[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Rules and Regulations]
[Pages 745-749]
[FR Doc No: 2022-28428]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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Federal Register / Vol. 88, No. 3 / Thursday, January 5, 2023 / Rules
and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2019-F-3519]

Food Additives Permitted for Direct Addition to Food for Human
Consumption; Vitamin D3

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the
food additive regulations to provide for the safe use of vitamin
D3 as a nutrient supplement in breakfast cereals and grain-
based bars (e.g., breakfast bars, granola bars, rice cereal bars), and
to update the reference for the Vitamin D3 specifications.
We are taking this action in response to a petition filed by Kellogg
Company (Kellogg).

DATES: This rule is effective January 5, 2023. The incorporation by
reference of certain material listed in the rule is approved by the
Director of the Federal Register as of January 5, 2023. See section
VIII for further information on the filing of objections. Either
electronic or written objections and requests for a hearing on the
final rule must be submitted by February 6, 2023.

ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. The https://www.regulations.gov electronic filing system
will accept objections until 11:59 p.m. Eastern Time at the end of
February 6, 2023. Objections received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
received on or before that date.

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection 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 objection, that information will be
posted on https://www.regulations.gov.
     If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection 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 objections submitted to the Dockets
Management Staff, FDA will post your objection, 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-2019-F-3519 for ``Food Additives Permitted for Direct Addition to
Food for Human Consumption; Vitamin D3.'' Received
objections, those filed in a timely manner (see ADDRESSES), 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections 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.'' We
will review this copy, including the claimed confidential information,
in our consideration of objections. 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 objections 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>.

FOR FURTHER INFORMATION CONTACT: Lane A. Highbarger, Center for Food
Safety and Applied Nutrition (HFS-255), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740-3835,<PHONE_NUMBER>, or Joan
Rothenberg, 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,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 12, 2019 (84 FR 39785), we
announced that we filed a food additive petition (FAP 9A4823) submitted
on behalf of Kellogg by Hogan Lovells US LLP, Columbia Square, 555
Thirteenth St. NW,

Washington, DC 20004. The petition proposed that FDA amend the food
additive regulations in Sec.  172.380 (21 CFR 172.380) to provide for
the safe use of vitamin D3 as a nutrient supplement in: (1)
breakfast cereals as defined in Sec.  170.3(n)(4) (21 CFR 170.3(n)(4))
at levels up to 560 international units (IU) vitamin D3 per
100 grams (g) and (2) grain-based nutrition bars at levels up to 400 IU
vitamin D3 per 100 g. (One IU of vitamin D is equivalent to
0.025 micrograms ([micro]g) of vitamin D. We also note that while the
petition uses ``grain-based nutrition bars,'' we consider this to refer
to the same category of food products as ``grain-based bars'' (e.g.,
breakfast bars, granola bars, rice cereal bars), which is used
elsewhere in existing FDA regulations (see 21 CFR 172.780 and 101.12);
therefore, for consistency of terminology, we are using ``grain-based
bars.'') FDA is also updating the reference for specifications for
vitamin D3 established in Sec.  172.380(b) by incorporating
by reference the most recent edition of the Food Chemicals Codex (FCC).
The current food additive regulation for the use of vitamin
D3 (Sec.  172.380) indicates that the additive must meet the
specifications in the 11th edition of the FCC (FCC 11). Since we
received the petition, the FCC has been updated to the 13th edition
(FCC 13). The specifications for Vitamin D3 from FCC 11 are
identical to those in FCC 13. Therefore, we are amending Sec.
172.380(b) by adopting, and incorporating by reference, the most recent
edition of the FCC (FCC 13).
    Vitamin D is essential for human health. The major function of
vitamin D is the maintenance of blood serum concentrations of calcium
and phosphorus by enhancing the absorption of these minerals in the
small intestine. Vitamin D deficiency can lead to abnormalities in
calcium and bone metabolism, such as rickets in children or
osteomalacia in adults. At high levels in the diet, vitamin D may be
toxic. Excessive intake of vitamin D elevates blood plasma calcium
levels (hypercalcemia) by increased intestinal absorption and/or
mobilization from the bone, and possibly associated with decreased
renal function and increased cardiovascular risk (Refs. 1 and 2).
    To ensure that vitamin D is not added to the U.S. food supply at
levels that could raise safety concerns, FDA affirmed vitamin D as
generally recognized as safe (GRAS) with specific limitations as listed
in Sec.  184.1950 (21 CFR 184.1950). Under Sec.  184.1(b)(2) (21 CFR
184.1(b)(2)), an ingredient affirmed as GRAS with specific limitations
may be used in food only within such limitations, including the
category of food, functional use of the ingredient, and level of use.
Any addition of vitamin D to food beyond those limitations set out in
Sec.  184.1950 requires a food additive regulation.
    Vitamin D comprises a group of fat-soluble seco-sterols and occurs
in many forms. The two major physiologically relevant forms are vitamin
D2 and vitamin D3. Vitamin D without a subscript
represents vitamin D2, vitamin D3, or both.
Vitamin D is affirmed as GRAS for use in certain foods as a nutrient
supplement (as defined under Sec.  170.3(o)(20)) under Sec.
184.1950(c)(1), in accordance with Sec.  184.1(b)(2), as the sole
source of added vitamin D only within the following specific
limitations:

------------------------------------------------------------------------
                                                         Maximum levels
                                                           in food (as
                   Category of food                      served) (IU/100
                                                               g)
------------------------------------------------------------------------
Breakfast cereals.....................................               350
Grain products and pasta..............................                90
Milk..................................................                42
Milk products.........................................                89
------------------------------------------------------------------------

    Vitamin D is also affirmed as GRAS under Sec.  184.1950(c)(2) and
(3) for use in infant formula and margarine, respectively. Vitamin
D2 is an approved food additive under Sec.  172.379 (21 CFR
172.379) for use as a nutrient supplement in edible plant-based
beverages intended as milk alternatives, edible plant-based yogurt
alternatives, soy beverage products, soy-based butter substitute
spreads, and soy-based cheese substitutes and soy-based cheese
substitute products. Vitamin D3 is an approved food additive
under Sec.  172.380 for use as a nutrient supplement in certain
calcium-fortified 100 percent fruit juices and fruit juice drinks; meal
replacement and other-type bars that are represented for special
dietary use in reducing or maintaining body weight; soy-protein based
meal replacement beverages that are represented for special dietary use
in reducing or maintaining body weight; certain cheese and cheese
products; certain meal replacement beverages that are not intended for
special dietary use in reducing or maintaining body weight; foods
represented for use as a sole source of nutrition for enteral feeding;
and milk that contains more than 42 IU vitamin D per 100 g and that
meets the requirements for foods named by use of a nutrient content
claim and a standardized term in accordance with 21 CFR 130.10. Vitamin
D2 baker's yeast is an approved food additive under Sec.
172.381 (21 CFR 172.381) for use as a source of vitamin D2
and as a leavening agent in yeast-leavened baked goods and baking
mixes, and yeast-leavened baked snack foods. Vitamin D2
mushroom powder is an approved food additive under Sec.  172.382 (21
CFR 172.382) for use as a source of vitamin D2 in foods to
which vitamin D2, vitamin D3, and vitamin
D2 baker's yeast are currently allowed to be added under
Sec. Sec.  184.1950, 172.379, 172.380, and 172.381, excluding cheese
and cheese products, foods represented for use as a sole source of
nutrition for enteral feeding, infant formula, milk and milk products,
and margarine; fruit smoothies; vegetable juices; extruded vegetable
snacks; certain soups and soup mixes; and plant protein products.
    To support their petition, Kellogg submitted dietary exposure
estimates of vitamin D from the proposed uses of vitamin D3,
as well as all naturally occurring dietary sources of vitamin D,
currently approved and affirmed uses of vitamin D under our food
additive and GRAS regulations, and dietary supplements. Kellogg
compared these dietary exposure estimates to the Tolerable Upper Intake
Level (UL) for vitamin D established by the Institute of Medicine (IOM)
of the National Academies (now the National Academy of Medicine).
Kellogg also submitted published scientific literature pertaining to
human clinical studies on vitamin D.

II. Evaluation of Safety

    To establish with reasonable certainty that a food additive is not
harmful under its intended conditions of use, we consider the projected
human dietary exposure to the additive, the additive's toxicological
data, and other relevant information (such as published scientific
literature) available to us. We compare the dietary exposure for the
additive from all food sources to an acceptable intake level
established by data. The dietary exposure is determined based on the
amount of the additive proposed for specific uses in foods and on data
regarding the amount consumed from all food sources of the additive. We
commonly use the dietary exposure for the 90th percentile consumer of a
food additive as a measure of high chronic dietary exposure (Ref. 3).

A. Acceptable Daily Intake for Vitamin D

    In 2011, the Standing Committee on the Scientific Evaluation of
Dietary Reference Intakes of the Food and Nutrition Board at the IOM
conducted an extensive review of relevant published scientific
literature to update established dietary reference intakes (DRI) for
vitamin D; these DRIs are a family of nutrient reference values that

includes ULs (Ref. 4). Based on this information, the IOM revised the
ULs for vitamin D and published a report on their findings (Ref. 5). In
their 2011 assessment of vitamin D, the IOM established the following
ULs for different age groups, including total consumption from food,
including dietary supplements and water:

------------------------------------------------------------------------
  UL IU/per person/day (p/d)                   Age group
------------------------------------------------------------------------
1,000........................  infants 0 months to 6 months of age.
1,500........................  infants 6 months to 12 months of age.
2,500........................  children 1-3 years of age.
3,000........................  children 4-8 years of age.
4,000........................  adolescents aged 9-18 years of age and
                                adults.
------------------------------------------------------------------------

    The IOM considers the UL as the maximum daily intake level of a
nutrient that is likely to pose no health hazard risk for almost all
individuals in the general population when the nutrient is consumed
over long periods of time. The UL is determined using a risk assessment
approach developed specifically for nutrients. The dose-response
assessment, which concludes with an estimate of the UL, is built upon
three toxicological concepts commonly used in assessing the risk of
exposures to chemical substances: no-observed-adverse-effect level,
lowest-observed-effect level, and application of an uncertainty factor.
We considered the ULs established by the IOM relative to the cumulative
dietary exposure estimates as the primary basis for assessing the
safety of the petitioned uses of vitamin D3. We also
reviewed published scientific literature on the safety of vitamin D
submitted in the petition, as well as other relevant published studies
available to FDA.

B. Dietary Exposure Estimate for Vitamin D

    Kellogg provided mean and 90th percentile eaters-only dietary
exposure estimates for vitamin D for the overall U.S. population and
eight population subgroups from the: (1) proposed uses of vitamin
D3; (2) current food sources of vitamin D (including
approved food additive and affirmed GRAS uses as a food ingredient,
naturally occurring sources of vitamin D, and dietary supplements); and
(3) the combined current and proposed food uses. Kellogg noted that
dietary exposure was not estimated for infants 0-6 months as this age
group is not expected to consume breakfast cereals or grain-based bars.
Additionally, Kellogg indicated that dietary exposure was not estimated
for infants 6-12 months for grain-based bars for the same reason;
however, they were included in the exposure estimate for breakfast
cereals (Ref. 3).
    Kellogg presented the dietary exposure estimates to vitamin D from
the proposed and existing uses. However, Kellogg did not provide an
overall dietary exposure from all proposed uses, but instead provided
separate dietary exposures for each of the petitioned uses of vitamin
D3. Kellogg then estimated a cumulative dietary exposure to
vitamin D by adding the dietary exposures from each of the proposed
uses and that from the existing uses. While the estimates of dietary
exposures to each of the proposed and the existing uses of vitamin D
are important to consider, it is not appropriate to estimate a
cumulative dietary exposure by summing all the values because the
populations of consumers for each of the food uses are not the same.
Additionally, since the submission of the current petition by Kellogg,
vitamin D2 mushroom powder was approved under Sec.  172.382
for use as a source of vitamin D2 in certain foods (see
Section I. Background). As a result, Kellogg did not include these uses
in its cumulative dietary exposure estimate. Therefore, FDA conducted
dietary exposure estimates to determine: (1) the overall dietary
exposure to vitamin D3 from the petitioned uses and (2) a
cumulative dietary exposure for vitamin D from all existing sources,
including the approved uses of vitamin D2 in mushroom
powder, and the petitioned uses for vitamin D3 (Ref. 3).
    FDA performed the dietary exposure estimate for vitamin
D3 from the proposed uses in breakfast cereals and grain-
based bars using the combined 2011-2014 National Health and Nutrition
Examination Survey. FDA also estimated a cumulative dietary exposure
for vitamin D that includes all existing sources of vitamin D (i.e.,
naturally occurring sources, approved and affirmed GRAS food uses of
vitamin D, and dietary supplements) and Kellogg's proposed uses for
vitamin D3 in breakfast cereals and grain-based bars.
Furthermore, FDA also included dietary exposure to the vitamin D
metabolite, 25-hydroxyvitamin D, in the cumulative estimate to account
for discrepancies seen between dietary intake and blood serum levels of
vitamin D (Ref. 3).
    For the overall U.S. population 1 year of age and older, we
estimated the cumulative dietary exposure at the 90th percentile from
all food sources of vitamin D, including the proposed uses and
background sources, to be 2,730 IU/p/d. Additionally, the estimated
90th percentile dietary exposure to vitamin D from all food sources for
infants 6 to 12 months of age is 1,060 IU/p/d. In summary, the
cumulative dietary exposure to vitamin D3 at the 90th
percentile from the petitioned and background sources is below the IOM
UL for all population groups for which ULs were established.

C. Safety of the Petitioned Uses of Vitamin D3

    We reviewed and evaluated the information submitted by Kellogg
regarding the safety of the dietary exposure to vitamin D3
from the proposed uses in grain-based bars and breakfast cereals.
Kellogg submitted reports of scientific studies published after the
2011 IOM report and concluded that these publications support a
conclusion that the proposed uses of vitamin D3 are safe.
    We reviewed the published reports of scientific studies on vitamin
D submitted by Kellogg, as well as other relevant published studies
available to us since our previous evaluations of food additive
petitions for fortifying a variety of foods with vitamin D (85 FR
41916, July 13, 2020; 81 FR 46578, July 18, 2016; 79 FR 46993, August
12, 2014; 77 FR 52228, August 29, 2012; 74 FR 11019, March 16, 2009; 70
FR 69435, November 16, 2005; 70 FR 37255, June 29, 2005; 70 FR 36021,
June 22, 2005; 68 FR 9000, February 27, 2003). These studies did not
raise any new safety concerns regarding the current or proposed uses of
vitamin D. The most recent food additive petition for a new use of
vitamin D resulted in our amendment of the food additive regulations in
Sec.  172.382 to allow for the safe use of vitamin D2
mushroom powder in specific food categories (85 FR 41916). The earlier
food additive petitions also resulted in amendments of the food
additive regulations to allow

for the safe use of vitamin D as a nutrient supplement in certain
foods.
    We consider the ULs established by the IOM relative to the dietary
exposure estimates as the primary basis for assessing the safety of the
petitioned uses of vitamin D3. Depending on the age group,
the IOM ULs for vitamin D for the U.S. population 4 years and older
range from 3,000 IU/p/d to 4,000 IU/p/d. FDA's cumulative dietary
exposure estimate for vitamin D from all food sources, including the
proposed uses, at the 90th percentile for the U.S. population 1 year of
age and older is estimated to be no greater than 2,740 IU/p/d, which is
below the IOM ULs for all population groups 4 years and above.
Estimated dietary exposure to vitamin D from all food sources for
infants 6 months to 12 months of age is 1,060 IU/p/d, and for children
aged 1 year to 3 years old is 1,730 IU/p/d. These estimates are below
the respective IOM UL of 1,500 IU/p/d for infants 6 months to 12 months
of age, and 2,500 IU/p/d for children aged older than 1 year to 3 years
old (Ref. 6).
    Because the estimated 90th percentile dietary exposure to vitamin D
from all current and proposed food uses for each population group is
less than the corresponding IOM UL for that population group, we
conclude that dietary exposure to vitamin D3 from the
proposed uses as a nutrient supplement in breakfast cereals and grain-
based bars are safe (Ref. 6).

III. Conclusion

    Based on the relevant data available to FDA and information in the
petition, we conclude that there is a reasonable certainty that no harm
will result from the use of vitamin D3 as a nutrient
supplement in breakfast cereals, as defined in Sec.  170.3(n)(4), at a
level up to 560 IU vitamin D3 per 100 g and in grain-based
bars at a level up to 400 IU vitamin D3 per 100 g.
Additionally, we are amending Sec.  172.380(b) by adopting, and
incorporating by reference, the most recent edition of the FCC (FCC
13).

IV. Incorporation by Reference

    FDA is incorporating by reference the monograph for vitamin
D3 from the Food Chemicals Codex, 13th ed., 2022, which was
approved by the Office of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may purchase a copy of the
material from the U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852, 1-800-227-8772, https://www.usp.org/. You may
inspect a copy at Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday. On our own
initiative, we have revised Sec.  172.380 to state that the referenced
material can be found at FDA's Dockets Management Staff instead of
FDA's Main Library. This change reflects a recent decision regarding
the location of referenced materials cited in FDA regulations.
    The FCC monograph sets forth a standard for purity and identity for
vitamin D3. The monograph provides specifications and
analytical methodologies to identify the substance and establish
acceptable purity criteria. The current food additive regulation for
the use of vitamin D3 (Sec.  172.380) indicates that the
additive must meet the specifications in the FCC 11. The petitioner
indicated that the vitamin D3 petitioned in FAP 9A4823
complies with the specifications in the monograph for vitamin
D3 in FCC 11. Since we received the petition, the FCC has
been updated to the 13th edition (FCC 13). The specifications for
vitamin D3 in FCC 13 are identical to those in FCC 11.
Therefore, we are amending Sec.  172.380(b) by adopting, and
incorporating by reference, the specifications for vitamin
D3 in FCC 13 in place of FCC 11.

V. Public Disclosure

    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition
and the documents that we considered and relied upon in reaching our
decision to approve the petition will be made available for public
disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec.
171.1(h), we will delete from the documents any materials that are not
available for public disclosure.

VI. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as
stated in the August 12, 2019, Federal Register notice of petition for
FAP 9A4823 (84 FR 39785). We stated that we had determined, under 21
CFR 25.32(k), that this action is of a type that does not individually
or cumulatively have a significant effect on the human environment such
that neither an environmental assessment nor an environmental impact
statement is required. We have not received any new information or
comments that would affect our previous determination.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

VIII. Objections

    If you will be adversely affected by one or more provisions of this
regulation, you may file with the Dockets Management Staff (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object, and
the grounds for your objection. Within each numbered objection, you
must specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific information you intend to present in support of the objection
in the event that a hearing is held. If you do not include such a
description and analysis for any particular objection, you waive the
right to a hearing on the objection.
    Any objections received in response to the regulation may be seen
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https:/
www.regulations.gov.

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

    Our review of this petition was limited to section 409 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348). This
final rule is not a statement regarding compliance with other sections
of the FD&C Act. For example, section 301(ll) of the FD&C Act (21
U.S.C. 331(ll)) prohibits the introduction or delivery for introduction
into interstate commerce of any food that contains a drug approved
under section 505 of the FD&C Act (21 U.S.C. 355), a biological product
licensed under section 351 of the Public Health Service Act (42 U.S.C.
262), or a drug or biological product for which substantial clinical
investigations have been instituted and their existence has been made
public, unless one of the exemptions in section 301(ll)(1) through (4)
of the FD&C Act applies. In our review of this petition, we did not
consider whether section 301(ll) of the FD&C Act or any of its
exemptions apply to food containing this additive. Accordingly, this
final rule should not be construed to be a statement that a food
containing this additive, if introduced or delivered for introduction
into interstate commerce, would not violate section 301(ll) of the FD&C
Act.

Furthermore, this language is included in all food additive final rules
and therefore should not be construed to be a statement of the
likelihood that section 301(ll) of the FD&C Act applies.

X. References

    The following references marked with an asterisk (*) are on display
in 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. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. 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. National Institutes of Health, Office of Dietary Supplements,
``Vitamin D--Fact Sheet for Consumers,'' 2021. Available at: https://ods.od.nih.gov/factsheets/Vitamind-Consumer/.
2. Pilz, S., W. Marz, K.D. Cashman, et al., ``Rationale and Plan for
Vitamin D Food Fortification: A Review and Guidance Paper,''
Frontiers in Endocrinology, 9, 2018. Available at: https://www.frontiersin.org/articles/10.3389/fendo.2018.00373/full.
* 3. FDA Memorandum from R. Shah, Chemistry Review Branch, Division
of Food Ingredients, to L. Highbarger, Regulatory Review Branch,
Division of Food Ingredients, October 13, 2022.
* 4. Institute of Medicine Committee to Review Dietary Reference
Intakes for Vitamin D and Calcium; Ross, A.C., C.L. Taylor, A.L.
Yaktine, et al., editors. ``Dietary Reference Intakes for Calcium
and Vitamin D.'' Washington (DC): National Academies Press, 2011.
Available at: https://www.ncbi.nlm.nih.gov/books/NBK56070/ NBK56070/.
5. Taylor, C., K. Patterson, J. Roseland, et al., ``Including Food
25-Hydroxyvitamin D in Intake Estimates May Reduce the Discrepancy
between Dietary and Serum Measures of Vitamin D Status.'' Journal of
Nutrition, 144: 654-659, 2014. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3985821/pdf/nut144654.pdf.
* 6. FDA Memorandum from S.A. Assimon, Toxicology Review Branch,
Division of Food Ingredients, to L. Highbarger, Regulatory Review
Branch, Division of Food Ingredients, October 14, 2022.

List of Subjects in 21 CFR Part 172

    Food additives, Incorporation by reference, Reporting and
recordkeeping requirements.

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

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION

0
1. The authority citation for part 172 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

0
2. Amend Sec.  172.380 by revising paragraph (b) and adding paragraphs
(c)(9) and (10) to read as follows:

Sec.  172.380  Vitamin D3.

* * * * *
    (b) Vitamin D3 meets the specifications of ``Vitamin
D3,'' Food Chemicals Codex, 13th edition, effective June 1,
2022, which is incorporated by reference. The Director of the Office of
the Federal Register approves this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain
copies from the U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852; website: https://www.usp.org. Copies may be
examined at the FDA or the National Archives and Records Administration
(NARA). Contact FDA at: the Dockets Management Staff (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852, between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
For information on inspecting this material at NARA, visit
www.archives.gov/federal-register/cfr/ibr-locations.html or email
[email protected].
    (c) * * *
    (9) At levels not to exceed 560 IU per 100 g in breakfast cereals
(as defined under Sec.  170.3(n)(4) of this chapter).
    (10) At levels not to exceed 400 IU per 100 g in grain-based bars
(e.g., breakfast bars, granola bars, rice cereal bars).

    Dated: December 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28428 Filed 1-4-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Page 8913]
[FR Doc No: 2015-03404]

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

[Release No. 31456]

Investment Company Act of 1940

 February 12, 2015.
    In the Matter of Wilshire Mutual Funds, Inc., Wilshire Variable
Insurance Trust, Wilshire Associates Incorporated, SEI Investments
Distribution Co., 1299 Ocean Avenue, Suite 700, Santa Monica, CA
90401, (812-14350) :

    Order Under Section 12(D)(1)(J) of the Investment Company Act of
1940 Granting an Exemption from Sections 12(D)(1)(A) and (B) of the
Act, under Sections 6(C) and 17(B) of the Act Granting an Exemption
from Sections 17(A)(1) and (2) of the Act, and under Section 6(C) of
the Act for an Exemption from Rule 12d1-2(A) under the Act
    Wilshire Mutual Funds, Inc., Wilshire Variable Insurance Trust,
Wilshire Associates Incorporated, and SEI Investments Distribution Co.
filed an application on August 19, 2014, and an amendment to the
application on November 10, 2014, requesting an order under section
12(d)(1)(J) of the Investment Company Act of 1940 (the ``Act'')
granting an exemption from sections 12(d)(1)(A) and (B) of the Act,
under sections 6(c) and 17(b) of the Act granting an exemption from
sections 17(a)(1) and (2) of the Act, and under section 6(c) of the Act
for an exemption from rule 12d1-2(a) under the Act. The order would (a)
permit certain registered open-end management investment companies that
operate as ``funds of funds'' to acquire shares of certain registered
open-end management investment companies and unit investment trusts
that are within and outside the same group of investment companies as
the acquiring investment companies, and (b) permit funds of funds
relying on rule 12d1-2 under the Act to invest in certain financial
instruments.
    On December 16, 2014, a notice of the filing of the application was
issued (Investment Company Act Release No. 31381). The notice gave
interested persons an opportunity to request a hearing and stated that
an order granting the application would be issued unless a hearing was
ordered. No request for a hearing has been filed, and the Commission
has not ordered a hearing.
    The matter has been considered and it is found, on the basis of the
information set forth in the application, as amended, that granting the
requested exemption is appropriate in and consistent with the public
interest and consistent with the protection of investors and the
purposes fairly intended by the policy and provisions of the Act.
    It is also found that the terms of the proposed transactions are
reasonable and fair and do not involve overreaching, and the proposed
transactions are consistent with the policies of each registered
investment company concerned and with the general purposes of the Act.
    Accordingly,
    It is ordered, that the relief requested under section 12(d)(1)(J)
of the Act from sections 12(d)(1)(A) and (B) of the Act, under sections
6(c) and 17(b) of the Act from sections 17(a)(1) and (2) of the Act,
and under section 6(c) of the Act for an exemption from rule 12d1-2(a)
under the Act by Wilshire Mutual Funds, Inc., et al. (File No. 812-
14350) is granted, effective immediately, subject to the conditions
contained in the application, as amended.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Brent J. Fields,
Secretary.
[FR Doc. 2015-03404 Filed 2-18-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 145 (Friday, July 27, 2012)]
[Proposed Rules]
[Pages 44198-44204]
[FR Doc No: 2012-18131]

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

40 CFR Part 52

[EPA-R04-OAR-2012-0555; FRL-9704-6]

Approval and Promulgation of Implementation Plans; State of
Florida: New Source Review; Prevention of Significant Deterioration;
Fine Particulate Matter (PM2.5)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve changes to the Florida State
Implementation Plan (SIP), submitted by the Florida Department of
Environmental Protection (FDEP) to EPA on March 15, 2012. The SIP
revision modifies Florida's New Source Review (NSR) Prevention of
Significant Deterioration (PSD) permitting program. The SIP revision
adopts, into the Florida SIP, federal NSR permitting provisions to
address the implementation of the fine particulate matter
(PM2.5) national ambient air quality standards (NAAQS) as
amended in EPA's 2008 NSR PM2.5 Implementation Rule
(hereafter referred to as the ``NSR PM2.5 Rule'') and the
2010 PM2.5 PSD Increment, Significant Impact Levels (SILs)
and Significant Monitoring Concentration (SMC) Rule (hereafter referred
to as the ``PM2.5 PSD Increment-SILs-SMC Rule''). EPA is
proposing to approve portions of Florida's SIP revision because the
Agency has preliminarily determined that the changes are consistent
with the Clean Air Act (CAA or Act) and EPA regulations regarding NSR
permitting.

DATES: Comments must be received on or before August 27, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No EPA-R04-
OAR-2012-0555, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: EPA-R04-OAR-2012-0555, Regulatory Development Section, Air
Planning Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Ms. Lynorae Benjamin, Chief,
Regulatory Development Section, Air Planning Branch, Air, Pesticides
and Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8:30 to 4:30, excluding federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2012-0555 EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov or
email, information that you consider to be CBI or otherwise protected.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 in www.regulations.gov or
in hard copy at the Regulatory Development Section, Air Planning
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 to 4:30, excluding
federal holidays.

FOR FURTHER INFORMATION CONTACT: For information regarding the Florida
SIP, contact Ms. Twunjala Bradley, Regulatory Development Section, Air
Planning Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. Telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>For information regarding NSR,
contact Ms. Yolanda Adams, Air Permits Section, at the same address
above. Telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>For information regarding PM2.5
NAAQS, contact Mr. Joel Huey, Regulatory Development Section, at the
same address above. Telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
I. What action is EPA proposing?
II. What is the background for EPA's proposed action?
III. What are the NSR implementation requirements for the
PM2.5 NAAQS?
IV. What is EPA's analysis of Florida's SIP revision?
V. Proposed Rule
VI. Statutory and Executive Order Reviews

I. What action is EPA proposing?

    On March 15, 2012, FDEP submitted a SIP revision to EPA for
approval into the Florida SIP to adopt federal requirements for NSR
permitting. Florida's SIP revision makes changes to the State's Air
Quality Regulations at Chapter 62-210, Florida Administrative Code
(F.A.C.), Stationary Sources--General Requirements, Section 200--
Definitions (rule 62-210.200), and Chapter 62-212, F.A.C., Stationary
Sources--Preconstruction Review, Section 300--General Preconstruction
Review Requirements (rule 62-212.300) and Section 400--Prevention of
Significant Deterioration (rule 62-212.400). These rule changes were
provided to comply with federal NSR permitting provisions related to
the implementation of the PSD program for the PM2.5 NAAQS as
promulgated in the NSR PM2.5 Rule entitled ``Implementation
of the New Source Review (NSR) Program for Particulate

Matter Less than 2.5 Micrometers (PM2.5),'' Final Rule, 73
FR 28321 (May 16, 2008) and the PM2.5 PSD Increment-SILs-SMC
Rule entitled ``Prevention of Significant Deterioration (PSD) for
Particulate Matter Less Than 2.5 Micrometers (PM2.5)--
Increments, Significant Impact Levels SILs and Significant Monitoring
Concentration (SMC),'' Final Rule,'' 75 FR 64864, (October 20, 2010).
Pursuant to section 110 of the CAA, EPA is proposing to approve into
the Florida SIP these changes submitted by the State, with the
exception of the SILs provisions pursuant to EPA's PM2.5 PSD
Increment-SILs-SMC Rule.\1\ See 75 FR 64864. More details regarding
SILs are summarized below in Sections III and IV.
---------------------------------------------------------------------------

    \1\ EPA's authority to implement the SILs and SMC for PSD
purposes has been challenged by the Sierra Club. Sierra Club v. EPA,
Case No 10-1413 United States Court of Appeals for the District of
Columbia (D.C. Circuit Court).
---------------------------------------------------------------------------

II. What is the background for EPA's proposed action?

    Today's proposed action to revise Florida's SIP relates to EPA's
NSR PM2.5 Rule \2\ and the PM2.5 PSD Increment-
SILs-SMC Rule. In the NSR PM2.5 Rule, EPA finalized
regulations to implement the NSR program for the PM2.5
NAAQS. As a result of EPA's final NSR PM2.5 Rule, states
were required to submit SIP revisions to EPA no later than May 16,
2011, to address these requirements for both the PSD and Nonattainment
NSR (NNSR) programs. EPA's PM2.5 PSD Increment-SILs-SMC Rule
established PSD increments, SILs and SMC which address additional
components for making PSD permitting determinations for the
PM2.5 NAAQS. These requirements address air quality modeling
and monitoring provisions for fine particle pollution in areas
protected by the PSD program (that is, attainment or unclassifiable/
attainment areas for the NAAQS). The PM2.5 PSD Increment-
SILs-SMC Rule requires states to submit SIP revisions to adopt the
required PSD increments by July 20, 2012. Promulgation of these two
rules provided the framework states need to address the NSR permitting
requirements for the PM2.5 NAAQS. Florida's March 15, 2012,
SIP revision adopts into the Florida SIP the PSD requirements
promulgated in these two rules to be consistent with federal
regulations for the PM2.5 NAAQS. More detail on the NSR
PM2.5 Rule and the PM2.5 PSD Increment-SILs-SMC
Rule can be found in EPA's May 16, 2008, and October 20, 2010, final
rules, respectively, and are summarized below. See 73 FR 28321 and 75
FR 64864.
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    \2\ On November 1, 2005, EPA proposed a rule to implement the
1997 PM2.5 NAAQS, including proposed revisions to the NSR
program. See 70 FR 65984.
---------------------------------------------------------------------------

A. Fine Particulate Matter and the NAAQS

    Fine particles in the atmosphere are made up of a complex mixture
of components. Common constituents include sulfate; nitrate; ammonium;
elemental carbon; a great variety of organic compounds; and inorganic
material (including metals, dust, sea salt, and other trace elements)
generally referred to as ``crustal'' material, although it may contain
material from other sources. Airborne particulate matter (PM) with a
nominal aerodynamic diameter of 2.5 micrometers or less (a micrometer
is one-millionth of a meter, and 2.5 micrometers is less than one-
seventh the average width of a human hair) are considered to be ``fine
particles'' and are also known as PM2.5. ``Primary''
particles are emitted directly into the air as a solid or liquid
particle (e.g., elemental carbon from diesel engines or fire
activities, or condensable organic particles from gasoline engines).
``Secondary'' particles (e.g., sulfate and nitrate) form in the
atmosphere as a result of various chemical reactions.
    The health effects associated with exposure to PM2.5
include potential aggravation of respiratory and cardiovascular disease
(i.e., lung disease, decreased lung function asthma attacks and certain
cardiovascular issues). Epidemiological studies have indicated a
correlation between elevated PM2.5 levels and premature
mortality. Groups considered especially sensitive to PM2.5
exposure include older adults, children, and individuals with heart and
lung diseases. For more details regarding health effects and
PM2.5 see EPA's Web site at http://www.epa.gov/oar/particlepollution/ (See heading ``Health and Welfare'').
    On July 18, 1997, EPA revised the NAAQS for PM to add new standards
for fine particles, using PM2.5 as the indicator.
Previously, EPA used PM10 (inhalable particles smaller than
or equal to 10 micrometers in diameter) as the indicator for the PM
NAAQS. EPA established health-based (primary) annual and 24-hour
standards for PM2.5, setting an annual standard at a level
of 15 micrograms per cubic meter ([mu]g/m\3\) and a 24-hour standard at
a level of 65 [mu]g/m\3\. See 62 FR 38652. At the time the 1997 primary
standards were established, EPA also established welfare-based
(secondary) standards identical to the primary standards. The secondary
standards are designed to protect against major environmental effects
of PM2.5, such as visibility impairment, soiling, and
materials damage. On October 17, 2006, EPA revised the primary and
secondary NAAQS for PM2.5. In that rulemaking, EPA reduced
the 24-hour NAAQS for PM2.5 to 35 [mu]g/m\3\ and retained
the existing annual PM2.5 NAAQS of 15 [mu]g/m\3\. See 71 FR
61236.

B. What is the NSR program?

    The CAA NSR program is a preconstruction review and permitting
program applicable to certain new and modified stationary sources of
air pollutants regulated under the CAA. The program includes a
combination of air quality planning and air pollution control
technology requirements. The CAA NSR program is composed of three
separate programs: PSD, NNSR, and Minor NSR. PSD is established in part
C of title I of the CAA and applies in areas that meet the NAAQS
(``attainment areas'') as well as areas where there is insufficient
information to determine if the area meets the NAAQS (``unclassifiable
areas''). The NNSR program is established in part D of title I of the
CAA and applies in areas that are not in attainment of the NAAQS
(``nonattainment areas''). The Minor NSR program addresses construction
or modification activities that do not qualify as ``major'' and applies
regardless of the designation of the area in which a source is located.
Together, these programs are referred to as the NSR program. EPA
regulations governing the implementation of these programs are
contained in 40 CFR 51.160-.166; 52.21, .24; and, part 51, appendix S.
Section 109 of the CAA requires EPA to promulgate a primary NAAQS to
protect public health and a secondary NAAQS to protect public welfare.
Once EPA sets those standards, states must develop, adopt, and submit a
SIP to EPA for approval that includes emission limitations and other
control measures to attain and maintain the NAAQS. See CAA section 110.
Each SIP is also required to include a preconstruction review program
for the construction and modification of any stationary source of air
pollution to assure the maintenance of the NAAQS. The applicability of
the PSD program to a major stationary source must be determined in
advance of construction and is a pollutant-specific determination. Once
a major source is determined to be subject to the PSD program (and thus
is a ``PSD source''), among other requirements, it must undertake a
series of analyses to demonstrate that it will use the best available
control technology and will

not cause or contribute to a violation of any NAAQS or increment.
Florida's March 15, 2012, SIP revision consists of rule amendments to
adopt into Florida's PSD program provisions related to the review and
control of PM2.5 emissions from major stationary sources and
modifications.

III. What are the NSR implementation requirements for the
PM2.5 NAAQS?

A. NSR PM2.5 Rule

    On May 16, 2008, EPA finalized the NSR PM2.5 Rule to
implement the PM2.5 NAAQS, including changes to the NSR
program. See 73 FR 28321. The NSR PM2.5 Rule revised the
federal NSR program requirements to establish the framework for
implementing preconstruction permit review for the PM2.5
NAAQS in both attainment and nonattainment areas. Specifically, the NSR
PM2.5 Rule established NSR requirements to implement the
PM2.5 NAAQS that: (1) Require NSR permits to address
directly emitted PM2.5 and precursor pollutants; (2)
establish significant emission rates for direct PM2.5 and
precursor pollutants (including sulfur dioxide (SO2) and
nitrogen oxides (NOX)); (3) establish PM2.5
emission offsets; (4) provide exceptions to the PM10
grandfathering policy; and (5) require states to account for gases that
condense to form particles (``condensables'') in PM2.5 and
PM10 emission limits in PSD or NNSR permits. Additionally,
the NSR PM2.5 Rule authorized states to adopt provisions in
their NNSR rules that would allow interpollutant offset trading.
Florida's March 15, 2012, SIP revision addresses the PSD permitting
requirements promulgated in the NSR PM2.5 Rule.\3\ A few key
issues described in greater detail below include the PM10
surrogate and grandfathering policy and the condensable provision.
---------------------------------------------------------------------------

    \3\ Florida's March 15, 2012, SIP revision only addresses the
State's PSD permitting program and does not adopt the NNSR
permitting requirements for PM2.5 emission offsets,
condensable provision or the discretionary interpollutant trading
policy and ratios promulgated in the 2008 NSR PM2.5 Rule.
Moreover Florida is attainment for the 1997 annual and 2006 24-hour
PM2.5 NAAQS.
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1. PM10 Surrogate and Grandfathering Policy
    After EPA promulgated the NAAQS for PM2.5 in 1997 (62 FR
38652, July 18, 1997), the Agency issued a guidance document entitled
``Interim Implementation of New Source Review Requirements for
PM2.5.'' John S. Seitz, EPA, October 23, 1997 (the ``Seitz
Memo''). The Seitz Memo was designed to help states implement NSR
requirements pertaining to the new PM2.5 NAAQS in light of
technical difficulties posed by PM2.5 at that time.
Specifically, the Seitz Memo stated: ``PM-10 may properly be used as a
surrogate for PM-2.5 in meeting NSR requirements until these
difficulties are resolved.'' EPA also issued a guidance document
entitled ``Implementation of New Source Review Requirements in PM-2.5
Nonattainment Areas'' (the ``2005 PM2.5 NNSR Guidance'') on
April 5, 2005, the date that EPA's PM2.5 nonattainment area
designations became effective for the 1997 NAAQS. The 2005
PM2.5 NNSR Guidance provided direction regarding
implementation of the nonattainment major NSR provisions in
PM2.5 nonattainment areas in the interim period between the
effective date of the PM2.5 nonattainment area designations
(April 5, 2005) and EPA's promulgation of final PM2.5 NNSR
regulations. Besides re-affirming the continuation of the
PM10 Surrogate Policy for PM2.5 attainment areas
set forth in the Seitz memo, the 2005 PM2.5 NNSR Guidance
recommended that until EPA promulgated the PM2.5 major NSR
regulations, ``States should use a PM10 nonattainment major
NSR program as a surrogate to address the requirements of nonattainment
major NSR for the PM2.5 NAAQS.''
    In the NSR PM2.5 Rule, EPA required that major
stationary sources seeking permits must begin directly satisfying the
PM2.5 requirements, as of the effective date of the rule,
rather than relying on PM10 as a surrogate, with two
exceptions. The first exception is the ``grandfathering'' provision in
the federal PSD program at 40 CFR 52.21(i)(1)(xi). This grandfathering
provision applied to sources that had applied for, but had not yet
received, a final and effective PSD permit before the July 15, 2008,
effective date of the May 16, 2008, final rule. The second exception
was that states with SIP-approved PSD programs could continue to
implement the Seitz Memo's PM10 Surrogate Policy for up to
three years (until May 2011) or until EPA approved the individual
revised state PSD programs for PM2.5, whichever came first.
See 73 FR 28321.\4\
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    \4\ Additional information on this issue can also be found in an
August 12, 2009, final order on a title V petition describing the
use of PM10 as a surrogate for PM2.5. In the
Matter of Louisville Gas & Electric Company, Petition No. IV-2008-3,
Order on Petition (August 12, 2009).
---------------------------------------------------------------------------

    On February 11, 2010, EPA proposed to repeal the grandfathering
provision for PM2.5 contained in the federal PSD program at
40 CFR 52.21(i)(1)(xi) and to end early the PM10 Surrogate
Policy applicable in states that have a SIP-approved PSD program. See
75 FR 6827. In support of this proposal, EPA explained that the
PM2.5 implementation issues that led to the adoption of the
PM10 Surrogate Policy in 1997 have been largely resolved to
a degree sufficient for sources and permitting authorities to conduct
meaningful permit-related PM2.5 analyses.
    On May 18, 2011 (76 FR 28646), EPA took final action to repeal the
PM2.5 grandfathering provision at 40 CFR 52.21(i)(1)(xi).
This final action ended the use of the 1997 PM10 Surrogate
Policy for PSD permits under the federal PSD program at 40 CFR 52.21.
In effect, any PSD permit applicant previously covered by the
grandfathering provision (for sources that completed and submitted a
permit application before July 15, 2008) \5\ that did not have a final
and effective PSD permit before the effective date of the repeal would
no longer be able to rely on the 1997 PM10 Surrogate Policy
to satisfy the PSD requirements for PM2.5 unless the
application included a valid surrogacy demonstration. See 76 FR 28646.
Florida's March 15, 2012, SIP revision did not adopt the grandfathering
provision at 40 CFR 52.21(i)(1)(xi), in accordance with the repeal of
the PM2.5 grandfathering provision.
---------------------------------------------------------------------------

    \5\ Sources that applied for a PSD permit under the federal PSD
program on or after July 15, 2008, are already excluded from using
the 1997 PM10 Surrogate Policy as a means of satisfying
the PSD requirements for PM2.5. See 76 FR 28321.
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2. ``Condensable'' Provision
    In the NSR PM2.5 Rule, EPA revised the definition of
``regulated NSR pollutant'' for PSD to add a paragraph providing that
``particulate matter (PM) emissions, PM2.5 emissions and
PM10 emissions'' shall include gaseous emissions from a
source or activity which condense to form particulate matter at ambient
temperatures and that on or after January 1, 2011, such condensable
particulate matter shall be accounted for in applicability
determinations and in establishing emissions limitations for PM,
PM2.5 and PM10 in permits. See 40 CFR
51.166(b)(49)(vi), 52.21(b)(50)(vi) and ``Emissions Offset
Interpretative Ruling'' (40 CFR part 51, appendix S). A similar
paragraph added to the NNSR rule does not include ``particulate matter
(PM) emissions.'' See 40 CFR 51.165(a)(1)(xxxvii)(D).
    On March 16, 2012, EPA proposed a rulemaking to amend the
definition of ``regulated NSR pollutant'' promulgated in the NSR
PM2.5 Rule regarding the PM condensable provision at 40 CFR
51.166(b)(49)(vi), 52.21(b)(50)(i) and

EPA's Emissions Offset Interpretative Ruling. See 77 FR 15656. The
rulemaking proposes to remove the inadvertent requirement in the NSR
PM2.5 Rule that the measurement of condensable ``particulate
matter emissions'' be included as part of the measurement and
regulation of ``particulate matter emissions.'' The term ``particulate
matter emissions'' includes particles that are larger than
PM2.5 and PM10 and is an indicator measured under
various New Source Performance Standards (NSPS) (40 CFR part 60).\6\
Florida's March 15, 2012, SIP revision did not adopt the term
``particulate matter emissions'' regarding the requirement to consider
condensables as promulgated in the NSR PM2.5 Rule.
---------------------------------------------------------------------------

    \6\ In addition to the NSPS for PM, states have regulated
``particulate matter emissions'' for many years in their SIPs for
PM, and the same indicator has been used as a surrogate for
determining compliance with certain standards contained in 40 CFR
part 63 regarding National Emission Standards for Hazardous Air
Pollutants.
---------------------------------------------------------------------------

B. PM2.5 PSD Increment-SILs-SMC-Rule

    As mentioned above, EPA finalized the PM2.5 PSD
Increment-SILs-SMC Rule to provide additional regulatory requirements
under the PSD program regarding the implementation of the
PM2.5 NAAQS for NSR.\7\ Specifically, the rule establishes
the following to implement the PM2.5 NAAQS for the PSD
program: (1) PM2.5 increments pursuant to section 166(a) of
the CAA to prevent significant deterioration of air quality in areas
meeting the NAAQS; (2) SILs used as a screening tool (by a major source
subject to PSD) to evaluate the impact a proposed major source or
modification may have on the NAAQS or PSD increment; and (3) a SMC,
(also a screening tool) used by a major source subject to PSD to
determine the subsequent level of data gathering required for a PSD
permit application for emissions of PM2.5. As part of the
response to comments on October 20, 2010 final rulemaking, EPA
explained that, the agency agrees that the SILs and SMC used as de
minimis thresholds for the various pollutants are useful tools that
enable permitting authorities and PSD applicants to screen out
``insignificant'' activities; however, the fact remains that these
values are not required by the Act as part of an approvable SIP
program. EPA believes that most states are likely to adopt the SILs and
SMC because of the useful purpose they serve regardless of our position
that the values are not mandatory. Alternatively, states may develop
more stringent values if they desire to do so. In any case, states are
not under any SIP-related deadline for revising their PSD programs to
add these screening tools. See 75 FR 64864, 64900.
---------------------------------------------------------------------------

    \7\ EPA proposed approval of the PSD Increments-SILs-SMC Rule on
September 21, 2007. See 72 FR 54112.
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    Florida's March 15, 2012, SIP revision adopts the PM2.5
PSD Increments (which are statutorily required) as well as the SILs and
SMC promulgated in the PM2.5 PSD Increment-SILs-SMC Rule to
be consistent with the federal NSR regulations and to appropriately
implement the State's NSR program for the PM2.5 NAAQS. More
detail on the PM2.5 PSD Increment-SILs-SMC Rule can be found
in EPA's October 20, 2010, final rule and is summarized below. See 75
FR 64864. EPA is not proposing to approve the SILs provisions
(promulgated in the PM2.5 PSD Increment-SILs-SMC Rule) into
the Florida SIP in this rulemaking. EPA's authority to implement the
SILs and SMC for PSD purposes has been challenged by the Sierra Club.
See Sierra Club v. EPA, Case No. 10-1413 (D.C. Circuit Court).\8\ More
details regarding Florida's changes to its NSR regulations are also
summarized below in Section IV.
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    \8\ On April 6, 2012, EPA filed a brief with the D.C. Circuit
court defending the Agency's authority to implement SILs and SMC for
PSD purposes.
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1. What are PSD increments?
    As established in part C of title I of the CAA, EPA's PSD program
protects public health from adverse effects of air pollution by
ensuring that construction of new or modified sources in attainment or
unclassifiable/attainment areas does not lead to significant
deterioration of air quality while simultaneously ensuring that
economic growth will occur in a manner consistent with preservation of
clean air resources. Under section 165(a)(3) of the CAA, a PSD permit
applicant must demonstrate that emissions from the proposed
construction and operation of a facility ``will not cause, or
contribute to, air pollution in excess of any maximum allowable
increase or allowable concentration for any pollutant.'' In other
words, when a source applies for a permit to emit a regulated pollutant
in an area that meets the NAAQS, the state and EPA must determine if
emissions of the regulated pollutant from the source will cause
significant deterioration in air quality. Significant deterioration
occurs when the amount of the new pollution exceeds the applicable PSD
increment, which is the ``maximum allowable increase'' of an air
pollutant allowed to occur above the applicable baseline concentration
\9\ for that pollutant. PSD increments prevent air quality in clean
areas from deteriorating to the level set by the NAAQS. Therefore an
increment is the mechanism used to estimate ``significant
deterioration'' of air quality for a pollutant in an area.
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    \9\ Section 169(4) of the CAA provides that the baseline
concentration of a pollutant for a particular baseline area is
generally the same air quality at the time of the first application
for a PSD permit in the area.
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    For PSD baseline purposes, a baseline area for a particular
pollutant emitted from a source includes the attainment or
unclassifiable/attainment area in which the source is located as well
as any other attainment or unclassifiable/attainment area in which the
source's emissions of that pollutant are projected (by air quality
modeling) to result in an ambient pollutant increase of at least 1
[mu]g/m\3\ (annual average). See 40 CFR 52.21(b)(15)(i). Under EPA's
existing regulations, the establishment of a baseline area for any PSD
increment results from the submission of the first complete PSD permit
application and is based on the location of the proposed source and its
emissions impact on the area. Once the baseline area is established,
subsequent PSD sources locating in that area need to consider that a
portion of the available increment may have already been consumed by
previous emissions increases. In general, the submittal date of the
first complete PSD permit application in a particular area is the
operative ``baseline date.'' \10\ On or before the date of the first
complete PSD application, emissions generally are considered to be part
of the baseline concentration, except for certain emissions from major
stationary sources. Most emissions increases that occur after the
baseline date will be counted toward the amount of increment consumed.
Similarly, emissions decreases after the baseline date restore or
expand the amount of increment that is available. See 75 FR 64864. As
described in the PM2.5 PSD Increment-SILs-SMC Rule, pursuant
to the authority under section 166(a) of the CAA, EPA promulgated
numerical increments for PM2.5 as a new pollutant \11\ for
which the NAAQS were

established after August 7, 1977,\12\ and derived 24-hour and annual
PM2.5 increments for the three area classifications (Class
I, II and III) using the ``contingent safe harbor'' approach. See 75 FR
64864 at 64869 and table at 40 CFR 51.166(c)(1).
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    \10\ Baseline dates are pollutant specific. That is, a complete
PSD application establishes the baseline date only for those
regulated NSR pollutants that are projected to be emitted in
significant amounts (as defined in the regulations) by the
applicant's new source or modification. Thus, an area may have
different baseline dates for different pollutants.
    \11\ EPA generally characterized the PM2.5 NAAQS as a
NAAQS for a new indicator of PM. EPA did not replace the
PM10 NAAQs with the NAAQS for PM2.5 when the
PM2.5 NAAQS were promulgated in 1997. EPA rather retained
the annual and 24-hour NAAQS for PM2.5 as if
PM2.5 was a new pollutant even though EPA had already
developed air quality criteria for PM generally. See 75 FR 64864
(October 20, 2012).
    \12\ EPA interprets 166(a) to authorize EPA to promulgate
pollutant-specific PSD regulations meeting the requirements of
section 166(c) and 166(d) for any pollutant for which EPA
promulgates a NAAQS after 1977.
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    In addition to PSD increments for the PM2.5 NAAQS, the
PM2.5 PSD Increment-SILs-SMC Rule amended the definition at
40 CFR 51.166 and 52.21 for ``major source baseline date'' and ``minor
source baseline date'' (including trigger dates) to establish the
PM2.5 NAAQS specific dates associated with the
implementation of PM2.5 PSD increments. See 75 FR 64864. In
accordance with section 166(b) of the CAA, EPA required the states to
submit revised implementation plans to EPA for approval (to adopt the
PM2.5 PSD increments) within 21 months from promulgation of
the final rule (by July 20, 2012). Each state was responsible for
determining how increment consumption and the setting of the minor
source baseline date for PM2.5 would occur under its own PSD
program. Regardless of when a State begins to require PM2.5
increment analysis and how it chooses to set the PM2.5 minor
source baseline date, the emissions from sources subject to PSD for
PM2.5 for which construction commenced after October 20,
2010, (major source baseline date) consume the PM2.5
increment and should be included in the increment analyses occurring
after the minor source baseline date is established for an area under
the state's revised PSD program. As discussed in detail in Section IV,
Florida's March 15, 2012, SIP revision adopts the PM2.5
increment permitting requirements promulgated in the PM2.5
PSD Increment-SILs-SMC Rule.
2. What are significant monitoring concentrations?
    Under the CAA and EPA regulations, an applicant for a PSD permit is
required to gather preconstruction monitoring data in certain
circumstances. Section 165(a)(7) calls for ``such monitoring as may be
necessary to determine the effect which emissions from any such
facility may have, or is having, on air quality in any areas which may
be affected by emissions from such source.'' In addition, section
165(e) requires an analysis of the air quality in areas affected by a
proposed major facility or major modification and calls for gathering
one year of monitoring data unless the reviewing authority determines
that a complete and adequate analysis may be accomplished in a shorter
period. These requirements are codified in EPA's PSD regulations at 40
CFR 51.166(m) and 40 CFR 52.21(m). In accordance with EPA's Guideline
for Air Quality Modeling (40 CFR part 51, appendix W), the
preconstruction monitoring data is primarily used to determine
background concentrations in modeling conducted to demonstrate that the
proposed source or modification will not cause or contribute to a
violation of the NAAQS. See 40 CFR part 51, appendix W, section 9.2.
SMCs are numerical values that represent thresholds of insignificant
(i.e., de minimis \13\), monitored (ambient) impacts on pollutant
concentrations. In EPA's PM2.5 PSD Increment-SILs-SMC Rule,
EPA established a SMC of 4 [micro]g/m\3\ for PM2.5 to be
used as a screening tool by a major source subject to PSD to determine
the subsequent level of data gathering required for a PSD permit
application for emissions of PM2.5. See 75 FR 64864.
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    \13\ The de minimis principle is grounded in decision described
by the court case Alabama Power Co. v. Costle, 636 F.2d 323, 360
(D.C. Cir. 1980). In this case reviewing EPA's 1978 PSD regulations,
the court recognized that ``there is likely a basis for an
implication of de minimis authority to provide exemption when the
burdens of regulation yield a gain of trivial or no value.'' 636
F.2d at 360.
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    Using the SMC as a screening tool, sources may be able to
demonstrate that the modeled air quality impact of emissions from the
new source or modification, or the existing air quality level in the
area where the source would construct, is less than the SMC (i.e., de
minimis), and as such, may be allowed to forego the preconstruction
monitoring requirement for a particular pollutant at the discretion of
the reviewing authority. See 40 CFR 51.166(i)(5) and 52.21(i)(5). SMCs
are not minimum required elements of an approvable SIP under the CAA.
This de minimis value is widely considered to be a useful component for
implementing the PSD program, but is not absolutely necessary for the
states to implement PSD programs. States can satisfy the statutory
requirements for a PSD program by requiring each PSD applicant to
submit air quality monitoring data for PM2.5 without using
de minimis thresholds to exempt certain sources from such requirements.
See 75 FR 64864. The SMC became effective under the federal PSD program
on December 20, 2010. States with EPA-approved PSD programs that adopt
the SMC for PM2.5, however, may use the SMC, once it is part
of an approved SIP, to determine when it may be appropriate to exempt a
particular major stationary source or major modification from the
monitoring requirements under its state PSD program. Florida's March
15, 2012, SIP revision adopts the SMC provision into the Florida SIP.
    Recently, the Sierra Club filed suit challenging EPA's authority to
implement the PM2.5 SILs \14\ as well as the SMC for PSD
purposes as promulgated in the October 20, 2010, rule. Sierra Club v.
EPA, Case No 10-1413, D.C. Circuit Court. Specifically regarding the
SMC, the Sierra Club claims that the use of an SMC to exempt a source
from submitting a year's worth of monitoring data is inconsistent with
the CAA. EPA responded to Sierra Club's claims in a Brief dated April
6, 2012, which described the Agency's authority to develop and
promulgate SMC.\15\ A copy of EPA's April 6, 2012, Brief can be found
in the docket for today's rulemaking at www.regulations.gov using
docket ID: EPA-R04-OAR-2012-0555.
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    \14\ As mentioned earlier, due to litigation by the Sierra Club,
EPA is not proposing to take action on the SILs portion of Florida's
March 15, 2012, SIP revision at this time but will take action once
the court case regarding SILs implementation is resolved.
    \15\ Additional information on this issue can also be found in
an April 25, 2010, comment letter from EPA Region 6 to the Louisiana
Department of Environmental Quality regarding the SILs-SMC
litigation. A copy of this letter can be found in the docket for
today's rulemaking at www.regulations.gov using docket ID: EPA-R04-
OAR-2012-0555.
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IV. What is EPA's analysis of Florida's SIP revision?

    Florida currently has a SIP-approved NSR program for new and
modified stationary sources. FDEP's PSD program definitions and
preconstruction permitting rules are found at rule 62-210.200, F.A.C,
and rules 62-212.300 through 62-212.400, F.A.C., respectively. These
rules apply to major stationary sources or modifications constructed in
areas designated attainment or unclassifiable/attainment as required
under part C of title I of the CAA with respect to the NAAQS. FDEP's
March 15, 2012, changes to Chapters 62-210, F.A.C., and 62-212, F.A.C.,
were submitted to adopt into Florida's NSR permitting program PSD
provisions promulgated in the NSR PM2.5 Rule and the
PM2.5 PSD Increment-SILs-SMC rule. These changes to
Florida's regulations became

state effective on March 28, 2012. EPA is proposing to approve these
changes into the Florida SIP to be consistent with federal NSR
regulations (at 40 CFR 51.166 and 52.21) and the CAA.

A. NSR PM2.5 Implementation Rule

    Florida's March 15, 2012, SIP revision establishes that the State's
existing NSR permitting program requirements for PSD apply to the
PM2.5 NAAQS and its precursors. Specifically, the SIP
revision adopts the following NSR PM2.5 Rule PSD provisions
into the Florida SIP: (1) The requirement for NSR permits to address
directly emitted PM2.5 and precursor pollutants; (2)
significant emission rates for direct PM2.5 and precursor
pollutants (SO2 and NOX) and (3) the requirement
that condensable PM be addressed in enforceable PM10 and
PM2.5 emission limits included in PSD permits. The March 15,
2012 changes revised the definition for ``significant emissions rates''
at 62-21.200(282) to establish SO2 and NOx as
PM2.5 precursors and adopt significant emission rates for
direct PM2.5 and PM2.5 precursors for major
modifications at existing sources (as amended at 40 CFR
51.166(b)(23)(i)) and established the requirement that condensable
PM10 and PM2.5 emissions be accounted for in PSD
applicability determinations and in establishing emissions limitations
for PM at 62-212.300(1)(f) as amended at 40 CFR 51.166(b)(49). In
addition, Florida's March 15, 2012, SIP revision added definitions for
``condensable PM10'' at 62-210.200(94), ``condensable PM2.5'' at 62-
210-200(95) and ``condensable PM'' at 62-210.200(93), for clarification
purposes. EPA is proposing to approve the aforementioned changes into
the Florida SIP.

B. PM2.5 PSD Increment-SILs-SMC Rule

    Florida's March 15, 2012, SIP revision adopts, into the Florida
SIP, the following PSD provisions promulgated in the PM2.5
PSD Increment-SILs-SMC Rule: (1) PSD increments for PM2.5
annual and 24-hour NAAQS pursuant to section 166(a) of the CAA (at
Chapter 62-210, F.A.C.); (2) SILs to be used as a screening tool to
evaluate the impact a proposed major source or modification may have on
the NAAQS or PSD increment (at Chapters 62-210, F.A.C., and 62-212,
F.A.C.); and (3) SMC, also used as a screening tool, to determine the
level of data gathering required of a major source in support of its
PSD permit application for PM2.5 emissions.
    Specifically, the SIP revision makes the following changes to
Florida's PSD regulations to adopt PSD increment provisions established
in the PM2.5 PSD Increment-SILs-SMC rule at Chapters 62-210
and 62-212, F.A.C.: (1) Revises the definition for ``maximum allowable
increase'' to incorporate by reference (IBR) the PM2.5 PSD
increments numerical values (established in the tables at 40 CFR
52.21(c) at 62-204.800, F.A.C.\16\); (2) amends definitions for ``major
source baseline date'' and ``minor source baseline date'' to establish
relevant dates for PM2.5 increment consumption and establish
trigger dates (as established at 40 CFR 51.166(b)(14)(i)(c) and
51.166(b)(14)(ii)(c) respectively) and; (3) revises the definition for
``baseline area'' as promulgated at 40 CFR 51.166(b)(15)(i) and (ii)
and adds definitions for ``baseline concentration.'' The March 15,
2012, SIP submission also adds a definitions for ``Class I and II
Areas'' at Chapter 62-210.200(77) and (78), F.A.C. respectively. The
definition for Class I Areas IBR 40 CFR part 81, Subpart D (the federal
Class I Area list) at rule 61 62-204.800, F.A.C.). In today's action,
EPA is proposing to approve Florida's March 15, 2012, SIP revision to
address PM2.5 PSD increments.
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    \16\ Florida IBR federal rules at rule 62-204.800 F.A.C.
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    Regarding the SILs and SMC established in the October 20, 2010,
PM2.5 PSD Increment-SILs-SMC Rule, the Sierra Club has
challenged EPA's authority to implement SILs and SMC. In a brief filed
in the D.C. Circuit on April 6, 2012, EPA described the Agency's
authority under the CAA to promulgate and implement the SMC and SILs de
minimis thresholds. Florida's SIP revision includes the SMC of 4
[micro]g/m\3\ for PM2.5 NAAQS (at rule 62-212.400(3)(e)1,
F.A.C.) that was added to the existing monitoring exemption at 40 CFR
51.166(i)(5)(i)(c) and 52.21(i)(5)(i)(c). With respect to the SMC, EPA
is proposing to approve these promulgated thresholds into the Florida
SIP as EPA believes the use of the SMC is a valid exercise of the
Agency's de minimis authority. Furthermore, Florida's March 15, 2012,
SIP revision is consistent with EPA's current promulgated provisions in
the October 20, 2010, rule. However, EPA notes that future court action
may require subsequent rule revisions and SIP revisions from Florida.
    The March 15, 2012, SIP revision submitted by Florida to adopt the
new PSD requirements for PM2.5 pursuant to the
PM2.5 PSD Increment-SILs-SMC Rule also includes the new
regulatory text at 40 CFR 51.166(k)(2) and 52.21(k)(2), concerning the
implementation of SILs for PM2.5. EPA stated in the preamble
to the October 20, 2010 final rule that we do not consider the SILs to
be a mandatory SIP element, but regard them as discretionary on the
part of regulating authority for use in the PSD permitting process.
Nevertheless, the PM2.5 SILs are currently the subject of
litigation before the U.S. Court of Appeals. (Sierra Club v. EPA, Case
No 10-1413 D.C. Circuit). In response to that litigation, EPA has
requested that the Court remand and vacate the regulatory text in the
EPA's PSD regulations at paragraph (k)(2) so that EPA can make
necessary rulemaking revisions to that text. In light of EPA's request
for remand and vacatur and our acknowledgement of the need to revise
the regulatory text presently contained at paragraph (k)(2) of sections
51.166 and 52.21, EPA does not believe that it is appropriate at this
time to approve that portion of the State's implementation plan
revision that contains or is related to the affected regulatory text in
the State's PSD regulations, at rule, 62-212.400(5), F.A.C and 62-
210.200(283)(c), F.A.C.. Instead, EPA is taking no action at this time
with regard to these specific provisions contained in the SIP revision.
EPA will take action on the SILs portion of Florida's March 15, 2012,
SIP revision in a separate rulemaking once the issue regarding the
court case has been resolved.
    The aforementioned amendments to Florida's SIP provide the
framework for implementation of PM2.5 NAAQS in the states
NSR permitting. Based on review and consideration of Florida's March
15, 2012, SIP revision, EPA has made the preliminary determination to
approve the aforementioned PSD permitting provisions promulgated in the
NSR PM2.5 Rule and PM2.5 PSD Increment-SILs-SMC
Rule into the Florida SIP to implement the NSR program for the
PM2.5 NAAQS.

V. Proposed Action

    EPA is proposing to approve portions of Florida March 15, 2012, SIP
revision adopting federal regulations amended in the May 16, 2008, NSR
PM2.5 Rule and the October 20, 2010, PM2.5 PSD
Increment-SILs-SMC rule into the Florida SIP with the exception of the
SILs provisions. EPA has made the preliminary determination that this
SIP revision, with regard to aforementioned proposed actions, is
approvable because it is consistent with section 110 of the CAA and EPA
regulations regarding NSR permitting.

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

Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR
52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve
state choices, provided that they meet the criteria of the CAA.
Accordingly, this proposed 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 proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen oxides, Particulate
matter, Reporting and recordkeeping requirements.

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

    Dated: July 16, 2012.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 2012-18131 Filed 7-26-12; 8:45 am]
BILLING CODE 6560-50-P