[Federal Register: January 31, 2008 (Volume 73, Number 21)]
[Notices]
[Page 5830-5831]
[DOCID:fr31ja08-53]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP08-60-000]

Arlington Storage Company, LLC; Notice of Application

January 25, 2008.
     Take notice that on January 23, 2008, Arlington Storage Company,
LLC (Arlington), Two Brush Creek Boulevard, Kansas City, Missouri
64112, filed in Docket No. CP08-60-000, a petition for Exemption of
Temporary Acts and Operations from Certificate Requirements, pursuant
to Rule 207(a)(5) of the Commission's Rules of Practice and Procedure,
and section 7(c)(1)(B) of the Natural Gas Act, seeking approval of an
exemption from certificate requirements to perform temporary activities
in order to drill up to two test wells in the Thomas Corners Fields to
assess the optimal manner in which to develop an underground natural
gas storage facility in Steuben County, New York, all as more fully set
forth in the application which is on file with the Commission and open
to public inspection. This filing may also be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number, excluding the last three digits, in the
docket number field to access the document. For assistance, call (202)
502-8659 or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
James M. Costan, Sullivan & Worcester LLP, 1666 K Street, NW.,
Washington, DC 20006, at<PHONE_NUMBER>, or by fax at<PHONE_NUMBER>,
or e-mail<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to

the party or parties directly involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: February 8, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-1738 Filed 1-30-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 13 (Friday, January 22, 2021)]
[Notices]
[Pages 6718-6719]
[FR Doc No: 2021-01281]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90925; File No. SR-CBOE-2020-034]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proceedings To
Determine Whether To Approve or Disapprove a Proposed Rule Change, as
Modified by Amendment No. 1, To Authorize for Trading Flexible Exchange
Options on Full-Value Indexes With a Contract Multiplier of One

January 14, 2021.
    On June 30, 2020, Cboe Exchange, Inc. filed with the Securities and
Exchange Commission (``Commission''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to authorize for trading flexible
exchange options on full-value indexes with a contract multiplier of
one. The proposed rule change was published in the Federal Register on
July 20, 2020.\3\ On September 2, 2020, pursuant to Section 19(b)(2) of
the Act,\4\ the Commission designated a longer period within which to
approve the proposed rule change, disapprove the proposed rule change,
or institute proceedings to determine whether to disapprove the
proposed rule change.\5\ On October 15, 2020, the Commission instituted
proceedings under Section 19(b)(2)(B) of the Act \6\ to determine
whether to approve or disapprove the proposed rule change.\7\ On
January 21, 2021, the

Exchange submitted Amendment No. 1 to the proposed rule change.\8\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 89308 (July 14,
2020), 85 FR 43923 (``Notice''). Comments received on the proposed
rule change are available on the Commission's website at: https://www.sec.gov/comments/sr-cboe-2020-034/srcboe2020034.htm.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 89743, 85 FR 55717
(September 9, 2020).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 90204, 85 FR 67037
(October 21, 2020).
    \8\ In Amendment No. 1, the Exchange provided additional support
for the proposal. The full text of Amendment No. 1 is available on
the Commission's website at: https://www.sec.gov/comments/sr-cboe-2020-034/srcboe2020034.htm.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \9\ provides that, after initiating
proceedings, the Commission shall issue an order approving or
disapproving the proposed rule change not later than 180 days after the
date of publication of notice of filing of the proposed rule change.
The Commission may extend the period for issuing an order approving or
disapproving the proposed rule change, however, by not more than 60
days if the Commission determines that a longer period is appropriate
and publishes the reasons for such determination. The proposed rule
change was published for comment in the Federal Register on July 20,
2020.\10\ The 180th day after publication of the Notice is January 16,
2021. The Commission is extending the time period for approving or
disapproving the proposal for an additional 60 days.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2).
    \10\ See supra note 3.
---------------------------------------------------------------------------

    The Commission finds that it is appropriate to designate a longer
period within which to issue an order approving or disapproving the
proposed rule change so that it has sufficient time to consider the
proposed rule change, as modified by Amendment No. 1. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\11\ designates
March 17, 2021, as the date by which the Commission shall either
approve or disapprove or the proposed rule change (File Number SR-CBOE-
2020-034), as modified by Amendment No. 1.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-01281 Filed 1-21-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Pages 47280-47283]
[FR Doc No: 2011-19748]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64991; File No. SR-CBOE-2011-039]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Order Granting Approval of Proposed Rule Change To List
and Trade Single Stock Dividend Options

July 29, 2011.
    On May 31, 2011, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (the ``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to list and trade cash-settled
options that overlie the ordinary cash

dividends paid by an issuer over an annual, semi-annual, or quarterly
``accrual period.'' The proposed rule change was published for comment
in the Federal Register on June 17, 2011.\3\ The Commission received no
comments on the proposal. This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 64654 (June 13,
2011), 76 FR 35503 (``Notice'').
---------------------------------------------------------------------------

I. Description of Proposal

    CBOE proposes to list and trade cash-settled, P.M.-settled,
European-style exercise options that overlie the ordinary cash
dividends paid by an issuer (``SSDO'') over an annual accrual period.
CBOE also may list series of SSDOs with an accrual period of less than
a year, but in no event less than one quarter of a year.

Product Design

    Each SSDO represents the accumulated ordinary dividend amounts paid
by a specific issuer over a specified accrual period.\4\ Each annual
accrual period will run from the business day after the third Friday of
December through the third Friday of the following December. For an
SSDO with an accrual period of less than a year, the accrual period
runs from the business day after the third Friday of the month
beginning the accrual period through the third Friday of the month
ending the accrual period.\5\
---------------------------------------------------------------------------

    \4\ For purposes of SSDOs, dividends are deemed to be ``paid''
on the ex-dividend date.
    \5\ The Exchange will assign separate trading symbols to SSDOs
overlying the accumulated ex-dividends of the same issuer that have
different accrual periods.
---------------------------------------------------------------------------

    The underlying value for SSDOs will be equal to ten (10) times the
ex-dividend amounts of an issuer accumulated over the specified accrual
period. Each day, CBOE will calculate the aggregate daily dividend
totals for the specific issuer, which are summed up over any accrual
period. During each business day, CBOE will disseminate the underlying
SSDO value, multiplied by ten (10), through the Options Price Reporting
Authority (``OPRA''), the Consolidated Tape Association (``CTA'') tape
and/or the Market Data Index (``MDI'') feed.

Options Trading

    Each SSDO will be quoted in decimals and one point will be equal to
$100. The Exchange proposes that the minimum price variation for quotes
shall be established on a class-by-class basis by the Exchange and
shall not be less than $0.01. CBOE also proposes to list series at 1
point ($1.00) or greater strike price intervals if the strike price is
equal to or less than $200 and 2.5 points ($2.50) or greater strike
price intervals if the strike price exceeds $200. Initially, the
Exchange will list in-, at- and out-of-the-money strike prices and may
open for trading up to five annual contract months expiring in December
in different years for any single stock underlying an SSDO and up to
ten contract months for accrual periods of less than a year.\6\ The
Exchange is proposing to use the expected dividend (i.e., the aggregate
value of dividends that are expected to be paid by the issuer over a
given accrual period) amount for setting the initial strikes. Near-term
SSDOs will reflect dividends accumulating in the then-current accrual
period. All other SSDO options (i.e., contracts listed for trading that
are not in the then-current accrual period) will reflect dividends
expected in comparable accrual periods beyond the current accrual
period. The Exchange may open for trading additional series, either in
response to customer demand or as the price of the expected dividends
for an issuer changes.
---------------------------------------------------------------------------

    \6\ See Notice, supra note 3, for an example of listing five
annual contract months expiring in December in different years.
---------------------------------------------------------------------------

Exercise and Settlement

    The proposed options will expire on the Saturday following the
third Friday of the expiring month. Trading in the expiring contract
month will normally cease at 3 p.m. Chicago time on the last day of
trading (ordinarily the Friday before expiration Saturday, unless there
is an intervening holiday). When the last trading day is moved because
of an Exchange holiday (such as when CBOE is closed on the Friday
before expiration), the last trading day for expiring options will be
Thursday.
    Exercise will result in delivery of cash on the business day
following expiration. SSDOs will be P.M.-settled. The Exchange is
proposing P.M.-settlement for SSDOs because options trading on
individual stocks are P.M. settled. As a result, the Exchange is
proposing to match the expiration style for SSDOs to individual stock
option exercise. The exercise-settlement amount will be equal to ten
times the ordinary cash dividends paid by the issuer over the accrual
period. The exercise settlement amount is equal to the difference
between the exercise-settlement value and the exercise price of the
option, multiplied by the contract multiplier ($100).
    If the exercise settlement value is not available or the normal
settlement procedure cannot be utilized due to a trading disruption or
other unusual circumstance, the settlement value will be determined in
accordance with the rules and bylaws of the OCC.

Surveillance

    CBOE has represented that it will use the same surveillance
procedures currently utilized for each of the Exchange's other single
stock options to monitor trading in SSDOs. Such procedures include, for
example, monitoring dividend announcements. The Exchange represents
that these surveillance procedures shall be adequate to monitor trading
in these option products. For surveillance purposes, the CBOE has
represented that it will have complete access to information regarding
trading activity in the pertinent securities whose dividend payment is
the basis for particular SSDOs.

Position Limits

    CBOE proposes that position and exercise limits for SSDOs will be
the same as those for standard options overlying the same security.
While positions in SSDOs will be aggregated with longer-dated positions
in SSDOs with the same underlying stock for position and exercise
limits purposes, they will not be aggregated with positions in the
ordinary options overlying the stock of the issuer paying the dividends
underlying the SSDO. CBOE represents that the reason for not
aggregating positions with ordinary options is that SSDOs are based
solely on expected dividends for an issuer and will reflect the forward
value of that expectation. CBOE states that because the pricing of
ordinary options versus SSDOs will differ dramatically, the Exchange
believes there is no need to aggregate positions to prevent
manipulative practices involving the underlying options.

Exchange Rules Applicable

    New Rule 5.9 is proposed to govern the listing and trading of
SSDOs. In addition, SSDOs will be margined in the same manner as single
stock options under Exchange Rule 12.3. Purchasers of puts or calls,
however, must be paid in full, even if there remains longer than nine
months until expiration for the position. For SSDOs, the aggregate
contract value on which the margin amount will be calculated will be
the product of the forward expected dividend amount for the accrual
period (as adjusted for any contract scaling factor) and the applicable
multiplier ($100).
    CBOE proposes to designate SSDO options as eligible for trading as
Flexible

Exchange Options (``FLEX options'') as provided for in Chapters XXIVA
(Flexible Exchange Options) and XXIVB (FLEX Hybrid Trading System).

Capacity

    CBOE represents that it has analyzed its capacity and believes that
the Exchange and OPRA have the necessary systems capacity to handle the
additional traffic associated with the listing of new series that will
result from the introduction of SSDOs.

II. Discussion and Commission Findings

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\7\
Specifically, the Commission finds that the proposal is consistent with
Section 6(b)(5) of the Act,\8\ which requires, among other things, that
the rules of a national securities exchange be 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.
---------------------------------------------------------------------------

    \7\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that CBOE's proposal gives options
investors the ability to make an additional investment choice in a
manner consistent with the requirements of Section 6(b)(5) of the
Act.\9\ The Commission notes that SSDOs will allow market participants
to hedge their exposure to changes in the dividend payment policies of
the underlying securities. Further, the Commission believes that the
listing rules proposed by CBOE for SSDOs are reasonable and consistent
with the Act, as discussed below.
---------------------------------------------------------------------------

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

    The Commission believes that permitting $1.00 strike price
intervals if the strike price is equal to or less than $200 will
provide investors with added flexibility in the trading of these
options and will further the public interest by allowing investors to
establish positions that are better tailored to meet their investment
objectives. As explained by CBOE, the underlying value of an SSDO is
expected to fluctuate around a limited expected dividend value
range,\10\ and therefore, the implementation of $1.00 strike price
intervals is designed to provide investors with flexibility. Because of
this characteristic the Commission believes that the implementation of
$1 strike price intervals for SSDOs, within the parameters of the rule,
is appropriate.
---------------------------------------------------------------------------

    \10\ The Commission notes that, in the Notice the Exchange
provided a number of examples of values underlying SSDOs using past
ordinary dividend payouts over varying accrual periods, and these
values ranged from 1 to 22.70. See Notice, supra note 3.
---------------------------------------------------------------------------

    The Commission believes that CBOE's proposal to allow the minimum
price variation to be no less than $0.01, as established on a class-by-
class basis, is consistent with the Act, given the expected low
underlying dividend values for SSDOs. CBOE has represented that it
expects that the underlying dividend values for SSDOs will be
relatively low, and that granular pricing will provide for more pricing
points. Further, CBOE has represented that it has analyzed its capacity
and believes that it and OPRA have the necessary systems capacity to
handle the additional traffic associated with the listing of new series
that will result from the introduction of SSDOs. In particular, the
Exchange noted that expected dividend payments, on which the value of
SSDOs are predicated, are generally much less volatile than share
prices, and thus there is less need to list numerous strike prices for
each expiration date of an SSDO or to add many new strikes over the
life of an SSDO.
    The Commission notes that, on a daily basis, CBOE will calculate
the aggregate daily dividend totals for the specific issuer, and will
disseminate the underlying SSDO value, multiplied by ten (10), through
OPRA, the CTA and/or the MDI feed.
    The Exchange has proposed to apply the same position and exercise
limits as those for standard options overlying the same security.
However, the Exchange notes that positions in SSDOs will not be
aggregated with positions in the ordinary positions overlying the stock
of the issuer paying the dividends underlying the SSDO, because the
pricing of ordinary options and SSDOs vary greatly and thus it is
unnecessary to aggregate the positions to prevent manipulative
practices involving the underlying. The Commission believes that CBOE's
proposed rules relating to position and exercise limits are appropriate
and consistent with the Act.
    The Exchange also proposes to margin SSDOs in the same manner as
single stock options; however, the aggregate contract value on which
the margin amount will be calculated will be the product of the forward
expected dividend amount for the accrual period and the applicable
modifier. The Commission believes that CBOE's proposed rules relating
to margin requirements are appropriate.
    The Commission also believes that CBOE's proposal to allow SSDOs to
be eligible for trading as FLEX options is consistent with the Act. The
Commission previously approved rules relating to the listing and
trading of FLEX options on CBOE, which give investors and other market
participants the ability to individually tailor, within specified
limits, certain terms of those options.\11\
---------------------------------------------------------------------------

    \11\ See Securities Exchange Act Release No. 31910 (February 23,
1993), 58 FR 12056 (March 2, 1993).
---------------------------------------------------------------------------

    The Commission notes that CBOE represented that it has an adequate
surveillance program to monitor trading of SSDOs and intends to apply
its existing surveillance program for single stock options to support
the trading of these options. As with other securities, there is a
potential risk that a corporate insider may exploit his or her advance
knowledge of changes to an issuer's dividend policy through the
purchase or sale of an SSDO. The Commission has taken a number of
enforcement actions in cases where insiders executed securities
transactions to exploit their knowledge of changes in issuers' dividend
policies.\12\ Accordingly, adequate surveillance is an important
responsibility of the CBOE. In addition, CBOE has represented that it
is confident that it has adequate tools in place to surveil for market
manipulation. Further, CBOE is a member of the ISG and can obtain
trading activity in information in the underlying securities whose
dividend payment is the basis for particular SSDOs from the exchanges
that list the securities. The Commission believes that CBOE should have
the ability and resources to adequately surveil for manipulation in
SSDOs.
---------------------------------------------------------------------------

    \12\ See, e.g., SEC v. David L. Johnson, Civil Action No. 05-CV-
4789 (USDC E.D. Pa.) (Sept. 7, 2005) (consent to permanent
injunction, disgorgement and civil penalty for a person who
allegedly sold shares of an issuer based on inside information of a
dividend cut, and tipped his son to do likewise); SEC v. Barry
Hertz, Civil Action No. 05-2848 (USDC E.D.N.Y.) (Mar. 16, 2007)
(consent to final judgment, including an injunction and two-year bar
from serving as an officer or director of a public corporation, for
a person alleged to have traded on inside information, including
purchasing shares of an issuer while in possession of positive news
of a first time dividend issuance).
---------------------------------------------------------------------------

    In approving the proposed rule change, the Commission has also
relied upon CBOE's representation that it has the necessary systems
capacity to support the new options series that will result from this
proposal.

III. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\13\ that the proposed rule change (SR-CBOE-2011-039) is hereby
approved.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-19748 Filed 8-3-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Rules and Regulations]
[Pages 74669-74672]
[FR Doc No: 2015-28161]

Vol. 80

Friday,

No. 228

November 27, 2015

Part V

 Department of Health and Human Services

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

Food and Drug Administration

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

21 CFR Part 112

 Final Environmental Impact Statement and Record of Decision for the
Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption; Availability; Final Rule

Federal Register / Vol. 80 , No. 228 / Friday, November 27, 2015 /
Rules and Regulations

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2014-N-2244]
RIN 0910-AG35

Final Environmental Impact Statement and Record of Decision for
the Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) has made
available for public review the Final Environmental Impact Statement
(EIS) and Record of Decision (ROD) for the standards for the growing,
harvesting, packing, and holding of produce for human consumption. FDA
prepared the Final EIS after taking into account public comment
received on the corresponding Draft EIS and is publishing the ROD at
the time of our decision. The Final EIS and ROD documents are available
in Docket No. FDA-2014-N-2244.

DATES: FDA announces the availability of the EIS and ROD on November
27, 2015.

FOR FURTHER INFORMATION CONTACT: Annette McCarthy, Center for Food
Safety and Applied Nutrition (HFS-205), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353),
signed into law by President Obama on January 4, 2011, enables FDA to
better protect public health by helping to ensure the safety and
security of the food supply. FSMA amends the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to establish the foundation of a
modernized, prevention-based food safety system. As part of our
implementation of FSMA, we published the proposed rule: Standards for
the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption (hereafter referred to as ``the 2013 proposed rule'') on
January 16, 2013, to establish science-based minimum standards for the
safe growing, harvesting, packing, and holding of produce (78 FR 3504).
On September 29, 2014, FDA issued a supplemental notice of proposed
rulemaking (``the supplemental proposed rule''), amending certain
specific provisions of the 2013 proposed rule (79 FR 58434). Taken
together, these publications constitute FDA's proposed standards for
the growing, harvesting, packing, and holding of produce for human
consumption (``the Produce Safety proposed rule'').
    FDA announced a ``Notice of Intent'' (NOI) to prepare an EIS to
evaluate the potential environmental effects of the Produce Safety
Proposed Rule in the Federal Register on August 19, 2013 (78 FR 50358).
In the NOI, FDA also announced the beginning of the scoping process and
solicited public comments to identify issues to be analyzed in an EIS.
The NOI asked for public comment by November 15, 2013, and FDA later
extended the deadline for the comment period to March 15, 2014 (78 FR
69006; November 18, 2013), and then April 18, 2014 (79 FR 13593; March
11, 2014).
    A public scoping meeting was held on April 4, 2014, in College
Park, MD. FDA prepared a Draft EIS for the Produce Safety proposed rule
and, on January 14, 2015, published a ``Notification of public
meeting'' in the Federal Register to: (1) Announce the availability of
the Draft EIS for public review and comment and (2) announce a public
meeting to inform the public of the findings in the Draft EIS, provide
information about the EIS process, solicit oral stakeholder and public
comments on the Draft EIS, and provide clarification, as needed, about
the contents of the Draft EIS (80 FR 1852). The public meeting was held
on February 10, 2015, in College Park, MD. The comment period on the
Draft EIS closed on March 13, 2015. FDA is now announcing the
availability of the Final EIS, which FDA prepared, taking into account
public comment received on the Draft EIS, and the ROD, which details
FDA's final decision, taking into account the findings of the Final EIS
and the Agency's stated purpose and need.
    In the Produce Safety proposed rule, FDA proposed science-based
minimum standards for the safe production and harvesting of produce. As
discussed in the Final EIS (Ref. 1), out of these standards, we
identified four provisions that could potentially significantly affect
the quality of the human environment, if finalized (hereinafter
referred to as ``potentially significant provisions''). For each of the
potentially significant provisions, FDA then identified alternative
provisions to consider. The potentially significant provisions are: (1)
Standards directed to agricultural water, (2) standards directed to
biological soil amendments (BSA) of animal origin, (3) standards
directed to domesticated and wild animals, and (4) general provisions
(i.e., cumulative impacts). Additionally, an overarching ``No Action''
alternative was considered for the purpose of evaluating conditions in
the absence of any final rule.
    For standards directed to agricultural water, we considered the
following alternatives: (1) As proposed by FDA, i.e., a statistical
threshold value (STV) not exceeding 410 colony forming units (CFU) of
generic Escherichia coli per 100 milliliters (ml) of water and a
geometric mean (GM) not exceeding 126 CFU of generic E. coli per 100 ml
of water, along with options to achieve the standard by applying either
a time interval between last irrigation and harvest using a microbial
die-off rate of 0.5 log per day and/or a time interval between harvest
and end of storage using an appropriate microbial die-off or removal
rates, including during activities such as commercial washing (proposed
21 CFR 112.44(c)); (2) a microbial quality standard of no more than 235
CFU (or most probable number (MPN), as appropriate) generic E. coli per
100 ml for any single sample or a rolling GM (n=5) of more than 126 CFU
(or MPN, as appropriate) per 100 ml of water, as was proposed in the
2013 proposed rule; (3) as proposed (i.e., Alternative 1), but with an
additional criterion establishing a maximum generic E. coli threshold;
and (4) for each of the previous alternatives, consider the
environmental impacts if each alternative includes root crops that are
irrigated using low-flow methods.
    For standards directed to BSAs of animal origin, FDA considered
standards for both untreated and treated BSAs. For untreated BSAs of
animal origin, the alternatives considered included a range of minimal
application intervals (the time between application and harvest) when
the BSA is applied in a manner that does not contact covered produce
during application and minimizes the potential for contact with covered
produce after application. The alternative application intervals
evaluated were: (1) 9 months; (2) 0 months; (3) 90 and 120 days;
consistent with the National Organic Program's regulations in 7 CFR
205.203(c)(1); (4) 6 months; and (5) 12 months. For standards directed
to treated BSAs, the alternatives considered included a range of
application intervals when the BSA is composted in accordance with the
requirements proposed in Sec.  112.54(c) and applied in a manner that
minimizes the potential for contact with covered produce during and
after application.

The application intervals evaluated were: (1) As proposed by FDA, 0
days (proposed Sec.  112.56(a)(4)(i)); (2) 45 days; and (3) 90 days.
    For standards directed at domesticated animals, we considered
alternatives under which, if working animals are used in a growing area
where a crop has been planted, measures would be required to prevent
the introduction of known or reasonably foreseeable hazards into or
onto covered produce with the waiting period between grazing and
harvesting varying by alternative. The following alternatives were
evaluated: (1) As proposed by FDA, an adequate waiting period between
grazing and harvesting for covered produce in any growing area that was
grazed to ensure the safety of the harvested crop (proposed Sec.
112.82(a)); (2) a minimum waiting period of 9 months; and (3) a minimum
waiting period of 90 days and 120 days before harvest, depending upon
whether the edible portion of the crop contacts the soil (applying the
timeframes for raw manure set forth in the National Organic Program's
regulations in 7 CFR 205.203(c)(1)). For standards directed to wild
animals, we considered alternatives to the proposed requirement that
under circumstances when there is a reasonable probability that animal
intrusion will contaminate covered produce, the grower would be
required to monitor those areas that are used for a covered activity
for evidence of animal intrusion: (1) As needed during the growing
season based on (i) the grower's covered produce and (ii) the grower's
observations and experience; and (2) immediately prior to harvest. The
alternatives evaluated were: (1) As proposed by FDA, if animal
intrusion occurs--as made evident by observation of significant
quantities of animals, animal excreta, or crop destruction via
grazing--the grower must evaluate whether the covered produce can be
harvested in accordance with the requirements of proposed Sec.  112.112
(proposed Sec.  112.83(a) and (b)); and (2) if animal intrusion is
reasonably likely to occur, the grower must take measures to exclude
animals from fields where covered produce is grown.
    The cumulative impacts of the proposed rule were considered using a
range of alternatives to the general provision in proposed Sec.  112.4,
which would specify the farms that would be covered under the rule
based on the farm's annual sales of produce. The alternatives evaluated
were to cover those farms that have: (1) As proposed by FDA, an average
annual monetary value of produce sold during the previous 3-year period
of more than $25,000 (on a rolling basis) (proposed Sec.  112.4); (2)
an average annual monetary value of food sold during the previous 3-
year period of more than $50,000 (on a rolling basis); (3) an average
annual monetary value of food sold during the previous 3-year period of
more than $100,000 (on a rolling basis); and (4) an average annual
monetary value of covered produce sold during the previous 3-year
period of more than $25,000 (on a rolling basis).
    In the Final EIS, FDA identifies the ``Agency's preferred
alternative,'' i.e., the alternative which the Agency believes will
fulfill its statutory mission and responsibilities for this rulemaking,
giving consideration to economic, environmental, technical, and other
factors. Slight modifications to the preferred alternative were made in
the ROD to reflect the Agency's final action. The Agency's preferred
alternative, as described in the ROD, is comprised of the following
alternatives for each of the potentially significant provisions listed
previously:
    For agricultural water and including root crops irrigated using
low-flow methods, generic E. coli: GM of 126 CFU/100 ml and STV of 410
CFU/100 ml, with additional flexibility for microbial die-off and/or
removal (Sec. Sec.  112.44(b) and 112.45(b));
    For treated biological soil amendments of animal origin, 0 day
application interval (Sec.  112.56(a)(2)); and
    For domesticated animals (grazing and working) and animal
intrusion, visual assessment for significant evidence of animal
potential contamination as needed during the growing season to identify
and not harvest produce that is or is likely to be contaminated
(Sec. Sec.  112.83, 112.84, and 112.112).
    As discussed in the supplemental proposed rule, FDA has chosen to
defer decision on a minimum application interval for untreated BSAs of
animal origin that are applied in a manner that does not contact
covered produce during application and minimizes the potential for
contact with covered produce after application (79 FR 58434) and,
therefore, has not identified an alternative that would best meet the
statutory mission and responsibilities. For the purpose of the
aggregate environmental impact analysis in the Final EIS, in the
absence of a decision on the alternative that would fulfill the
statutory mission, the impacts associated with the 0-day application
interval were included as the environmental impacts associated with
this alternative.
    FDA has made the Final EIS and ROD available for public review in
Docket No. FDA-2014-N-2244 (see Ref. 1 and 2).

Waiver of 30-Day Review of Final EIS

    Under CEQ regulation 40 CFR 1506.10(b)(2), no decision on the
proposed action shall be made or recorded by a Federal Agency under 40
CFR 1505.2 until 30 days after publication of the notice for a Final
EIS. However, 40 CFR 1506.10(b)(2) also provides the following
exception from the rules of timing: An agency engaged in rulemaking
under the Administrative Procedure Act or other statute for the purpose
of protecting the public health or safety, may waive the time period in
paragraph (b)(2) and publish a decision on the final rule
simultaneously with publication of the notice of the availability of
the final environmental impact statement.
    Consistent with the circumstances in 40 CFR 1506.10(b)(2) under
which a waiver may be used, FDA is waiving the 30-day time period
between the publication of the Final EIS and FDA's decision on the
Produce Safety final rule. FDA is publishing this notice of
availability of the Final EIS simultaneously with the publication of
the Produce Safety final rule and ROD. FDA considers the use of the
waiver to be appropriate, in order to enhance food safety and protect
public health, consistent with the purpose of FSMA and the Produce
Safety final rule and the urgency for its release. We explain our
reasons as follows:
    The Produce Safety final rule establishes standards to minimize the
risk of serious adverse health consequences or death (SAHCOD) resulting
from contaminated produce. This rule implements section 419 of the FD&C
Act (21 U.S.C. 350h), which requires FDA to adopt a final produce
safety regulation based on known safety risks, that sets forth
procedures, processes, and practices to minimize the risk of serious
adverse health consequences or death, including those that are
reasonably necessary to prevent the introduction of known or reasonably
foreseeable hazards into produce and to provide reasonable assurances
that produce is not adulterated under section 402 of the FD&C Act (21
U.S.C. 342).
    The history of foodborne illness outbreaks, including outbreaks
resulting in severe illnesses and death associated with contaminated
produce, make clear that produce-related outbreaks are a serious and
ongoing food safety problem. From 1996 to 2010, approximately 131
produce-related reported outbreaks occurred, resulting in 14,132
outbreak-related illnesses; 1,360 hospitalizations; and 27 deaths.

These outbreaks were associated with approximately 20 different produce
commodities (Ref. 3). Even after enactment of FSMA outbreaks from
produce continue to occur, between January 2011 and 2014, there were 44
outbreaks; 3,120 illnesses; 735 hospitalizations; and 42 deaths
associated with produce (Ref. 4). These outbreaks were associated with
approximately 10 different produce commodities. The illness numbers
cited previously are the reported illnesses; the Centers for Disease
Control estimates that only a fraction of foodborne illness is reported
(http://www.cdc.gov/foodborneburden/estimates-overview.html).
    This history of produce-related outbreaks was the impetus for
Congress, in FSMA, to require Federal produce safety standards to
establish requirements for prevention-focused regulation in a sector of
the food industry that had previously seen little Federal food safety
oversight and underscores the urgent public health need for
implementation of FDA produce safety standards to begin. Annualizing
benefits over the first 10 years after publication of the rule, we
expect benefits of the Produce Safety final rule to be approximately
362,059 illnesses averted per year, valued at $976 million annually
(see the Regulatory Impact Analysis accompanying the rule for
additional information (Ref. 5)).
    There is a public health need to publish the Produce Safety final
rule and begin implementation of the produce safety standards. Congress
conveyed its sense of urgency in the timeframes established in FSMA for
the Produce Safety final rule: 1 year after enactment of FSMA for a
proposed rule (section 419(a)(1)(A) of the FD&C Act) and 1 year after
the close of the comment period for a final rule (section 419(b)(1) of
the FD&C Act). Congress recognized the urgent need to establish
standards for produce safety to prevent SAHCOD hazards and, therefore,
included specific timeframes for issuance of the proposed and final
produce safety rules within the statute. Although FDA was unable to
meet these statutory timeframes, FDA has nonetheless acted as swiftly
as possible to complete the rulemaking process to establish the produce
safety regulation in 21 CFR part 112.
    Formulating the produce safety standards involved highly complex
scientific, regulatory, and practical considerations. For example,
establishing the appropriate microbial quality criteria for
agricultural water that is used during growing activities involved
extensive review of scientific literature on pathogen presence,
transmission, and survival under various conditions; other relevant
national and international standards; diverse uses and methods of
application of water; and the wide array of commodities and practices
that affect potential risk of contamination of produce. As another
example, we considered various options before adopting a regulatory
framework that is based on practices, procedures, and processes
associated with growing, harvesting, packing, and holding of all
covered produce, rather than one that (based solely on a history of
outbreaks or illnesses associated with the commodity) would be
applicable to individual commodities or classes of commodities. FDA's
integrated approach to produce safety standards draws on our past
experiences and appropriately reflects the need to tailor requirements
to specific on-farm routes of contamination. Through this rule (along
with other FSMA rules) FDA is putting in place a framework for food
safety that is modern and brings to bear the most recent science on
provisions to enhance food safety, that is risk-based and focuses
effort where the hazards are reasonably likely to occur, and that is
flexible and practical given our current knowledge of food safety
practices.
    The rule notably sets standards in an area that is extremely
diverse. Therefore, FDA has spent considerable time to achieve the
right balance in establishing standards that would adequately protect
public health and yet be flexible and practicable to be implemented
successfully by the highly diverse produce industry. This necessitated
enormous outreach, including numerous farm visits all over the United
States, throughout the rulemaking process, to solicit and consider
stakeholder input in preparing the final rule. We believe we have acted
responsibly in taking the time to craft a regulation that provides
critical public health protection and also is implementable by the
produce industry. Implementation of the produce safety standards by
covered farms engaged in the growing, harvesting, packing, and/or
holding of produce is critical to achieve the public health goals set
out in FSMA and, therefore, we set reasonable timeframes for compliance
with the rule. It is important for FDA to finalize the rule as quickly
as possible to enable farmers, packers, handlers, and others covered
under the rule to begin taking the steps that will safeguard public
health and safety.

II. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. Final Environmental Impact Statement for the Proposed Rule:
Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption, http://www.fda.gov/food/guidanceregulation/fsma/ucm396564.htm.
2. Record of Decision. Final Environmental Impact Statement--
Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption, October 2015.
3. D'Lima, C., K. Vierk, and FDA, ``Memorandum to the Record'',
2011.
4. Merriweather, C., T. C. Cloyd, C. Robinson, D. Gubernot, and FDA,
2011-2014 Produce Related Outbreaks and Illnesses [Memorandum]. May
8, 2015.
5. FDA, ``Final Regulatory Impact Analysis: Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption,'' http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm.

    Dated: October 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28161 Filed 11-13-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Proposed Rules]
[Page 32336]
[FR Doc No: 2015-13864]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2014-0002; Internal Agency Docket No. FEMA-B-1017]

Proposed Flood Elevation Determinations for St. Mary Parish,
Louisiana, and Incorporated Areas

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule; withdrawal.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) is withdrawing
its proposed rule concerning proposed flood elevation determinations
for St. Mary Parish, Louisiana, and Incorporated Areas.

DATES: This withdrawal is effective on June 8, 2015.

ADDRESSES: You may submit comments, identified by Docket No. FEMA-B-
1017, to Luis Rodriguez, Chief, Engineering Management Branch, Federal
Insurance and Mitigation Administration, Federal Emergency Management
Agency, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On November 10, 2008, FEMA published a
proposed rulemaking at 73 FR 66578, proposing flood elevation
determinations along one or more flooding sources in St. Mary Parish,
Louisiana, and Incorporated Areas. FEMA is withdrawing the proposed
rulemaking because FEMA has or will be issuing a Revised Preliminary
Flood Insurance Rate Map, and if necessary a Flood Insurance Study
report, featuring updated flood hazard information. A Notice of
Proposed Flood Hazard Determinations will be published in the Federal
Register and in the affected community's local newspaper following
issuance of the Revised Preliminary Flood Insurance Rate Map.

    Authority:  42 U.S.C. 4104; 44 CFR 67.4.

    Dated: May 21, 2015.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2015-13864 Filed 6-5-15; 8:45 am]
 BILLING CODE 9110-12-P