[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
[Rules and Regulations]
[Pages 23273-23278]
[FR Doc No: 2014-09248]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2012-0581; A-1-FRL-9909-37-Region-10]

Approval and Promulgation of Air Quality Implementation Plans;
Idaho Amalgamated Sugar Company Nampa BART Alternative

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a
revised Best Available Retrofit Technology (BART) determination for The
Amalgamated Sugar Company, LLC (TASCO) facility, located in Nampa,
Idaho. On June 22, 2011, the EPA approved Idaho's regional haze state
implementation plan (SIP), including its BART determination for the
TASCO facility, as meeting the visibility protection requirements of
the Clean Air Act (CAA). On June 29, 2012, the State submitted a
regional haze SIP revision, including a new BART determination for the
TASCO facility that consisted of a stricter emission limit for oxides
of nitrogen (NOX), a stricter emission limit for particulate
matter (PM), and an alternative control measure (BART Alternative) to
replace the previously approved BART determination and emission limit
for sulfur dioxide (SO2). The EPA is fully approving this
SIP revision.

DATES: Effective Dates: This final rule is effective May 28, 2014.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R10-OAR-2010-0581. 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, e.g., Confidential Business
Information (CBI) 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 State
and Tribal Air Programs Unit, Office of Air Waste and Toxics, EPA
Region 10, 1200 Sixth Avenue, Seattle, WA 98101. EPA requests that if
at all possible, you contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section to view the hard copy of the docket. You
may view the hard copy of the docket Monday through Friday, 8:00 a.m.
to 4:00 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Steve Body, EPA Region 10, Suite 900,
Office of Air, Waste and Toxics, 1200 Sixth Avenue, Seattle, WA 98101.
The phone number is<PHONE_NUMBER> and email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The words or initials Act, CAA, or Clean Air Act mean or refer
to the Clean Air Act, unless the context indicates otherwise.
    (ii) The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
    (iii) The initials SIP mean or refer to State Implementation Plan.
    (iv) The words Idaho and State mean the State of Idaho.

Table of Contents

I. Background Information
II. Response to Comments
III. Final Action
IV. Statutory and Executive Orders Review

I. Background Information

    In the CAA Amendments of 1977, Congress established a program to
protect and improve visibility in the national parks and wilderness
areas. See CAA section 169A. Congress amended the visibility provisions
in the CAA in 1990 to focus attention on the problem of regional haze.
See CAA section 169B. The EPA promulgated regional haze regulations
(hereafter the ``RHR'') in 1999 to implement sections 169A and 169B of
the CAA. These regulations require states to develop and implement
regional haze SIPs to ensure reasonable progress toward improving
visibility in mandatory Class I Federal areas \1\ (Class

I areas). 64 FR 35714 (July 1, 1999); see also 70 FR 39104 (July 6,
2005) and 71 FR 60612 (October 13, 2006).
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    \1\ Areas designated as mandatory Class I Federal areas consist
of national parks exceeding 6000 acres, wilderness areas and
national memorial parks exceeding 5000 acres, and all international
parks that were in existence on August 7, 1977. 42 U.S.C. 7472(a).
In accordance with section 169A of the Clean Air Act, EPA, in
consultation with the Department of Interior, promulgated a list of
156 areas where visibility is identified as an important value. 44
FR 69122 (November 30, 1979). The extent of a mandatory Class I area
includes subsequent changes in boundaries, such as park expansions.
42 U.S.C. 7472(a). Although states and tribes may designate as Class
I additional areas which they consider to have visibility as an
important value, the requirements of the visibility program set
forth in section 169A of the Clean Air Act apply only to ``mandatory
Class I Federal areas.'' Each mandatory Class I Federal area is the
responsibility of a ``Federal Land Manager.'' 42 U.S.C. 7602(i).
When we use the term ``Class I area'' in this action, we mean a
``mandatory Class I Federal area.''
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    The RHR requires each state's regional haze SIP to contain emission
limitations representing BART and schedules for compliance with BART
for each source subject to BART, unless the state demonstrates that an
emissions trading program or other alternative will achieve greater
reasonable progress toward natural visibility conditions. A state may
opt to implement or require participation in an emission trading
program or other alternative measure rather than require sources
subject to BART to install, operate, and maintain BART.
    On April 16, 2007, Idaho submitted to the EPA for approval, new and
revised rules that provide the Idaho Department of Environmental
Quality (IDEQ) the regulatory authority to address regional haze and to
implement BART. The EPA approved these rules on June 9, 2011. 76 FR
33651. Idaho submitted to EPA a regional haze SIP to meet the
requirements of 40 CFR 51.308 on October 25, 2010 (2010 RH SIP). The
2010 RH SIP covered the planning period from 2008 through 2018 and,
among the other required elements, included a BART determination for
the TASCO facility.\2\ On June 22, 2011, the EPA approved the BART-
related provisions of Idaho's 2010 RH SIP, including the final BART
determination for the TASCO facility.\3\ 76 FR 36329. That approval
incorporated by reference the September 7, 2010 TASCO Tier II Operating
Permit No. T2-2009.0105 (2010 TASCO Tier II Operating Permit) that
contained the BART emission limits for the TASCO facility. On November
8, 2012, the EPA took final action to approve the remaining elements in
the 2010 RH SIP. 77 FR 66929. Thus, Idaho's 2010 RH SIP is fully
approved.
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    \2\ TASCO operates a sugar beet processing facility in Nampa,
Idaho that includes a fossil fuel-fired boiler which is referred to
as the ``Riley boiler.'' The Riley boiler is the only BART-eligible
unit at the TASCO facility, and it is subject to BART.
    \3\ Upon EPA's final action in 2011, TASCO filed a petition for
review in the Ninth Circuit Court of Appeals challenging EPA's
approval of Idaho's BART determination for their Nampa facility. See
Amalgamated Sugar v. EPA, No. 11-72445 (9th Cir.) The case is
pending before the Ninth Circuit.
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    On June 29, 2012, Idaho submitted revisions to the 2010 RH SIP that
address BART for the fossil fuel-fired Riley boiler at the TASCO
facility (2012 RH SIP). The 2012 RH SIP contains: A revised
NOX BART determination with a more stringent NOX
emission limit; a more stringent PM BART emission limit; and a BART
Alternative to replace the federally approved SO2 BART
determination. In addition to the more stringent NOX and PM
emission limits for the Riley boiler, the BART Alternative relies on
control of NOX emissions from two non-BART-eligible boilers
at the TASCO facility. The BART Alternative also takes into account
emission reductions resulting from the permanent shutdown of three
coal-fired pulp-dryers. The revised NOX BART determination
and emission limitation, more stringent PM emission limitation, and the
BART Alternative are contained in a revised Tier II Operating Permit,
T2-2009.0105, issued to TASCO on December 23, 2011 (2011 TASCO Tier II
Operating Permit). Idaho included the permit as part of the 2012 RH
SIP. On June 28, 2013, 78 FR 38872, EPA proposed to approve the revised
NOX BART determination and emission limitation, to approve
the revised PM BART emission limitation, to vacate the previously
approved SO2 BART determination, and to approve the BART
Alternative. Additional details regarding the revisions are explained
in the June 28, 2012 Federal Register notice and in Idaho's 2012 RH
SIP. As explained below, the BART Alternative and revised permit result
in greater reasonable progress toward natural visibility conditions
than the improvement expected from the previously approved BART
determination. Therefore, the EPA is taking final action to approve the
2012 RH SIP as proposed.

II. Response to Comments

    We received one comment letter, from the National Park Service, on
the proposed action. The comments can be summarized into three
elements: (1) Whether selective catalytic reduction (SCR) is
technically feasible; (2) whether the incremental cost of SCR was
properly considered; and (3) whether the emission reductions from the
permanent shutdown of three pulp dryers are surplus for purposes of the
BART Alternative.
    Comment: The commenter requests that the IDEQ and the EPA
reconsider the original BART determination for the Riley boiler and
evaluate the technical feasibility of selective catalytic reduction
(SCR) or in the alternative, provide additional justification for why
SCR was eliminated from consideration.
    The commenter asserts that SCR is technically feasible and
economically reasonable. In regards to the technical feasibility of
SCR, the commenter argues that tail-end SCR (reheating an exhaust gas
stream to proper temperature) has been in use around the world for
decades. The commenter states that neither Idaho nor the EPA made any
showing that tail-end SCR would not be technically feasible at TASCO.
Instead, the EPA relied upon Idaho's analysis, which concluded:
``[I]nstallation after the baghouse would not provide adequate exhaust
temperature for SCR to function properly. . . . Thus, the 2012 RH SIP
submittal finds that LNB is the only technically feasible
NOX control technology for the Riley Boiler.''
    The commenter concludes that if the only issue preventing
application of tail-end SCR at TASCO is temperature, then EPA should
investigate the cost of reheating the gas stream--which is typical for
tail-end SCR, turning the issue into one of economic feasibility.
Neither Idaho nor the EPA addressed how the cost of reheating the gas
stream impacts the economic feasibility of SCR.
    Response: EPA disagrees with the commenter that SCR is BART for the
Riley boiler. We do not think that it is necessary to evaluate Idaho's
conclusion that the installation of SCR to the Riley boiler is
technically infeasible in order to reach this conclusion. Assuming for
the sake of argument that SCR is technically feasible, Idaho adequately
demonstrated in its 2010 RH SIP that the high incremental cost-
effectiveness and low incremental visibility improvement associated
with SCR, when compared with low NOX burners with overfire
air (LNB/OFA), precluded SCR's selection as BART. Adjusting these
calculations to take into account the stricter NOX emission
limit in Idaho's 2012 RH SIP would increase the incremental cost and
reduce the incremental visibility improvement of SCR even further.
Finally, if Idaho or EPA were to investigate the additional cost of
reheating the gas stream, as the commenter suggests, the only possible
result would be a conclusion that SCR is less economically feasible.
    Comment: The commenter questions our reliance on the use of
incremental costs (for determining cost-effective controls), which the
commenter states are subject to manipulation by the

introduction of invalid control strategies that bias the analysis
against higher-performing control strategies. The commenter states that
in this case, when the LNB/OFA option is eliminated due to technical
infeasibility (as presented in the 2012 SIP), the incremental cost
between SCR and LNB shrinks to $7,327/ton which, in its view, is not a
significant enough incremental difference to justify rejecting SCR.
    The commenter also claims that the EPA and Idaho have placed undue
weight on incremental costs and states that because of the exponential
nature of pollution control costs versus removal efficiency,
incremental costs will always exceed average costs. The commenter
further asserts that the EPA has provided no guidance on what an
acceptable incremental cost might be, other than to say in the BART
Guidelines:

    The average cost (total annual cost/total annual emission
reductions) for each may be deemed to be reasonable. However, the
incremental cost (total annual cost A-B/total annual emission
reductions A-B) of the additional emission reductions to be achieved
by control B may be very great. In such an instance, it may be
inappropriate to choose control B, based on its high incremental
costs, even though its average cost may be considered reasonable.
(Emphasis added by commenter)

    The commenter provides examples from North Dakota and Oregon to
support its claim that in this case, the incremental cost of SCR over
LNB is $7327/ton (as calculated by the commenter), and this incremental
cost, in combination of an average cost-effectiveness of $3768/ton, is
reasonable.
    Response: The BART Guidelines suggest that states calculate and
consider incremental cost-effectiveness in combination with average
cost-effectiveness when considering whether to eliminate a control
option. 40 CFR part 51, Appendix Y, (IV)(D)(4)(e). However, as stated
previously, BART determinations are based on the consideration of five
factors, cost of compliance being only one of the five. The RHR
requires that compliance costs be weighed, among other factors, against
the visibility improvement achieved from each particular control
technology.
    Further, it appears that the commenter improperly calculated the
incremental cost-effectiveness of SCR over LNB. The commenter reports a
value of $7327/ton by using the original performance of LNB in the 2010
RH SIP, rather than the revised, more stringent NOX emission
limit in the 2012 RH SIP. The commenter's calculation appears to assume
a 50% control efficiency for LNB with an emission reduction of 521 ton/
yr from the base case of 1042 ton/yr. Using the revised emission limit
of 147 lb/hr, the emission reduction from LNB is 632 ton/yr, and
represents a control efficiency of 60%. When the incremental cost is
calculated based on SCR cost and emission reduction compared to the
original LNB costs and new LNB performance of 147 lb/hr, the
incremental cost-effectiveness of SCR over LNB is $9982/ton.
    The Oregon example provided in the comments, which states that,
``Oregon DEQ established a cost/ton threshold of $7300/ton based upon
the premise that improving visibility in multiple Class I areas
warrants a higher cost/ton than where only one Class I area is
affected.'' does not demonstrate Idaho inappropriately considered cost
of compliance. See footnote 1 of the comments. Additionally, as noted
below in the discussion of visibility improvement, use of SCR over the
proposed BART limit of 147 lb/hr would only provide for a 0.03 dv
improvement on the 22nd best day over three years at the Class I area
most impacted by TASCO. The commenter's examples do not demonstrate
that Idaho's decision regarding cost-effectiveness is unreasonable.
    Idaho determined that the cost effectiveness of SCR at $3768/ton is
a reasonable cost for the TASCO facility. However, Idaho calculated the
incremental cost of SCR over LNB/OFA at $10,245/ton and determined that
the cost for an additional 15% increase in removal efficiency is
relatively high. See 2010 RH SIP Chapter 10, Section 10.5.1. We also
note that the annualized cost for SCR, as used in Idaho's calculation,
does not take into account the added cost for design, installation and
operation of equipment that would be necessary to re-heat the exhaust
gases after the baghouse. Nor did this calculation account for
increased emissions from the exhaust gas re-heater. Thus, the
incremental cost-effectiveness value of SCR over LNB is likely to be
even greater.
    The EPA also considered the incremental cost along with the degree
of expected improvement in visibility from SCR and the visibility
improvement expected from the revised NOX BART
determination. In the 2012 RH SIP, Idaho provided a revised visibility
analysis and compared the visibility improvement expected to result
using the new, more stringent NOX emission limit for LNB to
the visibility improvement expected from SCR. Table 1 below shows the
emission reductions for LNB with the new emission limit and SCR at the
Class I area most impacted by the TASCO facility, the Eagle Cap
Wilderness Area. Table 1 also shows the visibility improvement over
base year conditions for each technology.

                Table 1--Comparison of New LNB Emission Limit With SCR Eagle Cap Wilderness Area
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                                                                                Days above
      Control Technology            Base       Emission    Controlled   Annualized   98th % 3 years  0.5 dv over
                                 emissions    reductions   emissions      costs                        3 years
----------------------------------------------------------------------------------------------------------------
Base Case.....................         1042            0         1042            0  1.4 dv.........       \3\ 97
New LNB BART..................         1042      \1\ 632      \1\ 410      479,841  0.64 \1\.......       \2\ 60
SCR...........................         1042      \4\ 938      \4\ 104    3,534,384  0.61 \4\.......       \4\ 40
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\1\ Values from TASCO BART Alternative Statement of Basis, TASCO Best Available Retrofit Technology
  Determinations Revised October 31, 2011,Tables 10 and 11.
\2\ From Modeling of new BART determination using 147 lb/hr for LNB (Table 4, `Statement of Basis', 2012 RH SIP)
\3\ Assumes pulp dryers shutdown; from 2010 SIP Submittal, Appendix F, TASCO BART Determination modeling.
\4\ 2010 SIP Submittal, Appendix F, TASCO BART Determination, Table 37, page F-312.

    Table 1 shows that the incremental visibility improvement of SCR
over the new LNB BART is 0.03 dv. An incremental cost of $9982/ton as
discussed previously and an incremental improvement of just 0.03 dv at
the most impacted Class I area clearly support SCR's elimination as
BART. These values are both outside the ranges that states and EPA have
found to be reasonable in other actions. The commenter has provided no
information to suggest that either of these values were calculated
incorrectly.

    Comment: The clear implication of EPA's advice in the BART
Guidelines is that incremental costs become a deciding factor only if
they greatly exceed average costs. For TASCO, the incremental cost is
less than double the average cost--this is well below the order of
magnitude presented in the BART Guidelines example, and is relatively
low when compared to other incremental cost analyses. If Idaho and EPA
are to use incremental costs to eliminate a control option, it should
be clear how those incremental costs are excessive when compared to
incremental costs that have been accepted elsewhere. EPA should also
explain what its threshold for an acceptable incremental cost is, and
how it arrived at that threshold.
    Response: There is no incremental cost threshold for BART that
applies in every case. As explained above, a BART decision is made
case-by-case, considering all five factors. In the TASCO facility case,
the State calculated the cost-effectiveness of SCR to be $3768/ton, and
we calculated the incremental cost-effectiveness of SCR over LNB (with
the new emission limit) to be greater than $9982/ton. We recognize that
standing alone the differential between average and incremental cost-
effectiveness may or may not justify rejecting the technology. However,
because a BART determination is based on consideration of a number of
factors, neither the incremental cost nor the average cost-
effectiveness value alone should determine BART. In this case, the
incremental visibility improvement is important. Considering the Eagle
Cap Wilderness Area, the Class I area most impacted by the Riley
boiler, NOX BART with an emission rate of 147 lbs/hr will
reduce the 98% day impact from 1.4 dv to 0.64 dv, while SCR with an
emission rate of 37 lb/hr would reduce it to 0.61 dv. See Idaho 2010 RH
SIP, Appendix F, TASCO Nampa BART Determination Table 34. While SCR may
result in an increased visibility improvement, the incremental
improvement between LNB and SCR is just 0.03 dv, too small to justify
the more stringent control technology's high incremental cost.
    Comment: The commenter says that taken at face value, it looks like
the proposal is for a greater NOX reduction in exchange for
a lesser SO2 reduction from the only BART source, the Riley
boiler. The commenter believes that the ``new information'' presented
by Idaho requires a re-analysis of tail-end SCR.
    Response: We do not understand how the above comment applies to the
proposed BART Alternative for the Riley boiler. The SO2 BART
Alternative consists of:
     Installing and operating LNB on the non-BART Babcock and
Wilcox (B&W) boilers 1 and 2 with a combined emission
limit of 103 lb/hr; and
     Permanently shutting down three pulp dryers.
    The BART Alternative does not involve NOX reductions
from the Riley boiler, so the technical feasibility of SCR is not
relevant to the BART Alternative.
    Comment: The commenter expressed concern that credit for emission
reductions achieved by the shutdown of the pulp driers may not be
``surplus'' and therefore not allowed under the RHR if these units were
shut-down as a result of another regulatory action under the CAA (i.e.,
compliance with the NAAQS for PM10). The comment notes that
the EPA refers to permitting actions which required shutdown of the
pulp dryers and requests clarification as to why such requirements were
necessary and asks that the EPA confirm that these reductions are truly
surplus in the RHR context.
    Response: We have confirmed that the emission reductions that will
result from the BART Alternative are surplus. The RHR requires that
emission reductions resulting from an alternative measure must be
``surplus to those reductions resulting from measures adopted to meet
requirements of the CAA as of the baseline date of the SIP.'' 40 CFR
51.308(e)(2)(iv). When promulgating this requirement in 1999, the EPA
explained that emission reductions must be ``surplus to the Federal
requirements as of the baseline date of the SIP, that is, the date of
the emissions inventories on which the SIP relies.'' See 64 FR 35714,
35742. See also 70 FR 39143 (explaining that ``[W]hatever the origin of
the emission reduction requirement, the relevant question for BART
purposes is whether the alternative program makes greater reasonable
progress.'') The Idaho RH SIP relies on emission inventories from 2002.
See Idaho 2010 SIP, Section 8.1. Thus, reductions resulting from any
measure adopted to meet requirements of the CAA after 2002 are
considered ``surplus'' under 40 CFR 51.308(e)(2)(iv). Therefore, the
emission reductions from the NOX control from B&W boilers
1 & 2 as proposed in the State's permit, along with
the shutdown requirements for the pulp dryers, are indeed surplus.

III. Final Action

    The EPA is vacating our previous approval of the State's
NOX and SO2 BART determinations and emission
limits for the TASCO facility and approving Idaho's 2012 RH SIP
submittal that includes a revised BART determination and emission limit
for NOX and a revised PM emission limit, vacates the
previously approved SO2 BART determination, and approves the
BART Alternative for SO2. Specifically we are approving the
2011 TASCO Tier II Operating Permit, T2-2009-0105, issued by Idaho on
December 23, 2011, conditions 1.2 (including the table of Regulated
Emission Point Sources), permit conditions 3.2, 3.3 (first paragraph
only), 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 3.11, 3.13, 3.14, 3.15, 3.16, and
4.1. The EPA is approving new BART emission limitations for
NOX and the revised emission limits for PM. The EPA is also
approving the BART Alternative at the TASCO facility because it
provides for greater overall reasonable progress.

IV. Statutory and Executive Orders Review

    Under the Clean Air Act, 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 Clean Air Act.
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 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, 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 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 June 27, 2014. 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, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Visibility, and Volatile organic compounds.

    Dated: March 20, 2014.
Daniel D. Opalski,
Acting Regional Administrator, Region 10.
    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

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

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

Subpart N--Idaho

0
2. Section 52.670 is amended as follows:
0
a. In paragraph (d) by removing the entry for ``The Amalgamated Sugar
Company LLC--Nampa Factory, Nampa, Idaho'' and adding in its place the
following entry for ``The Amalgamated Sugar Company LLC--Nampa Factory,
Nampa, Idaho.''
0
b. In paragraph (e) by adding one entry to the end of the table.
    The additions read as follows:

Sec.  52.670  Identification of plan.

* * * * *
    (d) * * *

                              EPA--Approved Idaho Source-Specific Requirements \1\
----------------------------------------------------------------------------------------------------------------
                                                       State effective
         Name of source               Permit No.             date          EPA approval date      Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
The Amalgamated Sugar Company          T2-2009.0105  12/23/11 (date       4/28/14 [Insert     The following
 LLC--Nampa Factory, Nampa,                           issued).             page number where   conditions; 1.2,
 Idaho.                                                                    the document        including the
                                                                           begins].            table of
                                                                                Regulated
                                                                                Emission Point
                                                                                Sources Table,
                                                                                3.2, 3.3 (first
                                                                                paragraph only),
                                                                                3.4, 3.5, 3.6,
                                                                                3.7, 3.8, 3.9,
                                                                                3.11, 3.13, 3.14,
                                                                                3.15, 3.16, and
                                                                                4.1

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ EPA does not have the authority to remove these source-specific requirements in the absence of a
  demonstration that their removal would not interfere with attainment or maintenance of the NAAQS, violate any
  prevention of significant deterioration increment or result in visibility impairment. Idaho Department of
  Environmental Quality may request removal by submitting such a demonstration to EPA as a SIP revision.

* * * * *
    (e) * * *

                    EPA-Approved Idaho Nonregulatory Provisions and Quasi-Regulatory Measures
----------------------------------------------------------------------------------------------------------------
                                        Applicable
      Name of SIP provision           geographic or          State       EPA approval date         Comments
                                    nonattainment area  submittal date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Regional Haze SIP Revision.......  State-wide.........         6/29/12  4/28/14 [Insert      The portion of the
                                                                         page number where    Regional Haze SIP
                                                                         the document         relating to BART
                                                                         begins].             for the TASCO,
                                                                                Nampa facility,
----------------------------------------------------------------------------------------------------------------

0
3. Section 52.672 is amended by adding paragraphs (g)(3) and (4) to
read as follows:

Sec.  52.672  Approval of plans.

* * * * *
    (g) * * *
    (3) The EPA is vacating its approval of Idaho's NOX and
SOX BART determination for the Riley boiler at The
Amalgamated Sugar Company, LLC Nampa facility, published June 22, 2011.
    (4) The EPA approves a Regional Haze SIP revision submitted by the
Idaho Department of Environmental Quality on June 29, 2012, as meeting
the requirements of Clean Air Act section 169A and 40 CFR 51.308(e)
regarding Best Available Retrofit Technology for The Amalgamated Sugar
Company LLC, facility located in Nampa, Idaho. The EPA is approving a
revised NOX BART determination and revised emission limit
for NOX, a revised emission limit for PM, and a
SO2 BART Alternative for The Amalgamated Sugar Company, LLC,
Nampa facility.

[FR Doc. 2014-09248 Filed 4-25-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 53 (Tuesday, March 21, 2017)]
[Notices]
[Pages 14597-14599]
[FR Doc No: 2017-05523]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0275]

Agency Information Collection Activities; Approval of a New
Information Collection Request: Commercial Driver's License (CDL)
Skills Testing Delays

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for review
and approval. This ICR is to collect data on the delays, by State, that
applicants face when scheduling a CDL skills test. This information
collection and subsequent data analysis is required by section 5506 of
the Fixing America's Surface Transportation Act, 2015 (FAST Act).

DATES: Please send your comments by April 20, 2017. OMB must receive
your comments by this date in order to act quickly on the ICR.

ADDRESSES: All comments should reference Federal Docket Management
System (FDMS) Docket Number FMCSA-2016-0275. Interested persons are
invited to submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the attention
of the Desk Officer, Department of Transportation/Federal Motor Carrier
Safety Administration, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Nicole Michel, Office of Analysis,
Research, and Technology/Research Division, Department of
Transportation, Federal Motor Carrier Safety Administration, 6th Floor,
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
Telephone:<PHONE_NUMBER>; Email Address<EMAIL_ADDRESS>Office
hours are from 9 a.m. to 5 p.m., Monday through Friday, except Federal
Holidays.

SUPPLEMENTARY INFORMATION:
    Title: Survey on CDL Skills Test Delays.
    OMB Control Number: 2126-00XX.
    Type of Request: New information collection.
    Respondents: Annual survey: State CDL Coordinators; Optional
quarterly report of delay time at each test site: State CDL
Coordinators and State CDL test location staff.
    Estimated Number of Respondents: Annual survey: 51 State CDL
Coordinators, one from each of the 50 States, and one from Washington,
DC. Optional quarterly report of delay time at each test site: 1,230
(51 State CDL Coordinators and 1,179 State CDL testing location
representatives).
    Estimated Time per Response: Annual survey: 2.3 hours (120 minutes
to gather data + 17.5 minutes to respond to survey). Optional quarterly
report of delay time at each test site: 30 minutes for State CDL
Coordinator to gather information and 1 minute for State CDL test
location representative to report current delay time at test site.
    Expiration Date: N/A. This is a new information collection.
    Frequency of Response: Annually; In addition, respondents have the
option to report delay time at test sites on a quarterly basis.
    Estimated Total Annual Burden: Annual survey: 116.9 hours (2.3
hours x 51 respondents = 116.9 hours). Optional quarterly report of
delay time at each test site: 180.6 hours [4 quarters x (30 minutes x
51 State CDL Coordinators + 1 minute x 1179 State CDL test location
representatives) = 180.6 hours] .

Background

    Section 5506 of the FAST Act (Pub. L. 114-94, Dec. 4, 2015, 49
U.S.C. 31305 note) requires FMCSA to produce a study on CDL skills test
delays on an annual basis. The requirements of the study are to submit
a report describing:
    ``(A) the average wait time from the date an applicant requests to
take a skills test to the date the applicant has the opportunity to
complete such test;
    (B) the average wait time from the date an applicant, upon failure
of a skills test, requests a retest to the date the applicant has the
opportunity to complete such retest;
    (C) the actual number of qualified commercial driver's license
examiners available to test applicants; and
    (D) the number of testing sites available through the State
department of motor vehicles and whether this number has increased or
decreased from the previous year.''
    The report is also required to describe ``specific steps the
Administrator is

taking to address skills testing delays in States that have average
skills test or retest wait times of more than 7 days.'' If this
information collection does not occur, FMCSA will not be able to
fulfill its mandate as directed by the FAST Act, noted above, by
conducting a study on CDL skills test delays, as there is currently no
repository of information on skills tests and the required data is not
available for all States at this time. If information collection occurs
on a less-than-annual basis, beyond negating its statutory duties, as
discussed above, FMCSA will not be able to make observations on yearly
trends or analyze differences in each State on a year-to-year basis.
    FMCSA has met with several stakeholders, including the American
Association of Motor Vehicle Administrators (AAMVA), the Commercial
Vehicle Training Association, and State Driver Licensing Agencies to
ensure that the information being collected in this survey has not
already been collected, is not currently available to FMCSA, and is not
in the process of being collected. Extensive background research was
conducted to ensure the study was not duplicative. A previous study,
done by the Government Accountability Office in 2015, asked for similar
information but did not produce specific enough data to be used in this
study.
    The survey will be sent out via email, with the option for online
completion using SurveyMonkey[supreg]. Each State can respond via email
or the online survey depending on which method is more convenient for
the respondent. The welcome letter will indicate that FMCSA prefers
responses via the online survey tool.
    The information collected will be published annually in a report to
the Committee on Commerce, Science, and Transportation of the Senate
and the Committee on Transportation and Infrastructure of the House of
Representatives. The first report is due to Congress no later than June
1, 2017. FMCSA plans to have a draft report available by June 1, 2017,
with the finalized report submitted to congress in August 2017.
Subsequent reports will be published on an annual basis thereafter.

Summary of Public Comments Received

    On October 5, 2016, FMCSA published a notice in the Federal
Register (81 FR 69184) with a 60-day public comment period to announce
this proposed information collection. The agency received eight
comments in response to this notice.
    Four commenters provided insights into States' current CDL skills
testing delays, including an applicant's average wait time to complete
a skills test; an applicant's average wait time to complete a retest;
the number of qualified commercial driver's license examiners; and the
number of State testing sites. FMCSA appreciates this information, and
encourages each State to fill out the complete survey when it is
administered.
    Two commenters indicated that they believe the information
collection is necessary and can provide useful information. One
commenter noted that FMCSA's primary mission is to reduce crashes,
injuries, and fatalities involving large trucks and buses, and that
this survey does not advance FMCSA's mission. While FMCSA agrees that
the correlation between CDL skills test and increased safety is not
immediately apparent, FMCSA believes skills testing is an integral part
of truck and bus safety mission. In addition, as discussed above, FMCSA
is required to collect this information at this interval based on the
FAST Act.
    While two commenters indicated that they believe the burden
estimate seems reasonable, one commenter strongly disagreed. The
commenter estimated that annual burden would be between 200 and 270
hours because the State does not currently track the information
subject to the ICR. FMCSA has re-evaluated the burden estimate based on
this feedback and feels that the new burden estimate accurately
reflects the commenter's concerns. FMCSA also believes the commenter
was accounting for a much more in depth analysis, which FMCSA
appreciates but does not plan to require. FMCSA has revised the
instructions and definitions accordingly to ensure States do not feel
unduly burdened by the information collection.
    FMCSA received valuable feedback on ways to enhance the quality,
usefulness, and clarity of the collected information. Specific
suggestions related to the inclusion of additional questions and better
defined terms and phrases.
    One commenter requested that FMCSA ensure data is as detailed as
possible. FMCSA believes the data will become more robust after the
first year, as States will be able to better prepare for the annual
survey.
    One commenter suggested FMCSA inquire as to the source of States'
reported estimates, while another commenter voiced concern that there
may not be enough space for providing feedback on how estimates were
developed, thereby introducing error in the analysis portion of this
study. FMCSA has revised the survey to include questions pertaining to
how the data was collected and calculated, and the sources used to
calculate delays, thereby allowing for more meaningful analysis and
more meaningful future data collection.
    Several commenters indicated that FMCSA should inquire about
mandatory waiting periods for skills testing and retesting. FMCSA has
covered this area in multiple questions in the survey to ensure
mandatory waiting periods are accurately understood in addition to
skills testing delays, as both contribute to the time it takes an
applicant to receive their CDL. FMCSA has ensured that mandatory wait
times are collected separately from delay periods throughout the ICR.
    One commenter requested FMCSA include a question pertaining to
shortest and longest wait times. FMCSA has revised the survey to
include this question, but has also included an option for States to
indicate they cannot collect this information. FMCSA understands that
some States will not be able to produce information pertaining to this
data.
    One commenter was concerned with the definition of ``average wait
time,'' when it should be calculated, and how it should be calculated.
In addition, the commenter noted that ``average wait time'' will vary
by region, or by testing location. FMCSA has included detailed
instructions in the survey to address these concerns. Furthermore, it
has provided the option for States to either provide wait times for all
testing locations, or to provide a minimum wait time (i.e. the wait
time at a rural, non-popular test site), the maximum (the wait time at
the busiest test site), and the average wait time for medium-density
test sites. Finally, FMCSA is providing an option for seasonal surveys
tailored to each State to minimize burden, as discussed in further
detail below.
    The commenter also requested FMCSA clarify what is meant by
``opportunity to complete such test.'' While FMCSA understands some
applicants may choose a later test date for personal reasons, a delay
incurred by the applicant's personal reasons is not something the State
has control over and should not be reflected in this study, to the best
ability of the State. FMCSA understands some States may not be able to
separate the two, in which case personal delays may be grouped together
with test scheduling delays.
    One commenter recommended the AAMVA add the required information to
additional reports in Commercial Skills Test Information Management
System (CSTIMS) to satisfy the information collection request. During

previous conversations with AAMVA, FMCSA determined that an additional
field to determine if the delay is due to a customer request or actual
delay would require funding and time that is not currently available.
Furthermore, given that not all States currently use CSTIMs, FMCSA
cannot justify pursuing this route at this time, but will continue
discussions with AAMVA for future efforts, as appropriate.
    Several comments addressed how the burden could be minimized
without reducing the quality of collected information. One commenter
indicated that they believe the burden is minimal as it stands. Another
commenter suggested that as States become accustomed to this annual
data collection, States will be able to collect data in a timelier
manner.
    One commenter suggested the burden could be minimized by not
requiring a year's worth of data to be accumulated and calculated. The
commenter suggested that FMCSA distribute a quarterly ``snapshot''
survey to collect wait times across different seasons and different
locales, or to work with AAMVA to readily produce this information in
CSTIMs. FMCSA did not intend for every CDL skills test to be included
in the average and has provided more concrete instructions for States
to collect data that is meaningful while not being overly burdensome.
FMCSA has considered the suggestion for a quarterly snapshot survey,
and will include a voluntary quarterly survey after the first annual
survey. This has been accurately updated in burden estimates and in the
information collection package.
    Finally, one commenter reported that if they are required to modify
their systems to provide the information subject to this ICR, grant
funding would be necessary and it would require a long time period to
complete these efforts. FMCSA does not intend for States to be required
to modify their existing systems, and believes most of the information
required should be readily available to a certain degree of
granularity.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the FMCSA to perform it's functions; (2)
the accuracy of the estimated burden; (3) ways for the FMCSA to enhance
the quality, usefulness, and clarity of the collected information; and
(4) ways that the burden could be minimized without reducing the
quality of the collected information.

    Issued under the authority delegated in 49 CFR 1.87 on: March 9,
2017.
G. Kelly Regal,
Associate Administrator for Office of Research and Information
Technology.
[FR Doc. 2017-05523 Filed 3-20-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 87, Number 193 (Thursday, October 6, 2022)]
[Notices]
[Pages 60689-60691]
[FR Doc No: 2022-21794]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0814]

Infant Formula Transition Plan for Exercise of Enforcement
Discretion: Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry entitled ``Infant Formula
Transition Plan for Exercise of Enforcement Discretion: Guidance for
Industry.'' We are issuing this guidance document to protect public
health by helping to stabilize the supply of infant formula in the
United States and to maintain a consistent supply of a variety of
infant formula products. Under the guidance, we intend to exercise
enforcement discretion until January 6, 2023, for infant formula
products that are listed in letters of enforcement discretion that FDA
has issued or will issue to specific manufacturers, in response to
information provided under our May 2022 ``Infant Formula Enforcement
Discretion Policy: Guidance for Industry,'' which remains in effect
until November 14, 2022. For those manufacturers that wish to continue
to market specific products in the United States under enforcement
discretion after January 6, 2023, the guidance further details
additional steps that manufacturers can take toward lawful marketing of
such products--and the timeline under which such steps should be
taken--for FDA to consider the continued exercise of enforcement
discretion. This guidance document will help infant formula
manufacturers meet applicable regulatory requirements while ensuring
that consumers have continued access to formulas that are currently
fulfilling the needs of infants consuming such products. We are also
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (PRA). The proposed
collection pertains to the submission of information necessary to
facilitate FDA's exercise of enforcement discretion, as discussed in
the guidance document.

DATES: Fax written comments on the collection of information by
November 7, 2022. FDA is requesting immediate OMB approval of this
emergency processing. The announcement of the guidance is published in
the Federal Register on October 6, 2022.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically,

including attachments, to https://www.regulations.gov will be posted to
the docket unchanged. Because your comment will be made public, you are
solely responsible for ensuring that your comment does not include any
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-0814 for ``Infant Formula Enforcement Discretion Policy:
Guidance for Industry.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
our consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Nutrition and Food Labeling, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Claudine Kavanaugh, Center for Food
Safety and Applied Nutrition, Office of Nutrition and Food Labeling
(HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740,<PHONE_NUMBER>; or Philip L. Chao, Center for Food Safety and
Applied Nutrition, Office of Regulations and Policy (HFS-024), Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2378.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Infant Formula Transition Plan for Exercise of Enforcement
Discretion: Guidance for Industry.'' We issued the guidance consistent
with our good guidance practices regulation (21 CFR 10.115). The
guidance represents the current thinking of FDA on this topic. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
    The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines infant
formula as a food which purports to be or is represented for special
dietary use solely as a food for infants by reason of its simulation of
human milk or its suitability as a complete or partial substitute for
human milk (section 201(z) of the FD&C Act (21 U.S.C. 321(z)). Our
regulations define infants as persons not more than 12 months old (21
CFR 105.3(e)). Among other requirements, section 412(c)(1)(B) of the
FD&C Act (21 U.S.C. 350a(c)(1)(B)) and FDA regulations (21 CFR 106.120)
require an infant formula manufacturer to submit notice (i.e., a new
infant formula submission) to FDA at least 90 days before a new infant
formula is introduced or delivered for introduction into interstate
commerce.
    Infant formula is often used as the sole source of nutrition by a
vulnerable population during a critical period of growth and
development. In general, the laws and regulations that apply to food
also apply to infant formula, but additional requirements that are
specific to infant formula appear in section 412 of the FD&C Act and in
our regulations at 21 CFR parts 106 and 107.
    The voluntary recall and facility shutdown conducted by Abbott
Nutrition in 2022 created a supply disruption with respect to certain
types of infant formula, which has been exacerbated by the overall
strains on supply chains during the COVID-19 pandemic. As part of the
Federal Government's response to the infant formula shortage, on May
16, 2022, FDA issued the ``Infant Formula Enforcement Discretion
Policy: Guidance for Industry'' (May 2022 Enforcement Discretion
Guidance; available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-enforcement-discretion-policy) discussing our intent to consider, on a
case-by-case basis, the temporary exercise of enforcement discretion
for the introduction into interstate commerce of infant formula that
may not meet certain statutory and regulatory requirements; the
guidance remains in effect until November 14, 2022. The May 2022
Enforcement Discretion Guidance describes the information that an
infant formula manufacturer should provide to FDA if the manufacturer
wishes to have FDA consider the exercise of enforcement discretion
relating to the introduction

into interstate commerce (including importation) of infant formula that
is safe and nutritionally adequate but that may not comply with all FDA
statutory and regulatory requirements. Consistent with the policies
described in the May 2022 Enforcement Discretion Guidance, certain
manufacturers have submitted information to FDA to substantiate the
safety and nutritional adequacy of specific infant formula products
and, following FDA's thorough review of the information provided, are
marketing such products under FDA's exercise of enforcement discretion.
    This guidance sets forth our current thinking on circumstances
under which we intend to exercise temporary enforcement discretion for
certain infant formula products beyond November 14, 2022, and to advise
infant formula manufacturers marketing products in accordance with
letters of enforcement discretion issued under the May 2022 Enforcement
Discretion Guidance about: (1) the type of information to provide to
FDA; and (2) our timing expectations related to such information, if
they would like us to consider the continued exercise of enforcement
discretion with respect to their products. This guidance document will
remain in effect until October 18, 2025, and FDA expects that all
infant formula products will comply with applicable U.S. requirements
by the end of the enforcement discretion period.
    We issued this guidance without prior public comment under section
701(h)(1)(C) of the FD&C Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR
10.115(g)(2) because we determined that prior public participation is
not feasible or appropriate, as this guidance provides time-sensitive
clarifications regarding FDA's intent to exercise enforcement
discretion with respect to specific formula products that are currently
fulfilling the needs of infants in the United States.
    As with all FDA guidance documents, the public may comment on the
guidance at any time.

II. Electronic Access

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

III. Paperwork Reduction Act of 1995

    FDA requested, and OMB has approved, emergency processing of this
proposed collection of information under section 3507(j) of the PRA (44
U.S.C. 3507(j) and 5 CFR 1320.13). Immediate implementation of the
information collection is critical to providing predictability,
stability, and continuity in the infant formula market, specifically
with respect to those products currently available to infants in the
Unites States under FDA's exercise of enforcement discretion. Because
we believe that routine procedures, which allow for a 60-day comment
period, would prevent our ability to immediately implement the
information collection, we requested a waiver from the requirement to
publish a 60-day notice for the information collection (see 5 CFR
1320.13(a)(2)(iii)).
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    We estimate the burden of the information collection as follows:

                             Table 1--Estimated One-Time Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Submit information in accordance             115               1             115              24           2,760
 with timing and content
 schedule discussed in guidance
 document for both exempt and
 non-exempt infant formulas.....
Letter of Intent................              15               1              15               5              75
Plan to Meet Applicable Infant                15               1              15              90           1,350
 Formula Requirements...........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           4,185
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate is based on submissions received in response to the
May 2022 Enforcement Discretion Guidance, for which we account for 115
respondents, each of whom submitted one request. We assume it requires
an average of 24 hours to prepare each submission, and therefore
calculate a total of 2,760 burden hours (115 requests x 24 hours). Of
those 115 respondents, we have currently issued 12 letters of
enforcement discretion but may issue additional letters through
November 14, 2022. We therefore assume that a total of 15 respondents
will initiate requesting enforcement discretion and final a letter of
intent. We assume this requires an average of 5 hours to prepare, for a
total of 75 burden hours (15 letters x 5 hours). We estimate these same
15 respondents will then submit a compliance plan and assume each plan
will require an average of 90 hours to prepare, for a total of 1,350
burden hours (15 plans x 90 hours).

    Dated: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21794 Filed 10-5-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Page 48857]
[FR Doc No: 2017-22759]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81885; File Nos. SR-DTC-2017-004; SR-NSCC-2017-005; SR-
FICC-2017-008]

Self-Regulatory Organizations; The Depository Trust Company;
National Securities Clearing Corporation; Fixed Income Clearing
Corporation; Notice of Designation of Longer Period for Commission
Action on Proceedings To Determine Whether To Approve or Disapprove
Proposed Rule Changes, as Modified by Amendments No. 1 and No. 3, To
Adopt the Clearing Agency Liquidity Risk Management Framework

October 16, 2017.
    On April 6, 2017, The Depository Trust Company (``DTC''), National
Securities Clearing Corporation (``NSCC''), and Fixed Income Clearing
Corporation (``FICC,'' and together with DTC and NSCC, the ``Clearing
Agencies''), filed with the Securities and Exchange Commission
(``Commission'') proposed rule changes SR-DTC-2017-004, SR-NSCC-2017-
005, SR-FICC-2017-008, respectively, pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder.\2\ On April 13, 2017, the Clearing Agencies each filed
Amendment No. 1 to their respective proposed rule changes. The proposed
rule changes, as modified in each instance by Amendment No. 1, were
published for comment in the Federal Register on April 25, 2017.\3\ On
June 7, 2017, the Commission designated a longer period for Commission
Action on the proposed rule changes, as amended in each instance by
Amendment No. 1.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 80489 (April 19, 2017),
82 FR 19120 (April 25, 2017) (SR-DTC-2017-004, SR-NSCC-2017-005, SR-
FICC-2017-008).
    \4\ Securities Exchange Act Release No. 80877 (June 7, 2017), 82
FR 27094 (June 13, 2017) (SR-DTC-2017-004, SR-NSCC-2017-005, SR-
FICC-2017-008).
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    On July 20, 2017, the Clearing Agencies each filed Amendment No. 2
to their respective proposed rule changes. On July 21, 2017, the
Clearing Agencies each filed Amendment No. 3 to their respective
proposed rule changes to supersede and replace Amendment No. 2, in its
entirety, due to a technical defect. On July 28, 2017, the Commission
published a notice in the Federal Register of filing Amendments No. 2
and No. 3, and issued an order instituting proceedings under Section
19(b)(2)(B) of the Act \5\ to determine whether to approve or
disapprove the proposed rule changes, as amended.\6\ The Commission did
not receive any comment letters on the proposed rule changes, as
modified by Amendments No. 1 and No. 3.
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    \5\ 15 U.S.C. 78s(b)(2)(B)(i).
    \6\ See Securities Exchange Act Release No. 81194 (July 28,
2017), 82 FR 35241 (July 28, 2017) (SR-DTC-2017-004; SR-NSCC-2017-
005; SR-FICC-2017-008).
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    Section 19(b)(2)(B)(ii) of the Act provides that, after initiating
proceedings, the Commission shall issue an order approving or
disapproving the proposed rule change not later than 180 days after the
date of publication of notice of filing of the proposed rule change.\7\
The Commission may, however, extend the period for issuing an order
approving or disapproving the proposed rule change by not more than 60
days if the Commission determines that a longer period is appropriate
and publishes the reasons for such determination.\8\
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    \7\ 15 U.S.C. 78s(b)(2)(B)(ii).
    \8\ Id.
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    The 180th day after publication of the notice for the Proposed Rule
Changes in the Federal Register is October 22, 2017. The Commission
finds it appropriate to designate a longer period within which to issue
an order approving or disapproving the proposed rule changes, as
amended, so that it has sufficient time to consider the proposed rule
changes and the amendments. Accordingly, the Commission, pursuant to
Section 19(b)(2)(B)(ii) of the Act,\9\ designates December 21, 2017 as
the date by which the Commission shall either approve or disapprove
proposed rule changes SR-DTC-2017-004, SR-NSCC-2017-005, SR-FICC-2017-
008, as amended.
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    \9\ Id.
    \10\ 17 CFR 200.30-3(a)(57).
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    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-22759 Filed 10-19-17; 8:45 am]
BILLING CODE 8011-01-P