[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)]
[Rules and Regulations]
[Pages 53019-53025]
[FR Doc No: 2016-19118]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0919; FRL-9946-30]

Halauxifen-methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
halauxifen-methyl and its metabolite, XDE-729 acid, in or on multiple
commodities which are identified and discussed later in this document.
Dow AgroSciences LLC requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 11, 2016. Objections and
requests for hearings must be received on or before October 11, 2016,
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-2012-0919, 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: Susan Lewis, 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
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0919 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 11, 2016. 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-2012-0919, 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 February 15, 2013 (78 FR 11126) (FRL-
9378-4), 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
2F8086) by Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN
46268. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the herbicide, halauxifen-
methyl (methyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-
methoxyphenyl)pyridine-2-carboxylate) and its major metabolite, XDE-729
acid, expressed as halauxifen-methyl (parent) equivalents, in or on
barley, grain at 0.01 parts per million (ppm); barley, hay at 0.01 ppm;
barley, straw at 0.01 ppm; cattle, fat at 0.01 ppm; cattle, meat at
0.01 ppm; cattle, meat byproducts at 0.01 ppm; goat, fat at 0.01 ppm;
goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; horse, fat
at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at 0.01
ppm; milk at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, meat at 0.01 ppm;
sheep, meat byproducts at 0.01 ppm; wheat, forage at 0.5 ppm; wheat,
grain at 0.01 ppm; wheat, hay at 0.04 ppm; and wheat, straw at 0.015
ppm. That document referenced a summary of the petition

prepared by Dow AgroSciences LLC, the registrant, which is available in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
determined that livestock commodity tolerances are not required for the
proposed uses. In addition, the proposed ``wheat, hay'' tolerance level
of 0.04 ppm will be set at a reduced tolerance level of 0.03 ppm. The
reason 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 halauxifen-methyl and its acid
metabolite, including exposure resulting from the tolerances
established by this action. EPA's assessment of exposures and risks
associated with halauxifen-methyl and its major metabolite, XDE-729
acid, 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 toxicology database for halauxifen-methyl is considered
adequate at this time. Following oral exposure and absorption, the
liver is exposed pre-systemically to halauxifen-methyl, where it is
hydrolyzed to its major metabolite, XDE-729 acid, before entering the
systemic circulation. Therefore, systemic exposure to organs and
tissues other than the liver is to XDE-729 acid, whereas the liver is
also exposed to the parent prior to its metabolism. The guideline
studies were conducted on XDE-729 acid and identified the kidney as the
main target organ. Bridging studies on halauxifen-methyl identified the
liver as the target organ, but the data could not bridge to the acid
metabolite because liver toxicity from exposure to halauxifen-methyl
occurred at lower doses than the kidney toxicity resulting from
exposure to XDE-729 acid. In lieu of conducting long-term oral studies
on halauxifen-methyl, mechanistic studies were performed to
characterize the mode of action (MOA) for liver toxicity. These studies
identified activation of the liver aryl hydrocarbon receptor (AhR) as
the MOA, and the molecular initiating event (MIE), for liver toxicity,
for which increased liver Cyp1a1 gene expression serves as a biomarker.
In the absence of this MIE, liver toxicity from parent halauxifen-
methyl, including induction of hepatocellular proliferation, will not
be observed. A point of departure (POD) of 3 mg/kg/day for increased
Cyp1a1 expression (observed at 10 mg/kg/day, the study NOAEL) was
identified in the rat 90-day dietary study on halauxifen-methyl and was
selected for chronic dietary risk assessment, since it protects for the
initial step in liver toxicity, regardless of exposure duration.
Therefore, the bridging and mechanistic studies were considered along
with the guideline studies in selection of the dose and endpoint for
halauxifen-methyl. Based on the abundance of guideline and mechanistic
data available, a MOA approach was used for the identification and
characterization of hazard. Due to the distinct toxicities of the two
compounds and the unique MOA for liver toxicity of halauxifen-methyl,
risk from the two compounds was assessed separately.
    There is no evidence of neurotoxicity or immunotoxicity for either
compound. Inhalation studies (including the acute LD50
study) were waived because MOEs for inhalation exposure, calculated
using a highly conservative endpoint from oral data, were high
(>=2,500), and the available oral and dermal studies did not indicate
the potential for portal of entry effects. In addition, halauxifen-
methyl has a low vapor pressure and adequate particle sizes for test
atmospheres could not be generated. Guideline rat or rabbit dermal
toxicity, rat two-generation reproductive toxicity, dog chronic
toxicity, rat chronic toxicity/carcinogenicity, mouse carcinogenicity,
rat acute and subchronic neurotoxicity studies on halauxifen-methyl
were also waived. The waivers were granted because adequate data were
available for XDE-729 acid, to which systemic exposure would occur. The
available data, when combined with the bridging and MOE data on
halauxifen-methyl, allowed identification of a protective POD for AhR-
mediated liver toxicity. Therefore, an additional database uncertainty
factor (UFDB) is not required for either compound. Both are
mild eye irritants (Category III) but not dermal irritants or
sensitizers. XDE-729 acid is classified as ``not likely to be
carcinogenic to humans.'' Halauxifen-methyl is classified as ``not
likely to be carcinogenic to humans at doses that do not induce Cyp1a1
expression,'' based on the premise that AhR activation and subsequent
promotion of hepatocellular tumors (via a prolonged increase in
hepatocellular proliferation), a well-known non-genotoxic mechanism of
liver carcinogenesis that has been previously described for other
chemicals, depend upon this molecular initiating event (MIE). Moreover,
based on its rapid metabolism to XDE-729 acid, halauxifen-methyl is not
expected to persist in the body; therefore, progression of liver
toxicity (including carcinogenic potential) from sustained AhR
activation is not expected. Neither compound showed evidence of
genotoxicity.
    There is no evidence of increased prenatal susceptibility to either
compound in developmental toxicity studies in two species. No
developmental toxicity was observed in the presence of maternal
toxicity for rats exposed to halauxifen-methyl or rabbits exposed to
XDE-729 acid. In rats exposed to XDE-729 acid, mild fetal effects
(decreased body weight and delayed ossification of the thoracic centra)
were observed in the presence of more significant maternal toxicity
(moribund sacrifice due to excessively decreased body weight and food
consumption, along with increased relative kidney weight). In rabbits
exposed to halauxifen-methyl, the fetal effects (decreased body weight,
increases in delayed ossification of the pubis) were observed in the
presence of maternal liver histopathology and

increased liver weight, at a dose greater than the maternal LOAEL, and
were therefore not considered indicative of greater sensitivity. In a
rat two-generation reproductive toxicity study on XDE-729 acid, there
was no evidence of increased postnatal susceptibility. Parental
toxicity in the rat two-generation reproductive toxicity study was
observed at 443 mg/kg/day (NOAEL 103 mg/kg/day), but no offspring or
reproductive toxicity was reported. A reproductive toxicity study was
not conducted on halauxifen-methyl. Residual concerns for postnatal
susceptibility to halauxifen-methyl in the absence of this study are
low, due to selection of a highly conservative endpoint and assumptions
for dietary exposure, as well as the low level of exposure expected
from proposed use patterns.
    Specific information on the studies received and the nature of the
adverse effects caused by halauxifen-methyl and its metabolite, XDE-729
acid, 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 document Halauxifen-
methyl--New Active Ingredient Human Health Risk Assessment for Proposed
Uses on Cereal Grains (Barley, Wheat, and Triticale) at page 42 in
docket ID number EPA-HQ-OPP-2012-0919.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for halauxifen-methyl used
in the Agency's human health risk assessment is shown in Table 1(a) of
this unit. No hazard from a single exposure was identified in the
available database; therefore, no risk is expected from acute dietary
exposure to halauxifen-methyl. For chronic dietary exposure, the rat
90-day oral study was selected. Although long-term oral toxicity
studies are not available for halauxifen-methyl, a dose and an endpoint
protective of long-term toxicity could be identified using the
subchronic data together with the MOA data. The rat 90-day study NOAEL
of 10.3 mg/kg/day was based on increased liver weight, hypertrophy and
vacuolization consistent with fatty change at the LOAEL of 53.4 mg/kg/
day. Liver effects at the LOAEL were of low severity but were
considered treatment-related. A marked increase (1,500-fold above
controls) in Cyp1a1 expression was also observed at the LOAEL. As
previously noted, mechanistic studies on halauxifen-methyl identified
activation of liver AhR as the MOA for liver toxicity, for which
increased expression of Cyp1a1 in the liver is a biomarker for AhR
activation, the MIE. In the absence of AhR activation, liver toxicity
will not occur. Although there were no liver effects observed at the
study NOAEL, a 52-fold increase in Cyp1a1 expression was observed. This
increase is well below the increase that was associated which mild
liver toxicity. Long-term effects on the liver from this lower level
increase are not known in the absence of chronic data, but the lowest
dose in the study, 3 mg/kg/day, showed essentially no Cyp1a1
activation. Cyp1a1 expression at 3 mg/kg/day was comparable to controls
in both the 28- and 90-day studies (1.2- and 3.6-fold higher than
controls, respectively), indicating that there is not expected to be
significant activation of the AhR receptor at this dose level over
time. Therefore, in order to be protective of potential adverse effects
on the liver following long-term exposure, the point of departure (POD)
of 3 mg/kg/day was selected, based on increased expression of liver
Cyp1a1 (52-fold) at 10 mg/kg/day. The selected dose and endpoint are
considered conservative, since the dose is below the study NOAEL, but
protective of residual uncertainty due to the lack of chronic data
because liver toxicity may not occur in the absence of the MIE,
regardless of exposure duration. They are also protective of chronic
effects from XDE-729 acid, which are observed at higher doses. A UF of
100 is based on the combined interspecies (10x) and intraspecies (10x)
UFs. An additional 10x UF for lack of chronic data was not applied for
the following reasons: (1) Progression of toxicity was not observed in
the 28- and 90-day dietary studies in the rat: the NOAELs and LOAELs
for both studies were the same, and the severity of the findings was
minimal at both exposure durations; (2) evaluation of Cyp1a1 expression
in the rat 28- and 90-day studies indicated that at the selected POD of
3 mg/kg/day, which is below the NOAELs for these studies, there is no
expectation of significant AhR activation that could lead to liver
toxicity. Observable liver toxicity in these studies was only
associated with significantly greater levels of Cyp1a1; (3) halauxifen-
methyl is rapidly metabolized to the acid, and neither bioaccumulate;
and (4) based on comparative in vitro studies, humans are not
anticipated to be more sensitive to liver effects of halauxifen-methyl
than rats.
    Carcinogenicity studies on halauxifen-methyl were not conducted.
Systemic exposure from halauxifen-methyl is primarily to XDE-729 acid,
which showed no evidence of carcinogenicity. However, pre-systemic
exposure of the liver to halauxifen-methyl was shown to activate the
AhR receptor, an effect that induces an increase in hepatocellular
proliferation and, subsequently, may promote an increased incidence of
liver tumors with long-term exposure. The molecular marker for AhR
activation, the MIE for liver toxicity, is increased expression of
hepatic Cyp1a1, which was observed at a dose below the LOAEL for
observable adverse effects of any type. The chronic dietary endpoint
for halauxifen-methyl is based on the point of departure (POD) from the
rat subchronic study for Cyp1a1 induction, as described above. The
selected POD is considered very conservative because it is below the
study NOAEL (the LOAEL was based on mild liver effects). Since Cyp1a1
induction is one of the early key events in the MOA leading to
hepatotoxicity and promotion of hepatocellular proliferation, a dose
that is protective of this event will be protective of the potential
risk for liver cancer with chronic exposure, based on the rapid onset
of AhR activation following initiation of exposure, and the lack of
evidence of temporal progression of

liver toxicity in the available studies (28- and 90-day). The MOA is
considered relevant to human health risk assessment, but in vitro data
suggest that humans are unlikely to be more sensitive than the rat.
Based on a weight-of-the-evidence consideration, halauxifen-methyl is
classified as ``not likely to be carcinogenic to humans'' at doses that
do not induce liver Cyp1a1 expression.

   Table 1(a)--Summary of Toxicological Doses and Endpoints for Halauxifen-methyl for Use in Human Health Risk
                                                   Assessment
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                                    Point of departure
        Exposure/Scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  No hazard from a single exposure was identified in the available database;
 including infants and children     therefore, no risk is expected from this exposure scenario.
 and females age 13-49).
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Chronic dietary (All populations)  POD = 3.0 mg/kg/day.  Chronic RfD = 0.03   90-day oral toxicity in the rat
                                   UFA = 10x...........   mg/kg/day.           (halauxifen-methyl).
                                   UFH = 10x...........  cPAD = 0.03 mg/kg/   NOAEL = 10 mg/kg/day.
                                   FQPA SF = 1x........   day.                At the NOAEL, increased Cyp1a1
                                                                               expression was observed (endpoint
                                                                               selected for risk assessment).
                                                                               The lowest dose of 3.0 mg/kg/day
                                                                               was selected to be protective of
                                                                               potential long-term effects from
                                                                               increased AhR expression in the
                                                                               liver.\1\
                                                                              LOAEL = 52 mg/kg/day based on mild
                                                                               liver enlargement and pathology.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Not likely to be carcinogenic to humans at dose levels that
                                    do not induce Cyp1a1 expression. The cRfD is considered protective of
                                    potential cancer effects because it protects for the MIE for hepatocellular
                                    proliferation (AhR activation) that, over time, may result in promotion of
                                    liver tumors.
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Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MIE = molecular initiating
  event.
1. The POD selected for risk assessment was based on a non-adverse finding, increased liver Cyp1a1 expression in
  a rat 90-day dietary study, which was observed below the study NOAEL of 10 mg/kg/day for liver toxicity. This
  effect is a biomarker for activation of AhR, which causes liver toxicity and hepatocellular proliferation. The
  POD was selected to be protective of potential liver effects resulting from chronic dietary exposure to
  halauxifen-methyl. Other tissues and organs will not be exposed to halauxifen-methyl due to rapid conversion
  to XDE-729 acid. The POD is protective of effects from exposure to XDE-729 acid.

    A summary of the toxicological endpoints for XDE-729 acid used for
human risk assessment is shown in Table 1(b) of this unit. No hazard
from a single exposure was identified in the available database;
therefore, no risk is expected from acute dietary exposure to XDE-729
acid. The chronic toxicity/carcinogenicity study using the rat was
chosen to assess chronic dietary risk to XDE-729 acid. A NOAEL of 20.3
was chosen based on hyperplasia of the renal pelvic epithelium in
females observed at 101 mg/kg/day. This NOAEL is protective of
developmental effects, observed in the rat at 526 mg/kg/day (NOAEL =
140 mg/kg/day), and of maternal toxicity in both the rat (LOAEL = 526
mg/kg/day) and rabbit (LOAEL 1094 mg/kg/day).
    There was no evidence of carcinogenicity in rat and mouse cancer
studies on XDE-729 acid, which is classified as ``not likely to be
carcinogenic to humans.''

     Table 1(b)--Summary of Toxicological Doses and Endpoints for XDE-729 Acid for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/Scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  No hazard from a single exposure was identified in the available database;
 including infants and children     therefore, no risk is expected from this exposure scenario.
 and females age 13-49).
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 20.3 mg/kg/   Chronic RfD = 0.20   Rat two-year dietary chronic
                                    day (females).        mg/kg/day.           toxicity/carcinogenicity study
                                                                              NOAEL = 101/20.3 mg/kg/day [M/F].
                                   UFA = 10x...........  cPAD = 0.20 mg/kg/   LOAEL = 404/101 mg/kg/day [M/F]
                                   UFH = 10x...........   day.                 based on increased mortality,
                                   FQPA SF = 1x........                        altered urinalysis parameters,
                                                                               decreased body weight, increased
                                                                               kidney weights, adrenal zone
                                                                               glomerulosa hypertrophy,
                                                                               increased degeneration and
                                                                               regeneration of renal tubules and
                                                                               kidney stones, and bladder
                                                                               pathology in males; in females,
                                                                               hyperplasia of pelvic epithelium
                                                                               of the kidney.
                                  ------------------------------------------------------------------------------

Cancer (Oral, dermal, inhalation)  Classification: Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to halauxifen-methyl and the XDE-729 acid metabolite, EPA
considered exposure under the petitioned-for tolerances. EPA assessed
dietary exposures to these compounds 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. No such effects were
identified in the toxicological studies for halauxifen-methyl or XDE-
729 acid; therefore, quantitative acute dietary exposure assessments
were determined unnecessary.
    ii. Chronic exposure. In conducting individual chronic dietary
exposure assessments for these two compounds, EPA used the food
consumption data collected between 2003 and 2008 for USDA's National
Health and Nutrition Survey/What We Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA used tolerance-level residues and
assumed 100 percent of all wheat, barley and triticale acres are
treated. No processing factors were used due to the lack of residue
concentration in processed commodities. Residue chemistry data indicate
that halauxifen-methyl (parent compound) converts to the XDE-729 acid
metabolite so quickly in the environment that dietary exposure to
halauxifen-methyl is expected to be minimal.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that halauxifen-methyl does not pose a cancer risk to humans
at dose levels that do not induce liver toxicity or Cypla1 expression.
EPA has also concluded that its XDE-729 acid metabolite does not pose a
cancer risk to humans. Therefore, separate dietary exposure assessments
for the purpose of assessing cancer risk are determined to be
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for halauxifen-methyl. Tolerance-level residues and
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for halauxifen-methyl and its metabolites (primarily XDE-729
acid) in drinking water. These simulation models take into account data
on the physical, chemical, and fate/transport characteristics of
halauxifen-methyl and its metabolites. Further information regarding
EPA drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of halauxifen-
methyl were estimated for chronic exposure in a non-cancer assessment.
Based on the Screening Concentration in Groundwater (SCI-GROW) model,
the EDWCs of the XDE-729 acid metabolite were estimated for chronic
exposure in a non-cancer assessment. Modeled estimates of drinking
water concentrations were directly entered into the dietary exposure
model. For chronic dietary risk assessment of halauxifen-methyl only,
the water concentration value of 0.007 ppb was used to assess the
contribution to drinking water. For chronic dietary risk assessment of
XDE-729 acid, a drinking water concentration value of 19.5 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). Halauxifen-methyl is
not used, nor is it being proposed for use in 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.'' EPA has not found
halauxifen-methyl or XDE-729 acid to share a common mechanism of
toxicity with any other substances, nor do they appear to produce any
toxic metabolites produced by other substances. For the purposes of
this tolerance action, therefore, EPA has assumed that neither of these
compounds have a common mechanism of toxicity with other substances.
For information regarding EPA's efforts to determine which chemicals
have a common mechanism of toxicity and to evaluate the cumulative
effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    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. There was no evidence of
increased prenatal susceptibility to either compound and no evidence of
postnatal susceptibility to XDE-729 acid. Residual concerns for
postnatal susceptibility to halauxifen-methyl in the absence of
reproductive toxicity data are low, due to selection of a conservative
endpoint and assumptions for dietary exposure, as well as the low level
of exposure expected from proposed use patterns.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for halauxifen-methyl and XDE-729 acid are
complete.
    ii. There is no indication that halauxifen-methyl or XDE-729 acid
are neurotoxic chemicals and there is no need for developmental
neurotoxicity studies or additional UFs to account for neurotoxicity.
    iii. There is no evidence to suggest that exposure to halauxifen-
methyl or XDE-729 acid results in increased in utero susceptibility in
rats or rabbits in the prenatal developmental studies or in young rats
in the 2-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary food exposure assessment was based on
100 PCT and tolerance-level residues. EPA also made conservative
assumptions in the ground and surface water modeling used to assess
exposure to halauxifen-methyl and XDE-729 acid in drinking water. These
assessments will not underestimate the exposure and risks posed by
these compounds.

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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
neither halauxifen-methyl, nor XDE-729 acid are expected to pose an
acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
halauxifen-methyl from food and water will utilize < 1% of the cPAD for
all infants, the population group receiving the greatest exposure. In
addition, EPA has concluded that chronic exposure to XDE-729 acid from
drinking water will also utilize < 1% of the cPAD for all infants. XDE-
729 is not a residue of concern in food; therefore, the chronic
assessment was based on drinking water only for this acid metabolite.
There are no residential uses for halauxifen-methyl being proposed at
this time; therefore chronic aggregate risk reflects only dietary
exposure to potential residues in food and drinking water.
    3. Short-term risk. Short-term risk is assessed based on short-term
residential exposure plus chronic dietary exposure. Because there is no
short-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-term risk), no
further assessment of short-term risk is necessary.
    4. Intermediate-term risk. Intermediate-term risk is assessed based
on intermediate-term residential exposure plus chronic dietary
exposure. Because there is no intermediate-term residential exposure
and chronic dietary exposure has already been assessed under the
appropriately protective cPAD, no further assessment of intermediate-
term risk is necessary.
    5. Aggregate cancer risk for U.S. population. Long-term dietary
studies conducted with XDE-729 acid in the rat and the mouse showed no
evidence of carcinogenicity. Based on the MOA and bridging data on
halauxifen-methyl, which allowed identification of a POD for liver
cancer, halauxifen-methyl is not expected to pose a cancer risk to
humans at dose levels below those that induce liver Cyp1a1 expression.
Genotoxicity studies were negative for both compounds.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to halauxifen-methyl and XDE-729 acid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (LC-MS/MS) with a limit of
quantitation of 0.01 ppm is available to enforce the tolerance
expression. The multi-residue method, QuEChERS, is adequate for the
determination of both residues of halauxifen-methyl and XDE-729 acid in
crop commodities. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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 MRLs have been established by Codex for halauxifen-methyl on the
commodities affected by this action.

C. Revisions to Petitioned-For Tolerances

    As noted in Unit II, the petitioned-for livestock commodity
tolerances (milk; fat, meat, meat byproducts of cattle, goat, horse,
and sheep) are not being established due to the lack of quantifiable
residues in livestock commodities associated with the proposed uses in
wheat, barley and triticale. In addition, although the petitioner
proposed a tolerance of 0.04 ppm for wheat, hay, EPA has determined
that a tolerance of 0.03 ppm is appropriate. When the petitioner
determined the proposed tolerances, the metabolite XDE-729 acid was
included as a residue of concern. EPA has subsequently determined that
this metabolite is not a residue of concern for tolerance enforcement.
Residues of metabolite XDE-729 acid were not

quantifiable in any of the residue field trials. Therefore, the values
for measuring compliance with these tolerances only include residues of
halauxifen-methyl. With the exception of wheat, hay, this revision to
the residues of concern for tolerance enforcement had no impact on the
plant commodity tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of halauxifen-
methyl, (methyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)
pyridine-2-carboxylate) and its major metabolite, XDE-729 acid,
expressed as halauxifen-methyl (parent) equivalents, in or on barley,
(grain, hay, straw) and wheat, grain at 0.01 ppm; wheat, forage at 0.50
ppm; wheat, hay at 0.03 ppm; and wheat, straw at 0.015 ppm.

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). 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: July 28, 2016.
Jack E. Housenger,
Director, 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. Add Sec.  180.691 to subpart C to read as follows:

Sec.  [emsp14]180.691  Halauxifen-methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide, halauxifen-methyl, including its metabolites and degradates,
in or on the commodities in the table below. Compliance with the
tolerance levels specified below is to be determined by measuring only
halauxifen-methyl (methyl (4-amino-3-chloro-6-(4-chloro-2-fluoro-3-
methoxyphenyl)-2-pyridine carboxylate).

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
Barley, grain.........................................              0.01
Barley, hay...........................................              0.01
Barley, straw.........................................              0.01
Wheat, forage.........................................              0.50
Wheat, grain..........................................              0.01
Wheat, hay............................................              0.03
Wheat, straw..........................................             0.015
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2016-19118 Filed 8-10-16; 8:45 am]
 BILLING CODE 6560-50-P


                    UNITED STATES OF AMERICA

            DEPARTMENT OF TRANSPORTATION

                    OFFICE OF THE SECRETARY

                             WASHINGTON, DC

                                   	    Issued by the Department of
Transportation on November 16, 2007

		       NOTICE OF ACTION TAKEN -- DOCKET DOT-OST-97-2302

________________________________________________________________________
_______________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of AMERICAN AIRLINES, INC. (AMERICAN) filed 10/6/06 for:

XX  Renewal of exemption under 49 U.S.C. 40109 to provide the following
service:

Scheduled foreign air transportation of persons, property, and mail
between Miami, Florida and Santa Cruz and La Paz, Bolivia.

Applicant rep.: Carl B. Nelson<PHONE_NUMBER>   DOT analyst: Thuy H.
Cooper<PHONE_NUMBER>

DISPOSITION

XX  Granted (subject to conditions, see below)

The above action was effective when taken: November 16, 2007, through
November 16, 2009.

Action taken by:  Paul L. Gretch, Director

	                 Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Bolivia.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX  Holder’s
Certificates of Public Convenience and Necessity

     XX  Standard Exemption Conditions (attached)

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

Remarks: The authority for which American requested renewal expired
December 14, 2006, but has been kept in force pursuant to the provisions
of the Administrative Procedure Act, 5 U.S.C. 558(c), as implemented by
14 CFR Part 377, pending action on its timely-filed renewal application.

________________________________________________________________________
________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov

APPENDIX

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration, the Transportation Security Administration, and with all
applicable U.S. Government requirements concerning security, including,
but not limited to, 49 CFR Part 1544.  To assure compliance with all
applicable U.S. Government requirements concerning security, the holder
shall, before commencing any new service (including charter flights) to
or from a foreign airport, contact its International Principal Security
Inspector (IPSI) to advise the IPSI of its plans and to find out whether
the Transportation Security Administration has determined that security
is adequate to allow such airport(s) to be served;

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										  11/06

 PAGE


[Federal Register Volume 79, Number 221 (Monday, November 17, 2014)]
[Notices]
[Page 68433]
[FR Doc No: 2014-27094]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL15-17-000]

Alterna Springerville LLC, LDVF1 TEP LLC, Wilmington Trust
Company, William J. Wade v. Tucson Electric Power Company; Notice of
Complaint

    Take notice that on November 7, 2014, pursuant to sections 206 and
306 of the Federal Power Act, 16 USC 824e and 825e and Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.206, Alterna Springerville LLC (Alterna),
LDVF1 TEP LLC (LDVF1), Wilmington Trust Company, and William J. Wade
(Complainants), filed a formal complaint against Tucson Electric Power
Company (Respondent or TEP), alleging that the TEP is engaging in
unjust, unreasonable, and unduly discriminatory and/or preferential
behavior; in violation of TEP's Pre-Order No. 888 grandfathered
contractual obligations and its Open Access Transmission Tariff with
regard to expanding transmission service to Alterna and LDVF1.
    The Complainants certify that copies of the complaint were served
on the contacts for the Respondent as listed on the Commission's list
of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention 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 electronic 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 email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on November 28, 2014.

    Dated: November 7, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-27094 Filed 11-14-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 134 (Wednesday, July 13, 2016)]
[Notices]
[Pages 45328-45330]
[FR Doc No: 2016-16478]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78237; File No. SR-FINRA-2016-021]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Clarify the Application of FINRA Rule 2210
(``Communications With the Public'') to Debt Research Reports

July 7, 2016.
    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 June 24, 2016, Financial Industry Regulatory Authority, Inc.
(``FINRA'') 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 FINRA. FINRA has
designated the proposed rule change as constituting a ``non-
controversial'' rule change under paragraph (f)(6) of Rule 19b-4 under
the Act,\3\ which renders the proposal effective upon receipt of this
filing by the Commission. 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.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    FINRA is proposing to clarify the application of FINRA Rule 2210
(``Communications with the Public'') to debt research reports as the
result of approval of a new FINRA debt research conflict of interest
rule.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA 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
    FINRA is proposing to make several conforming changes to FINRA Rule
2210 to expressly address its application to debt research reports in
light of the Commission's approval of a dedicated debt research
conflict of interest rule. On July 16, 2015, the SEC approved a
proposed rule change to adopt FINRA Rule 2242 to address conflicts of
interest relating to the publication and distribution of debt research
reports.\4\ Rule 2242 will be implemented on July 16, 2016.\5\ Until
that rule becomes effective, FINRA's research conflict of interest
rules apply only to equity research as set forth in FINRA Rule 2241
(``Research Analysts and Research Reports'').
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 75472 (July 16,
2015), 80 FR 43528 (July 22, 2015) (Order Approving File No. SR-
FINRA-2014-048). See also Regulatory Notice 15-31 (August 2015).
    \5\ See Securities Exchange Act Release No. 77158 (February 17,
2016), 81 FR 9065 (February 23, 2016) (Notice of Filing and
Immediate Effectiveness of File No. SR-FINRA-2016-008), see also
Securities Exchange Act Release No. 77726 (April 27, 2016), 81 FR
26593 (May 3, 2016) (Notice of Filing and Immediate Effectiveness of
File No. SR-FINRA-2016-013).
---------------------------------------------------------------------------

    First, Rule 2210(b)(1)(A) requires an appropriately qualified
registered principal to approve each ``retail communication'' before
the earlier of its use or filing with FINRA's Advertising Regulation
Department. Both a debt and equity research report constitutes a
``retail communication,'' unless it is distributed or made available
only to ``institutional investors'' as defined in Rule 2210(a)(4), in
which case it would be considered an ``institutional communication''
not subject to the pre-use approval requirement.
    Rule 2210(b)(1)(B) states that the pre-use approval requirement may
be satisfied by a Supervisory Analyst approved pursuant to NYSE Rule
344 with respect to: (i) Research reports on debt and equity
securities; (ii) retail communications as described in Rule
2241(a)(11)(A); and (iii) other research that does not meet the
definition of ``research report'' under Rule 2241(a)(11), provided that
the Supervisory Analyst has technical expertise in the particular
product areas. For dual FINRA and New York Stock Exchange members, this
provision therefore broadly allows a Series 16 qualified Supervisory
Analyst to satisfy the pre-use approval requirement with respect to any
research-related communication, including those expressly excepted by
the definition of ``research report'' under Rule 2241(a)(11)(A) or not
otherwise captured by that definition of ``research report'' under the
equity research rule.
    The proposed rule change would clarify and streamline the scope of
approval permitted by Supervisory Analysts to specifically reference
the definitions of ``research report'' and ``debt research report'' in
Rules 2241(a)(11) and 2242(a)(3), respectively. It also would add a
specific reference to the exceptions under Rule 2242(a)(3)(A), thereby
making express the references to debt research-related retail
communications consistent with the references to equity research-
related retail communications. The proposal maintains the ability for a
Supervisory Analyst to approve other research communications--e.g.,
research on options--provided that the Supervisory Analyst has
technical expertise in the product area and any other required
registrations for such product.
    Second, Rule 2210(b)(1)(D)(i) excepts from the pre-use approval
requirement any retail communication that is excepted from the
definition of ``research report'' under Rule 2241(a)(11)(A), unless the
communication makes any financial or investment recommendation. Those
communications still must be supervised and reviewed in the same manner
as correspondence pursuant to FINRA's supervision rules.\6\ FINRA
adopted this exception due to concerns that the pre-use approval
requirements for these types of research communications in some
circumstances may have inhibited the flow of information to traders and
other investors who base their investment decisions on timely market
analysis.\7\ The proposed change would make this exception from the
pre-use approval requirements consistent for debt and equity research
communications.
---------------------------------------------------------------------------

    \6\ See FINRA Rules 3110(b) and 3110.06 through .09.
    \7\ See Regulatory Notice 09-10 (February 2009).
---------------------------------------------------------------------------

    Third, Rule 2210(d)(7) requires specific applicable disclosures in
retail communications that include a recommendation of securities;
however, the requirements do not apply to communications that meet the
definition of an equity research report under Rule 2241(a), as long as
the research report includes all the required disclosures under that
rule. Similarly, Rule 2210(f)(2) requires specific applicable
disclosures where an associated person recommends a security in a
public appearance, but Rule 2210(f)(5) excepts from those disclosure
requirements public appearances by an equity ``research analyst'' as
defined in Rule 2241(a)(8), provided the research analyst makes all of
the disclosures required under that rule. The basis for these
exceptions is that the equity research rule has more extensive required
disclosures in both research reports and public appearances than Rule
2210(d)(7) and (f)(2), respectively. New Rule 2242 requires similarly
extensive corresponding disclosures in debt research reports and public
appearances by debt research analysts. As such, FINRA believes it
appropriate to similarly except debt research reports from the
disclosure requirements of Rule 2210(d)(7) and except public
appearances by debt research analysts from the disclosure requirements
of Rule 2210(f)(2) for consistency purposes.
    Finally, the proposed rule change would also make technical changes
to FINRA Rules 2210(d)(7) and (f)(5) to make the rule language more
readable.\8\
---------------------------------------------------------------------------

    \8\ FINRA notes that in 2014 the Commission approved a proposed
rule change to exclude from the filing requirements in Rule 2210(c)
equity research reports as defined in Rule 2241 that concern only
securities that are listed on a national securities exchange, other
than research reports required to be filed with the Commission
pursuant to Section 24(b) of the Investment Company Act. See
Securities Exchange Act Release No. 72480 (June 26, 2014), 79 FR
37796 (July 2, 2014) (Order Approving File No. SR-FINRA-2014-012).
In connection with that filing, FINRA indicated that it would
consider a similar exclusion for debt research reports if and when a
debt research rule was approved. FINRA has not yet made a
determination whether to propose such an exclusion.
---------------------------------------------------------------------------

    FINRA has filed the proposed rule change for immediate
effectiveness and has requested that the SEC waive the requirement that
the proposed rule change not become operative for 30 days after the
date of the filing. The implementation date for the proposed rule
change will be July 16, 2016, to coincide with the effective date of
FINRA Rule 2242.\9\
---------------------------------------------------------------------------

    \9\ See supra notes 4 and 5 for additional detail.
---------------------------------------------------------------------------

2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of section 15A(b)(6) of the Act,\10\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes the proposed rule change will promote

consistent application of the communications with the public rules and
provide greater clarity to members and the public regarding FINRA's
rules.
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    \10\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA 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. The proposed rule change brings
clarity and consistency to FINRA rules without adding any burden on
firms.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing 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 for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-
4(f)(6) thereunder.\12\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) under the Act
\13\ normally does not become operative before 30 days from the date of
the filing. However, pursuant to Rule 19b-4(f)(6)(iii),\14\ the
Commission may designate a shorter time if such action is consistent
with the protection of investors and the public interest. FINRA has
asked the Commission to waiver the 30-day operative delay. The
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
The proposed rule change is designed to clarify the application of
FINRA Rule 2210 to debt research reports as the result of the
Commission's approval of a new FINRA debt research conflict of interest
rule (Rule 2242).\15\ A waiver of the 30-day operative delay will allow
the proposed rule change to become operative on July 16, 2016, the same
date on which Rule 2242 will be implemented.\16\ Therefore, the
Commission hereby waives the 30-day operative delay and designates the
proposed rule change to be operative on July 16, 2016.\17\
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    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
    \15\ See note 4 supra.
    \16\ See note 5 supra.
    \17\ For purposes of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    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-FINRA-2016-021 on the subject line.

Paper Comments

     Send paper comments in triplicate to Robert W. Errett,
Deputy Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2016-021. 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
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. 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-FINRA-2016-021 and should be
submitted on or before August 3, 2016.
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    \18\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
Brent J. Fields,
Secretary.
[FR Doc. 2016-16478 Filed 7-12-16; 8:45 am]
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[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Notices]
[Pages 6267-6268]
[FR Doc No: 2014-02184]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Quiet Aircraft Technology Incentive for Commercial Air Tour
Operators in Grand Canyon National Park

AGENCY: Federal Aviation Administration, Transportation.

ACTION: Release of FAA-held allocations for quiet aircraft technology
in Grand Canyon National Park.

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SUMMARY: The Moving Ahead for Progress in the 21st Century Act (MAP-21)
directs the Administrator of the Federal Aviation Administration (FAA)
and the Secretary of the Interior to provide incentives for commercial
air tour operators in Grand Canyon National Park that convert to quiet
aircraft technology. The FAA holds a limited number of flight
allocations that are authorized under 14 CFR part 93, Subpart U,
``Special Flight Rules in the Vicinity of Grand Canyon National Park.''
The FAA, in consultation with the National Park Service (NPS), intends
to provide these allocations to commercial air tour operators that
currently hold allocations in proportion to the number of quiet
aircraft technology operations that are flown by respective operators
in the first six months of calendar year 2014. This is a one-time
release of FAA-held allocations that will be available to operators for
quiet aircraft technology flights during the 2014 air tour season and
beyond. The FAA and NPS are continuing to make progress on additional
quiet aircraft technology incentives for commercial air tour operators
in Grand Canyon National Park.

FOR FURTHER INFORMATION CONTACT: Keith Lusk--Mailing address: Federal
Aviation Administration, P.O. Box 92007, Los Angeles, California 90009-
2007. Telephone:<PHONE_NUMBER>. Email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Authority

    1. Sec. 35001(b)(2) in title V of the Moving Ahead for Progress in
the 21st Century Act (MAP-21), Public Law 112-141 signed July 6, 2012,
directs the Administrator of the Federal Aviation Administration (FAA)
and the Secretary of the Interior to provide incentives for commercial
air tour operators that convert to quiet aircraft technology (QT), such
as increasing the flight allocations for such operators on a net basis
consistent with section 804(c) of the National Parks Air Tour
Management Act of 2000 (title VIII of Pub. L. 106-181), provided that
the cumulative impact of such operations does not increase noise at
Grand Canyon National Park (``the park''). Appendix A of 14 CFR Part
93, Subpart U, ``Special Flight Rules in the Vicinity of Grand Canyon
National Park,'' contains procedures for determining the QT designation
for aircraft in the park.
    2. Under 14 CFR Part 93, Subpart U, an allocation is defined as
authorization to conduct a commercial air tour in the Grand Canyon
National Park Special Flight Rules Area (SFRA). Sec. 93.319 and 93.321
provide for the authorized annual number and the management of
allocations, and Sec. 93.325 requires air tour operators to file
quarterly reports with the FAA and specifies the content of those
reports. Since the effective date of this regulation, a limited number
of authorized annual allocations have reverted from commercial air tour
operators to the FAA.
    3. This Federal Register Notice announces the FAA's intent, in
consultation with the NPS, to release the allocations it currently
holds, amounting to 49 allocations in the Dragon and Zuni Point
corridors of the park and 1672 allocations elsewhere in the park SFRA,
to commercial air tour operators that currently hold allocations in
proportion to the number of QT operations that are flown by the
respective operators in these areas during the first six months of
calendar year 2014. These allocations are within the total annual
number that are authorized to be flown in the Dragon and Zuni Point
corridors and elsewhere in the SFRA, respectively, under 14 CFR Part
93, Subpart U. They will be used for operations using QT, as defined in
Appendix A of 14 CFR Part 93, Subpart U.

II. Description of Quiet Aircraft Technology Incentive

    1. The FAA currently holds 49 out of a total of 44,960 annual
allocations authorized to be flown by commercial air tour operators in
the Dragon and Zuni Point corridors of the park and 1672 out of a total
of 49,011 annual allocations authorized to be flown elsewhere in the
SFRA. The FAA intends to provide these allocations to commercial air
tour operators that currently hold allocations in proportion to the
number of QT operations that are flown by the respective operators in
these areas of the park during the first six months of 2014. Consistent
with Sec. 93.321(b)(4)(ii), allocations provided in the Dragon and Zuni
Point corridors may be transferred for use outside of these corridors,
while allocations provided for use elsewhere in the SFRA may not be
transferred into the Dragon and Zuni Point corridors.
    2. Consistent with the FAA and NPS approach to QT incentives, the
FAA has selected the first six months of calendar year 2014 as the
basis for the release of FAA held allocations to recognize the progress
made to date by operators that have already invested in QT and to
encourage additional QT operations in 2014. The FAA will use the first
and second quarter operator reports required under Sec. 93.325 to
determine the numbers of QT operations by each operator in the Dragon
and Zuni Point corridors and elsewhere in the SFRA, respectively. An
operation will be considered QT if conducted in an aircraft that meets
the noise limits identified in Appendix A of 14 CFR Part 93, Subpart U.
Aircraft meeting those noise limits are listed in Appendices I and II
of FAA Advisory Circular AC-93-2, ``Noise Levels for Aircraft Used for
Commercial Operations in Grand Canyon National Park Special Flight
Rules Area.'' The FAA's receipt of the second quarter reports, due by
the end of July, will enable the FAA to complete its analysis and
provide its allocations by September to round out the 2014 air tour
season. In the FAA's experience, additional allocations have not been
needed by operators earlier than September. This is a one-time release
of FAA-held allocations that will be available to operators for quiet
aircraft technology flights during the 2014 air tour season and beyond.
The additional allocations and the condition that they be used for QT
operations will be reflected in the operations specifications of
individual operators.

III. Environmental Considerations

    As provided in MAP-21, the cumulative impact of operations using
FAA-held allocations does not increase noise at the park. The 49 FAA
allocations in the Dragon and Zuni Point corridors are 0.1% of the
total 44,960 allocations authorized in those corridors. The 1672 FAA
allocations

comprise 3.4% of the total 49,011 allocations authorized elsewhere in
the SFRA. In addition, there are 254,013 air tour operations authorized
as of 2013 under contract with the Hualapai tribe that are exempt from
allocations--bringing the total authorized number of air tour
operations in the park to 347,984. The 1721 total FAA allocations are
0.5% of the total 347,984 authorized air tour operations. Analysis
shows that such a small number of QT operations on existing routes will
not cumulatively increase noise at the park and will not diminish the
substantial restoration of natural quiet. The provision of FAA-held
allocations to commercial air tour operators through amendments to
their operations specifications is categorically excluded from more
detailed environmental review.

    Issued in Hawthorne, CA on: January 28, 2014.
Dale Bouffiou,
Deputy Regional Administrator, Western-Pacific Region, Federal Aviation
Administration.
[FR Doc. 2014-02184 Filed 1-31-14; 8:45 am]
BILLING CODE 4910-13-P