[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Notices]
[Pages 64149-64153]
[FR Doc No: 2019-25104]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87539; File No. SR-CboeBYX-2019-020]

Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
the Fee Schedule

November 14, 2019.
    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 November 1, 2019, Cboe BYX Exchange, Inc. (the ``Exchange'' or
``BYX'') 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 Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe BYX Exchange, Inc. (the ``Exchange'' or ``BZX'') is filing
with the Securities and Exchange Commission (``Commission'') a proposed
rule change to amend the fee schedule. The text of the proposed rule
change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/byx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend its fee schedule in connection with
its Add Volume Tiers.
    The Exchange first notes that it operates in a highly-competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of 13 registered equities exchanges, as well as a
number of alternative trading systems and other off-exchange venues
that do not have similar self-regulatory responsibilities under the
Exchange Act, to which market participants may direct their order flow.
Based on publicly available information,\3\ no single registered
equities exchange has more than 18% of the market share. Thus, in such
a low-concentrated and highly competitive market, no single equities
exchange possesses significant pricing power in the execution of order
flow. The Exchange in particular operates a ``Taker-Maker'' model
whereby it pays credits to members that remove liquidity and assesses
fees to those that add liquidity. The Exchange's Fees Schedule sets
forth the standard rebates and rates applied per share for orders that
provide and remove liquidity, respectively. Particularly, for
securities at or above $1.00, the Exchange provides a standard rebate
of $0.0005 per share for orders that remove liquidity and assesses a
fee of $0.0019 per share for orders that add liquidity. The Exchange
believes that the ever-shifting market share among the exchanges from
month to month demonstrates that market participants can shift order
flow, or discontinue to reduce use of certain categories of products,
in response to fee changes. Accordingly, competitive forces constrain
the Exchange's transaction fees, and market participants can readily
trade on competing venues if they deem pricing levels at those other
venues to be more favorable. In response to the competitive
environment, the Exchange also offers tiered pricing which provides
Members opportunities to qualify for higher rebates or reduced fees
where certain volume criteria and thresholds are met. Tiered pricing
provides incremental incentives for Members to strive for higher or
different tier levels by offering increasingly higher discounts or
enhanced benefits for satisfying increasingly more stringent criteria
or different criteria.
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    \3\ See Cboe Global Markets, U.S. Equities Market Volume Summary
(October 25, 2019), available at https://markets.cboe.com/us/equities/market_statistics/.
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    For example, pursuant to footnote 1 of the Fees Schedule, the
Exchange offers Add Volume Tiers that provide Members an opportunity to
receive a discounted rate from the standard fee assessment for
liquidity adding orders that yield fee codes ``B'',\4\ ``V'' \5\ and
``Y''.\6\ The Add Volume Tiers currently offer five different tiers
that vary in levels of criteria difficulty and incentive opportunities
in which Members may qualify for discounted rates for such orders. The
Exchange notes that these tiers are designed to encourage Members that
provide displayed, liquidity adding orders on the Exchange to increase
their order flow, thereby contributing to a deeper and more liquid
market to the benefit of all market participants.
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    \4\ Appended to displayed orders that add liquidity to BYX (Tape
B), and assessed a fee of $0.0019.
    \5\ Appended to displayed orders that add liquidity to BYX (Tape
A), and assessed a fee of $0.0019.
    \6\ Appended to displayed orders that add liquidity to BYX (Tape
C), and assessed a fee of $0.0019.
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    Specifically, the Exchange proposes to amend Add Volume Tier 4,
which currently provides Members an opportunity to qualify for a
reduced fee of $0.0016 for orders yielding fee codes B, V, and Y where
a Member has an ADAV \7\ of greater than or equal to 0.25% of the
TCV,\8\ and a Step-Up ADAV \9\ of greater than or equal to 0.05% of the
TCV from April 2017 baseline. The Exchange proposes to remove the
requirement that a Member have a Step-Up ADAV of greater than or equal
to 0.05% of the TCV from April 2017 baseline, and slightly decrease the
fee reduction rate from the current $0.0016 to a proposed rate of
$0.0017. The Exchange notes that the proposed change to this tier's
criteria is designed to make it easier to achieve by removing the Step-
Up ADAV component. As a result, the proposed criteria would become the
least difficult tier to achieve in comparison to current Add Volume
Tiers 1 through 3. Therefore, to maintain the Add Volume Tiers in order
of incremental difficulty and corresponding rates, the Exchange moves
this proposed criteria and fee reduction rate to Tier 1 (and updates
the subsequent Tier numbers).
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    \7\ ``ADAV'' means average daily volume calculated as the number
of shares added per day. ADAV is calculated on a monthly basis.
    \8\ ``TCV'' means total consolidated volume calculated as the
volume reported by all exchanges and trade reporting facilities to a
consolidated transaction reporting plan for the month for which the
fees apply.
    \9\ ``Step-Up ADAV'' means ADAV in the relevant baseline month
subtracted from current ADAV.
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    The Exchange notes that the proposed change to this tier is
designed to make the tier criteria easier to reach by removing the
Step-Up ADAV component of the criteria. The Exchange believes that by
easing the tier criteria difficulty it will encourage those Members who
could not previously achieve current Tier 4 to increase their order
flow as a means to receive the tier's proffered fee reduction. The
Exchange also notes that the proposed decrease in the current fee
reduction rate is commensurate with the proposed decrease in the tier's
criteria. The Exchange believes the proposed criteria modification for
displayed, liquidity adding orders will incentivize increased overall
order flow to the Book and gives liquidity providing Members on the
Exchange an additional opportunity to receive a discounted rate. It is
designed

to provide Members that submit displayed liquidity on the Exchange a
further incentive to contribute to a deeper, more liquid market, in
turn, providing additional execution opportunities at transparent
prices as a result of such increased, displayed liquidity. The Exchange
believes that this benefits all Members by enhancing overall market
quality and contributing towards a robust and well-balanced market
ecosystem. The Exchange notes the proposed tier is available to all
Members and is competitively achievable for all Members that submit
displayed order flow, in that, all firms that submit the requisite
displayed order flow could compete to meet the tier.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\10\ in general, and
furthers the objectives of Section 6(b)(4),\11\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members and issuers and other persons
using its facilities. The Exchange also believes that the proposed rule
change is consistent with the objectives of Section 6(b)(5) \12\
requirements that the rules of an exchange be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, 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, and, particularly, is not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \10\ 15 U.S.C. 78f.
    \11\ 15 U.S.C. 78f(b)(4).
    \12\ 15 U.S.C. 78f.(b)(5).
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    The Exchange operates in a highly-competitive market in which
market participants can readily direct order flow to competing venues
if they deem fee levels at a particular venue to be excessive or
incentives to be insufficient. The proposed rule change reflects a
competitive pricing structure designed to incentivize market
participants to direct their order flow to the Exchange, which the
Exchange believes would enhance market quality to the benefit of all
Members.
    In particular, the Exchange believes the proposed tier is
reasonable because it restructures an opportunity for Members to
receive a discounted rate by making it easier to reach the proposed
threshold by means of liquidity adding displayed orders. The Exchange
notes that relative volume-based incentives and discounts have been
widely adopted by exchanges,\13\ including the Exchange,\14\ and are
reasonable, equitable and non-discriminatory because they are open to
all members on an equal basis and provide additional benefits or
discounts that are reasonably related to (i) the value to an exchange's
market quality and (ii) associated higher levels of market activity,
such as higher levels of liquidity provision and/or growth patterns.
Additionally, as noted above, the Exchange operates in highly
competitive market. The Exchange is only one of several equity venues
to which market participants may direct their order flow, and it
represents a small percentage of the overall market. It is also only
one of several taker-maker exchanges. Competing equity exchanges offer
similar tiered pricing structures to that of the Exchange, including
schedules of rebates and fees that apply based upon members achieving
certain volume and/or growth thresholds. These competing pricing
schedules, moreover, are presently comparable to those that the
Exchange provides, including the pricing of comparable tiers.\15\
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    \13\ See e.g., The Nasdaq Stock Market LLC Rules, Equity 7, Sec.
118(a)(1), which generally provides credits to members for
displayed, liquidity providing orders that reach certain thresholds
of consolidated volume.
    \14\ See e.g., Cboe BYX U.S. Equities Exchange Fee Schedule,
Footnotes 1 and 2, Remove Volume and Non-Displayed Liquidity
Incentive tiers provide similar incentives for volume removing
orders and for volume adding, non-displayed orders, respectively.
    \15\ See supra note 12. For example, Nasdaq offers a rebate of
$0.00305 per share with shares of liquidity provided in all
securities through one or more of its Nasdaq Market Center MPIDs
that represent more than 1.25% of Consolidated Volume during the
month. The Exchange notes that this rebate of $0.00305 is
substantially similar to the proposed fee reduction of $0.0017
(which is essentially a `rebate' of $0.002 from the $0.0019 standard
fee assessed).
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    Moreover, the Exchange believes the proposed modification to remove
the Step-Up component from current Add Volume Tier 4 (proposed Tier 1)
is a reasonable means to further incentivize Members to increase their
overall displayed order flow to the Exchange based on increasing their
daily total added volume (ADAV) above a percentage of the total volume
(TCV). Particularly, the Exchange believes that decreasing the tier's
criteria will encourage those Members who could not achieve the tier
previously to increase their order flow as a means to receive the
tier's reduced rate. The Exchange believes that easing the current Tier
4 criteria will encourage displayed liquidity providing Members to
provide for a deeper, more liquid market, and, as a result, increased
priced transparency, execution opportunities, and overall order flow.
The Exchange believes that these increases benefit all Members by
enhancing market quality and contributing towards a robust and well-
balanced market ecosystem. Increased overall order flow benefits all
investors by deepening the Exchange's liquidity pool, providing greater
execution incentives and opportunities, offering additional flexibility
for all investors to enjoy cost savings, supporting the quality of
price discovery, promoting market transparency and improving investor
protection. In line with the proposed ease in criteria difficulty, the
Exchange also believes that the proposed lesser fee reduction than
offered currently is reasonable as it is commensurate with the proposed
decreased criteria. Similarly, moving the proposed criteria and the
adjusted corresponding fee reduction to Tier 1 is reasonable because it
appropriately reflects the incremental difficulty in achieving the
existing Add Volume Tiers and the incrementally higher reduction in
fees that correspond to each.
    The Exchange believes that the proposal represents an equitable
allocation of rebates and is not unfairly discriminatory because all
Members are eligible for the proposed Add Volume Tier, and would have
the opportunity to meet the tier's criteria and would receive the
proposed rebate if such criteria is met. Given previous months' data,
the Exchange notes that two of its Members reached current Tier 4 in
the last month. Without having a view of activity on other markets and
off-exchange venues, the Exchange has no way of knowing whether this
proposed rule change would definitely result in any Members qualifying
for this tier. While the Exchange has no way of predicting with
certainty how the proposed tier will impact Member activity, the
Exchange anticipates that at least four Members will be able to compete
for and reach the proposed tier. Accordingly, the Exchange believes the
proposed criteria modification is reasonably designed as an incentive
to any and all Members interested in meeting the tier criteria to
submit additional displayed order flow to achieve the proposed
discount. The Exchange anticipates that these will include multiple
Member types, liquidity providers (e.g., wholesale firms

that mainly are market makers for retail orders) and broker-dealers
(e.g., bulge bracket firms that conduct trading on behalf of
customers), each providing distinct types of order flow to the Exchange
to the benefit of all market participants. For example, broker-dealer
customer order flow provides more trading opportunities, which attracts
Market Makers. Increased Market Maker activity facilitates tighter
spreads which potentially increases order flow from other market
participants. The Exchange also notes that the proposed tier will not
adversely impact any Member's pricing or their ability to qualify for
other rebate tiers. Rather, should a Member not meet the proposed
criteria, the Member will merely not receive an enhanced rebate.
Furthermore, the proposed rate would uniformly apply to all Members
that meet the required criteria under the modified tier.

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 intramarket or intermarket competition that is not
necessary or appropriate in furtherance of the purposes of the Act.
Rather, as discussed above, the Exchange believes that the proposed
change would encourage the submission of additional order flow to a
public exchange, thereby promoting market depth, execution incentives
and enhanced execution opportunities, as well as price discovery and
transparency for all Members. As a result, the Exchange believes that
the proposed change furthers the Commission's goal in adopting
Regulation NMS of fostering competition among orders, which promotes
``more efficient pricing of individual stocks for all types of orders,
large and small.'' \16\
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    \16\ Securities Exchange Act Release No. 51808, 70 FR 37495,
37498-99 (June 29, 2005) (S7-10-04) (Final Rule).
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    The Exchange believes the proposed rule change does not impose any
burden on intramarket competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Particularly, the proposed
change applies to all Members equally in that all Members are eligible
for the proposed tier, have a reasonable opportunity to meet the tier's
criteria and will all receive the proposed fee rate if such criteria is
met. Additionally the proposed change is designed to attract additional
order flow to the Exchange. The Exchange believes that the modified
tier criteria would incentivize market participants to direct displayed
liquidity and, as a result, executable order flow and improved price
transparency, to the Exchange. Greater overall order flow and pricing
transparency benefits all market participants on the Exchange by
providing more trading opportunities, enhancing market quality, and
continuing to encourage Members to send orders, thereby contributing
towards a robust and well-balanced market ecosystem, which benefits all
market participants.
    Next, the Exchange believes the proposed rule change does not
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. As previously
discussed, the Exchange operates in a highly competitive market.
Members have numerous alternative venues that they may participate on
and direct their order flow, including 12 other equities exchanges and
off-exchange venues and alternative trading systems. Additionally, the
Exchange represents a small percentage of the overall market. Based on
publicly available information, no single equities exchange has more
than 18% of the market share.\17\ Therefore, no exchange possesses
significant pricing power in the execution of order flow. Indeed,
participants can readily choose to send their orders to other exchange
and off-exchange venues if they deem fee levels at those other venues
to be more favorable. Moreover, the Commission has repeatedly expressed
its preference for competition over regulatory intervention in
determining prices, products, and services in the securities markets.
Specifically, in Regulation NMS, the Commission highlighted the
importance of market forces in determining prices and SRO revenues and,
also, recognized that current regulation of the market system ``has
been remarkably successful in promoting market competition in its
broader forms that are most important to investors and listed
companies.'' \18\ The fact that this market is competitive has also
long been recognized by the courts. In NetCoalition v. Securities and
Exchange Commission, the D.C. Circuit stated as follows: ``[n]o one
disputes that competition for order flow is `fierce.' . . . As the SEC
explained, `[i]n the U.S. national market system, buyers and sellers of
securities, and the broker-dealers that act as their order-routing
agents, have a wide range of choices of where to route orders for
execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .''.\19\ Accordingly, the Exchange does not believe its
proposed fee change imposes any burden on competition that is not
necessary or appropriate in furtherance of the purposes of the Act.
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    \17\ See supra note 3.
    \18\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
    \19\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
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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 unsolicited written comments from Members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \20\ and paragraph (f) of Rule 19b-4 \21\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
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    \20\ 15 U.S.C. 78s(b)(3)(A).
    \21\ 17 CFR 240.19b-4(f).
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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_ADDRESS>Please include
File Number SR-CboeBYX-2019-020 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-CboeBYX-2019-020. 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-CboeBYX-2019-020 and should be submitted
on or before December 11, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
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    \22\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-25104 Filed 11-19-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 40 (Tuesday, March 1, 2011)]
[Rules and Regulations]
[Pages 11080-11082]
[FR Doc No: 2011-4380]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2010-0850; FRL-9271-9]

Approval and Promulgation of Air Quality Implementation Plans;
Wisconsin; The Milwaukee-Racine and Sheboygan Areas; Determination of
Attainment of the 1997 8-Hour Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is making determinations under the Clean Air Act (CAA)
that the Milwaukee-Racine and Sheboygan, Wisconsin areas have attained
the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS).
The Milwaukee-Racine area includes Milwaukee, Ozaukee, Racine,
Washington, Waukesha, and Kenosha Counties. The Sheboygan area includes
Sheboygan County. The determinations are based on complete, quality-
assured and certified ambient air monitoring data that show that the
areas have monitored attainment of the 1997 8-hour ozone standard for
the 2006-2008 and 2007-2009 monitoring periods. Quality assured data
available for 2010 indicate that the areas continue to monitor
attainment. As a result of these determinations, the requirements for
these areas to submit attainment demonstrations and associated
reasonably available control measures (RACM), reasonable further
progress plans (RFP), contingency measures, and other State
Implementation Plan (SIP)

revisions related to attainment of the standard are suspended for as
long as the areas continue to attain the 1997 8-hour ozone standard.
These determinations also suspend the requirement for EPA to promulgate
attainment demonstration, RFP, and any other attainment-related Federal
Implementation Plans (FIPs) for these areas. EPA published proposed and
direct final approvals of this request on December 15, 2010. We
received an adverse comment on our proposed rulemaking, which is
addressed below. As a result, EPA withdrew the direct final approval on
January 28, 2011.

DATES: This final rule is effective on March 31, 2011.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2010-0850. All documents in the docket are listed in
the http://www.regulations.gov index. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available either
electronically in www.regulations.gov or in hard copy at the
Environmental Protection Agency, Region 5, Air and Radiation Division,
77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. We recommend that you telephone Kathleen D'Agostino,
Environmental Engineer, at<PHONE_NUMBER> before visiting the Region 5
office.

FOR FURTHER INFORMATION CONTACT: Kathleen D'Agostino, Environmental
Engineer, Attainment Planning and Maintenance Section, Air Programs
Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What did EPA propose?
II. What comments did we receive on the proposed action?
III. What actions is EPA taking?
IV. Statutory and Executive Order Reviews

I. What did EPA propose?

    On December 15, 2010, EPA published proposed (75 FR 78197) and
direct final (75 FR 78164) determinations under the CAA that the
Milwaukee-Racine and Sheboygan, Wisconsin areas have attained the 1997
8-hour ozone NAAQS. EPA received an adverse comment on this action and
withdrew the direct final approval on January 28, 2011 (76 FR 5078).

II. What comments did we receive on the proposed action?

    EPA received an adverse comment from Midwest Environmental Defense
Center, Inc.
    Comment: The commenter asserts that section 107(d)(3)(E) of the CAA
prohibits redesignation of a nonattainment area to attainment unless
five requirements are met. The commenter contends that EPA's Federal
Register document describes air quality monitoring data in the
Milwaukee-Racine and Sheboygan areas, but does not discuss the other
requirements for redesignation. The commenter argues that unless all
five criteria for redesignation are met, the Administrator cannot grant
the redesignation.
    Response: The commenter's concerns are misplaced; the actions that
are the subject of these rulemakings are determinations of attainment,
and not redesignations to attainment. As EPA stated in its December 15,
2010, direct final rule, the determinations of attainment in this
notice are not equivalent to redesignations to attainment under section
107(d)(3) of the CAA. While the commenter is correct that rulemakings
redesignating an area to attainment would need to satisfy the criteria
of section 107(d)(3)(E), EPA's actions here are not redesignations. EPA
is not purporting here to redesignate the Milwaukee-Racine and
Sheboygan areas, and thus we acknowledged in the direct final
rulemaking that we were not attempting to approve maintenance plans for
the areas as required under section 175A of the CAA, nor have we found
that the areas have met the other statutory requirements for
redesignation. The designation status of each of the areas remains
nonattainment for the 1997 8-hour ozone NAAQS until such time as EPA
determines, through notice and comment rulemaking, that it meets the
CAA requirements for redesignation to attainment. Thus, EPA's
rulemaking here addresses only the air quality issue of whether the
areas are attaining the 1997 8-hour ozone standard. The commenter
offered no objection to EPA's proposed determinations that the
Milwaukee-Racine and Sheboygan nonattainment areas are attaining that
standard.

III. What actions is EPA taking?

    EPA is making final determinations that the Milwaukee-Racine and
Sheboygan, Wisconsin areas have attained the 1997 8-hour ozone NAAQS.
The determinations are based upon complete, quality-assured and
certified ambient air monitoring data, which show that the areas have
monitored attainment of the 1997 8-hour ozone standard for the 2006-
2008 and 2007-2009 monitoring periods. Quality assured data for 2010
available to date indicate that the areas continue to monitor
attainment.
    As provided in 40 CFR 51.918, the determinations of attainment for
the Milwaukee-Racine and Sheboygan areas suspend the requirements for
the State of Wisconsin to submit for these areas: An attainment
demonstration, associated RACM, RFP plan, contingency measures, and any
other planning SIPs related to attainment of the 1997 8-hour ozone
NAAQS. These determinations also suspend any requirement for EPA to
promulgate FIPs for these areas deriving from the concomitant SIP
obligations.
    The attainment-related SIP and FIP obligations remain suspended for
each area for so long as it continues to attain the 1997 8-hour ozone
NAAQS or until it is redesignated for that NAAQS, at which time the
obligations end. 40 CFR 51.918.

IV. Statutory and Executive Order Reviews

    These actions make determinations based on air quality data, and
would, if finalized, result in the suspension of certain Federal
requirements. For that reason, these actions:
     Are not ``significant regulatory actions'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Do not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or

safety risks subject to Executive Order 13045 (62 FR 19885, April 23,
1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because a determinations of attainment is an action that affects the
status of a geographical area and does not impose any new regulatory
requirements on tribes, impact any existing sources of air pollution on
tribal lands, nor impair the maintenance of ozone national ambient air
quality standards in tribal lands. However, because there are tribal
lands located in Milwaukee County, we provided the affected tribe with
the opportunity to consult with EPA on the attainment determination.
The consultation occurred on November 15, 2010. The affected tribe
raised no concerns.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. These actions are not ``major rules'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by May 2, 2011. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of these actions for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. These actions may not be challenged later in proceedings to
enforce their requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: February 14, 2011.
Susan Hedman,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart YY--Wisconsin

0
2. Section 52.2585 is amended by adding paragraph (y) to read as
follows:

Sec.  52.2585  Control strategy: Ozone.

* * * * *
    (y) Determination of attainment. EPA has determined, as of March 1,
2011 that the Milwaukee-Racine, WI and Sheboygan, WI areas have
attained the 1997 8-hour ozone standard. These determinations suspend
the requirements for these areas to submit attainment demonstrations
and associated reasonably available control measures (RACM), reasonable
further progress plans (RFP), contingency measures, and other State
Implementation Plan (SIP) revisions related to attainment of the
standard for as long as the areas continue to attain the 1997 8-hour
ozone standard. These determinations also stay the requirement for EPA
to promulgate attainment demonstration and RFP Federal Implementation
Plans (FIPs) for these areas.
[FR Doc. 2011-4380 Filed 2-28-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 27, 2010 (Volume 75, Number 166)]
[Notices]
[Page 52819]
[DOCID:fr27au10-117]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Public Notice for Waiver of Aeronautical Land-Use Assurance;
Rickenbacker International Airport, Columbus, OH

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of release of waiver with respect to land.

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SUMMARY: The Federal Aviation Administration (FAA) is considering a
proposal to change a portion of the airport from aeronautical use to
non-aeronautical use and to authorize the release of 13.105 acres of
airport property for the proposed development of bulk warehouse/
distribution facilities as a component of the Rickenbacker Global
Logistics Park. The land was acquired by the Rickenbacker Port
Authority through two Quitclaim Deeds dated March 30, 1984 from the
Administrator of General Services for the United States of America and
May 11, 1999 from the United States of America, acting by and through
the Secretary of the Air Force. The property is no longer needed for
aeronautical use. Approval does not constitute a commitment by the FAA
to financially assist in the disposal of the subject airport property
nor a determination of eligibility for grant-in-aid funding from the
FAA. The disposition of proceeds from the disposal of the airport
property will be in accordance with FAA's Policy and Procedures
Concerning the Use of Airport Revenue, published in the Federal
Register on February 16, 1999.
    In accordance with section 47107(h) of title 49, United States
Code, this notice is required to be published in the Federal Register
30 days before modifying the land-use assurance that requires the
property to be used for an aeronautical purpose.

DATES: Comments must be received on or before September 27, 2010.

FOR FURTHER INFORMATION CONTACT: Diane Morse, Program Manager, Detroit
Airports District Office, 11677 South Wayne Road, Suite 107, Romulus,
Michigan 48174. Telephone Number:<PHONE_NUMBER>/FAX Number: (734)-229-
2950. Documents reflecting this FAA action may be reviewed at this same
location or at Rickenbacker International Airport, Columbus, Ohio.

SUPPLEMENTARY INFORMATION: Following is a legal description of the
property situated in the State of Ohio, County of Pickaway, Townships
of Harrison and Madison, lying in Section 18, Township 10, Range 21,
Congress Lands, being part of the remainder of the original 2995.065
acre tract conveyed as Tract 1 to Columbus Municipal Airport Authority
by deed of record in Official Record 514, Page 2561, (all references
are to the records of the Recorder's Office, Pickaway County, Ohio) and
being more particularly described as follows:

Legal Description of Property

    Beginning at an angle point in the southerly line said 2995.065
acre (Tract 1) at the northwesterly corner of a 201.7757 acre tract
conveyed to The Landings at Rickenbacker, LLC;
    Thence the following six (6) courses and distances on, over and
across the said 2995.065 acre (Tract 1):
    North 39[deg]42'45'' West, a distance of 666.60 feet, to a point;
    North 53[deg]46'55'' West, a distance of 821.06 feet, to a point;
    North 86[deg]24'00'' West, a distance of 151.16 feet, to a point;
    North 03[deg]24'05'' East, a distance of 607.19 feet, to a point;
    South 44[deg]30'28'' East, a distance of 2298.53 feet, to a point
on the northerly line of said 201.7757 acre tract;
    North 86[deg]24'01'' West, a distance of 408.93 feet, along said
northerly line to the Point of Beginning, containing 13.105 acres, more
or less, in Pickaway County.
    The bearings in the above description are based on the bearing of
North 86[deg]24'01'' West, for the southerly line of the 2995.065 Acre
(Tract 1) conveyed to Columbus Regional Airport Authority.
    This description was prepared from record information from
Recorder's Office, Franklin and Pickaway Countries and is not for the
use of the transfer of real property.

Stephanie R. Swann,
Acting Manager, Detroit Airports District Office FAA, Great Lakes
Region.
[FR Doc. 2010-21210 Filed 8-26-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 231 (Friday, November 30, 2012)]
[Rules and Regulations]
[Pages 71312-71316]
[FR Doc No: 2012-28967]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. FDA-1999-F-4617 (Formerly Docket No. 1999F-5321)]

Irradiation in the Production, Processing and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of a 4.5 kilogray
(kGy) maximum absorbed dose of ionizing radiation to treat
unrefrigerated (as well as refrigerated) uncooked meat, meat
byproducts, and certain meat food products to reduce levels of
foodborne pathogens and extend shelf life. This action is in response
to a petition filed by the U.S. Department of Agriculture, Food Safety
and Inspection Service (USDA/FSIS).

DATES: This rule is effective November 30, 2012. Submit either
electronic or written objections and requests for a hearing by December
31, 2012. See section VIII of this document for information on the
filing of objections.

ADDRESSES: You may submit either electronic or written objections and
requests for a hearing identified by Docket No. FDA-1999-F-4617, by any
of the following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand Delivery/Courier (For paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-1999-F-4617 for this rulemaking. All objections
received will be posted without change to http://www.regulations.gov,
including any personal information provided. For detailed instructions
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
objections received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lane A. Highbarger, Center for Food
Safety and Applied Nutrition (HFS-255), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Safety Evaluation
    A. Radiation Chemistry
    B. Toxicological Considerations
    C. Nutritional Considerations
    D. Microbiological Considerations
III. Labeling
IV. Comments
V. Conclusions
VI. Paperwork Reduction Act of 1995
VII. Environmental Impact
VIII. Objections
IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
X. References

I. Background

    In a notice published in the Federal Register of December 22, 1999
(64 FR 71792), FDA announced that a food additive petition (FAP 9M4695)
had been filed by the USDA/FSIS, 300 12th St. SW., rm. 112, Washington,
DC 20250 (currently, Food Safety and Inspection Service, Stop Code
3782, Patriots Plaza III, Cubicle 8-163A, 1400 Independence Ave. SW.,
Washington, DC 20250-3700). The petition proposed that the food
additive regulations in part 179, Irradiation in the Production,
Processing and Handling of Food (21 CFR part 179), be amended to
provide for the safe use of a 4.5 kGy maximum dose of ionizing
radiation to treat unrefrigerated (as well as refrigerated \1\)
uncooked meat, meat byproducts,\2\ and certain meat food products to
reduce levels of foodborne pathogens and extend shelf-life.
---------------------------------------------------------------------------

    \1\ For the purpose of this final rule, refrigeration
temperature is a maximum of 40 [deg]F (4 [deg]C).
    \2\ The Agency notes that in the filing notice dated December
22, 1999 (64 FR 71792), the phrase ``meat products'' was used while
the petitioner used the phrase ``meat byproducts'' in their filing
request dated August 19, 1999.
---------------------------------------------------------------------------

    FDA's current regulation under Sec.  179.26(b)(8) permits the
irradiation of refrigerated or frozen, uncooked products that are meat
within the meaning of 9 CFR 301.2(rr), meat byproducts within the
meaning of 9 CFR 301.2(tt), or meat food products within the meaning of
9 CFR 301.2(uu), with or without nonfluid seasoning, that are otherwise
composed solely of intact or ground meat, meat byproducts, or both meat
and meat byproducts. The foods covered under Sec.  179.26(b)(8) are
subject to the Federal Meat Inspection Act (21 U.S.C. 601, et seq.),
and, as described previously in this document, are defined by the USDA/
FSIS in Title 9 of the Code of Federal Regulations. In this document,
the term ``meat'' will be used to refer collectively to meat, meat
byproducts, and certain meat food products applicable to this notice.

II. Safety Evaluation

    FDA has previously reviewed the irradiation of meat and meat
byproducts (62 FR 64107, December 3, 1997), and concluded that the
irradiation of refrigerated meat and meat byproducts is safe. The
current rulemaking concerns the irradiation of meat at temperatures
that are above refrigerated temperature. FDA has previously reviewed
and evaluated the safety of irradiated food products in a variety of
applications. Discussions of these applications have been presented in
various Federal Register documents (see, e.g., 62 FR 64107 and 70 FR
48057, August 16, 2005). FDA has also updated its review

of the safety of irradiation of food with a thorough survey of the
literature to the present time and found no new studies on the
irradiation of meat (Ref. 1).
    Under section 201(s) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 321(s)), a source of radiation used to treat food
is a food additive. The additive is not added to food literally, but is
rather a source of radiation used to process or treat food such that,
analogous to other food processing technologies, its use can affect the
characteristics of the food. Under section 409(c)(3)(A) of the FD&C Act
(21 U.S.C. 348(c)(3)(A)), a food additive cannot be approved for a
particular use unless a fair evaluation of the evidence establishes
that the additive is safe under the conditions of that use.
Importantly, the statute does not prescribe the safety tests to be
performed but leaves that determination to the discretion and
scientific expertise of FDA. Not all food additives require the same
amount or type of testing to establish safety. The testing and data
required to establish the safety of an additive will vary depending on
the particular additive and its intended use.
    In evaluating the safety of a source of radiation to treat food
intended for human consumption, the Agency must identify the various
effects that may result from irradiating the food and assess whether
any of these effects pose a public health concern. In doing so, the
following three general areas need to be addressed: (1) Potential
toxicity, (2) nutritional adequacy, and (3) effects on the
microbiological profile of the treated food. Each of these areas is
discussed in this document.
    The term ``radiation chemistry'' refers to the chemical reactions
that occur as a result of the absorption of ionizing radiation. Because
an understanding of radiation chemistry is fundamental in addressing
these three areas, key aspects of radiation chemistry are also
discussed.
    FDA has fully considered the data and studies submitted in the
subject petition as well as other data and information relevant to
safety. The safety data that have been obtained from irradiating
various foods under various conditions support conclusions about the
safety of many irradiated foods, including unrefrigerated meat (Refs. 2
through 6).

A. Radiation Chemistry

    The conditions under which foods are irradiated are important in
considering the radiation chemistry of a given food. These conditions
include: The radiation dose, the physical state of the food (e.g.,
frozen or dried), and the atmosphere in the package.
    The radiolysis products generated in any food are directly
proportional to the absorbed radiation dose (Ref. 2). Radiation-induced
chemical changes may cause changes in the organoleptic properties of
the food. The radiation chemistry of food is strongly influenced by the
physical state of the food. If all other conditions, including
radiation dose and ambient atmosphere, are the same, the extent of
chemical change that occurs in a particular food in the frozen state is
less than the change that occurs in the non-frozen state. This is
because of the reduced mobility, in the frozen state, of the initial
radiolysis products, which will tend to recombine rather than diffuse
and react with other food components. For similar reasons, if all other
conditions are the same, the extent of chemical change that occurs in
the dehydrated state is less than the change that occurs in the fully
hydrated state (62 FR 64107 at 64110 and references cited therein).
1. Radiation Chemistry of the Major Components of Meat
    The major components of meat are proteins and lipids and the ratios
vary. Ground beef is a food defined by USDA and ranges from 5 percent
to 30 percent lipids. The ratio of protein to lipid in whole cuts of
beef varies depending on many factors.\3\ FDA has extensively reviewed
the radiation chemistry of flesh foods \4\ in its rulemakings on the
use of ionizing radiation to treat meat (62 FR 64107) and molluscan
shellfish (70 FR 48057). In the meat rule (62 FR 64107 at 64111), FDA
concluded: ``In summary, the results obtained from chemical analyses of
irradiated flesh foods establish that there would be very small amounts
of individual radiolytic products generated by radiation doses
comparable to those proposed in the petition. In addition, most of
these radiolytic products are either the same as, or structurally very
similar to, compounds found in foods that have not been irradiated.
Because of their structural similarities to compounds found in foods
that have not been irradiated, these radiolytic products would be
expected to be toxicologically similar to such compounds as well. Thus,
the available information regarding the radiation chemistry of the
major components of flesh foods supports the proposition that there is
no reason to suspect a toxicological hazard due to consumption of an
irradiated flesh food.''
---------------------------------------------------------------------------

    \3\ Information on the composition of foods can be found at:
http://www.nal.usda.gov/fnic/foodcomp/search/; the USDA National
Nutrient Database for Standard Reference. Search with keyword: Meat.
    \4\ Defined by USDA as meat, fish, poultry, and egg products.
---------------------------------------------------------------------------

    During its review of this food additive petition (FAP 9M4695), the
Agency evaluated the changes that may occur from the irradiation of
meat at temperatures greater than those previously approved. These
evaluations are discussed in the following sections of this section
II.A.1.
    a. Proteins. As noted previously in this document, FDA has
previously provided detailed discussions of the radiation chemistry of
proteins in its rulemakings on the use of ionizing radiation to treat
meat (62 FR 64107 at 64110) and molluscan shellfish (70 FR 48057 at
48059-48060). Those prior discussions support the findings in this
rule. Studies conducted with high-protein foods (e.g., meat, poultry,
and seafood), have established that most of the radiolysis products
derived from food proteins have the same amino acid composition as the
original protein and are altered only in their secondary and tertiary
structures (i.e., they are denatured, Ref. 2). These changes are
similar to those that occur as a result of heating, but in the case of
irradiation, even at doses up to 50 kGy and when food is irradiated at
temperatures ranging from -168 [deg]C to 60 [deg]C in various studies,
such changes are far less pronounced than heating and the amounts of
reaction products generated are far lower (62 FR 64107 at 64110). Based
on these studies and on the analysis set forth in the prior rulemakings
referenced previously in this document, FDA concludes that there will
be no significant change in the amino acid composition of meat that is
irradiated at doses up to 4.5 kGy at temperatures higher than
refrigeration temperature.
    b. Lipid. FDA has also previously provided detailed discussions of
the radiation chemistry of lipids in the meat rule (62 FR 64107 at
64110-64111) and molluscan shellfish rule (70 FR 48057 at 48060). Those
discussions also support this rule.
    To summarize the previous discussions, a variety of radiolysis
products derived from lipids have been identified. These include the
following: Fatty acids, esters, aldehydes, ketones, alkanes, alkenes,
and other hydrocarbons (Ref. 2). Identical or analogous products are
found in foods that have not been irradiated. In particular, heating
food produces generally the same types of products, but in amounts far
greater than the trace amounts produced by irradiating food (62 FR
64107 at 64111 and references cited therein).

    A class of radiolysis products that is derived from lipids, 2-
alkylcyclobutanones (2-ACBs), has been reported to form in small
quantities when fats are exposed to ionizing radiation. Any 2-ACB
formed will depend on the fatty acid composition of the food, e.g., 2-
dodecylcyclobutanone (2-DCB) is a radiation byproduct of palmitic acid
(Refs. 7 and 8). In the molluscan shellfish rule, the Agency noted the
reported creation of 2-DCB in irradiated chicken and ground beef, which
contain triglycerides with esterified palmitic acid. FDA did not find
that the presence of low levels of 2-DCB raised a safety issue (70 FR
48057 at 48060).
2. Furan
    During the course of reviewing the chemical effects of irradiation,
FDA became aware of a report that suggested that the irradiation of
apple juice might produce furan (Ref. 9). Because furan has been shown
to cause tumors in laboratory animals, FDA has extensively researched
the occurrence of furan in irradiated foods over the last 10 years. FDA
has confirmed that certain foods form furan in low quantities when
irradiated (Ref. 10). Studies conducted by FDA scientists and other
researchers show that some foods form furan when heated and still other
foods form furan during storage at refrigeration temperatures (Refs. 10
and 12). Testing of irradiated non-refrigerated meat found no furan at
the limit of detection in the tests and detected no furan above the
background levels of natural furan formation during storage (Refs. 10,
11, and 12). Therefore, the Agency concludes that the irradiation of
meat at the requested maximum absorbed dose will not increase the
amount of furan in the diet and does not present a toxicological hazard
under the conditions proposed in the USDA/FSIS petition.

B. Toxicological Considerations

    As discussed previously in this document, the available information
from chemical analyses of irradiated foods suggests that there is no
reason to suspect a toxicological hazard due to consumption of an
irradiated food (Ref. 4.) The Agency notes that the large body of data
from studies where irradiated foods were fed to laboratory animals
provides an independent way to assess toxicological safety. These
studies include those relied on by the Agency in previous evaluations
of the safety of irradiated foods (see 51 FR 13376, April 18, 1986; 55
FR 18538, May 2, 1990; 62 FR 64107; 65 FR 45280, July 21, 2000; and 70
FR 48057, August 16, 2005). The Agency is also relying on additional
data and information in FDA files (Ref. 13). The Agency reviewed the
data from chemical analysis of beef irradiated at 45 kGy (Ref. 19) and
concluded that, although there will be an increase in the yields of
some of the radiolysis products produced by irradiating meat at 30-40
[deg]C versus 5 [deg]C, the increase is no greater than an order of
magnitude (Ref. 14), and is insignificant with respect to toxicity
(Ref. 15).
    In summary, FDA has reviewed data relevant to the assessment of
potential toxicity of irradiated meat. While all of the studies are not
of equal quality or rigor, the Agency has concluded that the quantity
and breadth of testing and the number and significance of endpoints
assessed would have identified any meaningful risk. Based on the
totality of the evidence, FDA concludes that irradiation of meat under
the conditions proposed in this petition does not present a
toxicological hazard.

C. Nutritional Considerations

    It has been established that the nutrient values of the
macronutrients in the diet (protein, fats, and carbohydrates) are not
significantly altered by irradiation at the petitioned doses (62 FR
64107 at 64114 and Refs. 16 and 17). Minerals (e.g., calcium and iron)
are also unaffected by irradiation (62 FR 64107 at 64114 and Ref. 17).
Levels of certain vitamins may be reduced as a result of irradiation.
The extent to which this reduction occurs depends on the specific
vitamin, the type of food, and the conditions of irradiation. Not all
vitamin loss is nutritionally significant; the extent to which the
reduction in a specific vitamin level is significant depends on the
relative contribution of the food in question to the total dietary
intake of the vitamin (62 FR 64107 at 64114).
    FDA has extensively reviewed the nutritional losses that occur when
meat is irradiated (62 FR 64107 at 64114). During this review, FDA
noted that the majority of meat would be irradiated at refrigerated
temperatures or frozen, and possibly in a reduced oxygen environment,
which would reduce the loss of vitamins. Although this rule covers
irradiation of meat under unrefrigerated conditions, FDA concludes that
this difference in temperature will not result in significant vitamin
loss. Thiamine is known to be more sensitive to irradiation than other
vitamins; FDA considered a worst-case scenario (e.g., thiamine levels
in all these foods would be reduced by 50 percent) and the Agency
concluded that, if all flesh foods (i.e., meat, poultry, and fish) were
irradiated under such conditions, there would be no deleterious effect
on the total dietary intake of thiamine as a result of irradiating
flesh foods, including meat (62 FR 64107 at 64115).
    In summary, based on the available data and information, FDA
concludes that amending the regulations, as set forth in this document,
to allow for the use of ionizing radiation to treat unrefrigerated meat
up to a maximum dose of 4.5 kGy will not have an adverse impact on the
nutritional adequacy of the overall diet.

D. Microbiological Considerations

    FDA previously examined the effects of radiation-induced changes in
the microbiological profile of meat and on the growth patterns of any
surviving microorganisms, including Clostridium botulinum, to determine
whether the microbiological safety of meat will be adversely affected
by irradiation (62 FR 64107 at 64115). The Agency determined that
irradiation of frozen and refrigerated meat and meat byproducts at a
dose up to 4.5 kGy will not result in any additional health hazard from
C. botulinum. Likewise, FDA also determined that irradiation will not
result in any additional hazard from common pathogens other than C.
botulinum (Ref. 18).
    The Agency has determined that, although the use would be modestly
different in the current petitioned request, the microbial hazards that
carcasses would be subjected to would be equivalent to the microbial
hazards from meat that has been further processed, i.e., meat from a
completely broken-down carcass that has been refrigerated. Moreover,
the same doses of irradiation would be expected to be equally effective
in lowering levels of pathogenic and spoilage microorganisms.\5\
Therefore, the Agency concludes, based on all the evidence before it,
that irradiation of meat under the conditions set forth in the
regulation presented in this document will not result in a
microbiological hazard (Ref. 18).
---------------------------------------------------------------------------

    \5\ USDA/FSIS provided a list of pertinent pathogens from
sources of the meat they regulate and irradiation D-values
(conditions under which 90 percent of the microorganisms have been
eliminated) derived from published sources. D-values are typically
obtained at various temperatures and FDA considers the food matrix
to be more important than temperature for D-values.
---------------------------------------------------------------------------

    In summary, based on the available data and information, FDA
concludes that irradiation of meat conducted in accordance with good
manufacturing practices will reduce or eliminate bacterial populations
with no increased

microbial risk from pathogens that may survive the irradiation process
(Ref. 18).

III. Labeling

    The meat products covered by this rule are defined under the
Federal Meat Inspection Act (21 U.S.C. 601, et seq.). Therefore, the
labeling of these products irradiated under the conditions set forth in
the regulation must comply with any requirements imposed by USDA/FSIS
under its authority to approve the labeling of such products.

IV. Comments

    FDA has received numerous comments, primarily form letters, from
individuals that state their opinions regarding the potential dangers
and unacceptability of irradiating food. FDA has also received several
comments from individuals or organizations that state their opinions
regarding the potential benefits of irradiating food and urging FDA to
approve the petition. Additionally, FDA received several comments from
Public Citizen (PC) and the Center for Food Safety (CFS) requesting the
denial of this and other food irradiation petitions.
    Overall, the comments were of a general nature and not necessarily
specific to the requests in the individual petitions, and did not
contain any substantive information that could be used in a safety
evaluation of irradiated meat. Many of these comments from PC and CFS
were also submitted to the docket for this Agency rulemaking on
irradiation of molluscan shellfish (Docket No. 1999F-4372, FAP 9M4682).
The topics raised in these comments included the following: Studies
reviewed in the 1999 Food and Agriculture Organization of the United
Nations/International Atomic Energy Agency/World Health Organization
(FAO/IAEA/WHO) report on high-dose irradiation; a review article that
analyzed studies of irradiated foods performed in the 1950s and 1960s;
the findings of a 1971 study in which rats were fed irradiated
strawberries; the findings regarding reproductive performance in a 1954
study in which mice were fed a special irradiated diet; issues
regarding mutagenicity studies; certain international opinions; issues
related to 2-ACBs, including purported promotion of colon cancer; the
findings of certain studies conducted by the Indian Institute of
Nutrition in the 1970s; general issues regarding toxicity data; FDA's
purported failure to meet certain statutory requirements; data from a
2002 study purportedly showing an irradiation-induced increase in trans
fatty acids in ground beef; studies regarding purported elevated
hemoglobin levels and their significance; and an affidavit describing
the opinions of a scientist regarding the dangers of irradiation and
advocating the use of alternative methods for reducing the risk of
foodborne disease. These comments have all been addressed by FDA in a
previous rulemaking. For a detailed discussion of the Agency's response
to each of the previous general comments, the reader is referred to the
molluscan shellfish rule (70 FR 48057 at 48062 through 48071). Because
these comments do not raise issues specific to irradiated meat and meat
byproducts, and the previous responses are sufficient to address these
issues as they pertain to the rule to permit the irradiation of meat as
described in this document, the Agency will not address these comments
further here.

V. Conclusions

    Based on the data and studies submitted in the petition and other
information in the Agency's files, FDA concludes that the proposed use
of irradiation to provide for the safe use of a 4.5 kGy maximum dose of
ionizing radiation to treat unrefrigerated (as well as refrigerated)
uncooked meat, meat byproducts, and certain meat food products to
reduce levels of foodborne pathogens and extend shelf-life is safe, and
therefore the regulations in Sec.  179.26 should be amended as set
forth in this document.
    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the use of irradiation of unrefrigerated meat in
response to the petition will be made available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person (see FOR FURTHER INFORMATION CONTACT). As
provided in Sec.  171.1(h), the Agency will delete from the documents
any materials that are not available for public disclosure before
making the documents available for inspection.

VI. Paperwork Reduction Act of 1995

    This final rule does not provide for the collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.

VII. Environmental Impact

    The Agency has carefully considered the potential environmental
effects of this action. The Agency has determined under 21 CFR 25.32(j)
that this action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.

VIII. Objections

    Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) either
electronic or written objections. Each objection must be separately
numbered, and each numbered objection must specify with particularity
the provisions of the regulation to which objection is made and the
grounds for the objection. Each numbered objection on which a hearing
is requested must specifically so state. Failure to request a hearing
for any particular objection constitutes a waiver of the right to a
hearing on that objection. Each numbered objection for which a hearing
is requested must include a detailed description and analysis of the
specific factual information intended to be presented in support of the
objection in the event that a hearing is held. Failure to include such
a description and analysis for any particular objection constitutes a
waiver of the right to a hearing on the objection. It is only necessary
to send one set of documents. Identify documents with the docket number
found in brackets in the heading of this document. Any objections
received in response to the regulation may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    FDA's review of this petition was limited to section 409 of the
FD&C Act. This final rule is not a statement regarding compliance with
other sections of the FD&C Act. For example, the Food and Drug
Administration Amendments Act of 2007, which was signed into law on
September 27, 2007, amended the FD&C Act to, among other things, add
section 301(ll) (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act
prohibits the introduction or delivery for introduction into interstate
commerce of any food that contains a drug approved under section 505 of
the FD&C Act (21 U.S.C. 355), a biological product licensed under
section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug
or biological product for which substantial clinical investigations
have been instituted and their existence has been made public, unless
one of the exceptions in section 301(ll)(1) to (ll)(4) of the FD&C Act
applies. In our review of this petition, FDA did not consider whether
section 301(ll) of the FD&C Act or any of its exemptions apply to the

ionizing radiation source. Accordingly, this final rule should not be
construed to be a statement that ionizing radiation used to treat meat,
if introduced or delivered for introduction into interstate commerce,
would not violate section 301(ll) of the FD&C Act. Furthermore, this
language is included in all food additive final rules and therefore,
should not be construed to be a statement of the likelihood that
section 301(ll) of the FD&C Act applies.

X. References

    The following sources are referred to in this document. References
marked with an asterisk (*) have been placed on display at the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and are
available electronically at http://www.regulations.gov. References
without asterisks are not on display; they are available as published
articles and books.

1. Memorandum for FAP 9M4695 from K. Morehouse, FDA, to L.
Highbarger, FDA, dated August 10, 2010.*
2. Diehl, J. F., ``Chemical Effects of Ionizing Radiation,'' pp. 43-
88, in Safety of Irradiated Foods, Second Edition, Marcel Dekker,
Inc., New York, 1995.
3. Elias, P. S. and A. J. Cohen, ``Recent Advances in Food
Irradiation,'' Elsevier Biomedical, Amsterdam, 1983.
4. World Health Organization, ``High-Dose Irradiation: Wholesomeness
of Food Irradiated With Doses Above 10 kGy,'' World Health
Organization Technical Report Series No. 890, pp. 9-37, Geneva,
1999.
5. Preservation of Food by Ionizing Radiation, edited by E. S.
Josephson, and M. S. Peterson, Vol. II, CRC Press, Boca Raton, 1982.
6. Diehl, J. F., ``Radiolytic Effects in Foods,'' pp. 279-357, in
Preservation of Food By Ionizing Radiation, Vol. I, edited by E. S.
Josephson, and M. S. Peterson, CRC Press, Boca Raton, 1982.
7. Crone, A. V. J., et al., ``Effect of Storage and Cooking on the
Dose Response of 2-Dodecylcyclobutanone, a Potential Marker for
Irradiated Chicken,'' Journal of the Science of Food and
Agriculture, 58:249-252, 1992.
8. Gadgil, P., K. A. Hachmeister, J. S. Smith, and D. H. Kropf, ``2-
Alkylcyclobutanones as Irradiation Dose Indicators in Irradiated
Ground Beef Patties,'' Journal of Agriculture and Food Chemistry,
50:5746-5750, 2002.
9. Seibersdorf Project Report, International Programme on
Irradiation of Fruit and Fruit Juices, Chemistry and Isotopes
Department, National Centre for Nuclear Energy, Madrid, Spain, Vol.
8, 1966.
10. Memorandum for FAP 9M4695 from K. Morehouse, FDA, to L.
Highbarger, FDA, dated May 18, 2009.*
11. Locas, C.; and V. A.Yaylayan, ``Origin and Mechanistic Pathways
of Formation of the Parent Furan--a Toxicant,'' Journal of
Agricultural and Food Chemistry, 52:6830-6836, 2005.
12. Fan, X., and K. J. B. Sokorai, ``Effect of Ionizing Radiation on
Furan Formation in Fresh-Cut Fruits and Vegetables,'' Journal of
Food Science, 73(2): C79-C83, 2008.
13. Memorandum from Food Additives Evaluation Branch, FDA (HFS-156),
to C. Takaguchi, Petition Control Branch, FDA, December 28, 1982.*
14. Memorandum for FAP 9M4696 from E. Jensen, FDA, to R. Alrefai,
FDA, dated December 10, 1999.*
15. Memorandum to the file for FAP 4M4428, from D. Hattan, FDA,
dated November 18, 1997.*
16. Underdal, B., J. Nordal, G. Lunde, and B. Eggum, ``The Effect of
Ionizing Radiation on the Nutritional Value of Fish (Cod) Protein,''
Lebensmittel Wissenschaft Technologie, 6:90-93, 1973.
17. Diehl, J. F., ``Nutritional Adequacy of Irradiated Foods,'' pp.
241-282, in Safety of Irradiated Foods, Marcel Dekker, New York,
1995.
18. Memorandum for FAP 9M4695 from R. Merker, FDA, to L. Highbarger,
FDA, dated May 26, 2010.*
19. Merritt, C., Jr., P. Angelini, E. Wierbicki, and G. W. Shults,
``Chemical Changes Associated With Flavor in Irradiated Meat,''
Journal of Agricultural and Food Chemistry, 23:1037-1041, 1975.

List of Subjects in 21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation
protection, Reporting and recordkeeping requirements, Signs and
symbols.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
179 is amended as follows:

PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF
FOOD

0
1. The authority citation for 21 CFR part 179 continues to read as
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.

0
2. Section 179.26 is amended in the table in paragraph (b) by adding a
new entry ``13.'' under the headings ``Use'' and ``Limitations'' to
read as follows:

Sec.  179.26  Ionizing radiation for the treatment of food.

* * * * *
    (b) * * *

------------------------------------------------------------------------
               Use                              Limitations
------------------------------------------------------------------------

                              * * * * * * *
13. For control of foodborne       Not to exceed 4.5 kGy.
 pathogens, and extension of
 shelf-life, in unrefrigerated
 (as well as refrigerated)
 uncooked meat, meat byproducts,
 and certain meat food products.
------------------------------------------------------------------------

* * * * *

    Dated: November 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28967 Filed 11-29-12; 8:45 am]
BILLING CODE 4160-01-P