[Federal Register Volume 79, Number 158 (Friday, August 15, 2014)]
[Rules and Regulations]
[Pages 48090-48094]
[FR Doc No: 2014-19450]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0444; FRL-9909-83]

Sweet Orange Peel Tincture; Exemption From the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of sweet orange peel tincture when used as
an inert ingredient not to exceed 10% (weight/weight) in pesticide
formulations for use as a surfactant, fragrance, and adjuvant on all
pre- and post-harvest food commodities. This regulation eliminates the
need to establish a maximum permissible level for residues of sweet
orange peel tincture.

DATES: This regulation is effective August 15, 2014. Objections and
requests for hearings must be received on or before October 14, 2014,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0444, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0444 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 14, 2014. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0444, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of July 19, 2013 (78 FR 43117) (FRL-9392-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10547) by
AG-Chem Consulting (12208 Quinque Lane, Clifton VA 21024), on behalf of
Oro-Agri, Inc., 990 Trophy Club Drive, Trophy Club, TX 76262. The
petition requested that 40 CFR 180.910 be amended by establishing an
exemption from the requirement of a tolerance for residues of sweet
orange peel tincture when used as an inert ingredient when used as a
surfactant, fragrance and adjuvant up to 10% (weight/weight)
concentration in pesticide products applied to all pre- and post-
harvest food commodities. That document referenced a summary of the
petition prepared by AG-Chem Consulting, the petitioner, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including

all anticipated dietary exposures and all other exposures for which
there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for sweet orange peel tincture
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with sweet
orange peel tincture follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by sweet orange peel tincture as well as
the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies are discussed in
this unit.
    Sweet orange peel tincture and sweet orange peel oil are chemically
the same (EINECS No. 232-433-8; CAS 8028-48-6). The only difference is
the method of extraction. Sweet orange peel tincture is extracted in
alcohol and the extraction process leads to the formation of a
``tincture''. Sweet orange peel oil is extracted by cold press
expression. Both are extracted from the same plant, Citrus sinensis
family Rutaceae. Both forms of the sweet orange peel extract contain d-
limonene as its primary component (>90%) and lesser amounts of myrcene.
The EPA has conducted a ``Screening-Level Hazard Assessment'' of a
class of compounds called monoterpene hydrocarbons, d-limonene and
myrcene are among the monoterpene hyrdrocarbons assessed. The chemical
class was ``based on structural similarity, similar molecular weights
and functional groups and the expectation that inherent
physicochemical, environmental and toxicological properties are
predicted to be similar''. That analysis also included a review of data
on sweet orange peel oil since it is a complex mixture containing
greater than 90% monoterpene hydrocarbons (including d-limonene and
myrcene), and is expected to have ``physicochemical, environmental and
toxicological properties similar to the major components . . . limonene
and myrcene''. Therefore, the Agency assessed the potential toxicity of
sweet orange peel tincture based on the available toxicity data for
sweet orange peel oil, and where data for sweet orange peel oil is
missing, relied upon available data for the monoterpene hydrocarbons
chemical class.
    The acute oral and dermal toxicity of sweet orange peel oil is low.
The oral LD50 was >5,000 milligram/kilogram (mg/kg) in rats
and rabbits, respectively.
    In a 28-day study with sweet orange peel oil, lesions in the non-
glandular stomach and clinical chemistry were observed at 1,500 mg/kg/
day (above the limit dose of 1,000 mg/kg/day) in rats. Lesions in the
non-glandular stomach is attributed to the irritating property of the
chemical. The NOAEL was 600 mg/kg/day.
    In a combined reproductive/developmental toxicity screening test
with sweet orange peel oil, stillbirths and pup mortality were observed
at 1,500 mg/kg/day. The offspring NOAEL was 750 mg/kg/day. Signs of
toxicity were not observed in maternal rats, the NOAEL was 1,500 mg/kg/
day.
    Evidence of mutagenicity was not observed in the Ames test.
Although evidence of mutagenicity was observed in mouse lymphoma assay,
it was noted that cytotoxic concentrations were not reported and this
could contribute to an inflated mutation rate. In addition, d-limonene
was not mutagenic in an Ames test, mouse lymphoma, sister chromatid
exchange nor in chromosome aberrations in Chinese hamster ovary cells
assays. Therefore, based on the weight of evidence sweet orange peel
tincture is not expected to be mutagenic.
    Evidence of immunotoxicity was not observed. Sweet orange peel oil
exhibited no effects on cell-mediated or humoral immune response at
doses up to 2,500 mg/kg/day in a plaque-forming cell assay in mice.
    Although a carcinogenicity study was not available for sweet orange
peel tincture, carcinogenicity studies were available in the rat and
mouse for d-limonene. An increased incidence of tumor formation was not
observed in a 2 year carcinogenicity study on female rats or in male
and female mice treated with d-limonene up to 1,000 mg/kg/day. An
increased incidence of tubular cell hyperplasia, adenomas, and
adenocarcinomas of the kidney was observed in the male rat. However,
these lesions are related to the accumulation of the alpha 2u-globulin
protein which is specific to the male rat and is not relevant for human
risk assessment. Based on this available information and the data
supporting EPA's conclusion that sweet orange peel tincture is not
expected to be mutagenic, EPA concludes that sweet orange peel tincture
is not likely to be carcinogenic.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that sweet orange peel
tincture has low toxicity. Since no endpoint of concern was identified
for sweet orange peel tincture, a qualitative risk assessment is
appropriate.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sweet orange peel tincture, EPA considered exposure under
the proposed exemption from the requirement of a tolerance (40 CFR
180.910 as an inert ingredient used in pesticide formulations applied
to growing crops). EPA assessed dietary exposures from sweet orange
peel tincture in food as follows:
    Dietary exposure can occur from eating foods containing residues of
sweet orange peel tincture. Because no hazard endpoint of concern was

identified for the acute and chronic dietary assessment (food and
drinking water), a quantitative dietary exposure risk assessment was
not conducted.
    2. Dietary exposure from drinking water. Sweet orange peel tincture
residues may be found in drinking water. However, since an endpoint of
concern was not identified for the dietary assessment (food and
drinking water), a quantitative dietary exposure risk assessment was
not conducted.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables). Sweet
orange peel tincture is used as an inert ingredient in pesticide
products that could result in short- and intermediate-term residential
exposure. However, based on the lack of toxicity, a quantitative
exposure assessment from residential exposures was not performed.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found sweet orange peel tincture to share a common
mechanism of toxicity with any other substances and sweet orange peel
tincture does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that sweet orange peel tincture does not have a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) Safety Factor (SF). In applying this provision, EPA either
retains the default value of 10X, or uses a different additional safety
factor when reliable data available to EPA support the choice of a
different factor.
    Based on an assessment of sweet orange peel oil, EPA has concluded
that there are no toxicological endpoints of concern for the U.S.
population, including infants and children, and has conducted a
qualitative assessment. As part of its qualitative assessment, the
Agency did not use safety factors for assessing risk, and no additional
safety factor is needed for assessing risk to infants and children.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate point of departure (PODs)
to ensure that an adequate MOE exists.
    Based on the lack of any endpoints of concern, EPA concludes that
there is a reasonable certainty that no harm will result to the general
population or to infants and children from aggregate exposure to sweet
orange peel tincture residues.

V. Other Considerations

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for sweet orange peel tincture (CAS
Reg. No. 8028-48-6) when used as an inert ingredient in pesticide
formulations for use as a surfactant, fragrance and adjuvant up to 10%
(weight/weight) on all pre- and post-harvest food commodities.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this final rule has been exempted from review
under Executive Order 12866, this final rule is not subject to
Executive Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption to the
requirement of a tolerance in this final rule, do not require the
issuance of a proposed rule, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule 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. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 7, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.910, the table is amended by alphabetically adding
entry for ``Sweet orange peel tincture * * *'' after the entry for
``Sulfuric acid * * * '' to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
      Pesticide chemical                Limits                Uses
------------------------------------------------------------------------

                              * * * * * * *
Sweet orange peel tincture      Not to exceed 10%       Surfactant,
 (CAS Reg. No. 8028-48-6).       (weight/weight) in      fragrance,
                                 pesticide formulation.  related
                                                         adjuvants of
                                                         surfactants.

                              * * * * * * *
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[FR Doc. 2014-19450 Filed 8-14-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Rules and Regulations]
[Pages 46833-46835]
[FR Doc No: 2016-17036]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2016-0555]
RIN 1625-AA00

Safety Zone; Navy UNDET, Apra Outer Harbor, GU

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters within a 700-yard radius on the surface and 1400-yard
radius underwater of the Navy underwater detonation operations in the
waters of Apra Outer Harbor, Guam. The Coast Guard believes this safety
zone regulation is necessary to protect all persons and vessel that
would otherwise transit or be within the affected areas from possible
safety hazards associated with underwater detonation operations. Entry
of vessels or persons into these zones is prohibited unless
specifically authorized by the Captain of the Port Guam.

DATES: This rule is effective from 8 a.m. through 4 p.m. on July 28,
2016.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2016-0555 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Kristina Gauthier, Sector Guam, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable and
contrary to public interest. The final details for this event were not
known to the Coast Guard until there was insufficient time remaining
before the operation to publish an NPRM. Thus, delaying the effective
dates of this rule to wait for a comment period to run would be
impracticable because it would inhibit the Coast Guard's ability to
protect vessels and waterway users from the hazards associated with
this operation.
    We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for making it effective less than 30
days after publication in the Federal Register. Due to the late notice
and inherent danger in underwater detonation exercises, delaying the
effective period of this safety zone would be contrary to public
interest.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Guam has determined that potential
hazards associated with the U.S. Navy training exercise, which include
detonation of underwater explosive on July 28, 2016, will be a safety
concern for anyone within a 700-yard radius on the surface and 1400-
yard radius underwater of the operation. This rule is needed to protect
personnel, vessels, and the marine environment in the navigable waters
within the safety zone during the exercise. Mariners and divers
approaching too close to such exercises could potentially expose the
mariner to flying debris or other hazardous conditions.

IV. Discussion of the Rule

    The safety zone will cover all navigable waters within 700-yards on
the surface and 1400-yards underwater of vessels and machinery being
used by the Navy. The duration of the zone is intended to protect
personnel, vessels, and the marine environment in these navigable
waters during the underwater detonation exercise. No vessel or person
will be permitted to enter the safety zones without obtaining
permission from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive order related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. Vessel traffic
will be able to safely transit around this safety zone which will
impact a small designated area of waters in Apra Outer Harbor for 8
hours. Moreover, the Coast Guard will issue Broadcast Notice to
Mariners via VHF-FM marine channel 16 about the zone and the rule
allows vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian

tribes, on the relationship between the Federal Government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes. If you believe this rule has
implications for federalism or Indian tribes, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this
action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a safety zone lasting eight hours that will prohibit
entry within 700-yards on the surface and 1400-yards underwater of
vessels and machinery being used by Navy personnel. It is categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of the
Commandant Instruction. An environmental analysis checklist supporting
this determination and a Categorical Exclusion Determination are
available in the docket where indicated under ADDRESSES. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191, 195; 33 CFR 1.05-
1(g), 6.04-1, 6.04-6, and 160.5; Department of Homeland Security
Delegation No. 0170.1

0
2. Add Sec.  165.T14-0555 to read as follows:

Sec.  165.T14-0555  Safety Zone; Navy UNDET, Apra Outer Harbor, GU.

    (a) Location. The following areas, within the Guam Captain of the
Port (COTP) Zone (See 33 CFR 3.70-15), from the surface of the water to
the ocean floor, are safety zones: Apra Outer Harbor, Guam July 28,
2016. All surface waters bounded by a circle with a 700-yard radius and
all underwater areas bounded by a circle with a 1400 yard radius
centered at 13[deg]27'42'' North Latitude and 144[deg]38'30'' East
Longitude, (NAD 1983).
    (b) Effective period. This section is effective from 8 a.m. through
4 p.m. on July 28th, 2016.
    (c) Regulations. The general regulations governing safety zones
contained in Sec.  165.23 apply. No vessels may enter or transit safety
zones and no persons in the water may enter or transit safety zone
unless authorized by the COTP or a designated representative thereof.
    (d) Enforcement. Any Coast Guard commissioned, warrant, or petty
officer, and any other COTP representative permitted by law, may
enforce these temporary safety zones.
    (e) Waiver. The COTP may waive any of the requirements of this
section for any person, vessel, or class of vessel upon finding that
application of the safety zone is unnecessary or impractical for the
purpose of maritime security.
    (f) Penalties. Vessels or persons violating this rule are subject
to the penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192.

    Dated: June 24, 2016.
James B. Pruett,
Captain, U.S. Coast Guard, Captain of the Port, Guam.
[FR Doc. 2016-17036 Filed 7-18-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 51 (Monday, March 16, 2020)]
[Proposed Rules]
[Pages 14843-14845]
[FR Doc No: 2020-05332]

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

40 CFR Part 52

[EPA-R04-OAR-2007-0113; FRL-10006-55-Region 4] Air Plan Approval;

Georgia: Definition for Permitting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a portion of a State Implementation Plan (SIP) revision
submitted by the State of Georgia, through the Georgia Department of
Natural Resources' Environmental Protection Division (also known as GA
EPD), on September 19, 2006, with a clarification submitted on November
6, 2006 and a supplemental submittal transmitted on November 27, 2019.
EPA is proposing to approve portions of a definition that impacts
existing minor new source review (NSR) permitting regulations because
the State has demonstrated it is consistent with the Clean Air Act (CAA
or Act).

DATES: Comments must be received on or before April 15, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2007-0113 at www.regulations.gov. Follow the online instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. 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, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: D. Brad Akers, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. Mr. Akers can also be
reached via telephone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What action is EPA proposing?

    EPA is proposing to approve certain changes to the Georgia SIP that
were provided to EPA by GA EPD via a letter dated September 19, 2006.
EPA previously approved the majority of the changes to Georgia rules
originally included in the September 19, 2006, submittal.\1\ In
addition, GA EPD has withdrawn several portions of the SIP revision
from EPA consideration.\2\ In this action, EPA is proposing to approve
the portion of this SIP revision that makes changes to the State's Rule
391-3-1-.01, Definitions. The portion of the SIP revision considered
adds a definition for ``Pollution control project'' (PCP)--which GA EPD
describes as environmentally-beneficial projects that reduce criteria
pollutant emissions--that relate to minor NSR applicability for
construction permitting under Rule 391-3-1-.03, Permits. The changes to
this rule and EPA's rationale for proposing approval are described in
more detail in Section II of this notice of proposed rulemaking (NPRM).
---------------------------------------------------------------------------

    \1\ EPA approved portions of the September 19, 2006, SIP
revision as follows: Changes to Rule 391-3-1-.01, Definitions, were
approved on February 9, 2010 (75 FR 6309); changes to Rule 391-3-
1-.02, Provisions, were approved on February 9, 2010 (75 FR 6309),
December 1, 2010 (75 FR 74642), and September 1, 2015 (80 FR 52627);
and changes to Rule 391-3-1-.03, Permits, were approved on April 9,
2013 (78 FR 21065) and November 22, 2019 (84 FR 64427).
    \2\ GA EPD withdrew portions of the September 19, 2006, SIP
revision as follows: 391-3-1-.02 on January 25, 2016 and portions of
391-3-1-.01 on November 27, 2019.
---------------------------------------------------------------------------

II. EPA's Analysis of the State's Submittal

A. Summary

    Georgia seeks to add a definition of ``Pollution control project''
to its SIP at Rule 391-3-1-.01(qqqq). This definition lists certain
projects, described as ``environmentally beneficial,'' that are
exempted from the minor NSR \3\ construction permit requirements
pursuant to Rule 391-3-1-.03(6)(j). The exemption does not apply to
sources subject to major NSR requirements under either 391-3-1-.02(7)
(``Prevention of Significant Deterioration [PSD] of Air Quality''), or
391-3-1-.03(8) ``Permit Requirements'' under paragraph (c), (Georgia's
nonattainment new source review (NNSR) program). The exemption for PCPs
applies to minor sources only, limiting any emissions increases from
the exempted projects to below the major source thresholds for all
pollutants.
---------------------------------------------------------------------------

    \3\ EPA's regulations governing the implementation of NSR
permitting programs are contained in 40 CFR 51.160--.166; 52.21,
.24; and part 51, appendix S. The CAA NSR program is composed of
three separate programs: PSD, NNSR, and Minor NSR. PSD is
established in part C of title I of the CAA and applies to major
stationary sources in areas that meet the national ambient air
quality standards (NAAQS)--``attainment areas''--as well as areas
where there is insufficient information to determine if the area
meets the NAAQS--``unclassifiable areas.'' The NNSR program is
established in part D of title I of the CAA and applies to major
stationary sources in areas that are not in attainment of the
NAAQS--``nonattainment areas.'' The Minor NSR program applies to
stationary sources that do not require PSD or NNSR permits.
Together, these programs are referred to as the NSR programs.
---------------------------------------------------------------------------

    EPA previously approved the exemption for PCPs for minor sources at
.03(6)(j) on February 9, 2010 (75 FR 6309) but did not act on the PCP
definition at Rule 391-3-1-.01(qqqq) at that time. In this action, EPA
is proposing to approve a definition of ``Pollution control project''
at .01(qqqq). Because this definition only applies to minor sources, it
is not impacted by the United States Court of Appeals for the District
of Columbia Circuit decision in New York v. EPA, 413 F.3d 3 (D.C.
Cir.), in which the D.C. Circuit vacated an exemption for PCPs from the
federal NSR regulations for major sources. Georgia's previously
approved NSR regulations governing major sources are consistent with
federal requirements and the D.C. Circuit decision on PCPs for major
NSR.
    On June 29, 2017, EPA published a NPRM (82 FR 29469) proposing
approval of changes to 391-3-1-.01, Definitions, and 391-3-1-.03,
Permits and published an accompanying direct final rulemaking notice
(82 FR 29418). EPA specifically proposed to approve a definition of
``Pollution control project'' at 391-3-1-.01(qqqq), which included
subparagraphs .01(qqqq)1. through 8., as a clarifying amendment to an
existing exemption from minor NSR permitting at 391-3-1-.03(6)(j). The
proposed rule stated that if EPA received adverse comment on the direct
final rule, then the Agency would withdraw the direct final rule and
address public comments received in a subsequent final rule based on
the proposed rule. EPA received one adverse comment regarding the
portion of the direct final rule revising 391-3-1-.01, Definitions, and
EPA accordingly withdrew the direct final rule on August 22, 2017 (82
FR 39671).\4\
---------------------------------------------------------------------------

    \4\ The adverse comment received on the June 29, 2017, proposed
rule is included in the docket for this action.
---------------------------------------------------------------------------

    Since the August 22, 2017, withdrawal of EPA's direct final rule,

GA EPD has withdrawn several portions of the definition at .01(qqqq)
from EPA consideration. Specifically, on November 27, 2019, GA EPD
withdrew .01(qqqq)1. and .01(qqqq)3. through 8., and submitted a
supplemental justification for the approval of .01(qqqq)2. into the
SIP.\5\ The remaining list of projects EPA is considering in this
action at .01(qqqq)2. are as follows: ``[e]lectrostatic precipitators,
baghouses, high-efficiency multiclones, or scrubbers for control of
particulate matter or other air contaminants.''
---------------------------------------------------------------------------

    \5\ The November 27, 2019, partial withdrawal letter and
accompanying Attachment A transmitting supporting documentation for
the remainder of the SIP revision are included in the docket for
this action.
---------------------------------------------------------------------------

B. Minor NSR and CAA Section 110(l)

    CAA Section 110(a)(2)(C) requires that SIPs include a program for
regulating the construction and modification of stationary sources as
necessary to ensure that the NAAQS are achieved. Under 40 CFR
51.160(e), the State must identify the types and sizes of sources
subject to the program and provide a basis for its determination.
Additionally, CAA Section 110(l) provides that EPA shall not approve a
revision to a plan if the revision would interfere with any applicable
requirement concerning attainment and reasonable further progress (as
defined in CAA section 171), or any other applicable requirement of the
CAA.
    Georgia has a SIP-approved minor NSR program at Rule 391-3-1-.03.
Under that program, the Director of GA EPD must determine prior to
issuing a construction permit that the construction or modification of
the source will not cause a violation of the NAAQS or other applicable
requirement. See Rule 391-3-1-.03(8)(a). However, EPA has previously
approved certain exemptions from the State's construction permit
requirements at Rule 391-3-1-.03(6). Of relevance here, paragraph
(6)(j) exempts PCPs from the requirement to obtain a construction
permit. In addition, paragraph (6)(i)(3) exempts the modification of an
existing facility where the combined emission increase resulting from
the modification falls below certain specified thresholds at paragraph
(6)(i)3.
    In this action, EPA is proposing to approve a definition of
``Pollution control project'' as consistent with applicable CAA
requirements. Under that definition, GA EPD's PCP minor NSR exemption
would apply to installation of the following types of equipment:
Electrostatic precipitators, baghouses, high-efficiency multiclones, or
scrubbers for control of particulate matter or other air contaminants.
Under Georgia Rule 391-3-1-.01(qqqq), these types of projects are
presumed to be environmentally beneficial and thus qualify for the
exemption; however, the Director of GA EPD may determine prior to
granting an operating permit to the source that application of the
exemption is not appropriate in a particular case.
    EPA has evaluated the exemption and believes, in its technical
judgment, that the listed projects will reduce emissions of both NAAQS
and non-NAAQS pollutants. Additionally, EPA notes that these projects
will not lead to collateral emissions increases of any NAAQS
pollutants. As a result, these types of projects already qualify for
Georgia's preexisting minor NSR exemption at Rule 391-3-1-.03(6)(i)3.
As noted above, that provision exempts projects that fall below certain
specified emissions thresholds. Since the projects included under Rule
391-3-1-.01(qqqq)2. will not increase emissions of any NAAQS pollutant,
they would previously have been exempted under those thresholds.
    More importantly, EPA believes that these projects are otherwise
appropriately exempted from Georgia's minor NSR program under CAA
Section 110(a)(2)(C). As noted above, that provision requires a program
within the State to regulate the construction and modification of
sources such that the NAAQS are maintained. By definition, a project
that will not lead to any emissions increases will not negatively
impact the NAAQS. For similar reasons, EPA also believes this exemption
is consistent with CAA Section 110(l), which prohibits EPA from
approving a SIP revision that would interfere with any applicable
requirement concerning attainment and reasonable further progress (as
defined in Section 7501 of the CAA), or any other applicable
requirement of the Act.
    GA EPD further supports this proposed conclusion in its SIP
submittal. Specifically, in its November 27, 2019, letter GA EPD
asserts that Rule 391-3-1-.01(qqqq)(2) includes control technologies
that are not expected to have collateral emissions increases, are
commonly used to reduce emissions, and are generally desirable from an
environmental protection perspective. GA EPD then explains that the
only requests it has received under .01(qqqq) and .03(6)(j) since those
rules became state effective in 2006 have been for the addition or
replacement of control equipment. In practice, those PCP examples did
not result in increases in collateral emissions, and therefore, reduced
emissions as intended. Although GA EPA acknowledges in its November 27,
2019 letter that these types of projects would have been exempted under
the State's minor NSR exemption thresholds at Rule 391-3-1-.03(6)(i)3.,
GA EPD believes there is a benefit to clarifying that the activities
listed at .01(qqqq)2. are exempt from construction permitting pursuant
to .03(6)(j). Therefore, the project list at .01(qqqq)2. serves to
provide examples for the public and the regulated community of projects
that are presumed to qualify for exemption.
    GA EPD also explains in its supplemental letter that the emission
limitations and standards which ensure attainment and maintenance of
the NAAQS are those at Rule 391-3-1-.02, Provisions, and that exemption
from the requirement to obtain a construction permit does not alter in
any way these limitations or standards, including work practice,
sampling, or monitoring requirements and federal NSR, New Source
Performance Standards, and National Emission Standards for Hazardous
Air Pollutants provisions incorporated into the rule.
    In sum, 40 CFR 51.160(e) requires that the SIP identify the ``types
and sizes of facilities, buildings, structures, or installations which
will be subject to review'' under the State's minor NSR program. EPA is
proposing approval of the definition of sources that qualify as PCPs at
Rule 391-3-1-.01(qqqq) because the definition describes projects that
already qualify for preexisting SIP-approved exemptions, and because
the projects will not increase emissions of pollutants, or otherwise
impact the State's ability to achieve the NAAQS, as required by CAA
sections 110(a)(2)(C) and 110(l).

C. CAA Section 193

    Section 193 of the CAA provides, in part, that ``[n]o control
requirement in effect, or required to be adopted by an order,
settlement agreement, or plan in effect before November 15, 1990, in
any area which is a nonattainment area for any air pollutant may be
modified after November 15, 1990, in any manner unless the modification
insures equivalent or greater emission reductions of such air
pollutant.'' As noted in Section II.B. of this NPRM, EPA believes the
proposed revisions will not lead to any increases of NAAQS pollutants.
Thus, to the extent Section 193 applies to this proposed action, EPA
has preliminarily concluded that the proposed revision is consistent
with the requirements of that provision.

III. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference the Georgia Rule 391-3-1-.01, entitled ``Definitions,''
effective July 20, 2017, which adds a definition for a ``Pollution
control project.'' 6 7 EPA has made, and will continue to
make, these materials generally available through www.regulations.gov
and at the EPA Region 4 office (please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section of this preamble for more
information).
---------------------------------------------------------------------------

    \6\ The effective date of the change to Rule 391-3-1-.01 made in
Georgia's September 19, 2006, SIP revision is July 13, 2006.
However, for purposes of the state effective date included at 40 CFR
52.570(c), that change to Georgia's rule is captured and superseded
by Georgia's update in a November 13, 2017, SIP revision, state
effective on July 20, 2017, which EPA previously approved on
December 4, 2018. See 83 FR 62466.
    \7\ Except for (qqqq)1. and (qqqq)3. through 8., which were
withdrawn from EPA consideration on November 27, 2019.
---------------------------------------------------------------------------

IV. Proposed Action

    EPA is proposing to approve the portion of the September 19, 2006,
SIP revision that adds a definition at Rule 391-3-1-.01(qqqq). EPA
believes this change is consistent with the CAA and will not impact the
NAAQS or interfere with any other applicable requirement of the Act.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 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. This action merely
proposes to approve State law as meeting Federal requirements and does
not impose additional requirements beyond those imposed by State law.
For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     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).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Sulfur oxides, Volatile organic compounds.

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

    Dated: March 4, 2020.
Mary S. Walker,
Regional Administrator, Region 4.
[FR Doc. 2020-05332 Filed 3-13-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 164 (Friday, August 23, 2019)]
[Notices]
[Pages 44317-44318]
[FR Doc No: 2019-18199]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3748]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Vaccines and
Related Biological Products Advisory Committee (VRBPAC). The general
function of the committee is to provide advice and recommendations to
the Agency on FDA's regulatory issues. The meeting will be open to the
public.

DATES: The meeting will be held on November 8, 2019, from 8:30 a.m. to
4:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. For those unable to attend in person, the meeting will also be
webcast and will be available at the following link: https://collaboration.fda.gov/vrbpac110819/. Answers to commonly asked
questions including information regarding special accommodations due to
a disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On November 8, 2019, the VRBPAC will meet in an open
session to discuss and make recommendations on the development of
chikungunya vaccines.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 1, 2019. Oral presentations from the public will be scheduled
between approximately 1:35 p.m. and 2:35 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before October 24, 2019.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by October 25, 2019.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Serina Hunter-

Thomas at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18199 Filed 8-22-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 143 (Wednesday, July 27, 2022)]
[Notices]
[Pages 45113-45114]
[FR Doc No: 2022-16074]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1802]

Cancer Clinical Trial Eligibility Criteria: Available Therapy in
Non-Curative Settings; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Cancer
Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative
Settings.'' The guidance provides recommendations to sponsors of
clinical trials of investigational cancer drugs regarding the inclusion
of patients who have not previously received available therapy
(commonly referred to as existing treatment options) for their cancer
in the non-curative setting. This guidance finalizes the draft guidance
of the same title issued on June 24, 2021.

DATES: The announcement of the guidance is published in the Federal
Register on July 27, 2022.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1802 for ``Cancer Clinical Trial Eligibility Criteria:
Available Therapy in Non-Curative Settings.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002 or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jennifer Gao, Oncology Center of
Excellence, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 2135, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Cancer Clinical Trial Eligibility Criteria: Available
Therapy in Non-Curative Settings.'' The guidance provides
recommendations regarding the inclusion of patients who have not
received available therapy for their cancer in clinical trials of
investigational cancer drugs and biological products in the non-
curative setting. For the purposes of this guidance, non-curative is
generally defined as: (1) unresectable, locally advanced, or metastatic
disease in solid tumors or (2) hematologic malignancies with
unfavorable long-term overall survival.
    Under 21 CFR part 312, which applies to clinical investigations of
drugs and biological products, FDA must determine that study subjects
are not exposed to an unreasonable and significant risk of illness or
injury (312.42(b)(1)(i) and (b)(2)(i)) to allow such trials to proceed.
Therefore, in clinical trials evaluating investigational cancer drugs,
eligibility criteria should generally require that patients have
received available therapy(ies) that offer the potential for cure in a
substantial proportion of patients. Alternatively, such available
therapy should be administered to all patients in the trial, where the
investigational drug is added to such therapy. However, eligibility
criteria in which patients receive an investigational drug(s) in lieu
of available therapy are reasonable in the non-curative setting when
patients have been provided with adequate information to make an
informed decision on trial participation. The guidance describes
information that should be included in the informed consent and
includes recommendations regarding evaluation of results when this
approach is taken.
    This guidance finalizes the draft guidance entitled ``Cancer
Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative
Settings'' issued on June 24, 2021 (86 FR 33710). FDA considered
comments received on the draft guidance as the guidance was finalized.
Changes from the draft to the final guidance include additional
recommendations for safety evaluation in early stage dose escalation
studies.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Cancer Clinical Trial Eligibility
Criteria: Available Therapy in Non-Curative Settings.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in part 312 have been approved under OMB control number
0910-0014; the collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001; and the collections of
information in 21 CFR part 601 have been approved under OMB control
number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16074 Filed 7-26-22; 8:45 am]
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