[Federal Register Volume 86, Number 101 (Thursday, May 27, 2021)]
[Notices]
[Pages 28662-28665]
[FR Doc No: 2021-11173]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91963; File No. SR-EMERALD-2021-18]

Self-Regulatory Organizations; MIAX Emerald, LLC; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt a
New Historical Market Data Product To Be Known as the Open-Close Report

May 21, 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 May 10, 2021, MIAX Emerald, LLC (``MIAX Emerald'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to adopt a new historical market data product
to be known as the Open-Close Report.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/emerald at MIAX
Emerald's principal office, 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 adopt a new historical market data product
to be known as the Open-Close Report, which will be available to all
Members and Non-Members.\3\ The proposed Open-Close Report would be
described in Exchange Rule 531(b)(1) and is based on market data
products currently available on most other options exchanges.\4\
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    \3\ The term ``Member'' means an individual or organization
approved to exercise the trading rights associated with a Trading
Permit. Members are deemed ``members'' under the Exchange Act. See
Exchange Rule 100.
    \4\ See Securities Exchange Act Release Nos. 89497 (August 6,
2020), 85 FR 48747 (August 12, 2020) (SR-CboeBZX-2020-059); 89498
(August 6, 2020), 85 FR 48735 (August 12, 2020) (SR-Cboe-EDGX-2020-
36); 85817 (May 9, 2019), 84 FR 21863 (May 15, 2019) (SR-CBOE-2019-
026); 89496 (August 6, 2020), 85 FR 48743 (August 12, 2020) (SR-C2-
2020-010); 89596 (August 17, 2020), 85 FR 51833 (August 21, 2020)
(SR-C2-2020-012); 62887 (September 10, 2010), 75 FR 57092 (September
17, 2010) (SR-Phlx-2010-121); 65587 (October 18, 2011), 76 FR 65765
(October 24, 2011) (SR-NASDAQ-2011-144); 61317 (January 8, 2010), 75
FR 2915 (January 19, 2010) (SR-ISE-2009-103); 62887 (September 10,
2010), 75 FR 57092 (September 17, 2010) (SR-Phlx-2010-121); 65587
(October 18, 2011), 76 FR 65765 (October 24, 2011) (SR-NASDAQ-2011-
144); and 81632 (September 15, 2017), 82 FR 44235 (September 21,
2017) (SR-GEMX-2017-42).
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    The Exchange proposes to offer the Open-Close Report, which will be
a volume summary of trading activity on the Exchange at the option
level by origin (Priority Customer, Non-Priority Customer, Firm,
Broker-Dealer, and Market Maker \5\), side of the market (buy or sell),
contract volume, and transaction type (opening or closing). The
Priority Customer, Non-Priority Customer, Firm, Broker-Dealer, and
Market Maker volume is further broken down into trade size buckets
(less than 100 contracts, 100-199 contracts, greater than 199
contracts). The Open-Close Report is proprietary Exchange trade data
and does not include trade data from any other exchange. It is also a
historical data product and not a real-time data feed. The Open-Close
Report would be described under proposed Exchange Rule 531(b)(1).\6\
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    \5\ See Exchange Rule 100 for the definitions of the terms
Priority Customer, Non-Priority Customer, Firm, Broker-Dealer, and
Market Maker.
    \6\ The Exchange also proposes to amend the title of Exchange
Rule 531 to include ``Market Data Products.''
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    Specifically, the Open-Close Report would include the following
data:
     Aggregate number of buy and sell transactions in the
affected series;
     Aggregate volume traded electronically on the Exchange in
the affected series;
     Aggregate number of trades effected on the Exchange to
open a position; \7\
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    \7\ The Open-Close Report would provide subscribers with the
aggregate number of ``opening purchase transactions'' in the
affected series. An opening purchase transaction is an Exchange
options transaction in which the purchaser's intention is to create
or increase a long position in the series of options involved in
such transaction. The Open-Close Report would also provide
subscribers with the aggregate number of ``opening writing
transactions.'' An opening writing transaction is an Exchange
options transaction in which the seller's (writer's) intention is to
create or increase a short position in the series of options
involved in such transaction.

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     Aggregate number of trades effected on the Exchange to
close a position; \8\
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    \8\ The Open-Close Report will provide subscribers with the
aggregate number of ``closing purchase transactions'' in the
affected series. A closing purchase transaction is an Exchange
options transaction in which the purchaser's intention is to reduce
or eliminate a short position in the series of options involved in
such transaction. The Open-Close Report would also provide
subscribers with the aggregate number of ``closing sale
transactions.'' A closing sale transaction is an Exchange options
transaction an Exchange options transaction in which the seller's
intention is to reduce or eliminate a long position in the series of
options involved in such transaction.
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     Origin of the orders and quotes involved in trades on the
Exchange in the affected series during a particular trading session,
specifically aggregated in the following categories of participants:
Priority Customer, Non-Priority Customer, Firm, Broker-Dealer, and
Market Maker.
    The Exchange anticipates a wide variety of market participants to
purchase the Open-Close Report, including, but not limited to,
individual customers, buy-side investors, and investment banks. The
Open-Close Report would provide subscribers data that should enhance
their ability to analyze option trade and volume data, and to create
and test trading models and analytical strategies. The Exchange
believes that Open-Close Report will be a valuable tool that
subscribers can use to gain comprehensive insight into the trading
activity in a particular option series. The proposed report is a
completely voluntary product, in that the Exchange is not required by
any rule or regulation to make this data available and that potential
subscribers may purchase it only if they voluntarily choose to do so.
The Exchange will establish a monthly subscriber fee for the Open-Close
Report by way of a separate proposed rule change, which the Exchange
will submit prior to the launch of the Open-Close Report.
    The Exchange proposes to offer two versions of the Open-Close
Report. One will contain historical data from the previous trading day
and will be available after the end of the trading day, generally on a
T+1 basis. The other version will include ``snapshots'' taken every 10
minutes throughout the trading day and would be available within five
minutes of the conclusion of each 10-minute period.
End of Day Report
    The end of day product would include the aggregate data described
above representing the entire trading session. It would be calculated
during an overnight process after the close of trading on the Exchange
and would be available to subscribers for download the following
morning at approximately 7:00 a.m., ET.
Intra-Day Report
    The Exchange also proposed to offer an intraday Open-Close Report
that would also include aggregated data described above, but would be
produced and updated every 10 minutes during the trading day. Data
would be captured in ``snapshots'' taken every 10 minutes throughout
the trading day and would be available to subscribers within five
minutes of the conclusion of each 10-minute period. For example,
subscribers to the intraday product would receive the first calculation
of intraday data no later than 9:45 a.m. ET, which represents data
captured from 9:30 a.m. to 9:40 a.m. Subscribers will receive the next
update by 9:55 a.m., representing the data previously provided
aggregated with data captured up to 9:50 a.m., and so forth. Each
update will represent combined data captured from the current
``snapshot'' and all previous ``snapshots'' and thus will provide open-
close data on an aggregate basis. The intraday Open-Close Report will
provide a volume summary of trading activity on the Exchange at the
option level by origin (Priority Customer, Non-Priority Customer, Firm,
Broker-Dealer, and Market Maker), side of the market (buy or sell), and
transaction type (opening or closing). All volume will be further
broken down into trade size buckets (less than 100 contracts, 100-199
contracts, greater than 199 contracts).
    The Exchange believes the proposed intraday Open-Close Report may
also provide helpful trading information regarding investor sentiment
that may allow market participants to make better trading decisions
throughout the day and may be used to create and test trading models
and analytical strategies and provides comprehensive insight into
trading on the Exchange. For example, intraday open data may allow a
market participant to identify new interest or possible risks
throughout the trading day, while intraday closing data may allow a
market participant to identify fading interests in a security.
2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with Section 6(b) of the Act \9\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \10\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
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 to protect investors and the public
interest, and that it is not designed to permit unfair discrimination
among customers, brokers, or dealers.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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    In adopting Regulation NMS, the Commission granted self-regulatory
organizations (``SROs'') and broker-dealers increased authority and
flexibility to offer new and unique market data to the public. It was
believed that this authority would expand the amount of data available
to consumers, and also spur innovation and competition for the
provision of market data. Particularly, the Open-Close Report further
broadens the availability of U.S. option market data to investors
consistent with the principles of Regulation NMS. The data product also
promotes increased transparency through the dissemination of the Open-
Close Report's data. The proposed rule change would benefit investors
by providing access to the Open-Close Report, which may promote better
informed trading throughout the trading day. Particularly, information
regarding opening and closing activity across different option series
during the trading day may indicate investor sentiment, which may allow
market participants to make better informed trading decisions
throughout the day. Subscribers to the data may also be able to enhance
their ability to analyze option trade and volume data and create and
test trading models and analytical strategies. The Exchange believes
the Open-Close Report provides a valuable tool that subscribers can use
to gain comprehensive insight into the trading activity in a particular
series, but also emphasizes such data is not necessary for trading.
    Moreover, other exchanges also off a substantially identical data
product.\11\ Specifically, NASDAQ OMX PHLX (``PHLX'') and the NASDAQ
Stock Market LLC (``NASDAQ'') offer the PHLX Options Trade Outline
(``PHOTO'') and NASDAQ Options Trade Outline (``NOTO''), respectively.
The Cboe Exchange, Inc. (``Cboe''), Cboe C2 Exchange, Inc. (``C2''),
Cboe BZX Exchange, Inc. (``BZX''), and Cboe EDGX

Exchange, Inc. (``EDGX'') all offer the market data products called the
End of Day and Intraday Open-Close Data. The Phlx, Nasdaq, Cboe, C2,
BZX, and EDGX products provide substantially the same information as
that included in the proposed Open-Close Report. Like the proposed
product, the data is provided to subscribers in the other exchange's
market data products after the end of the trading and cumulatively
every 10 minutes and provided within five minutes of the conclusion of
each 10-minute period.
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    \11\ See supra note 4.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. Rather, the
Exchange believes that the proposal will promote competition by
permitting the Exchange to offer a data product similar to those
offered by other competitor options exchanges.\12\ The Exchange is
proposing to introduce the Open-Close Report in order to keep pace with
changes in the industry and evolving customer needs, and believes this
proposed rule change would contribute to robust competition among
national securities exchanges. As noted, most other options exchanges
offer a market data product that is similar to the Open-Close
Report.\13\ As a result, the Exchange believes this proposed rule
change permits fair competition among national securities exchanges.
Therefore, the Exchange does not believe the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.
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    \12\ Id.
    \13\ Id.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A) of the Act \14\ and Rule 19b-4(f)(6) \15\ thereunder.
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) of the Act \16\ and Rule 19b-4(f)(6) \17\
thereunder.
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    \14\ 15 U.S.C. 78(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6).
    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of 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.
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    A proposed rule change filed under Rule 19b-4(f)(6) \18\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\19\ the Commission
may designate a shorter time if such action is consistent with
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposed
rule change may become operative on June 1, 2021, the anticipated date
upon which the Exchange expects to start to offer the Open-Close
Report. In support of its waiver request, the Exchange notes that other
exchanges offer a substantially identical data product.\20\ The
Commission believes that, as described above, the Exchange's proposal
does not raise any new or novel issues. Therefore, the Commission
believes that waving the 30-day operative delay is consistent with the
protection of investors and the public interest. Accordingly, the
Commission designates the proposed rule change to be operative on June
1, 2021.\21\
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    \18\ 17 CFR 240.19b-4(f)(6).
    \19\ 17 CFR 240.19b-4(f)(6).
    \20\ See supra note 11 and accompanying text.
    \21\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule'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 will institute proceedings to
determine whether the proposed rule change 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-EMERALD-2021-18 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-EMERALD-2021-18. 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-EMERALD-2021-18 and should be submitted
on or before June 17, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
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    \22\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-11173 Filed 5-26-21; 8:45 am]
BILLING CODE 8011-01-P


effects from environmental stressors.\105\ Underserved communities may
have a compromised ability to cope with or recover from such exposures
due to a range of physical, chemical, biological, social, and cultural
factors.\106\ The EPA is committed to environmental justice for all
people, and we acknowledge that the San Joaquin Valley nonattainment
area includes minority and low income populations that are subject to
higher levels of PM2.5 and other pollution relative to State
and national averages, and that such concerns could be affected by this
action.
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    \105\ EPA, ``Technical Guidance for Assessing Environmental
Justice in Regulatory Analysis,'' June 2016, section 4.
    \106\ Id. at section 4.1.
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    Regarding the specific contingency measures proposed herein, we
have considered the geographic scope of each proposed contingency
measure on PM2.5 concentrations in each county of the San
Joaquin Valley, as well as other environmental considerations that
pertain to applicable pollutant (i.e., combustion PM2.5,
dust PM2.5, or NOX) and the applicable source
category or categories.
    For residential wood burning, our proposed contingency measure
would lower the No Burn (i.e., curtailment) thresholds for the five
non-hot spot counties (Kings, Merced, San Joaquin, Stanislaus, and
Tulare counties) to match the tighter No Burn thresholds for the three
hot spot counties (Fresno, Madera, and Kern counties). A prominent
effect of this change would be to provide similar protections to people
in the two southern-most non-hot spot counties that record among the
highest year-to-year PM2.5 design values in the San Joaquin
Valley (i.e., Kings County, including Corcoran and Hanford monitoring
sites, and Tulare County, including Visalia monitoring site).\107\ Were
No Burn days to be called in Kings or Tulare County according to the
more stringent thresholds, we also anticipate there would be smaller
but still beneficial effect in the adjacent Fresno or Kern counties,
depending on the meteorology of the day.
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    \107\ For example, the certified 2020-2022 PM2.5
design value for Visalia (AQS Site ID 061072003) is 18.4 [micro]g/
m\3\ for the 2012 annual PM2.5 NAAQS and 65 [micro]g/m\3\
for the 2006 24-hour PM2.5 NAAQS. EPA design value
workbook dated May 23, 2023,
``PM25_DesignValues_2020_2022_FINAL_05_23_23.xlsx,'' worksheets
``Table5a. Site Status Ann'' and ``Table5b.Site Status 24hr.'' The
certified design value includes all available data; no data flagged
for exceptional events have been excluded. The EPA's Air Quality
System (AQS) contains ambient air pollution data collected by
federal, state, local, and tribal air pollution control agencies
from thousands of monitors. More information is available at:
https://www.epa.gov/aqs.
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    Where these direct PM2.5 emission reductions from
combustion occur, we also note that they do not require further
chemical transformation in the atmosphere to form PM2.5
(i.e., the benefit is immediate) and, as they include fine particulate
matter under one micron and toxic air chemicals, the reduction of such
sub-micron particles would similarly reduce exposure of all residents
in these areas, including minority and low-income populations to these
environmental stressors. These reductions would also specifically
reduce emissions on the winter days with the highest ambient
PM2.5 levels. We also note that environmental and community
groups have recommended several measures to reduce direct
PM2.5 emissions from residential wood burning, including a
recommendation that requirements apply District-wide, rather than
distinguishing between hot spot and non-hot spot counties.\108\ The
proposed measure, if triggered, would align all counties to the tighter
No Burn thresholds of the hot spot counties.
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    \108\ Letter dated May 18, 2022, from Tom Frantz, Association of
Irritated Residents, et al., to Michael S. Regan, EPA Administrator,
May 18, 2022, Attachment A, Attachment, 2; Attachment B, 2, 7; and
Attachment C, 2, 16-17, 38-48, and 69.
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    For open areas, the proposed contingency measure, if triggered,
would lower the applicability threshold for the rural open area
requirements of Rule 8051 (i.e., for parcels having at least 1,000
square feet of disturbed soil) from 3.0 acres to 1.0 acre. Based on our
analysis of land use to date, such rural open areas are found in all
counties of the San Joaquin Valley, though with some variation from
county to county consistent with overall land use types (e.g., San
Joaquin County has the smallest proportion of rural open areas, while
Madera County has the highest proportion of rural open areas).
Furthermore, there is variation in the number of rural open areas that
would be newly subject to the rule, i.e., those between 1.0 to 3.0
acres in size (e.g., Kern County has the most total rural open area
acreage from parcels between 1.0 to 3.0 acres in size, while Tulare
County has the least). Given the overall land use and emission factors,
as discussed further in the EPA's Proposed Contingency Measures TSD,
and assuming roughly equal levels of activity in each county (i.e.,
soil disturbances over 1,000 square feet), we anticipate that the
proposed contingency measure would provide air quality benefits in all
counties of the San Joaquin Valley, with most air quality benefits
occuring in Fresno, Kern, Kings and Madera counties.
    Given that Rule 8051 for open areas was originally introduced as a
PM10 control measure, we anticipate that the proposed
measure would provide co-benefits to limiting PM10 levels in
the San Joaquin Valley, with the same geographical distribution as
discussed herein for direct PM2.5 emission reductions.\109\
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    \109\ We also note that environmental and community groups have
recommended that fugitive dust sources in the San Joaquin Valley be
subject to specific requirements rather than having the option to
select from a menu of control requirements in Rule 8011 (where the
definition for open areas is found). Letter dated May 18, 2022, from
Tom Frantz, Association of Irritated Residents, et al., to Michael
S. Regan, EPA Administrator, Attachment B, 7. The proposed measure
would not alter the existing structure but rather tighten the
applicability threshold for rural open areas.
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V. Proposed Action and Request for Public Comment

    The EPA is proposing to promulgate a FIP under CAA section 110(c)
intended to meet the CAA section 172(c)(9) requirements for contingency
measures for purposes of the 1997 annual PM2.5 NAAQS, the
2006 24-hour PM2.5 NAAQS, and the 2012 annual
PM2.5 NAAQS (Moderate area requirements only) for the San
Joaquin Valley PM2.5 nonattainment area. The contingency
measures would apply to residential wood burning heaters and fireplaces
and rural open areas. Unless and until replaced through the EPA's
approval of a contingency measure SIP submission, the proposed FIP, if
finalized, would be implemented by the EPA, or by the State or District
if the EPA delegates that authority to the State or District.
    We will accept comments from the public on these proposals for the
next 45 days. The deadline and instructions for submission of comments
are provided in the DATES and ADDRESSES sections at the beginning of
this proposed rule.

VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review

    This is not a significant regulatory action subject to review by
the Office of Management and Budget under Executive Orders 12866 (58 FR
51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023).

B. Paperwork Reduction Act

    The information collection activities in this proposed rule have
been submitted to the Office of Management and Budget (OMB) for
approval under the PRA. The Information Collection Request (ICR)
document that the EPA has prepared has been assigned EPA ICR number
2782.01. You can find a copy of the ICR in the docket for this rule,
and it is briefly summarized here.
    This ICR covers information collection requirements in a CAA FIP
for contingency measures for the 1997 annual, 2006 24-hour, and 2012
annual fine particulate matter (PM2.5) national ambient air
quality standards (NAAQS) in the San Joaquin Valley PM2.5
nonattainment area in California (40 CFR part 52, subpart F, Sec.
52.249), herein referred to as the SJV FIP.
    The EPA's proposed FIP will include provisions to lower the
existing applicability threshold of District Rule 8051 for rural areas
from 3.0 acres or larger with at least 1,000 square feet of disturbed
surface area to 1.0 acres or larger with the same square footage of
disturbed surface area. If this FIP contingency measure is enacted and
triggered, dust minimization control measures and recordkeeping and
annual reporting would be required for the newly regulated parcels when
owners or operators disturb the surface of the applicable rural open
areas. In general, such owners or operators will be required to
maintain records of rule compliance consistent with the requirements
applicable to those owners or operators already subject to the rule,
with two additional requirements. First, the EPA would add a
requirement that owners and operators of rural open areas newly subject
to the requirements of Rule 8051 pursuant to this FIP use two existing
District forms for such recordkeeping, which the EPA intends to adapt
for use in connection with this proposed FIP contingency measure.
Second, while the EPA generally would apply the same record retention
requirements found in the District rule to newly subject owners and
operators--i.e., the requirement to maintain records for one year
following project completion, except for owners/operators subject to
Rule 2520, who must retain records for five years--the EPA would also
add a requirement that the owners and operators of rural open areas who
perform such recordkeeping pursuant to the FIP contingency measure
submit copies of the records prepared during a calendar year to the EPA
by March 31st of the following year. These records and reports are
essential in determining compliance and are required of all sources
subject to this proposed FIP that disturb the surface of applicable
rural open areas.
    Respondents/affected entities: Potential respondents are owners or
operators of open area parcels that range in size of at least 1.0 acre
but less than 3.0 acres and which contain at least 1,000 square feet of
disturbed surface area in the San Joaquin Valley PM2.5
nonattainment area.
    Respondents' obligation to respond: Mandatory (CAA sections 110 and
114(a)).
    Estimated number of respondents: 3,546.
    Frequency of response: An annual report is required for any year in
which an owner or operator's rural open area parcel triggers the FIP's
open area dust control requirements. Records showing adherence to such
requirements must be maintained for one year, or for five years for
certain sources, when the control requirements are triggered.
    Total estimated burden: 3,546 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $360,923 (per year), includes $0 in
annualized capital or operation & maintenance costs.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden using the docket identified at the
beginning of this rule. The EPA will respond to any ICR-related
comments in the final rule. You may also send your ICR-related comments
to OMB's Office of Information and Regulatory Affairs using the
interface at https://www.reginfo.gov/public/do/PRAMain. Find this
particular information collection by selecting ``Currently under
Review--Open for Public Comments'' or by using the search function. OMB
must receive comments no later than September 7, 2023.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
proposed rule includes two separate contingency measures: one
applicable to residential wood burning heaters and fireplaces and one
applicable to rural open areas. The proposed residential wood burning
measure primarily applies to private residents, which do not qualify as
small entities, but also applies to businesses, such as restaurants and
hotels, some of which constitute ``small entities.'' However, the
proposed measure is not expected to impose any additional costs because
any increase in heating costs during additional curtailment days would
be offset by savings on purchases of seasoned wood or pellets, which
these entities would otherwise be allowed to burn.\110\
---------------------------------------------------------------------------

    \110\ June 2023 Contingency Measure SIP Submission, App. D
(``Economic Analysis for Rule 4901''), D-3.
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    The ``small entities'' subject to the requirements of the rural
open areas measure are those that are owners/operators of residential
and commercial lots in rural areas with open areas (i.e., vacant
portions of residential or commercial lots and contiguous parcels) of
1.0 acre or more and less than 3.0 acres in the San Joaquin Valley, and
which contain at least 1,000 square feet of disturbed surface area, as
defined in District Rule 8011, section 3.36. These ``small entities''
may include industrial entities such as construction, oilfield,
equipment and vehicle storage, and truck stop owners/operators, as
identified in the District's ``Regulation VIII Recordkeeping Reporting
Forms'' (revised June 1, 2009), as well as other residential,
industrial, institutional, governmental, or commercial lot owners/
operators. To identify the small entities for these industries, the EPA
identified North American Industry Classification System (NAICS) codes,
the applicable small entity thresholds (based on the U.S. Small
Business Administration's table of small business size standards), and
then compared the cost of the proposed rural open areas measure against
average annual receipts data available from the Census Bureau's
Statistics of U.S. Businesses for 2017 (the latest year for which
annual receipts are listed by NAICS). The

Agency has determined that, while most potentially affected entities in
these industries are small, such entities in the San Joaquin Valley may
experience an impact of 0% to 0.58% of annual revenues (i.e., not a
significant impact). Details of this analysis are presented in section
III.F of the EPA's Proposed Contingency Measures TSD.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local, or tribal governments. To the extent that the contingency
measures of this proposed rule, if triggered, would impose costs on the
private sector, they would collectively be less than the $100 million
expenditure threshold identified in 2 U.S.C. 1532(a).

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not 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.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175, because this proposed rule would not apply on
any Indian reservation land or in any other area where the EPA or an
Indian tribe has demonstrated that a tribe has jurisdiction, and will
not impose substantial direct costs on tribal governments or preempt
tribal law. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to
any rule that: (1) is determined to be economically significant as
defined under Executive Order 12866; and (2) concerns an environmental
health or safety risk that we have reason to believe may have a
disproportionate effect on children. The EPA interprets Executive Order
13045 as applying only to those regulatory actions that concern health
or safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because it is not
economically significant under Executive Order 12866 and because it
implements specific standards established by Congress in statutes.
However, to the extent this proposed rule will reduce emissions of
direct PM2.5 or NOX (as a PM2.5
precursor), the rule will have a beneficial effect on children's health
by reducing air pollution.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not a significant regulatory action under
Executive Order 12866.

I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Population

    Executive Order 12898 (59 FR 7629 (February 16, 1994)) directs
Federal agencies to identify and address ``disproportionately high and
adverse human health or environmental effects'' of their actions on
minority populations and low-income populations to the greatest extent
practicable and permitted by law. The EPA defines environmental justice
(EJ) as ``the fair treatment and meaningful involvement of all people
regardless of race, color, national origin, or income with respect to
the development, implementation, and enforcement of environmental laws,
regulations, and policies.'' The EPA further defines the term fair
treatment to mean that ``no group of people should bear a
disproportionate burden of environmental harms and risks, including
those resulting from the negative environmental consequences of
industrial, governmental, and commercial operations or programs and
policies.'' Consistent with the EPA's discretion under the CAA, the EPA
has evaluated the environmental justice considerations of this action,
as is described in section IV (``Environmental Justice
Considerations'') of this proposed rule. The analysis was done for the
purpose of providing additional context and information about this
rulemaking to the public, not as a basis of the action. Due to the
nature of the action being proposed, this proposed action is expected
to have a neutral to positive impact on the air quality of the San
Joaquin Valley. In addition, the information in the record is
sufficient to support the stated goal of Executive Order 12898 of
achieving environmental justice for people of color, low-income
populations, and Indigenous peoples.

List of Subjects 40 CFR Part 52

    Environmental protection, Air pollution control, Ammonia,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Particulate matter, Reporting and recordkeeping requirements,
Sulfur dioxide, Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

Michael S. Regan,
Administrator.

    For the reasons stated in the preamble, part 52 of title 40 of the
Code of Federal Regulations is proposed to be amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for Part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.249 is added to read as follows:

Sec.  52.249  Contingency measures--San Joaquin Valley Air Basin.

    (a) The requirements of section 172(c)(9) of the Clean Air Act and
40 CFR 51.1014 are not met in the San Joaquin Valley Air Basin for the
1997 Annual PM2.5 NAAQS, the 2006 24-hour PM2.5
NAAQS, and the 2012 annual PM2.5 NAAQS.
    (1) Triggers for implementation of contingency measures. The
provisions in paragraphs (a)(2) and (3) of this section shall apply 60
days after the effective date of a final EPA determination under 40 CFR
51.1014(a) for the 1997 Annual PM2.5 NAAQS, the 2006 24-hour
PM2.5 NAAQS, or the 2012 annual PM2.5 NAAQS.
    (2) Wood burning fireplaces and wood burning heaters. The
requirements of Sec.  52.220(c)(535)(i)(A)(1) shall apply except as
provided in paragraphs (a)(2)(i), (ii) and (iii) of this section.
    (i) The episodic wood burning curtailment provisions of Paragraphs
<IP_ADDRESS> and <IP_ADDRESS> shall apply throughout the entire jurisdiction of
the San Joaquin Valley Unified Air Pollution Control District.

    (ii) The episodic wood burning curtailment provisions in Paragraphs
<IP_ADDRESS> and <IP_ADDRESS> are deleted.
    (iii) The EPA shall notify the public of each episodic wood burning
curtailment required pursuant to this paragraph (a)(2) of this section
by any of the following methods:
    (A) Provide notice to newspapers of general circulation within the
San Joaquin Valley.
    (B) Broadcast of messages presented by radio or television stations
operating in the San Joaquin Valley.
    (C) A recorded telephone message for which the telephone number is
published.
    (D) Messages posted on the EPA's website.
    (E) Any other method as the EPA determines is appropriate.
    (3) Rural open areas dust. The requirements of Sec.
52.220(c)(334)(i)(B)(2) shall apply except as provided in paragraphs
(a)(3)(i) and (ii) of this section.
    (i) The Applicability provision in Paragraph 2.0 is revised to the
following:
    This rule applies to any open area having 0.5 acres or more within
urban areas, or 1.0 acres or more within rural areas; and contains at
least 1,000 square feet of disturbed surface area.
    (ii) The Recordkeeping provision in Paragraph 6.2 is revised to the
following:
    An owner/operator shall comply with the recordkeeping requirements
of Sec.  52.220(c)(334)(i)(B)(2), except that owners/operators of open
areas of 1.0 acres or more to less than 3.0 acres within rural areas
shall use forms made available by the EPA and shall submit copies of
the forms prepared during a calendar year to the EPA by March 31st of
the following year.
    (iii) Records that are required to be submitted under this rule
must be sent to: U.S. EPA Region IX, Rules Section Manager, Air and
Radiation Division (Air-3-2), 75 Hawthorne Street, San Francisco, CA
94105.
    (b) In the event that paragraphs (a)(2) and (3) of this section are
triggered, and within one year of the triggering of paragraphs (a)(2)
and (3) of this section, the Administrator shall undertake rulemaking
to promulgate any contingency measures that are determined to be
appropriate for the EPA and needed to meet the contingency measure
requirement for the 1997 annual PM2.5 NAAQS, the 2006 24-
hour PM2.5 NAAQS, or the 2012 annual PM2.5 NAAQS
in the San Joaquin Valley.
    (c) This section shall not apply on any Indian reservation land or
in any other area where the EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction.
    (d) The Administrator may delegate the authority to implement the
measures in paragraph (a)(2) or (3) of this section to the San Joaquin
Valley Unified Air Pollution Control District or to the California Air
Resources Board. Nothing in this paragraph shall prevent the
Administrator from implementing or enforcing the measures in paragraphs
(a)(2) and (3) of this section.

[FR Doc. 2023-16748 Filed 8-7-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 190 (Monday, October 3, 2022)]
[Rules and Regulations]
[Pages 59695-59697]
[FR Doc No: 2022-21355]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2021-0483; FRL-9158-02-R2]

Approval of Air Quality Implementation Plans; New York; Revisions
to Architectural and Industrial Maintenance Coatings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a
revision to the New York State Implementation Plan (SIP) for the
purposes of implementing control of air pollution for volatile organic
compounds (VOC). The final SIP revision consists of amendments to
regulations outlined within New York's Codes, Rules, and Regulations
(NYCRR) that implement control measures for architectural and
industrial maintenance coatings. The effect of this action is to
approve control strategies which will result in VOC emission reductions
that will help attain and maintain the national ambient air quality
standards for ozone. These actions are being taken in accordance with
the requirements of the Clean Air Act.

DATES: This final rule is effective on November 2, 2022.

ADDRESSES: The EPA has established a docket for this action under
Docket ID Number EPA-R02-OAR-2021-0483. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available electronically through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Linda Longo, Air Programs Branch,
Environmental Protection Agency, 290 Broadway, New York, New York
10007-1866, at<PHONE_NUMBER>, or by email at [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What is the background for this action?
II. What comments were received in response to the EPA's proposed
action?
III. What action is the EPA taking?
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. What is the background for this action?

    On August 11, 2022 (87 FR 49570), the EPA published a notice of
proposed rulemaking that proposed to approve a State Implementation
Plan (SIP) revision submitted by the State of New York on October 15,
2020, for purposes of revising title 6 of the NYCRR, part 205,
``Architectural and Industrial Maintenance Coatings.'' The EPA's
evaluation recognizes that the SIP revision is consistent with the
Ozone Transport Commission Model Rule for AIM coating categories and
will help the State attain the National Ambient Air Quality Standards
(NAAQS) by improving air quality through reduced VOC emissions and
promoting regional AIM coating consistency. The specific details of New
York's SIP revision submittal and the rationale for the EPA's approval
action are explained in the EPA's proposed rulemaking and are not
restated in this final action. For this detailed information, the
reader is referred to the EPA's August 11, 2022, proposed rulemaking
(87 FR 49570). The attendant revisions to 6 NYCRR part 200, ``General
Provisions,'' section 200.9, Table 1, ``Referenced material,'' for 6
NYCRR part 205 have been addressed under a separate rulemaking at 87 FR
52337, effective September 26, 2022.

II. What comments were received in response to the EPA's proposed
action?

    The EPA provided a 30-day review and comment period for the August
11, 2022, proposed rule. The comment period ended on September 12,
2022. We received no comments on the EPA's action.

III. What action is the EPA taking?

    The EPA is approving New York's revisions to the New York SIP and
amendment to 6 NYCRR part 205, ``Architectural and Industrial
Maintenance Coatings,'' with a State effective date of January 11,
2022. Specifically, this rulemaking will reduce VOC emissions for 12
coating categories, create VOC limits for 12 additional coating
categories, eliminate 15 coating categories without relaxation of the
regulation, and narrow the exemption previously provided to coatings
sold in one-liter (or quart-size) containers, referred to the as the
``quart exemption.'' The revisions will help the State to comply with
Federal requirements pertaining to attainment and maintenance of the
ozone NAAQS.

IV. Incorporation by Reference

    In this document, the EPA is finalizing regulatory text that
includes incorporation by reference. In accordance with requirements of
1 CFR 51.5, the EPA is finalizing the incorporation by reference of the
6 NYCRR part 205, ``Architectural and Industrial Maintenance
Coatings,'' regulations described in the amendments to 40 CFR part 52
as discussed in section III of this preamble.

The EPA has made, and will continue to make, these materials generally
available through www.regulations.gov and at the EPA Region 2 Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information). Therefore,
these materials have been approved by the EPA for inclusion in the
State Implementation Plan, have been incorporated by reference by the
EPA into that plan, are fully federally enforceable under sections 110
and 113 of the CAA as of the effective date of the final rulemaking of
the EPA's approval, and will be incorporated by reference in the next
update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    This action is subject to the Congressional Review Act, and the EPA
will submit a rule report to each House of the Congress and the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by December 2, 2022. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

Lisa Garcia,
Regional Administrator, Region 2.

    For the reasons set forth in the preamble, 40 CFR part 52 is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart HH--New York

0
2. In Sec.  52.1670, paragraph (c) is amended in the table by revising
the entry for ``Title 6, Part 205'' to read as follows:

Sec.  52.1670  Identification of plan.

* * * * *
    (c) * * *

                                EPA-Approved New York State Regulations and Laws
----------------------------------------------------------------------------------------------------------------
                                                                State       EPA approval
          State citation                Title/subject      effective date       date              Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Title 6, Part 205.................  Architectural and           1/11/2022       10/3/2022   EPA approval
                                     Industrial                                             finalized at [insert
                                     Maintenance Coatings.                                  Federal Register
                                                                                citation].

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

* * * * *
[FR Doc. 2022-21355 Filed 9-30-22; 8:45 am]
BILLING CODE 6560-50-P


5/ 17/ 06 Request for Additional Information and Suggestions for the Reregistration of Aldicarb Public Comment Period:

Dear Reader:

The purpose of this document is to summarize the current human health risk picture for aldicarb and solicit mitigation options. The preliminary human health risk assessments will be released for 60 day public comment period May 17, 2006, and will end July 17, 2006.

Human Studies Review Board A human toxicity intentional dosing study was used in the aldicarb risk assessment. EPA's use of a human toxicity study in the aldicarb risk assessment is in accordance with the Agency's Final Rule promulgated on January 26, 2006. For additional information relating to the Human Studies Review Board determination for the adicarb specific study used in the risk assessment, refer to EPA's website at http:// www. epa. gov/ osa/ hsrb/.

Dietary Risks Under the Food Quality Protection Act ( FQPA), all food and drinking water risks for a given pesticide must fit within the pesticide's " risk cup". The risk cup can be simply defined as the " acceptable level of exposure" to an individual from a pesticide, on an acute or chronic basis. When dietary risks are of concern, EPA is required to mitigate the risks down to acceptable levels.

The current dietary ( food only) risk assessment utilizes PDP and the Carbamate Task Force ( CTF) market basket data for potatoes and citrus, respectively. Field trial data were used for all other commodities ( except sorghum, sugar beet and sugar cane); however, residues were either very low or non detectable. Percent crop treated information and processing/ cooking data were also utilized where appropriate. It's important to note that since aldicarb is systemic, typical food preparation practices such as washing and peeling are not expected to significantly reduce residues.

Sugar beet and sugarcane were excluded from the assessment since aldicarb residues are not expected in the processed commodities as consumed. A low tolerance level was used for sorghum as well as percent crop treated but resulting estimates did not contribute to risk.

Estimated acute dietary exposure and risk from food alone exceed EPA's level of concern ( i. e., > 100 % of the aPAD) for children 1 2 years and children 3 5 years old when compared to the rat red blood cell ( RBC) cholinesterase inhibition ( ChEI) endpoint. The estimated dietary risks for these two population subgroups at the 99.9th percentile of exposure were 159% and 129%, of the acute population adjusted dose ( aPAD), respectively. For the general U. S. population, the dietary risk was 72% of the aPAD. Estimated risks were below EPA's level of concern ( i. e., < 100 % of the aPAD) at the 99.8th percentile for both children 1 2 years old and children 3 5 years old. Because dietary exposure estimates were above EPA's level of concern at the 99.9th percentile of exposure, an analysis was conducted to determine which food or food forms made the greatest contribution to dietary risk. For all population subgroups, aldicarb residues in potatoes were the most significant source of dietary exposure. When potatoes are removed from the dietary exposure assessment, all remaining risk estimates are below EPA's level of concern. Drinking Water Risks Since acute dietary risks from food alone were above EPA's level of concern ( i. e., > 100 % of the aPAD), a drinking water only assessment was conducted. If all of the allowable exposure occurred through drinking water, EPA would not have concerns for acute exposure to aldicarb residues in surface water. Acute surface water risk estimates for infants, the most highly exposed population subgroup, range from 1% of the aPAD [ potatoes] to 15% of the aPAD [ cotton] at the 95th percentile of exposure. Acute surface water risk estimates for the general U. S. population and all other population subgroups ranged from < 1% of the aPAD to 7% of the aPAD.

Seven regional ground water monitoring residue levels were used to derive an acute dietary exposure estimate for ground water alone. The data indicate that acute exposure from ground water sources of drinking water is of concern, with acute risk estimates ranging from 20% of the aPAD to 945% of the aPAD.

Drinking water risks based on ground water monitoring data overestimate the risks for all but those who obtain their drinking water from wells in vulnerable aldicarb use areas. However, since acute food only exposures exceed the aPAD, EPA is concerned about any additional exposure ( to all subpopulations) through drinking water, regardless of the source.

Occupational Risks The occupational risk assessment for aldicarb is based on potential exposure to agricultural workers during loading and application of granular products. Aldicarb is applied early in the growing season, and labels require immediate soil incorporation of granules; postapplication exposures are not expected for workers, so a quantitative postapplication risk assessment has not been conducted.

Unlike some pesticides, aldicarb has worker exposure data that has been conducted with aldicarb and mirrors how aldicarb is packaged, handled, and used in agriculture. This study was used to conduct the occupational risk assessment for aldicarb. Pesticide Handler's Exposure Data ( PHED) were also used in conducting the risk assessment since the aldicarb specific study did not quantify potential risks from closed loading and closed cab scenarios. Therefore, for the portion of the occupational assessment which used the aldicarb specific worker exposure data, risks were not of concern for most loader and applicator exposure scenarios. However, risks for loaders were identified for two scenarios ( MOEs for loaders range from 14 to 130 and MOEs for applicators range from 34 to 324).

When using the PHED data for the closed loading and closed cab scenarios, similar results to those found with the aldicarb specific study were noted for loaders. However, when using PHED data for applicators, all scenarios exceeded EPA's level of concern ( MOEs for loaders range from14 to 139; MOEs for applicators range from 1 to 13).

Environmental Risks The environmental risk assessment is based on maximum rates and average usage rates of aldicarb. The environmental risk assessment includes risks to terrestrial and aquatic organisms. Using multiple lines of evidence ( such as use scenarios, average or " typical" application rates, registrant submitted toxicity studies, open literature data, and field monitoring data), aldicarb poses acute risks ( mortality) to birds, mammals, and aquatic organisms. In addition, there is the potential for chronic reproductive effects in fish and invertebrates.

Terrestrial Organisms For terrestrial organisms, acute levels of concern are consistently exceeded by a factor of greater than 100x and are frequently exceeded by more than 1000x. Granules left exposed on the surface appear to be the main source of exposure, but other sources such as residues taken up by plants and contaminated earthworms may also serve as a means of exposure.

Aquatic Organisms For aquatic organisms, there are acute risks for freshwater fish and invertebrates and estuarine/ marine fish and invertebrates for all of the registered uses with the exception of potatoes for freshwater fish and invertebrates and estuarine/ marine fish.

The chronic level of concern is exceeded for freshwater invertebrates ( reproductive effects) and estuarine/ marine invertebrates ( average number of offspring endpoint) for all of the registered uses. Chronic concerns ( larval and juvenile survival) also exist for freshwater fish for soybean, cotton, and pecan use patterns.

Aldicarb residues are most likely to exceed levels of concern for fish and aquatic invertebrates in low order streams because these streams are dominated by base flow conditions ( where 100% of stream flow consists of discharged groundwater), and most of the toxic residues are believed to form within the subsurface ( especially within the saturated zone). In addition, much larger contributing land areas sustain higher order streams, so there is a greater dilution effect. In addition to risk based exposure estimates from modeling, there were also exceedances of the Agency levels of concern based on monitoring data.

Solicitation for Benefits Information and Risk Management Suggestions At this time the dietary and occupational risks from aldicarb are of concern for some registered uses. In addition, the Agency has performed preliminary alternatives analyses, to identify available alternatives for the uses of aldicarb that pose the highest risks ( see " Preliminary Impact Analysis for Aldicarb on Potatoes", " Preliminary Impact Analysis for Aldicarb on Major Citrus Crops", and " Impact Analysis for Aldicarb on Cotton"). It is important to note that FQPA does not allow for the consideration of benefits analyses for risks associated with dietary exposure assessments; therefore, benefits analyses play an important role in only non dietary considerations, such as ecological and worker risks. Alternative analyses for potatoes, citrus and cotton are available in the docket, and show that although there are alternatives available for aldicarb, they tend to be more costly and less effective. At this time, the Agency has not been able to identify many viable options for effectively mitigating the dietary risks from aldicarb. Thus, EPA is soliciting input from interested stakeholders on benefits information ( i. e. critical uses of aldicarb, and impacts to growers from the loss of aldicarb), as well as risk management suggestions. If you would like to provide this type of input, please submit your comments directly to the docket.

Here is a list of sample questions that may help you in preparing comments:

( 1) In what regions ( state/ county, etc.) of the U. S. is aldicarb use occurring? ( 2) What are the pests that you feel aldicarb is critical for controlling? ( 3) What are the details of typical usage patterns ( e. g., number of applications per season, use rate per application, acres treated, and time of application in the season?) ( 4) What worker activities typically occur when aldicarb is applied? ( 5) What alternatives, if any, do you believe are available to replace aldicarb?

Please provide as much detail and documentation in your comments as possible so that the Agency is fully informed in its decision making.


[Federal Register Volume 88, Number 158 (Thursday, August 17, 2023)]
[Notices]
[Pages 56024-56025]
[FR Doc No: 2023-17718]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3104]

Optimizing the Use of Postapproval Pregnancy Safety Studies;
Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Optimizing the Use of Postapproval Pregnancy Safety
Studies'' convened by the Duke-Margolis Center for Health Policy and
supported by a cooperative agreement between FDA and Duke-Margolis.
This workshop will include discussions of designs of postapproval
pregnancy safety studies for drug and biological products regulated by
the Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER) and experiences with
implementing these studies. The workshop also will include discussion
of considerations for further development of a framework that describes
how data from different types of postapproval pregnancy safety studies
might optimally be used when it has been determined that this data
should be collected.

DATES: The public workshop will be held in person and virtually on
September 18, 2023, from 10 a.m. to 4 p.m., Eastern Daylight Time, and
on September 19, 2023, from 10 a.m. to 2:30 p.m. Either electronic or
written comments on this public workshop must be submitted by November
30, 2023. See the SUPPLEMENTARY INFORMATION section for registration
date and information.

ADDRESSES: The public workshop will be held in person at the National
Press Club, 529 14th St. NW, Washington, DC 20045 and virtually using
the Zoom Platform. The link for the public workshop will be sent to
registrants upon registration for virtual attendance.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered for the subsequent workshop
report describing the proposed framework, which will be published by
October 2, 2024. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time on November
30, 2023. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are received on or
before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-3104 for ``Optimizing the Use of Postapproval Pregnancy
Safety Studies.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions: To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments. You must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Commander Vicky Chan, Food and Drug
Administration, CDER, 10903 New Hampshire Ave., Bldg. 22, Rm. 3404,
Silver Spring, MD 20993,<PHONE_NUMBER>, [email protected] or Anne
Taylor, CBER, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the United States, approximately 5.5 million pregnancies occur
each year (Ref. 1). Half of individuals who are pregnant use at least
one drug or biological product to treat chronic (e.g., diabetes,
seizure disorders, or asthma), acute (e.g., infection) or serious
medical conditions (Ref. 2). Typically at the time of initial market
approval, there are limited to no human data on the safety of drug or
biological products used during pregnancy. As a result, for most
products, human pregnancy safety data are collected after a product is
available on the market (i.e., postapproval).
    In May 2019, FDA published a draft Guidance for Industry entitled
``Postapproval Pregnancy Safety Studies'' (available at https://www.fda.gov/media/124746/download), which discusses the strengths and
limitations of postapproval study types including studies based on
registry data and cohort studies using electronic health records or
claims data. However, more research is needed to better understand the
key considerations for determining the optimal postapproval study
designs to obtain timely evidence to ensure the safe use of drug and
biological products in pregnant individuals. The public workshop is a
preliminary discussion with stakeholders to inform FDA's further
development of a framework and also meets a performance goal under the
FDA User Fee Reauthorization Act of 2022, in accordance with the
Prescription Drug User Fee Act (PDUFA) Reauthorization Performance
Goals and Procedures Fiscal Years 2023 Through 2027 letter (PDUFA VII
Commitment Letter), which is available at https://www.fda.gov/media/151712/download. Specifically, the PDUFA VII Commitment Letter outlines
the commitment of a public workshop to discuss postapproval pregnancy
safety studies to facilitate determination of ideal study designs.

II. Topics for Discussion at the Public Workshop

    The public workshop will include the following topics for
discussion:
    1. FDA's considerations for constructing a framework describing how
data from different types of post-market pregnancy safety studies might
optimally be used.
    2. Stakeholders' perspectives on opportunities to optimize
postapproval pregnancy safety study types and designs.
    3. Design considerations and potential approaches to bridge
knowledge gaps in developing the framework, including understanding how
the Sentinel Initiative (i.e., Sentinel System and Biologics
Effectiveness and Safety (BEST)) may address these gaps.
    4. Stakeholders' perspectives on considerations for FDA's proposed
framework.
    Meeting updates, the agenda, and background materials (if any) will
be made available at https://duke.is/nj5kg prior to the workshop.

III. Participating in the Public Workshop

    Registration: To register for this hybrid public workshop, please
visit the following website: https://duke.is/nj5kg. Please provide
complete contact information for each attendee, including attendance
format (in-person or virtual), name, title, affiliation, and email.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by 10 a.m. Eastern Daylight Time, September 18,
2023. Early registration is recommended due to limited seating;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive a confirmation email when they
have been registered.
    If you need special accommodations due to a disability, please
contact Luke Durocher, Duke-Margolis Center for Health Policy, 202-621-
2800, [email protected], no later than 5 p.m. Eastern Time,
September 5, 2023.
    Requests for Oral Comments: During online registration, you may
indicate if you wish to speak during a public comment session. We will
do our best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to
consolidate or coordinate their comments and request a time for joint
commentary. All requests to make oral comments must be received by
11:59 p.m. Eastern Time on September 5, 2023. FDA will determine the
amount of time allotted to each commenter and the approximate time each
comment is to begin and will select and notify participants by
September 11, 2023.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed by the Dockets Management Staff.

IV. References

    The following references marked with an asterisk (*) have been
placed on display at the Dockets Management Staff (see ADDRESSES) and
are available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they are also available electronically at
https://www.regulations.gov. References without asterisks are not on
public display at https://www.regulations.gov because they have
copyright restriction. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff. FDA has verified the website addresses,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.

*1. Centers for Disease Control and Prevention, National Center for
Health Statistics. ``U.S. Pregnancy Rates Drop During Last Decade.''
Hyattsville (MD); 2023 April 12, Available from: https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2023/20230412.htm.
2. Mitchell, A.A, S.M. Gilboa, M.M. Werler, et al. ``Medication Use
During Pregnancy, with Particular Focus on Prescription Drugs: 1976-
2008.'' American Journal of Obstetrics & Gynecology 2011;205:51.e1-
8.

    Dated: August 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17718 Filed 8-16-23; 8:45 am]
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[Federal Register: June 23, 2010 (Volume 75, Number 120)]
[Notices]
[Page 35810-35812]
[DOCID:fr23jn10-82]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0517; FRL-8832-3]

Registration Review; Pesticide Dockets Opened for Review and
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has established registration review dockets for the
pesticides listed in the table in Unit III.A. With this document, EPA
is opening the public comment period for these registration reviews.
Registration review is EPA's periodic review of pesticide registrations
to ensure that each pesticide continues to satisfy the statutory
standard for registration, that is, the pesticide can perform its
intended function without unreasonable adverse effects on human health
or the environment. Registration review dockets contain information
that will assist the public in understanding the types of information
and issues that the Agency may consider during the course of
registration reviews. Through this program, EPA is ensuring that each
pesticide's registration is based on current scientific and other
knowledge, including its effects on human health and the environment.
This document also announces the Agency's intent not to open a
registration review docket for 2-hydroxyethyl octyl sulfide. This
pesticide does not currently have any actively registered pesticide
products and is not, therefore, scheduled for review under the
registration review program.

DATES: Comments must be received on or before August 23, 2010.

ADDRESSES: Submit your comments identified by the docket identification
(ID) number for the specific pesticide of interest provided in the
table in Unit III.A., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
     Instructions: Direct your comments to the docket ID numbers listed
in the table in Unit III.A. for the pesticides you are commenting on.
EPA's policy is that all comments received will be included in the
docket without change and may be made available on-line at http://
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or e-mail. The
regulations.gov website is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
     Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although, listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-

4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For pesticide-specific information
contact: The Chemical Review Manager identified in the table in Unit
III.A. for the pesticide of interest.
     For general information contact: Kevin Costello, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farmworker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

 B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Authority

    EPA is initiating its reviews of the pesticides identified in this
document pursuant to section 3(g) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations
for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of
FIFRA provides, among other things, that the registrations of
pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide
product may be registered or remain registered only if it meets the
statutory standard for registration given in FIFRA section 3(c)(5).
When used in accordance with widespread and commonly recognized
practice, the pesticide product must perform its intended function
without unreasonable adverse effects on the environment; that is,
without any unreasonable risk to man or the environment, or a human
dietary risk from residues that result from the use of a pesticide in
or on food.

III. Registration Reviews

A. What Action is the Agency Taking?

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations identified in the table in this unit to assure that they
continue to satisfy the FIFRA standard for registration--that is, they
can still be used without unreasonable adverse effects on human health
or the environment. A pesticide's registration review begins when the
Agency establishes a docket for the pesticide's registration review
case and opens the docket for public review and comment. At present,
EPA is opening registration review dockets for the cases identified in
the following table.

                Table--Registration Review Dockets Opening
------------------------------------------------------------------------
                                                        Chemical Review
  Registration Review Case Name                       Manager, Telephone
           and Number              Docket ID Number     Number, E-mail
                                                            Address
------------------------------------------------------------------------
Bifenthrin (7402)                 EPA-HQ-OPP-2010-03  Jacqueline Guerry,
                                   84<PHONE_NUMBER>,
                                                      guerry.jacqueline@
                                                       epa.gov
------------------------------------------------------------------------
Chlorfenapyr (7419)               EPA-HQ-OPP-2010-04  Susan Bartow,
                                   67<PHONE_NUMBER>,
<EMAIL_ADDRESS>                                                       ov
------------------------------------------------------------------------

Ethephon (0382)                   EPA-HQ-OPP-2010-00  Wilhelmena
                                   98                  Livingston,
<PHONE_NUMBER>,
                                                      livingston.wilhelm
<EMAIL_ADDRESS>------------------------------------------------------------------------
Fenpropathrin (7601)              EPA-HQ-OPP-2010-04  K. Avivah Jakob,
                                   22<PHONE_NUMBER>,
<EMAIL_ADDRESS>                                                       ov
------------------------------------------------------------------------
Fosamine ammonium (2355)          EPA-HQ-OPP-2010-02  Russell Wasem,
                                   15<PHONE_NUMBER>,
                                                      wasem.russell@epa.
                                                       gov
------------------------------------------------------------------------
Linuron (47)                      EPA-HQ-OPP-2010-02  Katherine St.
                                   28                  Clair,
<PHONE_NUMBER>,
                                                      stclair.katherine@
                                                       epa.gov
------------------------------------------------------------------------
Methiocarb (577)                  EPA-HQ-OPP-2010-02  Jude Andreasen,
                                   78<PHONE_NUMBER>,
                                                      andreasen.jude@epa
                                                       .gov
------------------------------------------------------------------------
Polybutene resins (4076)          EPA-HQ-OPP-2009-06  Jose Gayoso,
                                   49<PHONE_NUMBER>,
<EMAIL_ADDRESS>                                                       v
------------------------------------------------------------------------

    EPA is also announcing that it will not be opening a docket for 2-
hydroxyethyl octyl sulfide because this pesticide is not included in
any products actively registered under FIFRA.

B. Docket Content

    1. Review dockets. The registration review dockets contain
information that the Agency may consider in the course of the
registration review. The Agency may include information from its files
including, but not limited to, the following information:
     An overview of the registration review case status.
     A list of current product registrations and registrants.
     Federal Register notices regarding any pending
registration actions.
     Federal Register notices regarding current or pending
tolerances.
     Risk assessments.
     Bibliographies concerning current registrations.
     Summaries of incident data.
     Any other pertinent data or information.
     Each docket contains a document summarizing what the Agency
currently knows about the pesticide case and a preliminary work plan
for anticipated data and assessment needs. Additional documents provide
more detailed information. During this public comment period, the
Agency is asking that interested persons identify any additional
information they believe the Agency should consider during the
registration reviews of these pesticides. The Agency identifies in each
docket the areas where public comment is specifically requested, though
comment in any area is welcome.
    2. Other related information. More information on these cases,
including the active ingredients for each case, may be located in the
registration review schedule on the Agency's website at http://
www.epa.gov/oppsrrd1/registration_review/schedule.htm. Information on
the Agency's registration review program and its implementing
regulation may be seen at http://www.epa.gov/oppsrrd1/registration_
review.
    3. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
     The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
    As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: June 17, 2010.
 Richard P. Keigwin, Jr.,
Director Re-evaluation Division, Office of Pesticide Programs.
[FR Doc. 2010-15212 Filed 6-22-10; 8:45 am]
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