[Federal Register Volume 83, Number 65 (Wednesday, April 4, 2018)]
[Notices]
[Pages 14528-14530]
[FR Doc No: 2018-06775]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82965; File No. SR-NYSE-2018-10]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Amending Its Price List

March 29, 2018.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on March 16, 2018, New York Stock Exchange LLC (``NYSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the self-
regulatory organization. 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\ 15 U.S.C. 78a.
    \3\ 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 amend its Price List for equity
transactions in stocks with a per share stock price of $1.00 or more to
introduce (1) a new fee for Floor broker executions at the open, and
(2) different charges for Discretionary e-Quotes (``d-Quotes'') above
the first 750,000 average daily volume (``ADV'') of aggregate
executions at the close based on the time of d-Quote entry. The
Exchange proposes to implement these changes to its Price List
effective April 1, 2018. The proposed rule change is available on the
Exchange's website at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to amend its Price List to introduce (1) a
new fee for Floor broker executions at the open, and (2) different
charges for d-Quotes above the first 750,000 ADV of aggregate
executions at the close based on time of d-Quote entry or modification.
    The proposed changes would only apply to fees and credits in
transactions in securities priced $1.00 or more.
    The Exchange proposes to implement these changes to its Price List
effective April 1, 2018.
Executions at the Open
    For securities priced $1.00 or more, the Exchange currently charges
a fee of $0.0010 per share for executions at the open, subject to a
monthly fee cap of $30,000 per member organization provided the member
organization executes an ADV that adds liquidity to the Exchange during
the billing month (``Adding ADV''), excluding liquidity added by a
Designated Market Maker, of at least five million shares.
    For securities priced $1.00 or more, the Exchange proposes to
introduce a fee of $0.0003 per share for executions at the open by
Floor brokers which, as proposed, would also be subject to the $30,000
per member organization monthly fee cap for executions at the open.\4\
The $0.0010 per share fee for executions at the opening would not be
changed. DMMs currently are not charged for executions at the opening
and would continue to not be charged.
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    \4\ The existing pricing for executions at the opening in
securities priced below $1.00 would remain unchanged (i.e., 0.3% of
the total dollar value of the transaction).
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Executions at the Close
    For d-Quotes above the first 750,000 ADV of the aggregate of
executions at the close by a member organization, the Exchange proposes
new charges differentiated by the last time such d-Quotes are last
modified.
    Currently, the Exchange does not charge member organizations for
the first 750,000 ADV of the aggregate of executions at the close for
d-Quote, Floor broker executions swept into the close, excluding verbal
interest, and executions at the close, excluding MOC Orders, LOC Orders
and CO Orders. For d-Quote, Floor broker executions swept into the
close, excluding verbal interest, and executions at the close,
excluding MOC Orders, LOC Orders and CO Orders after the first 750,000
ADV of the aggregate of executions at the close by a member
organization, the Exchange charges $0.0007 per share.
    The Exchange proposes to continue not to charge member
organizations for the first 750,000 ADV of the aggregate of executions
at the close for d-Quote, Floor broker executions swept into the close,
excluding verbal interest, and executions at the close, excluding MOC
Orders, LOC Orders and CO Orders.
    The Exchange proposes the following fees differentiated by time of
entry (or last modification) for d-Quotes at the close after the first
750,000 ADV of the aggregate of executions at the close by a member
organization:
     $0.0003 per share for executed d-Quotes last modified \5\
by the member organization earlier than 25 minutes before the scheduled
close of trading.
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    \5\ As set forth in proposed footnote 10 to the Price List, as
used in the Price List, the phrase ``last modified'' would mean the
later of the order's entry time or the final modification or
cancellation time for any d-Quote order with the same broker badge,
entering firm mnemonic, symbol, and side.
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     $0.0007 per share for executed d-Quotes last modified from
25 minutes up to but not including 3 minutes before the scheduled close
of trading.
     $0.0008 per share for executed d-Quotes last modified in
the last 3 minutes before the scheduled close of trading for firms in
MOC/LOC Tiers 1 and 2; all other firms, $0.0010 per share.
    All other orders from continuous trading swept into the close would
continue to be charged the existing rate of $0.0007.
    The Exchange proposes to add a new footnote 9 to the Price List
that would provide that, for member organizations that execute an ADV
on the NYSE during a billing month in excess of 750,000 shares, the
Exchange would determine the average fee applicable to that member
organization based on all executions at the close for that month and
would not charge that average fee for executions below the 750,000 ADV.
    The following example demonstrates the operation of the new fee
structure for executions at the close.
     Assume that Member Organization A has a combined ADV of d-
Quote, Floor broker and other orders executed at the close of 5 million
shares in a 20 day month, or 100 million shares for the month. Further
assume that Member Organization A is not at MOC/LOC Tier 1 or 2. Assume
a regular 4:00 p.m. close of trading and that the firm therefore does
not qualify for a MOC/LOC Tier.
     Assume further that a total of 75 million shares were d-
Quotes last

modified before 3:35 p.m., and therefore subject to a fee of $0.0003; 5
million shares were d-Quotes last modified from 3:35 p.m. and prior to
3:57 p.m., and therefore subject to a fee of $0.0007; 15 million shares
were d-Quotes last modified from 3:57 p.m. up to the close., and
therefore subject to a fee of $0.0010; and 5 million shares were other
executions at the close, and therefore subject to a fee of $0.0007.
     Member Organization A's combined initial fee for that
month would be $44,500.00 an average fee of $0.000445 per share
($44,500.00 divided by 100 million shares).
     Since under the proposed Price List, the first 750,000
shares ADV would not be charged, the Exchange would reduce the initial
$44,500.00 fee by $6,675.00, which is the product of 750,000 shares
multiplied by 20 days multiplied by the average fee of $0.000445.
     Member Organization A's net fee for the month would thus
be $37,825.00 ($44,500.00 minus $6,675.00 for the 750,000 ADV that is
not charged).
     If Member Organization A was at MOC/LOC Tier 1 or MOC/LOC
Tier 2, Member Organization A's monthly fee would be $35,275.00,
representing an initial $41,500.00 fee reduced by $6,225.00 based on
750,000 ADV without charge for 20 days on the average initial fee of
$0.0004150 per share.
* * * * *
    The proposed changes are not otherwise intended to address any
other issues, and the Exchange is not aware of any problems that member
organizations would have in complying with the proposed change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\6\ in general, and furthers the
objectives of Sections 6(b)(4) and 6(b)(5) of the Act,\7\ in
particular, because it provides for the equitable allocation of
reasonable dues, fees, and other charges among its members, issuers and
other persons using its facilities and does not unfairly discriminate
between customers, issuers, brokers or dealers.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4) & (5).
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    The Exchange believes that the proposed fee changes for certain
executions at the close are reasonable. The Exchange's closing auction
is a recognized industry benchmark,\8\ and member organizations receive
a substantial benefit from the Exchange in obtaining high levels of
executions at the Exchange's closing price on a daily basis.
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    \8\ For example, the pricing and valuation of certain indices,
funds, and derivative products require primary market prints.
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Executions at the Open
    The Exchange believes that the proposed fee for executions at the
open sent to a Floor broker for representation on the Exchange is
reasonable because it would encourage additional liquidity on the
Exchange's opening auction and because members and member organizations
benefit from the substantial amounts of liquidity that are present on
the Exchange during such time.
    The Exchange believes the proposed change is equitable and not
unfairly discriminatory because it would continue to encourage member
organizations to send orders to the trading Floor for execution,
thereby contributing to robust levels of liquidity on the trading
Floor, which benefits all market participants. The proposed fee will
encourage the submission of additional liquidity to a national
securities exchange, thereby promoting price discovery and transparency
and enhancing order execution opportunities for member organizations
from the substantial amounts of liquidity that are present on the
Exchange during the opening. Moreover, the requirement is equitable and
not unfairly discriminatory because it would apply equally to all
similarly situated member organizations. Finally, the Exchange notes
that the proposed fee and the current cap together are comparable to
those for executions at the opening on other markets.\9\
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    \9\ For example, NASDAQ charges $0.0015 per share for certain
orders executed in the NASDAQ Opening Cross and applies at $35,000
fee cap per month per firm for such executions. See Nasdaq Rule
7018(e).
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Executions at the Close
    The Exchange believes that charging different rates for d-Quotes
that execute in the close based on time of entry or last modification
is reasonable and not unfairly discriminatory because it encourages all
member organizations to enter or modify d-Quotes as early possible,
beginning with as early as 25 minutes before the close of trading, in
order to build up liquidity going into the closing auction. Further, it
is reasonable to charge member organizations a higher rate for entering
or modifying their interest in the final minute of regular trading
hours because such interest most benefits from the flexibility afforded
the order type.
    Similarly, the Exchange believes that calculating how a member
organization that executes an ADV on the Exchange during a billing
month in excess of 750,000 shares is not charged for those first
750,000 shares is reasonable because the Exchange would reduce a member
organization's total charges for d-Quote and other executions at the
close by the average fee applicable to the member organization for that
month for executions at the close times 750,000 shares per day. The
Exchange believes it is reasonable to reduce the fee by the average fee
applicable to that member organization because the Exchange would now
charge four rates for d-Quotes and other executions at the close
($0.0003, $0.0007, $0.0008 or $0.0010). The average rate would
therefore be the member organization's weighted average of those three
rates and the Exchange would not charge that average price for the
first 750,000 shares per day.
    The Exchange believes that offering a lower fee for members at MOC/
LOC Tier 1 and 2 of $0.0008 for d-Quotes executed from 3:57 p.m. up to
the close is reasonable and not unfairly discriminatory because the
proposed change would encourage greater marketable and other liquidity
at the closing auction, and higher volumes of MOC and LOC orders
contribute to the quality of the Exchange's closing auction and provide
market participants whose orders are swept into the close with a
greater opportunity for execution. The Exchange believes that the
proposed fee for MOC/LOC Tier 1 and 2 is equitable and not unfairly
discriminatory because all similarly situated member organizations will
be subject to the same fee structure, which will automatically adjust
based on prevailing market conditions.
    Finally, the Exchange believes that it is subject to significant
competitive forces, as described below in the Exchange's statement
regarding the burden on competition.
    For the foregoing reasons, the Exchange believes that the proposal
is consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act,\10\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Instead, the Exchange believes that the proposed
changes would encourage the submission of additional liquidity to a
public exchange, thereby promoting

price discovery and transparency and enhancing order execution
opportunities for member organizations. The Exchange believes that this
could promote competition between the Exchange and other execution
venues, including those that currently offer similar order types and
comparable transaction pricing, by encouraging additional orders to be
sent to the Exchange for execution.
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    \10\ 15 U.S.C. 78f(b)(8).
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    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees and rebates to remain competitive with other exchanges and
with alternative trading systems that have been exempted from
compliance with the statutory standards applicable to exchanges.
Because competitors are free to modify their own fees and credits in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited. As a result of all of these considerations, the
Exchange does not believe that the proposed changes will impair the
ability of member organizations or competing order execution venues to
maintain their competitive standing in the financial markets.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \11\ of the Act and subparagraph (f)(2) of Rule
19b-4 \12\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \13\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \13\ 15 U.S.C. 78s(b)(2)(B).
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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 protected]. Please include
File Number SR-NYSE-2018-10 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-NYSE-2018-10. 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-NYSE-2018-10 and should be submitted on
or before April 25, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2018-06775 Filed 4-3-18; 8:45 am]
 BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

	OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

									PC Code: 	098301

									DP Barcode:	299866

MEMORANDUM							DATE: July 24, 2007

SUBJECT: 	Review of “A Retrospective Groundwater Monitoring Study for
Aldicarb and Its Metabolites in the Southeastern United States (MRID
467937-06); Mississippi Delta (MRID 467937-05); Texas (MRID 467937-04);
California (MRID 467937-03);and Pacific Northwest (MRID 467937-02)

TO:		Sherrie Kinard, PM

Robert McNally, Branch Chief

		Special Review and Reregistration Division (7508P)

FROM: 	Nelson Thurman, Senior Environmental Scientist

Environmental Risk Branch 2

		Environmental Fate and Effects Division (7507P)

THROUGH:	Dana Spatz, Acting Branch Chief

		Environmental Risk Branch 2

		Environmental Fate and Effects Division (7507C)

Bayer CropScience recently submitted retrospective groundwater
monitoring studies for aldicarb and its metabolites for the southeastern
US, Mississippi Delta, Pacific Northwest, California, and Texas.
Although this study was unsolicited by EPA, it provides valuable data in
support of the drinking water exposure assessments for both aldicarb and
the N-methyl carbamate cumulative assessments. Results have been
incorporated into those assessments.

In addition to reported detections of aldicarb residues (the parent plus
sulfone and sulfoxide degradates), the study included a substantial
amount of supporting information on aldicarb use and well, soil,
environmental, and hydrologic conditions that would influence the
transport of aldicarb to ground water.

The attached report summarizes EPA’s review of Bayer’s retrospective
ground water monitoring study.

REVIEW OF 2005 RETROSPECTIVE GROUND WATER MONITORING STUDY FOR ALDICARB

Study References:

Jones, R.L., and T.S. Ramanarayanan. 2006. TEMIK® brand 15G Aldicarb
Pesticida: Summary of Five Retrospective Ground Water Monitoring Studies
conducted for Aldicarb and Its Metabolites in the Pacific Northwest,
California, Texas, Mississippi Delta and the Southeast Regions of the
United States in 2005. Bayer CropScience Study No. RAAVY010. MRID
487937-01.

Lee, R.E., R.L. Jones, D.R. Wyatt, and U.B. Handihalli. 2006. A
Retrospective Groundwater Monitoring Study for Aldicarb and Its
Metabolites in the Southeastern United States. Bayer CropScience Study
No. RAAVY009. MRID 467937-06.

Wyatt, D.R., R.L. Jones, U.B. Handihalli, and R.E. Lee. 2006. A
Retrospective Groundwater Monitoring Study for Aldicarb and Its
Metabolites in Mississippi Delta Region. Bayer CropScience Study No.
RAAVY008. MRID 467937-05.

Mosier, D.G., R.L. Jones, U.B. Handihalli, and R.E. Lee. 2006. A
Retrospective Groundwater Monitoring Study for Aldicarb and Its
Metabolites in Texas. Bayer CropScience Study No. RAAVY007. MRID
467937-04.

Lenz, M, R.L. Jones, D.R. Wyatt, U.B. Handihalli, and R.E. Lee. 2006. A
Retrospective Groundwater Monitoring Study for Aldicarb and Its
Metabolites in California. Bayer CropScience Study No. RAAVY006. MRID
467937-03.

Freeseman, P.I., R.L. Jones, R.E. Lee, U.B. Handihalli, and D.R. Wyatt.
2006. A Retrospective Groundwater Monitoring Study for Aldicarb and Its
Metabolites in the Pacific Northwest. Bayer CropScience Study No.
RAAVY005. MRID 467937-02.

Reviewed By:	Nelson Thurman, Senior Environmental Scientist

Environmental Risk Branch 2

			Environmental Fate and Effects Division (7507P)

			USEPA Office of Pesticide Programs

Secondary

Review By:		Dana Spatz, Acting Branch Chief, ERB2

Date:			July 5, 2007

SUMMARY

Bayer CropScience conducted a retrospective ground water monitoring
study to look for residues of aldicarb and its sulfoxide and sulfone
metabolites in potable water from private wells in aldicarb use areas.
This study monitored 1,673 drinking water wells and collected
information on ground-water depth, well depth, casing depth, well type
and age, soil types, recent aldicarb use history, crops, and distance of
the well from the treated field. The study provides useful information
on measured concentrations of aldicarb residues in drinking water wells
in selected areas of the United States with recent/current aldicarb use.
The study sampled 1,673 drinking water wells in five regions of the
country: the Southeastern US (800 wells), the Mississippi Delta (169
wells), the Pacific Northwest (303 wells), Texas (201 wells), and
California (200 wells).

The study found that

Aldicarb residues – predominantly the sulfoxide and sulfone
metabolites – were detected in 10 percent of the wells sampled (160
out of 1,673), with the greatest frequencies of detections in the
Southeastern US (16%, with a maximum detect of 2.9 ug/L) and the
Mississippi Delta (9%, with a maximum detect of 2.6 ug/L) regions.
Because the single samples represent a snapshot in time, the Agency
assumed that the measured concentrations reflected a median
concentration for that particular well.

Aldicarb detections showed a regional pattern, with this highest
frequency of detects in Alabama (22%) and South Carolina (21%) in the
Southeast region and southeastern Missouri/northeastern Arkansas (23%)
in the Mississippi Delta region.

Frequency and magnitudes of detection for aldicarb residues were
generally greater for wells located within 300 feet of a field (~10% of
wells had detections); aldicarb residues were detected in 4-6% of wells
located >300 feet from the field, although detections were < 1ug/L.
Because the existing label has well setback requirements of 300 feet for
vulnerable soils, the Agency assumed that the monitoring data for those
wells that meet the setback criteria reflect aldicarb applications no
closer than 300 feet from the well.

Frequency and magnitudes of detection for aldicarb residues also were
generally greater where the reported ground water was closer to the
surface (23% detects for groundwater at <25 feet; 12% for groundwater at
25-50 feet), although residues were detected in 9% of wells where the
depth to groundwater was not known or not reported, with maximum detects
of up to 2.66 ug/L. Aldicarb residues were detected in 24-30% of wells
with reported well depths of <100 feet. However, detects of up to 2.66
ug/L were reported for deeper or unknown well depths.

A comparison of wells located near fields with restricted soils (as
identified in the TEMIK® 15G label) to those where the surrounding
fields contained no restricted soils showed that, while the frequency of
aldicarb detections was greater for wells near restricted soil types,
the magnitude of aldicarb residues was greater for wells with no
restricted soil types.

The study pointed to some potential issues that pertain to the existing
label restrictions:

While depth to ground water is the key criteria for determining whether
well setbacks should be applied in certain states, that depth was
unknown or unreported for 42% of the wells sampled in the study. This
suggests that a substantial portion of aldicarb users do not know
whether the label restrictions even apply to their fields.

Although the Norfolk soil series is listed as a restricted soil type in
North Carolina, it is not listed in adjacent states.

No restricted soil types are listed for Arkansas. However, aldicarb
detections in a number of wells in northeastern Arkansas (along with
southeastern Missouri) indicate that restricted soil types should be
considered for that state. A number of restricted soils in adjacent
states are also found in Arkansas.

BACKGROUND

Monitoring data provide a valuable check on exposures estimates from
models, which are intended to represent the upper end of potential
exposure. Comparison of model and monitoring results are most relevant
when monitoring sites are selected to be similarly representative of the
upper end of potential exposure, or where sufficient ancillary data are
provided to put the monitoring results in context to the relative
vulnerability within the use area.

The registrant for aldicarb (Bayer CropScience) voluntarily conducted
this retrospective groundwater monitoring study in 2005 in response to
EPA’s preliminary risk assessment for aldicarb. Bayer provided no
protocol for review by the Agency prior to study initiation. In
preliminary assessments dating 2005 and earlier, EPA used available
ground-water monitoring data for its drinking water exposure assessment
while noting that current monitoring data is scarce.

In 2005, EPA used the Pesticide Root Zone Model (PRZM) to estimate
concentrations of N-methyl carbamate residues (including aldicarb and
its sulfoxide and sulfone metabolites) in shallow, private drinking
water wells (USEPA OPP, 2005a, 2005b). The Agency subsequently used the
same methods to estimate drinking water exposures for a revised drinking
water exposure assessment for aldicarb (USEPA OPP, 2006).

Median and maximum concentrations of total aldicarb residues (parent,
sulfoxide, sulfone) in shallow private wells estimated with PRZM were
1.7 and 3.0 ug/l, respectively, in the Florida central ridge, 3.1 and
6.5 ug/l in the southern Georgia coastal plain representing the southern
coastal plain from South Carolina westward to Alabama, and 0.6 and 1.3
ug/l in the North Carolina coastal plain, representing the coastal plain
regions of North Carolina and Virginia (USEPA OPP, 2006). The estimated
exposures for the FL central ridge were less than maximum reported
detects in private well monitoring data collected by the state of FL,
dating back to 1990. However, the high detections in that study
pre-dated recent label changes intended to reduce aldicarb residues in
drinking water wells. A comparison with recent in-field monitoring
(USGS, 2006) indicated that PRZM provided reasonable, protective
exposures compared to wells in the field. However, the Agency noted that
recent monitoring data that reflected label changes for aldicarb were
scarce or absent for most of the aldicarb use areas. Monitoring data
collected by the state of FL was of little use because of high method
detection limits (ranging from 2 to 4 ug/l) in wells sampled after the
label changes.

This review evaluates the extent to which the registrant’s study
design and subsequent conduct were tailored to address the uncertainties
identified in the N-methyl carbamate cumulative risk assessment (NMC
CRA) and in the 2006 aldicarb drinking water exposure assessment. The
second part summarizes the monitoring results, with an emphasis on use
in support of the drinking water exposure assessment.

EVALUATION OF METHODS

Study Purpose

The purpose of the study was to analyze for aldicarb residues (aldicarb,
aldicarb sulfoxide, aldicarb sulfone) in potable water samples from
private wells located within 1,000 feet of fields treated with aldicarb
between 2002 and 2005. The study focused on aldicarb use areas in five
regions of the country:

Site Selection and number of wells

Bayer first targeted specific aldicarb use regions of the country.
Within each region, they identified targets by county based on aldicarb
sales data (details not specified), setting target goals by county. The
original study goal was to sample 200 wells from each of 9 major use
areas in 5 regions:

Southeastern US (excluding FL)

Alabama

Georgia

South Carolina

North Carolina and Virginia

Mississippi delta

Texas

Pacific Northwest

Washington and northern Oregon

Idaho and southwestern Oregon

California

Bayer then contacted growers in these areas who had purchased TEMIK®
(aldicarb) products between 2002 and 2005. Bayer used calls to identify
drinking water wells located within 1,000 feet of fields treated with
aldicarb in 2002 or later. Other candidate wells were identified by
asking the growers and pesticide distributors/dealers whether they knew
of other growers who might be using aldicarb with nearby wells. Bayer
continued contacting growers until the sample target was reached. If the
target was not reached, Bayer would look for wells in other counties
within the use area.

The study ultimately analyzed samples from 1,673 drinking water wells in
the five regions:

Southeastern US - 800 wells

Mississippi Delta  - 169 wells

Texas - 201 wells

Pacific Northwest - 303 wells

California - 200 wells

Site selection was based on sales data first, and then on history of
recent use and proximity of the well to the treated fields. The process
did not consider leaching vulnerability of the soils/vadose zone in site
selection. This might have left out other areas where, while overall
aldicarb sales are not as high, may have been vulnerable because of
soil/hydrologic/geologic conditions.

Because the samples do not represent a statistical sampling, but rely on
user/grower-identified and -volunteered wells, no inferences are
possible beyond the population of wells being sampled. Thus the results
of the study cannot be used to characterize the percentage of wells with
aldicarb detects within the larger use regions. Because this study
relied on the willingness of the grower to participate, the pool of
wells sampled in the study cannot be considered an unbiased sampling of
the larger population.

Sample collection and handling

Samples were collected from an indoor or outdoor tap. Where a treatment
system existed, attempts were made to collect samples that bypassed the
treatment; otherwise, the presence of the treatment system was
documented.

The taps were flushed for 30 seconds and then duplicate samples were
collected in 125-ml amber HDPE bottles. The samples were buffered with
0.5 ml of ammonium acetate to maintain the pH at 5. Samples were stored
on ice at the time of collection and shipping and were refrigerated or
frozen until analysis.

Analytical Method

Aldicarb, aldiarb sulfone, and aldicarb sulfoxide were measured by
direct injection of the water sample onto an LC/MS/MS system. The Method
Detection Limit (MDL) was 0.007 ug/L for aldicarb and aldicarb sulfone
and 0.009 ug/L for aldicarb sulfoxide. The Limit of Quantification (LOQ)
was 0.021 ug/L for aldicarb and aldicarb sulfone and 0.027 ug/L for
aldicarb sulfoxide.

Bayer analyzed the first sample from each well and analyzed the second
replicate sample if aldicarb residues were detected (>MDL) in the first
sample. Confirmatory methods used alternate monitoring ions.

QA/QC procedures included

Method verification on untreated controls and samples fortified at 0.025
ug/L and 0.25 ug/L (~LOD and 10X the LOD)

Analyte	% recovery: primary method	% recovery: confirmatory method

	0.025 ug/L	0.25 ug/L	0.025 ug/L	0.25 ug/L

Aldicarb	94.9	88.1	91.7	87.3

Ald. Sulfoxide	94.1	96.6	116	99.4

Ald. Sulfone	106	100	102	92.0

Procedural/ analytical recoveries for each set on samples fortified at
0.025 and 0.25 ug/L (see table below)

Analyte	Fortified at LOQ (0.025 ug/L)	Fortified at 10x LOQ (0.25 ug/L)

	% recovery	sd	n	% recovery	sd	n

Aldicarb	95.7	5.5	58	97.5	6.0	46

Ald. Sulfoxide	92.7	9.9	58	89.2	8.0	46

Ald. Sulfone	94.4	8.8	58	94.1	7.9	46

Field spike recoveries ranged from 93 to 106 percent.

Storage stability studies on aldicarb, aldicarb sulfone, and aldicarb
sulfoxide showed stability for up to 30 months in freezer storage and up
to 4 months in refrigerated storage. The longest time between sample and
analysis in the study was 38 days, well within the stability range. In
addition, for those samples that were stored at ambient temperatures for
a longer than expected time, triplicate samples fortified at 0.5 ug/L
were analyzed at daily intervals.

Ancillary data collection

The study provides a substantial amount of ancillary data that extend
the value of the study beyond the reported concentrations of aldicarb
residues in well water. Such information collected during the study and
compiled in the study reports include

Aldicarb use history for 2002-2005

Latitude and longitude, valuable for spatial analyses

Soil maps showing the well locations in relation to soils and fields

Nature of the well (age, type, depth, construction, casing and screen
depths)

Distance from the well to the nearest field (NOTE: there is no
indication as to whether additional setback distances were followed
where conditions described in the label existed)

Depth to groundwater (presumably as reported by the owner)

This information allowed EPA to evaluate not just frequency and
magnitude of detections in the study areas, but also factors that may
have influenced the monitoring results.

RESULTS AND DISCUSSION

Overall Study

Aldicarb residues were detected in just under 10 percent of the wells in
the monitoring study (Table 1). A single sample point from each well
provides no indication of temporal fluctuations in aldicarb residues.
While variations in pesticide residues over time are less drastic in
ground water than in surface water, such variations do occur (see, for
example, USGS, 2006). Thus, the samples provide a snapshot of aldicarb
residues and may not necessarily represent longer-term trends.
Additionally, travel time from the surface through the vadose zone to
ground water varies with factors such as depth, permeability of the
soil, amount of rainfall/irrigation, distance between the field of
application and the well, and hydraulic gradient between the well and
the field. While some wells may reflect the recent applications of
aldicarb reported in the study, other wells (especially deeper wells)
may reflect older aldicarb applications.

Table 1 – Summary of frequency and magnitude of detections of aldicarb
residues by state and region.

Region	State	Ttl Wells	Ttl Detects	% Detects	Max Detect	Min Detect

Southeast	AL	192	43	22.4%	1.77	0.008

	GA	202	11	5.4%	2.9	0.01

	SC	203	43	21.2%	2.66	0.008

	NC	177	29	16.4%	1.57	0.009

	VA	21	4	19.0%	0.024	0.007

	MS	3	0	0.0%	-	-

	TN	2	0	0.0%	-	-

	Total	800	130	16.3%	2.9	0.007

Mississippi Delta

	AR	55	6	10.9%	0.23	0.009

	LA	27	0	0.0%	-	-

	MO	35	8	22.9%	2.59	0.007

	MS	39	1	2.6%	0.22	-

	TN	13	0	0.0%	-	-

	Total	169	15	8.9%	2.59	0.007

Texas	TX	201	0	0.0%	-	-

California	CA	200	3	1.5%	0.33	0.13

Pacific Northwest

	ID	197	9	4.6%	0.68	0.009

	OR	11	0	0.0%	-	-

	WA	95	3	3.2%	0.025	0.011

	Total	303	12	4.0%	0.68	0.009

All Sites	Total	1673	160	9.6%	2.9	0.007

Figure   SEQ Figure \* ARABIC  1  – Well monitoring locations for
Bayer study, highlighting detections. Underlying aldicarb use data is
based on Thelin and Geonessi (2000).

Detections showed a regional distinction that reflected soil, geologic,
hydrologic, and climatic differences (Figure 1). In the southeast, 16%
of the wells had detections, with this highest frequency of detects in
Alabama (22%) and South Carolina (21%). The greatest detection was 2.9
ug/L from a well in Georgia. In the Mississippi Delta region, aldicarb
residues were detected in 9% of the wells. Almost all of the detections
in this region occurred in southeastern Missouri and northeastern
Arkansas, with the greatest detection of 2.59 ug/L from a well in
Missouri. No detections were reported in the Texas sites, where aldicarb
is predominantly used in western TX/ panhandle region where rainfall is
lower. In the Pacific Northwest, 4% of the wells had detections,
although the highest detection was 0.68 ug/L. While localized exceptions
may occur, the frequency and magnitude of aldicarb detections in the
western part of the United States is expected to be lower than in the
southeast because the rainfall is generally lower and the soils and
vadose zone are generally neutral to alkaline in pH, a condition which
favors more rapid hydrolysis of the sulfone and sulfoxide residues of
aldicarb.

Contributing Factors

The ancillary data collected for each well allowed EPA to evaluate the
influence of various factors on aldicarb concentrations found in the
wells. Table 2 focuses on the influence of well construction, depth, and
distance from the treated fields.

Table 2 – Influence of well location, depth, and distance from field
on aldicarb detections.

	Ttl Wells	% of Ttl Wells	Ttl Detect	% Detect	Max Detect	99.9th%ile	99th
%ile	95th %ile

All Monitoring Sites	1673

160	9.6%	2.9	2.61	0.69	0.06

	Well Type	Drilled	1584	94.7%	150	9.5%	2.9	2.62	0.68	0.05

	Dug	22	1.3%	6	27.3%	0.36	-	-	0.19

	Unknown	67	4.0%	4	6.0%	0.71	-	0.49	0.03

	GW Depth	0-24 ft	246	14.7%	56	22.8%	2.59	2.39	1.50	0.33

	25-49 ft	198	11.8%	24	12.1%	2.9	2.50	0.77	0.08

	50-99 ft	200	12.0%	12	6.0%	1.57	1.44	0.71	0.01

	100+ ft	331	19.8%	6	1.8%	0.71	0.52	0.05	<0.01

	Unknown	698	41.7%	62	8.9%	2.66	1.16	0.38	0.03

	Well Depth	0-24 ft	33	2.0%	9	27.3%	1.57	1.55	1.41	0.64

	25-49 ft	150	9.0%	45	30.0%	2.59	2.42	1.41	0.43

	50-99 ft	194	11.6%	47	24.2%	2.9	2.68	0.92	0.26

	100+ ft	1005	60.1%	36	3.6%	1.57	0.89	0.10	<0.01

	Unknown	291	17.4%	23	7.9%	2.66	2.03	0.19	0.01

	Dis-tance from field	0-100 ft	875	52.3%	91	10.4%	2.9	2.63	0.75	0.06

	101-300 ft	576	34.4%	58	10.1%	2.66	2.03	0.50	0.07

	301-500 ft	135	8.1%	6	4.4%	0.77	0.76	0.46	<0.01

	500+ ft	86	5.1%	5	5.8%	0.15	0.14	0.12	0.01

While dug wells, which tend to be shallower and uncased, had a much
higher frequency of detections than did drilled wells (27% to 10%), too
few dug wells were included in the study to draw meaningful conclusions.

The frequency of aldicarb detections shows a general trend with reported
depth to groundwater, decreasing from 23% for groundwater within 25 feet
of the surface to 2% for groundwater greater than 100 feet from the
surface (Table 2). However, the depth to groundwater was listed as
“unknown” for 42% of the wells sampled, increasing the uncertainty
of the data for evaluating the influence of depth to groundwater on
aldicarb detections in wells.

Well depths were reported for a larger fraction of wells (83% vs. 58%).
The frequency of detections for aldicarb residues ranged from 24 to 30
percent for wells less than 100 feet deep (Table 2). While the majority
of detections greater than 1 ug/L occurred in wells less than 400 feet
deep, detections greater than 2.5 ug/L occurred in wells with reported
well depths of over 750 feet (Figure 2).

Aldicarb detections occurred in 10% of sampled wells that were located
within 300 feet of the treated fields (Table 2). Detections occurred in
6% of wells located greater than 500 feet from treated fields. The study
does not indicate whether additional setback distances were applied
between the wells and the fields. While the summary data and figures do
not distinguish between wells located in restricted soil types, the
Agency assumed that aldicarb was applied according to label restrictions
(see the section below). Thus, while some of the wells are located less
than 300 feet from the field, the concentrations in those that meet the
label requirements reflect the effect of the 300-foot setback distance.
Total aldicarb residues tended to decrease with distance between the
well and the treated fields (Figure 3), with practically no detections
reported for wells located greater than 600 feet from treated fields.

Figure   SEQ Figure \* ARABIC  3  - Relationship between concentrations
of total aldicarb residues and distance between treated fields and the
well.

Comparing vulnerable areas identified on the label

The current aldicarb (TEMIK® 15G) label identifies soil restrictions in
a number of states as a precaution for ground water contamination. These
restrictions are triggered “if a vulnerable soil is present and the
water table is less than 25 feet below the ground surface” (from the
TEMIK® 15G label). Because the depth to groundwater was unknown or not
reported for a substantial portion of the sampled wells, the Agency
could not fully evaluate the effectiveness of the existing label
restrictions on the frequency and magnitude of aldicarb detections.
Further, the label is not clear as to whether presence of a listed
“vulnerable” soil refers to anywhere in the treated field or only in
the close proximity of the well.

Restricted soil types are listed for those states included in the
Southeast and Mississippi Delta regions, except for Arkansas. No
restricted soil types are listed for California, Texas, or the Pacific
Northwest states.

In the absence of definitive information on groundwater depth, EPA
compared aldicarb residues in wells located near fields with restricted
soils to those where the surrounding fields contained no restricted
soils (Table 3). If a restricted field was identified in the
accompanying soil maps for the treated fields, the well was tagged as
having restricted soils for this analysis. While the frequency of
aldicarb detections was greater for wells near restricted soil types,
the magnitude of aldicarb residues was greater for wells with no
restricted soil types (Table 3). Wells located in the vicinity of soils
identified as vulnerable to leaching according to the Bayer made up 16%
of the total wells sampled in the Southeast region and 14% of the wells
sampled in the Mississippi Delta region (excluding Arkansas, which is
not included in the list of states containing restricted soils).

Table 3 – Magnitude and frequency of aldicarb detections for wells
located in relation to restricted soils (as identified on the TEMIK®
15G label).

Region	State	Wells w/ Restricted Soils	Wells w/ no restricted soils

Wells	Det.	% Det.	Max Det.	Wells	Det.	% Det.	Max Det.

South-east

	AL 	10	1	10.0%	0.03	182	42	23.1%	1.77

	GA 	16	3	18.8%	0.017	186	8	4.3%	2.9

	SC 	20	7	35.0%	1.4	183	36	19.7%	2.66

	NC	78	13	16.7%	1.57	99	16	16.2%	1.42

	VA	3	1	33.3%	0.007	18	3	16.7%	0.024

	MS	0	0	-	-	3	0	-	-

	TN	0	0	-	-	2	0	-	-

	Total 	127	25	19.7%	1.57	673	105	15.6%	2.9

Missi-ssippi Delta	AR (1)	20	4	20.0%	0.23	35	2	5.7%	0.042

	LA	0	0	-	-	27	0	-	-

	MO	22	4	18.2%	2.59	13	4	30.8%	0.074

	MS	1	0	0.0%	-	38	1	2.6%	0.22

	TN	0	0	-	-	13	0	-	-

	Total 	43	8	18.6%	2.59	126	7	5.6%	0.22

(1) The TEMIK® label lists no restricted soil types listed for Arkansas
(soils identified in adjacent states are listed here).

Of the wells located adjacent to fields with restricted soils identified
on the TEMIK® label, 37% of the wells in the Southeast and 67% of the
soils in the Mississippi Delta region were also located in areas where
the reported depth to ground water was less than 25 feet below the
surface. However, depth to ground water was not known for 34% of these
wells in the Southeast and 33% of these wells in the Mississippi Delta
region.

The Norfolk soil is included on the restricted soil list for North
Carolina, but not in Alabama, Georgia, and South Carolina. Table 4
summarizes the frequency and magnitude of detections of wells located
near fields with Norfolk soils in those states. Wells located near
Norfolk soils are not included in the “wells with restricted soils”
column for AL, GA, and SC in Table 3. It is not clear from the label why
this soil was included as a vulnerable soil for North Carolina but not
for the other states in the southern Coastal Plain.

Table 4 – Magnitude and frequency of aldicarb detections in wells
located near Norfolk soils.

State	Wells near Norfolk Soils

	No. Wells	No. Detects	% Detects	Max Detect

AL	17	4	23.5%	0.5

GA	16	1	6.3%	0.04

SC	40	8	20.0%	1.57

NC	63	9	14.3%	1.06

Total 	136	22	16.2%	1.57

Bayer’s criteria for including a soil on the restricted soil type list
for a state is based on soil texture and organic matter content of the
soil. For states in the southeast and Mississippi delta regions, the
criteria are:

“Loamy sand or sand surface soils and subsoils with an average organic
matter in the upper 12 inches of less than 2% by weight.”

For states in the Midwest, the criteria vary slightly:

“Sandy loam, loamy sand, or sand surface soils, and loamy sand or sand
subsoils, with an average organic matter in the upper 12 inches of less
than 2% by weight.”

Soil texture and organic matter content act as surrogates for
identifying those soils that have a high potential for leaching and a
low capacity for retaining the pesticide. While these properties are
relatively simple to describe and can be identified with a knowledge of
the soil series mapped for the treated fields, they do not fully
integrate those soil properties that affect leaching potential and are
imperfect indicators of the potential for aldicarb residues to move to
groundwater.

An alternative approach that more accurately assesses the potential for
aldicarb to reach ground water is the USDA Natural Resource Conservation
Service (NRCS) classification for soil leaching potential for pesticides
(USDA NRCS. 2003). NRCS used the rating criteria (Table 5) to derive the
soil leaching potential for all soils in the SSURGO county surveys for
Florida (available for download from the USDA NRCS Soil Data Mart at
HYPERLINK "http://soildatamart.nrcs.usda.gov/"
http://soildatamart.nrcs.usda.gov/ ). The criteria could be used to
identify soils that are vulnerable to pesticide leaching throughout the
country, particularly in the aldicarb use states, to provide a more
definitive list of vulnerable soils (those rated as having a HIGH soil
leaching potential for pesticides) than the current list of soils based
solely on soil texture and organic matter content.

Table 5: USDA NRCS (2003) Criteria Used for Soil Leaching Potential for
Pesticides.

Rating	Criteria

High	Hydrologic Group = A and % Surface Horizon Organic Matter Content X
Depth of the First Soil Horizon <= 30 or

Hydrologic Group = B and % Surface Horizon Organic Matter Content X
Depth of the First Soil Horizon <= 9 and the K Factor is <= 0.48 or

Hydrologic Group = B and % Surface Horizon Organic Matter Content X
Depth of the First Soil Horizon <= 15 and the K Factor is <= 0.26

Low	Hydrologic Group = B and % Surface Horizon Organic Matter Content X
Depth of the First Soil Horizon >= 35 and the K Factor is >= 0.40 or

Hydrologic Group = B and % Surface Horizon Organic Matter Content X
Depth of the First Soil Horizon >= 45 and the K Factor is >= 0.20 or

Hydrologic Group = C and % Surface Horizon Organic Matter Content X
Depth of the First Soil Horizon <= 10 and the K Factor is >= 0.28 or

Hydrologic Group = C and % Surface Horizon Organic Matter Content X
Depth of the First Soil Horizon >= 10

Very Low	Hydrologic Group = D

Intermediate	All other conditions

REFERENCES

Thelin, G.P., and L.P. Gianessi. 2000. Method for Estimating Pesticide
Use for County Areas of the Conterminous United States. US Geological
Survey Open-File Report 00-250. Sacramento, California, 2000.
HYPERLINK "http://ca.water.usgs.gov/pnsp/rep/ofr00250/"
http://ca.water.usgs.gov/pnsp/rep/ofr00250/

USDA NRCS. 2003. Florida NRCS Field Office Technical Guide. Section II.
Water Quantity and Quality. Available from the electronic FOTG site at
HYPERLINK "http://efotg.nrcs.usda.gov/treemenuFS.aspx"
http://efotg.nrcs.usda.gov/treemenuFS.aspx

USEPA OPP. 2005a. N-methyl Carbamate Cumulative Risk Assessment: Pilot
Cumulative Analysis. Presented to the FIFRA Scientific Advisory Panel,
February 15-18, 2005 (  HYPERLINK
"http://www.epa.gov/scipoly/sap/meetings/2005/index.htm#feb"
http://www.epa.gov/scipoly/sap/meetings/2005/index.htm#feb ).

USEPA OPP. 2005b. Estimation of Cumulative Risk From N-Methyl Carbamate
Pestidices: Preliminary Assessment. Presented to the FIFRA Scientific
Advisory Panel, August 23-26, 2005 (  HYPERLINK
"http://www.epa.gov/scipoly/sap/meetings/2005/index.htm#august"
http://www.epa.gov/scipoly/sap/meetings/2005/index.htm#august ).
Preliminary document available at   HYPERLINK
"http://www.epa.gov/scipoly/sap/meetings/2005/august/preliminarynmc.pdf"
 http://www.epa.gov/scipoly/sap/meetings/2005/august/preliminarynmc.pdf
; SAP comments available at   HYPERLINK
"http://www.epa.gov/scipoly/sap/meetings/2005/august/minutes.pdf"
http://www.epa.gov/scipoly/sap/meetings/2005/august/minutes.pdf .

USEPA OPP. 2006. Drinking Water Exposure Assessment for Total Aldicarb
Residues (Parent, Aldicarb Sulfoxide, and Aldicarb Sulfone) Based on the
N-Methyl Carbamate Cumulative Risk Assessment. Memorandum dated October
23, 2006, from Thurman and Angier to Kinard and Fort. The OPP web site
for aldicarb (  HYPERLINK
"http://www.epa.gov/oppsrrd1/reregistration/aldicarb/"
http://www.epa.gov/oppsrrd1/reregistration/aldicarb/ ) provides
information on how to access aldicarb documents on the public document.

U.S. Geological Survey. 2006. Lake Wales Ridge Ground-Water Monitoring
Study. USGS Water Resources Investigations Report in preparation.
Available:   HYPERLINK "http://fisc.er.usgs.gov/Lake_Wales_Ridge/"
http://fisc.er.usgs.gov/Lake_Wales_Ridge/ . Page last modified April 11,
2006.

 PAGE

 PAGE   15

Figure   SEQ Figure \* ARABIC  2  - Relationship between concentrations
of total aldicarb residues and well depth.


[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5493-5494]
[FR Doc No: 2018-02397]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82615; File No. SR-CboeEDGX-2018-003]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change to Rule
21.1, Definitions, To Modify a Time in Force Applicable to the
Exchange's Equity Options Platform

February 1, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 25, 2018, Cboe EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange filed a proposal to amend Rule 21.1 to modify a Time
in Force applicable to the Exchange's equity options platform (``EDGX
Options'').
    The text of the proposed rule change is available at the Exchange's
website at www.markets.cboe.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts 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 amend Exchange Rule 21.1, Definitions, to
modify the Good Til Day (or ``GTD'') Time in Force. Currently, GTD
orders are limited to the specific trading day on which they are
entered, as the Exchange does not currently offer any orders that
continue to remain on the Exchange for more than a single trading day
(i.e., does not carry any orders overnight). The Exchange notes that it
received approval to offer the GTC Time in Force as part of its
proposal to adopt rules to allow trading of complex orders on EDGX
Options.\5\ The GTC Time in Force is not limited to the trading day on
which an order is entered.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 81891 (October 17,
2017), 82 FR 49058 (October 23, 2017) (SR-Bats-EDGX-2017-29).
---------------------------------------------------------------------------

    The Exchange plans to make available the GTC Time in Force
effective January 26, 2018. In connection with such release, the
Exchange proposes to modify the GTD Time in Force to also allow orders
with such Time in Force to remain in effect past the day on which they
were entered, and therefore proposes to remove language that refers to
the time of expiration as needing to be ``during such trading day''. In
addition, to avoid confusion, the Exchange proposes to modify the name
of the GTD Time in Force to ``Good Til Date'', which is more reflective
of a Time in Force that can last for more than one trading day.
    The Exchange does not believe that offering GTD functionality that
allows orders to remain with the Exchange for more than one trading day
raises any issues that are not already present with GTC orders. In
turn, GTC is a common time in force and is typically implemented to
allow orders to remain for more than one trading day.\6\ The Exchange
simply has not offered such functionality previously and therefore has
had specific language reflecting that an expiration time must be during
the trading day. The Exchange also notes that a GTD modifier providing
a Time in Force that could last more than one day has been previously
offered by at least one equities exchange not affiliated with the
Exchange.\7\
---------------------------------------------------------------------------

    \6\ See, e.g., C2 Rule 6.10(d)(2).
    \7\ See Securities Exchange Act Release No. 75497 (July 21,
2015), 80 FR 45022 (July 28, 2015) (SR-NYSEArca-2015-56) (notice of
filing by NYSE Arca describing proposed changes in connection with
migration of technology to new platform, including retirement of GTD
modifier).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \8\ in general, and furthers the objectives of Section
6(b)(5) of the Act \9\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
The Exchange believes the proposed amendment will provide additional
flexibility to Users that wish to enter an order that will last past
the trading day on which it is entered by allowing such Users to set a
specific expiration time. The Exchange also believes the proposed
amendment will increase the understanding of the Exchange's operations
for all Users of the Exchange. In particular, the Exchange intends to
release the GTC Time in Force in the near future, which will persist
over multiple trading days unless cancelled, and believes that the Time
in Force of GTD should similarly be able to persist over multiple
trading days. The Exchange believes it could be confusing and
inconsistent to offer a GTC Time in Force that can persist for longer
than a

single trading day and a GTD Time in Force, which commonly means ``Good
Til Date'', but that would have to expire no later than the end of the
trading day on which it was entered. As such, the proposed rule change
would foster cooperation and coordination with persons engaged in
facilitating transactions in securities and would remove impediments to
and perfect the mechanism of a free and open market and a national
market system.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

(B) Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed change is a
minor update to an existing Time in Force, GTD, given the update to the
Exchange's technology that will allow orders to persist for more than
one trading day. The Exchange does not believe that the proposed
changes will have any direct impact on competition. Thus, the Exchange
does not believe that the proposal creates any significant impact on
competition.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \10\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \11\ 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.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \12\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \13\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the Exchange
may, as soon as possible, implement the proposed rule change. The
Exchange notes that the proposal will promote consistency between the
GTC and GTD Times in Force offered by the Exchange. The Commission
believes that waiver of the 30-day operative delay is consistent with
the protection of investors and the public interest. Accordingly, the
Commission hereby waives the operative delay and designates the
proposed rule change as operative upon filing.\14\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-CboeEDGX-2018-003 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-CboeEDGX-2018-003. 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-CboeEDGX-2018-003 and should be
submitted on or before February 28, 2018.
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-02397 Filed 2-6-18; 8:45 am]
 BILLING CODE 8011-01-P


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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION III

	1650 Arch Street

	Philadelphia, Pennsylvania  19103

DATE:	February 3, 2011

SUBJECT:	Technical Support Document for Pennsylvania’s Adoption of
Control Techniques Guidelines for Paper, Film, and Foil Surface Coating
Processes

			/s/

FROM:	Irene Shandruk, Physical Scientist

Office of Air Program Planning

TO:		File

			/s/

THRU: 	Cristina Fernandez, Associate Director

Office of Air Program Planning

A.  BACKGROUND

Section 172(c)(1) of the Clean Air Act (CAA) provides that state
implementation plans (SIPs) for nonattainment areas must include
reasonably available control measures (RACM), including reasonably
available control technology (RACT), for sources of emissions.  Section
182(b)(2)(A) provides that for certain nonattainment areas, States must
revise their SIPs to include RACT for sources of volatile organic
compound (VOC) emissions covered by a control techniques guidelines
(CTG) document issued after November 15, 1990 and prior to the area’s
date of attainment.

The United States Environmental Protection Agency (EPA) defines RACT as
“the lowest emission limitation that a particular source is capable of
meeting by the application of control technology that is reasonably
available considering technological and economic feasibility.” (44 FR
53761, Sept. 17, 1979).  In subsequent Federal Register notices, EPA has
addressed how states can meet the RACT requirements of the CAA.

CTGs are intended to provide state and local air pollution control
authorities information that should assist them in determining RACT for
VOCs from various sources, including paper, film, and foil coatings.  In
developing these CTGs, EPA, among other things, evaluated the sources of
VOC emissions from this industry and the available control approaches
for addressing these emissions, including the costs of such approaches.
Based on available information and data, EPA provides recommendations
for RACT for VOCs from paper, film, and foil coatings.

In December 1977, EPA published a CTG for surface coating of paper
(EPA-450/2-77-008).  This CTG discusses the nature of VOC emissions from
this industry, available control technologies for addressing such
emissions, the costs of available control options, and other items.

EPA also promulgated a national standard of performance for new
stationary sources (NSPS) for surface coating of pressure sensitive tape
and labels, which is a subset of the paper, film, and foil surface
coating industry in 1983 (40 CFR part 60, subpart RR), and published a
national emission standard for hazardous air pollutants (NESHAP) for
surface coating of paper in 2002 (40 CFR part 63, subpart JJJJ).

In 2006 and 2007, after conducting a review of currently existing state
and local VOC emission reduction approaches for this industry, reviewing
the 1977/1978 CTG and the NESHAP for this industry, and taking into
account the information that has become available since then, EPA
developed a new CTG surface coating of paper, entitled Control
Techniques Guidelines for Paper, Film, and Foil Coatings (Publication
No. EPA 453/R-07-003; September 2007).

Description of Paper, Film, and Foil Coatings

The paper, film, and foil product category listed under section 183(e)
of the CAA includes coatings that are applied to paper, film, or foil
surfaces in the manufacturing of several major product types for the
following industry sectors:  pressure sensitive tape and labels;
photographic film; industrial and decorative laminates; abrasive
products; and flexible packaging. The category also includes coatings
applied during miscellaneous coating operations for several products
including:  corrugated and solid fiber boxes; die-cut paper paperboard
and cardboard; converted paper and paperboard not elsewhere classified;
folding paperboard boxes, including sanitary boxes; manifold business
forms and related products; plastic asceptic packaging; and carbon paper
and inked ribbons.

Coating performed on or in-line with any offset lithographic, screen,
letterpress, flexographic, rotogravure, or digital printing press is not
part of the paper, film, and foil coating category.  In addition, size
presses and on-machine coaters that function as part of an in-line
papermaking system are not part of the paper, film, and foil coating
category.

The paper, film, and foil surface coating process can be described as a
web coating process, which is a process that applies a continuous layer
of coating material across essentially the entire width or any portion
of the width of a web substrate to:  (1) provide a covering, finish,
functional or protective layer to a substrate; (2) saturate a substrate
for lamination; or (3) provide adhesion between two substrates for
lamination.  The web coating operations and emission control techniques
do not vary significantly among the sectors of the paper, film, and foil
surface coating industry.

VOC emissions from paper, film, and foil surface coating operations
primarily result from the evaporation of volatile components of the
coatings and cleaning materials.  The majority of VOC emissions from
these materials occur during coating application/flash-off, coating
curing/drying, and cleaning.  The remaining VOC emissions are from
cleaning operations.

EPA’s Recommended Control Option for Paper, Film, and Foil Coatings

EPA issued a CTG for Paper, Film, and Foil Coatings in September 2007
(Publication No. EPA 453/R-07-003).  The following summarizes
recommendations for controlling VOC emissions from paper, film, and foil
coatings:

A.  Coatings:  To control VOC emissions from coatings used in paper,
film, and foil surface coating, an overall VOC control efficiency of 90%
for each coating line is recommended.  Alternatively, emission limits
that are equivalent to 90 percent overall control is recommended.
Applying the control recommendations only to individual surface coating
lines with the potential to emit, prior to controls, at least 25 tpy of
VOC from coatings is recommended.  The coating line is defined as a
series of coating applicators, flash-off areas, and any associated
curing/drying equipment between one or more unwind/feed stations and one
or more rewind/cutting stations.  It’s also recommended that paper,
film, and foil surface coating facilities be provided with the option of
using an enforceable limitation on potential emissions to keep an
individual paper, film, and foil surface coating line below the 25 tons
per year (tpy) potential to emit threshold.

An overall VOC control efficiency of 90 percent is recommended as RACT
for each paper, film, and foil surface coating line.  However, as an
alternative to an overall 90 percent control efficiency, VOC
content-based emission limits that are equivalent to 90 percent overall
control are recommended, which can be met by use of low VOC content
materials or combinations of materials and controls.  To determine these
equivalent content-based emission limits for this product category
(except for pressure sensitive tape and label surface coating lines), 20
weight percent solids and 80 weight percent solvent was used.  Using
this baseline coating content, the VOC content-based emission limits
equivalent to 90 percent emission reduction are 0.40 kg VOC/kg (0.40 lb
VOC/lb) solids applied and 0.08 kg VOC/kg (0.08 lb VOC/lb) coating
applied.

As an alternative to 90 percent emission reduction, a limit of 0.20 kg
VOC/kg (0.20 lb VOC/lb) solids applied is recommended, and an additional
equivalent limit of 0.067 kg VOC/kg (0.067 lb VOC/lb) of coating is RACT
for pressure sensitive tape and label surface coating lines.

Table 1:  Recommended Emission Limits for Paper, Film, and Foil Coatings

Units	RACT Limits

	Pressure Sensitive Tape and Label Surface Coating	Paper, Film, and Foil
Surface Coating (Not including Pressure Sensitive Tape and Label)

kg VOC/kg solids

(lb VOC/lb solids)	0.20	0.40

kg VOC/kg coating

(lb VOC/lb coating)	0.067	0.08

The VOC content limits can be met by averaging the VOC content of
materials used on a single surface coating line each day (i.e. daily
within-line averaging).

B.  Cleaning Materials:  To control VOC emissions from cleaning
materials used in paper, film, and foil surface coating, it is
recommended that facilities implement work practices to ensure that VOC
emissions are minimized from mixing, storage, and handling of cleaning
materials, and cleaning-related waste materials.  Specifically, the
following is recommended:  (1) store all VOC-containing cleaning
materials in closed containers; (2) ensure that mixing and storage
containers used for VOC-containing materials are kept closed at all
times except when depositing or removing these materials; (3) minimize
spills of VOC-containing cleaning materials; (4) convey VOC-containing
cleaning materials from one location to another in closed containers or
pipes; and (6) minimize VOC emissions from cleaning of storage, mixing,
and conveying equipment.

B.  STATE SUBMITTAL

On January 4, 2011, Pennsylvania Department of Environmental Protection
(PADEP) submitted to EPA a SIP revision concerning the adoption of the
EPA paper, film, and foil surface coating processes.  EPA develops CTGs
as guidance on control requirements for source categories.  States can
follow the CTGs or adopt more restrictive standards.  The Commonwealth
of Pennsylvania has adopted EPA’s CTG standards for paper, film, and
foil surface coating processes.  These regulations are in 25 Pa. Code
Chapter 121 –

General Provisions and in Chapter 129 – Standards for Sources.
Specifically, this revision amends the existing regulations at §§
121.1, 129.51 and 129.52 and adds new § 129.52b.  Section 129.52b,
which covers control of VOC emissions from paper, film, and foil surface
coating processes, supersedes the existing paper surface coating
requirements and limits in § 129.52.  The requirements of § 129.52b
also supersede the requirements of a RACT permit issued to the owner or
operator of a source subject to § 129.52(b)(a) prior to January 1, 2012
under §§ 129.91 – 129.95 to control, reduce, or minimize VOC
emissions from a paper, film, or foil surface coating process, except to
the extent the RACT permit contains more stringent requirements.

Chapter 121:  General Provisions

Section 121.1:  Definitions

“coating line” definition is added

“coating” definition is amended for purposes of section 129.52(b)

“paper coating” definition was amended to correspond to the broader
terms “paper, film, or foil” and “paper, film, or foil surface
coating,” which are used in other sections of Chapter 129

Chapter 129: Standards for Sources – Sources of VOCs

Section 129.51:  General

Section 129.51(a) is amended to extend its coverage to paper, film, and
foil surface coating processes

Section 129.52:  Surface coating processes

Subsection (j) is added clarifying that the requirements and limits
already specified in section 129.52 for paper coatings are superseded by
the requirements and limits adopted in this revision.

Section 129.52b:  Control of VOC emissions from paper, film, and foil
surface coating processes

This section includes VOC emission limits, work practices, and
recordkeeping and reporting requirements, all of which are consistent
with EPA’s CTG for paper, film, and foil surface coating processes.
The requirements in section 129.52b supersede the requirements in 129.52
relating to control of VOC emissions from paper, film, and foil surface
coating processes beginning January 1, 2012.

Subsection (a) establishes applicability for the emission limits, work
practice requirements and related compliance monitoring, and
recordkeeping and reporting requirements.

Subsection (b) explains that the requirements of section 129.52b
supersede the requirements of a RACT permit from a paper, film, or foil
surface coating operation already issued to the owner or operator
subject to section129.52b unless the RACT permit contains more stringent
requirements.

Subsection (c) establishes VOC emission limits which take effect
beginning January 1, 2012.

Subsection (d) establishes compliance monitoring procedures and
identifies daily records that must be kept in order to demonstrate
compliance.

Subsection (e) establishes recordkeeping and reporting requirements.

Subsection (f) explains that VOCs may not be emitted into the atmosphere
from the application of paper, film, or foil surface coatings, unless
the coatings are applied using one or more of the following coating
application methods:

Rotogravure coating

Reverse roll coating

Knife coating

Dip coating

Slot die coating

Flexographic coating

Extrusion coating

Subsection (g) exempts coatings which are used exclusively for
determining product quality and commercial acceptance if the quantity of
coating used does not exceed 50 gallons per year for all coatings
combined for the facility and if the owner or operator of the facility
requests this exemption in writing and PADEP approves, in writing, the
exemption prior to use of the coating.

Subsection (h) establishes work practice requirements for cleaning
materials.

Additionally, VOC emission limits for paper coatings only and the
associated applicability criteria that were in section 129.52(a)(2) were
added to section 129.52b in order to carry forward previously regulated
paper coating sources so as to eliminate the potential for backsliding.
These VOC emission limits apply only to paper coatings if actual VOC
emissions have exceeded 3 pounds per hour, 15 pounds per day or 2.7 tpy
in any year since January 1, 1987.  The limits are shown in Table 2.

Table 2:  Emission Limits of VOCs for Paper Coating

Units

RACT Limit for Paper Coating

lb VOC/gal coating solids	4.84

kg VOC/l coating solids	0.58

C.  EPA EVALUATION

PADEP has adopted the standards and requirements of EPA’s CTG for
paper, film, and foil surface coating processes and is amending the
Pennsylvania SIP to reflect these amendments.  The maximum benefit from
these amendments will be provided during the ozone season when VOCs
readily combine with NOx to form ground-level ozone.  Specifically, a
maximum of 176 tons of additional annual VOC emission reductions are
anticipated from the paper, film, or foil surface coatings facilities in
Pennsylvania as a result of this rulemaking.  Therefore, this revision
will help Pennsylvania attain and maintain the NAAQS for ozone.

D.  CONCLUSIONS AND RECOMMENDED AGENCY ACTION

The adoption of the EPA CTG requirements for paper, film, and foil
surface coating processes by the Commonwealth of Pennsylvania will
result in the reduction of VOC emissions from paper, film, and foil
surface coating processes.  EPA’s approval of the SIP revision is
recommended.

 PAGE

 PAGE   1


[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)]
[Proposed Rules]
[Pages 3443-3445]
[FR Doc No: 2018-01298]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2017-D-6592]

Application of the Foreign Supplier Verification Program
Regulation to Importers of Grain Raw Agricultural Commodities: Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of a guidance for industry entitled
``Application of the Foreign Supplier Verification Program Regulation
to Importers of Grain Raw Agricultural Commodities: Guidance for
Industry.'' This guidance is intended to explain our intent to exercise
enforcement discretion for importers of grain raw agricultural
commodities (RACs) that are solely engaged in the storage of grain
intended for further distribution or processing and grain importers
that do not take physical possession of the grain they import, but
instead arrange for the delivery of the grain to others for storage,
packing, or manufacturing/processing.

DATES: The announcement of the guidance is published in the Federal
Register on January 25, 2018.

ADDRESSES: You may submit either electronic or written comments on FDA
guidances at any time as follows:

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-2017-D-6592 for ``Application of the Foreign Supplier Verification
Program Regulation to Importers of Grain Raw Agricultural Commodities:
Guidance for Industry.'' Received comments 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.
     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 and 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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5).
    Submit written requests for single copies of the guidance to Office
of Food Safety, Center for Food Safety and Applied Nutrition, Food and
Drug Administration (HFS-300), 5001 Campus Dr., College Park, MD 20740.
Send two self-addressed adhesive labels to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Sharon Mayl, Office of Foods and
Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Application of the Foreign Supplier Verification Program
Regulation to Importers of Grain Raw Agricultural Commodities: Guidance
for Industry.'' We are issuing the guidance consistent with our good
guidance practices regulation Sec.  10.115 (21 CFR 10.115). In
accordance with Sec.  10.115(g)(2), we are implementing the guidance
immediately because we have determined that prior public participation
is not feasible or appropriate. We made this determination because this
guidance document provides information pertaining to regulations with
which many importers were required to comply as of May 30, 2017, and it
sets out compliance policy that reduces regulatory burdens for
importers of certain raw agricultural commodities. Although the
guidance document is immediately in effect, we invite comments at any
time in accordance with the Agency's good guidance practices (Sec.
10.115(g)(3)).
    The guidance represents the current thinking of FDA on this topic.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternate approach if it satisfies
the requirements of the applicable statutes and regulations. This
guidance is not subject to Executive Order 12866.
    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. It amended the Federal Food,
Drug, and Cosmetic Act (FD&C Act) to add, among other food safety
requirements, provisions requiring the verification of the safety of
food imported from foreign suppliers of that food.
    Section 805(c) of the FD&C Act (21 U.S.C. 384a(c)) directs FDA to
issue regulations on the content of Foreign Supplier Verification
Programs (FSVPs). We issued the FSVP final rule on November 27, 2015
(80 FR 74225). The FSVP regulation requires food importers to develop,
maintain, and follow an FSVP that provides adequate assurances that the
foreign supplier uses processes and procedures that provide the same
level of public health protection as those required under the
preventive controls and produce safety provisions of FSMA (if
applicable) and regulations implementing those provisions, as well as
assurances that the imported food is not adulterated and that human
food is not misbranded with respect to allergen labeling.

    FSMA also includes provisions requiring certain food facilities to
implement preventive controls to, among other things, provide
assurances that hazards identified in a hazard analysis will be
significantly minimized or prevented. FDA's final rules on current good
manufacturing practice, hazard analysis, and risk-based preventive
controls for human food (80 FR 55908, September 17, 2015) and for
animal food (80 FR 56170, September 17, 2015) include provisions
requiring receiving facilities to conduct a hazard analysis and to
establish and implement supply-chain programs for domestic and imported
raw materials and other ingredients for which the facility has
identified a hazard requiring a supply-chain applied control.
    The preventive controls requirements, including the supply-chain
program provisions, do not apply to facilities that are solely engaged
in the storage of non-produce RACs (including grain RACs) intended for
further distribution or processing. However, the FSVP regulation
applies to all importers of non-produce RACs, including importers that
are solely engaged in the storage of these RACs intended for further
processing.
    The guidance describes FDA's current thinking on the application of
the FSVP regulation to importers of grain RACs. To better align the
FSVP regulation with the exemption from preventive controls
requirements for facilities solely engaged in the storage of non-
produce RACs, and because of the nature of the hazards associated with
grain RACs and how they are generally addressed in the distribution
chain, we intend to exercise enforcement discretion for importers of
grain RACs that are solely engaged in the storage of grain intended for
further distribution or processing with respect to the FSVP regulation.
This intent to exercise enforcement discretion with respect to FSVP
also applies to grain importers that do not take physical possession of
the grain they import but instead arrange for the delivery of the grain
to others for storage, packing or manufacturing/processing.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 1, subpart L have been
approved under OMB control number 0910-0752.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: January 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01298 Filed 1-24-18; 8:45 am]
 BILLING CODE 4164-01-P