.02 ppm; Bean, mung, edible podded at 0.02 ppm; Bean, navy,
edible podded at 0.02 ppm; Bean, rice, edible podded at 0.02 ppm; Bean,
scarlet runner, edible podded at 0.02 ppm; Bean, snap, edible podded at
0.02 ppm; Bean, sword, edible podded at 0.02 ppm; Bean, urd, edible
podded at 0.02 ppm; Bean, wax, edible podded at 0.02 ppm; Bean,
yardlong, edible podded at 0.02 ppm; Bushberry subgroup 13-07B at 0.08
ppm; Cowpea, edible podded at 0.02 ppm; Jackbean, edible podded at 0.02
ppm; Longbean, chinese, edible podded at 0.02 ppm; Pea, winged, edible
podded at 0.02 ppm; Soybean, vegetable, edible podded at 0.02 ppm; and
Velvetbean, edible podded at 0.02 ppm.
    Upon establishment of the aforementioned tolerances, the
established tolerance for the residues of buprofezin, including its
metabolites and degradates in or on Bean, snap, succulent at 0.02 ppm
will be removed, as it is superseded by the new tolerances on the
edible podded bean commodities. In addition, EPA is revising the
tolerance expression in paragraph (a) to correct the chemical name of
buprofezin.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to petitions 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). 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 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 4, 2022.
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.  180.511, amend paragraph (a) by:
0
a. Revising the introductory text.
0
b. Adding in alphabetical order to the table the entries ``Bean,
asparagus, edible podded''; ``Bean, catjang, edible podded''; ``Bean,
french, edible podded''; ``Bean, garden, edible podded''; ``Bean, goa,
edible podded''; ``Bean, green, edible podded''; ``Bean, guar, edible
podded''; ``Bean, kidney, edible podded''; ``Bean, lablab, edible
podded''; ``Bean, moth, edible podded''; ``Bean, mung, edible podded'';
``Bean, navy, edible podded''; ``Bean, rice, edible podded''; ``Bean,
scarlet runner, edible podded''; and ``Bean, snap, edible podded''.
0
c. Removing the entry from the table for ``Bean, snap, succulent''.
0
d. Adding in alphabetical order to the table the entries ``Bean, sword,
edible podded''; ``Bean, urd, edible podded''; ``Bean, wax, edible
podded''; ``Bean, yardlong, edible podded''; ``Bushberry subgroup 13-
07B''; ``Cowpea, edible podded''; ``Jackbean, edible podded'';
``Longbean, chinese, edible podded''; ``Pea, winged, edible podded'';
``Soybean, vegetable, edible podded''; and ``Velvetbean, edible
podded''.
    The revision and additions read as follows:

Sec.  180.511   Buprofezin; tolerances for residues.

    (a) General. Tolerances are established for residues of buprofezin,
including its metabolites and degradates in or on the commodities in
the table in this paragraph (a). Compliance with the tolerance levels
specified in the table in this paragraph (a) is to be determined by
measuring only the buprofezin, 2-[(1,1-dimethylethyl)imino]tetrahydro-
3-(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one, in the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Bean, asparagus, edible podded..............................        0.02
Bean, catjang, edible podded................................        0.02
Bean, french, edible podded.................................        0.02
Bean, garden, edible podded.................................        0.02
Bean, goa, edible podded....................................        0.02
Bean, green, edible podded..................................        0.02
Bean, guar, edible podded...................................        0.02
Bean, kidney, edible podded.................................        0.02
Bean, lablab, edible podded.................................        0.02
Bean, moth, edible podded...................................        0.02
Bean, mung, edible podded...................................        0.02
Bean, navy, edible podded...................................        0.02
Bean, rice, edible podded...................................        0.02
Bean, scarlet runner, edible podded.........................        0.02
Bean, snap, edible podded...................................        0.02

                                * * * * *
Bean, sword, edible podded..................................        0.02
Bean, urd, edible podded....................................        0.02
Bean, wax, edible podded....................................        0.02
Bean, yardlong, edible podded...............................        0.02

                                * * * * *
Bushberry subgroup 13-07B...................................        0.08

                                * * * * *
Cowpea, edible podded.......................................        0.02

                                * * * * *
Jackbean, edible podded.....................................        0.02

                                * * * * *
Longbean, chinese, edible podded............................        0.02

                                * * * * *
Pea, winged, edible podded..................................        0.02

                                * * * * *
Soybean, vegetable, edible podded...........................        0.02

                                * * * * *
Velvetbean, edible podded...................................        0.02
------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-05065 Filed 3-9-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 23, 2008 (Volume 73, Number 121)]
[Rules and Regulations]
[Page 35341]
[DOCID:fr23jn08-4]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882,
886, 888, 890, and 892

[Docket No. FDA-2008-N-0331]

Medical Devices; Change of Name; Technical Amendment

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is amending its
regulations to implement a nomenclature change and to ensure accuracy
and clarity in the agency's regulations.

DATES: This rule is effective June 23, 2008.

FOR FURTHER INFORMATION CONTACT: Paul S. Gadiock, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This document amends FDA's regulations to reflect a nomenclature
change. It replaces the phrase ``good manufacturing practice
regulations'' with the phrase ``good manufacturing practice
requirements of the quality system regulation'' in 21 CFR parts 860,
862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886, 888, 890, and
892.
    Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has
determined that notice and public comment are unnecessary because these
changes are nonsubstantive.

II. Environmental Impact

    The agency has determined under 21 CFR 25.30(i) that this final
rule is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this rule makes only typographical and
nonsubstantive changes in existing regulations and does not change in
any way how devices are regulated, the agency certifies that the final
rule will not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

IV. Paperwork Reduction Act of 1995

    FDA has determined that this final rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.

V. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects 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. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886, 888, 890,
and 892 are amended as follows:

PARTS 860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886,
888, 890, and 892--[AMENDED]

0
1. Parts 860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886,
888, 890, and 892 are amended by removing the phrase ``good
manufacturing practice regulations'' wherever it appears and by adding
in its place the phrase ``good manufacturing practice requirements of
the quality system regulation''.

    Dated: June 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14153 Filed 6-20-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 85 (Thursday, May 4, 2017)]
[Notices]
[Pages 20948-20951]
[FR Doc No: 2017-08978]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80551; File No. SR-FINRA-2017-006]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Order Granting Approval of a Proposed Rule Change To
Amend Rule 6191 To Implement an Anonymous, Grouped Masking Methodology
for Over-the-Counter Activity in Connection With Web Site Data
Publication of Appendix B Data Pursuant to the Regulation NMS Plan To
Implement a Tick Size Pilot Program

April 28, 2017.

I. Introduction

    On March 3, 2017, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend FINRA Rule 6191 to implement an
anonymous, grouped masking methodology for over-the-counter (``OTC'')
activity in connection with Web site publication of Appendix B data
pursuant to the Regulation NMS

Plan to Implement a Tick Size Pilot Program (``Plan'' or ``Pilot'').\3\
The proposed rule change was published for comment in the Federal
Register on March 15, 2017.\4\ The Commission received three comment
letters on the proposed rule change.\5\ This order approves the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 74892 (May 6, 2015),
80 FR 27513 (May 13, 2015) (``Approval Order''). Unless otherwise
specified, capitalized terms used in this order are defined as set
forth in the Plan.
    \4\ See Securities Exchange Act Release No. 80193 (Mar. 9,
2017), 82 FR 13901 (``Notice'').
    \5\ See Letters to Brent J. Fields, Secretary, Commission from
Alisa McCoy, dated March 13, 2017 (``McCoy Letter''); Christopher W.
Bok, Financial Information Forum, dated April 5, 2017 (``FIF
Letter''); and Stephen John Berger, Managing Director, Government &
Regulatory Policy, Citadel, dated April 7, 2017 (``Citadel
Letter'').
---------------------------------------------------------------------------

II. Description of the Proposal

    FINRA Rule 6191(b) (Compliance with Data Collection Requirements)
implements the data collection and Web site publication requirements of
the Plan. FINRA Rule 6191(b)(2)(A) describes the data collection and
submission requirements for data that is required under Appendix B.I.
and B.II. of the Plan. FINRA Rule 6191(b)(2)(B) provides, among other
things, that FINRA will publish data collected pursuant to FINRA Rule
6191(b)(2)(A) on its Web site within 120 calendar days following month
end at no charge,\6\ and that such publication will not identify the
Trading Center that generated the data.
---------------------------------------------------------------------------

    \6\ FINRA Rule 6191.12 provides that the Web site publication of
Appendix B data shall commence on April 28, 2017.
---------------------------------------------------------------------------

    FINRA Rule 6191(b)(3)(A) describes the data collection and
submission requirements for data specified under Appendix B.IV. of the
Plan. FINRA Rule 6191(b)(3)(C) provides, among other things, that FINRA
will publish data collected pursuant to FINRA Rule 6191(b)(3)(A) on its
Web site within 120 calendar days following month end at no charge,\7\
and that such publication will not identify the Trading Center that
generated the data.
---------------------------------------------------------------------------

    \7\ Id.
---------------------------------------------------------------------------

    FINRA proposes new Supplementary Material .15 to FINRA Rule 6191 to
implement an anonymous, grouped masking methodology for Appendix B.I.,
B.II. and B.IV. data (``Appendix B data''). FINRA also proposes to
incorporate the OTC Trading Centers for which Chicago Stock Exchange,
Inc. (``CHX'') is the designated examining authority (``DEA'') into the
anonymous, grouped masking methodology and publish OTC-wide statistics
for Appendix B data on the FINRA Web site.\8\
---------------------------------------------------------------------------

    \8\ In connection with the instant filing, FINRA and CHX
requested exemptive relief from the Plan to permit the publication
on the FINRA Web site of data relating to OTC activity pursuant to
Appendix B.I., B.II. and B.IV. using an anonymous, grouped masking
methodology. See Letter from Marcia E. Asquith, Executive Vice
President, Board and External Relations, FINRA, to Robert W. Errett,
Deputy Secretary, Commission, dated March 2, 2017. The Commission,
pursuant to its authority under Rule 608(e) of Regulation NMS, has
granted FINRA and CHX a limited exemption from the requirement to
comply with certain provisions of the Plan as specified in the
letters and noted herein. See letter from David Shillman, Associate
Director, Division of Trading and Markets, Commission to Marcia E.
Asquith, Executive Vice President, Board and External Relations,
FINRA, dated April 28, 2017 (``SEC Exemption Letter'').
---------------------------------------------------------------------------

A. Grouping Methodology

    FINRA proposes to establish ATS and non-ATS categories. Thereafter,
FINRA would assign OTC Trading Centers into groups of five to twenty-
five, using an undisclosed methodology to assign each Trading Center to
a group.
    The Trading Center group assignments will not be published and
generally will remain unchanged for the duration of the data
publication period, with the exception of the entrance of a new Trading
Center (i.e., new FINRA member). FINRA will assign an anonymized
identifier for each group that will remain unchanged for the duration
of the data publication period. The anonymized identifier will be used
for all Appendix B data sets. The number of Trading Centers assigned to
each group will not specifically be disclosed; however, as noted above,
each group will contain between five and twenty-five market participant
identifiers (``MPIDs''). In addition, for each day's statistics, the
number of MPIDs in each group with activity in any Pilot Security for
that day will be published.

B. Appendix B.I. Data Aggregation Methodology

    FINRA proposes to aggregate the Appendix B.I. data by aggregating
statistics within each group by Pilot Security for each trading day.
The methodology used for computing the statistics at the group level
will be the same methodology used to compute these statistics at the
Trading Center level in the non-public version of the data (and in the
public version of the exchange data).\9\ Specifically, FINRA would
calculate group-level sums for statistics that are quantity counts \10\
and use all underlying data within a group to calculate statistics
requiring averages or weighted averages.\11\ Data will be aggregated
separately for each order type and subcategory, and will not be
aggregated across order types or subcategories.
---------------------------------------------------------------------------

    \9\ See Tick Size Appendix B and C Statistics FAQs (available at
http://www.finra.org/sites/default/files/Tick-Size-Pilot-Appendix-B-and-C-FAQ.pdf).
    \10\ See e.g., Appendix B.I.a(7) (cumulative number of orders).
    \11\ See e.g., Appendix B.I.a(28) (the share weighted average
realized spread for executions of orders); and Appendix B.I.a(29)
(the received share-weighted average percentage for shares not
displayable as of order receipt). FINRA will calculate averages for
all price variables and percentages.
---------------------------------------------------------------------------

C. Appendix B.II. Data Aggregation Methodology

    Appendix B.II. data includes order-level statistics; thus, FINRA
proposes that all individual orders be displayed for all Trading
Centers within a group, with each order attributed to the group rather
than the underlying Trading Center. In addition, Appendix B.II. order
information would be displayed in chronological order based on time of
order receipt.

D. Appendix B.IV. Data Aggregation Methodology

    FINRA proposes to aggregate Appendix B.IV. data by aggregating
statistics within each group by trading day by summing the statistics
of all Market Maker activity represented within the group. The number
of Market Makers would be displayed as the unique number of Market
Makers \12\ across all Trading Centers within the group.
---------------------------------------------------------------------------

    \12\ As provided in FINRA Rule 6191.11, FINRA will provide a
count of the number of Market Makers used in the participation
calculations. Thus, if a single unique Market Maker traded on
multiple Trading Centers within the same masking group, for the
Appendix B.IV. count of unique Market Makers on a given trading day,
FINRA will count this activity as attributed to one unique Market
Maker.
---------------------------------------------------------------------------

III. Summary of Comment Letters

    The Commission received three comment letters expressing general
support for the proposed rule change.\13\ One commenter praised ``the
significant steps taken to improve the masking methodology'' for the
Pilot data.\14\ Another commenter commended FINRA for ``taking into
account the feedback received from market participants and working to
devise an approach that seeks to address identified confidentiality
concerns while still maintaining the usefulness of the publicly
available data.'' \15\
---------------------------------------------------------------------------

    \13\ One letter reads in its entirety ``That is great idea since
all of the compromise.'' See McCoy Letter.
    \14\ See FIF Letter.
    \15\ See Citadel Letter.
---------------------------------------------------------------------------

    One commenter, however, expressed a continued concern related to
FINRA's

proposed grouping methodology.\16\ Specifically, this commenter
believed that the proposal to break ATS and non-ATS OTC Trading Centers
into groupings of five to twenty-five MPIDs may allow interested
parties the opportunity to discern the identity of the Trading Center,
perhaps by comparing the published data to Rule 605 reports of OTC
volume data published by FINRA. This commenter also expressed concern
that the disclosure of the number of active MPIDs in each group could
potentially lead to the identification of broker-dealer Trading
Centers. As an alternative, the commenter suggested that all OTC
Trading Centers be aggregated into either a single ATS or non-ATS
category.
---------------------------------------------------------------------------

    \16\ See FIF Letter.
---------------------------------------------------------------------------

    Another commenter recommended eliminating the proposed daily
publication of the number of MPIDs with activity in each group of
Trading Centers.\17\ This commenter suggested that FINRA reconsider
whether this additional information is necessary to provide a useful
data set to the public because, ``in practice, FINRA will thus be
disclosing information regarding the number of trading centers assigned
to each group.'' In this commenter's view, FINRA must ensure that the
additional data cannot be used to ``undermine the confidentiality of
FINRA's methodology for assigning trading centers to particular groups
or the actual group assignments.''
---------------------------------------------------------------------------

    \17\ See Citadel Letter.
---------------------------------------------------------------------------

IV. Discussion and Commission's Findings

    After careful review of the proposed rule change and the comment
letters, the Commission finds that the proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities association.\18\ Specifically,
the Commission finds that the proposed rule change is consistent with
Section 15A(b)(6) of the Act,\19\ which requires, among other things,
that FINRA rules must be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest, and Section 15A(b)(9) of the Act,\20\ which requires
that FINRA rules not impose any burden on competition that is not
necessary or appropriate.
---------------------------------------------------------------------------

    \18\ In approving this rule change, the Commission has
considered the rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \19\ 15 U.S.C. 78o-3(b)(6).
    \20\ 15 U.S.C. 78o-3(b)(9).
---------------------------------------------------------------------------

    In the Approval Order, the Commission noted that the Pilot is, by
design, an objective, data-driven test that should ``provide measurable
data that should facilitate the ability of the Commission, the public
and market participants to review and analyze the effect of tick size
on the trading, liquidity and market quality of securities of smaller
capitalization companies.'' \21\ The Commission further stated that the
Plan should provide ``a data-driven approach to evaluate whether
certain changes to the market structure for Pilot Securities would be
consistent with the Commission's mission to protect investors, maintain
fair, orderly and efficient markets and facilitate capital formation.''
\22\ To that end, the Plan provides for the collection, submission and
publication of data specified in Appendix B of the Plan. The Plan
further provides that the data to be made publicly available not
identify the Trading Center that generated the data. As discussed
below, the Commission believes that FINRA's proposal is consistent with
the requirements of the Act and would further the purpose of the Plan
to provide measurable data.
---------------------------------------------------------------------------

    \21\ See Approval Order, supra note 3.
    \22\ Id.
---------------------------------------------------------------------------

    FINRA, as a Participant in the Plan, has an obligation to comply,
and enforce compliance by its members, with the terms of the Plan. Rule
608(c) of Regulation NMS provides that ``[e]ach self-regulatory
organization shall comply with the terms of any effective national
market system plan of which it is a sponsor or participant.'' \23\
Proposed FINRA Rule 6191, Supplementary Material .15 would establish a
means to anonymize the identities of OTC Trading Centers when
publishing the data set forth in Appendix B to the Plan. The Commission
also believes that the proposal is consistent with the Act because it
is designed to assist FINRA in meeting its regulatory obligations
pursuant to Rule 608 of Regulation NMS and the Plan.
---------------------------------------------------------------------------

    \23\ 17 CFR 242.608(c).
---------------------------------------------------------------------------

    FINRA's proposal seeks to address the provision in the Plan that
individual OTC Trading Centers not be identified in the published data.
FINRA proposes to create ATS and non-ATS categories and then assign OTC
Trading Centers into groups of five to twenty-five. In addition, FINRA
proposes to aggregate and publish data from those OTC Trading Centers
for which CHX is DEA. Thereafter, FINRA would publish Appendix B data
for OTC Trading Centers by group on its Web site using an anonymized
identifier.
    The Commission notes that commenters had previously raised concerns
about the publication of OTC Trading Centers' Appendix B data on a
disaggregated basis.\24\ FINRA noted that it filed the proposed rule
change to mitigate the confidentiality concerns of the commenters.
---------------------------------------------------------------------------

    \24\ See Letters from William Hebert, Managing Director,
Financial Information Forum, to Robert W. Errett, Deputy Secretary,
Commission, dated December 21, 2016; and Adam C. Cooper, Senior
Managing Director and Chief Legal Officer, Citadel Securities, to
Brent J. Fields, Secretary, Commission, dated December 21, 2016. See
also Securities Exchange Act Release No. 79424 (November 29, 2016),
81 FR 87603 (December 5, 2016) (Notice of Filing and Immediate
Effectiveness of File No. SR-FINRA-2016-042).
---------------------------------------------------------------------------

    As noted above, while commenters were generally supportive of
FINRA's proposal, some believe FINRA should do more to mitigate
confidentiality concerns related to OTC Trading Centers' Appendix B
data. These commenters suggested that FINRA eliminate the sub-groupings
of ATS and non-ATS OTC Trading Centers, or the daily identification of
the number of active MPIDs in each group. While these commenters
broadly suggested this information might be used to identify the group
to which a particular OTC Trading Center was assigned, they did not
articulate why the identification of that group, if possible, could
reveal proprietary information or otherwise harm the interests of the
OTC Trading Center. In this regard, the Commission notes that the
activity of each OTC Trading Center would be combined with that of at
least four other OTC Trading Centers, and would be at least four months
old.
    The Commission believes that FINRA's proposal to develop an
anonymous, grouped masking methodology is reasonably designed to
address concerns that the activity of individual Trading Centers might
be identified. The Commission notes that the identities of individual
Trading Centers within each group would not be disclosed and the
activity of each Trading Center would be aggregated with the activity
of four to twenty-four other Trading Centers. At the same time, the
Commission believes that the maintenance of these groups, and the daily
identification of the number of active MPIDs in each group, should
substantially enhance the usefulness of the Pilot data for academics
and others seeking to analyze it. For example, establishing smaller
groups of OTC Trading Centers should increase the ability of
researchers to control for group fixed effects, and thereby help

isolate the impact of the Pilot so that more precise and robust
analysis can be performed. Similarly, identifying daily the number of
active MPIDs should increase the ability of researchers to assess the
impact of the Pilot by allowing them to control for changes in the
number of OTC Trading Centers in each group that are active in Pilot
Securities.\25\
---------------------------------------------------------------------------

    \25\ The Commission also notes that FINRA will publish Appendix
B data from OTC Trading Centers 120 days after the month end. This
delay in publication should help support FINRA's efforts to mitigate
confidentiality concerns.
---------------------------------------------------------------------------

    The Commission also believes that FINRA's proposal to aggregate and
publish data from those OTC Trading Centers for which CHX is the DEA
should help to mitigate confidentiality concerns. The Commission notes
that CHX is DEA to a small number of OTC Trading Centers. Therefore,
including these OTC Trading Centers in the broader anonymous data set
should mitigate concerns about the disclosure of their identities.
    For the reasons noted above, the Commission finds that the proposal
is consistent with the requirements of the Act. The proposal clarifies
and implements certain data collection requirements set forth in the
Plan.

V. Conclusion

    It is therefore ordered that, pursuant to Section 19(b)(2) of the
Act,\26\ that the proposed rule change (SR-FINRA-2017-006), be and
hereby is, approved.
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-08978 Filed 5-3-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 84 (Tuesday, May 1, 2012)]
[Rules and Regulations]
[Pages 25590-25591]
[FR Doc No: 2012-10411]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0362]

Drawbridge Operation Regulation; Lake Washington Ship Canal,
Seattle, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs University Bridge across the Lake
Washington Ship Canal, mile 4.3, at Seattle, WA. This deviation is
necessary to accommodate the Beat the Bridge charity foot race
scheduled for Sunday, May 20, 2012. This deviation allows the bridge to
remain in the closed position to allow safe movement of event
participants.

DATES: This deviation is effective from 8 a.m. on May 20, 2012 through
9:30 a.m. May 20, 2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2012-0362 and are available online
by going to http://www.regulations.gov, inserting USCG-2012-0362 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email the Bridge Administrator, Coast Guard Thirteenth
District; telephone<PHONE_NUMBER> email<EMAIL_ADDRESS>If
you have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Washington State Department of
Transportation has requested that University Bridge remain closed to
vessel traffic to facilitate safe passage of participants of the Beat
the Bridge charity event. Beat the Bridge is an annual foot race held
in Seattle, WA to benefit diabetes research. The race course passes
over University Bridge. University Bridge crosses the Lake Washington
Ship Canal at mile 4.3 and while in the closed position provides 30
feet of vertical clearance throughout the navigation channel and 45
feet of vertical clearance through the center of the bridge; vertical
clearance referenced to the Mean Water Level of Lake Washington.
Vessels which do not require a bridge opening may continue to transit
beneath the bridge during this closure period. Under normal conditions
this bridge operates in accordance with 33 CFR 117.1051(d) which
requires the bridge to open on signal, except that the bridge need not
open for vessels less than 1,000 gross tons from 7 a.m. to 9 a.m. and 4
p.m. to 6 p.m. Monday through Friday. This deviation period is from 8
a.m. on Sunday, May 20, 2012 through 9:30 a.m. on Sunday, May 20, 2012.
The deviation allows the bascule span of the University Bridge to
remain in the closed position and need not open for maritime traffic
from 8 a.m. through 9:30 a.m. on May 20, 2012. The bridge shall operate
in accordance to 33 CFR 117.1051(d) at all other times. Waterway usage
on the Lake Washington Ship Canal ranges from commercial tug and barge
to small pleasure craft. Mariners will be notified and kept informed of
the bridge's operational status via the Coast Guard Notice to Mariners
publication and Broadcast Notice to Mariners as appropriate. The draw
span will be required to open, if needed, for vessels engaged in
emergency response operations during this closure period.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: April 19, 2012.
Randall D. Overton,
Bridge Administrator.
[FR Doc. 2012-10411 Filed 4-30-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Proposed Rules]
[Pages 69600-69602]
[FR Doc No: 2013-27639]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0964; Directorate Identifier 2013-CE-035-AD]
RIN 2120-AA64

Airworthiness Directives; Piaggio Aero Industries S.p.A Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Piaggio Aero Industries S.p.A. Model P-180 airplanes. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as insufficient clearance between
one of the horizontal stabilizer end ribs and the corresponding
elevator horn. We are issuing this proposed AD to require actions to
address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by January 6, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Piaggio Aero Industries S.p.A--Airworthiness Office, Via Luigi
Cibrario, 4-16154 Genova-Italy; phone: +39<PHONE_NUMBER>; fax: +39 010
6481881; email<EMAIL_ADDRESS>Internet: http://www.piaggioaero.com/#/en/aftersales/service-support. You may review
this referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Mike Kiesov, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2013-0964;
Directorate Identifier 2013-CE-035-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued AD
No. 2013-0239, dated September 30, 2013 (referred to after this as
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    Insufficient clearance between one of the horizontal stabilizer
end rib and the corresponding elevator horn was found on an in-
service aeroplane.
    This condition, if not detected and corrected, could lead to
interference between the elevator and horizontal stabilizer
surfaces, resulting in restricted elevator control and consequent
reduced control of the aeroplane.
    To address this potential unsafe condition, Piaggio Aero
Industries (PAI) issued Service

Bulletin (SB) 80-0381 to provide inspection instructions.
    For the reasons described above, this AD requires accomplishment
of a one-time measurement of the actual clearance between the
elevator horn and the horizontal stabilizer tip rib, and depending
on findings, restoration of the required minimum clearance value.
This AD also requires reporting of the inspection result to PAI.

You may examine the MCAI on the Internet at http://www.regulations.gov
by searching for and locating it in Docket No. FAA-2013-0964.

Relevant Service Information

    Piaggio Aero Industries S.p.A. has issued Mandatory Service
Bulletin No.: 80-0381, Rev. 0, dated May 2, 2013. The actions described
in this service information are intended to correct the unsafe
condition identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Costs of Compliance

    We estimate that this proposed AD would affect 112 products of U.
S. registry. We also estimate that it would take about 1 work-hour per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour.
    Based on these figures, we estimate the cost of this proposed AD on
U.S. operators to be $9,520, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 5 work-hours and require parts costing $50, for a cost of
$475 per product. We have no way of determining the number of products
that may need these actions.

Paperwork Reduction Act

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

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Piaggio Aero Industries S.p.A: Docket No. FAA-2013-0964; Directorate
Identifier 2013-CE-035-AD.

(a) Comments Due Date

    We must receive comments by January 6, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Piaggio Aero Industries S.p.A Model P-180
airplanes, manufacturer serial numbers 1002 and 1004 through 1231,
certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority
of another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as
insufficient clearance between one of the horizontal stabilizer end
ribs and the corresponding elevator horn. We are issuing this
proposed AD to detect and correct insufficient clearance between one
of the horizontal stabilizer end rib and the corresponding elevator
horn, which could result in interference between the elevator and
horizontal stabilizer surfaces, consequently resulting in restricted
elevator control and reduced control of the airplane.

(f) Actions and Compliance

    Unless already done, do the following actions as specified in
paragraphs (f)(1) through (f)(3) of this AD:
    (1) Within 200 hours time-in service (TIS) after the effective
date of this AD or 12 months after the effective date of this AD,
whichever occurs first, measure the clearances between the horns of
the elevator and the end ribs of the horizontal stabilizer (HS) on
left-hand (LH) and right-hand (RH) sides following Part A of the
Accomplishment Instructions section of

Piaggio Aero Industries S.p.A. Mandatory Service Bulletin No.: 80-
0381, Rev. 0, dated May 2, 2013.
    (2) If the clearance is less than 5 mm on HS LH or RH side
during the measurement as required by paragraph (f)(1) of this AD,
before further flight, rework the affected elevator to restore the
required minimum clearance between the horn of the elevator and the
end rib of the horizontal stabilizer following Part B of the
Accomplishment Instructions section of Piaggio Aero Industries
S.p.A. Mandatory Service Bulletin No.: 80-0381, Rev. 0, dated May 2,
2013.
    (3) Within 30 days after accomplishment of the measurement as
required by paragraph (f)(1) of this AD, report the results to
Piaggio Aero Industries S.p.A. following Part C of the
Accomplishment Instructions section of Piaggio Aero Industries
S.p.A. Mandatory Service Bulletin No.: 80-0381, Rev. 0, dated May 2,
2013.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Mike Kiesov, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any airplane
to which the AMOC applies, notify your appropriate principal
inspector (PI) in the FAA Flight Standards District Office (FSDO),
or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.
2013-0239, dated September 30, 2013, for related information. You
may examine the MCAI on the Internet at http://www.regulations.gov
by searching for and locating it in Docket No. FAA-2013-0964. For
service information related to this AD, contact Piaggio Aero
Industries S.p.A--Airworthiness Office, Via Luigi Cibrario, 4-16154
Genova-Italy; phone: +39<PHONE_NUMBER>; fax: +39<PHONE_NUMBER>; email:
Internet: http://www.piaggioaero.com/#/en/aftersales/service-support. You may review this referenced service information at the
FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

    Issued in Kansas City, Missouri, on November 5, 2013.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2013-27639 Filed 11-19-13; 8:45 am]
BILLING CODE 4910-13-P