EPA Permit Fee Incentive Rulemaking

Meeting # 1

July 13, 2006

Meeting Summary

Meeting Agenda

Introductions (all participants)

Background and EPA Perspective (Jim Hanlon)

Previous Efforts

PART Review

Summary of Current State Permit Fee Programs

Conferencing Tool Orientation (Len Bechtel)

Schedule and Mission (Len Bechtel)

July 13 -- Meeting #1: Planning Parameters/Assumptions

July 26 -- Meeting #2: Review of Potential Options/Propose Alternatives

August 9 -- Meeting #3: Narrowing Options

[EPA to schedule internal option selection]

August 22 -- Meeting #4: Review of Proposed Draft Rule Language

Planning Parameters/Assumptions (all participants)

Examples:

To the extent possible, maintain funding levels for core programs

Tie incentive to elements already in grant allocation formula

Provide lead time for states without fee programs to accomplish actions
necessary to establish such programs (e.g., coordinate with their
legislatures)

Develop an incentive that will provide a benefit, sufficient enough to
surpass any States’ cost-benefit analysis of this rulemaking,
encouraging states to establish or expand fee programs.

Meeting Participants

NAME	AGENCY/Affiliation	EMAIL

Leonard Bechtel	EPA<EMAIL_ADDRESS>
Gul Beg	EPA<EMAIL_ADDRESS>
Laura Blake	The Cadmus Group, Inc<EMAIL_ADDRESS>
James Blizzard	EPA Office of Congressional & Intergovernmental Relations
<EMAIL_ADDRESS>
Elaine Brenner	EPA OWM -  Water Permits Division<EMAIL_ADDRESS>
Steve Brown	ECOS<EMAIL_ADDRESS>
Brian Cavanaugh	ME DEP<EMAIL_ADDRESS>
Vince Chavez	Washington State Department of Ecology<EMAIL_ADDRESS>
Kristen Dunne	ECOS<EMAIL_ADDRESS>
Carolyn Gillette	The Cadmus Group, Inc<EMAIL_ADDRESS>
Ron Hammerschmidt	Kansas Department of Health and Environment
<EMAIL_ADDRESS>
Jim Hanlon	EPA HQ<EMAIL_ADDRESS>
Linda Eichmiller	ASIWPCA<EMAIL_ADDRESS>
Roger Larson	Wisconsin Department of Natural Resources
<EMAIL_ADDRESS>
Dennis Lau	Hawaii Department of Health<EMAIL_ADDRESS>
Karl Mueldener	Kansas Department of Health and Environment
<EMAIL_ADDRESS>
Duane Schuettpelz	Wisconsin Department of Natural Resources
<EMAIL_ADDRESS>
Susan Sylvester	Wisconsin Department of Natural Resources
<EMAIL_ADDRESS>
Mike Tate	Kansas Department of Health and Environment
<EMAIL_ADDRESS>
Burt Tuxford	Virginia Department of Environmental Quality
<EMAIL_ADDRESS>
Kyle Winter	Virginia Department of Environmental Quality
<EMAIL_ADDRESS>
David Bullard	Georgia Department of Natural Resources
<EMAIL_ADDRESS>
Robert Moyer	EPA OGC<EMAIL_ADDRESS>
Nizanna Bathersfield	EPA OWM – Water Permits Division
<EMAIL_ADDRESS>

Background and EPA Perspective

Jim Hanlon, Director of EPA’s Office of Wastewater Management (OWM),
initiated the meeting by providing background information detailing
EPA’s motives for pursuing a rule that would assist in
creating/implementing “adequate” State permit fee programs.  EPA
also provided participants with its vision regarding the forthcoming
rule development process, including timelines.  He noted that he
previously provided similar information to representatives from the
Environmental Council of the States (ECOS), Association of State and
Interstate Water Pollution Control Administrators (ASIWPCA), National
Governors Association (NGA), and National Council of State Legislature
(NCSL) during a meeting at EPA in June.

Hanlon said that EPA’s actions are influenced by the significance of
the language in the President’s FY07 budget directing EPA to develop a
final rule with regard to Section 106 grants that will establish
financial incentives for states that implement adequate NPDES permit fee
programs.  This ’07 budget language results from OMB’s Section 106
PART follow-up action items, one of which was providing additional
resources that could be made available to help support state CWA
implementation, if adequate fees were charged for the issuance of NPDES
permits.

In addition to the June 20th meeting, mentioned above, the rule
development process was also discussed with the ASIWPCA membership
during their March meeting in Washington, D.C.

As an initial step, EPA has reviewed and summarized existing state NPDES
permit fee programs, and determined that at least 42 states now have
some sort of permit fee structure in place.  Fees are charged for a
variety of permit types, including municipal permits, industrial
permits, stormwater discharges, and animal/agricultural permits.  Fees
can be of different types, such as: application; initial one time;
annual; and renewal.  The associated data analysis tried to capture not
only the dollar value of the fees assessed, but also a breakdown of
these fees into the permit types and categories.

EPA could not collect detailed background information on the genesis of
the fee amounts.  However, based on conversations with several states,
EPA is aware that some states with fee programs have had fees in place
for 10 or more years, but for a variety of reasons have not been able to
increase fees despite increases in state costs of implementing the
program and issuing permits.

Some permit fee programs are designed to fully fund or capture the cost
of issuing permits, while others are designed to only capture a portion
of the costs incurred.  EPA is aware of the fact that State permit
summary data collected thus far needs to be validated, in order to
ensure the establishment of an accurate State permit fee programmatic
baseline.

EPA plans to provide a final regulation by December 31, 2006.

There are a number of issues and questions, as follow below, that the
meeting participants need to consider throughout the establishment of
this rule.

What is an “adequate” fee program?

What kind of financial incentives should be offered?

How should the financial incentive be structured in terms of size and
dollar value?

Should generated fees be limited?

With a final rulemaking target date of 12/31/06, should the incentive
program be implemented in FY 08, or should there be other implementation
dates to allow states that do not now have adequate fee programs to
develop such programs?

Finally, the intended result of this rulemaking is to provide additional
financial resources to implement the CWA.  Therefore, fees generated
should remain available for States to implement the CWA.  Some states
return permit fee revenue into the general fund and, while that revenue
is returned to the water program for some states, there are other states
that use that revenue to fund other state programs.

EPA’s target is to have a formal proposal ready for publication (to
solicit comment from the states and affected stakeholders) by the end of
August or early September 2006.  This target date will provide for an
adequate comment period and allow EPA reasonable time to consider
submitted comments, in order to publish a final rule by the target date
of 12/31/06.

Rulemaking Schedule and Mission

Mr. Bechtel, OWM’s Director of Planning, Information, & Resources
Management Staff, discussed the timeline for this rule’s development
process.  The plan is to provide a draft rule to states for comment by
early September 2006.  In order to meet this deadline, a total of four
meetings are planned, as follows:

July 13 -- Meeting #1:  Planning Parameters/Assumptions

The purpose of the July 13 meeting was to seek various perspectives from
the meeting participants regarding the questions that EPA should
consider in the development of options, such as:

What are the important issues?

What are the important mechanical areas that EPA needs to think about?

What are the impacts that EPA should anticipate as they are developing
the options?

This July 13 meeting was a brainstorming session to elevate issues and
perspectives of importance to EPA staff, as they work toward developing
options for consideration.

July 26 -- Meeting #2:  Review of Potential Options/Propose Alternatives

Between July 13 and July 26, EPA will start the process of formulating
options.  The goal of the July 26 meeting is to discuss the pros/cons of
the various proposed options and identify any suggested alternative
options meeting participants may propose at this meeting.  Before the
July 26 meeting, EPA will distribute the proposed 4-5 options.

August 9 -- Meeting #3:  Narrowing Options

Between July 26 and August 9, EPA will, if needed, further refine the
options, based on discussions that occurred in the July 26th meeting.
The August 9 meeting will involve additional discussion of the refined
options, if needed.  However, the primary purpose of the August 9
meeting is for meeting participants to provide EPA with further
clarification on States’ preferences as related to the various
options.

Between the August 9th and 22nd meetings, EPA will brief Agency Senior
Management on the developed/refined options, for purposes of senior
management decision-making, providing EPA with one recommended option to
move forward with.  EPA will then draft a rule, in preparation for the
August 22nd meeting.

August 22 -- Meeting #4:  Review of Proposed Draft Rule Language

At the August 22 meeting, participants will be asked to provide input on
the draft language.

EPA recognizes that this is an aggressive workload and schedule both for
EPA staff and other participants.  EPA appreciates the time and effort
that all participants will provide.

Development of Planning Parameters/Assumptions (all participants)

EPA tasked the meeting participants with developing planning assumptions
that EPA will use as they develop the various options and alternatives
associated with the rule.

Mr. Bechtel provided the following examples to help initiate and
facilitate an open exchange of ideas with the meeting participants:

To the extent possible, maintain funding levels for core programs

Tie incentive to elements already in grant allocation formula

Provide lead time for states without fee programs to accomplish actions
necessary to establish programs (e.g., coordinate with their
legislatures)

Develop an incentive that will provide a sufficient benefit to encourage
states to establish or expand fee programs

Ensure fees are flowing back into permit fee programs

State Identification of Perspectives and Issues that EPA Should Consider

State representatives provided the following suggestions for EPA’s
consideration throughout the development of this rule:

Option #1:	Maintain level of funding for core program

Option #2:	Modest increase in funding for core program

Option #3:	Do not touch other core categorical grant programs (e.g., 319
grants) at the expense of this rule

Option #4:	No decline in interest/support for the program

Option #5:	Needs to be fair to all parties (permittees, states, etc.)

Option #6:	Not all states would need exactly the same fee program
structure

Option #7:	Offer programmatic advantages (e.g., streamlining) in
addition to financial incentives

Option #8:	New permit fees should not merely replace current funding

Option #9:	Provide adequate lead time (phase-in period)

Option #10:	 State has option to include existing state expenditures as
equivalent to fee revenue

Option #11:	 Assume state funding, fee funding, and federal funding

Option #12: Do not penalize states that make the effort and fail

Option #13: Do not prescribe set fee determination/financial/collection
structure; give states flexibility

Option #14: Do not create incentive for states to return delegation to
EPA

Option #15: States should not be asked to collect fees if EPA does not
in non-delegated states

Option #16: Credit states for penalty collections

Option #17: Provide funding to help states get fee program up and
running (EPM account? IPA?)

Option #18: Offer customer (permittee) better service as a result of fee
program

Option #19: Strive for both collection and program efficiency

Option #20: Start with core permit types

Option #21: Core -- permitting, compliance, and enforcement (excludes
standards/monitoring)

Option #22: Assure that federal grant level of funding will be sustained

Summary of Discussion & Comments Made During the “Options”
Brainstorming Process

OMB directed EPA to provide an incentive for “adequate” permit fee
programs.  EPA will have to consider what constitutes an “adequate”
permit fee program (i.e., what is meant by “adequate?”).  For
example, is it full cost collections across all types of permits?  What
are the perspectives that the states have on what EPA should consider in
terms of defining “adequate?”

ECOS’ research indicates that states currently supply about 2/3 of the
funding for permit programs through state funds and permit fees (this
ratio is higher in some states and lower in others).  It could be argued
that this is an “adequate” amount?

Does special consideration need to be given for federal facilities?
This issue was “tabled” for now.

EPA suggested initiating the incentive program 2 years after rule
issuance to give states time to work through the legislative process of
instituting a permit fee program.

Meeting participants stressed that the incentive must be attractive
enough to get legislative action.  How big of an incentive is necessary?
 Given EPA’s budget difficulties, EPA’s financial incentives are not
likely to be adequate enough for state legislatures to take action.
Aside from financial incentives, what are the true incentives?

Meeting participants questioned the source of the financial incentive.
Mr.  Bechtel explained that EPA is considering a variety of ways to
achieve a financial incentive, such as setting aside a portion of the
initial Section 106 allocation and allocating it to those states with an
adequate permit fee program.  Participants noted that most states will
likely not endorse a “disincentive” option for this rulemaking.
Another option would be to designate portions of any future increases in
Section 106 funding for distribution to those states with adequate
permit fee programs.

Hawaii discussed a similar exercise that the State went through in the
mid-1990s.  At that time, the state legislature wanted the Hawaii
Department of Health to develop a permit fee program that would put
sufficient income back into the program to run it.  The Department found
that most of the fees would be paid by municipalities and power plants,
i.e., the largest dischargers.  When the Department presented the
figures to the legislature, the municipalities and power companies
lobbied against the fees and the Department.  Therefore, the Department
established a small equal fee for all permit holders.  Hawaii is also
concerned that if permit fees are collected to operate the program, the
legislature will cut their general fund by the amount generated by
permit fees.

Georgia indicated that their stormwater program does charge some permit
fees, but there are no permit fees for municipal or industrial permits.
The water department is not sure why this is the case.  The issue is
periodically reviewed with no results.

The basis that many states use for instituting permit fees is that
better service (e.g., faster processing) will be provided to permittees
as a result.

Collecting permit fees partially assists in removing permit programs
from the problems incurred when tax revenues decline, affecting program
funding.  However, Louisiana experienced program funding cuts even
though they were fee funded.

Another benefit to implementing an adequate permit fee program is the
ability to remove EPA from the permitting process.

Participants stressed that there needs to be a phase-in period for
states without permit fee programs to establish such programs before the
incentive program takes effect.

What is the extent of the support that a fee program would provide?  For
example, do states only need to collect fees to cover the costs of
processing applications?  What about compliance and enforcement?  What
about derivation of water quality standards (WQS), which has a direct
impact on what constitutes a permit – should WQS development also be
supported by permit fee revenues?

Regardless of the final incentive program that EPA develops, it should
not carry a mandate for a specific fee structure.

Mr. Bechtel noted that the overall goals of this rulemaking are to help
states with limited or no fee programs to expand existing fee programs
or implement new fee programs, and to reward states that already have
adequate permit fee programs in place.

Meeting participants inquired about permit fees charged (by EPA) for the
5 non-delegated states.  EPA does not charge permit fees because it
would cost more to run a permit fee program (on account of the limited
number of permittees) than would be collected in fees.

Mr. Bechtel asked meeting participants to consider how states with
limited or no permit fee programs could be encouraged to expand or
implement a fee program.  They commented that EPA may need to create
non-financial incentives, as financial incentives alone may not prompt
states to create an adequate permit fee program.  For those states that
do not yet have a permit fee program, one attractive incentive might be
to offer start-up costs for initiating the program.  Participants
commented that this could work well if the source of funding was a grant
that came out of the EPM account.  This could also be done through an
IPA.

Virginia conducted a permit efficiency study (mandated by the state
general assembly) to investigate the state’s interaction with
permittees over a 5-year cycle, including permitting and inspections.
The state was required to investigate the development of new categories
of general permits that will ultimately reduce the permit fees being
collected by the state (fees for general permits are $600 every 5 years
as opposed to the thousands of dollars collected for individual
permits).

Water programs might like to see permit fees instituted or increased.
However, this decision is up to the state legislature, not the water
programs.  Since many permit fees (e.g., municipal or power plants) will
be passed on to the public (i.e., in the form of taxes), state
legislatures may not want to impose increased taxes on the public
(through increased permit fees to permitees).

One idea that most meeting participants generally supported was a grant
to a state to assist them in working with constituencies in their state
to approach the legislature with a consensus opinion about either
increasing or creating a permit fee.  This option does not negatively
affect any of the states and would help those states that would like to
create a permit fee program, but lack necessary funding, begin to take
necessary actions toward developing such a program.

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[Federal Register: October 6, 2005 (Volume 70, Number 193)]
[Notices]
[Page 58494-58496]
[DOCID:fr06oc05-171]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 35-28041]

Filings Under the Public Utility Holding Company Act of 1935, as
Amended (``Act'')

September 30, 2005.
    Notice is hereby given that the following filing(s) has/have been
made with the Commission pursuant to provisions of the Act and rules
promulgated under the Act. All interested persons are referred to the
application(s) and/or declaration(s) for complete statements of the
proposed transaction(s) summarized below. The application(s) and/or
declaration(s) and any amendment(s) is/are available for public
inspection through the Commission's Branch of Public Reference.
    Interested persons wishing to comment or request a hearing on the
application(s) and/or declaration(s) should submit their views in
writing by October 21, 2005, to the Secretary, Securities and Exchange
Commission, Washington, DC 20549-0609, and serve a copy on the relevant
applicant(s) and/or declarant(s) at the address(es) specified below.
Proof of service (by affidavit or, in the case of an attorney at law,
by certificate) should be filed with the request. Any request for
hearing should identify specifically the issues of facts or law that
are disputed. A person who so requests will be notified of any hearing,
if ordered, and will receive a copy of any notice or order issued in
the matter. After October 21, 2005, the application(s) and/or
declaration(s), as filed or as amended, may be granted and/or permitted
to become effective.

Northeast Utilities, et al. (70-9755)

    Northeast Utilities (``NU''), a public utility holding company
registered under the Act, Building 111-4, One Federal Street,
Springfield, Massachusetts 01105; Yankee Energy System, Inc. (``YES''),
a public utility holding company subsidiary of NU, exempt from
registration under section 3(a)(1) of the Act by rule 2, and Northeast
Utilities Service Company, NU's service company subsidiary, 107 Selden
Street, Berlin, Connecticut 06037; NU's direct and indirect public
utility subsidiaries, The Connecticut Light and Power Company
(``CL&P'') and Yankee Gas Services Company (``Yankee Gas''), 107 Selden
Street, Berlin, Connecticut 06037, Western Massachusetts Electric
Company, Building 111-4, One Federal Street, Springfield, Massachusetts
01105 (``WMECO'' and with CL&P and Yankee Gas, the ``Utility
Borrowers''), Public Service Company of New Hampshire, Energy Park, 780
North Commercial Street, Manchester, New Hampshire 03101 (``PSNH''),
and Holyoke Water Power Company (``HWP''), 107 Selden Street, Berlin,
Connecticut 06037; and NU's direct and indirect nonutility
subsidiaries, Northeast Nuclear Energy Company, The Rocky River Realty
Company, The Quinnehtuk Company, Properties, Inc., Yankee Energy
Financial Services Company, Yankee Energy Services Company, NorConn
Properties, Inc., NU Enterprises, Inc., Northeast Generation Company,
Northeast Generation Services Company, E. S. Boulos Company, Woods
Electrical Company, Inc., Woods Network Services, Inc., Select Energy,
Inc., Select Energy New York, Inc., and Mode 1 Communications, Inc.,
107 Selden Street, Berlin, Connecticut 06037, and North Atlantic Energy
Corporation, North Atlantic Energy

Service Corporation (``NAESC''), Energy Park, 780 North Commercial
Street, Manchester, New Hampshire, 03101; and Select Energy Services,
Inc., 24 Prime Parkway, Natick, Massachusetts 01760 (all of the above
named companies collectively the ``Applicants'') have filed a post-
effective amendment to an application/declaration (``Amendment'') under
sections 6(a) and 7 of the Act.
    Applicants state that by order dated June 30, 2004 (Holding Co. Act
Release No. 27870) (``2004 Order''), the Commission granted authority
for NU, YES and the Utility Borrowers to issue short-term debt
securities, subject to certain conditions. NU was authorized to issue
up to an aggregate of $450 million of short-term debt at any one time
outstanding through June 30, 2007 (``Authorization Period''). The 2004
Order also authorized continued operation of the NU Money Pool through
the Authorization Period, based, in part, on the commitment by NU, YES
and the Utility Borrowers that, apart from the securities issued for
the purpose of funding money pool operations, no securities would be
issued under the authority obtained under the 2004 Order unless: (i)
The security to be issued, if rated, is rated investment grade; (ii)
all outstanding securities of the issuer that are rated are rated
investment grade; and (iii) all outstanding securities of NU and YES
that are rated, are rated investment grade (``Investment Grade
Conditions''). The 2004 Order also approved a Money Pool borrowing
limit for HWP of $10 million.
    With this Amendment, the Applicants seek the following
authorizations: to increase the amount of short-term debt that NU may
incur through the Authorization Period from $450 million to $700
million; to delete the Investment Grade Conditions on issuance of
certain securities by NU, YES and the Utility Borrowers; to add NAESC
as a participant in the NU Money Pool; and to increase HWP's Money Pool
limit from $10 million to $35 million. Applicants state that no further
authorizations are being requested by the Amendment and all other terms
and conditions in the 2004 Order will remain applicable.
    According to the Applicants, management believes that the increase
is necessary at this time to continue to support the credit and
liquidity requirements of its regulated and competitive businesses. The
Applicants also state that NU needs the additional liquidity to meet
possible near-term, temporary cash needs, such as cash payments to buy
our or buy down certain wholesale contracts, associated with the
holding company's previously announced exit from the wholesale
competitive energy business. In addition, a number of Select Energy's
energy contracts require, according to Applicants, the posting of
additional collateral in the form of cash or letters of credit in the
event NU's credit ratings were to decline and in increasing amounts
dependent upon the severity of the decline. Were NU's unsecured ratings
to decline to sub-investment grade, Select Energy states that it could,
under its present contracts, be asked to provide, as of March 31, 2005,
approximately $500 million of collateral or letters of credit to
various unaffiliated counterparties and approximately $154 million to
several independent system operators and unaffiliated local
distribution companies, which, management states, NU would currently be
able to provide. In addition, according to Applicants, Standard and
Poor's credit rating agency, has imposed reporting requirements
industry-wide for its new liquidity tests. Standard and Poor's
liquidity tests demonstrate, according to Applicants, that NU needs
additional credit capacity to support its businesses in the event of
certain hypothetical adverse developments affecting credit ratings and
forward prices of energy commodity products.
    According to the Applicants, the external short-term debt which NU
is requesting authority to issue may take a variety of forms, including
commercial paper and unsecured notes with banks or other institutional
lenders under credit facilities that are generally available to
borrowers with comparable credit ratings. All short-term debt issued by
NU as a result of this Amendment will have maturities of less than one
year from the date of issuance. NU states that it will not issue any
secured debt.
    Commercial paper issued by NU may be issued manually or through The
Depository Trust Company in the form of book entry notes in
denominations of not less than $50,000 of varying maturities. This
commercial paper would typically be sold to dealers at the discount
rate prevailing at the date of issuance for commercial paper of
comparable quality and maturities sold to commercial paper dealers
generally. The Applicants expect that the dealers acquiring the
commercial paper will reoffer it at a discount to corporate and
institutional investors. The Applicants state that no commercial paper
will be issued by NU unless the issuer believes that the effective cost
to it will be equal to or less than the effective interest rate at
which it could issue short-term notes in an amount at least equal to
the principal amount of the commercial paper. The commercial paper will
be publicly issued and sold without registration under the Securities
Exchange Act of 1933 in reliance upon one or more applicable exemptions
from registration under that Act.
    According to NU, the effective cost of money on the short-term debt
will not exceed competitive market rates available at the time of
issuance for securities having the same or reasonably similar terms and
conditions issued by companies of comparable credit quality, provided
that in no event will the effective cost of capital exceed 300 basis
points over the comparable term London Interbank Offered Rate. Issuance
expenses will not exceed 5% of the principal amount of the securities.
NU states that specific terms of the short-term debt will be determined
by NU at the time of issuance but that those terms will comply in all
regards to the parameters of financings authorizations set forth in the
Amendment. A copy of all new notes or loan agreements executed as a
result of the authority requested will be filed under cover of the next
quarterly report under rule 24. NU states that, subject to the NU
Aggregate Short-term Debt Limit, NU intends to renew and extend
outstanding short-term debt as it matures, to refund such short-term
debt with other similar short-term debt, to repay such short-term debt
or to increase the amount of their short-term debt from time to time
through the Authorization Period.
    In a recent order issued by the Commission (Pepco Holdings, Inc.,
Holding Co. Act Release No. 27991, June 30, 2005), the Commission
modified the investment grade conditions applicable to the issuance of
securities by holding companies and their public utility subsidiaries,
including the elimination of investment grade requirements for the
issuance of short-term debt. Since the 2004 Order only authorized the
issuance of short-term debt and interest rate hedges, the Applicants
request that the Commission eliminate the Investment Grade Conditions
set forth in the 2004 Order.
    According to the Applicants, HWP has embarked on a capital spending
program which will require it, among other things, to install
additional pollution control equipment at its Mt. Tom generating
facility. This program, expected to cost approximately $17 million,
plus contingencies and other requirements associated with ongoing
remediation of site contamination at Mt. Tom, necessitates an increase
in HWP's borrowing capacity. It has no external sources of funds at
present and is close

to its authorized Money Pool limit. The Money Pool represents an
economic alternative for HWP's short-term funding needs. Applicants
request an increase in HWP's Money Pool limit from $10 million to $35
million.
    NAESC, which seeks authority to participate in the NU Money Pool,
formerly operated the Seabrook Nuclear Station, which was sold in 2002.
NAESC currently retains cash against certain future obligations, and
Applicants state that NU's cash management system will be enhanced by
the addition of NAESC to the NU Money Pool on the terms and conditions
set forth in the 2004 Order.
    NU states that at all times during the Authorization Period it will
maintain common equity (as reflected in the most recent Form 10-K or
Form 10-Q filed with the Commission) of at least 30% of its
consolidated capitalization (net of securitization debt). The term
``consolidated capitalization'' is defined to include, where
applicable, common stock equity (comprised of common stock, additional
paid in capital, retained earnings, accumulated other comprehensive
income or loss, and/or treasury stock), minority interest, preferred
stock, preferred securities, equity linked securities, long-term debt,
short-term debt and current maturities (net of securitization debt).
    NU states that, as of June 30, 2005, NU's consolidated
capitalization (net of securitization debt) consisted of 38.6% common
equity, 2.1% preferred stock, 59.3% long-term and short-term debt. When
securitization debt (Rate Reduction Bonds) is included, NU's
consolidated capitalization as of June 30, 2005, was 30.5% common
equity, 1.7% preferred stock and 46.8% debt, 21.0% Rate Reduction
Bonds.
    The proceeds from the issuance of short-term debt as requested in
this Amendment will be used for (i) general corporate purposes,
including investments by and capital expenditures of NU and its
subsidiaries, including, without limitation, the funding of future
investments in exempt wholesale generators (``EWGs''), foreign utility
companies (``FUCOs'') (each to the extent permitted under the Act or
Commission order), energy-related companies (``Rule 58 Subsidiaries'')
to the extent permitted under the Act or Commission order, and exempt
telecommunications companies (``ETCs''), (ii) the repayment,
redemption, refunding or purchase by NU or any subsidiary of any of its
own securities from non-affiliates under rule 42, and (iii) financing
working capital requirements of NU and its subsidiaries.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Jonathan G. Katz,
Secretary.
 [FR Doc. E5-5475 Filed 10-5-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Rules and Regulations]
[Pages 48442-48448]
[FR Doc No: 2017-22495]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R05-OAR-2017-0256; FRL-9969-67-Region 5]

Air Plan Approval; Ohio; Redesignation of the Fulton County Area
to Attainment of the 2008 Lead Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving the
State of Ohio's request to revise the designation of, or
``redesignate,'' the Fulton County nonattainment area (Fulton County)
to attainment of the 2008 National Ambient Air Quality Standards (NAAQS
or standard) for lead. EPA is also approving the maintenance plan and
related elements of the redesignation. EPA is approving reasonably
available control measure (RACM)/reasonably available control
technology (RACT) measures and a comprehensive emissions inventory as
meeting the Clean Air Act (CAA) requirements. EPA is taking these
actions in accordance with the CAA and EPA's implementation regulations
regarding the 2008 lead NAAQS.

DATES: This direct final rule will be effective December 18, 2017,
unless EPA receives relevant adverse comments by November 17, 2017. If
adverse comments are received, EPA will publish a timely withdrawal of
the direct final rule in the Federal Register informing the public that
the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2017-0256 at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Matt Rau, Environmental Engineer,
Control Strategies 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. Why is EPA concerned about lead?
II. What is the background for these actions?
III. What are the criteria for redesignation to attainment?
IV. What is EPA's analysis of Ohio's request?
V. What action is EPA taking?
VI. Statutory and Executive Order Reviews

I. Why is EPA concerned about lead?

    Lead is a metal found naturally in the environment and present in
some manufactured products. However, lead has serious public health
effects and depending on the level of exposure can adversely affect the
nervous system, kidney function, immune system, reproductive and
developmental systems and the cardiovascular system. Infants and young
children are especially sensitive to even low levels of lead, which may
contribute to behavioral problems, learning deficits and lowered
intelligence quotient. The major sources of lead for air emissions have
historically been from fuels used in on-road motor vehicles (such as
cars and trucks) and industrial sources. As a result of EPA's
regulatory efforts to remove lead from on-road motor vehicle gasoline,
emissions of lead from the transportation sector declined by 95 percent
between 1980 and 1999, and levels of lead in the air decreased by 94
percent between 1980 and 1999.

II. What is the background for these actions?

    On November 12, 2008 (73 FR 66964), EPA established the 2008
primary and secondary lead NAAQS at 0.15 micrograms per cubic meter
([mu]g/m\3\) based on a maximum arithmetic three-month mean
concentration for a three-year period. 40 CFR 50.16.
    On November 22, 2010 (75 FR 71033), EPA published its initial air
quality designations and classifications for the 2008 lead NAAQS based
upon air quality monitoring data for calendar years 2007-2009. These
designations became effective on December 31, 2010. A portion of Fulton
County was designated as nonattainment for lead, specifically portions
of Swan Creek and York Townships. 40 CFR 81.336.
    On April 27, 2017, Ohio requested EPA to designate the applicable
Fulton County area as attainment of the lead NAAQS. Ohio documented
that its request meets the redesignation criteria of CAA section 107.
    Ohio used the emissions inventory to find that there were no area,
mobile, or nonroad sources of lead emissions that contributed to
nonattainment. The Bunting Bearings LLC facility (Bunting) in the
village of Delta is the only point source of lead emissions in the
nonattainment area. Bunting manufactures continuous cast products in
copper alloys, typically bronze, that contain lead. The lead component
of the alloys is important as it allows for machining the bronze.

III. What are the criteria for redesignation to attainment?

    The requirements for redesignating an area from nonattainment to
attainment are found in CAA section 107(d)(3)(E). There are five
criteria for redesignating an area. First, the Administrator must
determine that the area has attained the applicable NAAQS based on
current air quality data. Second, the Administrator must have fully
approved the applicable SIP for the area under CAA section 110(k). The
third criterion is for the Administrator to determine that the air
quality improvement is the result of permanent and enforceable emission
reductions. Fourth, the Administrator must have fully approved a
maintenance plan meeting the CAA section 175A requirements. The fifth
criterion is that the state has met all of the applicable requirements
of CAA section 110 and part D.

IV. What is EPA's analysis of Ohio's request?

A. Attainment Determination and Redesignation

1. The Area Has Attained the 2008 Lead NAAQS (Section 107(d)(3)(E)(i))
    On May 26, 2015, EPA determined that Fulton County has attained the
2008 lead NAAQS. 80 FR 29964. EPA made its clean data determination
based

upon complete, quality-assured and certified ambient air monitoring
data for the 2012-2014 period. The Fulton County area attained the 2008
lead NAAQS, with a design value of 0.09 [micro]g/m\3\ for 2012-2014,
well below the 0.15 [micro]g/m\3\ standard.
    EPA has reviewed the current monitoring data for Fulton County,
Ohio. The latest available monitoring data continue to show attainment
of the 2008 lead NAAAQS. The 2014-2016 design value for the County is
0.12 [micro]g/m\3\.
2. The Area Has Met All Applicable Requirements Under Section 110 and
Part D and Has a Fully Approved SIP Under Section 110(k) (Section
107(d)(3)(E)(ii) and (v))
    EPA has determined that Ohio has met all currently applicable SIP
requirements for purposes of redesignation for the Fulton County area
under section 110 of the CAA (general SIP requirements). In addition,
with the exceptions of the RACM/RACT requirements under section
172(c)(1) and the emissions inventory under section 172(c)(3), all
applicable requirements of the Ohio SIP for purposes of redesignation
have either been approved or have been suspended, by either a clean
data determination or determination of attainment. EPA is also
approving Ohio's 2013 emissions inventory as meeting the section
172(c)(3) comprehensive emissions inventory requirement as well as
approving the RACM provisions as meeting the section 172(c)(1)
requirement. Thus, we are determining that Ohio's submission meets all
SIP requirements currently applicable for purposes of redesignation
under part D of title I of the CAA, in accordance with sections
107(d)(3)(E)(ii) and 107(d)(3)(E)(v).
    In making these determinations, EPA has ascertained which SIP
requirements are applicable for purposes of redesignation, and
concluded that the Ohio SIP includes measures meeting those
requirements and that they are fully approved under section 110(k) of
the CAA. Further discussion of EPA's review of Ohio's submittal
regarding these criteria follows.
a. Ohio Has Met All Applicable Requirements for Purposes of
Redesignation of the Fulton County Area Under Section 110 and Part D of
the CAA
i. Section 110 General SIP Requirements
    Section 110(a) of title I of the CAA contains the general
requirements for a SIP. Section 110(a)(2) provides that the
implementation plan submitted by a state must have been adopted by the
state after reasonable public notice and hearing, and, among other
things, must: (1) Include enforceable emission limitations and other
control measures, means or techniques necessary to meet the
requirements of the CAA; (2) provide for establishment and operation of
appropriate devices, methods, systems, and procedures necessary to
monitor ambient air quality; (3) provide for implementation of a source
permit program to regulate the modification and construction of any
stationary source within the areas covered by the plan; (4) include
provisions for the implementation of part C, Prevention of Significant
Deterioration (PSD) and part D, New Source Review (NSR) permit
programs; (5) include criteria for stationary source emission control
measures, monitoring, and reporting; (6) include provisions for air
quality modeling; and (7) provide for public and local agency
participation in planning and emission control rule development.
Section 110(a)(2)(D) of the CAA requires that SIPs contain measures to
prevent sources in a state from significantly contributing to air
quality problems in another state.
    EPA interprets the ``applicable'' requirements for an area's
redesignation to be those requirements linked with a particular area's
nonattainment designation. Therefore, EPA believes that the section 110
elements described above that are not connected with nonattainment plan
submissions and not linked with an area's attainment status, such as
the ``infrastructure SIP'' elements of section 110(a)(2), are not
applicable requirements for purposes of redesignation. A state remains
subject to these requirements after an area is redesignated to
attainment, and thus EPA does not interpret such requirements to be
relevant applicable requirements to evaluate in a redesignation. For
example, the requirement to submit state plans addressing interstate
transport obligations under section 110(a)(2)(D)(i)(I) continue to
apply to a state regardless of the designation of any one particular
area in the state, and thus are not applicable requirements to be
evaluated in the redesignation context.
    EPA has applied this interpretation consistently in many
redesignations over a period of decades. See e.g., 81 FR 44210 (July 7,
2016) (final redesignation for the Sullivan County, Tennessee area); 79
FR 43655 (July 28, 2014) (final redesignation for Bellefontaine, Ohio
lead nonattainment area); 61 FR 53174-53176 (October 10, 1996) and 62
FR 24826 (May 7, 1997) (proposed and final redesignation for Reading,
Pennsylvania ozone nonattainment area); 61 FR 20458 (May 7, 1996)
(final redesignation for Cleveland-Akron-Lorain, Ohio ozone
nonattainment area); and 60 FR 62748 (December 7, 1995) (final
redesignation of Tampa, Florida ozone nonattainment area). See also 65
FR 37879, 37890 (June 19, 2000) (discussing this issue in final
redesignation of Cincinnati, Ohio 1-hour ozone nonattainment area); 66
FR 50399 (October 19, 2001) (final redesignation of Pittsburgh,
Pennsylvania 1-hour ozone nonattainment area).
    EPA has reviewed the Ohio SIP and has determined that it meets the
general SIP requirements under section 110 of the CAA to the extent the
requirements are applicable for purposes of redesignation. EPA has
previously approved provisions of Ohio's SIP addressing section 110
requirements, including provisions addressing lead, at 40 CFR 52.1870.
    On October 12, 2011, and supplemented on June 7, 2013, Ohio
submitted its infrastructure SIP elements for the 2008 lead NAAQS as
required by CAA section 110(a)(2). EPA approved Ohio's infrastructure
SIP requirements for the 2008 lead NAAQS on October 6, 2014. 79 FR
60075. The requirements of section 110(a)(2) are statewide requirements
that are not linked to the lead nonattainment status of the Fulton
County area or Ohio's redesignation request.
ii. Part D Requirements
    EPA has determined that upon approval of the base year emissions
inventories and RACM provisions discussed in this rulemaking, the Ohio
SIP will meet the applicable SIP requirements for the Fulton County
area applicable for purposes of redesignation under part D of the CAA.
Subpart 1 of part D sets forth the basic nonattainment requirements
applicable to all nonattainment areas.
(1) Section 172 Requirements
    Section 172(c) sets out general nonattainment plan requirements. A
thorough discussion of these requirements can be found in the General
Preamble for Implementation of Title I (57 FR 13498, April 16, 1992)
(``General Preamble''). EPA's longstanding interpretation of the
nonattainment planning requirements of section 172 is that once an area
is attaining the NAAQS, those requirements are not ``applicable'' for
purposes of CAA section 107(d)(3)(E)(ii) and therefore need not be
approved into the SIP before EPA can redesignate the area. In the
General Preamble, EPA set forth its interpretation of applicable

requirements for purposes of evaluating redesignation requests when an
area is attaining a standard. 57 FR 13564. EPA noted that the
requirements for reasonable further progress (RFP) and other measures
designed to provide for an area's attainment do not apply in evaluating
redesignation requests because those nonattainment planning
requirements ``have no meaning'' for an area that has already attained
the standard. Id. This interpretation was also set forth in the
September 4, 1992, Processing Requests to Redesignate Areas to
Attainment: Policy Memorandum (Calcagni Memorandum).
    EPA's understanding of section 172 also forms the basis of its
Clean Data Policy. Under the Clean Data Policy, EPA promulgates a
determination of attainment, published in the Federal Register and
subject to notice-and-comment rulemaking, and this determination
formally suspends a state's obligation to submit most of the attainment
planning requirements that would otherwise apply, including an
attainment demonstration and planning SIPs to provide for RFP, RACM,
and contingency measures under section 172(c)(9). The Clean Data Policy
has been codified in regulations regarding the implementation of the
ozone and fine particulate matter NAAQS. 70 FR 71612 (November 29,
2005) and 72 FR 20586 (April 25, 2007). The Clean Data Policy has also
been specifically applied in a number of lead nonattainment areas where
EPA has determined that the area is attaining the lead NAAQS. 79 FR
46212 (August 7, 2014) (proposed determination of attainment of Lyons,
Pennsylvania lead nonattainment area); 80 FR 51127 (determination of
attainment of Eagan, Minnesota lead nonattainment area). EPA finalized
a Clean Data Determination under this policy for the Fulton County lead
nonattainment area on May 26, 2015. 80 FR 29964.
    EPA's long-standing interpretation regarding the applicability of
section 172(c) attainment planning requirements for an area that is
attaining a NAAQS applies in this redesignation of the Fulton County
lead nonattainment area as well, except for the applicability of the
requirement to implement all reasonably available control measures
under section 172(c)(1). On July 14, 2015, the United States Court of
Appeals for the Sixth Circuit (6th Circuit) ruled that to meet the
requirement of section 107(d)(3)(E)(ii), states are required to submit
plans addressing RACM/RACT under section 172(c)(1) and EPA is required
to approve those plans prior to redesignating the area, regardless of
whether the area is attaining the standard. Sierra Club v. EPA, 793
F.3d 656 (6th Cir. 2015). As Ohio is within the jurisdiction of the 6th
Circuit, EPA is acting in accordance with the Sierra Club decision by
approving RACM provisions in parallel with this redesignation
action.\1\
---------------------------------------------------------------------------

    \1\ Although the approach being implemented here is inconsistent
with the Agency's longstanding national policy, such deviation is
required in order to act in accordance with an applicable Circuit
Court decision. Consistent with 40 CFR 56.5(b), the Region does not
need to seek concurrence from EPA Headquarters for such deviation in
these circumstances. 81 FR 51102 (August 3, 2016).
---------------------------------------------------------------------------

    Section 172(c)(1) requires the plans for all nonattainment areas to
provide for the implementation of all RACM as expeditiously as
practicable and to provide for attainment of the primary NAAQS. Under
this requirement, a state must consider all available control measures,
including reductions that area available from adopting RACT on existing
sources, for a nonattainment area and adopt and implement such measures
as are reasonably available in the area as components of the area's
attainment demonstration. EPA is today approving Ohio's RACM
submission. Therefore, Ohio has met its requirements under CAA sections
172(c)(1) and 107(d)(3)(E)(v).
    The remaining section 172(c) ``attainment planning'' requirements
are not applicable for purposes of evaluating Ohio's redesignation
request. Specifically, the RFP requirement under section 172(c)(2),
which is defined as progress that must be made toward attainment, the
requirement to submit section 172(c)(9) contingency measures, which are
measures to be taken if the area fails to make reasonable further
progress to attainment, and the section 172(c)(6) requirement that the
SIP contain control measures necessary to provide for attainment of the
standard, are not applicable requirements that Ohio must meet here
because the Fulton County area has monitored attainment of the 2008
lead NAAQS. As noted, EPA issued a determination of attainment (or
clean data determination) for the Fulton County area in May 2015, which
formally suspended the obligation to submit any of the attainment
planning SIPs. 80 FR 29964 (May 26, 2015).
    Section 172(c)(3) requires submission and approval of a
comprehensive, accurate, and current inventory of actual emissions.
Ohio submitted 2008 and 2013 emission inventories with its
redesignation request. The 2013 inventory can be used as the most
accurate and current inventory. As discussed in section III.B., EPA is
approving the 2013 base year inventory as meeting the section 172(c)(3)
emissions inventory requirement for the Fulton County area.
    Section 172(c)(4) requires the identification and quantification of
allowable emissions for major new and modified stationary sources in an
area, and section 172(c)(5) requires source permits for the
construction and operation of new and modified major stationary sources
anywhere in the nonattainment area. EPA approved Ohio's current NSR
program January 10, 2003. 68 FR 1366. In addition, the state's
maintenance plan does not rely on nonattainment NSR, therefore having a
fully approved NSR program is not an applicable requirement, but,
nonetheless, EPA has approved the state's program.\2\
---------------------------------------------------------------------------

    \2\ A detailed rationale for this view is described in a
memorandum from Mary Nichols, Assistant Administrator for Air and
Radiation, dated October 14, 1994, entitled, ``Part D New Source
Review Requirements for Areas Requesting Redesignation to
Attainment.''
---------------------------------------------------------------------------

    Section 172(c)(6) requires the SIP to contain control measures
necessary to provide for attainment of the standard. No additional
measures are needed to provide for attainment because attainment has
been reached.
    Section 172(c)(7) requires the SIP to meet the applicable
provisions of section 110(a)(2). EPA has determined that the Ohio SIP
meets the section 110(a)(2) applicable requirements for purposes of
redesignation.
(2) Section 176 Conformity Requirements
    CAA section 176(c) requires states to establish criteria and
procedures to ensure that Federally-supported or funded activities,
including highway and transit projects, conform to the air quality
planning goals in the applicable SIPs. The requirement to determine
conformity applies to transportation plans, programs and projects
developed, funded or approved under title 23 of the U.S. Code and the
Federal Transit Act (transportation conformity) as well as to all other
Federally-supported or funded projects (general conformity).
Considering the elimination of lead additives in gasoline,
transportation conformity does not apply to the lead NAAQS. 73 FR
66964, 67043 n.120. EPA approved Ohio's general conformity SIP on March
11, 1996. 61 FR 9646.
b. Ohio Has a Fully Approved Applicable SIP Under Section 110(k) of the
CAA
    Upon final approval of Ohio's comprehensive 2013 emissions
inventories and approval of RACM for

the Fulton County lead area, EPA will have fully approved the Ohio SIP
for the Fulton County area under section 110(k) of the CAA for all
requirements applicable for purposes of redesignation, in accordance
with section 107(d)(3)(E)(ii). EPA may rely on prior SIP approvals in
approving a redesignation request (See page 3 of the September 4, 1992,
Processing Requests to Redesignate Areas to Attainment: Policy
Memorandum (Calcagni memorandum)); Southwestern Pennsylvania Growth
Alliance v. Browner, 144 F.3d 984, 989-990 (6th Cir. 1998); Wall v.
EPA, 265 F.3d 426 (6th Cir. 2001)). EPA also relies on measures
approved in conjunction with a redesignation action. See 68 FR 25413
(May 12, 2003) (approving I/M program for St. Louis) and 68 FR 25413,
25426 (May 12, 2003). Ohio has adopted and submitted, and EPA has fully
approved, required SIP provisions addressing the 2008 lead standards.
Of the CAA requirements applicable to this redesignation request only
two remain applicable, the emissions inventory requirement of section
172(c)(3) and the RACM requirement of section 172(c)(1).
    EPA is approving Ohio's 2013 emissions inventories for the Fulton
County area as meeting the requirement of section 172(c)(3) of the CAA,
and approving RACM provisions meeting the requirement of 172(c)(1). No
SIP provisions are currently disapproved, conditionally approved, or
partially approved in the Fulton County area under section 110(k) in
accordance with section 107(d)(3)(E)(ii).
3. The Improvement in Air Quality Is Due to Permanent and Enforceable
Reductions in Emissions Resulting From Implementation of the SIPs and
Applicable Federal Air Pollution Control Regulations and Other
Permanent and Enforceable Reductions (Section 107(d)(3)(E)(iii))
    To support the revision of an area's designation from nonattainment
to attainment, CAA section 107(d)(3)(E)(iii) requires EPA to determine
that the air quality improvement in the area is due to permanent and
enforceable reductions in emissions. Permanent and enforceable emission
reductions result from the implementation of the SIP and applicable
Federal air pollution control regulations and other permanent and
enforceable emission reductions.
    Bunting is the lone source of lead emissions in the Fulton County
nonattainment area. Ohio implemented a preventative maintenance plan
(PMP) for Bunting. The PMP specifies the required inspections to be
performed, requires continuous operation of a fabric filter bag leak
detection system, and specifies the correct actions Bunting is to take
following an inspection suggesting a leak or an alarm of the leak
detection system. The PMP was implemented to correct control equipment
malfunctions and poor housekeeping that caused additional lead
emissions from the Bunting facility. Ohio incorporated the PMP
requirements into the Air Pollution Permits-to-install and operate
P0121822, P0120836, and P0121942 issued to Bunting on February 28,
2017. Those permits are permanent and Federally enforceable.
4. Ohio Has a Fully Approved Maintenance Plan Pursuant to Section 175A
of the CAA (Section 107(d)(3)(E)(iv))
    In conjunction with its request to redesignate the Fulton County
nonattainment area to attainment, Ohio requested a SIP revision to
provide for maintenance of the 2008 lead NAAQS in the area through
2030.
a. What is required in a maintenance plan?
    The required elements of a maintenance plan for areas seeking
redesignation from nonattainment to attainment are contained in section
175A of the CAA. Section 175A requires a state seeking redesignation to
attainment to submit a SIP revision to provide for the maintenance of
the NAAQS in the area ``for at least 10 years after the
redesignation''. EPA has interpreted this as a showing of maintenance
``for a period of ten years following redesignation''. Calcagni
memorandum at 9. Eight years after redesignation, the state must submit
a revised maintenance plan which demonstrates that attainment will
continue to be maintained for the subsequent 10 years.
    To address the possibility of future NAAQS violations, the
maintenance plan must contain contingency measures with a schedule for
implementation as EPA deems necessary to assure prompt correction of
any future lead violations.
    The Calcagni memorandum provides additional guidance on the content
of a maintenance plan. The memorandum states that a maintenance plan
should address the following items: The attainment emissions inventory,
a maintenance demonstration showing maintenance for the 10 years of the
maintenance period, a commitment to maintain the existing monitoring
network, factors and procedures to be used for verification of
continued attainment of the NAAQS, and a contingency plan to prevent or
correct future violations of the NAAQS.
    Ohio's maintenance plan shows that the Fulton County area's
emissions will remain below the attainment year levels through 2030.
b. Attainment Inventory
    Ohio provided lead emissions inventories for the nonattainment year
(2008), the attainment year (2013), an interim year (2021), and a
future year (2030). The lead emissions in tons per year (TPY) for
Fulton County, Ohio are listed in Table 1.

               Table 1--Fulton County, Ohio Lead Emissions
------------------------------------------------------------------------

------------------------------------------------------------------------
2008.............  0.0050 TPY................  nonattainment year.
2013.............  0.0035 TPY................  attainment year.
2021.............  0.00315 TPY...............  future year (interim).
2030.............  0.00284 TPY...............  future year
                                                (maintenance).
------------------------------------------------------------------------

c. Demonstration of Maintenance
    Ohio included a section 175(A) maintenance plan in its submission.
In the plan, Ohio has provided both an emissions inventory and air
dispersion modeling of the emission limits resulting from the PMP to
demonstrate that the area is expected to maintain the standard into the
future. Where the emissions inventory method of showing maintenance is
used, its purpose is to show that emissions during the maintenance
period will not increase over the attainment year inventory. Calcagni
memorandum at 9-10. A maintenance demonstration need not be based on
modeling. See Wall v. EPA, 265 F.3d 426 (6th Cir. 2001), Sierra Club v.
EPA, 375 F. 3d 537 (7th Cir. 2004). See also 66 FR 53094, 53099-53100
(October 19, 2001), 68 FR 25413, 25430-25432 (May 12, 2003).
    The plan demonstrates maintenance of the 2008 lead standard through
2030 by showing that current and future emissions of lead in the area
remain at or below attainment year emission levels. In addition, the
area can show modeled attainment of the NAAQS. The emissions inventory
comparison showing the decline in emissions between 2013 and 2030
indicates maintenance. The modeling Ohio conducted also supports the
conclusion that the Fulton County area will maintain attainment into
the future.
    A summary of the air dispersion modeling for Bunting was included
in Ohio's submission. The modeling evaluated the PMP measures including
the emission limits from Air Pollution Permits-to-install and operate
P0108083, P0121822, P0120836, and P0121942. Ohio used the American
Meteorology

Society/Environmental Protection Agency Regulatory Model, known as
AERMOD. That analysis yielded a maximum impact of 0.12 [micro]g/m\3\,
which is below the 2008 lead NAAQS of 0.15 [micro]g/m\3\. This modeling
analysis is valid for the Fulton County redesignation because the
Bunting control measures are responsible for the emission reductions
that brought the area into attainment.
    Ohio's maintenance plan submission shows that the Fulton County
area's lead emissions will remain below the attainment year inventories
through 2030. See Table 1. The reductions in lead emissions in the
Fulton County area result from the permanent and enforceable control
measures for Bunting, the lone lead source in the area. Monitoring data
show that the Fulton County area ambient lead concentrations have
remained below the NAAQS since the PMP was applied to Bunting. Because
of the control measures implemented, it is reasonable to expect the
emissions to remain at a level that meets the standard. Thus, it is
reasonable to expect the Fulton County area will continue to attain the
2008 lead NAAQS through 2030. EPA has determined that Ohio's submission
demonstrates that the area will continue to maintain the 2008 lead
NAAQS at least through 2030. In addition, the air dispersion modeling
indicates that with the permitted emission limitation implemented the
Fulton County area ambient lead concentration will be below the 2008
lead NAAQS. Based on the showing, in accordance with section 175A, that
the Ohio's maintenance plan provides for maintenance for at least 10
years after redesignation, EPA is approving the redesignation request
and maintenance plans.
d. Monitoring Network
    Ohio has committed to monitor ambient lead levels in the Fulton
County area during the maintenance period to confirm continued
maintenance of the 2008 lead NAAQS, and to continue to operate an
adequate monitoring network. EPA has determined that the Fulton County,
Ohio area lead monitoring network is adequate to confirm maintenance.
e. Verification of Continued Attainment
    Ohio will also continue to enter its air monitoring data into the
Air Quality System in accordance with Federal guidelines. It will also
submit periodic emissions inventories to EPA as required by the Federal
Consolidated Emissions Reporting Rule. 67 FR 39602, June 10, 2002. Both
actions will help to verify continued attainment of the NAAQS in
accordance with 40 CFR part 58.
f. Contingency Plan
    The contingency plan provisions are designed to promptly correct or
prevent a violation of the NAAQS that might occur after redesignation
of an area to attainment. CAA section 175A requires that the
maintenance plan include such contingency measures. The maintenance
plan should identify the contingency measures to be adopted, a schedule
and procedure for adoption and implementation of the contingency
measures, and a time limit for action by the state. The state should
also identify specific indicators to be used to determine when the
contingency measures need to be adopted and implemented. The
maintenance plan must include a requirement that the state will
implement all pollution control measures that were contained in the SIP
before redesignation of the area to attainment. Section 175A(d) of the
CAA.
    Ohio's contingency plan defines a warning level and action level
response. The warning level response will trigger when a lead monitor
three-month rolling average exceeds 0.135 [micro]g/m\3\ in the
maintenance area. If a warning level response is triggered, Ohio will
conduct a study to determine whether the lead values indicate a trend
toward exceeding the standard and what control measure would be
necessary to reverse the trend within 12 months of the conclusion of
the calendar year. The action level response will be prompted by the
determination of the warning level study that a reverse of the trend is
needed, or by the three-month rolling average exceeding 0.143 [micro]g/
m\3\. The action level response will require Ohio to work with the
entity found to be responsible for the ambient concentration to
evaluate and implement the needed control measures to bring the area
into attainment within 18 months of the conclusion of the calendar year
that triggered the response.
    Should the 2008 lead NAAQS be violated during the maintenance
period, Ohio will implement one or more contingency measures. The
contingency measures will be considered based on the cause of the
elevated lead levels. Potential measures include improvements to
existing control devices, the addition of a secondary control device,
and improvements to housekeeping and maintenance.
    EPA has determined that Ohio's maintenance plan adequately
addresses the five basic components of a maintenance plan: Attainment
inventory, maintenance demonstration, monitoring network, verification
of continued attainment, and a contingency plan.
    As required by section 175A(b) of the CAA, Ohio commits to submit
to the EPA an updated lead maintenance plan eight years after
redesignation of the Fulton County area to cover an additional ten-year
period beyond the initial ten-year maintenance period.
    For the reasons set forth above, EPA is approving Ohio's 2008 lead
maintenance plan for the Fulton County area as meeting the requirements
of CAA section 175A.

B. Comprehensive Emissions Inventory

    Section 172(c)(3) of the CAA requires areas to submit a
comprehensive, accurate, and current emissions inventory. Ohio provided
such an inventory in its submission.
    Ohio identified Bunting as the lone source of lead emissions in the
Fulton County nonattainment area. Thus, the emissions from Bunting
represent the emissions of the Fulton County area. In 2013, the lead
emissions were 0.0035 TPY. See Table 1.
    EPA approves the lead emissions inventories submitted by Ohio in
April 2017 as fully meeting the comprehensive inventory requirement of
section 172(c)(3) of the CAA for the Fulton County area for the 2008
lead NAAQS.

C. RACM Requirements

    Based on the 6th Circuit decision discussed above, EPA requires
areas in the jurisdiction of the 6th Circuit to have approved RACM/RACT
provisions in order to be redesignated. Ohio performed a RACM analysis
for Bunting. EPA is approving the existing controls and maintenance
provisions for Bunting as fulfilling this requirement. Bunting has
combined limits in Federally enforceable permits for the units
controlled by each of its three baghouses. Baghouse A has a combined
limit of 0.150 pound lead per hour (lb/hr) for the exhaust of units
P006 to P011, P013, P020 to P025, P029 to P032, P035, and P036.
Baghouse B has a combined limit of 0.150 lb/hr for units P014 to P019
and P028. Baghouse C has a combined limit of 0.075 lb/hr for unit P005.
The current controls and PMP have brought the area into attainment and
constitute RACM, which meets the requirement of CAA section 172(c)(1).

V. What action is EPA taking?

    EPA has determined that the Fulton County area is attaining the
2008 lead NAAQS and that the area has met the requirements for
redesignation under

section 107(d)(3)(E) of the CAA. EPA is thus approving the request from
Ohio to change the legal designation of the Fulton County area from
nonattainment to attainment for the 2008 lead standard. EPA is
approving Ohio's maintenance plan for the Fulton County area as a
revision to the Ohio SIP because we have determined that the plan meets
the requirements of section 175A of the CAA. EPA is approving the
emission controls in Air Pollution Permits-to-install and operate
P0108083, P0121822, P0120836, and P0121942 as meeting the RACM/RACT
requirements of CAA section 172(c)(1). EPA is approving the 2013
emissions inventory as meeting the comprehensive emissions inventory
requirements of section 172(c)(3) of the CAA. EPA is taking these
actions in accordance with the CAA and EPA's implementation regulations
regarding the 2008 lead NAAQS.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan if relevant adverse
written comments are filed. This rule will be effective December 18,
2017 without further notice unless we receive relevant adverse written
comments by November 17, 2017. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. Public
comments will then be addressed in a subsequent final rule based on the
proposed action. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. If we do
not receive any comments, this action will be effective December 18,
2017.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation
land or in any other area where EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
rule does not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).
    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 Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by December 18, 2017. 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. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the proposed
rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, Reporting and
recordkeeping requirements.

40 CFR Part 81

    Environmental protection, Administrative practice and procedure,
Air pollution control, Designations and classifications,
Intergovernmental relations, Lead, Reporting and recordkeeping
requirements.

    Dated: September 28, 2017.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.

    40 CFR parts 52 and 81 are amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

0
2. In Sec.  52.1870 the table in paragraph (e) is amended by adding a
new entry for ``Lead (2008)'' under sub-heading ``Summary of Criteria
Pollutant Maintenance Plan'' to read as follows:

Sec.  52.1870  Identification of plan.

* * * * *
    (e) * * *

                         EPA-Approved Ohio Nonregulatory and Quasi-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                Applicable
          Title            geographical or non-    State date        EPA approval               Comments
                              attainment area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Lead (2008)..............  Delta (partial             4/27/2017  10/18/2017, [insert   Includes approval of the
                            Fulton County).                       Federal Register      2013 lead base year
                                                                  citation].            emissions inventory and
                                                                                Preventative Maintenance
                                                                                Plan as RACM for the
                                                                                Bunting Bearing LLC
                                                                                Delta facility.

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

0
3. Section 52.1893 is amended by adding new paragraphs (f), (g) and (h)
to read as follows:

Sec.  52.1893  Control strategy: Lead (Pb).

* * * * *
    (f) Ohio's 2013 lead emissions inventory for the Fulton County
area, submitted on April 27, 2017, to meet the emission inventory
requirements of section 172(c)(3) of the Clean Air Act for the Fulton
County area.
    (g) Approval--The 2008 lead maintenance plan for the Fulton County,
Ohio nonattainment area, submitted on April 27, 2017.
    (h) Existing controls and maintenance provisions in the Air
Pollution Permits-to-install and operate P0108083, P0121822, P0120836,
and P0121942 for the Bunting Bearing LLC Delta facility including the
preventative maintenance plan as fulfilling the RACM/RACT 172(c)(1)
requirement. Permits P0120836, P0121822, and P0121942, all issued
February 28, 2017, require a combined limit of 0.150 pounds lead per
hour for the exhaust of units P006 to P011, P013, P020 to P025, P029 to
P032, P035, and P036. Permit P0108083, issued October 29, 2012,
requires a combined limit of 0.150 pounds lead per hour for units P014
to P019 and P028 and a combined limit of 0.075 lb/hr for unit P005.

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
4. The authority citation for part 81 continues to read as follows:

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

0
5. Section 81.336 is amended by revising the entry for Delta, OH in the
table entitled ``Ohio--2008 Lead NAAQS'' to read as follows:

Sec.  81.336  Ohio.

* * * * *

                          Ohio--2008 Lead NAAQS
------------------------------------------------------------------------
                                    Designation for the 2008 NAAQS \a\
        Designated area         ----------------------------------------
                                    Date \1\               Type
------------------------------------------------------------------------

                              * * * * * * *
Delta, OH:
    Fulton County (part).......      10/18/2017  Attainment.
        The portions of Fulton
         County that are
         bounded by: sections
         12 and 13 of York
         Township and sections
         7 and 18 of Swan Creek
         Township.

                              * * * * * * *
------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as
  otherwise specified.
\1\ December 31, 2011, unless otherwise noted.

[FR Doc. 2017-22495 Filed 10-17-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Notices]
[Page 64976]
[FR Doc No: 2012-26184]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC13-17-000.
    Applicants: Midland Cogeneration Venture Limited Partnership,
Sparta Acquisition Corporation.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act and Request for Waivers, Confidential Treatment,
Expedited Action and Shortened Comment Period of Midland Cogeneration
Venture LP and Sparta Acquisition Corporation.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5144.
    Comments Due: 5 p.m. ET 11/6/12.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER12-678-003.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: VLR Compliance Amendment to be effective 9/1/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5117.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-101-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: ATCLLC Amendment to OATT Order 1000 Compliance to be
effective 10/11/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5116.
    Comments Due: 5 p.m. ET 11/9/12.

    Docket Numbers: ER13-142-000.
    Applicants: Georgia-Pacific Consumer Products LP.
    Description: Georgia-Pacific Entities to be effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5104.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-143-000.
    Applicants: Georgia-Pacific LLC, Crossett.
    Description: Georgia-Pacific Entities to be effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5106.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-144-000.
    Applicants: Georgia-Pacific Monticello LLC.
    Description: Georgia-Pacific Entities to be effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5108.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-145-000.
    Applicants: Leaf River Cellulose, LLC.
    Description: Georgia-Pacific Entities to be effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5109.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-146-000.
    Applicants: Georgia-Pacific Toledo LLC.
    Description: Georgia-Pacific Entities to be effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5110.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-147-000
    Applicants: Georgia-Pacific Consumer Products LP.
    Description: Georgia-Pacific Entities to be effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5111.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-148-000.
    Applicants: Georgia-Pacific Consumer Products LP.
    Description: Georgia-Pacific Entities to be effective 10/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5112.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-149-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: OATT & OA re IMM Process Improvements to be effective
12/17/2012.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5120.
    Comments Due: 5 p.m. ET 11/6/12.

    Docket Numbers: ER13-150-000.
    Applicants: Northern Indiana Public Service Company, Midwest
Independent Transmission System Operator, Inc.
    Description: 10-16-12 NIPSCO Attachment O and GG to be effective 1/
1/2013.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5121.
    Comments Due: 5 p.m. ET 11/6/12.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF13-41-000.
    Applicants: Recovered Energy Investors I, LLC.
    Description: Form 556--Notice of Self-Certification for Qualifying
Cogeneration Facility Status of Recovered Energy Investors I, LLC.
    Filed Date: 10/16/12.
    Accession Number: 20121016-5060.
    Comments Due: None Applicable.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR Sec.  385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
may be considered, but intervention is necessary to become a party to
the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 17, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-26184 Filed 10-23-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Proposed Rules]
[Pages 70918-70919]
[FR Doc No: 2023-22613]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2023-F-4332]

Kerry Ingredients and Flavours Ltd.; Filing of Food Additive
Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by Kerry Ingredients and
Flavours Ltd., proposing that the food additive regulations be amended
to provide for the safe use of vitamin D3 as a nutrient
supplement in powdered drink mixes added to water or carbonated water,
excluding drinks or drink mixes that are specially formulated or
processed for infants.

DATES: The food additive petition was filed on April 26, 2023.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this document into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lane A. Highbarger, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that
we have filed a food additive petition (FAP 2A4834), submitted on
behalf of Kerry Ingredients and Flavours Ltd. by Hogan Lovells US LLP,
Columbia Square, 555 13th Street NW, Washington, DC 20004. The petition
proposes to amend the food additive regulations in 21 CFR 172.380
``Vitamin D3,'' to provide for the safe use of vitamin
D3 as a nutrient supplement in powdered drink mixes added to
water or carbonated water at levels not to exceed 180 international
units per 360 milliliters (mL) as consumed, excluding drinks or drink
mixes that are specially formulated or processed for infants (Refs. 1
and 2). If calcium is added, calcium is present at levels greater than
or equal to 150 milligrams of calcium per 360 mL as consumed (Refs. 1
and 2).
    The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(k) because the substance is intended to
remain in food through ingestion by consumers and is not intended to
replace macronutrients in food. In addition, the petitioner has stated
that, to their knowledge, no extraordinary circumstances exist that
would warrant an environmental assessment (see 21 CFR 25.21). If FDA
determines a categorical exclusion applies, neither an environmental
assessment nor an environmental impact statement is required. If FDA
determines a categorical exclusion does not apply, we will request an
environmental assessment and make it available for public inspection.

References

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

1. Emails from M. Gradison, to L. Highbarger, March 8, 2023, and
March 30, 2023.
2. FDA Memorandum from L. Highbarger, Regulatory Review Branch,
March 30, 2023.

    Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22613 Filed 10-12-23; 8:45 am]
BILLING CODE 4164-01-P