[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Rules and Regulations]
[Pages 45426-45434]
[FR Doc No: 2019-18365]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0161; FRL-9997-41]

Buprofezin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
buprofezin in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project No. 4
(IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 29, 2019. Objections and
requests for hearings must be received

on or before October 28, 2019, 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-2018-0161, 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), West William Jefferson Clinton 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main 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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing 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-2018-0161 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 28, 2019. 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-2018-0161, 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.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 24, 2018 (83 FR 34968) (FRL-9980-
31), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E8654) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201W, Princeton,
NJ 08540. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of buprofezin, 2-(1,1-
dimethylethyl)iminotetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-
thiadiazin-4-one in or on the following raw agricultural commodities:
Fig at 0.70 parts per million (ppm), Leafy greens subgroup 4-16A,
except head lettuce and radicchio at 35 ppm; Brassica, leafy greens,
subgroup 4-16B at 60 ppm; Vegetable, brassica, head and stem, group 5-
16 at 12.0 ppm; Leaf petiole vegetable subgroup 22B at 35 ppm; Celtuce
at 35 ppm; Fennel, Florence at 35 ppm; Kohlrabi at 12.0 ppm; Tropical
and subtropical, small fruit, edible peel, subgroup 23A at 5.0 ppm;
Tropical and subtropical, small fruit, inedible peel, subgroup 24A at
0.30 ppm; Cottonseed subgroup 20C at 0.35 ppm; Fruit, citrus, group 10-
10 at 2.5 ppm; Fruit, stone, group 12-12, except apricot and peach at
2.0 ppm; Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13-07F at 2.5 ppm and Nut, tree, group 14-12 at 0.05 ppm. The petition
also requested to remove the established tolerances for residues of
buprofezin in or on the following raw agricultural commodities: Acerola
at 0.30 ppm; Brassica, head and stem, subgroup 5A at 12.0 ppm;
Brassica, leafy greens, subgroup 5B at 60 ppm; Cotton, undelinted seed
at 0.35 ppm; Fruit, citrus, group 10 at 2.5 ppm; Fruit, stone, group
12, except apricot and peach at 1.9 ppm; Grape at 2.5 ppm; Longan at
0.30 ppm; Lychee at 0.30 ppm; Nut, tree group 14 at 0.05 ppm; Olive at
3.5 ppm; Olive, oil at 4.8 ppm; Pistachio at 0.05 ppm; Spanish lime at
0.30 ppm; Turnip, greens at 60 ppm; Vegetable, leafy, except Brassica,
group 4, except head lettuce and radicchio at 35 ppm; and Wax jambu at
0.30 ppm. That document referenced a summary of the petition prepared
by Nichino America, Inc., the registrant, which is available in the
docket, http://www.regulations.gov. No comments were received on the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the levels at which some of the tolerances are being
established and has corrected some of the commodity definitions to be
consistent with Agency nomenclature. The reasons for these changes are
explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 buprofezin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with buprofezin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
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.
    The primary organs of buprofezin toxicity are the liver and the
thyroid. In subchronic toxicity studies in rats, increased microscopic
lesions in liver and thyroid, increased liver weights, and increased
thyroid weight in males were seen. In chronic studies in the rat, an
increased incidence of follicular cell hyperplasia and hypertrophy in
the thyroid of males were reported. In chronic studies in the dog,
increased relative liver weights were reported in females. Effects
observed in a 24-day dermal toxicity study in rats included
inflammatory infiltrate of the liver and an increase in acanthosis and
hyperkeratosis of the skin in females. Following inhalation exposure of
rats, the adrenal gland was the target of buprofezin toxicity (i.e.,
increased weight and microscopic findings of minimal hypertrophy of the
cortex).
    The developmental toxicity study in the rat showed reduced
ossification and reduced pup weight at maternally toxic doses (death,
decreased pregnancy rates, increased resorption rates). No
developmental toxicity was observed in the rabbit at or below
maternally toxic dose levels. The reproductive toxicity study showed
decreased pup body weights at dose levels where liver effects
(increased relative and/or absolute liver weights) and decreased body
weight gains were observed in the parental generations. In contrast,
evidence of post-natal offspring sensitivity was observed in the
comparative thyroid toxicity assay (CTA) study. Rat pups experienced
decreased body weight during early lactation and increased thyroid
stimulating hormone (TSH) levels at a dose that did not elicit toxicity
in the dams. Higher doses were required to elicit maternal toxicity
which included increased serum TSH concentration, decreased serum T4
levels and histopathological findings in the thyroid (increased
follicular cell height and follicular cell hypertrophy). Pre-natal
sensitivity was not evident in the CTA study as fetal toxicity
(increased thyroid weight in males and increased TSH levels in males
and females) was observed only at maternally toxic doses.
    EPA has classified buprofezin into the category of ``Suggestive
Evidence of Carcinogenicity, but not sufficient to assess human
carcinogenic potential'' based on liver tumors in female mice only.
Buprofezin was negative in in vitro and in vivo genotoxicity assays.
The Agency noted findings from the published literature indicate that
buprofezin causes cell transformation and induces micronuclei in vitro,
but determined that, in the absence of a positive response in an in
vivo micronucleus assay, buprofezin may have aneugenic potential which
is not expressed in vivo. The Agency has determined that the cRfD is
protective for carcinogenic effects.
    Aniline is a substance that may be formed in food from buprofezin
and its aniline-containing metabolites as a result of cooking but is
toxicologically different from buprofezin and its other metabolites.
EPA has classified aniline as a B2-probable human carcinogen with an
oral cancer slope factor of 5.7 x 10-3 (mg/kg/
day)-1 which is considered very conservative for cancer
assessment of aniline. The Agency did not identify any other oral
endpoint.
    Specific information on the studies received and the nature of the
adverse effects caused by buprofezin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Buprofezin. Human Health
Risk Assessment for Proposed New Uses on Figs and Greenhouse-Grown
Peppers and the Establishment of Permanent Tolerances in/on Fig and
Tolerance Conversions to Leafy Greens, Subgroup 4-16A, Except Head
Lettuce and Radicchio; Brassica, Leafy Greens, Subgroup 4-16B;
Vegetable, Brassica, Head and Stem, Group 5-16; Leaf Petiole Vegetable
Subgroup 22B; Celtuce; Florence Fennel; Kohlrabi; and Tolerance
Expansions to All Members of Fruit, Citrus Group 10-10; Fruit, Stone,
Group 12-12; Nut, Tree, Group 14-12; Tropical and Subtropical, Small
Fruit, Edible Peel, Subgroup 23A; Tropical and Subtropical, Small
Fruit, Inedible Peel, Subgroup 24A; Cottonseed Subgroup 20C; and Fruit,
Small, Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F'' on
pages 59-63 in docket ID number EPA-HQ-OPP-2018-0161.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for buprofezin and aniline
used for human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Buprofezin and Aniline for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD for risk     Study and toxicological effects
                                      safety factors          assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  An acute RfD for the general population including infants and children was
 including infants and children).   not selected because the effects observed in the animal studies that could
                                    be attributed to a single day exposure were not applicable to the general
                                    population.
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13 to 49    NOAEL = 200 mg/kg/    Acute RfD = 2.0 mg/  Developmental Toxicity Study--Rat.
 years of age).                     day.                  kg/day.             Developmental LOAEL = 800 mg/kg/
                                   UFA = 10x...........  aPAD = 2.0 mg/kg/     day based on reduced ossification
                                   UFH = 10x...........   day.                 & decreased fetal body weight.
                                   FQPA SF = 1x........
Chronic dietary (All populations)  LOAEL = 10 mg/kg/day  Chronic RfD = 0.033  Comparative Thyroid Toxicity
                                   UFA = 3x............   mg/kg/day.           Analysis (CTA) Study--rats.
                                   UFH = 10x...........  cPAD = 0.033 mg/kg/  Offspring LOAEL = 10.0 mg/kg/day
                                   FQPA SF = 10x (UFL).   day.                 based on significantly decreased
                                                                               pup body weight ([darr]8-13% in
                                                                               males during LD 4-10 and [darr]8-
                                                                               9% in females during LD 4-7)
                                                                               compared to controls and
                                                                               increased TSH levels on LD 4 and
                                                                               LD 21 ([uarr]23-34% in males).
----------------------------------------------------------------------------------------------------------------
Cancer--Buprofezin (Oral, dermal,  ``Suggestive Evidence of Carcinogenicity, but not sufficient to assess human
 inhalation).                       carcinogenic potential''. The cRfD is considered protective of the cancer
                                    effects.
----------------------------------------------------------------------------------------------------------------
Cancer--Aniline (Oral, dermal,     B2--probable human carcinogen with an oral cancer slope factor of 5.7 x 10-3
 inhalation).                       (mg/kg/day)-1
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. NOAEL = no-
  observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.
  UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
  sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to buprofezin, EPA considered exposure under the petitioned-
for tolerances as well as all existing buprofezin tolerances in 40 CFR
180.511. EPA assessed dietary exposures from buprofezin in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for buprofezin.
    In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
National Health and Nutrition Examination Survey, What We Eat in
America, (NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA
assumed 100 percent crop treated (PCT) for all commodities. Total
residues of concern in crop commodities (i.e., buprofezin and the BF4
Conjugate (2-(2-hydroxy-1,1-dimethylethylimino)-3-isopropyl-5-phenyl-
1,3,5-thiadiazinan-4-one) which is not detectable by data collection
methods but which may be estimated from metabolism data) were based on
tolerance level residues of buprofezin and available metabolism/
magnitude of the data to estimate other residues of concern. Given the
potential for BF9 (3-isopropyl-5-phenyl-1,3,5-thiadiazinan-2,4-dione)
and BF12 (1-isopropyl-3-phenylurea) to concentrate to a greater degree
than buprofezin in processed commodities, Dietary Exposure Evaluation
Model (DEEM) default processing factors were retained for all
commodities, except for tomato paste and puree, which were reduced
based on empirical data. Based on the submitted lemon metabolism data,
which indicated that residues of concern are primarily found in/on the
peel, the maximum theoretical concentration factor for peel was used to
estimate residues of concern in citrus peel. Total residues of concern
in meat (i.e., buprofezin and BF2 (2-tert-butylimino-5-(4-
hydroxyphenyl)-3-isopropyl-1,3,5-thiadiazinan-4-one)) and milk (i.e.,
buprofezin and BF23 (N-(4-hydroxyphenyl) acetamide)) were based on the
feeding study data which were used to establish meat and milk
tolerances. Based on the submitted data, which indicated a 5x
concentration of residues into milk cream and fat and a Log
Kow of 4.31, a default 25x concentration factor was applied
for milk fat.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA (2003-2008). A partially refined chronic dietary analysis was
conducted using the same residue estimates used for the acute dietary
analysis and average PCT estimates when available.
    iii. Cancer. Buprofezin: Based on the data summarized in Unit
III.A., EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to buprofezin. Cancer risk was assessed using
the same exposure estimates as discussed in Unit III.C.1.ii., chronic
exposure.
    Aniline: EPA determines whether quantitative cancer exposure and
risk assessments are appropriate for a food-use pesticide based on the
weight of the evidence from cancer studies and other relevant data. If
quantitative cancer risk assessment is appropriate, Cancer risk may be
quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode of action is available, a
threshold or nonlinear approach is used and a cancer RfD is calculated
based on an earlier noncancer key event. If carcinogenic mode of action
data are not available, or if the mode of action data determines a
mutagenic mode of action, a default linear cancer slope factor approach
is utilized. Based on the data summarized in Unit III.A., EPA has
concluded that aniline should be classified as ``Probable human
carcinogen'' and a linear approach has been used to quantify cancer
risk. A refined cancer dietary analysis was conducted for this

assessment using percent crop treated estimates when available along
with USDA Pesticide Data Program (PDP) monitoring data for buprofezin.
In addition, residues of aniline from the B4 conjugate was estimated
using a cooking residue study.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the PCT for registered uses as follows:
    The acute dietary exposure analyses assumed 100 PCT. Average PCT
was used for the following crops for refinement of the chronic
analyses: Almond 1%, apple 2.5%, apricot 10%, broccoli 5%, Brussels
sprout 2.5%, cabbage 5%, cantaloupe 5%, cauliflower 10%, cherry 2.5%,
cotton 1%, grapefruit 5%, grape 5%, lemon 2.5%, lettuce 10%, nectarine
5%, olive 2.5%, orange 2.5%, peach 5%, pear 10%, pepper 2.5%, pistachio
10%, plum/prune 5%, pomegranate 15%, pumpkin 1%, spinach 1%, squash 1%,
strawberry 15%, tomato 1%, walnut 1%, and watermelon 2.5%. These
average PCT data were also used to refine the cancer dietary exposure
analysis for buprofezin-derived aniline.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figures for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for buprofezin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of buprofezin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model version 5 and Variable
Volume Water Model (PRZM5/VVWM) and Pesticide Root Zone Model Ground
Water (PRZM GW) models, the estimated drinking water concentrations
(EDWCs) of buprofezin for acute exposures are estimated to be 78.8
parts per billion (ppb) for surface water and for chronic exposures are
estimated to be 19 ppb for surface water. There was no breakthrough of
buprofezin into ground water during a 100-year simulation using the
PRZM-GW model. Buprofezin, therefore, is not expected to be detected in
shallow ground water. For aniline, the Agency has determined that there
is no expectation of buprofezin-derived aniline in drinking water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 78.8 ppb was used to
assess the contribution to drinking water. For the chronic dietary risk
assessment, the water concentration of value 19 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Buprofezin is not registered for any specific use patterns that
would result in residential exposure.
    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.''
    In 2016, EPA's Office of Pesticide Programs released a guidance
document entitled ``Pesticide Cumulative Risk Assessment: Framework for
Screening Analysis'' (https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework). This document provides guidance on how to screen groups of
pesticides for cumulative evaluation using a two-step approach
beginning with the evaluation of available toxicological information
and if necessary, followed by a risk-based screening approach. This
framework supplements the existing guidance documents for establishing
common mechanism groups (CMGs) and conducting cumulative risk
assessments (CRA). EPA has utilized this framework for buprofezin and
determined that the available toxicological data suggests buprofezin
does not share a similar toxicological profile, and thus no common
mechanism of toxicity, with other pesticides. No further cumulative
evaluation is necessary for buprofezin.

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 toxicity
studies in rats and rabbits and reproduction studies in rats provided
no indication of increased susceptibility of rats or rabbits following
in utero exposure or of rats following pre/postnatal exposure to
buprofezin. However, a comparative thyroid study demonstrated offspring
susceptibility, but not fetal susceptibility to buprofezin oral
(gavage) administration. Points of departure (PODs) for risk assessment
that are derived from this comparative thyroid study are based on the
most sensitive endpoint of concern.
    3. Conclusion. For exposure scenarios using a NOAEL as POD (i.e.,
acute dietary exposure for females 13 to 49 years of age), EPA has
determined that the FQPA SF which was previously retained due to data
deficiency may be reduced to 1x. However, for assessments that use the
comparative thyroid study to derive a POD (i.e., chronic dietary,
incidental oral, short-term and intermediate-term dermal, and cancer),
a FQPA SF of 10x is retained to account for the lack of a NOAEL. That
decision is based on the following findings:
    i. The toxicity database for buprofezin is complete, with the
exception of a NOAEL in the comparative thyroid study.
    ii. There was no evidence of neurotoxicity in the toxicity
database.
    iii. There was no evidence in developmental and reproductive
toxicity studies of quantitative or qualitative sensitivity in the
young; however, the comparative thyroid study demonstrated enhanced
sensitivity in pups but not fetuses relative to maternal animals. A
NOAEL could not be established for rat pups in the comparative thyroid
study and, as a result, the 10x FQPA SF was retained to account for the
uncertainty in the offspring sensitivity introduced by the lack of a
NOAEL.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment uses conservative
assumptions which result in protective estimates of dietary exposure.
The dietary drinking water assessment uses values generated by models
and associated modeling parameters which are designed to provide
protective, high-end estimates of water concentrations. These
assessments will not underestimate the exposure and risks posed by
buprofezin.

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 PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to buprofezin will occupy 4.8% of the aPAD at the 95th percentile of
exposure for females 13 to 49 years old, the only population group of
concern.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
buprofezin from food and water will utilize 51% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however, buprofezin
is not registered for any use patterns that would result in either
short- or intermediate-term residential exposure. Short- and
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. Because there
is no short- or intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess short- or intermediate-term risk), no further assessment of
short-or intermediate-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short- and intermediate-
term risk for buprofezin.
    4. Aggregate cancer risk for U.S. population. Buprofezin: As
explained in Unit III.A., the Agency has determined that the
quantification of risk using a non-linear (i.e., RfD) approach will
adequately account for all chronic toxicity, including carcinogenicity,
that could result from exposure to buprofezin. Therefore, based on the
results of the chronic risk assessment discussed in Unit III.E.2.,
buprofezin is not expected to pose a cancer risk to humans.
    Aniline: A highly refined cancer dietary exposure and risk
assessment for buprofezin-derived aniline residues was conducted for
cooked foods only using an oral cancer slope factor of 5.7 x
10-3 (mg/kg/day)-1 for aniline. Average residues
of buprofezin and its aniline-containing metabolites in/on foods prior
to cooking were estimated using (1) monitoring data for uncooked raw
agricultural commodities (RACs) provided by USDA PDP, where available,
(2) an additional factor based on metabolism data (1.8x) to estimate
aniline-containing metabolites, where needed, and (3) average
buprofezin PCT data where available. A conversion factor of 18.9%, the
highest found in the hydrolysis study, was applied to estimate residues
of buprofezin-derived aniline which may form in food as a result of
cooking. Only cooked food forms were included in the dietary analysis.
The highly refined estimated exposure of the highest exposed adult
population (adults 20 to 49 years old) to buprofezin-derived aniline is
0.000053 mg/kg/day which results in an upper bound cancer risk estimate
of 3 x 10-7 and is below the Agency's level of concern.
    5. 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 buprofezin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available in Pesticide Analytical
Manual Volume I (PAM I) and PAM II for enforcement of buprofezin
tolerances, including gas chromatography (GC) methods with nitrogen
phosphorus detection (GC/NPD), and a GC/mass spectrometry (MS) method
for confirmation of buprofezin residues in plant commodities. The
validated limit of quantitation (LOQ) is 0.05 ppm.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food

safety standards and agricultural practices. EPA considers the
international maximum residue limits (MRLs) established by the Codex
Alimentarius Commission (Codex), as required by FFDCA section
408(b)(4). The Codex Alimentarius is a joint United Nations Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    No Codex MRLs have been established for residues of buprofezin in/
on fig.
    Codex has established several MRLs for residues of buprofezin in/on
other raw agricultural commodities (RACs) included in this petition,
including cherries, plums, grapes, almonds, and table olives, which are
harmonized with the U.S. tolerances being established in this action.
Additionally, Codex has an established MRL on dried grapes (including
currants, raisins, and sultanas), which is harmonized with the U.S.
tolerance being established for grape, raisin. Codex has also
established a more restrictive MRL in/on citrus fruits which is too low
to harmonize with U.S. tolerances due to significant differences in
good agricultural practices (GAP).

C. Revisions to Petitioned-For Tolerances

    The tolerances being established by the Agency differ from the
requested tolerances as follows:
    All trailing zeroes have been removed from petitioned-for
tolerances in accordance with Agency policy.
    The following requested commodity definitions have been revised to
be consistent with Agency nomenclature: Florence fennel is changed to
fennel, Florence, fresh leaves and stalk; and vegetable, brassica, head
and stem, group 5-16 is changed to vegetable, Brassica, head and stem,
group 5-16.
    The petitioned-for tolerance in/on the fruit, stone, group 12-12,
except apricot and peach at 2.0 ppm which is based on cherry and plum
data has been revised to fruit, stone, group 12-12, except nectarine
and peach at 2 ppm. The petitioned-for stone fruit crop group
conversion from group 12 to 12-12 has resulted in a change of the
representative commodity for apricot from peach to plum; hence, the
petitioned-for tolerance was revised to remove the exclusion for
apricot and the established tolerance in/on apricot (9.0 ppm) is
removed as inappropriate, thus lowering the tolerance level for apricot
from 9.0 ppm to the appropriate tolerance level of 2 ppm. Nectarine was
added to the tolerance exclusion since the higher established tolerance
in/on peach (9.0 ppm) also covers residues in/on nectarine (40 CFR
180.1(g)). This does not represent a tolerance level change for
nectarine.
    The petitioned-for tolerance in/on the citrus crop group 10-10 has
been revised from 2.5 ppm to 4 ppm. The tolerance level has been
increased to harmonize with the Canadian MRL for citrus fruit
commodities. The Canadian MRL was determined using U.S. orange data and
the Organization for Economic Cooperation and Development (OECD)
calculation procedures, while the established U.S. tolerance was
determined with older tolerance calculation procedures, including the
North American Free Trade Agreement (NAFTA) spreadsheet.
    The petitioned-for tolerance in/on the fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F has been revised from 2.5 ppm
to 1 ppm to harmonize with the currently established Codex and Canada
MRLs in/on grapes.
    A tolerance of 2 ppm in/on grape, raisin has been be added due to
the crop group expansion and lowering of the currently established
tolerance in/on grape (2.5 ppm) to the fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F (1 ppm).
    The petitioned-for tolerance in/on leafy greens subgroup 4-16A,
except head lettuce and radicchio at 35 ppm is changed to leafy greens
subgroup 4-16A at 35 ppm. The tolerances in/on head lettuce and
radicchio are covered by the crop subgroup 4-16A tolerance and are
being increased to 35 ppm to harmonize with the Canadian MRLs for head
lettuce and radicchio. Currently established separate tolerances in/on
head lettuce and radicchio at 6.0 ppm are being removed as unnecessary.

D. International Trade Considerations

    In this final rule, EPA is reducing the existing tolerances for the
commodities of apricot from 9 ppm to 2 ppm and of grape from 2.5 ppm to
1 ppm. The Agency is reducing the tolerances since data indicate the
higher tolerance is no longer needed to cover residues from approved
domestic uses and in order to harmonize the tolerance in/on grapes with
Codex and Canadian MRLs.
    In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the
WTO of this revision in order to satisfy its obligation. In addition,
the SPS Agreement requires that Members provide a ``reasonable
interval'' between the publication of a regulation subject to the
Agreement and its entry into force to allow time for producers in
exporting Member countries to adapt to the new requirement. At this
time, EPA is establishing an expiration date for the existing
tolerances to allow those tolerances to remain in effect for a period
of six months after the effective date of this final rule, in order to
address this requirement. After the six-month period expires, residues
of buprofezin on apricot and grape cannot exceed the new tolerance
levels established in this rulemaking.
    This reduction in tolerance levels is not discriminatory; the same
food safety standard contained in the FFDCA applies equally to
domestically produced and imported foods. The new tolerance levels are
supported by available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of buprofezin in
or on Brassica, leafy greens, subgroup 4-16B at 60 ppm; celtuce at 35
ppm; cottonseed subgroup 20C at 0.35 ppm; fennel, Florence, fresh
leaves and stalk at 35 ppm; fig at 0.7 ppm; fruit, citrus, group 10-10
at 4 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13-07F at 1 ppm; fruit, stone, group 12-12, except nectarine and peach
at 2 ppm; grape, raisin at 2 ppm; kohlrabi at 12 ppm; leaf petiole
vegetable subgroup 22B at 35 ppm; leafy greens subgroup 4-16A at 35
ppm; nut, tree, group 14-12 at 0.05 ppm; tropical and subtropical,
small fruit, edible peel, subgroup 23A at 5 ppm; tropical and
subtropical, small fruit, inedible peel, subgroup 24A at 0.3 ppm; and
vegetable, Brassica, head and stem, group 5-16 at 12 ppm.
    Additionally, the existing tolerances on the following commodities
are removed as unnecessary due to the establishment of the above
tolerances: Acerola; Brassica, head and stem, subgroup 5A; Brassica,
leafy greens, subgroup 5B; cotton, undelinted seed; fruit, citrus,
group 10; fruit, stone, group 12, except apricot and peach; lettuce,
head; longan; lychee; nut, tree group 14; olive; olive, oil; pistachio;
radicchio; Spanish lime; turnip, greens; vegetable, leafy, except
Brassica, group 4, except head lettuce and radicchio; and wax jambu.
Finally, expiration dates are added to the existing tolerances for
apricot and grape.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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 action has been
exempted from review under Executive Order 12866, this action 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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action 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 tolerances 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (NTTAA) (15 U.S.C. 272 note).

VII. 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 16, 2019.
Daniel Rosenblatt,
Acting 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.  180.511, amend the table in paragraph (a) as follows:
0
a. Remove the entry for ``Acerola'';
0
b. Revise the entry for ``Apricot'';
0
c. Remove the entries for ``Brassica, head and stem, subgroup 5A'' and
``Brassica, leafy greens, subgroup 5B'';
0
d. Add alphabetically the entries for ``Brassica, leafy greens,
subgroup 4-16B'' and ``Celtuce'';
0
e. Remove the entry for ``Cotton, undelinted seed'';
0
f. Add alphabetically the entries for ``Cottonseed subgroup 20C'';
``Fennel, Florence, fresh leaves and stalk''; ``Fig''; and ``Fruit,
citrus, group 10-10'';
0
g. Remove the entry for ``Fruit, citrus, group 10'';
0
h. Add alphabetically the entries for ``Fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F'' and ``Fruit, stone, group 12-
12, except nectarine and peach'';
0
i. Remove the entry for ``Fruit, stone, group 12, except apricot and
peach'';
0
j. Revise the entry for ``Grape'';
0
k. Add alphabetically the entries for ``Grape, raisin''; ``Kohlrabi'';
``Leaf petiole vegetable subgroup 22B''; and ``Leafy greens subgroup 4-
16A'';
0
l. Remove the entries for ``Lettuce, head''; ``Longan''; ``Lychee'';
and ``Nut, tree group 14'';
0
m. Add alphabetically the entry for ``Nut, tree, group 14-12'';
0
n. Remove the entries for ``Olive''; ``Olive, oil''; ``Pistachio'';
``Radicchio''; and ``Spanish lime'';
0
o. Add alphabetically the entries for ``Tropical and subtropical, small
fruit, edible peel, subgroup 23A'' and ``Tropical and subtropical,
small fruit, inedible peel, subgroup 24A'';
0
p. Remove the entry for ``Turnip, greens'';
0
q. Add alphabetically the entry for ``Vegetable, Brassica, head and
stem, group 5-16'';
0
 r. Remove the entries for ``Vegetable, leafy, except Brassica, group
4, except head lettuce and radicchio'' and ``Wax jambu''; and
0
s. Add footnote 3.
    The revisions and additions read as follows:

Sec.  180.511  Buprofezin; tolerances for residues.

* * * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Apricot \3\.................................................         9.0

                                * * * * *
Brassica, leafy greens, subgroup 4-16B......................          60

                                * * * * *
Celtuce.....................................................          35

                                * * * * *
Cottonseed subgroup 20C.....................................        0.35

                                * * * * *
Fennel, Florence, fresh leaves and stalk....................          35
Fig.........................................................         0.7
Fruit, citrus, group 10-10..................................           4

                                * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit,                   1
 subgroup 13-07F............................................
Fruit, stone, group 12-12, except nectarine and peach.......           2

                                * * * * *
Grape \3\...................................................         2.5
Grape, raisin...............................................           2

                                * * * * *
Kohlrabi....................................................          12
Leaf petiole vegetable subgroup 22B.........................          35
Leafy greens subgroup 4-16A.................................          35

                                * * * * *
Nut, tree, group 14-12......................................        0.05

                                * * * * *
Tropical and subtropical, small fruit, edible peel, subgroup           5
 23A........................................................
Tropical and subtropical, small fruit, inedible peel,                0.3
 subgroup 24A...............................................
Vegetable, Brassica, head and stem, group 5-16..............          12

                                * * * * *
------------------------------------------------------------------------
 * * * * *
 \3\ This tolerance expires on March 2, 2020.

* * * * *
[FR Doc. 2019-18365 Filed 8-28-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: November 26, 2008 (Volume 73, Number 229)]
[Proposed Rules]
[Page 71949-71951]
[DOCID:fr26no08-26]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1025; Directorate Identifier 2008-NE-31-AD]
RIN 2120-AA64

Airworthiness Directives; General Electric Company CF6-80C2 and
CF6-80E1 Series Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for General Electric Company (GE) CF6-80C2 and CF6-80E1 series turbofan
engines with high-pressure compressor rotor (HPCR) spool shaft stage 14
disks, part number (P/N) 1703M49G02, 1703M49G03, or 1509M71G10
installed. This proposed AD would require a one-time eddy current
inspection (ECI) of the HPCR spool shaft stage 14 disk web for crack
indications, and removing from service any parts with web cracks. This
proposed AD results from reports of 12 HPCR spool shaft stage 14 disks
with web cracks discovered to date. We are proposing this AD to prevent
cracks from propagating to an uncontained failure of the disk and
damage to the airplane.

DATES: We must receive any comments on this proposed AD by January 26,
2009.

ADDRESSES: Use one of the following addresses to comment on this
proposed AD.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    You can get the service information identified in this proposed AD
from General Electric Company via Lockheed Martin Technology Services,
10525 Chester Road, Suite C, Cincinnati, Ohio 45215, telephone (513)
672-8400, fax<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Christopher Richards, Aerospace
Engineer, Engine Certification Office, FAA, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, MA 01803; e-
mail<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax
(781) 238-7199.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send us any written relevant data, views, or
arguments regarding this proposal. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2008-1025; Directorate
Identifier 2008-NE-31-AD'' in the subject line of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of the proposed AD. We will consider
all comments received by the closing date and may amend the proposed AD
in light of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

Discussion

    Since July 2001, GE has reported 12 HPCR spool shaft stage 14 disks
with web cracks that were installed in CF6-80C2 and CF6-80E1 series
turbofan engines. GE determined that the cracks were caused by defects
created during the manufacturing process as a result of high amplitude
fatigue (HAF). Although the parts were fluorescent penetrant inspected
(FPI) during manufacture, the FPI did not detect the cracks. GE has
since revised their manufacturing process to eliminate the HAF. Failure
to inspect each affected HPCR spool shaft stage 14 disk web for cracks
could result in uncontained failure of the disk and damage to the
airplane.

Relevant Service Information

    We have reviewed and approved the technical contents of GE Alert
Service Bulletin (ASB) No. CF6-80C2 S/B 72-A1122, Revision 1, dated
June 19, 2006 (CF6-80C2 series engines), and GE ASB No. CF6-80E1 S/B
72-A0258, Revision 1, dated June 15, 2006 (CF6-80E1 series engines).
Those ASBs describe procedures for performing a one-time ECI of the
HPCR spool shaft stage 14 disk web for crack indications.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other products
of this same type design. We are proposing this AD, which would
require, at the next engine shop visit where the separation of a major
engine flange will occur, a one-time ECI of the HPCR spool shaft stage
14 disk web for crack indications, and removal from service of parts
found cracked. The proposed AD would require you to use the service
information described previously to perform these actions.

Costs of Compliance

    We estimate that this proposed AD would affect 126 CF6-80C2 and
CF6-80E1 series turbofan engines installed on airplanes of U.S.
registry. We also estimate that it would take about 10 work-hours per
engine to perform the inspection, and about 281 hours to complete the
proposed actions if done at module level, and that the average labor
rate is $80 per work-hour. The pro-rated cost of a HPCR stage 10-14
spool shaft, based on average life remaining on disks found cracked, is
$526,890. Using data on the percentage of the affected fleet already in
compliance with the corrective actions, we estimate there will be 10
disks found cracked as a result of these inspections. Based on these
figures, we estimate the total cost of the proposed AD to U.S.
operators to be $594,500.

Authority for This Rulemaking

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

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Under the authority delegated to me by the Administrator, the
Federal Aviation Administration proposes to amend 14 CFR part 39 as
follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new
airworthiness directive:

General Electric Company: Docket No. FAA-2008-1025; Directorate
Identifier 2008-NE-31-AD.

Comments Due Date

    (a) The Federal Aviation Administration (FAA) must receive
comments on this airworthiness directive (AD) action by January 26,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to General Electric Company (GE) CF6-80C2
and CF6-80E1 series turbofan engines with high-pressure compressor
rotor (HPCR) spool shaft stage 14 disks part number (P/N)
1703M49G02, 1703M49G03, or 1509M71G10 installed. These engines are
installed on, but not limited to, Airbus A300-600R/F, A310-200/300,
and A330-200/300, and Boeing 747-300/400/400ER, 767-200/200ER/300/
300ER/400ER and MD-11 airplanes.

Unsafe Condition

    (d) This AD results from reports of 12 cracked HPCR spool shaft
stage 14 disk webs discovered to date. We are issuing this AD to
prevent cracks from propagating to an uncontained failure of the
disk and damage to the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed at the next engine shop visit where the separation of a
major engine flange will occur after the effective date of this AD,
unless the actions have already been done.
    (f) For the purpose of this AD, introduction of an engine into a
shop solely for the following maintenance actions is not considered
an engine shop visit:
    (1) Removal of a compressor case for airfoil or variable stator
vane bushing maintenance.
    (2) Removal or replacement of the stage 1 fan disk.
    (3) Replacement of the turbine rear frame.
    (4) Removal or replacement of the accessory and/or transfer
gearbox.
    (5) Removal or replacement of the fan forward case.
    (6) Any combination of the maintenance actions listed above.

One-Time Eddy Current Inspection (ECI)

    (g) Using the following Alert Service Bulletin (ASB)
instructions, perform a one-time ECI of the HPCR spool shaft stage
14 disk web for crack indications, and remove from service those
parts found to be cracked.
    (1) Use paragraphs 3.B.(1) through 3.B.(5) of the Accomplishment
Instructions of GE ASB No. CF6-80C2 S/B 72-A1122, Revision 1, dated
June 19, 2006, to ECI the CF6-80C2 series engine HPCR spool shaft
stage 14 disk web at the module level.
    (2) Use paragraph 3.C.(1) of the Accomplishment Instructions of
GE ASB No. CF6-80C2 S/B 72-A1122, Revision 1, dated June 19, 2006,
to ECI the CF6-80C2 series engine HPCR spool shaft stage 14 disk web
at the piece-part level.
    (3) Use paragraphs 3.B.(1) through 3.B.(5) of the Accomplishment
Instructions of GE ASB No. CF6-80E1 S/B 72-A0258, Revision 1, dated
June 15, 2006, to ECI the CF6-80E1 series engine HPCR spool shaft
stage 14 disk web at the module level.
    (4) Use paragraph 3.C.(1) of the Accomplishment Instructions of
GE ASB No. CF6-80E1 S/B 72-A0258, Revision 1, dated June 15, 2006,
to ECI the HPCR spool shaft stage 14 disk web at the piece-part
level.

Previous Credit

    (h) Performance of a one-time ECI of the HPCR spool shaft stage
14 disk web for crack indications, done before the effective date of
this AD and following the procedures defined in GE ASB No. CF6 80C2
S/B 72-A1122, dated January 19, 2004, for CF6-80C2 series engines or
GE ASB No. CF6 80E1 S/B 72-A0258, dated January 19, 2004, for CF6-
80E1 series engines satisfies the compliance requirements specified
in this AD.

Alternative Methods of Compliance

    (i) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD, if
requested using the procedures found in 14 CFR 39.19.

Related Information

    (j) Contact Christopher Richards, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax (781)
238-7199, for more information about this AD.

    Issued in Burlington, Massachusetts, on November 18, 2008.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E8-28054 Filed 11-25-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 113 (Monday, June 13, 2011)]
[Notices]
[Pages 34226-34227]
[FR Doc No: 2011-14542]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 2

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP11-1566-002.
    Applicants: Tennessee Gas Pipeline Company.
    Description: Tennessee Gas Pipeline Company submits tariff filing
per 154.203: Redesignated Docket No. Compliance Motion Rate Case Sheets
to be effective 6/1/2011. Filing Type: 580.
    File Date: 05/27/2011.
    Accession Number: 20110527-5261.
    Comment Date: 5 p.m. Eastern Time on Friday, June 10, 2011.

    Docket Numbers: RP11-2008-001.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits tariff filing per
154.203: RP11-2008-001 Compliance Filing (Creditworthiness) to be
effective 5/15/2011.
    File Date: 05/27/2011.
    Accession Number: 20110527-5144.
    Comment Date: 5 p.m. Eastern Time on Friday, June 10, 2011.

    Docket Numbers: RP99-106-017.
    Applicants: TransColorado Gas Transmission Company LLC.
    Description: Form of TransColorado Gas Transmission Company LLC
Revenue Sharing Report.
    File Date: 05/27/2011.
    Accession Number: 20110527-5205.
    Comment Date: 5 p.m. Eastern Time on Friday, June 10, 2011.

    Docket Numbers: RP01-382-021.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas submits for filing its annual
report setting forth the Carlton Resolution buyout, surcharge and
penalty dollars reimbursed to the Carlton Sourcers on their May
reservation invoices for the 2010-2011 heating season.
    File Date: 06/03/2011.
    Accession Number: 20110603-5220.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 15, 2011.

    Docket Numbers: RP11-1435-003.
    Applicants: Columbia Gulf Transmission Company.
    Description: Columbia Gulf Transmission Company submits tariff
filing per 154.203: Rate Case--Compliance Filing--Errata to be
effective 5/1/2011.
    File Date: 06/03/2011.
    Accession Number: 20110603-5021.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 15, 2011.

    Docket Numbers: RP11-1435-002.
    Applicants: Columbia Gulf Transmission Company.
    Description: Columbia Gulf Transmission Company submits tariff
filing per 154.203: Rate Case--Compliance Filing to be effective 5/1/
2011.
    File Date: 05/31/2011.
    Accession Number: 20110531-5182.
    Comment Date: 5 p.m. Eastern Time on Monday, June 13, 2011.

    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of

Practice and Procedure (18 CFR 385.211). Protests to this filing will
be considered by the Commission in determining the appropriate action
to be taken, but will not serve to make protestants parties to the
proceeding. Such protests must be filed on or before 5 p.m. Eastern
time on the specified Comment Date. Anyone filing a protest must serve
a copy of that document on all the parties to the proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons
unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: June 6, 2011.
Nathaniel J. Davis, Sr.
Deputy Secretary.
[FR Doc. 2011-14542 Filed 6-10-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 165 (Monday, August 26, 2019)]
[Notices]
[Pages 44672-44673]
[FR Doc No: 2019-18328]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Public Notice for Intent To Release Airport Property

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of intent to rule on request to release airport property
for non-aeronautical use; Fairbanks International Airport (FAI),
Fairbanks, Alaska.

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

SUMMARY: The FAA proposes to rule and invites public comment on the
release of the aeronautical use only provision for land at the
Fairbanks International Airport, Fairbanks, Alaska.

DATES: Comments must be received on or before September 25, 2019.

ADDRESSES: Documents are available for review by appointment at the FAA
Anchorage Airports Regional Office, Molly Lamrouex, Compliance Manager,
222 W 7th Avenue, Anchorage, AK. Telephone:<PHONE_NUMBER> and the
Fairbanks International Airport, 6450 Airport Way, Suite 1, Fairbanks,
AK 99709. Telephone:<PHONE_NUMBER>.
    Written comments on the Sponsor's request must be delivered or
mailed to: Molly Lamrouex, Compliance Manager, Federal Aviation
Administration, Airports Anchorage Regional Office, 222 W 7th Avenue,
Anchorage AK 99513, Telephone Number:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Molly Lamrouex, Compliance Manager,
Federal Aviation Administration, Alaskan Region Airports District
Office, 222 W 7th Avenue, Anchorage, AK 99513. Telephone Number: (907)
271-5439/FAX Number:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:  The FAA invites public comment on the
request to release the aeronautical use only grant provision for three
parcels on the west side of FAI, under the provisions of 49 U.S.C.
47107(h)(2). The Alaska Department of Transportation and Public
Facilities has requested from the FAA that West lease lot block 10
(lots 8/9); West lease lot Block 3 (lot 12) and West lease lot Block 3
(lot 13) be released for non-aeronautical use. These lease lots have no
direct access to the

airfield. The FAA has determined that the release of the property will
not likely adversely impact future aviation needs at the airport and
will generate revenue for the airport via assessment of lease rates at
the non-aeronautical rate. The FAA may approve the request, in whole or
in part, no sooner than 30 days after the publication of this notice.

    Issued in Anchorage, Alaska, on August 21, 2019.
Matthew K. Stearns,
Acting Director, Alaskan Airports Regional Office, FAA, Alaskan Region.
[FR Doc. 2019-18328 Filed 8-23-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 113 (Monday, June 13, 2011)]
[Notices]
[Pages 34277-34278]
[FR Doc No: 2011-14672]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold an Open Meeting

on June 15, 2011 at 10 a.m., in the Auditorium, Room L-002.
    The subject matter of the Open Meeting will be:
    The Commission will consider whether to propose amendments to Rule
17a-5--the broker-dealer reporting rule--under the Securities Exchange
Act of 1934.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    June 8, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-14672 Filed 6-9-11; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 218 (Thursday, November 12, 2015)]
[Notices]
[Pages 70036-70039]
[FR Doc No: 2015-28698]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76370; File No. SR-Phlx-2015-90]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Adopt
Business Continuity and Disaster Recovery Plans Testing Requirements

November 5, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 2, 2015, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and
II, below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to adopt business continuity and disaster
recovery plans (``BC/DR Plans'') testing requirements for certain
Exchange Member Organizations \3\ and PSX Participants \4\
(``Participants'') in

connection with Regulation Systems Compliance and Integrity
(``Regulation SCI'').\5\
---------------------------------------------------------------------------

    \3\ The term ``Member Organization'' is defined as ``a
corporation, partnership (general or limited), limited liability
partnership, limited liability company, business trust or similar
organization, transacting business as a broker or a dealer in
securities and which has the status of a member organization by
virtue of (i) admission to membership given to it by the Membership
Department pursuant to the provisions of Rules 900.1 or 900.2 or the
By-Laws or (ii) the transitional rules adopted by the Exchange
pursuant to Section 6-4 of the By-Laws. References herein to officer
or partner, when used in the context of a member organization, shall
include any person holding a similar position in any organization
other than a corporation or partnership that has the status of a
member organization.'' See Exchange Rule 1(o).
    \4\ The term ``PSX Participant'' or ``Participant'' is defined
as ``an entity that fulfills the obligations contained in Rule 3211
regarding participation in the System, and includes: (1) `Equities
ECNs,' which are member organizations that meet all of the
requirements of Rule 3223, and that participate in the System with
respect to one or more System Securities; (2) `PSX Market Makers' or
`Market Makers', member organizations that are registered as PSX
Market Makers for purposes of participation in the System on a fully
automated basis with respect to one or more System securities; and
(3) `Order Entry Firms,' which are member organizations that are
registered for the purposes of entering orders in System Securities
into the System. This term shall also include any Electronic
Communications Network or Alternative Trading System (as such terms
are defined in Regulation NMS) that fails to meet all the
requirements of Rule 3223.'' See PSX Rule 3301(c).
    \5\ See Securities Exchange Act Release No. 73639 (November 19,
2014), 79 FR 72252 (December 5, 2014) (``SCI Adopting Release'').
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is proposing to adopt new Rule 926 to implement the
BC/DR Plans requirements of Rule 1004 of Regulation SCI. As adopted by
the Commission, Regulation SCI applies to certain self-regulatory
organizations (including the Exchange), alternative trading systems
(``ATSs''), plan processors, and exempt clearing agencies
(collectively, ``SCI entities''), and will require these SCI entities
to comply with requirements with respect to the automated systems
central to the performance of their regulated activities. Among the
requirements of Regulation SCI is Rule 1001(a)(2)(v), which requires
the Exchange and other SCI entities to maintain ``[b]usiness continuity
and disaster recovery plans that include maintaining backup and
recovery capabilities sufficiently resilient and geographically diverse
and that are reasonably designed to achieve next business day
resumption of trading and two-hour resumption of critical SCI systems
following a wide-scale disruption.'' \6\ The Exchange has put extensive
time and resources toward planning for system failures and already
maintains robust BC/DR Plans consistent with the Rule. As set forth
below, in connection with Regulation SCI, the Exchange is proposing to
require certain Member Organizations and Participants to participate in
testing of the operation of the Exchange's BC/DR Plans.
---------------------------------------------------------------------------

    \6\ 17 CFR 242.1001(a)(2)(v).
---------------------------------------------------------------------------

    With respect to an SCI entity's BC/DR Plans, including its backup
systems, paragraph (a) of Rule 1004 of Regulation SCI requires each SCI
entity to: ``[e]stablish standards for the designation of those members
or participants that the SCI entity reasonably determines are, taken as
a whole, the minimum necessary for the maintenance of fair and orderly
markets in the event of the activation of such plans.'' \7\ Paragraph
(b) of Rule 1004 of Regulation SCI further requires each SCI entity to
``[d]esignate members or participants pursuant to the standards
established in paragraph (a) of [Rule 1004] and require participation
by such designated members or participants in scheduled functional and
performance testing of the operation of such plans, in the manner and
frequency specified by the SCI entity, provided that such frequency
shall not be less than once every 12 months.'' \8\ In order to comply
with Rule 1004 of Regulation SCI, the Exchange proposes to adopt new
Rule 926, which incorporates the requirements of Rule 1004 of
Regulation SCI as part of the Exchange's rules, and sets forth the
notice, selection criteria and obligations of Member Organizations and
Participants with respect to BC/DR Plans testing.
---------------------------------------------------------------------------

    \7\ 17 CFR 242.1004(a).
    \8\ 17 CFR 242.1004(b).
---------------------------------------------------------------------------

    The Exchange proposes to adopt Rule 926(a), which will set forth
the Exchange's obligations with respect to the selection of Members
Organizations and Participants for testing. Specifically, the rule will
require the Exchange to ``[e]stablish standards for the designation of
those Members Organizations and Participants that the Exchange
reasonably determines are, taken as a whole, the minimum necessary for
the maintenance of fair and orderly markets in the event of the
activation of such plans.'' The proposed new rule further provides that
``[s]uch standards may include volume-based and/or market share-based
criteria, and may be adjusted from time to time by the Exchange.''
Lastly, the proposed new rule will require the Exchange to provide
public notice of the standards that it adopts.
    The Exchange is proposing to adopt Rule 926(b), which will set
forth the obligations of the Exchange and its Members Organizations and
Participants with respect to testing. Specifically, the rule will
require the Exchange to ``designate Members Organizations and PSX
Participants pursuant to the standards established in paragraph (a) of
this rule and require participation by such designated Members
Organizations and PSX Participants in scheduled functional and
performance testing of the operation of such plans, in the manner and
frequency specified by the Exchange, provided that such frequency shall
not be less than once every 12 months.'' Moreover, the rule will
require the Exchange to provide at least six months prior notice to
Members Organizations and Participants that are designated for
mandatory testing. Lastly, the rule will provide notice that
participation in testing is a condition of membership for Members
Organizations and Participants that are designated for testing.
    The Exchange encourages all Member Organizations and Participants
to connect to the Exchange's backup systems and to participate in
testing of such systems; \9\ however, certain Member Organizations and
Participants will be obligated to participate in BC/DR Plans testing.
In adopting new Rule 926, the Exchange will require mandatory
participation in BC/DR Plans testing by those Member Organizations and
Participants that the Exchange reasonably determines are, taken as a
whole, the minimum necessary for the maintenance of fair and orderly
markets in the event of the activation of such plans on the Exchange
and PSX, respectively. The Exchange believes that using overall
participation on its

markets (by volume and/or market share) as a measure to select Member
Organizations and Participants for mandatory participation in BC/DR
Plans testing is a reasonable means by which it can determine which
Member Organizations and Participants are necessary for the maintenance
of fair and orderly markets in the event of the activation of such
plans.\10\ For each BC/DR Plans test cycle, the Exchange will select
the top ten Member Organizations on the Exchange and the top five
Participants on PSX based on the Exchange's measure of overall
participation on each of those markets. All notices concerning BC/DR
Plans testing will be posted on the Exchange's Web site.
---------------------------------------------------------------------------

    \9\ In this regard, the Exchange will allow any Member
Organization or Participant to participate in the testing of the
Exchange's BC/DR Plans, which is consistent with the Plan. See SCI
Adopting Release, supra note 5 at 72350. The Exchange will provide
instructions on how a Member Organization and Participant must
inform the Exchange of its interest in participating in an upcoming
BC/DR Plans test via the announcement of the test date. A Member
Organization or Participant must provide the Exchange notice of its
interest to participate at least a week prior to the test date and
must have the appropriate connection for testing in place.
    \10\ The Exchange will provide notice of the specific selection
criteria and measurement period in a notice to Member Organizations
and Participants. The initial selection criteria and measurement
period will be announced no later than November 3, 2015.
---------------------------------------------------------------------------

    The Exchange is proposing to initially select Member Organizations
and Participants with the highest levels of trading volume on the
Exchange and PSX over four calendar months (``Measurement Period'') as
mandatory testing Member Organizations and Participants,
respectively.\11\ Specifically, the Measurement Period will be the four
calendar months of trading immediately prior to the Exchange's
announcement of the next BC/DR Plans test date. The Measurement Period
will always begin at a point after the Exchange announces the criteria
to be used in the next BC/DR Plans test. By way of example, if on
October 6, 2017 the Exchange announced the BC/DR Plans test selection
criteria and on March 2, 2018 the Exchange announced a BC/DR Plans test
date of September 8, 2018, the Measurement Period used to select Member
Organizations and Participants subject to mandatory testing would be
November 2017 through February 2018. Members Organizations and
Participants not obligated to participate that wish to participate in
this test must inform the Exchange no later than September 1, 2018.\12\
---------------------------------------------------------------------------

    \11\ The Exchange may change the total number of Member
Organizations and Participants selected from time to time.
    \12\ See note 9.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6 of the Act,\13\ in general, and further the objectives
of Section 6(b)(5) of the Act,\14\ in particular, in that it is
designed to prevent fraudulent and manipulative acts and practices, 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, to protect investors and the public interest; and are not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers. The proposal will ensure that the Member
Organizations and Participants necessary to ensure the maintenance of
fair and orderly markets are properly designated consistent with Rule
1004 of Regulation SCI. Specifically, the proposal will adopt clear and
objective criteria with respect to the designation of Member
Organizations and Participants that are required to participate in the
testing of the Exchange's BC/DR Plans, as well as appropriate
notification regarding such designation. As set forth in the SCI
Adopting Release, ``SROs have the authority, and legal responsibility,
under Section 6 of the Exchange Act, to adopt and enforce rules
(including rules to comply with Regulation SCI's requirements relating
to BC/DR testing) applicable to their members or participants that are
designed to, among other things, 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, to
protect investors and the public interest.'' \15\ The Exchange believes
that this proposal is consistent with such authority and legal
responsibility.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f.
    \14\ 15 U.S.C. 78f(b)(5).
    \15\ See SCI Adopting Release, supra note 5 at 72350.
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. To
the contrary, the proposal is not a competitive proposal but rather is
necessary for the Exchange's compliance with Regulation SCI.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A) of the Act \16\ and Rule 19b-4(f)(6)(iii) thereunder.\17\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.\18\ A proposed rule change filed under Rule
19b-4(f)(6)(iii) \19\ normally does not become operative prior to 30
days after the date of the filing. However, pursuant to Rule 19b-
4(f)(6)(iii),\20\ the Commission may designate a shorter time if such
action is consistent with the protection of investors and the public
interest.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \17\ 17 CFR 240.19b-4(f)(6).
    \18\ In addition, Rule 19b-4(f)(6) requires a self-regulatory
organization to give the Commission written notice of its intent to
file the proposed rule change at least five business days prior to
the date of filing of the proposed rule change, or such shorter time
as designated by the Commission. The Exchange has satisfied this
requirement.
    \19\ 17 CFR 240.19b-4(f)(6).
    \20\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Commission believes that waiving the 30-day operative delay
is consistent with the protection of investors and the public interest
as it will allow the Exchange to incorporate changes required under
Regulation SCI, such as establishing standards for designating BC/DR
participants, prior to the November 3, 2015 compliance date.
Accordingly, the Commission designates the proposed rule change to be
operative upon filing.\21\
---------------------------------------------------------------------------

    \21\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the

Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act. If the Commission takes such
action, the Commission shall institute proceedings to determine whether
the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2015-90 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2015-90. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
    Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.
    All submissions should refer to File Number SR-Phlx-2015-90 and
should be submitted on or before December 3, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-28698 Filed 11-10-15; 8:45 am]
 BILLING CODE 8011-01-P