[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Rules and Regulations]
[Pages 49230-49234]
[FR Doc No: 2021-18995]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2018-C-4117]

Listing of Color Additives Exempt From Certification; Butterfly
Pea Flower Extract

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 an aqueous
extract of butterfly pea flower (Clitoria ternatea) as a color additive
in various food categories at levels consistent with good manufacturing
practice. We are taking this action in response to a color additive
petition (CAP) submitted by Exponent, Inc., on behalf of Sensient
Colors, LLC (Sensient).

DATES: This rule is effective October 5, 2021. See section X for
further information on the filing of objections. Submit either
electronic or written objections and requests for a hearing on the
final rule by October 4, 2021.

ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. Electronic objections must be submitted on or before
October 4, 2021. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
October 4, 2021. Objections received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is 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-2018-C-4117 for ``Listing of Color Additives Exempt From
Certification; Butterfly Pea Flower Extract.'' 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, 240-
402-7500.
     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 comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Stephen DiFranco, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notification published in the Federal Register of November 13,
2018 (83 FR 56258), we announced that we filed a color additive
petition (CAP 8C0313) submitted by Sensient Colors, LLC, c/o Exponent,
Inc., 1150 Connecticut Avenue NW, Suite 1100, Washington, DC 20036. The
petition proposed to amend the color additive regulations in part 73
(21 CFR part 73), ``Listing of Color Additives Exempt from
Certification,'' to provide for the safe use of an aqueous extract of
butterfly pea flower (Clitoria ternatea) as a color

additive in: (1) Alcoholic beverages (liquor, liqueurs, and flavored
alcoholic beverages); \1\ (2) ready-to-drink non-alcoholic beverages;
(3) liquid coffee creamers (dairy and non[hyphen]dairy); (4) ice cream
and frozen dairy desserts; (5) fruit preparation in yogurt; (6) chewing
gum; (7) coated nuts; (8) hard candy; and (9) soft candy, at levels
consistent with good manufacturing practice (GMP).
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    \1\ The proposed scope was subsequently amended to include all
alcoholic beverages.
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    The petition describes butterfly pea flower extract as a dark blue
water-soluble extract derived from the flower petals of Clitoria
ternatea.

II. Background

    The color additive that is subject of this petition is the dark
blue liquid produced through the water extraction of the dried flower
petals of Clitoria ternatea, commonly known as the butterfly pea plant.
Butterfly pea flower extract contains 42 to 62 percent water, 22 to 43
percent carbohydrates, and 8 to 12 percent proteins. The principal
coloring components in butterfly pea flower extract are anthocyanins,
mainly delphinidin derivatives. The extract also contains flavonols,
mainly quercetin and kaempferol derivatives as minor components. These
anthocyanins and flavonols are naturally present in various fruits and
vegetables commonly consumed in the U.S. diet (Ref. 1).
    The color additive is manufactured by sourcing dried flowers of
Clitoria ternatea. An infusion is prepared by adding demineralized
water to the flower petals, which is separated from the plant mass via
filtration. The butterfly pea flower extract is further processed by
ultrafiltration to remove any residues of plant products greater than
2,500 daltons (Da). The extract is then concentrated to a standardized
liquid with an anthocyanin content of approximately 2 percent and
pasteurized. Citric acid may be added to control the pH of the extract
(Ref. 2).
    The petitioner proposed specifications for butterfly pea flower
extract of less than 1 milligram per kilogram (mg/kg) (1 part per
million (ppm)) of arsenic, less than 1 mg/kg (1 ppm) of cadmium, less
than 1 mg/kg (1 ppm) of lead, and less than 1 mg/kg (1 ppm) of mercury,
and pH 3.75  0.75 in the butterfly pea flower extract. Upon
consideration of the data in the petition and other information
available to FDA, we amended the proposed specification for pH to not
less than 3.0 and not more than 4.5 at 25 [deg]C (Ref. 2).
    The petitioner manufactures the extract starting with butterfly pea
flowers grown without the use of added pesticide substances. The
petition provides data to support its assertion that no detectable
levels of 340 substances commonly used as pesticide are found in the
finished extract. The flowers were analyzed using the California
Department of Food and Agriculture multi-residue pesticide analysis
(Ref. 3).
    Currently, there are no residual pesticide tolerance levels for
Clitoria ternatea codified by the U.S. Environmental Protection Agency
in 40 CFR part 180. In cases where no tolerance levels are set, the
allowable residual pesticide levels that may remain on the raw
agricultural commodity are zero (40 CFR 180.5). Under section
402(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 342(a)(2)(B)), food is adulterated if it bears or contains
pesticide chemical residue that is unsafe within the meaning of section
408(a) of the FD&C Act (21 U.S.C. 346a(a)).

III. Safety Evaluation

    Under section 721(b)(4) of the FD&C Act (21 U.S.C. 379e(b)(4)), a
color additive may not be listed for a proposed use unless the data and
information available to FDA establish that the color additive is safe
for that use. Our color additive regulations at 21 CFR 70.3(i) define
``safe'' to mean that there is convincing evidence establishing with
reasonable certainty that no harm will result from the intended use of
the color additive.
    To determine whether a color additive is safe under the general
safety clause, the FD&C Act requires FDA to conduct a fair evaluation
of the available data and consider, among other relevant factors: (1)
Probable consumption of, or other relevant exposure from, the additive
and of any substance formed in or on food, drugs or devices, or
cosmetics because of the use of the additive; (2) cumulative effect, if
any, of such additive in the diet of man or animals, taking into
account chemically or pharmacologically related substance or substances
in such diet; and (3) safety factors recognized by experts ``as
appropriate for the use of animal experimentation data'' (see section
721(b)(5)(A) through (C) of the FD&C Act).
    As part of our safety evaluation to establish with reasonable
certainty that a color additive is not harmful under its intended
conditions of use, we consider the additive's manufacturing and
stability; the projected human dietary exposure to the additive and any
impurities resulting from the petitioned use of the additive; the
additive's toxicological data; and other relevant information (such as
published literature) available to us.

IV. Safety of Petitioned Use of the Color Additive

A. Exposure Estimate

    The petitioner requested that butterfly pea flower extract be
permitted at levels consistent with GMP and provided the maximum use
levels for the color additive, representing GMP, for each proposed food
use (Ref. 4). The petitioner used food consumption data from the 2011-
2014 National Health and Nutrition Examination Survey (NHANES) to
estimate exposure to butterfly pea flower extract from the proposed
uses. Upon further clarification of the proposed uses to include all
alcoholic beverages (Ref. 5), we amended the petitioner's exposure
estimate to include all alcoholic beverages (Ref. 4).
    Using food consumption data from the 2011-2014 NHANES, we estimated
the eaters-only exposure to butterfly pea flower extract to be 198
milligrams per person per day (198 mg/p/d) at the mean and 453 mg/p/d
at the 90th percentile for the U.S. population aged 2 years and older
and 56 mg/p/d at the mean and 118 mg/p/d at the 90th percentile for
children 2 to 5 years of age (Ref. 4).
    The petition indicated that butterfly pea flower extract could
contain up to 2 percent anthocyanins (by weight). Assuming a maximum of
2 percent, we estimated the dietary exposure to anthocyanins from the
proposed uses to be 4 mg/p/d at the mean and 9 mg/p/d at the 90th
percentile for the U.S. population 2 years of age and older (Ref. 4).
Because delphinidin was stated to be the principal anthocyanin in
butterfly pea flower extract, the exposure to anthocyanins represents
the exposure to delphinidin from the proposed uses of butterfly pea
flower extract.
    Similarly, we estimated the dietary exposure to quercetin resulting
from the proposed uses of butterfly pea flower extract. The petition
indicates that butterfly pea flower contains approximately 3 percent
(by weight) of flavonols, which are comprised of various quercetin and
kaempferol derivatives. We conservatively presumed that all the
flavonols present in butterfly pea flower extract were present as
quercetin (see below) and estimated quercetin exposure to be 6 mg/p/d
at the mean and 14 mg/p/d at the 90th percentile for the U.S.
population 2 years of age and older (Ref. 4).

B. Toxicological Considerations

    To establish that butterfly pea flower extract is safe for use as a
color additive for the proposed uses, the petitioner used a weight-of-
evidence approach based on: (1) Toxicological information about the
extract's major coloring component, delphinidin, including a 2013
European Food Safety Authority (EFSA) review of anthocyanins (Ref. 6);
(2) a 28-day subacute range finding feeding study in rats; (3) a 90-day
feeding study in rats; (4) a bacterial reverse mutation test and an in
vitro micronucleous test addressing possible mutagenicity and
genotoxicity of butterfly pea flower extract; (5) an in vivo somatic
mutation and recombination test conducted on the unprocessed butterfly
pea flower parts; (6) in vivo genotoxicity data from published
literature on anthothyanins (including delphinidin) and flavonol
components (Refs. 7 and 8); (7) clinical human studies of anthocyanins
(including delphinidin) and spray-dried butterfly pea flower extract;
(8) clinical studies of quercetin and kaempferol, the primary flavonols
present; (9) a proteomic assessment of butterfly pea flower extract
aimed at establishing that cyclotides found in the tissues of Clitoria
ternatea are not present in the butterfly pea flower extract; and (10)
an allergenicity assessment of butterfly pea flower extract.
    We reviewed the oral toxicity studies and agree with the
petitioner's conclusions that the no observed adverse effect level in
the 90-day study is the highest dose tested (3,500 mg/kg/d of butterfly
pea flower extract), which is nearly 500-fold of the 90th percentile
daily exposure for U.S. population 2 years and older (Ref. 9). While
chronic studies were not provided by the petitioner nor available from
the published literature, we believe that chronic toxicity from the
intended use of butterfly pea flower extract is unlikely because: (1)
We did not identify any potential toxicity effects associated with the
use of either butterfly pea flower extract or its anthocyanins and
flavonol components from literature that warrant further chronic
toxicity studies (Refs. 9 and 10); (2) the systemic oral absorption of
anthocyanins and flavonols is generally low (Ref. 9); (3) there are
available human clinical studies indicating that the main anthocyanins
and flavonol components of butterfly pea flower extract are well
tolerated in humans (Ref. 9); and (4) anthocyanins and flavonols are
naturally present and widely distributed in many plants used as food,
and the exposures to anthocyanins and flavonols from the use of
butterfly pea flower extract were estimated to be comparable or lower
than the exposure from a typical diet (Ref. 11).
    We also did not find any scientific data suggesting reproductive or
developmental toxicity; moreover, the genotoxicity studies demonstrate
that butterfly pea flower extract is non-mutagenic and non-genotoxic
(Ref. 9).
    Based on the totality of evidence and a weight of evidence analysis
that considered the lack of overall genotoxicity, mode of action, and
the level of exposure, we conclude that butterfly pea flower extract is
not likely to pose a carcinogenic risk to humans at its intended use
levels (Refs. 9 and 10).
    Among the available relevant clinical studies, one study of
butterfly pea flower extract indicated no acute adverse effect at doses
up to 2 grams per person. Other clinical studies, using either
anthocyanins or flavonols, suggested tolerance at doses much higher
than the exposure level from the consumption of butterfly pea flower
extract under the intended condition of use (Ref. 9).
    The petitioner provided analytical evidence demonstrating that the
cyclotides identified in butterfly pea flower petals were not detected
in the butterfly pea flower extract. Therefore, there is no toxicity
concern for cyclotides from the consumption of the extract (Ref. 9).
    Although there is no evidence in the scientific literature
specifically suggesting that either Clitoria ternatea flowers or the
coloring component delphinidin is associated with allergic or
hypersensitive reactions, we note that butterfly pea flower extract
contains 8 to 12 percent protein by weight. To address the
allergenicity potential of butterfly pea flower extract, the petitioner
provided bioinformatic analyses of the 193 protein sequences of
Clitoria ternatea identified in the National Center for Biotechnology
Information protein database. These protein sequences were compared for
similarity with the known allergenic protein sequences collected in the
AllergenOnline database (Ref. 12). The analysis revealed five protein
sequence matches (defined as 35 percent or higher identity over an 80-
amino-acid sliding window); however, these proteins are expected to be
over 5,000 Da and not likely to pass through the 2,500 Da
ultrafiltration system used in the manufacturing process. To mitigate
the possible risk that allergenic proteins and other large peptides
might pose, our regulation at 21 CFR 73.69(a)(1) requires that the
aqueous extract used to produce the color additive undergo
ultrafiltration. We agree with the petitioner that the totality of the
evidence supports the conclusion that it is extremely unlikely that the
proteins in butterfly pea flower extract could act as allergens (Ref.
9).

V. Conclusion

    Based on the data and information in the petition and other
available relevant information, we conclude that the petitioned use of
butterfly pea flower extract as a color additive in: Alcoholic
beverages, sport and energy drinks, flavored or carbonated water, fruit
drinks (including smoothies and grain drinks), carbonated soft drinks
(fruit-flavored or juice, ginger ale, and root beer), fruit and
vegetable juice, nutritional beverages, chewing gum, teas, coated nuts,
liquid coffee creamers (dairy and non-dairy), ice cream and frozen
dairy desserts, hard candy, dairy and non-dairy drinks, fruit
preparations in yogurts, and soft candy is safe, provided the amount of
butterfly pea flower extract does not exceed levels consistent with
good manufacturing practice.
    We further conclude that this color additive will achieve its
intended technical effect and is suitable for the petitioned use.
Therefore, we are amending the color additive regulations in part 73 to
provide for the safe use of this color additive as set forth in this
document. In addition, based on the factors in 21 CFR 71.20(b), we
conclude that batch certification of butterfly pea flower extract is
not necessary to protect the public health.

VI. Public Disclosure

    In accordance with Sec.  71.15 (21 CFR 71.15), 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.  71.15, we
will delete from the documents any materials that are not available for
public disclosure.

VII. Analysis of Environmental Impact

    As stated in the November 13, 2018, Federal Register notification
of filing, the petitioner claimed that this action is categorically
excluded under Sec.  25.32(k) (21 CFR 25.32(k)) because butterfly pea
flower extract would be added directly to food and is intended to
remain in the food through ingestion by consumers and is not intended
to replace macronutrients in food. We further stated that if FDA
determines a categorical exclusion applies, neither an environmental
assessment nor an

environmental impact statement is required. We did not receive any new
information or comments regarding this claim of categorical exclusion.
We considered the petitioner's claim of categorical exclusion and
determined that this action is categorically excluded under Sec.
25.32(k). Therefore, neither an environmental assessment nor an
environmental impact statement is required.

VIII. 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.

IX. Section 301(ll) of the FD&C Act

    Our review of this petition 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 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 color additive.
Accordingly, this final rule should not be construed to be a statement
that a food containing this color 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.

X. 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 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 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.
    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. We will publish notice of the objections that we
have received or lack thereof in the Federal Register.

XI. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are 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. *Wu, X., G. R. Beecher, J. M. Holden, et al.,
``Concentrations of Anthocyanins in Common Foods in the United
States and Estimation of Normal Consumption.'' Journal of
Agricultural and Food Chemistry, 54: 4069-4075, 2006.
    2. *Memorandum from B. Petigara Harp, Color Technology Branch,
Division of Color Certification and Technology, Office of Cosmetics
and Colors, Center for Food Safety and Applied Nutrition (CFSAN),
FDA, to S. DiFranco, Division of Food Ingredients (DFI), Office of
Food Additive Safety (OFAS), CFSAN, FDA, June 4, 2021.
    3. Lee, S. M., M. L. Papathakis, H-M. C. Feng, et al.,
``Multipesticide Residue Method for Fruits and Vegetables:
California Department of Food and Agriculture.'' Fresenius' Journal
of Analytical Chemistry, 339, 376-383, 1991.
    4. *Memorandum from D. Doell, Chemistry Review Team, DFI, OFAS,
CFSAN, FDA, to S. DiFranco, DFI, OFAS, CFSAN, FDA, June 7, 2021.
    5. *Memorandum of Teleconference from S. DiFranco, Regulatory
Review Team, DFI, OFAS, CFSAN, FDA, to the file, April 7, 2020.
    6. *EFSA, ``Scientific Opinion on the Re-evaluation of
Anthocyanins (E163) as a Food Additive.'' EFSA Journal, 11(4): 3145,
2013.
    7. *NTP, ``Toxicology and Carcinogenesis Studies of Quercetin
(CAS No. 117-39-5) in F344 Rats (Feed Studies).'' NTP Technical
Report Series, No. 409, 1992.
    8. Hard, G. C., J. C. Seeley, L. J. Betz, et al., ``Re-
evaluation of the Kidney Tumors and Renal Histopathology Occurring
in a 2-Year Rat Carcinogenicity Bioassay of Quercetin.'' Food and
Chemical Toxicology, 45: 600-608, 2007.
    9. *Memorandum from Y. Zang, Toxicology Review Team, DFI, OFAS,
CFSAN, FDA, to S. DiFranco, DFI, OFAS, CFSAN, FDA, June 9, 2021.
    10. *Memorandum from S. Mog and S. Francke to Y. Zang. Pathology
Consultation Review on Renal Neoplasms in Male F344 rats from
National Toxicology Program Technical Report (NTP TR 409) on
Quercetin in F344/N Rats (feed studies), October 31, 2019.
    11. *USDA. ``Table 1a. Flavonoids from Food and Beverages: Mean
Intake (standard error) per Individuals, by Gender and Age, in the
United States, What We Eat in America.'' NHANES 2007-2010, 2016.
    12. Goodman R. E., M. Ebisawa, F. Ferreira, et al.,
``AllergenOnline: A Peer-reviewed, Curated Allergen Database to
Assess Novel Food Proteins for Potential Cross-reactivity.''
Molecular Nutrition and Food Research, 60(5):1183-1198, 2016.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

    Therefore, 21 CFR part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for 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. Add Sec.  73.69 to subpart A to read as follows:

Sec.  73.69  Butterfly pea flower extract.

    (a) Identity. (1) The color additive butterfly pea flower extract
is a dark blue liquid prepared by the aqueous extraction of dried
butterfly pea flowers from Clitoria ternatea. The extract is further
processed by ultrafiltration to remove residues of plant products,
followed by concentration and pasteurization. Citric acid may be used
to control the pH. The color additive

contains anthocyanins as the principal coloring component.
    (2) Color additive mixtures for food use made with butterfly pea
flower extract may contain only those diluents that are suitable and
are listed in this subpart as safe for use in color additive mixtures
for coloring foods.
    (b) Specifications. Butterfly pea flower extract must conform to
the following specifications and must be free from impurities, other
than those named, to the extent that such other impurities may be
avoided by good manufacturing practice:
    (1) pH, not less than 3.0 and not more than 4.5 at 25 [deg]C.
    (2) Lead, not more than 1 milligram per kilogram (mg/kg) (1 part
per million (ppm)).
    (3) Arsenic, not more than 1 mg/kg (1 ppm).
    (4) Mercury, not more than 1 mg/kg (1 ppm).
    (5) Cadmium, not more than 1 mg/kg (1 ppm).
    (c) Uses and restrictions. Butterfly pea flower extract may be
safely used for coloring alcoholic beverages, sport and energy drinks,
flavored or carbonated water, fruit drinks (including smoothies and
grain drinks), carbonated soft drinks (fruit-flavored or juice, ginger
ale, and root beer), fruit and vegetable juice, nutritional beverages,
chewing gum, teas, coated nuts, liquid coffee creamers (dairy and non-
dairy), ice cream and frozen dairy desserts, hard candy, dairy and non-
dairy drinks, fruit preparations in yogurts, and soft candy in amounts
consistent with good manufacturing practice, except that it may not be
used for coloring foods for which standards of identity have been
issued under section 401 of the Federal Food, Drug, and Cosmetic Act,
unless the use of added color is authorized by such standards.
    (d) Labeling requirements. The label of the color additive and any
mixtures prepared therefrom intended solely or in part for coloring
purposes must conform to the requirements of Sec.  70.25 of this
chapter.
    (e) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health and
therefore batches are exempt from the certification requirements of
section 721(c) of the Federal Food, Drug, and Cosmetic Act.

    Dated: August 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18995 Filed 9-1-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Proposed Rules]
[Page 25978]
[FR Doc No: 2021-10043]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2020-0412; FRL-10023-85-Region 5]

Air Plan Approval; Michigan; Part 18 and Part 19 Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve Michigan Department of Environment, Great Lakes, and Energy
(EGLE) promulgated revisions to its Part 18 Prevention of Significant
Deterioration of Air Quality rule and the Part 19 New Source Review for
Major Sources Impacting Nonattainment Areas rule. The revisions made to
Parts 18 and 19 were adopted to ensure consistency with Federal rule
language and other parts of the Michigan air quality rules. The
proposed rule changes are administrative and are intended to provide
clarity to the already approved rule language.

DATES: Comments must be received on or before June 11, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2020-0412 at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: YeChan Lim, Environmental Engineer,
Air Permits Section, Air Programs Branch (AR-18J), Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>The EPA Region 5
office is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays and facility closures due to COVID-19.

SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no relevant adverse comments are received in response to this
rule, no further activity is contemplated. If EPA receives such
comments, the direct final rule will be withdrawn, and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: May 7, 2021.
Cheryl Newton,
Acting Regional Administrator, Region 5.
[FR Doc. 2021-10043 Filed 5-11-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 57 (Friday, March 24, 2023)]
[Proposed Rules]
[Pages 17751-17752]
[FR Doc No: 2023-05710]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0434; Product Identifier 91-NM-255-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to remove Airworthiness Directive (AD) 92-02-
14, which applies to certain Airbus SAS Model A320 series airplanes. AD
92-02-14 was prompted by failure of the overwing emergency escape
slides to deploy due to incorrect cable installations. AD 92-02-14
requires inspection for correct installation of the flexible control
cables on the overwing emergency escape slides. AD 92-02-14 is no
longer necessary because no new occurrences of incorrect cable
installations have been reported, and existing maintenance activities
are adequate to prevent new occurrences. Therefore, the FAA has
determined that AD 92-02-14 is no longer necessary. Accordingly, the
FAA proposes to remove AD 92-02-14.

DATES: The FAA must receive comments on this proposed AD by May 8,
2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0434; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, International Validation Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; phone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-0434; Product Identifier
91-NM-255-AD'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as

private, and that is relevant or responsive to this NPRM, it is
important that you clearly designate the submitted comments as CBI.
Please mark each page of your submission containing CBI as ``PROPIN.''
The FAA will treat such marked submissions as confidential under the
FOIA, and they will not be placed in the public docket of this NPRM.
Submissions containing CBI should be sent to Dan Rodina, Aerospace
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA 98198; phone<PHONE_NUMBER>; email
[email protected]. Any commentary that the FAA receives that is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Background

    The FAA issued AD 92-02-14, Amendment 39-8150 (57 FR 5375, February
14, 1992) (AD 92-02-14), for certain Airbus SAS Model A320 series
airplanes. AD 92-02-14 was prompted by failure of the overwing
emergency escape slides to deploy due to incorrect cable installations.
AD 92-02-14 requires inspection for correct installation of the
flexible control cables on the overwing emergency escape slides. The
FAA issued AD 92-02-14 to prevent failure of the overwing emergency
escape slides to deploy, which would compromise use of the exit during
an emergency.
    AD 92-02-14 corresponded to AD 91-153-018, dated July 10, 1991,
issued by the Direction G[eacute]n[eacute]rale de l'Aviation Civile
(DGAC), the former airworthiness authority of France (DGAC France AD
91-153-018).

Actions Since AD 92-02-14 Was Issued

    Since the FAA issued AD 92-02-14, EASA issued AD Cancellation
Notice 2022-0160-CN, dated August 4, 2022 (EASA AD Cancellation Notice
2022-0160-CN), to cancel DGAC France AD 91-153-018. EASA Cancellation
Notice 2022-0160-CN states that since DGAC France AD 91-153-018 was
issued, affected slides have been overhauled (dismantled and
maintained) every 3 calendar years. No new occurrences have been
reported of incorrect cable installations. It has also been determined
that existing Aircraft Maintenance Manual and Maintenance Review Board
Report tasks are adequate to prevent new occurrences.

FAA's Conclusions

    Upon further consideration, the FAA has determined that AD 92-02-14
is no longer necessary. Accordingly, this proposed AD would remove AD
92-02-14. Removal of AD 92-02-14 would not prevent the FAA from issuing
another related action or commit the FAA to any course of action in the
future. This proposed AD would terminate, and therefore remove, all
requirements of AD 92-02-14.

Related Costs of Compliance

    This proposed AD would add no cost. This proposed AD would remove
AD 92-02-14 from 14 CFR part 39; therefore, operators would no longer
be required to show compliance with that AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority.

Regulatory Findings

    The FAA has determined that this proposed AD would not have
federalism implications under Executive Order 13132. This proposed AD
would not have a substantial direct effect on the States, on the
relationship between the national Government and the States, or on the
distribution of power and responsibilities among the various levels of
government.
    For the reasons discussed above, I certify that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive 92-02-14, Amendment 39-8150 (57 FR
5375, February 14, 1992), and
0
b. Adding the following new airworthiness directive:

Airbus SAS: Docket No. FAA-2023-0434; Product Identifier 91-NM-255-
AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by May 8, 2023.

(b) Affected Airworthiness Directive (AD)

    This AD replaces AD 92-02-14, Amendment 39-8150 (57 FR 5375,
February 14, 1992) (AD 92-02-14).

(c) Applicability

    This AD applies to Airbus Model A320-211, A320-212, and A320-231
airplanes, certificated in any category, manufacturer serial numbers
002 through 162 inclusive, 167, and 171 through 174 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
Furnishings.

(e) Terminating Action

    This AD terminates all requirements of AD 92-02-14.

(f) Related Information

    For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; phone 206-
231-3225; email [email protected].

(g) Material Incorporated by Reference

    None.

    Issued on March 14, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-05710 Filed 3-23-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 248 (Friday, December 27, 2019)]
[Notices]
[Pages 71409-71410]
[FR Doc No: 2019-27932]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9048-6]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa/.

Weekly receipt of Environmental Impact Statements
Filed December 16, 2019, 10 a.m. EST, through December 20, 2019 10 a.m.
EST
Pursuant to 40 CFR 1506.9.

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20190296, Final, USFS, CA, Omya Sentinel & Butterfield Quarries
Expansion, Review Period Ends: 01/27/2020, Contact: Scott Eliason 909-
382-2830
EIS No. 20190302, Final, BLM, NV, Gemini Solar Final Resource Plan
Amendment and Final EIS, Review Period Ends: 01/27/2020, Contact:
Herman Pinales<PHONE_NUMBER>
EIS No. 20190303, Draft Supplement, USACE, CA, Lower Cache Creek, Yolo
County, CA, City of Woodland and Vicinity, Draft Supplemental
Environmental Impact Statement for the Potential Flood Risk Reduction
Project, Comment Period Ends: 02/10/2020, Contact: Keleigh Duey 916-
557-5131

EIS No. 20190304, Final, USACE, CA, Amoruso Ranch, Review Period Ends:
01/27/2020, Contact: Leah M. Fisher<PHONE_NUMBER>
EIS No. 20190305, Draft Supplement, USFS, MT, Greater Red Lodge
Vegetation and Habitat Management Project., Comment Period Ends: 02/10/
2020, Contact: Victoria Regula<PHONE_NUMBER>

    Amended Notice:
EIS No. 20190272, Draft Supplement, USACE, AL, Allatoona Lake Water
Supply Storage Reallocation Study and Updates to Weiss and Logan Martin
Reservoirs Project Water Control Manuals, Comment Period Ends: 01/29/
2020, Contact: Jennifer Jacobson<PHONE_NUMBER>

    Revision to FR Notice Published 11/15/2019; Extending the Comment
Period from 12/30/2019 to 1/29/2020.

    Dated: December 20, 2019.
Robert Tomiak,
Director, Office of Federal Activities.
[FR Doc. 2019-27932 Filed 12-26-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 34 (Thursday, February 20, 2014)]
[Proposed Rules]
[Pages 9697-9701]
[FR Doc No: 2014-03639]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2013-0247; FRL-9906-87-Region 10]

Approval and Promulgation of Air Quality Implementation Plans:
Idaho, Northern Ada County PM10 Second Ten-Year Maintenance
Plan and Pinehurst PM10 Contingency Measures

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: On March 11, 2013 the Idaho Department of Environmental
Quality (IDEQ) submitted a revised plan for particulate matter with an
aerodynamic diameter less than or equal to ten micrometers
(PM10) for Northern Ada County for the PM10
National Ambient Air Quality Standard (NAAQS). This revised Maintenance
Plan addresses maintenance of the PM10 standard for a second
ten-year period beyond redesignation, extends the horizon years, and
contains revised transportation conformity budgets. The Environmental
Protection Agency (EPA) is proposing to approve this State
Implementation Plan (SIP) revision. The EPA is also proposing to
approve the February 15-16, 2011 high wind exceptional event at the
Boise Fire Station monitor, as well as contingency measures for the
Pinehurst PM10 Air Quality Improvement Plan. The EPA is
proposing to approve the second ten-year PM10 Maintenance
Plan for Northern Ada County and the Pinehurst PM10
contingency measures under section 110 of the Clean Air Act (CAA). The
EPA is proposing to approve the February 2011 exceptional event
pursuant to 40 CFR 50.14.

DATES: Written comments must be received by March 24, 2014.

ADDRESSES: Submit your comments, identified by Docket Number EPA-R10-
OAR-2013-0247, by one of the following methods:
     www.regulations.gov. Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: Lucy Edmondson, Air Quality Planner, Office of Air
Waste and Toxics, EPA Region 10, Washington Operations Office, 300
Desmond Drive SE., Suite 102, Lacey, WA 98503.
     Hand Delivery/Courier: Such deliveries are accepted Monday
through Friday, 8 a.m. to 4:55 p.m., excluding Federal holidays.
Special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-R10-OAR-
2013-0247. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information the disclosure of which
is restricted by statute. Do not submit information that you consider
to be CBI or otherwise protected through http://www.regulations.gov or
email. The www.regulations.gov Web site is an ``anonymous access''
system, which means the 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 the 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, the 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 the EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, the 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 docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
the disclosure of which is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available either
electronically in www.regulations.gov or in hard copy during normal
business hours at the Office of Air, Waste and Toxics, EPA Region 10,
1200 6th Ave, Seattle, Washington 98101.

FOR FURTHER INFORMATION CONTACT: Lucy Edmondson at<PHONE_NUMBER>,
<EMAIL_ADDRESS>or the above, EPA, Region 10 address.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Purpose
II. Background
III. Current PM10 levels in Ada County
IV. The EPA's Evaluation of the Northern Ada County PM10
Second Ten-Year Maintenance Plan
V. The EPA's Evaluation of the February 2011 Exception Events
Request
VI. The EPA's Proposed Approval of Contingency Measures for the
Pinehurst PM10 Air Quality Improvement Plan
VII. Proposed Action
VIII. Statutory and Executive Order Reviews

    Definitions: For the purpose of this document, we are giving
meaning to certain words or initials as follows:
    (i) The words or initials ``Act'' or ``CAA'' mean or refer to the
Clean Air Act, unless the context indicates otherwise.
    (ii) The words ``the EPA,'' ``we,'' ``us'' or ``our'' mean or refer
to the Environmental Protection Agency.
    (iii) The initials ``NAAQS'' mean National Ambient Air Quality
Standard.
    (iv) The initials ``SIP'' mean or refer to State Implementation
Plan.
    (v) The word ``State'' means the State of Idaho, unless the context
indicates otherwise.
    (vi) ``PM10'' means particulate matter with an
aerodynamic diameter less than or equal to ten micrometers.
    (vii) ``MOVES'' refers to Motor Vehicle Emissions Simulator, the
EPA's modeling system for mobile sources.

I. Purpose

    Section 175A of the CAA requires the submission of a second ten-
year maintenance plan eight years after any nonattainment area is
redesignated to attainment. This rulemaking proposes approval of the
second ten-year maintenance plan submitted by IDEQ for the Northern Ada
County PM10 attainment/maintenance area, which demonstrates
continued maintenance of the PM10 NAAQS through 2023. In
this revised maintenance plan, the State has updated mobile source
PM10 emission levels using the Motor Vehicle Emissions
Simulator model (MOVES), updated the transportation projections and
stationary source inventories, and revised the motor vehicle emissions
budgets (MVEBs). As described below, the EPA has determined that the
revised maintenance plan demonstrates continued maintenance of the
PM10 NAAQS and meets the requirements of sections 110 and
175A of the CAA. In addition, the EPA is approving the exclusion of
data from the high wind event of February 15-16, 2011, and the
Contingency Measures for the Pinehurst PM10 Air Quality
Improvement Plan.

II. Background

    Northern Ada County was identified as an area of concern for
PM10 with the promulgation of the PM10 NAAQS in
1987, and was formally designated as a moderate PM10
nonattainment area upon passage of the 1990 CAA. Idaho developed a SIP
and submitted it to the EPA in November 1991, later submitting
revisions in December 1994 and July 1995. The EPA finalized approval of
the Northern Ada County PM10 SIP on May 30, 1996 (61 FR
27019). Idaho submitted a maintenance plan and a request to redesignate
the area to attainment on September 27, 2002, and provided supplemental
information on July 10, 2003 and July 21, 2003. On October 27, 2003,
the EPA approved the Northern Ada County PM10 Maintenance
Plan and redesignated the area to attainment status for PM10
(68 FR 61106).
    In actions dated August 25, 1994 (59 FR 43475) and May 26, 1995 (60
FR 27891), the EPA conditionally approved the SIP for the Pinehurst,
Idaho PM10 nonattainment area. The conditional approval
concluded that IDEQ had not satisfied the requirement for contingency
measures for both the City of Pinehurst and the Pinehurst Expansion
area. The EPA set a deadline of July 20, 1995 for IDEQ to submit the
required contingency measures. IDEQ met the established deadline with
its submission ``Contingency Measures for the Pinehurst PM10
Air Quality Improvement Plan,'' dated July 13, 1995.
    On September 23, 2013, IDEQ submitted documentation in accordance
with the Exceptional Events Rule (72 FR 13560) to show that the
monitored PM10 values on February 15-16, 2011 at the Boise
monitor were due to a high wind event and resulting dust storm that
originated in Nevada.

III. Current PM10 levels in Ada County

    The national primary and secondary 24-hour ambient air quality
standards for PM10 are 150 micrograms per cubic meter
([mu]g/m\3\) based on a 24-hour average concentration. The standard is
attained when the expected number of days per calendar year with a 24-
hour concentration above 150 [mu]g/m\3\ is equal to or less than one
per year over a three year period. The Northern Ada County
PM10 Second Ten-Year Maintenance Plan, submitted by IDEQ on
March 11, 2013, relies on ambient air quality data from 2007 through
2011. In addition, we have reviewed ambient air quality data from 2000
through 2011. With the EPA's December 2013 concurrence on the exclusion
of data associated with the high wind event of February 15-16, 2011 at
the Boise Fire Station Monitor, Northern Ada County shows continuous
attainment of the PM10 NAAQS based on the most recent 2000-
2012 data archived in the EPA's Air Quality System Database
(www.epa.gov/ttn/airs/airsaqs/detaildata/AQIindex.htm).

IV. The EPA's Evaluation of the Northern Ada County PM10
Second Ten-Year Maintenance Plan

    The criteria EPA used to review and evaluate the maintenance plan
are derived from the CAA, the General Preamble for State Implementation
Plans (57 FR 13498), and the guidance memorandum from John Calcagni,
Procedures for Processing Requests to Redesignate Areas to Attainment,
September 4, 1992. The following are the key elements of a maintenance
plan for PM10: Emissions Inventory, Maintenance
Demonstration, Monitoring Network/Verification of Continued Attainment,
Control Strategies, Contingency Measures, and the Motor Vehicle
Emissions Budget for PM10 as required for Transportation
Conformity. Below, we describe our evaluation of these elements as they
pertain to the Northern Ada County PM10 Second Ten-Year
Maintenance Plan.
    A. Emissions Inventory: An emissions inventory was prepared for the
entirety of Ada County for the base year of 2008. In addition to the
base year 2008 inventory, emissions forecasts were

prepared for future year projections for 2015 and 2023. Using an
emissions inventory prepared for the entire county enabled IDEQ to
capture emissions both within and outside of the North Ada County
PM10 Maintenance Area. The projections in Table 1 below show
that direct primary emissions of PM10 increase 27% from 2008
to 2023, while the chemical precursors to secondarily formed
PM10 significantly decrease. The largest source of primary
PM10 is fugitive dust from on-road mobile sources and the
projected PM10 increases are mostly from projected increases
in on-road vehicle traffic. We find that IDEQ has prepared adequate
recent and future year emission inventories for the area that meet
Maintenance Plan requirements.

                                    Table 1--Annual Emissions for Ada County
                                                 [Tons per year]
----------------------------------------------------------------------------------------------------------------
                              Year                                     PM10             NOx             SO2
----------------------------------------------------------------------------------------------------------------
2008............................................................          20,395          14,149             250
2015............................................................          21,756           9,294             151
2023............................................................          25,875           7,207             172
----------------------------------------------------------------------------------------------------------------

    B. Maintenance Demonstration: The EPA-approved Northern Ada County
First Ten-Year PM10 Maintenance Plan used the CAMx
photochemical transport model to demonstrate maintenance of the
PM10 standard. IDEQ used a photochemical transport model for
the North Ada County First PM10 Ten-Year Maintenance Plan
because of concerns about secondary production of PM10 from
the chemical precursors nitrogen oxides (NOX) and sulfur
dioxide (SO2) and the potential growth in these precursor
emissions. However, future year emissions projections for 2015 and 2023
now indicate significant reductions in NOX and
SO2 from 2008 baseline values, and the PM10
design values in Northern Ada County have been well below the standard
over the past decade. The EPA has approved a more simplified roll-
forward modeling approach appropriate for evaluating the effects of
primary PM10 emissions changes on ambient PM10
values in Northern Ada County. Use of this more simplified roll-forward
modeling approach is also a conservative approach because it does not
allow credit to be taken for emissions reductions in the secondary
PM10 precursors NOX and SO2. For the
Northern Ada County PM10 Second Ten-Year Maintenance Plan,
the roll-forward model can be used to conservatively estimate whether
the PM10 concentrations can be maintained below the NAAQS in
future years. With the exception of the high wind exceptional event on
February 15-16, 2011 at the Boise Fire Station monitor, discussed in
more detail below, a review of data from 2000-2011 shows that average
PM10 concentrations remain below the 24-hour PM10
NAAQS.
    C. Monitoring Network/Verification of Continued Attainment:
PM10 ambient air monitoring in Northern Ada County consists
of one monitor, operated by IDEQ, located at Fire Station 5 at
16th and Front Streets in downtown Boise. The monitor is a tapered
element oscillating microbalance (TEOM) monitor, which provides
continuous, real-time direct measurement of PM10
concentrations. The TEOM monitor is part of the approved IDEQ
monitoring network and is operated in accordance with 40 CFR Part 58.
In its submission, IDEQ commits that it will continue to operate an
appropriate PM10 air quality monitor in accordance with 40
CFR Part 58 to verify continued attainment of the PM10
NAAQS. The EPA will continue its annual review of the monitoring
network to ensure ongoing compliance with the EPA's air monitoring
requirements and continued maintenance of the PM10 NAAQS.
    D. Control Strategies: The Northern Ada County PM10
Second Ten-Year Maintenance Plan includes the following control
strategies, which are the same as those used in the Northern Ada County
PM10 First Ten-Year Maintenance Plan (61 FR 27019): 1) the
air quality index program through which IDEQ provides information on
the measured and predicted ambient air pollution levels along with
information on mandatory and voluntary open burning bans and indoor
burning bans; 2) a residential wood burning program; 3) an open burning
ban; and 4) stationary source controls. The stationary source controls
include conditions in Tier II permits for eight facilities in the
maintenance area, as well as The Amalgamated Sugar Company (TASCO)
factory in Nampa, Idaho that is outside the maintenance area but was
included within the original modeling domain. The eight facilities are:
     LP Wood Polymers--(now Fiber Composites)
     Mike's Sand and Gravel--(now Clement's Concrete)
     Crookham Company
     Plum Creek Lumber Company
     C. Wright Construction
     Idaho Concrete (3 separate facilities)
    The Tier II permits for the eight facilities in the maintenance
area include limits on the potential to emit. The Tier II permit for
the TASCO facility required reductions in PM10 emissions
from the facility \1\. Retention of the Tier II permits maintains these
control strategies in a manner that is consistent with applicable
guidance. The EPA approved these control measures when approving the
first Ten-Year Maintenance plan and they became federally enforceable
at that time.
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    \1\ On December 23, 2011, IDEQ finalized Tier II permit number
T2-2009.0105 for certain TASCO emission units as part of its
Regional Haze Plan. The conditions of this permit impose additional
PM10 reductions from the facility that will benefit
maintenance of the PM10 NAAQS in Ada County.
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    E. Contingency Measures: Section 175A(d) of the CAA requires that a
maintenance plan include contingency measures to assure that any
violation of the standard is promptly corrected. To meet this
requirement, the State has identified appropriate contingency measures
along with a schedule for the development and implementation of such
measures. As stated in Section 8 of the Northern Ada County
PM10 Second Ten-Year Maintenance Plan, the contingency
measures will be triggered by a violation of the PM10 NAAQS.
Such a violation will prompt IDEQ to implement one or more contingency
measures, as appropriate, to correct the violation. Potential
contingency measures include: (1) adopt local ordinances that require
covering all loads of material that have the potential to contribute to
particulate matter pollution; (2) adopt local ordinances that require
no track-out onto paved roads; (3) adopt local ordinances that prohibit
burning of outdoor trash; (4) eliminate local permits that allow any
kind of uncontrolled outdoor burning not specifically allowed under
state rules; (5) expand mandatory burning

restrictions to include clean-burning woodstoves during air quality
alerts; (6) adopt local ordinances that prohibit constructing any
unpaved roads, driveways or parking lots; (7) revise street sweeping
plans working with local highway districts and the Idaho Transportation
Department, based on the latest traffic data so as to prioritize street
sweeping efforts to reduce fugitive road dust; and (8) analyze the
impacts from all industrial sources and develop potential emission
reductions, if necessary to maintain attainment, in accordance with the
rules. In addition, IDEQ indicates it may evaluate other strategies to
address any future violations in the most appropriate and cost-
effective manner possible. We find that the contingency measures
contained in the Northern Ada County PM10 Second Ten-Year
Maintenance Plan are sufficient and meet the requirements of Section
175A(d) of the CAA. We note the contingency measures and methodology to
implement the measures are the same as those we approved in the
original SIP and the First Ten-Year Maintenance Plan.
    F. Transportation Conformity Requirements: Motor Vehicle Emission
Budget for PM10: Under Section 176(c) of the CAA,
transportation plans, programs, and projects in nonattainment or
maintenance areas that are funded or approved under the Federal Transit
Act must conform to the applicable SIP. In short, a transportation plan
is deemed to conform to the applicable SIP if the emissions resulting
from implementation of that transportation plan are less than or equal
to the motor vehicle emission level established in the SIP for the
maintenance year and other analysis years. In this maintenance plan,
procedures for estimating motor vehicle emissions are well documented.
On-road mobile source emissions were calculated using the MOVES model.
The motor vehicle emission budgets for on-road motor vehicle
PM10 emissions in Ada County for 2008, 2015, 2023 are shown
in Table 2, below.

                          Table 2-- MVEBs for Northern Ada County PM10 Maintenance Area
                                                 [Tons per day]
----------------------------------------------------------------------------------------------------------------
                           Budget year                                 PM10             NOX             VOC
----------------------------------------------------------------------------------------------------------------
2008............................................................            31.0            29.5            12.6
2015............................................................            42.9            29.5            12.6
2023............................................................            60.1            34.2            17.2
----------------------------------------------------------------------------------------------------------------

    On June 6, 2013, the EPA published a notice of our finding that the
MVEBs for PM10, NOX, and volatile organic
compounds (VOC) for the years 2008, 2015 and 2023 in the Northern Ada
County PM10 Second Ten-Year Maintenance Plan were adequate
for transportation conformity purposes. This adequacy determination
became effective on June 21, 2013 (78 FR 34095).

V. The EPA's Evaluation of the February 2011 Exceptional Events Request

    The EPA is proposing to approve the State's request to exclude data
from February 15-16, 2011 in determining PM10 attainment as
a high wind exceptional event. The EPA evaluated IDEQ's exceptional
event demonstration for the flagged values of the 24-hour
PM10 NAAQS for February 15-16, 2011 at the monitor in Boise,
Idaho, with respect to the requirements of the EPA's Exceptional Events
Rule (40 CFR 50.14) and determined that IDEQ met each requirement. The
EPA concurred on the exceptional event on December 13, 2013. For
further information, refer to the State's Exceptional Event
demonstration package and EPA's concurrence and analysis located in the
docket.

VI. The EPA's Proposed Approval of Contingency Measures for the
Pinehurst PM10 Air Quality Improvement Plan

    As provided in section 172(c)(9) of the CAA, all nonattainment area
SIPs that demonstrate attainment must include contingency measures.
Contingency measures consist of other available measures that are not
part of the area's control strategy but are included in the plan
revision as measures to be undertaken if the area fails to make
reasonable further progress or to attain by the applicable attainment
date. These measures must take effect in any such case without further
action by the state.
    In response to the EPA's conditional approval of the Pinehurst
PM10 nonattainment SIP, IDEQ submitted its ``Contingency
Measures for the Pinehurst PM10 Air Quality Improvement
Plan,'' specifying the contingency measures for the Pinehurst
PM10 nonattainment area. These contingency measures require
implementation of additional emission control actions in the Pinehurst
residential wood burning program, including wood stove replacements,
voluntary wood stove curtailment, public awareness and home
weatherization. The EPA believes that the implementation of these
measures, if necessary, would provide additional reductions of
PM10 emissions and further attainment of the PM10
NAAQS. The Pinehurst PM10 nonattainment area has monitored
attainment of the PM10 NAAQS since IDEQ submitted the
contingency measures for EPA's approval in 1995. The EPA is proposing
to approve these measures as satisfying the section 172(c)(9)
contingency measure requirement for the Pinehurst PM10
attainment plan, finalizing our approval of the plan.

VII. Proposed Action

    The EPA is proposing to approve the Northern Ada County
PM10 Second Ten-Year Maintenance Plan adopted by IDEQ to
ensure maintenance of the NAAQS for PM10 in Northern Ada
County for a second ten-year maintenance period, to protect the health
and welfare of the area citizens from adverse effects of degraded air
quality levels. In addition, the EPA is proposing to approve the
exclusion of data from the high wind event of February 15-16, 2011, and
the Contingency Measures for the Pinehurst PM10 Air Quality
Improvement Plan.

VIII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the 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 the requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because this action does not involve technical standards; and
     does not provide the 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 the 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, Particulate matter, and Reporting and recordkeeping
requirements.

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

    Dated: January 23, 2014.
Dennis J. McLerran,
Regional Administrator, Region 10.
[FR Doc. 2014-03639 Filed 2-19-14; 8:45 am]
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[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Page 42521]
[FR Doc No: 2015-17613]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4222-DR; Docket ID FEMA-2015-0002]

Oklahoma; Amendment No. 9 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Oklahoma (FEMA-4222-DR), dated May 26, 2015, and
related determinations.

DATES: Effective date: July 2, 2015.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Oklahoma is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of May 26, 2015.

    Mayes and Tulsa Counties for Individual Assistance.
    Carter, Jefferson, Latimer, Okfuskee, Okmulgee, Pushmataha, and
Stephens Counties for Individual Assistance (already designated for
Public Assistance).

    (The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2015-17613 Filed 7-16-15; 8:45 am]
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