[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Rules and Regulations]
[Pages 32303-32307]
[FR Doc No: 2015-13834]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket Nos. FDA-2014-C-1616 and FDA-2015-C-0245]

Listing of Color Additives Exempt From Certification; Mica-Based
Pearlescent Pigments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (``FDA'' or ``we'') is
amending the color additive regulations to provide for the safe use of
mica-based pearlescent pigments prepared from titanium dioxide and mica
as color additives in cordials, liqueurs, flavored alcoholic malt
beverages, wine coolers, cocktails, non-alcoholic cocktail mixers and
mixes, and in egg decorating kits for coloring shell eggs. This action
is in response to two color additive petitions (CAPs) submitted
separately by EMD Millipore Corp. and by Signature Brands, LLC.

DATES: This rule is effective July 9, 2015. See section VIII for
further information on the filing of objections. Submit either
electronic or written objections and requests for a hearing by July 8,
2015.

ADDRESSES: You may submit either electronic or written objections and
requests for a hearing identified by Docket No. FDA-2014-C-1616 (Mica-
based pearlescent pigments in cordials, liqueurs, flavored alcoholic
malt beverages, wine coolers, cocktails, non-alcoholic cocktail mixers
and mixes) or Docket No. FDA-2015-C-0245 (Mica-based pearlescent
pigments in egg decorating kits), by any of the following methods:

Electronic Submissions

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

Written Submissions

    Submit written objections in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug

Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2014-C-1616 (Mica-based pearlescent pigments in
cordials, liqueurs, flavored alcoholic malt beverages, wine coolers,
cocktails, non-alcoholic cocktail mixers and mixes) or Docket No. FDA-
2015-C-0245 (Mica-based pearlescent pigments in egg decorating kits)
for this rulemaking. All objections received will be posted without
change to http://www.regulations.gov, including any personal
information provided. For detailed instructions on submitting
objections, see the ``Objections'' heading of the SUPPLEMENTARY
INFORMATION section.
    Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket numbers, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ellen Anderson, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In notices published in the Federal Register on October 21, 2014,
and February 5, 2015 (79 FR 62932 and 80 FR 6468, respectively), we
announced that we filed CAPs (4C0299 and 5C0301, respectively) to amend
the color additive regulations in Sec.  73.350 Mica-based pearlescent
pigments (21 CFR 73.350).
    CAP 4C0299 was submitted by EMD Millipore Corp. (EMD), c/o Hyman,
Phelps & McNamara, P.C., 700 13th St. NW., Suite 1200, Washington, DC
20005. CAP 4C0299 proposed to amend the color additive regulations in
Sec.  73.350 to expand the safe use of mica-based pearlescent pigments
prepared from titanium dioxide and mica as a color additive in
cordials, liqueurs, cocktails, and certain other alcoholic beverages,
and non-alcoholic cocktail mixers and mixes. The maximum use level of
the pigments proposed by the petitioner is 0.07 percent by weight in
the beverages, mixers, and mixes, consistent with approval in Sec.
73.350(c)(1)(ii) for the use of mica-based pearlescent pigments in
distilled spirits containing not less than 18 percent and not more than
23 percent alcohol by volume, but not including distilled spirits
mixtures containing more than 5 percent wine on a proof gallon basis.
In correspondence with FDA, EMD subsequently refined the petitioned use
of mica-based pearlescent pigments to cordials, liqueurs, flavored
alcoholic malt beverages, wine coolers, cocktails, and non-alcoholic
cocktail mixers and mixes.
    CAP 5C0301 was submitted by Signature Brands, LLC, c/o Keller and
Heckman, LLP, 1001 G St. NW., Suite 500 West, Washington, DC 20001. CAP
5C0301 proposed to amend Sec.  73.350 to provide for the safe use of
mica-based pearlescent pigments prepared from titanium dioxide and mica
in egg decorating kits for coloring boiled shell eggs, in amounts
consistent with good manufacturing practice (GMP).
    Mica-based pearlescent pigments prepared from titanium dioxide and
mica are currently approved under Sec.  73.350(c)(1)(i) for use as a
color additive in amounts up to 1.25 percent by weight in cereals,
confections and frostings, gelatin deserts, hard and soft candies
(including lozenges), nutritional supplement tablets and gelatin
capsules, and chewing gum. Mica-based pearlescent pigments prepared
from titanium dioxide and mica are also currently approved under Sec.
73.350(c)(1)(ii) in amounts up to 0.07 percent, by weight, in distilled
spirits containing not less than 18 percent and not more than 23
percent alcohol by volume, but not including distilled spirits mixtures
containing more than 5 percent wine on a proof gallon basis. Mica-based
pearlescent pigments prepared from titanium dioxide on mica, iron oxide
on mica, and titanium dioxide and iron oxide on mica are approved for
specified uses as a color additive in ingested drugs under Sec.
73.1350 (21 CFR 73.1350). Mica-based pearlescent pigments formed by
depositing titanium or iron salts from a basic solution onto mica,
followed by calcination to produce titanium dioxide or iron oxides on
mica, are approved for specified uses in contact lenses under Sec.
73.3128 (21 CFR 73.3128). The color additive that is the subject of the
two color additive petitions at issue, mica-based pearlescent pigments
prepared from titanium dioxide and mica, will be referred hereinafter
in this final rule as mica-based pearlescent pigments.

II. Safety Evaluation

A. Determination of Safety

    Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be
listed for a particular use unless the data and information available
to FDA establish that the color additive is safe for that use. FDA's
color additive regulations in 21 CFR 70.3(i) define ``safe'' to mean
that there is convincing evidence that establishes with reasonable
certainty that no harm will result from the intended use of the color
additive. To establish with reasonable certainty that a color additive
intended for use in food 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 literature) available to us. We compare
an individual's estimated daily intake (EDI) of the additive from all
food sources to an acceptable daily intake (ADI) established by
toxicological data. The EDI is determined by projections based on the
amount of the additive proposed for use in particular foods and on data
regarding the amount consumed from all food sources of the additive. We
typically use the EDI for the 90th percentile consumer of a color
additive as a measure of high chronic dietary exposure.

B. Petitioned Uses of the Color Additive

    In CAP 4C0299, EMD proposed to amend the color additive regulations
in Sec.  73.350 to provide for the safe use of mica-based pearlescent
pigments as a color additive in amounts up to 0.07 percent, by weight,
in cordials, liqueurs, flavored alcoholic malt beverages, wine coolers,
cocktails, and non-alcoholic cocktail mixes and mixers. According to
the standards of identity for distilled spirits regulations issued by
the Alcohol and Tobacco Tax and Trade Bureau (TTB), which regulates the
labeling of certain alcoholic beverages, cordials and liqueurs are a
class of distilled spirits obtained by mixing or redistilling distilled
spirits with or over fruits, flowers, plants, or pure juices therefrom,
or other natural flavoring materials, or with extracts derived from
infusions, percolation, or maceration of such materials, and containing
sugar, dextrose, or levulose, or a combination thereof, in an amount
not less than 2\1/2\ percent by weight of the finished product (27 CFR
5.22(h)). Neither FDA nor TTB has a regulatory definition for
``cocktail.'' The petition defines cocktails as ``products that are
sold as mixtures of distilled spirits and non-alcoholic ingredients.''
Subsequent communication with the petitioner clarified that the
following are descriptions of the types of cocktail products included
within the scope of the petition: (1) Cocktails containing

one or more alcoholic beverages and one or more non-alcoholic mixers
(e.g., margarita, gin and tonic, cosmopolitan, fuzzy navel, Bloody
Mary, caipirinha, Irish coffee, Long Island iced tea, daiquiri,
hurricane); (2) cocktails containing one or more alcoholic beverages
without non-alcoholic mixers (e.g., vodka martini, stinger, black
Russian, Manhattan); (3) cocktails containing beer (e.g., caipbeerinha,
boilermaker, beer Bloody Mary); (4) cocktails containing wine (e.g.,
mimosa, Kir Royale, wine cooler, wine spritzer); and (5) non-alcoholic
mixes and mixers for use in cocktails (e.g., margarita mix, daiquiri
mix, Bloody Mary mix). We note that mica-based pearlescent pigments are
intended to be used in both liquid and powdered forms of non-alcoholic
cocktail mixes and mixers, at a maximum use level of 0.07 percent by
weight of the mix or mixer (Ref. 1). Furthermore, only non-alcoholic
mixes and mixers that are marketed specifically for use in cocktails,
such as margarita mix and Bloody Mary mix, are included within the
scope of this petition (Ref. 1). Beverages that are typically consumed
without added alcohol (e.g., fruit juices, carbonated water, soft
drinks) are outside the scope of this petition. The petition also
proposed to amend Sec.  73.350 to provide for the safe use of mica-
based pearlescent pigments in flavored alcoholic malt beverages and
wine coolers. Like ``cocktail,'' the term ``wine cooler'' does not have
a regulatory definition. According to TTB, products traditionally known
as wine coolers have generally been replaced in recent years by
flavored alcoholic malt beverages, which are manufactured with a malt
base rather than with wine (Ref. 1). Flavored alcoholic malt beverages
are sold under many proprietary names and include alcoholic lemonades,
alcoholic colas, and other flavored alcoholic beverages (see 70 FR 194
at 195 (January 3, 2005) (TTB final rule pertaining to ``Flavored Malt
Beverage and Related Regulatory Amendments'')). Products marketed as
wine coolers and flavored alcoholic malt beverages are included in the
scope of the petition to amend the color additive regulations in Sec.
73.350. Traditional malt beverages, such as beer, ale, and malt liquor,
differ substantially from flavored alcoholic malt beverages (see 70 FR
194) and are not included within the scope of the petition. Wine, which
has a standard of identity defined under TTB's regulations at 27 CFR
part 4, subpart C, is also outside the scope of the petition.
Furthermore, the petitioner clarified that the scope of the petition
does not include sangria, which is typically a mixture of wine, fruit,
and other ingredients.
    In CAP 5C0301, Signature Brands, LLC proposed to amend the color
additive regulations in Sec.  73.350 to provide for the safe use of
mica-based pearlescent pigments as a color additive in egg decorating
kits to color the shells of boiled eggs in amounts consistent with GMP.
The petitioner proposed to use mica-based pearlescent pigments in a
packet of glaze that is part of egg decorating kits sold for in-home
use. According to the kit instructions, the glaze containing the mica-
based pearlescent pigments is intended to be rubbed on the shells of
colored boiled eggs to impart a metallic sheen.

C. Safety of the Petitioned Uses of the Color Additive

    During our safety review of the uses of mica-based pearlescent
pigments proposed in CAPs 4C0299 and 5C0301, we considered the exposure
to the color additive from its petitioned uses and from the currently
permitted uses in food and ingested drugs under Sec. Sec.  73.350 and
73.1350, respectively. In estimating the cumulative estimated dietary
intake (CEDI) of these pigments, we determined that the exposure to
mica-based pearlescent pigments from the use in contact lenses (Sec.
73.3128) is negligible and, therefore, need not be included in our
exposure estimate. Furthermore, we concluded that the exposure to the
additive from the petitioned use in coloring the shells of boiled eggs
is also negligible. In CAP 5C0301, the petitioner noted that, because
eggshells are not consumed, exposure to mica-based pearlescent pigments
would be limited to the amount of additive that migrates through the
shell and the inner membrane that separates the shell from the edible
egg. The petitioner asserted that, given the pigments' relatively large
particle size and insolubility in food, the amount of mica-based
pearlescent pigments that could actually be found in the edible portion
of the egg is insignificant. The petitioner provided a conservative
estimate for potential exposure to the additive from the petitioned use
based on a worst-case scenario that presumed the theoretical maximum
solubility of mica-based pearlescent pigments is equivalent to that of
mica (80 milligrams/kilograms in 10 percent acetic acid). Exposure to
mica-based pearlescent pigments from decorated eggshells is likely
further reduced by the typically limited seasonal availability of the
egg decorating kits. We agree with the rationale proposed in CAP 5C0301
that the exposure to the additive from the petitioned use is
negligible, and that the petitioned use would not result in a
significant contribution to the CEDI for mica-based pearlescent
pigments (Ref. 2).
    We estimate the eaters-only exposure to mica-based pearlescent
pigments from the proposed uses in cordials, liqueurs, flavored
alcoholic malt beverages, wine coolers, cocktails, and non-alcoholic
cocktail mixers and mixes for the U.S. population to be 0.15 grams/
person/day (g/p/d) at the mean and 0.34 g/p/d at the 90th percentile
(Ref. 1). (An eaters-only exposure is the total of the amount of food
consumed per day averaged over the number of days in the survey period
by individuals consuming the food at least once during the survey
period.) In a previous amendment to Sec.  73.350 (78 FR 35115 at 35115
and 35116 (June 12, 2013)), we estimated a CEDI for the use of mica-
based pearlescent pigments in food (Sec.  73.350) and ingested drugs
(Sec.  73.1350) using food consumption data from the 2003 to 2008
National Health and Nutrition Examination Survey (NHANES). In our
current safety assessment, we updated the previous exposure to mica-
based pearlescent pigments from all approved uses in foods using NHANES
food consumption data from 2007 to 2010. In estimating the exposure to
mica-based pearlescent pigments from the use in ingested drugs, we
relied on the estimates used in a previous safety evaluation (Ref. 1).
The updated eaters-only CEDI of mica-based pearlescent pigments,
including the petitioned use in cordials, liqueurs, flavored alcoholic
malt beverages, wine coolers, cocktails, and non-alcoholic cocktail
mixers and mixes, and the currently approved uses in food and ingested
drugs, is 0.25 g/p/d at the mean and 0.50 g/p/d at the 90th percentile
for the U.S. population (Ref. 1). The updated CEDIs for mica-based
pearlescent pigments are not significantly different from the previous
CEDIs (78 FR 35115 at 35116). This is not unexpected, as both the
previous and updated exposure estimates were based on a similar set of
NHANES food codes that included cordials, liqueurs, and cocktails (Ref.
1). In addition, the percent of the population consuming alcoholic
beverages from the petitioned use is significantly lower compared to
the proportion of the population that consumes foods and ingested drugs
containing mica-based pearlescent pigments, thereby resulting in a
smaller contribution to the CEDI (Ref. 1).
    To support the safety of the proposed uses of mica-based
pearlescent pigments in food, the petitioners of CAPs 4C0299 and 5C0301
referenced the safety

determination made by FDA for previously filed petitions (70 FR 42271
(July 22, 2005); 71 FR 31927 (June 2, 2006); and 78 FR 35115). In a
prior safety evaluation, we concluded that the bioavailability of
ingested mica-based pearlescent pigments and/or their individual
components is expected to be low based on the chemical nature of these
inorganic pigments and their individual components and the low
solubility of mica-based pearlescent pigments in media relevant to
human health (e.g., digestive fluids in the gastrointestinal tract) (70
FR 42271 at 42272). We are not aware of any new studies on the
bioavailability of mica-based pearlescent pigments published since our
previous evaluation (70 FR 42271). As part of our current safety
evaluation, we also reviewed several recent studies on titanium
dioxide, which is a component of mica-based pearlescent pigments, to
further clarify the extent of the color additive's bioavailability. We
determined that the new information on titanium dioxide supports our
previous conclusion that mica-based pearlescent pigments are not
bioavailable to any significant extent upon ingestion (Ref. 3).
    In our previous safety evaluation, which the petitioners
referenced, we established an ADI for mica-based pearlescent pigments
to be 1.8 g/p/d based on a 2-year rat carcinogenicity bioassay (71 FR
31927 at 31928). Since the updated CEDI (0.50 g/p/d at the 90th
percentile) for mica-based pearlescent pigments for the U.S. population
is less than the ADI, we conclude that the proposed expanded use of
mica-based pearlescent pigments as a color additive at levels of up to
0.07 percent by weight in cordials, liqueurs, flavored alcoholic malt
beverages, wine coolers, cocktails, and non-alcoholic cocktail mixers
and mixes is safe (Ref. 3). We also conclude that the proposed expanded
use of mica-based pearlescent pigments in egg decorating kits to color
the shells of eggs at levels consistent with GMP is safe, since the
exposure to mica-based pearlescent pigments contributed by this use is
negligible (Ref. 3).

III. Conclusion

    Based on the data and information in the petitions and other
relevant material, FDA concludes that the petitioned use of mica-based
pearlescent pigments prepared from titanium dioxide and mica as a color
additive at levels of up to 0.07 percent by weight in cordials,
liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails,
and non-alcoholic cocktail mixers and mixes is safe. We also conclude
that the petitioned use of mica-based pearlescent pigments prepared
from titanium dioxide and mica as a color additive in egg decorating
kits used to color the shells of eggs in amounts consistent with GMP is
safe. We further conclude that the additive will achieve its intended
technical effect and is suitable for the petitioned uses. Therefore, we
are amending the color additive regulations in part 73 (21 CFR part 73)
as set forth in this document. In addition, based upon the factors
listed in 21 CFR 71.20(b), we conclude that certification of titanium
dioxide-coated mica-based pearlescent pigments is not necessary for the
protection of the public health.

IV. Public Disclosure

    In accordance with Sec.  71.15 (21 CFR 71.15), the petitions and
the documents that we considered and relied upon in reaching our
decision to approve the petitions will be made available for public
disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec.
71.15, we will delete from the documents any materials that are not
available for public disclosure.

V. Environmental Impact

    We previously considered the environmental effects of this rule, as
stated in the October 21, 2014, and February 5, 2015, notices of filing
for CAPs 4C0299 and 5C0301 (79 FR 62932 and 80 FR 6468, respectively).
For CAP 4C0299, 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. For CAP 5C0301, we stated that we had
determined, under Sec.  25.32(r), 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
determinations.

VI. 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.

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

    Our review of these petitions was limited to section 721 of the
FD&C Act. 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) to (4) of the FD&C Act applies. In our review of these
petitions, 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
color additive final rules that pertain to food and therefore should
not be construed to be a statement of the likelihood that section
301(ll) of the FD&C Act applies.

VIII. Objections

    This rule is effective as shown in the DATES section, except as to
any provisions that may be stayed by the filing of proper objections.
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Division of Dockets Management (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 factual 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.
    It is only necessary to send one set of documents. Identify
documents with the docket number found in brackets in the

heading of this document. Any objections received in response to the
regulation may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday, and will be posted to the
docket at http://www.regulations.gov. We will publish notice of the
objections that we have received or lack thereof in the Federal
Register.

IX. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.

1. FDA Memorandum from H. Lee, Chemistry Review Group, Division of
Petition Review, to E. Anderson, Regulatory Group II, Division of
Petition Review, January 5, 2015.
2. FDA Memorandum from H. Lee, Chemistry Review Group, Division of
Petition Review, to E. Anderson, Regulatory Group II, Division of
Petition Review, March 13, 2015.
3. FDA Memorandum from S. Park, Toxicology Team, Division of
Petition Review, to E. Anderson, Regulatory Group II, Division of
Petition Review, March 18, 2015.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for 21 CFR part 73 continues to read as
follows:

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.

0
2. Section 73.350 is amended by revising paragraph (c)(1)(ii) and by
adding paragraph (c)(1)(iii) to read as follows:

Sec.  73.350  Mica-based pearlescent pigments.

* * * * *
    (c) * * *
    (1) * * *
    (ii) In amounts up to 0.07 percent, by weight, in the following:
    (A) Distilled spirits containing not less than 18 percent and not
more than 23 percent alcohol by volume but not including distilled
spirits mixtures containing more than 5 percent wine on a proof gallon
basis.
    (B) Cordials, liqueurs, flavored alcoholic malt beverages, wine
coolers, and cocktails.
    (C) Non-alcoholic cocktail mixes and mixers, such as margarita mix,
Bloody Mary mix, and daiquiri mix, but excluding eggnog, tonic water,
and beverages that are typically consumed without added alcohol (e.g.,
fruit juices, fruit juice drinks, and soft drinks).
    (iii) In egg decorating kits used for coloring the shells of eggs
in amounts consistent with good manufacturing practice.
* * * * *

    Dated: June 2, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2015-13834 Filed 6-5-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 59 (Thursday, March 27, 2014)]
[Rules and Regulations]
[Pages 17054-17060]
[FR Doc No: 2014-06697]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2012-0248; FRL-9908-48-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Carbon Monoxide Second Limited Maintenance Plan for the
Pittsburgh Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve a State Implementation Plan (SIP) revision
submitted by the Commonwealth of Pennsylvania. The revision consists of
a second limited maintenance plan for the carbon monoxide (CO)
Pittsburgh Area (``the Pittsburgh Area'' or ``the Area'') in Allegheny
County, formerly designated as a CO nonattainment area. The maintenance
plan ensures maintenance of the CO national ambient air quality
standard (NAAQS) in the Pittsburgh Area for a second 10-year period
after redesignation of the Area from nonattainment to attainment,
through year 2022. EPA is approving these revisions in accordance with
the requirements of the Clean Air Act (CAA).

DATES: This rule is effective on May 27, 2014 without further notice,
unless EPA receives adverse written comment by April 28, 2014. If EPA
receives such comments, it will publish a timely withdrawal of the
direct final rule in the Federal Register and inform the public that
the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2012-0248 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2012-0248, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2012-0248. 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 information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. 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.
    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 during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Pennsylvania Department of Environmental
Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market
Street, Harrisburg, Pennsylvania 17105 and at the Allegheny County
Health Department, Bureau of Environmental Quality, Division of Air
Quality, 301 39th Street, Pittsburgh, Pennsylvania 15201.

FOR FURTHER INFORMATION CONTACT: Emlyn V[eacute]lez-Rosa, (215) 814-
2038, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On July 18, 2011, Pennsylvania Department of
Environmental Protection (PADEP) submitted, on behalf of Allegheny
County Health Department (ACHD), a revision to the Pennsylvania SIP,
which was supplemented on November 26, 2013. The SIP revision ensures
maintenance of the CO NAAQS in the Pittsburgh Area for a second ten-
year period after redesignation, through year 2022.

Table of Contents

I. Background
II. EPA's Requirements
III. Summary of SIP Revision
IV. EPA's Evaluation
    A. Limited Maintenance Plan Eligibility
    B. Attainment Inventory
    C. Maintenance Demonstration
    D. Monitoring Network and Verification of Continued Attainment
    E. Contingency Plan
    F. Transportation and General Conformity
V. Final Action
VI. Statutory and Executive Order Reviews

I. Background

A. Designations

    CO is a colorless, odorless gas emitted from combustion processes.
Nationally and, particularly in urban areas, the majority of CO
emissions to ambient air come from mobile sources. CO can cause harmful
health effects by reducing oxygen delivery to the body's organs (like
the heart and brain) and tissues. At extremely high levels, CO can
cause death.
    EPA initially established the CO NAAQS on April 30, 1971 (36 FR
8186). The primary standards, protective of public health, were set at
9 parts per million (ppm) as an 8-hour average, and 35 ppm, as a 1-hour
average, neither to be exceeded more than once per year. Later in 1971,
EPA set the secondary standards identical to the primary standards for
protection of the public welfare. See 40 CFR 50.8. In a review of the
standards completed in 1985 (50 FR 37484, September 13, 1985), EPA
retained the primary standard, but revoked the secondary standard due
to lack of evidence of direct adverse effect on public welfare at or
near ambient concentrations. Although the air quality criteria have
changed over the past two decades, the CO primary standard has been
retained without revision.
    On September 12, 1978 (43 FR 40513), EPA designated for the first
time portions of Allegheny County as a CO nonattainment area, referred
to as the Pittsburgh Area. The Pittsburgh Area

was defined to include the high traffic density areas within the
Central Business District of Allegheny County and certain other high
traffic density areas. The Central Business District is defined as the
area enclosed by the Allegheny River, the Monongahela River, and 579
interstate highway, while ``the other high traffic density areas'' are
defined as the Oakland neighborhood of Pittsburgh, Pennsylvania.
    As part of the 1990 CAA Amendments, a provision was added under
section 186(a) which authorized EPA to classify nonattainment areas
according to the degree of severity of the nonattainment problem.
Specifically, CAA section 186(a)(1) provides that each area designated
nonattainment for CO should be classified at the time of such
designation as ``Moderate'' (9.1-16.4 ppm) or ``Serious'' (16.5 ppm and
above) based on the design value of the area. Additionally, under
section 107(d)(a)(C), at the date of enactment of the 1990 CAA
Amendments, all areas of the country were designated with respect to
ozone and CO in accordance with the pre-enactment designations by
operation of the law.
    On November 6, 1991 (56 FR 56694), EPA made final designations and
classifications for all areas in the country for all the six criteria
pollutants. The designations and classifications for CO (post-enactment
of 1990 CAA Amendments) were based on quality assured air monitoring
data for years 1988-1989. The Pittsburgh Area maintained its pre-
enactment designation as a CO nonattainment area by operation of law.
In this designation process, EPA determined that the Pittsburgh Area
was a ``nonclassifiable'' area with respect CO NAAQS, based on the fact
that the 1988-1989 air quality design values for the Area were below
the lowest CO nonattainment classification of ``Moderate'' (below 9.1
ppm).

B. Compliance With the CO NAAQS

    A monitor is meeting the CO NAAQS if over a 2-year period the
second-highest 1-hour value is less than or equal to 35 ppm, and the
second-highest, non-overlapping 8-hour value is less than or equal to 9
ppm. These calculated values are referred as the 1-hour and the 8-hour
design value, respectively. A design value is calculated to compare to
the NAAQS and determine compliance. The CO design values are usually
discussed in terms of the 8-hour CO NAAQS, rather than the 1-hour
NAAQS, because the 8-hour NAAQS is typically the standard of concern.
The design value of an area is the highest site-specific design value
of the monitors located within the area. A CO nonattainment area is
considered for redesignation if the design value of the Area is below
the standards, that is, if there are no violations of the CO NAAQS for
two consecutive years. The method for calculating CO design values is
presented in detail in EPA's June 18, 1990 memorandum, ``Ozone and
Carbon Monoxide Design Value Calculations.''

C. Redesignation to Attainment and Maintenance Plan

    EPA may redesignate areas to attainment if sufficient monitoring
data are available to warrant such change and the area meets the
criteria contained in section 107(d)(3)(E) of the CAA. These criteria
include, among others, a full approval of a maintenance plan that
covers at least 10 years after redesignation, and meets the
requirements of section 175A of the CAA. In addition, section 175A of
the CAA require states to submit a revision to the maintenance plan
eight years after redesignation to provide for maintenance of the NAAQS
for 10 years following the end of the first 10-year maintenance period.
To address potential future NAAQS violations, the maintenance plan must
contain contingency measures, with a schedule for implementation
adequate to assure prompt correction of any air quality problems.
    On August 17, 2001, the Commonwealth submitted to EPA a
redesignation request and a maintenance plan for the Pittsburgh Area
for the CO NAAQS. EPA allowed the Commonwealth to develop a ``limited
maintenance plan'' (LMP) for the Pittsburgh Area in addressing the
maintenance plan requirements, and thus meeting the applicable
requirements for redesignation. According to EPA's October 6, 1995
guidance ``Limited Maintenance Plan Option for Nonclassifiable CO
Nonattainment Areas,'' the LMP option is only available to
nonclassifiable CO nonattainment areas with design values at or below
the 85 percent (%) of the level of the 8-hour CO NAAQS, or 7.65 ppm.
The LMP option allows the areas meeting this requirement to submit a
less rigorous maintenance plan than generally required for the CO
NAAQS. Since the Pittsburgh Area was designated as a
``nonclassifiable'' nonattainment area and the Area's 8-hour design
value at the time of redesignation was 3.9 ppm, based on 1998-1999
quality assured air monitoring data, EPA concurred with the
Commonwealth's determination of submitting an LMP for the Area. On
November 12, 2002 (67 FR 68521), EPA granted the Commonwealth's
redesignation request and approved as a SIP revision the maintenance
plan for the Pittsburgh Area. The SIP revision ensured maintenance of
the standard until January 2013.
    On July 18, 2011, the Commonwealth submitted as a SIP revision a
second 10-year CO maintenance plan for the Pittsburgh Area. In
recognition of the continuing record of monitoring data showing ambient
CO 8-hour concentrations in the Pittsburgh Area well below 7.65 ppm,
ACHD once more chose the LMP option for the development of this second
maintenance plan. Further discussion of the maintenance plan
requirements and the LMP option is provided in section II of this
rulemaking action.

II. EPA's Requirements

    Section 175A defines the general framework of a maintenance plan.
The maintenance plan will constitute a SIP revision and must provide
for maintenance of the relevant NAAQS for at least 10 years after
redesignation. Section 175A further states that the plan shall contain
such additional measures, if any, as may be necessary to ensure such
maintenance. In addition, the maintenance plan should contain such
contingency measures as EPA deems necessary to ensure prompt correction
or any violation of the NAAQS.
    For nonclassifiable CO areas seeking redesignation to attainment
whose design value at the time of redesignation is 85 percent or less
than the 8-hour CO NAAQS, or 7.65 ppm, a state may choose to submit a
less rigorous maintenance plan than generally required. This option is
termed a LMP. EPA believes that the full maintenance plan requirements
do not need to be applied to these areas because they have achieved air
quality levels well below the standard without application of control
measures required by the CAA for moderate and serious nonattainment
areas. Also, these areas do not have either a recent history of
monitored violations of the CO NAAQS or a long prior history of
monitored air quality problems for CO. Therefore, EPA believes that for
a limited maintenance area, the air quality along with the continued
applicability of the prevention of significant deterioration (PSD)
permitting requirements, any control measures already in the SIP, and
Federal measures, should provide adequate assurance of maintenance over
the10-year maintenance period. The same applies for areas submitting
their second maintenance plans.
    To qualify for the LMP option, the CO design value for the area,
based on the

eight consecutive quarters (two years of data) used to demonstrate
attainment must be at or below 7.65 ppm for the 8-hour CO NAAQS.
Additionally, the design value for the area must continue to be at or
below the 7.65 ppm for the 8-hour CO NAAQS until the time of EPA's
final action. According to EPA's October 6, 1995 guidance ``Limited
Maintenance Plan Option for Non-classifiable CO Nonattainment Areas,''
a LMP submittal must include: An attainment emissions inventory, a
maintenance demonstration, a verification of continued attainment,
contingency measures, and transportation conformity determination.
    As for any maintenance plan, the state should develop an attainment
emissions inventory to identify the level of emissions in the area
which is sufficient to attain the NAAQS. This inventory should be
consistent with EPA's most recent guidance on emissions inventories for
nonattainment areas available at the time and should include the
emissions during the time period associated with the monitoring data
showing attainment. Emissions of CO are generally expected to be the
highest during the winter season. Thus, for CO nonattainment areas, the
inventory should be based on actual ``typical winter day'' emissions
for the time period associated with the monitoring data showing
attainment of the standard. For more information on developing seasonal
CO emissions inventories, refer to EPA's guidance documents ``Emissions
Inventory Requirements for Carbon Monoxide State Implementation Plans''
(EPA-450/4-91-011, March 1991) and ``Procedures for the Preparation of
Emissions Inventories for Carbon Monoxide and Precursors of Ozone;
Volume I'' (EPA-450/4-91-016, May 1991).
    In LMP, the maintenance demonstration requirement is considered to
be satisfied if the monitoring data show that the area is meeting the
air quality criteria for a limited maintenance area, 7.65 ppm. The
design value requirement is expected to provide adequate assurance of
maintenance over the 10-year period. The maintenance demonstration does
not require the state to project emissions over the maintenance period.
In LMP, to verify the attainment status of the area over the
maintenance period, the state must show continuous operation of an
appropriate EPA-approved air quality monitoring network, in accordance
with 40 CFR part 58.
    As for any maintenance plan, the state is required to adopt
contingency provisions, as necessary, to promptly correct any violation
of the NAAQS that occurs after redesignation of the area. In order for
the maintenance plan to be approved, a state is not required to have
full adopted contingency measures that will take effect without further
action by the state; however, the contingency plan is considered to be
an enforceable part of the SIP and should ensure that the contingency
measures are adopted expediently once they are triggered. The plan
should clearly identify the measures to be adopted, a schedule and
procedure for adoption and implementation, and a specific time limit
for action by the state. As necessary, the state should also identify
specific indicators, or triggers, which will be used to determine when
the contingency measures need to be implemented.
    Transportation conformity is required under section 176(c) of the
CAA to ensure that Federally supported highway, transit projects, and
other activities are consistent with (conform to) the purpose of the
SIP. The CAA requires Federal actions in nonattainment and maintenance
areas to ``conform to'' the goals of the SIP. This means that such
actions will not cause or contribute to violations of a NAAQS; worsen
the severity of an existing violation; or delay timely attainment of
any NAAQS or any interim milestone. EPA has established criteria and
procedures for Federal agencies to follow in determining conformity of
their actions. EPA's rule governing transportation plans and Federally
supported highway, transit projects, and other activities is referred
to as the Transportation Conformity Rule (See 40 CFR part 93, subpart
A), and EPA's rule governing all other types of Federal agency actions
is referred to as the General Conformity Rule (See 40 CFR part 93,
subpart B).
    Under the Transportation Conformity Rule, metropolitan planning
organizations (MPOs) in nonattainment and maintenance areas coordinate
with state air quality and transportation agencies, EPA, Federal
Highway Administration (FHWA), and Federal Transit Administration (FTA)
to demonstrate that their metropolitan transportation plans and
transportation improvement plans conform to applicable SIPs. This is
typically determined by showing that estimated emissions from existing
and planned highway and transit systems are less than or equal to the
motor vehicle emissions budgets (MVEBs) contained in a SIP. While EPA's
LMP option does not exempt an area from the need to affirm conformity,
the area may demonstrate conformity without submitting an emissions
budget. Under the LMP option, the emissions budgets are essentially not
constraining for the length of the maintenance period, because it is
unreasonable to expect that the qualifying area will experience so much
growth in that period that a violation of the CO NAAQS would result.
For this reason, any Federal actions requiring conformity
determinations under the Transportation Conformity Rule could be
considered to satisfy the ``budget test,'' required in 40 CFR
93.158(a)(5)(i)(A), 93.118, 93.119, and 93.120. While not subject to
the budget test, the limited maintenance areas remain subject to other
transportation conformity requirements of 40 CFR part 93, subpart A.

III. Summary of SIP Revision

    On July 18, 2011, PADEP submitted, on behalf of ACHD, a SIP
revision which was then supplemented on November 26, 2013. The SIP
revision consists of the second 10-year update to the CO NAAQS
maintenance plan for the Pittsburgh Area, as required by CAA section
175A(b). The July 18, 2011 submission included a maintenance
demonstration, a verification of continued attainment, and a
contingency plan. The November 26, 2013 supplemental SIP revision
included the attainment emissions inventory. The submittals also
include appendices that explain the methodology used for developing
emissions inventories, a technical support document, and evidence of
public notice, public hearing, response to comments, and adoption of
the plan. The maintenance plan also carries forward essentially the
same contingency plan as contained in the initial maintenance plan. A
more detailed summary of Pennsylvania's SIP submittal may be found in
EPA's Technical Support Document (TSD) for this rulemaking action,
which is available online at www.regulations.gov, Docket number EPA-
R03-OAR-2012-0248.

IV. EPA's Evaluation

A. Limited Maintenance Plan Eligibility

    Monitoring data shows that the Pittsburgh Area continues to attain
the CO NAAQS. Table 1 presents the historic CO 8-hour design values
(i.e., the second highest 8-hour average CO levels) for the CO
monitoring sites in the Area over the 1988-2013 period, as recorded in
EPA's Air Quality System (AQS) and included in the submittal. As shown,
the second highest 8-hour CO

average concentrations recorded at all monitoring stations in the
Pittsburgh Area have remained below 7.65 ppm since 1994. In addition,
ACHD reported that the 1-hour CO NAAQS has not been violated in the
Pittsburgh Area since 1980, and has been below 15 ppm since 1988. Thus,
monitoring data show that the Pittsburgh Area continues to be eligible
for the LMP option.

       Table 1--Pittsburgh Area's CO Second Highest 8-Hour Average Concentrations During 1988-2013, in ppm
----------------------------------------------------------------------------------------------------------------
                                                            Forbes Avenue at   Gateway Center      Flag Plaza
                                          Oakland \a\ (42-    Grant Street     Subway Entrance  (Bedford Avenue)
                  Year                        003-0026)     (Courthouse) (42- (Point) \b\ (42-    \b\ (42-003-
                                                                003-0038)         003-0052)           0031)
----------------------------------------------------------------------------------------------------------------
1988....................................               8.4               6.6               6.5  ................
1989....................................               6.5               7.8               6.7  ................
1990....................................               6.9               8.1               6.5  ................
1991....................................               5.0               6.2               6.6  ................
1992....................................               7.7               7.8               6.7  ................
1993....................................               4.8               6.2               5.2  ................
1994....................................               5.6               7.5               6.8  ................
1995....................................               4.3               5.9               3.8  ................
1996....................................               5.0               4.8               3.9  ................
1997....................................               2.5               3.9               2.9  ................
1998....................................  ................               4.9               3.1  ................
1999....................................  ................               4.0               3.1  ................
2000....................................  ................               3.5               2.6  ................
2001....................................  ................               3.4  ................  ................
2002....................................  ................               2.9  ................  ................
2003....................................  ................               3.5  ................               2.2
2004....................................  ................               2.5  ................               1.9
2005....................................  ................               2.3  ................               1.8
2006....................................  ................               2.1  ................               1.8
2007....................................  ................               3.5  ................               1.3
2008....................................  ................               1.6  ................               1.3
2009....................................  ................               1.5  ................               1.3
2010....................................  ................               1.7  ................               1.2
2011....................................  ................               1.6  ................               1.4
2012....................................  ................               1.7  ................               1.5
2013\c\.................................  ................               1.5  ................               1.4
----------------------------------------------------------------------------------------------------------------
Source: Pennsylvania's July 18, 2011 SIP submittal and EPA's January 9, 2014 AQS Reports AMP450.
\a\ The CO monitor at the Oakland site (AQS ID: 42-003-0026) was terminated in October 1997, as approved by EPA.
\b\ EPA approved the removal of the CO monitor at the Gateway Center Subway Entrance (Point) (AQS ID: 42-003-
  0052) in May 2000 and its relocation to the Flag Plaza (AQS ID: 42-003-0031) near the Civic Arena, which
  started operating in 2003.
\c\ Air quality monitoring data for 2013 is preliminary.

B. Attainment Emissions Inventory

    For the CO maintenance plan, ACHD developed a 2008 attainment
emissions inventory to identify the level of actual emissions in the
Pittsburgh Area that is sufficient for the Area to continue to attain
the CO NAAQS. The Pittsburgh Area's CO attainment inventory is based on
the latest available planning assumptions for 2008, reflecting typical
winter day CO emissions for the Area. ACHD selected the 2008 year for
its attainment emissions inventory because it contained at the time of
submittal the most current and comprehensive emissions estimates that
were representative of actual emissions in Allegheny County, and
because during this time the air quality was showing maintenance of the
CO NAAQS in the Area. The 2008 emissions inventory is based on EPA's
2008 National Emissions Inventory (NEI) (Version 2, April 10, 2012) for
the months of January, February and December, and seasonal adjustment
factors were applied as necessary.
    The 2008 attainment inventory contains CO typical winter day
emissions estimates of point, area, mobile onroad and mobile nonroad
sources in the Area. The primary source of CO emissions in the
Pittsburgh Area is the onroad (highway) sources, contributing to 54% of
total CO emissions of the Area. Table 2 provides a summary of the 2008
attainment inventory submitted with the maintenance plan. For a more
detailed evaluation of the 2008 emissions inventory, see EPA's TSD
dated February 4, 2014 for this rulemaking action, which is available
online at www.regulations.gov, Docket number EPA-R03-OAR-2012-0248.

  Table 2--Pittsburgh Area's CO 2008 Attainment Emissions Inventory, in
                           Tons Per Day (tpd)
------------------------------------------------------------------------
                                                           CO typical
                    Source category                        winter day
                                                            emissions
------------------------------------------------------------------------
Point.................................................             22.76
Area..................................................             57.65
Onroad................................................            396.38
Nonroad...............................................             96.99
                                                       -----------------
    Total.............................................            573.78
------------------------------------------------------------------------

C. Maintenance Demonstration

    Under the LMP option, there is no requirement to project emissions
over the 10-year maintenance period for the Pittsburgh Area, as long as
the Area continues to have CO air quality at or below 7.65 ppm. The
monitoring data presented in Table 1 show that the Pittsburgh Area has
historically measured and continues to measure concentrations below
7.65 ppm. The continuous downward trend in CO monitoring data in the
Area has

demonstrated that air quality improvements can be attributed to
permanent, enforceable reductions of CO emissions. In addition, EPA
acknowledges that Allegheny County has a SIP-approved PSD permitting
program (78 FR 13493, February 18, 2013), which prevents increase of CO
emissions from construction or modification of major stationary
sources. EPA believes that the LMP eligibility together with the
continuation of existing CO emissions control programs, sufficiently
and adequately demonstrate that the Pittsburgh Area will maintain the
CO NAAQS through the second 10-year maintenance period and beyond.
    Although not required, ACHD included a maintenance demonstration as
part of its second maintenance plan to show maintenance of the CO NAAQS
during the second 10-year period for the Pittsburgh Area. ACHD used
projected inventories to show that the Pittsburgh Area continues to
remain in attainment and developed projected inventories for an interim
year of 2013 and a maintenance end year of 2022. The projected 2013 and
2022 emissions inventories include typical winter day CO emissions
estimates only for the onroad sources in the Pittsburgh Area. As
mentioned earlier in this rulemaking action, this sector constitutes
the primary emissions source category in the Pittsburgh Area, thus
emissions reductions from this source category should be sufficient to
demonstrate maintenance of the CO NAAQS for the Area. The projected
2013 and 2022 onroad emissions inventories were developed with EPA's
latest highway emissions model at the time of submittal, MOVES2010a,\1\
in accordance with EPA's ``Technical Guidance on the Use of MOVES2010a
for Emission Inventory Preparation in State Implementation Plans and
Transportation Conformity.''
---------------------------------------------------------------------------

    \1\ MOVES2010 is a computer model designed by EPA to estimate
air pollution emissions and emissions inventories of various
pollutants and precursors from on-road mobile sources for SIP and
transportation conformity purposes. MOVES2010 was designed to
replace the previous emissions model, MOBILE6.2, which was released
in 2004 (69 FR 28830). MOVES2010 was released on March 2, 2010 (75
FR 9411), while MOVES2010a, a minor revision to enhance model
performance, was released subsequently on September 8, 2010. ACHD
used MOVES2010a in developing the projected emissions inventories.
---------------------------------------------------------------------------

    ACHD used growth rates based on 2008 local traffic data and
socioeconomic forecasts to project traffic parameters to 2013 and 2022
data. Daily and monthly seasonal factors were used to adjust traffic
data to a typical winter day. The projected inventories take into
account control measures which were in place in 2008 and are expected
to be in place throughout 2022 for Allegheny County, which include: The
National Low Emission Vehicle Program (NLEV) and Federal Tier II Low
Sulfur Program, emissions standards for medium and heavy duty vehicles
in 2002, 2004, 2007, and 2011, Stage II and Onboard Refueling Vapor
Recovery (ORVR), and the Pennsylvania Clean Vehicles (PCV) Program
(PaCode, Title 25, Chapter 126) that incorporates the California Low
Emission Vehicle Program (CA LEVII).
    After thorough review of the methodology and data assumptions used
by ACHD, EPA finds that the 2013 and 2022 emissions inventories were
developed in conformance with EPA's guidance, and therefore, are
approvable as part of the maintenance demonstration. A summary of the
projected onroad CO emissions inventories for the Pittsburgh Area is
provided in Table 3. A more detailed evaluation and EPA's rationale for
approving the 2013 and 2022 inventories may be found in EPA's TSD for
this rulemaking action, which is available online at
www.regulations.gov, Docket number EPA-R03-OAR-2012-0248.

    Table 3--Pittsburgh Area's CO Projected 2013 and 2022 Vehicle Miles Traveled (VMT) and Typical Winter Day
                                      Emissions for Onroad Sources, in tpd
----------------------------------------------------------------------------------------------------------------
                          2013                                                     2022
----------------------------------------------------------------------------------------------------------------
                                CO typical winter day                                    CO typical winter day
            VMT                       emissions                       VMT                      emissions
----------------------------------------------------------------------------------------------------------------
           25,727,530                       394.53                   28,377,731                      336.27
----------------------------------------------------------------------------------------------------------------

    The purpose of the maintenance demonstration is to show that future
CO emissions will remain at or below the 2008 attainment emissions
levels for the Pittsburgh Area through the 2022 maintenance plan end
year. Table 4 provides a comparison of the CO emissions inventories for
the Pittsburgh Area for the 2008 attainment year, the 2013 interim
year, and the 2022 maintenance plan end year. Despite the projected
increase in VMT (see Table 3) in the Area, the inventories show that
the CO emissions between 2008 and 2022 for the Area are projected to be
reduced by 15 percent, due to the implementation of the vehicle control
measures in Allegheny County. EPA finds that the maintenance
demonstration shows that the Pittsburgh Area will continue to maintain
the CO NAAQS during the second maintenance period, throughout 2022.

 Table 4--Comparison of the 2008, 2013, and 2022 CO Typical Winter Day Emissions Inventories for Onroad Sources
                                         in the Pittsburgh Area, in tpd
----------------------------------------------------------------------------------------------------------------
                    Emissions of onroad sources                                  Emissions reductions
----------------------------------------------------------------------------------------------------------------
         2008                   2013                   2022                2008-2013              2008-2022
----------------------------------------------------------------------------------------------------------------
            396.38                 394.53                 336.27                   1.85                  60.11
----------------------------------------------------------------------------------------------------------------

D. Monitoring Network and Verification of Continued Attainment

    In accordance with 40 CFR part 58, ACHD operates and maintains an
EPA-approved CO monitoring network in the Pittsburgh Area, in order to
verify attainment of the CO NAAQS and ensure the need to trigger
contingency measures. Currently, the monitoring network consists of two
monitoring sites: The Forbes Avenue and Grant Street site (AQS ID: 42-
003-0038) and

the Flag Plaza site (AQS ID: 42-003-0031), whose data is eligible for
comparison to the CO NAAQS.
    EPA believes ACHD's current CO monitoring network is adequate to
verify continued attainment of the CO NAAQS in the Pittsburgh Area.
ACHD has committed to continue maintaining a CO monitoring network in
accordance with EPA's requirements.

E. Contingency Plan

    The Pittsburgh Area's second CO maintenance plan carries forward
the same contingency provisions that were included in the first
maintenance plan and previously approved by EPA. As a triggering event
for implementation of the contingency measures of this plan, a verified
ambient CO concentration for an 8-hour period over the 8-hour CO NAAQS,
or 9.00 ppm, must be recorded at least twice at one monitor station
from November to February. In the event of a violation of the 8-hour CO
NAAQS, a ``vehicle idling restriction'' will be implemented as a
contingency measure. The vehicle idling restriction is applicable from
November to February throughout Allegheny County and consists of
limiting to five minutes the amount of time that a gasoline engine
vehicle is permitted to idle. This restriction will have the following
exceptions: The need for heating and powering of refrigeration systems
on trucks, operation of emergency vehicles and vehicles that are
motionless due to traffic conditions beyond operator's control. Three
(3) months after ACHD records a violation or once EPA notifies ACHD
that this contingency measure must be implemented, ACHD will adopt
within 12 months the vehicle idling restriction as a regulation. The
regulation will be implemented within 8 months after adoption. In the
future, ACHD may request EPA to consider the approval of alternative
contingency measures by providing a demonstration that the alternative
measures will provide an air quality and public health benefit equal to
or greater than that resulting from the implementation of the idling
restriction. EPA finds this contingency measure approvable for purposes
of satisfying CAA section 175A.

F. Transportation Conformity

    ACHD did not submit any MVEBs with the Pittsburgh Area's CO second
maintenance plan. However, EPA believes that the second maintenance
plan demonstrates that it is unreasonable to expect that the Area would
experience enough growth in motor vehicle (onroad) emissions for a
violation of the CO NAAQS to occur, and on that basis, EPA is proposing
to approve this plan for transportation conformity purposes. In
accordance with the Transportation Conformity Rule, after EPA's
approval of this limited maintenance plan, there will be no requirement
for ACHD to satisfy the regional emissions analysis with respect to CO
under 40 CFR 93.118 and/or 40 CFR 93.119 in determining the conformity
of transportation plans, programs and projects in the Pittsburgh Area.
See 40 CFR 93.109(e).

V. Final Action

    EPA finds that the Pittsburgh Area second CO maintenance plan
concurs with EPA's guidance for limited maintenance plans and thus,
satisfies the requirements of CAA section 175A. EPA is approving as an
update to the Pennsylvania SIP the Pittsburgh Area CO second
maintenance plan, which was submitted as a SIP revision by the
Commonwealth of Pennsylvania on July 18, 2011 and supplemented on
November 26, 2013. The plan demonstrates maintenance of the CO NAAQS in
the Pittsburgh Area for a second 10-year period after redesignation,
through year 2022.
    EPA is publishing this rule without prior proposal because EPA
views this as a noncontroversial amendment and anticipates no adverse
comment. However, in the ``Proposed Rules'' section of today's Federal
Register, EPA is publishing a separate document that will serve as the
proposal to approve the SIP revision if adverse comments are filed.
This rule will be effective on May 27, 2014 without further notice
unless EPA receives adverse comment by April 28, 2014. If EPA receives
adverse comment, EPA will publish a timely withdrawal in the Federal
Register informing the public that the rule will not take effect. EPA
will address all public comments in a subsequent final rule based on
the proposed rule. EPA will not institute a second comment period on
this action. Any parties interested in commenting must do so at this
time.

VI. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive 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.

B. Submission to Congress and the Comptroller General

    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).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by May 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. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking action. This action, approving the Pittsburgh Area's CO
second maintenance plan, 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements.

    Dated: March 7, 2014.
W.C. Early,
Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by
revising the entry for Carbon Monoxide Maintenance Plan for the City of
Pittsburgh. The revised text reads as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
   Name of non-regulatory SIP        Applicable                                                    Additional
            revision               geographic area   State submittal date   EPA approval date     explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Carbon Monoxide Maintenance      City of                          8/17/01  11/12/02 67 FR      52.2063(c)(189).
 Plan.                            Pittsburgh--Centr                         68521.
                                  al Business
                                  District &
                                  Oakland.
                                                        7/18/12; 11/26/13  3/27/14 [Insert     Limited
                                                                            page number where   maintenance plan
                                                                            the document        covering the 10-
                                                                            begins].            year period
                                                                                through 2022.

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

* * * * *
[FR Doc. 2014-06697 Filed 3-26-14; 8:45 am]
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[Federal Register Volume 86, Number 84 (Tuesday, May 4, 2021)]
[Notices]
[Page 23774]
[FR Doc No: 2021-09350]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-058, OMB Control No. 3235-0065]

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Form S-1.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form S-1 (17 CFR 239.11) is used by domestic issuers who are not
eligible to use other forms to register a public offering of their
securities under the Securities Act of 1933 (15 U.S.C. 77a et seq.).
The information collected is intended to ensure that the information
required to be filed by the Commission permits verification of
compliance with securities law requirements and assures the public
availability of such information. Form S-1 takes approximately 653.5436
hours per response and is filed by approximately 894 respondents. We
estimate that 25% of the 653.5436 hours per response (163.3859 hours)
is prepared by the registrant for a total annual reporting burden of
146,067 hours (163.3859 hours per response x 894 responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Cynthia
Roscoe, 100 F Street NE, Washington, DC 20549 or send an email to:
<EMAIL_ADDRESS>
    Dated: April 29, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-09350 Filed 5-3-21; 8:45 am]
BILLING CODE 8011-01-P