[Federal Register Volume 80, Number 20 (Friday, January 30, 2015)]
[Notices]
[Pages 5188-5190]
[FR Doc No: 2015-01791]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74142; File Nos. SR-FICC-2014-810; SR-NSCC-2014-811;
SR-DTC-2014-812]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
National Securities Clearing Corporation; the Depository Trust Company;
Notice of No Objection to Advance Notices, as Amended, To Amend and
Restate the Third Amended and Restated Shareholders Agreement, Dated as
of December 7, 2005

January 27, 2015.
    On November 5, 2014, Fixed Income Clearing Corporation (``FICC''),
National Securities Clearing Corporation (``NSCC''), and The Depository
Trust Company (``DTC,'' together with FICC and NSCC, ``Clearing
Agencies'') filed with the Securities and Exchange Commission
(``Commission'') advance notices SR-FICC-2014-810, SR-NSCC-2014-811 and
SR-DTC-2014-812 (``Advance Notices''), pursuant to Section 806(e)(1) of
the Payment, Clearing, and Settlement Supervision Act of 2010
(``Clearing Supervision Act'') \1\ and Rule 19b-4(n)(1)(i) under the
Securities Exchange Act of 1934.\2\ On November 17, 2014, the Clearing
Agencies each filed Amendments No. 1 to the Advance Notices.\3\ On
November 17, 2014 FICC withdrew Amendment No. 1 and filed Amendment No.
2 to advance notice SR-FICC-2014-810.\4\ The Advance Notices, as
amended, were published for comment in the Federal Register on December
11, 2014.\5\ On December 31, 2014, the Commission published notice of
its extension of the review period for the Advance Notices.\6\ The
Commission did not receive any comments on the Advance Notices. This
publication serves as notice of no objection to the Advance Notices, as
amended.
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    \1\ 12 U.S.C. 5465(e)(1).
    \2\ 17 CFR 240.19b-4(n)(1)(i).
    \3\ NSCC and DTC filed Amendment Nos. 1 to provide additional
description of the changes proposed in advance notices SR-NSCC-2014-
811 and SR-DTC-2014-812, respectively.
    \4\ FICC withdrew Amendment No. 1 to advance notice SR-FICC-
2014-810 due to an error in filing the amendment. FICC filed
Amendment No. 2 to advance notice SR-FICC-2014-810 in order to
provide additional description of the changes proposed in the
advance notice.
    \5\ Release No. 34-73755 (Dec. 5, 2014), 79 FR 73665 (Dec. 11,
2014).
    \6\ Release No. 34-73975 (Dec. 31, 2014), 80 FR 918 (Jan. 7,
2015).
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I. Description of the Advance Notices

    The Advance Notices are a proposal by the Clearing Agencies, which
are wholly owned subsidiaries of the Depository Trust and Clearing
Corporation (``DTCC''), to amend and restate their Third Amended and
Restated Shareholders Agreement, dated as of December 7, 2005
(``Existing Shareholders Agreement'') \7\ -- a single agreement
covering all of the Clearing Agencies and their respective members and
participants (``Members''). The Clearing Agencies state that the
proposed revisions to the Existing Shareholders Agreement (``Revised
Shareholders Agreement'') are the product of a comprehensive review by
DTCC of its ownership, governance, and capital structure, undertaken
for the purposes of increasing the financial resources available to
support the conduct of the businesses of the Clearing Agencies and
enhancing regulatory risk management.
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    \7\ When the changes proposed in the Advance Notices become
effective, the title of the Existing Shareholders Agreement will
become the ``Fourth Amended and Restated Shareholders Agreement.''
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    With the Advance Notices of the Revised Shareholders Agreement, the
Clearing Agencies propose: (1) To issue new common stock of DTCC
(``Common Shares''), which mandatory common shareholders (``Mandatory
Shareholders'') \8\ will be required to purchase, upon approval by the
DTCC Board of Directors (``Board'') and two-thirds of Mandatory
Shareholders; (2) to buyback such newly issued Common Shares From
Mandatory Shareholders, at the Board's discretion and approval; (3) to
modify the formula for allocating Common Shares among shareholders
(``Common Shareholders''); (4) to modify the formula for pricing the
Common Shares; (5) to remove restrictions on the frequency with which
DTCC can reallocate Common Shares; and (6) make other conforming and
technical changes. Details of these proposed changes are summarized
below.
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    \8\ Pursuant to the Existing Shareholders Agreement and the
rules of each of the Clearing Agencies, some Members, generally
full-service Members, are required to own Common Shares (i.e.,
Mandatory Shareholders) while other Members, generally limited-
service Members, are permitted but not required to own such shares
(``Voluntary Shareholders''). Further, certain Members are not
permitted to purchase and own Common Shares or become parties to the
Existing Shareholders Agreement.

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A. Capital Raise Through the Sale of Newly Issued Common Shares to
Mandatory Shareholders

    Historically, the Clearing Agencies have operated on an at-cost or
near-cost basis and rebated excess revenues to Members. Recently,
however, the Clearing Agencies have experienced a greater need to
increase capital to meet higher operating costs and, as systemically
important financial market utilities (``SIFMUs''), to satisfy
heightened risk-management requirements.
    In order to raise capital for business purposes, the Revised
Shareholders Agreement will enable DTCC to sell newly issued Common
Shares to Mandatory Shareholders, who will be required to purchase such
shares. The exercise of this new authority will require approval by the
Board and two-thirds of the Mandatory Shareholders. The proceeds of the
sale of the new issuance will be provided by DTCC to the Clearing
Agencies as working capital. Voluntary Shareholders will not be
required or permitted to purchase newly issued Common Shares.
    DTCC states that it has performed extensive analyses to determine
these needs and has considered alternative means to address them. DTCC
deemed an increase in fees impractical because it would not necessarily
generate sufficient resources in a reasonable period and fees depend on
transactional volumes, which may be volatile. DTCC also was concerned
with the financial burden that significant fee increases could place on
Members over an extended period.

B. Mandatory Repurchase of Newly Issued Common Shares from Mandatory
Shareholders

    To allow flexibility to return capital to Mandatory Shareholders if
the Clearing Agencies have excess, the Revised Shareholders Agreement
will provide a mechanism under which DTCC may repurchase Common Shares
from Mandatory Shareholders, on a mandatory basis, in an aggregate
amount up to the aggregate amount of all newly issued Common Shares.
Exercise of this new authority will be at the discretion of the
Board.\9\
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    \9\ The directors of the boards of FICC, NSCC, and DTC are the
same as the Board's directors.
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C. Updates to the Common Share Allocation Formula

    The formula used to periodically reallocate entitlements to
purchase Common Shares (``Allocation Formula'') is based on the
historic development of DTCC.\10\ The Allocation Formula provides that
(i) 80% of the entitlement to purchase Common Shares is based on the
amount of fees paid by a Member to the Clearing Agencies, and (ii) the
remaining 20% of the entitlement is based on the average market value
of all securities credited to the DTC account of that Member (``Long
Positions'').
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    \10\ See Release No. 34-73755 (Dec. 5, 2014), 79 FR 73665, 73667
(Dec. 11, 2014).
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    Today, all users of the Clearing Agencies pay fees to one or more
of the Clearing Agencies based on usage of the services and facilities
of the Clearing Agencies, including fees for Long Positions.
Accordingly, DTCC has determined that it is no longer appropriate for
the Allocation Formula to include both the market value of Long
Positions and fees paid to DTC for such Long Positions. As such, the
Revised Shareholders Agreement will update the Allocation Formula to
eliminate the market value of Long Positions, so that the formula will
be based solely on fees paid to the Clearing Agencies.

D. Amendments to the Common Share Price Formula

    The price of Common Shares is used in connection with the purchase
and sale of such shares among Common Shareholders in the periodic
reallocation of Common Shares, as well as in connection with the
transfer of the Common Shares of retiring or disqualified Common
Shareholders.
    Under the Existing Shareholders Agreement, the price of Common
Shares is determined by a formula (``Pricing Formula'') that excludes a
portion of the retained earnings of the Clearing Agencies from DTCC's
book value, which DTCC argues is a vestige of the historical
development of DTCC.\11\ Additionally, the basis of the Pricing Formula
is the full book value of DTCC, which includes intangibles such as
goodwill.\12\
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    \11\ See id.
    \12\ Intangible items of book value used in this calculation are
shown on DTCC's Consolidated Statement of Financial Condition. DTCC
Financial Statements, available at http://dtcc.com/legal/financial-statements.aspx.
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    To make the price of the Common Shares more closely reflect the
liquidation value of DTCC, the Revised Shareholders Agreement will make
two amendments to the Pricing Formula. First, the formula will be
updated to no longer exclude a portion of the retained earnings of the
Clearing Agencies from DTCC's book value. Second, the formula will be
updated to reflect the tangible book value of DTCC and the liquidation
preference of the preferred stock of DTCC.

E. Amendments to the Frequency of Reallocating Common Shares

    The reallocation of Common Shares among Common Shareholders is a
means of aligning the entitlement to own such shares with the use of
the Clearing Agencies by the Common Shareholders. The Existing
Shareholders Agreement limits reallocations to no more than once a
year, but no less than every three years.
    To allow more frequent reallocations, the Revised Shareholders
Agreement will permit reallocations to occur more than once a year, as
determined by the Board, but still no less than once every three years.

F. Other Conforming and Technical Amendments to the Existing
Shareholders Agreement

    The Revised Shareholders Agreement will also include certain other
technical amendments, including conforming and clarifying changes. For
example, the Revised Shareholders Agreement will: (i) Amend the
definition of ``Common Share Amount'' to clarify that the calculation
does not include any fees that are pass-through fees (i.e., amounts
collected by one of the Clearing Agencies for the account of a third
party and paid by that Clearing Agency to a third party); (ii) amend
the definition of ``Settlement'' to move the time at which settlement
is effected from 5:00 p.m. New York City Time on the Settlement Date,
as such terms are defined in the Existing Shareholders Agreement, to
4:00 p.m. New York City Time on the Settlement Date; \13\ (iii) update
the definition of ``Deliver'' to include more convenient and
contemporary methods of delivering notices, (e.g., by electronic mail),
as appropriate; and (iv) include Members of FICC's Mortgage-Backed
Security Division (``MBSD''), other than Cash-Settling Bank Members (as
such term is defined in the rules of MBSD),\14\ within the definition
of ``Mandatory Purchaser Participants.''
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    \13\ This is an operational change in order to align Common
Share settlement times with the routine times of end of day
settlement for each of the Clearing Agencies.
    \14\ MBSD Rules & Procedures, available at http://www.dtcc.com/
~/media/Files/Downloads/legal/rules/ficc_mbsd_rules.pdf. As a result
of FICC becoming a central counterparty for transactions processed
and cleared at MBSD, Release No. 34-66550 (Mar. 9, 2012), 77 FR
15155 (Mar. 14, 2012), the general rule that full-service Members,
including users of guaranteed services, of one of the Clearing
Agencies are Mandatory Purchaser Participants applies to Members of
MBSD.
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    The Revised Shareholders Agreement also will amend the definition
of ``Qualified Person,'' which sets forth the types of entities that
may hold Common Shares, to exclude: (i) Federal Reserve

Banks because DTCC never intended that such governmental authorities
should be required to own shares in DTCC, notwithstanding that they may
use certain services of the Clearing Agencies; (ii) central
counterparties or central securities depositories because these link
arrangements are for the purpose of extending clearing agency services
across borders, or among closely related activities and products, but
not for ownership purposes; and (iii) any other financial market
infrastructure or utility that the Board determines shall not be a
Qualified Person.
    Finally, the Revised Shareholders Agreement will provide that the
pro-rata re-distribution of the Common Shares of a Common Shareholder
that is no longer a Qualified Person to all other Common Shareholders
takes place at the beginning of the following calendar year, rather
than contemporaneously with such Common Shareholder ceasing to be a
Qualified Person. This change reflects current practice and is more
administratively practical.

II. Discussion and Commission Findings

    Although the Clearing Supervision Act does not specify a standard
of review for an advance notice, the Commission believes that the
stated purpose of the Clearing Supervision Act is instructive.\15\ The
stated purpose of the Clearing Supervision Act is to mitigate systemic
risk in the financial system and promote financial stability by, among
other things, promoting uniform risk management standards for SIFMUs
and strengthening the liquidity of SIFMUs.\16\
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    \15\ See 12 U.S.C. 5461(b).
    \16\ Id.
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    Section 805(a)(2) of the Clearing Supervision Act \17\ authorizes
the Commission to prescribe risk management standards for the payment,
clearing, and settlement activities of designated clearing entities and
financial institutions engaged in designated activities for which it is
the supervisory agency or the appropriate financial regulator. Section
805(b) of the Clearing Supervision Act \18\ states that the objectives
and principles for the risk management standards prescribed under
Section 805(a) shall be to:
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    \17\ 12 U.S.C. 5464(a)(2).
    \18\ 12 U.S.C. 5464(b).
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     Promote robust risk management;
     promote safety and soundness;
     reduce systemic risks; and
     support the stability of the broader financial system.
    The Commission has adopted risk management standards under Section
805(a)(2) of the Clearing Supervision Act \19\ (``Clearing Agency
Standards'').\20\ The Clearing Agency Standards became effective on
January 2, 2013, and require registered clearing agencies to establish,
implement, maintain, and enforce written policies and procedures that
are reasonably designed to meet certain minimum requirements for their
operations and risk management practices on an ongoing basis. As such,
it is appropriate for the Commission to review advance notices against
these Clearing Agency Standards and the objectives and principles of
these risk management standards as described in Section 805(b) of the
Clearing Supervision Act.\21\ The Commission believes that the proposed
changes to the Existing Shareholders Agreement promote robust risk
management, promote safety and soundness, reduce systemic risks, and
support the stability of the broader financial system, and, thus, align
with the stated purpose of the Clearing Supervision Act.
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    \19\ 12 U.S.C. 5464(a)(2).
    \20\ Rule 17Ad-22, 17 CFR 240.17Ad-22. Release No. 34-68080
(Oct. 22, 2012), 77 FR 66220 (Nov. 2, 2012).
    \21\ 12 U.S.C. 5464(b).
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    First, allowing DTCC to issue new Common Shares to Mandatory
Shareholders for the purpose of infusing the Clearing Agencies with
additional working capital will enable the Clearing Agencies, which are
designated SIFMUs, to maintain operations for a longer period during
times of financial stress. As such, the proposed change promotes the
safety and soundness of the Clearing Agencies, reduces systemic risks
presented by the Clearing Agencies, and supports the stability of the
broader financial system.
    Second, allowing DTCC to buy back newly issued Common Shares from
Mandatory Shareholders will enable DTCC to return capital to those
Members, most of which play substantial roles in the financial system,
when the Clearing Agencies have excess capital. Therefore, the proposed
change further supports the stability of the broader financial system
by enabling capital to move from the Clearing Agencies back to Members
when appropriate.
    Third, the proposal to update the Allocation Formula to no longer
account for securities held at DTC will more closely align the
allocation of Common Shares with Common Shareholders' use of the
Clearing Agencies. Therefore, ownership of the Clearing Agencies will
more accurately reflect usage of the Clearing Agencies, which should
further align risks and promote robust management at the Clearing
Agencies.
    Fourth, the proposal to update the Pricing Formula to (i) no longer
exclude a portion of the retained earnings of the Clearing Agencies,
and (ii) change the basis of the formula from DTCC's book value to its
tangible book value will more accurately reflect the actual liquidation
value of DTCC. By more accurately reflecting the liquidation value of
DTCC, shareholders can more accurately account for the value of their
shares and payments that they may make or receive in a future
reallocation of Common Shares. Thus, the Mandatory and Voluntary
Shareholders can better assess their financial position, promoting
stability of the broader financial system.
    Fifth, the proposal to allow for more than one reallocation of
Common Shares among Common Shareholders per year will enable DTCC to
contemporaneously align ownership of Common Shares with Common
Shareholders' usage of the Clearing Agencies as needed. Similar to the
proposed change to the Allocation Formula, discussed above, the ability
to allocate Common Shares more often helps ensure that ownership of the
Clearing Agencies more accurately reflects use of the Clearing
Agencies, which should further promote robust risk management at the
Clearing Agencies.
    Sixth, the technical and conforming changes to the Shareholders
Agreement will make the Shareholders Agreement more consistent,
current, and clear, which promotes a more safe and sound execution of
the agreement by DTCC and its applicable Members.

Conclusion

    It is therefore noticed, pursuant to Section 806(e)(1)(I) of the
Clearing Supervision Act,\22\ that the Commission does not object to
advance notices SR-FICC-2014-810, SR-NSCC-2014-811, and SR-DTC-2014-
812, as amended, and that FICC, NSCC, and DTC be and hereby are
authorized to implement the changes contained in their respective
advance notices as of the date of this notice.
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    \22\ 12 U.S.C. 5465(e)(1)(I).

    By the Commission.
Brent J. Fields,
Secretary.
[FR Doc. 2015-01791 Filed 1-29-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 231 (Friday, November 30, 2012)]
[Rules and Regulations]
[Pages 71316-71321]
[FR Doc No: 2012-28968]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. FDA-1999-F-1267 (Formerly Docket No. 1999F-5322)]

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 increase the maximum dose of ionizing radiation
permitted in the treatment of poultry products, to include specific
language intended to clarify the poultry products covered by the
regulations, and to remove the limitation that any packaging used
during irradiation of poultry shall not exclude oxygen. 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-1267
(formerly Docket No. 1999F-5322) 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-1267 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 21, 1999
(64 FR 71461), FDA announced that a food additive petition (FAP 9M4696)
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 to amend the food
additive regulation, Ionizing radiation for the treatment of food
(Sec.  179.26 (21 CFR 179.26)) in item 6 of the table in paragraph (b)
to: (1) Increase the maximum dose of ionizing radiation permitted in
the treatment of poultry products; (2) include specific language
intended to clarify the poultry products covered by the regulations;
and (3) remove the limitation that any packaging used during
irradiation of poultry shall not exclude oxygen.
    FDA's current regulation under Sec.  179.26(b)(6) permits the
irradiation of fresh or frozen, uncooked poultry products that are: (1)
Whole carcasses or disjointed portions of such carcasses that are
``ready-to-cook poultry'' within the meaning of 9 CFR 381.1(b)(44) or
(2) mechanically separated poultry product (a finely comminuted
ingredient produced by the mechanical deboning of poultry carcasses or
parts of carcasses) up to a maximum absorbed dose of 3.0 kiloGray (kGy)
with the restriction that any packaging used shall not exclude oxygen.
    The amended regulation clarifies the range of poultry products that
may be irradiated, increases the maximum dose of ionizing radiation
permitted in the treatment of covered poultry products, and will remove
the requirement that the packaging for covered poultry products must
not exclude oxygen. The amended regulation clarifies that the
regulation covers fresh (refrigerated or unrefrigerated) or frozen,
uncooked poultry products that are: (1) Whole carcasses or disjointed
portions (or other parts) of such carcasses that are ``ready-to-cook
poultry'' within the meaning of 9 CFR 381.1(b) (with or without
nonfluid seasoning; includes, e.g., ground poultry) or (2) mechanically
separated poultry product (a finely comminuted ingredient produced by
the mechanical deboning of poultry carcasses or parts of carcasses). In
this document, the term ``poultry'' will be used to refer collectively
to all of these products.
    This amendment will bring the poultry regulation into conformity
with the current regulation permitting the irradiation of refrigerated
or frozen, uncooked products that are meat, meat byproducts, or meat
food products; i.e., it permits a maximum absorbed dose of 4.5 kGy for
non-frozen products and 7.0 kGy for frozen products (Sec.
179.26(b)(8)), and provides no limitation that the packaging shall not
exclude oxygen, which would allow the use of packaging including
modified atmosphere packaging and vacuum packaging.

II. Safety Evaluation

    FDA has previously evaluated the safety of irradiated protein food
products in a variety of applications. Discussions of these
applications have been presented in various Federal Register documents
(see 51 FR 13376, April 18, 1986; 55 FR 18538, May 2, 1990; 62 FR
64107, December 3, 1997; 65 FR 45280, July 21, 2000; and 70 FR 48057,
August 16, 2005). FDA specifically reviewed the irradiation of flesh
foods and concluded that the irradiation of refrigerated flesh foods is
safe at the absorbed doses that were reviewed (see 62 FR 64107 at
64111). FDA has also updated its review of the safety of irradiation of
food with a thorough review of the literature to the present time and
found no new studies on the irradiation of poultry (Ref. 1).
    Under section 201(s) of the Federal Food, Drug, and Cosmetic Act
(the 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
the three areas noted in this document, 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 relevant data and information. The
safety data that have been obtained from irradiating various foods
under various conditions support conclusions about the safety of
irradiating the poultry products covered in this rule (Refs. 2 and 4
through 7).

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, and 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 Poultry
    FDA has previously determined that flesh foods, including poultry,
can be considered a single group for the purposes of evaluating the
safety of irradiation because they are similar in composition (62 FR
64107 at 64111). Specifically, the approximate composition of beef and
lamb is 17 percent to 20 percent protein, 15 percent to 25 percent fat,
and 56 percent to 65 percent water. Chicken (depending on cut and
whether or not skin is included) is about 18 percent to 25 percent
protein, 5 percent to 19 percent fat, and 57 percent to 75 percent
water (Ref. 3). Fatty acids in the triglycerides from all flesh foods
are comprised of the same predominant species: Oleic, palmitic,
linoleic, and stearic acid.
    Because of the commonality in the chemistry of the components of
flesh foods and the predictability of the types and amounts of
radiolytic products produced when food is irradiated, the Agency
determined in the 1997 rule permitting the irradiation of meat, meat
byproducts, and certain meat food products, that the conclusions
regarding the irradiation of specific flesh foods can be used to draw
conclusions about the irradiation of flesh foods as a class (62 FR
64107 at 64111). The effects of irradiation on non-frozen poultry
irradiated at levels up to 4.5 kGy and in frozen poultry irradiated at
levels up to 7.0 kGy are similar to the effects that occur in
irradiated meat and have been shown to be safe.
    a. Protein. 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, meat byproducts, and certain meat food products (62 FR 64107 at
64110) and molluscan shellfish (70 FR 48057 at 48059-48060). 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,
FDA concludes that there will be no significant change in the amino
acid composition of poultry that is irradiated at absorbed doses not to
exceed 4.5 kGy for non-frozen products and not to exceed 7.0 kGy for
frozen products.
    b. Lipid. FDA has also previously provided a detailed discussion of
the radiation chemistry of lipids in the rules to permit the
irradiation of meat, meat byproducts, and certain meat food products
(62 FR 64107 at 64110-64111) and molluscan shellfish (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
also 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. 8 and 9). 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 may produce furan (Ref. 10). 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. 11). 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. 11 and 13). Testing of irradiated poultry 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. 11,
12, and 13). Therefore, the Agency concludes that the irradiation of
poultry 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. 5). 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). Additionally, FDA has looked at data and
information in FDA files summarized by the Bureau of Foods Irradiated
Food Committee (Refs. 14 and 15).
    In summary, FDA has reviewed data relevant to the assessment of
potential toxicity of irradiated poultry. 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 poultry
under the conditions proposed in the 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 made the following finding with respect to the nutritional
impact of consuming non-frozen flesh foods irradiated at levels up to
4.5 kGy and frozen flesh foods irradiated at levels up to 7.0 kGy: The
effects of irradiation on the nutritional adequacy of irradiated flesh
foods, which includes poultry, at or above the petitioned doses have
been considered previously. Although the meat final rule (62 FR 64107,
December 3, 1997), codified only the irradiation of red meat at up to
the petitioned doses, the safety evaluation took into account the
effects on the diet of irradiating all flesh foods. The Agency
concluded that permitting the irradiation of poultry at the petitioned
levels will not affect the nutritional status of poultry consumers
(Ref. 3).
    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 poultry up to a
maximum absorbed dose of 4.5 kGy for non-frozen products and not to
exceed 7.0 kGy for frozen products will not have an adverse impact on
the nutritional adequacy of the overall diet.

D. Microbiological Considerations

    In the 1990 final rule for irradiation of poultry (55 FR 18538),
FDA determined that while irradiation at a dose of 3 kGy reduces the
number of many pathogenic and spoilage bacteria, it does not eliminate
the relatively radiation-resistant spore-forming bacteria such as
Clostridium botulinum (55 FR 18541). FDA also determined in the final
rule that C. botulinum, if present, would not render fresh poultry
irradiated at 3 kGy toxic before normal signs of spoilage became
apparent (55 FR 18542).\1\ As an extra margin of safety, however, the
final rule established the limitation that packaging shall not exclude
oxygen with respect to poultry, because C. botulinum does not grow in
oxygenated environments (Ref. 18).
---------------------------------------------------------------------------

    \1\ We note that C. botulinum is not able to grow at
temperatures below freezing.
---------------------------------------------------------------------------

    Since the final rule permitting the irradiation of poultry was
published in 1990, the Agency notes that poultry production practices
have changed, making C. botulinum contamination and growth less of a
concern.\2\ As part of the 1990 rulemaking, the Agency considered the
fact that C. botulinum type E could potentially contaminate fish meal,
which was typically used in chicken feed. Currently, however, fish meal
has almost been completely replaced with high protein soybean and corn
meal. Additionally, C. botulinum does not produce toxin when held at 10
[deg]C (Ref. 19), and current USDA/FSIS regulations generally require
that poultry plants maintain poultry at temperatures below 10 [deg]C
during processing (9 CFR 381.66(b)(1)). Finally, controlling
microbiological contamination, including contamination from C.
botulinum, is now required under mandatory USDA/FSIS poultry processing
Hazard Analysis Critical Control Point plans (9 CFR part 417).
---------------------------------------------------------------------------

    \2\ We note that C. botulinum generally occurs in very low
numbers in chicken.
---------------------------------------------------------------------------

    In addition to the changes in poultry production practices after
the issuance of the 1990 final rule, a study published after the
issuance of the 1990 poultry regulation demonstrates that lactic acid
producing bacteria predominate on irradiated raw chilled meat at doses
up to 5 kGy (Ref. 20) and flourish in an anaerobic environment that
could potentially allow C. botulinum to grow. The growth of C.
botulinum and other pathogens is inhibited by these non-pathogenic
lactic acid producing bacteria (such as Lactobacillus species).
    All of the previously mentioned factors would render it unlikely
that C. botulinum could either grow or produce toxin in poultry under
the conditions of irradiation specified in the regulation as amended by
this final rule, including removal of the restriction on packaging that
excludes oxygen (Ref. 18). Further, the presence of spoilage bacteria
will warn consumers of spoilage before any C. botulinum present would
produce toxin.
    In summary, based on the available data and information, FDA
concludes that irradiation of poultry under the conditions in this
amended regulation will reduce or eliminate bacterial populations with
no increased microbial risk from pathogens that may survive the
irradiation process in either an aerobic or anaerobic atmosphere (Ref.
18).

III. Labeling

    Poultry products are subject to the Poultry Products Inspection Act
(21 U.S.C. 451, 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 poultry. Many of the comments from PC and CFS
were also submitted to the docket for the 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 previously mentioned 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 poultry, and the previous responses are sufficient to
address these issues as they pertain to the rule to permit the
irradiation of poultry 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 treat fresh (refrigerated and unrefrigerated) poultry
food products \3\ with absorbed doses that will not exceed 4.5 kGy and
frozen poultry products not to exceed 7.0 kGy is safe with no need for
a requirement that the packaging shall not exclude oxygen, and
therefore, Sec.  179.26 should be amended as set forth in this
document.
---------------------------------------------------------------------------

    \3\ The term ``fresh poultry'' is defined by USDA to include
both refrigerated and unrefrigerated poultry food products.
---------------------------------------------------------------------------

    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 poultry 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 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 shall be separately
numbered, and each numbered objection shall 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 shall specifically so state. Failure to request a hearing
for any particular objection shall constitute a waiver of the right to
a hearing on that objection. Each numbered objection for which a
hearing is requested shall 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
shall constitute 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
poultry products, 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 9M4696 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. Memorandum for FAP 9M4696 from E. Jensen, FDA, to R. Alrefai,
FDA, dated December 10, 1999.*
4. Elias, P.S. and A.J. Cohen, ``Recent Advances in Food
Irradiation,'' Elsevier Biomedical, Amsterdam, 1983.
5. 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.
6. Preservation of Food by Ionizing Radiation, edited by E.S.
Josephson and M.S. Peterson, Vol. II, CRC Press, Boca Raton, 1982.
7. 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.
8. 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.
9. 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.
10. 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.
11. Memorandum for FAP 9M4697 from K. Morehouse, FDA, to L.
Highbarger, FDA, dated February 20, 2008. *
12. 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.
13. 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.
14. Memorandum from Food Additives Evaluation Branch, FDA (HFS-156),
to C. Takaguchi, Petition Control Branch, FDA, December 28, 1982.*
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. Internal Memorandum for FAP 9M4696 from J. Newland, FDA, to the
file, dated July 7, 2000.*
19. Firstenberg-Eden, R., D.B. Rowley, and G.E. Shattuck. ``Factors
Affecting Growth and Toxin Production by Clostidium Botulinum Type E
on Irradiated (0.3 Mrad) Chicken Skins.'' Journal of Food
Protection, 47:867-870, 1982.
20. Matilla-Sandholm, T. and E. Skytta. ``The Effect of Spoilage
Flora on the Growth of Food Pathogens in Minced Meat Stored at
Chilled Temperature.'' Lebensmittel-Wissenschaft Technologie,
24:116-120, 1991.

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 revising
entry ``6.'' under the headings ``Use'' and ``Limitations'' to read as
follows:

Sec.  179.26  Ionizing radiation for the treatment of food.

* * * * *
    (b) * * *

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

                              * * * * * * *
6. For control of food-borne       Not to exceed 4.5 kGy for non-frozen
 pathogens in fresh (refrigerated   products; not to exceed 7.0 kGy for
 or unrefrigerated) or frozen,      frozen products.
 uncooked poultry products that
 are: (1) Whole carcasses or
 disjointed portions (or other
 parts) of such carcasses that
 are ``ready-to-cook poultry''
 within the meaning of 9 CFR
 381.l(b) (with or without
 nonfluid seasoning; includes,
 e.g., ground poultry), or (2)
 mechanically separated poultry
 product (a finely comminuted
 ingredient produced by the
 mechanical deboning of poultry
 carcasses or parts of carcasses).

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

* * * * *

    Dated: November 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28968 Filed 11-29-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 155 (Monday, August 12, 2013)]
[Rules and Regulations]
[Pages 48806-48809]
[FR Doc No: 2013-19360]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0582; FRL-9845-2]

Approval and Promulgation of Implementation Plans; Tennessee;
Infrastructure Requirements for the 2008 Lead National Ambient Air
Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is taking final action to approve a portion of the State
Implementation Plan (SIP) submission, submitted by the State of
Tennessee, through the Tennessee Department of Environment and
Conservation (TDEC), to demonstrate that the State meets the prevention
of significant deterioration (PSD) related infrastructure requirements
of the Clean Air Act (CAA or Act) for the 2008 Lead national ambient
air quality standards (NAAQS). The CAA requires that each state adopt
and submit a SIP for the implementation, maintenance, and enforcement
of each NAAQS promulgated by EPA, which is commonly referred to as an
``infrastructure'' SIP. TDEC certified that the Tennessee SIP contains
provisions that ensure the 2008 Lead NAAQS are implemented, enforced,
and maintained in Tennessee (hereafter referred to as ``infrastructure
submission''). Tennessee provided to EPA an infrastructure submission
on October 19, 2009, to address the infrastructure requirements for the
2008 Lead NAAQS, however the subject of this notice is limited to the
PSD-related infrastructure elements. All other applicable Tennessee
infrastructure elements have been addressed in a separate rulemaking.

DATES: This rule will be effective September 11, 2013.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2012-0582. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Regulatory Development Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 to 4:30 excluding Federal
holidays.

FOR FURTHER INFORMATION CONTACT: Zuri Farngalo, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-9152. Mr. Farngalo can be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. This Action
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background

    Upon promulgation of a new or revised NAAQS, sections 110(a)(1) and
(2) of the CAA require states to address basic SIP requirements,
including emissions inventories, monitoring, and modeling to assure
attainment and maintenance for that new NAAQS. Section 110(a) of the
CAA requires states to submit SIPs to provide for the implementation,
maintenance, and enforcement of a new or revised NAAQS within three
years following the promulgation of such NAAQS, or within such shorter
period as EPA may prescribe. Section 110(a) imposes the obligation upon
states to make a SIP submission to EPA for a new or revised NAAQS, but
the contents of that submission may vary depending upon the facts and
circumstances. In particular, the data and analytical tools available
at the time the state develops and submits the SIP for a new or revised
NAAQS affects the content of the submission. The contents of such SIP
submissions may also vary depending upon what provisions the state's
existing SIP already contains.
    More specifically, section 110(a)(1) provides the procedural and
timing requirements for SIPs. Section 110(a)(2) lists specific elements
that states must meet for ``infrastructure'' SIP requirements related
to a newly established or revised NAAQS. As already mentioned, these
requirements include SIP infrastructure elements such as modeling,
monitoring, and emissions inventories that are designed to assure
attainment and maintenance of the NAAQS. The requirements of the
section 110(a) infrastructure SIP for purposes of the 2008 Lead NAAQS
are listed below \1\ and in EPA's October 14, 2011, memorandum
entitled'' Guidance on Infrastructure State Implementation

Plan (SIP) Elements Required Under Sections 110(a)(1) and 110(a)(2) for
the 2008 Lead (Pb) National Ambient Air Quality Standards (NAAQS).''
---------------------------------------------------------------------------

    \1\ Two elements identified in section 110(a)(2) are not
governed by the three year submission deadline of section 110(a)(1)
because SIPs incorporating necessary local nonattainment area
controls are not due within three years after promulgation of a new
or revised NAAQS, but rather are due at the time the nonattainment
area plan requirements are due pursuant to section 172. These
requirements are: (1) Submissions required by section 110(a)(2)(C)
to the extent that subsection refers to a permit program as required
in part D Title I of the CAA, and (2) submissions required by
section 110(a)(2)(I) which pertain to the nonattainment planning
requirements of part D, Title I of the CAA. Today's final rulemaking
does not address the section 110(a)(2)(C) and (J) infrastructure
elements as they relate to the requirement as part D, Title I of the
CAA.
---------------------------------------------------------------------------

     110(a)(2)(A): Emission limits and other control measures.
     110(a)(2)(B): Ambient air quality monitoring/data system.
     110(a)(2)(C): Program for enforcement of control
measures.\2\
---------------------------------------------------------------------------

    \2\ This rulemaking only addresses requirements for this element
as they relate to attainment areas.
---------------------------------------------------------------------------

     110(a)(2)(D): Interstate transport.
     110(a)(2)(E): Adequate resources.
     110(a)(2)(F): Stationary source monitoring system.
     110(a)(2)(G): Emergency power.
     110(a)(2)(H): Future SIP revisions.
     110(a)(2)(I): Areas designated nonattainment and meet the
applicable requirements of part D.\3\
---------------------------------------------------------------------------

    \3\ This requirement was inadvertently omitted from EPA's
October 2, 2007, memorandum entitled ``Guidance on SIP Elements
Required Under Section 110(a)(1) and (2) for the 1997 8-Hour Ozone
and PM2.5 National Ambient Air Quality Standards,'' but
as mentioned above is not relevant to today's proposed rulemaking.
---------------------------------------------------------------------------

     110(a)(2)(J): Consultation with government officials;
public notification; and PSD and visibility protection.
     110(a)(2)(K): Air quality modeling/data.
     110(a)(2)(L): Permitting fees.
     110(a)(2)(M): Consultation/participation by affected local
entities.

On November 12, 2008 (75 FR 81126), EPA issued a final rule to revise
the primary and secondary Lead NAAQS. The revised primary and secondary
Lead NAAQS were revised to 0.15 [micro]g/m\3\. Tennessee provided its
infrastructure submission for the 2008 Lead NAAQS on October 19, 2009.
    On March 20, 2013, EPA proposed to approve, and in the alternative,
conditionally approve in part, Tennessee's 2008 Lead NAAQS
infrastructure SIP. In that proposed action, EPA explained that the
Agency was proposing to conditionally approve the PSD-related portions
of sections 110(a)(2)(C), 110(a)(2)(D)(i)(II) (hereafter referred to as
prong 3 of 110(a)(2)(D)(i)),\4\ and 110(a)(2)(J), and a portion of
section 110(a)(2)(E)(ii) of Tennessee's October 19, 2009,
infrastructure submission because Tennessee's SIP (at the time of EPA's
proposal) did not include provisions to comply with all of the
requirements associated with the aforementioned sections. Further, in
the proposal, EPA explained that Tennessee had committed to submit SIP
revisions to address these deficiencies. As such, EPA also proposed, in
the alternative, to approve the entire Tennessee SIP, including the
sections described above, as meeting the applicable infrastructure
requirements for the 2008 Lead NAAQS, and explained that should
Tennessee submit, and EPA approve, the necessary provisions to correct
the identified infrastructure SIP deficiencies prior to EPA taking
final action on the October 19, 2009, infrastructure submission, that
EPA anticipated finalizing full approval of the infrastructure SIP. It
was also explained that, if EPA did not approve necessary provisions
prior to taking final action on the October 19, 2009, infrastructure
submission, EPA anticipated finalizing conditional approvals for those
elements for which the Tennessee infrastructure SIP remained deficient.
See 78 FR 17168. On June 18, 2013, EPA took final action on a majority
of Tennessee's October 19, 2009, submissions with regards to the 2008
Lead NAAQS. See 78 FR 36440. Today's final rulemaking takes action on
the remaining required elements of Tennessee's October 19, 2009, SIP
revision (110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J) as
each relates to PSD requirements) regarding the infrastructure
requirements for the 2008 Lead NAAQS.
---------------------------------------------------------------------------

    \4\ Section 110(a)(2)(D)(i) includes four requirements referred
to as prongs 1 through 4. Prongs 1 and 2 are provided at section
110(a)(2)(D)(i)(I); prongs 3 and 4 are provided at section
110(a)(2)(D)(i)(II).
---------------------------------------------------------------------------

    The PSD-related requirements of section 110(a)(2)(C), prong 3 of
section 110(a)(2)(D)(i), and section 110(a)(2)(J) include four
necessary SIP revisions to address required changes to the State's part
C PSD permit program. The first revision was required by the November
29, 2005, Ozone Implementation Rule New Source Review (NSR) Update--
Phase 2 Rule (hereafter referred to as the Ozone Implementation NSR
Update). Among other requirements, the Ozone Implementation NSR Update
required that SIPs include the recognition of nitrogen oxides as a
precursor for ozone consistent with 40 CFR 51.166 and 40 CFR 52.21. See
70 FR 71612. In addition to the Ozone Implementation NSR Update, there
are three other requirements that states must satisfy in order to meet
the PSD-related requirements of section 110(a)(2)(C), prong 3 of
section 110(a)(2)(D)(i), and section 110(a)(2)(J). These three
revisions are related to (1) the ``Prevention of Significant
Deterioration and Title V Greenhouse Gas Tailoring Rule'' (June 3,
2010, 75 FR 31514), (2) the NSR PM2.5 Rule (May 16, 2008, 73
FR 28321), and (3) the portion of the final rulemaking entitled ``Final
Rule Prevention of Significant Deterioration (PSD) for Particulate
Matter Less Than 2.5 Micrometers (PM2.5)--Increments,
Significant Impact Levels (SILs) and Significant monitoring
Concentration (SMC): Final Rule'' that relates to the PM2.5
PSD increments requirements (hereafter referred to as the
PM2.5 PSD Increment-SILs-SMC Rule (only as it relates to
PM2.5 PSD Increments)) (75 FR 64864).
    Tennessee's SIP has been revised to meet each of the above PSD-
related requirements. Specifically, Tennessee's Ozone Implementation
NSR Update SIP revision was submitted by TDEC on May 28, 2009, and
approved by EPA on February 7, 2012. See 77 FR 6016. Tennessee
submitted its Greenhouse Gas (GHG) Tailoring Rule SIP revision to EPA
on January 11, 2012, and EPA approved it on February 28, 2012. See 77
FR 11744. Tennessee submitted its NNSR SIP revision related to the
implementation of the NSR PM2.5 Rule on July 29, 2011, and
EPA approved this revision on July 30, 2012. See 77 FR 44481. Lastly,
on May 10, 2013, Tennessee submitted a SIP revision to satisfy the
requirements of the PSD PM2.5 Increments, SILs and SMC Rule,
and the final rulemaking for this SIP revision was published on July
23, 2013. See 78 FR 44886.

II. This Action

    EPA is taking final action to approve Tennessee's infrastructure
submission as demonstrating that the State meets the PSD-related
requirements of section 110(a)(2)(C), prong 3 of section
110(a)(2)(D)(i), and section 110(a)(2)(J) of the CAA for the 2008 Lead
NAAQS. Section 110(a) of the CAA requires that each state adopt and
submit a SIP for the implementation, maintenance, and enforcement of
each NAAQS promulgated by the EPA, which is commonly referred to as an
``infrastructure'' SIP. Tennessee, through TDEC, certified that the
Tennessee SIP contains provisions that ensure the 2008 Lead NAAQS is
implemented, enforced, and maintained in Tennessee. EPA received no
adverse comments on its March 20, 2013, proposed approval of
Tennessee's October 19, 2009, infrastructure submission pertaining to
section 110(a)(2)(C), prong 3 of section 110(a)(2)(D)(i), and section
110(a)(2)(J). EPA has determined that the Tennessee infrastructure
submission, adequately addresses the PSD-related requirements of
section 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J) of
the

CAA for the 2008 Lead NAAQS, and is consistent with section 110 of the
CAA.\5\
---------------------------------------------------------------------------

    \5\ As described above, in a previous rulemaking, EPA took
action on Tennessee's October 19, 2009, submission for all other
required infrastructure elements associated with the 2008 Lead
NAAQS. See 78 FR 36440.
---------------------------------------------------------------------------

III. Final Action

    EPA is taking final action to approve, Tennessee's October 19,
2009, submission as demonstrating that the State meets the PSD-related
requirements of section 110(a)(2)(C), prong 3 of section
110(a)(2)(D)(i), and section 110(a)(2)(J) of the CAA for the 2008 Lead
NAAQS because this submission is consistent with section 110 of the
CAA. TDEC has addressed the aforementioned elements of the CAA
110(a)(1) and (2) SIP requirements pursuant to EPA's November 12, 2008,
guidance to ensure that the 2008 Lead NAAQS are implemented, enforced,
and maintained in Tennessee.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.
    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. This action is not a ``major rule'' 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 October 11, 2013. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

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

    Dated July 31, 2013.
Beverly H. Banister,
Acting Regional Administrator, Region 4.
    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATIONS OF IMPLEMENTATION PLANS

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

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

Subpart RR--Tennessee

0
3. Section 52.2220(e), is amended by adding an entry ``110(a)(1) and
(2) Infrastructure Requirements for the 2008 Lead National Ambient Air
Quality Standards'' at the end of the table to read as follows:

Sec.  52.2220  Identification of plan.

* * * * *
    (e) * * *

                                                    EPA-Approved Tennessee Non-Regulatory Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                State
     Name of nonregulatory SIP      Applicable geographic  submittal date/            EPA approval date                         Explanation
             provision              or nonattainment area  effective date
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
110(a)(1) and (2) Infrastructure    Tennessee............      10/19/2009  8/12/2013 [Insert citation of           This approval is for sections
 Requirements for the 2008 Lead                                             publication].                           110(a)(2)(C), prong 3 of
 National Ambient Air Quality                                                                                110(a)(2)(D)(i), and 110(a)(2)(J)
 Standards.                                                                                only.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2013-19360 Filed 8-9-13; 8:45 am]
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[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59714-59715]
[FR Doc No: 2016-20795]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Noise Exposure Map Notice for Baltimore/Washington International
Thurgood Marshall Airport, Anne Arundel County, Maryland

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the noise exposure maps submitted by the Maryland
Aviation Administration for Baltimore/Washington International Thurgood
Marshall Airport under the provisions of 49 U.S.C. 47501 et seq.
(Aviation Safety and Noise Abatement Act) and 14 CFR part 150 are in
compliance with applicable requirements.

DATES: Effective Date: The effective date of the FAA's determination on
the noise exposure maps is August 31, 2016.

FOR FURTHER INFORMATION CONTACT: Washington Airports District Office
(WAS ADO), Marcus Brundage, Environmental Protection Specialist,
Federal Aviation Administration, WAS ADO, Washington Airports District
Office, 23723 Air Freight Lane, Suite 210, Dulles, VA 20166, Telephone:
(703) 661-1354.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA finds
that the noise exposure maps submitted for the Baltimore/Washington
International Thurgood Marshall Airport are in compliance with
applicable requirements of 14 CFR part 150, effective January 13, 2004.
Under 49 U.S.C. 47503 of the Aviation Safety and Noise Abatement Act
(hereinafter referred to as ``the Act''), an airport operator may
submit to the FAA noise exposure maps which meet applicable regulations
and which depict non-compatible land uses as of the date of submission
of such maps, a description of projected aircraft operations during a
forecast period that is at least five (5) years in the future, and the
ways in which such operations will affect such maps. The Act requires
such maps to be developed in consultation with interested and affected
parties in the local community, government agencies, and persons using
the airport. An airport operator who has submitted noise exposure maps
that are found by FAA to be in compliance with the requirements of
Federal Aviation Regulations (FAR) Part 150, promulgated pursuant to
the Act, may submit a noise compatibility program for FAA approval
which sets forth the

measures the operator has taken or proposes to take to reduce existing
non-compatible uses and prevent the introduction of additional non-
compatible uses.
    The FAA has completed its review of the noise exposure maps and
accompanying documentation submitted by the Mayland Aviation
Administration. The documentation that constitutes the ``Noise Exposure
Maps'' (NEM) as defined in Section 150.7 of part 150 includes: 2014
Base Year NEM Figure (20) and 2019 Future Year NEM Figure (21). The
Noise Exposure Maps contain current and forecast information, including
the depiction of the airport and its boundaries, the runway
configurations, and land uses such as residential, open space,
commercial/office, community facilities, libraries, churches, open
space, infrastructure, vacant and warehouse and those areas within the
Day Night Average Sound Level (DNL) 65, 70 and 75 noise contours.
Estimates for the area within these contours for the 2014 Base Year are
shown in Table 3-1 and Table 15; and in Chapter 5 of the NEM. Estimates
of the future residential population within the 2019 Future Year noise
contours are shown in Table 15 and in Chapter 5 of the NEM. Figure 24
displays the location of noise monitoring sites. Flight tracks for the
existing and the five-year forecast Noise Exposure Maps are found in
Chapter 4 and Appendix F. The type and frequency of aircraft operations
(including nighttime operations) are found in Appendix C. The FAA has
determined that these noise exposure maps and accompanying
documentation are in compliance with applicable requirements. This
determination is effective on August 17, 2016.
    FAA's determination on an airport operator's noise exposure maps is
limited to a finding that the maps were developed in accordance with
the procedures contained in Appendix A of FAR Part 150. Such
determination does not constitute approval of the applicant's data,
information or plans; or a commitment to approve a noise compatibility
program or to fund the implementation of that program. If questions
arise concerning the precise relationship of specific properties to
noise exposure contours depicted on a noise exposure map submitted
under Section 47503 of the Act, it should be noted that the FAA is not
involved in any way in determining the relative locations of specific
properties with regard to the depicted noise contours, or in
interpreting the noise exposure maps to resolve questions concerning,
for example, which properties should be covered by the provisions of
Section 47506 of the Act. These functions are inseparable from the
ultimate land use control and planning responsibilities of local
government. These local responsibilities are not changed in any way
under Part 150 or through FAA's review of noise exposure maps.
Therefore, the responsibility for the detailed overlaying of noise
exposure contours onto the map depicting properties on the surface
rests exclusively with the airport operator that submitted those maps,
or with those public agencies and planning agencies with which
consultation is required under Section 47503 of the Act. The FAA has
relied on the certification by the airport operator, under Section
150.21 of FAR Part 150, that the statutorily required consultation has
been accomplished.
    Copies of the full noise exposure map documentation and of the
FAA's evaluation of the maps are available for examination at the
following locations:

Federal Aviation Administration, Eastern Region, Airports Division,
AEA-600, 1 Aviation Plaza, Jamaica, New York 11434.
Federal Aviation Administration, Washington Airports District Office,
23723 Air Freight Lane, Suite 210, Dulles, VA 20166.
Maryland Aviation Administration, 991 Corporate Boulevard, Linthicum,
MD 21090.

FOR FURTHER INFORMATION CONTACT: Washington Airports District Office
(WAS ADO), Marcus Brundage, Environmental Protection Specialist,
Federal Aviation Administration, WAS ADO, 23723 Air Freight Lane, Suite
210, Dulles, VA 17011, Telephone:<PHONE_NUMBER>.

    Issued in Dulles, VA, on August 17, 2016.
Matthew J. Thys,
Manager, Washington Airports District Office, Eastern Region.
[FR Doc. 2016-20795 Filed 8-29-16; 8:45 am]
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