[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Rules and Regulations]
[Page 50884-50891]
[DOCID:fr18au10-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0601 and EPA-HQ-OPP-2008-0602; FRL-8836-3]

2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and
Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl; 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 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl)
benzotriazole (CAS Reg. No. 25973-55-1) and Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl; (CAS Reg. No. 23328-53-2) when
used as a ultraviolet (UV)

stabilizer at a maximum concentration of 0.6% in insecticide
formulations applied pre-harvest to adzuki beans, canola, chickpeas,
cotton, faba beans, field peas, lentils, linola, linseed, lucerne,
lupins, mung beans, navy beans, pigeon peas, safflower, sunflower, and
vetch under 40 CFR 180.920. Ag-Chem Consulting on behalf of Caltex Inc.
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting establishment of an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of 2-(2'-hydroxy-3',
5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl.

DATES: This regulation is effective August 18, 2010. Objections and
requests for hearings must be received on or before October 18, 2010,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0601 and EPA-HQ-OPP-2008-
0602. All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available in the
electronic docket at http://www.regulations.gov, or, if only available
in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket Facility telephone number
is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Deirdre Sunderland, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail 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.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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 cite at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2008-0601 and EPA-HQ-OPP-2008-0602 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 18, 2010. 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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
numbers EPA- EPA-HQ-OPP-2008-0601 and EPA-HQ-OPP-2008-0602, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Exemption

     In the Federal Register of December 3, 2008 (73 FR 73648) (FRL-
8391-3), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP 8E7362
and PP 8E7363) by, Ag-Chem Consulting, 12208 Quinque Lane, Clifton, VA
21024 on behalf of Caltex Inc., 2 Market Street, Sydney, Australia. The
petition requested that 40 CFR 180.920 be amended by establishing an
exemption from the requirement of a tolerance for residues of 2-(2'-
hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole (CAS Reg. No. 25973-
55-1) and Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl; (CAS
Reg. No. 23328-53-2) when used as an inert ingredient as an ultraviolet
(UV) stabilizers at a maximum concentration of 0.6% in insecticide
formulations applied to adzuki beans, canola, chickpeas, cotton, faba
beans, field peas, lentils, linola, linseed, lucerne, lupins, mung
beans, navy beans, pigeon peas, safflower, sunflower, and vetch. That
notice referenced a summary of the petition prepared by Ag-Chem
Consulting on behalf of Caltex Inc., 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 section 408(c)(2)(A) of FFDCA, 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 2-(2'-hydroxy-3', 5'-di-tert-
amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-
dodecyl-4-methyl including exposure resulting from the exemption
established by this action. EPA's assessment of exposures and risks
associated with 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole
and Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl 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 2-(2'-hydroxy-3', 5'-di-tert-
amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-
dodecyl-4-methyl 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.
    The petition provided evidence that Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl is structurally and toxicologically similar to
2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole. The Agency
agrees that data on 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl)
benzotriazole would represent a worst case scenario for Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl and has, therefore, been used
when determining risk associated with the use of both of these
chemicals.
    Acute studies with 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl)
benzotriazole revealed low acute toxicity with an oral LD50
>2325 mg/kg. Acute inhalation and dermal studies resulted in
LC50 >1,420 mg/m3 and LD50 >2,000 mg/
kg, respectively for analog chemicals. Skin irritation studies with 2-
(2'-hydroxy-5'-methylphenyl) benzotriazole (CAS Reg. No. 2440-22-4), an
analog chemical, on rats and mice showed no local irritation and no
systemic toxicity. 2-(2'-hydroxy-5'-methylphenyl) benzotriazole was
found to be slightly irritating to rabbit eyes. Skin sensitization
studies with 2-(2'-hydroxy-5'-methylphenyl) benzotriazole in guinea
pigs showed skin sensitization; however, studies conducted on humans
showed no sensitization.
    A 90-day toxicity study in Wistar rats administered 2-(2'-hydroxy-
3', 5'-di-tert-amylphenyl) benzotriazole through the diet. Thyroid,
liver, kidney, spleen, and testes weights were increased in higher
exposure groups. The primary target organ was the liver which showed
microscopic changes and a greenish-drab discoloration at higher dose
levels. Reproductive organs were not evaluated microscopically.
Pigmentation was also seen in the proximal tubular cells of females. No
mortality was observed. The no-observed-adverse-effect-level (NOAEL) of
20 mg/kg/day is based on liver and kidney effects seen at the lowest-
observed-adverse-effect-level (LOAEL) of 40 mg/kg/day.
    In a 90-day dog study, Beagles were administered 2-(2'-hydroxy-3',
5'-di-tert-amylphenyl) benzotriazole via the diet. Animals in the high-
dose group showed decreases in body weight and food consumption, and
changes in blood chemistry. Males showed decreases in testes, prostate,
and epididymal weights (>=120 mg/kg/day) and females showed deceases in
uterus weight (>=60 mg/kg/day). One male dog in the highest dose group
died. Histopathologic effects were noted in the liver (the primary
target organ), kidney, and testes (>=60 mg/kg/day) groups along with
atrophy of uterus, abnormal spermiogenesis, and atrophy of the
prostate. Liver damage was observed in a few dogs. The NOAEL was 30 mg/
kg/day based on body weight, liver, and kidney effects seen at the
LOAEL of 60 mg/kg/day.
    Developmental studies have been conducted on two structurally
similar chemicals. Rats and mice received the test substance containing
2-(2'-hydroxy-5'-methylphenyl) benzotriazole (CAS Reg. No. 2440-22-4)
on days 6-15 of gestation. No maternal toxicity was evident and the
rates of implantation and embryotoxicity were not affected by
treatment. No teratogenic effects were observed. The NOAEL for maternal
and developmental toxicity was 1,000 mg/kg/day (highest dose tested) in
mice and rats. A second developmental rat study showed no maternal
toxicity at any dose tested for 2-(2H- Benzotriazol-2-yl)-4,6-

bis(1-methyl-1-phenylethyl) phenol (CAS Reg. No. 70321-86-7). A
significant reduction in fetal body weight and an increased delay of
skeletal maturation was observed in the 1,000 mg/kg/day dose group.
However, there were no similar effects in the high dose group
indicating that these effects may be ``incidental''. An omphalocele was
seen in one fetus in the high dose group. The maternal toxicity NOAEL
was 3,000 mg/kg/day (highest dose tested). A developmental toxicity
NOAEL of 1,000 mg/kg/day was chosen based on the omphalocele seen at
the LOAEL of 3,000 mg/kg/day.
    All genetic toxicity tests (in vitro and in vivo) conducted
indicated that this group of chemicals are not mutagenic and will not
undergo chromosomal aberrations. No evidence of carcinogenicity was
observed in rats when 142 mg/kg/day of 2-(2'-hydroxy-5'-methylphenyl)
benzotriazole (CAS Reg. No. 2440-22-4) was administered in the diet for
104 weeks. Negative finding were also seen in rats and mice given up to
62 mg/kg/day for 24 months. No clinical signs of neurotoxicity were
seen in any of the repeat dose studies. Therefore, 2-(2'-hydroxy-3',
5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl are not expected to be neurotoxic.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level -- generally referred to as
a population-adjusted dose (PAD) or a reference dose (RfD) -- and a
safe margin of exposure (MOE). For non-threshold risks, the Agency
assumes that any amount of exposure will lead to some degree of risk.
Thus, the Agency estimates risk in terms of the probability of an
occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://
www.epa.gov/pesticides/factsheets/riskassess.htm.
     The point of departure for risk assessment for all durations and
routes of exposure was from the 90-day toxicity study in rats. The
NOAEL was 20 mg/kg/day and the LOAEL was 40 mg/kg/day based on
increases in liver, kidney, spleen, and testes weights. Although the
chronic point of departure was selected from a subchronic study,
longer-term studies are available that shows the lack of toxicity even
at higher doses (NOAEL higher than 60 mg/kg/day in carcinogenicity
studies on a structurally similar chemical). No additional uncertainty
factor is needed for extrapolating from subchronic to chronic exposure.
A 1,000 fold uncertainty factor was used for the chronic exposure (10X
interspecies extrapolation, 10X for intraspecies variability and 10X
FQPA factor for the lack of reproduction studies). The NOAEL of 20 mg/
kg/day was used for all exposure duration via dermal and inhalation
routes of exposure. The residential, occupational and aggregate level
of concern (LOC) is for MOEs that are less than 1,000 and is based on
10X interspecies extrapolation, 10X for intraspecies variability and
10X FQPA factor for the lack of reproduction studies. Dermal absorption
is estimated to be 10% based on SAR analysis. A 100% inhalation is
assumed.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and
Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl, EPA considered
exposure under the proposed exemption from the requirement of a
tolerance. EPA assessed dietary exposures from 2-(2'-hydroxy-3', 5'-di-
tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-
dodecyl-4-methyl in food as follows:
    In conducting the chronic dietary exposure assessment, EPA used
food consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). In the absence of specific residue
data, EPA has developed an approach which uses surrogate information to
derive upper bound exposure estimates for the subject inert ingredient.
Upper bound exposure estimates are based on the highest tolerance for a
given commodity from a list of high-use insecticides, herbicides, and
fungicides. The Agency believes the assumptions used to estimate
dietary exposures lead to an extremely conservative assessment of
dietary risk. A complete description of the general approach taken to
assess inert ingredient risks in the absence of residue data is
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water)
Dietary Exposure and Risk Assessments for the Inerts.'' (D361707, S.
Piper, 2/25/09) and can be found at http://www.regulations.gov in
docket ID number EPA-HQ-OPP-2008-0738.
    In the case of 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl)
benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl,
EPA made a specific adjustment to the dietary exposure assessment to
account for the use limitations of the amount of 2-(2'-hydroxy-3', 5'-
di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl that may be in formulations (no more than 0.6%
by weight in pesticide products applied to adzuki beans, canola,
chickpeas, cotton, faba beans, field peas, lentils, linola, linseed,
lucerne, lupins, mung beans, navy beans, pigeon peas, safflower,
sunflower, and vetch) and assumed that the 2-(2'-hydroxy-3', 5'-di-
tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-
dodecyl-4-methyl are present at the maximum limitation rather than at
equal quantities with the active ingredient.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for 2-(2'-hydroxy-3', 5'-
di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl, a conservative drinking water concentration
value of 100 ppb based on screening level modeling was used to assess
the contribution to drinking water for the chronic dietary risk
assessments for parent compound. These values were directly entered
into the dietary exposure model.
    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).
     Residential uses of these chemicals are extremely limited.
However, in order to account for all of the current and unanticipated
potential residential uses of these chemicals various exposure models
were employed. The

Agency believes that the scenarios assessed represent highly
conservative worse-case short and intermediate term exposures and risks
to residential handlers and those experiencing post-application
exposure resulting from the use of indoor and outdoor pesticide product
containing these inert ingredients in residential environments. Based
on the use pattern the chronic exposure is not anticipated. Therefore,
the risk from the chronic residential exposure was not assessed.
     Further details of this residential exposure and risk analysis can
be found at http://www.regulations.gov in the memorandum entitled
``JITF Inert Ingredients. Residential and Occupational Exposure
Assessment Algorithms and Assumptions Appendix for the Human Health
Risk Assessments to Support Proposed Exemption from the Requirement of
a Tolerance When Used as Inert Ingredients in Pesticide Formulations''
(D364751, 5/7/09, Lloyd/LaMay in docket ID number EPA-HQ-OPP-2008-0710.
    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 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl)
benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl
share a common mechanism of toxicity with any other substances, and 2-
(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that 2-(2'-hydroxy-3', 5'-
di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl do 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 website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. 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 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.
    2. Prenatal and postnatal sensitivity. Developmental studies have
been conducted on two structurally similar chemicals. In one study, no
maternal toxicity was evident and the rates of implantation and
embryotoxicity were not affected by treatment. No teratogenic effects
were observed; however, the study does not specify what developmental
endpoints were examined. The NOAEL for maternal and developmental
toxicity was 1,000 mg/kg/day (highest dose tested). There was no
evidence of increased susceptibility in this developmental toxicity
study in rats and mice.
    In a second study, no maternal toxicity was observed at any dose
tested. The maternal toxicity NOAEL was 3,000 mg/kg/day. The
developmental NOAEL was 1,000 mg/kg/day based on omphalocele seen in
the one fetus in the high dose group (LOAEL 3,000 mg/kg/day). The data
suggest evidence of increased susceptibility in this developmental
toxicity study in rats. However, there is a low concern for this
susceptibility because this effect (omphalocele) was seen at a very
high dose of 3,000 mg/kg/day and only in one fetus. In addition, the
study did not provide historical controls that would assist in making
determination whether this effect is treatment related or not.
    The dietary assessment includes estimates using highly conservative
model assumptions. In addition, the drinking water assessment was
conducted using the highly conservative value of 100 ppb. These model
estimates are highly conservative so as to not under estimate the risk.
    3. Conclusion. EPA has determined that it does not have reliable
data to vary from the default FQPA safety factor of 10X. EPA considered
the following factors:
    i. The database for 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl)
benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl
is incomplete. EPA lacks a 2-generation reproductive study or any study
measuring reproductive performance parameters in male and female rats.
EPA also does not have an immunotoxicity study. In a 90-day toxicity
study in rats, slight increases in spleen weights without
histopathological findings was observed at the highest dose tested (80
mg/kg/day). There was no other evidence of immunotoxicity in the
database.
    ii. No clinical signs of neurotoxicity were seen in any of the
repeat dose studies. Therefore, 2-(2'-hydroxy-3', 5'-di-tert-
amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-
dodecyl-4-methyl are not expected to be neurotoxic.
    iii. As discussed above, there is low concern for increased
sensitivity in the young from exposure to 2-(2'-hydroxy-3', 5'-di-tert-
amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-
dodecyl-4-methyl.
    iv. The dietary assessment includes estimates using highly
conservative model assumptions. In addition, the drinking water
assessment was conducted using the highly conservative value of 100
ppb. Finally, the model estimates for residential exposure are highly
conservative so as to not under estimate the risk. Of principal concern
to EPA is the lack of a 2-generation reproductive study or any other
study measuring reproductive performance parameters in male and female
rats.

E. Aggregate Risks and Determination of Safety

    Determination of safety section. 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 PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-
(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl are not expected to pose an
acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure and the use limitation described previously
in Unit C, the EPA has concluded that chronic exposure to 2-(2'-
hydroxy-3', 5'-di-tert-amylphenyl)

benzotriazole and Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl
from food and water will be 0.3% of the cPAD for US populations and 2.8
% for non-nursing infants, the population group receiving the greatest
exposure. Based on its use pattern, chronic residential exposure is not
anticipated. Therefore, chronic residential exposure to residues of 2-
(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl were not assessed.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol,
2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl could potentially be used
as an inert ingredient in pesticide products that may be registered for
uses that could result in short-term residential exposure, and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short-term residential exposures
to 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol,
2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl.
    Using the exposure assumptions described in this unit for short-
term exposures and the use limitation described previously in Unit C,
EPA has concluded the combined short-term food, water, and residential
exposures result in aggregate MOEs of 7,100 for adult males and
females. Adult residential exposure combines high end dermal and
inhalation handler exposure from liquids/trigger sprayer in home
gardens with a high end post application dermal exposure from contact
with treated lawns. EPA has concluded the combined short-term
aggregated food, water, and residential exposures result in an
aggregate MOE of 10,000 for children. Children's residential exposure
includes total exposures associated with contact with treated lawns
(dermal and hand-to mouth exposures). The EPA's level of concern for 2-
(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl is for MOEs that are lower than
1,000; therefore, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol,
2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl could potentially be used
as inert ingredients in pesticide products that may be registered for
uses that could result in intermediate-term residential exposure, and
the Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with intermediate-term residential
exposures to 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and
Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 55,000 for adult males and 54,000 for adult females.
Adult residential exposure includes high end post application dermal
exposure from contact with treated lawns. EPA has concluded the
combined intermediate term aggregated food, water, and residential
exposures result in an aggregate MOE of 16,000 for children. Children's
residential exposure includes total exposures associated with contact
with treated lawns (dermal and hand-to-mouth exposures). The level of
concern is for MOEs that are lower than 1,000; therefore, this MOE is
not of concern.
    5. Aggregate cancer risk for U.S. population. 2-(2'-hydroxy-3', 5'-
di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-benzotriazole-2-
yl)-6-dodecyl-4-methyl are not expected to be carcinogenic since there
was no evidence of carcinogenicity in the available studies.
    6. Determination of safety. Based on these risk assessments, 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 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and
Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl residues.

V. Other Considerations

A. Analytical Enforcement Methodology

     An analytical method is not required for enforcement purposes
since the Agency is not establishing a numerical tolerance for residues
of 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole or Phenol, 2-
(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl in or on any food
commodities. EPA is establishing a limitation on the amount of 2-(2'-
hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole and Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl that may be used in pesticide
formulations. That limitation will be enforced through the pesticide
registration process under the Federal Insecticide, Fungicide, and
Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register
any pesticide for sale or distribution that contains greater than 0.6%
of 2-(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole or Phenol, 2-
(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl by weight in the pesticide
formulation.

B. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for 2-
(2'-hydroxy-3', 5'-di-tert-amylphenyl) benzotriazole or Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl nor have any CODEX Maximum
Residue Levels (MRLs) been established for any food crops at this time.

VI. Conclusions

     Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for 2-(2'-hydroxy-3', 5'-di-tert-
amylphenyl) benzotriazole (CAS Reg. No. 25973-55-1) and Phenol, 2-(2H-
benzotriazole-2-yl)-6-dodecyl-4-methyl; (CAS Reg. No. 23328-53-2) when
used as an inert ingredient [as an ultraviolet (UV) stabilizers at a
maximum concentration of 0.6%] in insecticide formulations applied to
adzuki beans, canola, chickpeas, cotton, faba beans, field peas,
lentils, linola, linseed, lucerne, lupins, mung beans, navy beans,
pigeon peas, safflower, sunflower, and vetch.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA 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 section 408(d) of FFDCA, such as the 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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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 9, 2010.
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. 180.920, the table is amended by adding alphabetically the
following inert ingredients to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
2-(2'-hydroxy-3',5'-di-tert-      maximum             Ultraviolet (UV)
 amylphenyl) benzotriazole (CAS    concentration of    stabilizer
 Reg. No. 25973-55-1)              0.6% in
                                   insecticide
                                   formulations
                                   applied to adzuki
                                   beans, canola,
                                   chickpeas,
                                   cotton, faba
                                   beans, field
                                   peas, lentils,
                                   linola, linseed,
                                   lucerne, lupins,
                                   mung beans, navy
                                   beans, pigeon
                                   peas, safflower,
                                   sunflower, and
                                   vetch
Phenol, 2-(2H-benzotriazole-2-    maximum             Ultraviolet (UV)
 yl)-6-dodecyl-4-methyl; (CAS      concentration of    stabilizer
 Reg. No. 23328-53-2)              0.6% in
                                   insecticide
                                   formulations
                                   applied to adzuki
                                   beans, canola,
                                   chickpeas,
                                   cotton, faba
                                   beans, field
                                   peas, lentils,
                                   linola, linseed,
                                   lucerne, lupins,
                                   mung beans, navy
                                   beans, pigeon
                                   peas, safflower,
                                   sunflower, and
                                   vetch
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-20299 Filed 8-17-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 182 (Thursday, September 19, 2013)]
[Rules and Regulations]
[Pages 57482-57485]
[FR Doc No: 2013-22760]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0741]
RIN 1625-AA00

Safety Zone; America's Cup Aerobatic Box, San Francisco Bay, San
Francisco, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing safety zones in the

navigable waters of the San Francisco Bay near Pier 27 in San
Francisco, CA in support of 2013 America's Cup air shows. These safety
zones are established to provide a clear area on the water for pilots
to initiate maneuvers and also provide for the safety of pilots,
spectators, and other vessels transiting the area in the unlikely event
that an aircraft crashes during the air show. All persons or vessels
are prohibited from entering the safety zones and all persons or
vessels are prohibited from anchoring or otherwise loitering in the
area during the scheduled events without the permission of the Captain
of the Port or their designated representative.

DATES: This rule is effective as to persons with actual notice starting
September 6, 2013. This rule is effective September 19, 2013, for
purposes of 5 U.S.C. 552 enforcement. This rule will be in effect until
September 23, 2013. This rule will be enforced on September 6, 2013
from 6 p.m. until 7 p.m., September 7, 2013 from 11:30 a.m. until 12:30
p.m., and any other time an air show event is scheduled to take place
within the effective period as announced by America's Cup Race
Management.

ADDRESSES: Documents mentioned in this preamble are part of Docket
Number USCG-2013-0741. To view documents mentioned in this preamble as
being available in the docket, go to http://www.regulations.gov, type
the docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on
``Open Docket Folder'' on the line associated with this rulemaking. You
may also visit the Docket Management Facility in Room W12-140 on the
ground floor of the Department of Transportation West Building, 1200
New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Junior Grade Joshua Dykman, U.S. Coast Guard
Sector San Francisco; telephone<PHONE_NUMBER> or email at<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call the Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

ACRM America's Cup Race Management
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking

A. Regulatory History and Information

    On January 30, 2012, the Coast Guard published a notice of proposed
rulemaking (NPRM) proposing to regulate the on-water activities
associated with the ``America's Cup World Series'' regattas in 2012 and
the ``Louis Vuitton Cup,'' ``Red Bull Youth America's Cup,'' and
``America's Cup Finals Match'' scheduled to occur in July, August, and
September, 2013 (77 FR 04501). After reviewing all comments received in
response to the NPRM, the Coast Guard published a temporary final rule
on July 17, 2012, that created a special local regulation (SLR) and
safety zone, establishing regulated areas on the water to enhance
safety and maximize access to the affected waterways during the
America's Cup sailing events (77 FR 41902).
    The Coast Guard is issuing this temporary final 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(d)(3), for the same reasons noted
earlier, the Coast Guard finds that good cause exists for making this
rule effective less than 30 days after publication in the Federal
Register. The U.S. Coast Guard was notified on August 02, 2013 that
America's Cup Race Management (ACRM) was planning on conducting air
shows in the navigable waters of the San Francisco Bay near Pier 27 on
several days throughout the month of September, 2013. The America's Cup
air show activities would occur before the rulemaking process would be
completed, and delaying the effective date of this rule to allow for a
comment period would be both impracticable and contrary to the public
interest because it would inhibit the Coast Guard's ability to protect
spectators and vessels from the hazards associated aircraft performing
aerobatic maneuvers in the navigable waters of the San Francisco Bay
near Pier 27. The safety zones are necessary to provide a clear area on
the water for pilots to initiate maneuvers and also provide for the
safety of pilots, spectators, and other vessels transiting the area in
the unlikely event that an aircraft crashes during the air show. For
the safety concerns noted, it is in the public interest to have these
regulations in effect during the event.

B. Basis and Purpose

    The legal basis for the proposed rule is 33 U.S.C. 1231; 46 U.S.C
Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1,
6.04-6, 160.5; Public Law 107-295, 116 Stat. 2064; Department of
Homeland Security Delegation No. 0170.1, which collectively authorize
the Coast Guard to establish safety zones.
    The Coast Guard has decided to establish safety zones in the
navigable waters of the San Francisco Bay near Pier 27 in San
Francisco, CA in support of America's Cup air shows to mitigate the
dangers posed by aircraft executing aerobatic maneuvers in the
navigable waters of the San Francisco Bay near Pier 27.

C. Discussion of the Final Rule

    The Coast Guard is establishing safety zones in the navigable
waters of the San Francisco Bay near Pier 27 in San Francisco, CA
during the America's Cup air shows in September of 2013 to ensure the
safety of pilots participating in the air shows and spectators viewing
the air show from the water. The safety zones will be effective from
September 6, 2013 to September 23, 2013.
    The Coast Guard will enforce the safety zones on September 6, 2013
from 6 p.m. until 7 p.m., September 7, 2013 from 11:30 a.m. until 12:30
p.m., and any other time an air show event is scheduled to place within
the effective period as announced by America's Cup Race Management. The
safety zones will encompass the navigable waters of the San Francisco
Bay within a shape bounded by the following coordinates: 37[deg]49'12''
N, 122[deg]24'10'' W; 37[deg]48'50'' N, 122[deg]24'35'' W;
37[deg]48'04'' N, 122[deg]23'30'' W; 37[deg]48'26'' N, 122[deg]23'05''
W; thence back to the point of origin (NAD 83). At the conclusion of
the scheduled events the safety zones shall terminate.
    The effect of the safety zones will be to provide a clear area on
the water for pilots to initiate maneuvers and also provide for the
safety of pilots, spectators, and other vessels transiting the area in
the unlikely event that an aircraft crashes during the air show. At the
conclusion of the scheduled air shows, the safety zones shall
terminate. Except for persons or vessels authorized by the Coast Guard
Patrol Commander, no person or vessel may enter or remain in safety
zones.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on numerous statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    We expect the economic impact of this rule does not rise to the
level of necessitating a full Regulatory Evaluation. The safety zone
and no loitering area are limited in duration, and are limited to a
narrowly tailored geographic area. In addition, although this rule
restricts access to a small section of the waters encompassed by the
safety zone, the effect of this rule will not be significant because
the local waterway users will have access to the no loitering area
during the event. The entities most likely to be affected are
waterfront facilities, commercial vessels, and pleasure craft engaged
in recreational activities.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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.
    This rule may affect owners and operators of waterfront facilities,
commercial vessels, and pleasure craft engaged in recreational
activities and sightseeing. The safety zones would not have a
significant economic impact on a substantial number of small entities
for the following reasons. The safety zones would be activated, and
thus subject to enforcement, for a limited duration. When the safety
zones are activated, vessel traffic could pass safely around the safety
zone. The maritime public will be advised in advance of these safety
zones via Broadcast Notice to Mariners.

3. Assistance for Small Entities

    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,
above.
    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.

4. 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).

5. Federalism

    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 determined
that this rule does not have implications for federalism.

6. 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.

7. 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.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. 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 (NEPA) (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 of limited size and
duration. This rule 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.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and 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; 46 U.S.C. Chapter 701; 50 U.S.C.
191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub. L. 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1.

0
2. Add temporary Sec.  165-T11-594 to read as follows:

Sec.  165-T11-594  Safety zone; America's Cup Aerobatic Box, San
Francisco Bay, San Francisco, CA

    (a) Location. These temporary safety zones are established for the
navigable waters of the San Francisco Bay near Pier 27 in San
Francisco, CA as depicted in National Oceanic and Atmospheric
Administration (NOAA) Chart 18650. The safety zone will encompass the
navigable waters of the San Francisco Bay within a shape bounded by the
following coordinates: 37[deg]49'12'' N, 122[deg]24'10'' W;
37[deg]48'50'' N, 122[deg]24'35'' W; 37[deg]48'04'' N, 122[deg]23'30''
W; 37[deg]48'26'' N, 122[deg]23'05'' W; thence back to the point of
origin (NAD 83).
    (b) Enforcement periods. This section will be enforced on September
6, 2013 from 6 p.m. until 7 p.m., September 7, 2013 from 11:30 a.m.
until 12:30 p.m., and any other time an air show event is scheduled to
take place within the effective period as announced by America's Cup
Race Management. This section will be in effect until September 23,
2013. The Captain of the Port San Francisco (COTP) will notify the
maritime community of periods during which this zone will be enforced
via Broadcast Notice to Mariners in accordance with 33 CFR 165.7 or via
actual notice on-scene.
    (c) Regulations. (1) The safety zone is closed to all persons and
vessels.
    (2) The public can contact Sector San Francisco Bay at (415) 399-
3530 to obtain information concerning enforcement of this rule.
    (d) Enforcement. All persons and vessels must comply with the
instructions of the COTP or the designated on-scene patrol personnel.
Patrol personnel comprise commissioned, warrant, and petty officers of
the Coast Guard onboard Coast Guard, Coast Guard Auxiliary, local,
state, and federal law enforcement vessels. The U.S. Coast Guard may be
assisted in the patrol and enforcement of the safety zone by local law
enforcement as necessary. Upon being hailed by U.S. Coast Guard patrol
personnel by siren, radio, flashing light, or other means, the operator
of a vessel must proceed as directed.

    Dated: September 5, 2013.
Gregory G. Stump,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2013-22760 Filed 9-18-13; 8:45 am]
BILLING CODE 9110-04-P


P-20-0185 Sanitized Support Documents Index:
 P-20-0185 Sanitized Premanufacture Notice (linked)
 P-20-0185 Sanitized Determination Document (linked)
 P-20-0185 Sanitized CHEM Report (attached)
 P-20-0185 Sanitized ECO Report (attached)
 P-20-0185 Sanitized ENG Report (attached)
 P-20-0185 Sanitized EXP Report (attached)
 P-20-0185 Sanitized Fate Report (attached)
 P-20-0185 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Notices]
[Pages 65037-65039]
[FR Doc No: 2012-26148]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68070; File No. SR-C2-2012-024]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Order Approving a Proposed Rule Change To Adopt a Designated Primary
Market-Maker Program

October 18, 2012.

I. Introduction

    On August 21, 2012, the C2 Options Exchange, Incorporated (the
``Exchange'' or ``C2'') filed with the Securities and Exchange
Commission (the ``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (the ``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to adopt a Designated Primary
Market-Maker (``DPM'') program. The proposed rule change was published
in the Federal Register on September 7, 2012.\3\ The Commission
received no comment letters on the proposal. This order approves the
proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 67772 (August 31,
2012), 77 FR 55257 (September 7, 2012) (the ``Notice'').
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II. Description of the Proposed Rule Change

    As set forth in the Notice, C2 has proposed to adopt a DPM program.
The associated proposed rules are based on the rules governing the DPM
program on the Chicago Board Options Exchange, Incorporated (``CBOE''),
excluding certain provisions that are inapplicable to C2 (such as
provisions related to floor trading and CBOE-specific provisions) and
other provisions that the Exchange believes are outdated.\4\
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    \4\ See CBOE Rules 6.45A(a)(ii)(2) and (iii), 6.45B(a)(i)(2) and
(iii), 8.80, 8.83-8.91, 8.95, and 17.50(g)(14).
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    The proposed rule change defines a DPM as a Participant \5\
organization that is approved by the Exchange to function in allocated
securities as a Market-Maker and is subject to obligations under
proposed Rule 8.17. Proposed Rule 8.14 sets forth the criteria that the
Exchange will consider when reviewing a Participant organization's
application to become a DPM. Each approved DPM will retain its status
to act as a DPM for one year. After each one-year term, a DPM may file
an application with the Exchange to renew its approval to act as a DPM.
In addition, the Exchange may take action to suspend or limit a DPM's
status, consistent with Rule 8.20 (concerning termination,
conditioning, or limiting approval to act as a DPM).\6\
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    \5\ A ``Participant'' is an Exchange-recognized holder of a
Trading Permit (``Trading Permit Holder'' or ``TPH''). A Trading
Permit is an Exchange-issued permit that confers the ability to
transact on the Exchange. See Rule 1.1.
    \6\ CBOE's DPM rules differ from proposed Rule 8.14 in several
ways. CBOE Rule 8.83 provides that a DPM's term is unlimited (until
the Exchange relieves or terminates the DPM of its approval to act
as a DPM), and accordingly, unlike the proposed rule, lacks a
provision allowing DPMs to renew their appointments after each one
year term (cf. CBOE Rule 8.83(e)). Further, CBOE Rule 8.83
contemplates the resignation of a DPM, while the proposed rule does
not because the Exchange believes resignation would be unnecessary
given the one-year DPM term. The DPM can simply choose not to renew
its application at the end of the term or ask C2 to relieve it of
its approval (cf. CBOE Rule 8.83(f)). CBOE Rule 8.89 also permits a
DPM to sell, transfer, or assign its appointment, which is
prohibited without the prior written approval of the Exchange by
proposed Rule 8.14(g). Finally, CBOE requires an annual review of
DPM operations and performance, but because C2 only permits DPMs to
have a one-year term, the Exchange believes an annual review is
unnecessary, though in proposed Rule 8.14(e), it may conduct an
evaluation of the extent to which the DPM has satisfied its
obligations under Rule 8.17 in determining whether to renew the
DPM's renewal application (cf. CBOE Rule 8.88(a)).
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    Proposed Rule 8.15 sets forth the manner in which the Exchange will
allocate securities to DPMs. Specifically, the Exchange will determine
for each security traded on the Exchange whether the security should be
allocated to a DPM and, if so, to which DPM. The proposed rule also
describes the criteria that the Exchange may consider in making
allocation determinations.
    Proposed Rule 8.15 further provides that the Exchange may remove an
allocation from a DPM and reallocate the security during a DPM's term
if the DPM fails to adhere to any market performance commitments made
by the DPM in connection with receiving the allocation or the Exchange
concludes that doing so is in the best interests of the Exchange based
on operational factors or efficiency. The proposed rule also describes
the procedures the Exchange must follow prior to taking any action to
remove an allocation.
    Proposed Rule 8.16 grants the Exchange the authority to establish:
(1) Restrictions applicable to all DPMs on the concentration of
securities allocable to a single DPM and to affiliated DPMs, and (2)
minimum eligibility standards applicable to all DPMs, which must be
satisfied in order for a DPM to receive allocations of securities,
including but not limited to standards relating to adequacy of capital
and operational capacity.\7\
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    \7\ The Commission notes that the exercise of the Exchange's
authority under this provision would be subject to the rule filing
requirements of Section 19 of the Act and, if so required, would
have to be filed with the Commission before such changes can become
effective. See 15 U.S.C. 78s.
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    Proposed Rule 8.17 describes the obligations of a DPM, including
the general obligation that a DPM must fulfill all of the obligations
of a Market-Maker under Exchange Rules. In addition, the rule sets
forth additional requirements applicable to DPMs, such as heightened
quoting obligations and a duty to make competitive markets on the
Exchange. In particular, DPMs will be subject to a requirement to
provide a continuous quote throughout each trading day in 99% of their
non-adjusted series (or 100% minus one put-call pair of each assigned
class). Proposed Rule 8.18 sets forth the specific financial
requirements for DPMs.
    Proposed Rule 8.19 grants a trade participation right to DPMs, and
gives the Exchange authority to establish a participation entitlement
formula that is applicable to all DPMs.\8\ The proposed rule provides
that: (1) A DPM will be entitled to a participation entitlement only if
quoting at the best bid or offer disseminated on the Exchange
(``BBO''); (2) a DPM may not be allocated a total quantity greater than
the quantity that the DPM is quoting at the BBO; and (3) the
participation entitlement is based on the number of contracts remaining
after all public customer orders in the Book at the BBO have been
satisfied. The proposed rule also provides that the collective DPM
participation entitlement shall be: 50% when there is one Market-Maker
also quoting at the BBO and 40% when there are two or more Market-
Makers also quoting at the

BBO.\9\ If only the DPM is quoting at the BBO (with no Market-Makers
quoting at the BBO), the participation entitlement will not be
applicable and the allocation procedures under Rule 6.12 (Order
Execution and Priority) will apply.
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    \8\ The Commission notes that any changes to the participation
entitlement formula would be subject to the rule filing requirements
of Section 19 of the Act and, if so required, would have to be filed
with the Commission before such changes can become effective. See 15
U.S.C. 78s.
    \9\ Cf. CBOE Rule 8.87 (providing a different DPM participation
entitlement--50% if there is one Market-Maker quoting at the BBO,
40% when there are two Market-Makers quoting at the BBO, and 30%
when there are three or more Market-Makers quoting at the BBO).
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    The Exchange proposed modifications to Rule 6.12 to accommodate the
participation entitlement for DPMs. The proposed rule change provides
that both PMMs and DPMs may be granted participation rights up to the
applicable participation right percentage designated in Rule 8.13 and
proposed Rule 8.19. Rule 6.12 also provides that, while the Exchange
may activate more than one trade participation right for an option
class (including at different priority sequences), in no case may more
than one trade participation right be applied on the same trade.
Further, the proposed rule provides that: (1) A DPM's order or quote
must be at the best price on the Exchange; (2) a DPM may not be
allocated a total quantity greater than the quantity that it is quoting
(including orders not part of quotes) at that price; (3) in
establishing the counterparties to a particular trade, the DPM's
participation right must be first counted against its highest priority
bids or offers; and (4) the DPM's participation right will only apply
to any remaining balance of an order once all higher priorities are
satisfied. The proposed rule change also adds paragraph (b)(2) to Rule
6.12 to provide for an optional small order priority overlay.
    Proposed Rule 8.20 governs the Exchange's authority to terminate,
condition, or otherwise limit the approval of a DPM. The proposed rule
provides that the Exchange may take such action if the Participant
incurs a material financial or operational change, or if it fails to
comply with any of the requirements under C2 Chapter 8 regarding DPM
obligations. The proposed rule also describes the procedures the
Exchange must follow if it chooses to exercise its authority under the
proposed rule.
    Proposed Rule 8.21 provides that a DPM must maintain information
barriers that are reasonably designed to prevent the misuse of
material, non-public information with any affiliates that may conduct a
brokerage business in option classes allocated to the DPM or act as a
specialist or Market-Maker in any security underlying options allocated
to the DPM, and otherwise comply with the requirements of CBOE
incorporated Rule 4.18 regarding the misuse of material non-public
information. The rule also requires a DPM to provide its information
barriers to the Exchange and obtain prior written approval.
    Finally, the Exchange is amending Rule 17.50(g)(14) to add DPM
quoting obligations to the Exchange's Minor Rule Violation Plan
(``MRVP'').\10\
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    \10\ The CBOE Rule 17.50(g)(14) provides that third and
subsequent offenses will be referred to its business conduct
committee, unlike the proposed rule change which allows C2 to either
fine a Market-Maker $5,000 for a third or subsequent offense, or
refer it to its business conduct committee.
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III. Discussion

    The Commission finds that the Exchange's proposed rule change to
adopt a DPM program on C2 is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to a national
securities exchange.\11\ In particular, the Commission believes that
the proposal is consistent with the requirements of Section 6(b)(5)
\12\ of the Act, which require, among other things, that the rules of
an exchange be designed to promote just and equitable principles of
trade, to foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect to,
and facilitating transactions in securities, to remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and in general, protect investors and the public
interest.\13\ Moreover, Section 6(b)(5) requires that the rules of a
national securities exchange be designed to not permit unfair
discrimination between customers, issuers, brokers or dealers.\14\
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    \11\ In approving this proposal, the Commission has considered
its impact on efficiency, competition, and capital formation. 15
U.S.C. 78c(f).
    \12\ 15 U.S.C. 78f(b)(5).
    \13\ Id.
    \14\ Id.
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    The Commission finds that the proposed rules are designed to
promote just and equitable principles of trade consistent with Section
6(b)(5) of the Act \15\ to the extent they require DPMs to undertake
certain obligations to the C2 market, including requirements to provide
continuous two-sided quoting and meet operational capacity
requirements. These requirements should help ensure that DPMs provide
liquidity in their allocated classes.
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    \15\ Id.
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    Pursuant to the proposed rules, the transactions of a DPM must
constitute a course of dealings reasonably calculated to contribute to
the maintenance of a fair and orderly market. A DPM must fulfill all of
the obligations of a Market-Maker under C2's rules, and must satisfy
the additional requirements imposed on a DPM in the securities
allocated to it. In particular, a DPM must, for example: (1) Provide
continuous quotes in at least the lesser of 99% of the non-adjusted
option series or 100% of the non-adjusted option series minus one call-
put pair of each option class allocated to it; (2) assure that each of
its displayed market quotations are for the number of contracts
required by Rule 8.6(a); (3) make competitive markets on the Exchange;
(4) supervise all persons associated with the DPM to assure compliance
with the C2 rules; (5) maintain minimum net capital in accordance with
C2's rules; (6) maintain information barriers that are reasonably
designed to prevent the use of material, non-public information; and
(7) continue to act as a DPM and to fulfill all of a DPMs obligations
while approved as a DPM. If C2 finds any failure by a DPM to comply
with the requirements of C2 Chapter 8 regarding DPM obligations and
responsibilities, or if, for any reason, the Exchange believes that a
Participant should no longer be eligible to act as a DPM or be
allocated particular securities, then C2 may terminate, condition, or
otherwise limit a Participant's approval to act as a DPM pursuant to
Rule 8.20. Together, these provisions are designed to help assure that
DPMs maintain and comply with their obligations to the Exchange and, in
so doing, protect investors and the public interest by promoting fair
and orderly trading on C2.
    Under C2's proposed rules, DPMs would receive certain benefits for
their heightened responsibilities. For example, proposed Rule 6.12
allows DPMs to be granted a participation entitlement pursuant to
proposed Rule 8.19. A DPM may receive the participation entitlement
only when it is one of the Participants quoting at the best price.
Further, pursuant to Rule 8.19(b)(3), a DPM will not receive its
participation entitlement in trades for which a Preferred Market-Maker
receives a participation entitlement. In addition, pursuant to Rule
6.12(b)(2)(B), the small order preference only applies to the
allocation of executions among non-customer orders and Market-Maker
quotes existing in the Book (i.e., a DPM may not take advantage of this
preference to execute an incoming order for 5 or fewer contracts if
there is a customer order resting in the Book).
    The Commission believes that a DPM must have sufficient affirmative
obligations to justify favorable

treatment. The Commission believes that C2's DPM requirements,
including those requiring additional liquidity and competitive quoting,
impose sufficient affirmative obligations on the Exchange's DPMs, while
allowing public customer orders at the best price to continue to be
satisfied before a participation entitlement will be applied.
Accordingly, the Commission believes that these requirements are
consistent with the Act.
    The Commission also finds that C2's proposed DPM qualification
requirements are consistent with the Act. In particular, the Exchange's
rules provide an objective process by which an applicant can become a
DPM on the Exchange and are designed to provide for oversight by C2 to
monitor for continued compliance by DPMs with the terms of their
application for such status and the Exchange's rules. The proposed
rules require that the Exchange consider several factors in determining
whether to allow a Participant to act as a DPM, including the
applicant's adequacy of capital, operational capacity, trading
experience, regulatory history, and willingness and ability to promote
the Exchange. These factors should ensure that those organizations
approved to act as DPMs have the ability to supply liquidity, quote
competitively, and perform their obligations competently.
    The Exchange also may condition its approval for an applicant's DPM
status, including by imposing conditions on the capital or operations
of the applicant or the number of securities allocated to the
applicant, which should contribute to the Exchange's ability to ensure
that a DPM applicant is able to perform its DPM functions. The
Commission believes that the financial requirements for DPMs proposed
by the Exchange are designed to promote investor protection by ensuring
that DPMs have sufficient capital to maintain an orderly market for
their allocated securities.
    Finally, the Commission believes that the Exchange's proposed
procedures for allocating securities to DPMs should help to ensure that
securities traded by the Exchange are allocated in an equitable manner,
giving all DPMs a fair opportunity to obtain allocations. In addition,
the Commission believes that the Exchange's proposed rule limiting each
DPM's term to one year should open opportunities to all Participants to
become a DPM.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\16\ that the proposed rule change (SR-C2-2012-024) be, and hereby
is, approved.
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    \16\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-26148 Filed 10-23-12; 8:45 am]
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[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)]
[Proposed Rules]
[Pages 63449-63450]
[FR Doc No: 2018-26569]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0998; Airspace Docket No. 18-AEA-19]
RIN 2120-AA66

Proposed Amendment of Class E Airspace, Corry, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace extending
upward from 700 feet above the surface at Corry-Lawrence Airport,
Corry, PA, to accommodate airspace reconfiguration due to the
decommissioning of the Corry non-directional radio beacon and
cancellation of the NDB approach. Controlled airspace is necessary for
the safety and management of instrument flight rules (IFR) operations
at this airport. This action also would update the geographic
coordinates of this airport.

DATES: Comments must be received on or before January 24, 2019.

ADDRESSES: Send comments on this proposal to: The U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
Telephone:<PHONE_NUMBER>, or<PHONE_NUMBER>. You must identify the
Docket No. FAA-2018-0998; Airspace Docket No. 18-AEA-19, at the
beginning of your comments. You may also submit comments through the
internet at http://www.regulations.gov.
    FAA Order 7400.11C, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11C at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority,
as it would amend Class E airspace at Corry-Lawrence Airport, Corry,
PA, to support IFR operations at this airport.

Comments Invited

    Interested persons are invited to comment on this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments

are specifically invited on the overall regulatory, aeronautical,
economic, environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (Docket No. FAA-
2018-0998 and Airspace Docket No. 18-AEA-19) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for the
address and phone number). You may also submit comments through the
internet at http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2018-0998; Airspace Docket No. 18-AEA-19.'' The postcard
will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this document may be changed in light of the
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays at the office
of the Eastern Service Center, Federal Aviation Administration, Room
350, 1701 Columbia Avenue, College Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace
Designations and Reporting Points, dated August 13, 2018, and effective
September 15, 2018. FAA Order 7400.11C is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11C lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA proposes an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to modify Class E airspace extending
upward from 700 feet or more above the surface within a 7.4-mile radius
(increased from a 6.3-mile radius), with a southeast extension from the
7.4-mile radius to 11-miles of Corry-Lawrence Airport, Corry, PA, due
to the decommissioning of the Corry NDB, and cancellation of the NDB
approach. The airspace redesign would enhance the safety and management
of IFR operations at the airport. The geographic coordinates of the
airport also would be adjusted to coincide with the FAA's aeronautical
database.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.11C, dated August 13, 2018, and effective September 15,
2018, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.11C, Airspace Designations and Reporting
Points, dated August 13, 2018, and effective September 15, 2018, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA PA E5 Corry, PA [Amended]

Corry-Lawrence Airport, PA
    (Lat. 41[deg]54'27'' N, long. 79[deg]38'28'' W)

    That airspace extending upward from 700 feet above the surface
within a 7.4-mile radius of Corry-Lawrence Airport, and within 4-
miles each side of the 140[deg] bearing from the airport, extending
from the 7.4-mile radius to 11 miles southeast of the airport.

    Issued in College Park, Georgia, on November 29, 2018.
Ryan W. Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2018-26569 Filed 12-7-18; 8:45 am]
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