[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Rules and Regulations]
[Pages 18461-18467]
[FR Doc No: 2014-07100]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0051; FRL-9907-05]

Propiconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
propiconazole in or on the rapeseed crop subgroup 20A. Syngenta Crop
Protection requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective April 2, 2014. Objections and
requests for hearings must be received on or before June 2, 2014, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0051, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers

determine whether this document applies to them. Potentially affected
entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of 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-2013-0051 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
June 2, 2014. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0051, 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
2F8135) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR 180.434 be amended by
establishing tolerances for residues of the fungicide propiconazole, 1-
[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-
triazole, and its metabolites determined as 2,4,-dichlorobenzoic acid
and expressed as parent compound, in or on rapeseed subgroup 20A at 0.3
parts per million (ppm). That document referenced a summary of the
petition prepared by Syngenta Crop Protection, the registrant, which is
available in the docket, http://www.regulations.gov. Comments were
received on the notice of filing. EPA's response to these comments is
discussed 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 propiconazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with propiconazole
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 target organ for propiconazole toxicity in animals is
the liver. Increased liver weights were seen in mice after subchronic
or chronic oral exposures to propiconazole. Liver lesions such as
vacuolation of hepatocytes, ballooned liver cells, foci of enlarged
hepatocytes, hypertrophy and necrosis are characteristic of
propiconazole toxicity in rats and mice. Decreased body weight gain was
also seen in subchronic, chronic, developmental and reproductive
studies in animal studies. Dogs appeared to be more sensitive to the
localized toxicity of propiconazole as manifested by stomach
irritations at 6 mg/kg/day and above.
    In rabbits, developmental toxicity occurred at a higher dose than
the maternally toxic dose, while in rats, developmental toxicity
occurred at lower doses than maternal toxic doses. Increased incidences
of rudimentary ribs occurred in rat and rabbit fetuses. Increased cleft
palate malformations were noted in two studies in rats. In one
published study in rats, developmental effects (malformations of the
lung and kidneys, incomplete ossification of the skull, caudal
vertebrae and digits, extra rib (14th rib) and missing sternbrae) were
reported at doses that were not maternally toxic. In the 2-generation
reproduction study in rats, offspring toxicity occurred at a higher
dose than the parental toxic dose suggesting lower susceptibility of
the offspring to the toxic doses of propiconazole.
    The acute neurotoxicity study resulted in decreased motor activity
at 300 mg/kg. The current acute dietary assessment is based on an
endpoint more sensitive than the neurotoxicity in the acute
neurotoxicity study. Based on a weight of evidence evaluation by the
Agency, the subchronic neurotoxicity data requirement (SCN) was waived.

Propiconazole was negative for mutagenicity in the in vitro BALB/3T3
cell transformation assay, bacterial reverse mutation assay, Chinese
hamster bone marrow chromosomal aberration assay, unscheduled DNA
synthesis studies in human fibroblasts and primary rat hepatocytes,
mitotic gene conversion assay and the dominant lethal assay in mice. It
caused proliferative changes in the rat liver with or without
pretreatment with an initiator, like phenobarbital, a known liver tumor
promoter. Liver enzyme induction studies with propiconazole in mice
demonstrated that propiconazole is a strong phenobarbital type inducer
of xenobiotic metabolizing enzymes. Hepatocellular proliferation
studies in mice suggest that propiconazole induces cell proliferation
followed by treatment-related hypertrophy in a manner similar to the
known hypertrophic agent phenobarbital.
    Propiconazole was carcinogenic to male mice. Propiconazole was not
carcinogenic to rats or to female mice. The Agency classified
propiconazole as a possible human carcinogen and recommended that, for
the purpose of risk characterization, the reference dose (RfD) approach
be used for quantification of human risk. Propiconazole is not
genotoxic and this fact, together with special mechanistic studies,
indicates that propiconazole is a threshold carcinogen. Propiconazole
produced liver tumors in male mice only at a high dose that was toxic
to the liver. At doses below the RfD, liver toxicity is not expected;
therefore, tumors are also not expected.
    Specific information on the studies received and the nature of the
adverse effects caused by propiconazole 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 ``Propiconazole Human Health
Risk Assessment for an Section 3 Registration on Rapeseed Crop Subgroup
20A,'' pp. 41-47 in docket ID number EPA-HQ-OPP-2013-0051.

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 propiconazole used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of May 11, 2011 (76 FR 27261) (FRL-
8873-2).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to propiconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing propiconazole
tolerances in 40 CFR 180.434. EPA assessed dietary exposures from
propiconazole 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 propiconazole. 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). This dietary survey was
conducted from 2003 to 2008. As to residue levels in food, EPA
conducted an acute dietary analysis for propiconazole residues of
concern using tolerance levels and 100 percent crop treated (PCT) for
all existing and proposed uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. This dietary survey was conducted from 2003 to 2008. As to
residue levels in food, EPA conducted a chronic dietary analysis for
propiconazole residues of concern using tolerance levels for some
commodities, average field trial residues for the remaining
commodities, and 100 PCT for all existing and proposed uses.
    iii. Cancer. 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.
Cancer risk is 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 a nonlinear RfD approach is appropriate
for assessing cancer risk to propiconazole. Cancer risk was assessed
using the same exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue 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.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for propiconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of propiconazole. 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 Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of

propiconazole for acute exposures are estimated to be 55.78 parts per
billion (ppb) for surface water and 0.64 ppb for ground water, and for
chronic exposures are estimated to be 21.61 ppb for surface water and
0.64 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 55.78 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 21.61ppb 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).
    Propiconazole is currently registered for the following uses that
could result in residential exposures: Turf, ornamentals, and in paint.
The highest incidental oral and dermal exposure scenarios are expected
from residential use on turf. EPA assessed short term risk to toddlers
from incidental oral and dermal exposure and short-term risk to adults
from dermal and inhalation residential handler exposure as well as from
post-application dermal exposure. The highest post application exposure
from residential use on turf was used to assess risk to short-term
aggregate exposures.
    The only residential use scenario that will result in potential
intermediate term exposure to propiconazole is dermal and incidental
oral post application exposure to children from wood treatment. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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.''
    Propiconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events (EPA, 2002). In conazoles, however, a variable
pattern of toxicological responses is found; some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes.
    Thus, there is currently no evidence to indicate that conazoles
share common mechanisms of toxicity and EPA is not following a
cumulative risk approach based on a common mechanism of toxicity for
the conazoles. For information regarding EPA's procedures for
cumulating effects from substances found to have a common mechanism of
toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
    Propiconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazolylalanine and triazolylacetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including propiconazole, U.S. EPA
conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazolylalanine, and triazolylacetic acid resulting from the
use of all current and pending uses of any triazole-derived fungicide.
The risk assessment is a highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). In addition, the Agency
retained the additional 10X FQPA safety factor for the protection of
infants and children. The assessment includes evaluations of risks for
various subgroups, including those comprised of infants and children.
The Agency's complete risk assessment is found in the propiconazole
reregistration docket at http://www.regulations.gov, Docket
Identification (ID) Number EPA-HQ-OPP-2005-0497.
    An updated dietary exposure and risk analysis for the common
triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA),
triazolylacetic acid (TAA), and triazolylpyruvic acid (TP) was
completed on October 24, 2013, in association with registration
requests for several triazole fungicides (propiconazole,
difenoconazole, and tebuconazole). That analysis concluded that risk
estimates were below the Agency's level of concern for all population
groups. This assessment may be found on http://www.regulations.gov by
searching for the following title and docket number: ``Common Triazole
Metabolites: Updated Aggregate Human Health Risk Assessment to Address
The New Section 3 Registrations For Use of Propiconazole on Rapeseed
Crop Subgroup 20A; Use of Difenoconazole on Rapeseed Crop Subgroup 20A;
and Use of Tebuconazole on Imported Oranges'' (located in docket ID
number EPA-HQ-OPP-2013-0051).

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 . In the developmental
toxicity study in rats, fetal effects observed in this study at a dose
lower than that evoking maternal toxicity are considered to be
quantitative evidence of increased susceptibility of fetuses to in
utero exposure to propiconazole. In the developmental toxicity study in
rabbits, neither quantitative nor qualitative evidence of increased
susceptibility of fetuses to in utero exposure to propiconazole was
observed in this study. In the 2-generation reproduction study in rats,
neither quantitative nor qualitative evidence of increased
susceptibility of neonates (as compared to adults) to prenatal and/or
postnatal exposure to propiconazole was observed. There is no evidence
of neuropathology or abnormalities in the development of the fetal
nervous system from the available toxicity studies conducted with
propiconazole. In the rat acute neurotoxicity study, there was evidence
of mild neurobehavioral

effects at 300 mg/kg, but no evidence of neuropathology from
propiconazole administration. Although there was quantitative evidence
of increased susceptibility of the young following exposure to
propiconazole in the developmental rat study, the Agency determined
there is a low degree of concern for this finding and no residual
uncertainties because the increased susceptibility was based on minimal
toxicity at high doses of administration, clear NOAELs and LOAELs have
been identified for all effects of concern, and a clear dose-response
has been well defined.
    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 propiconazole is complete. The most
recently published Federal Register notice on April 19, 2013 (78 FR
23497) (FRL-9381-8) cited an immunotoxicity study as a data gap, but
since the publication of that final rule, the Agency has evaluated and
granted a waiver request for this data requirement for the conazoles as
a class based on the following considerations:
     There was no evidence of adverse effects on the immune
system in mice, rats, or dogs in the data base for any of the conazole
pesticides.
     The liver, not the immune system, is generally the target
organ for this chemical class, and hepatotoxicity or body weight
changes are the primary toxicological endpoints of concern and were
used in risk assessments.
     The conazoles do not belong to a class of chemicals (e.g.,
the organotins, heavy metals, or halogenated aromatic hydrocarbons)
that would be expected to be immunotoxic.
    There was no evidence of immunotoxicity with six other
structurally-related conazole fungicides, namely, flutriafol,
metconazole, tebuconazole, tetraconazole, triadimefon, and
triticonazole. For another conazole fungicide, triflumizole, the
effects on the immune system occurred only at the highest dose tested.
Immunotoxicity was demonstrated with difenoconazole, however it was
observed in the presence of systemic toxicity and at a relatively high
dose. PODs based on the most sensitive endpoints obtained via the
appropriate routes of exposure in the most sensitive species are
currently used for dietary and non-dietary risk assessments.
    All these factors indicate that an immunotoxicity study would most
likely not result in an adverse effect that could be used as an
endpoint for conazole risk assessment. Based on a weight of evidence
approach, the Agency concluded that immunotoxicity studies are not
required for propiconazole. An immunotoxicity study is not anticipated
to provide a lower POD or result in a more sensitive endpoint than
those already used. Based on a weight of the evidence approach, EPA has
waived the requirement for a subchronic neurotoxicity study for
propiconazole. This data waiver was based on the following
considerations:
    i. Other than the mild effects seen at 300 mg/kg in the acute
neurotoxicity study, the lack of neurotoxicity and neurobehavioral
effects seen in the propiconazole toxicity database;
    ii. The liver, not the nervous system, is the primary target organ
of propiconazole toxicity, and decreased body weight is the most
sensitive endpoint in repeated-dose studies. EPA concludes that a
subchronic neurotoxicity study is unlikely to provide a lower endpoint
than those currently used for risk assessment.
    Finally, EPA waived the requirement for a subchronic inhalation
data based on, among other things, its conclusion that even if an
additional 10X safety factor was applied, inhalation exposure would not
raise a risk of concern.
    iii. Although an apparent increased quantitative susceptibility was
observed in fetuses and offspring, for the reasons noted in this unit
residual uncertainties or concerns for prenatal and/or postnatal
toxicity are minimal.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary food exposure assessments were performed
based on 100 PCT and tolerance-level residues, while the chronic used a
combination of tolerance-level residues and reliable data on average
field trial residues and 100 PCT. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to propiconazole in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
propiconazole.

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 propiconaozle will occupy 84% of the aPAD for children 1-2 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
propiconazole from food and water will utilize 24% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
propiconazole is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Propiconazole
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to propiconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs from post-
application activities (the highest exposure scenario) of 200 for
adults and 96 for children 1-2 years old. This assessment is considered
conservative since it is based on a combination of tolerance-level
residues and reliable data on average field trial residues and 100 PCT,
conservative assumptions in the ground and surface water modeling, and
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. Additionally,
the assessment could be further refined by using PCT estimates and
anticipated residues for all crops. Accordingly, even though this MOE
for children 1-2 years old is slightly below the target MOE of 100, the
difference is small and is more than offset by the conservative
exposure assumptions and therefore not of concern.

    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Propiconazole is currently registered for use as a wood treatment
that could result in intermediate-term residential exposure, and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with intermediate-term residential
exposures to propiconazole.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in an
aggregate MOE of 110 for children 1-2 years old. Because EPA's level of
concern for propiconazole is a MOE of 100 or below, this MOE is not of
concern.
    5. Aggregate cancer risk for U.S. population. EPA considers the
chronic aggregate risk assessment to be protective of any aggregate
cancer risk.
    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 propiconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, a high performance liquid
chromatography with ultraviolet detection method (HPLC/UV Method AG-
671A) is available to enforce the tolerance expression. 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.
    The Codex has established MRLs for propiconazole in or on rapeseed
at 0.02 ppm. This MRL is different than the tolerance being established
for propiconazole in the United States, which, as noted earlier, is 0.3
ppm. The approved uses for propiconazole in the United States will
result in residues that exceed the Codex MRLs.

C. Response to Comments

    The Agency received a comment objecting to the presence of any
pesticide residues on crops and stated that EPA should set no pesticide
tolerance greater than zero. The comment also stated that the Agency
should have more information on long term testing before moving
forward. A second comment also objected to this petition and stated
that this product should be banned and never used and never produced in
the USA. In addition, the second comment also noted several adverse
effects seen in animal toxicology studies with propiconazole and claims
because of these effects no tolerance should be approved. The Agency
understands the concerns raised in the comments and recognizes that
some individuals believe that pesticides should be banned completely.
However, the existing legal framework provided by section 408 of the
Federal Food, Drug and Cosmetic Act (FFDCA), contemplates that
tolerances greater than zero may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. The comments appear to be
directed at the underlying statute and not EPA's implementation of it;
no contention has been made that EPA has acted in violation of the
statutory framework. In addition, EPA has found that there is a
reasonable certainty of no harm to humans after considering these
toxicological studies and the exposure levels of humans to
propiconazole.
    A third comment dealt with a different chemical entirely and thus
needs no response.

V. Conclusion

    Therefore, a tolerance is established for residues of
propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole, and its metabolites determined as 2,4,-
dichlorobenzoic acid and expressed as parent compound, in or on
rapeseed subgroup 20A at 0.30 ppm.

VI. Statutory and Executive Order Reviews

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

rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

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: March 21, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.434, add alphabetically the following commodity to the
table in paragraph (a) to read as follows:

Sec.  180.434  Propiconazole; tolerances for residues.

    (a) * * *

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

                                * * * * *
Rapeseed subgroup 20A......................................         0.30

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-07100 Filed 4-1-14; 8:45 am]
BILLING CODE 6560-50-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on March 9, 2006

NOTICE OF ACTION TAKEN -- DOCKET OST-2006-23955

________________________________________________________________________
________________________________________________________

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).

Applicant:  VOLGA-DNEPR J.S. CARGO AIRLINE (Volga-Dnepr)
Date Filed:  February 14, 2006

								           as supplemented March 7, 2006

Relief requested:  Exemption from 49 USC § 40109(g) to permit the
applicant to operate four, one-way, all-cargo charter flights, using its
AN-124-100 aircraft, carrying outsized cargo on behalf of the U.S.
Department of Defense, from Fort Drum, New York, to Victorville,
California, during the period March 13 through March 17, 2006.  The
applicant states that the flights would carry nine OH-58D helicopters
and associated equipment.  The applicant asserts that DOD needs the
subject lift to meet highly time-sensitive training and operational
mission schedules; that the DOD organic lift scheduled to transport the
cargo was diverted to other areas; that the cargo is too large for
transportation on U.S.-carrier aircraft; and that surface transportation
is not feasible because of the delicate nature of the cargo and urgency
of the shipment.

Applicant representative:  Glenn P. Wicks,<PHONE_NUMBER>
 DOT analyst:  Robert J. Finamore,<PHONE_NUMBER>

Responsive pleadings:  Volga-Dnepr served its application on those U.S.
carriers operating large all-cargo aircraft.  Each carrier indicated
that it did not have aircraft available to conduct the proposed
operations and that it had no comment or did not oppose grant of the
requested authority.

Statutory Standards:  Under 49 USC § 40109(g), we may authorize a
foreign air carrier to carry commercial traffic between U.S. points
(i.e., cabotage traffic) under limited circumstances.  Specifically, we
must find that the authority is required in the public interest; that
because of an emergency created by unusual circumstances not arising in
the normal course of business the traffic cannot be accommodated by U.S.
carriers holding certificates under 49 USC § 41102; that all possible
efforts have been made to place the traffic on U.S. carriers; and that
the transportation is necessary to avoid unreasonable hardship to the
traffic involved (an additional required finding, concerning emergency
transportation during labor disputes, was not relevant here).

DISPOSITION

Action: Approved.

Action date: March 9, 2006

Effective dates of authority granted: March 13, 2006, through March 17,
2006.

Basis for approval:  We are granting Volga-Dnepr’s request to operate
the four proposed one-way flights (described above), on behalf of DOD.
We found that its request met all the relevant criteria of 49 USC §
40109(g) for the grant of an exemption of this type, and that the grant
was required in the public interest.  Specifically, we were persuaded
that the need to move the cargo to meet highly time-sensitive training
and operational mission schedules; the fact that the DOD organic lift
scheduled to transport the cargo was diverted to other areas; and the
unique, outsized nature of the cargo, constituted an emergency not
arising in the normal course of business.  Moreover, based on the
representations of the U.S. carriers, we concluded that no U.S. carrier
had aircraft available that could be used to conduct the operations at
issue here.  We also found that grant of this authority would prevent
unreasonable hardship to DOD.  Finally, we found that the applicant was
qualified to perform its proposed operations.

Except to the extent exempted/waived, this authority is subject to our
standard exemption conditions (attached) and to the condition that the
applicant must comply with an FAA-approved flight routing for the
authorized operation.

Action taken by:        				Michael W. Reynolds

Acting Assistant Secretary for Aviation

and International Affairs

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

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
                       		       ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
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;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

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

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

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

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

05/2004


[Federal Register Volume 76, Number 244 (Tuesday, December 20, 2011)]
[Notices]
[Pages 78966-78967]
[FR Doc No: 2011-32500]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Approval of Noise Compatibility Program for Kona International
Airport at Keahole, Keahole, North Kona, HI

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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

SUMMARY: The Federal Aviation Administration (FAA) announces its
findings on the noise compatibility program submitted by the Hawaii
State Department of Transportation, Airports Division (DOT-A) under the
provisions of 49 U.S.C. 47501 et seq. (formerly the Aviation Safety and
Noise Abatement Act, hereinafter referred to as ``the Act'') and 14
Code of Federal Regulations (CFR) Part 150 (hereinafter referred to as
``Part 150''). On January 12, 2010, the FAA determined that the noise
exposure maps submitted by the DOT-A under Part 150 were in compliance
with applicable requirements. On April 20, 2011 the FAA approved the
Kona International Airport at Keahole noise compatibility program. All
of the recommendations of the program were approved. No program
elements relating to new or revised flight procedures for noise
abatement were proposed.

DATES: Effective Date: The effective date of the FAA's approval of the
Noise Compatibility Program for Kona International Airport at Keahole
is April 20, 2011.

FOR FURTHER INFORMATION CONTACT: Gordon Wong, Environmental Protection
Specialist, FAA Western-Pacific Region, Honolulu Airports District
Office, 300 Ala Moana Boulevard, Room 7-128, Honolulu, Hawaii,
telephone number<PHONE_NUMBER>. Documents reflecting this FAA action
may be reviewed at this same location.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA has given
its overall approval to the Noise Compatibility Program for Kona
International Airport at Keahole, effective April 20, 2011. Under
section 104(a) of the Aviation Safety and Noise Abatement Act of 1979,
as amended (herein after referred to as the ``Act'') [recodified as 49
U.S.C. 47504], an airport operator who has previously submitted a Noise
Exposure Map may submit to the FAA a Noise Compatibility Program which
sets forth the measures taken or proposed by the airport operator for
the reduction of existing non-compatible land uses and prevention of
additional non-compatible land uses within the area covered by the
Noise Exposure Maps. The Act requires such programs to be developed in
consultation with interested and affected parties including local
communities, government agencies, airport users, and FAA personnel.
    Each airport noise compatibility program developed in accordance
with Federal Aviation Regulations (FAR) part 150 is a local program,
not a Federal program. The FAA does not substitute its judgment for
that of the airport proprietor with respect to which measures should be
recommended for action. The FAA's approval or disapproval of FAR part
150 program recommendations is measured according to the standards
expressed in part 150 and the Act, and is limited to the following
determinations:
    a. The Noise Compatibility Program was developed in accordance with
the provisions and procedures of FAR part 150;
    b. Program measures are reasonably consistent with achieving the
goals of reducing existing non-compatible land uses around the airport
and preventing the introduction of additional non-compatible land uses;
    c. Program measures would not create an undue burden on interstate
or foreign commerce, unjustly discriminate against types or classes of
aeronautical uses, violate the terms of airport grant agreements, or
intrude into areas preempted by the Federal Government; and
    d. Program measures relating to the use of flight procedures can be
implemented within the period covered by the program without derogating
safety, adversely affecting the efficient use and management of the
navigable airspace and air traffic control systems, or adversely
affecting other powers and responsibilities of the Administrator
prescribed by law.
    Specific limitations with respect to FAA's approval of an airport
noise compatibility program are delineated in FAR part 150, section
150.5. Approval is not a determination concerning the acceptability of
land uses under Federal, state, or local law. Approval does not by
itself constitute an FAA implementing action. A request for Federal
action or approval to implement specific noise compatibility measures
may be required, and an FAA decision on the request may require an
environmental assessment of the proposed action. Approval does not
constitute a commitment by the FAA to financially assist in the
implementation of the program nor a determination that all measures
covered by the program are eligible for grant-in-aid funding from the
FAA under the Airport and Airway Improvement Act of 1982, as amended.
Where federal funding is sought, requests for project grants must be
submitted to the FAA Airports District Office in Honolulu, Hawaii.
    The DOT-A submitted to the FAA on April 27, 2009, the Noise
Exposure Maps for evaluation. The FAA determined that the Noise
Exposure Maps for Kona International Airport at Keahole were in
compliance with applicable requirements on January 12, 2010. Notice of
this determination was published in the Federal Register on January 25,
2010 (Volume 75/No. 15/pages 3959-3960).
    The Kona International Airport at Keahole study contains a proposed
noise compatibility program comprised of actions designed for phased
implementation by airport management and adjacent jurisdictions. It was
requested that the FAA evaluate and approve this material as a Noise
Compatibility Program as described in 49 U.S.C. 47504 (formerly Section
104(b) of the Act). The FAA began its review of the program on October
27, 2010, and was required by a provision of the Act to approve or
disapprove the program within 180 days (other than the use of new or
modified flight procedures for noise control). Failure to approve or
disapprove such program within the 180-day period shall be deemed to be
an approval of such program.
    The Noise Compatibility Program recommended one Noise Abatement
Element, eight Land Use Management Elements and three Program
Management Elements. The FAA completed its review and determined

that the procedural and substantive requirements of the Act and FAR
Part 150 have been satisfied. The overall program was approved, by the
Manager of the Airports Division, Western-Pacific Region, effective
April 20, 2011.
    Approval was granted for one Noise Abatement Element, eight Land
Use Management Elements and three Program Management Elements. The
approved measures included: a pilot education program; maintaining an
established communication process between DOT-A, Hawaii County, and
Hawaii State Land Use Commission for the review of proposed development
near the airport; DOT-A to encourage Hawaii County to revise the
Environmental Quality Section of Hawaii County General Plan to include
additional policies related to airport land use compatibility;
establish an Airport Influence Area for Kona International Airport to
define the area that land use compatibility policies would apply; DOT-A
to encourage Hawaii County to adopt an airport compatibility checklist
for discretionary review of projects within its vicinity; maintain
compatible zoning designations within the 2013 60 DNL noise contour;
require the dedication of noise and avigation easements through the
subdivision approval process; adopt fair disclosure regulations to
notify property owners of the noise generated by aircraft operations;
adopt an airport noise overlay zone; monitor implementation of the part
150 Noise Compatibility Program; updated the Noise Exposure Maps and
Noise Compatibility Programs as necessary; and acquire and implement a
noise monitoring system.
    The FAA determinations are set forth in detail in the Record of
Approval signed by the Manager of the Airports Division, Western-
Pacific Region, on April 20, 2011. The Record of Approval, as well as
other evaluation materials and the documents comprising the submittal,
are available for review at the FAA office listed above and at the
administrative offices of the Kona International Airport at Keahole.
The Record of Approval also will be available on-line at: http://www.faa.gov/airports/environmental/airport_noise/part_150/states/

    Issued in Hawthorne, California on December 12, 2011.
Mark A. McClardy,
Manager, Airports Division, Western-Pacific Region, AWP-600.
[FR Doc. 2011-32500 Filed 12-19-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 187 (Tuesday, September 27, 2016)]
[Notices]
[Pages 66268-66271]
[FR Doc No: 2016-23237]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-10-000; Docket No. CP16-13-000]

Mountain Valley Pipeline LLC, Equitrans LP; Notice of
Availability of the Draft Environmental Impact Statement for the
Proposed Mountain Valley Project and Equitrans Expansion Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a draft environmental impact statement (EIS)
for the projects proposed by Mountain Valley Pipeline LLC (Mountain
Valley) and Equitrans LP (Equitrans) in the above-referenced dockets.
Mountain Valley requests authorization to construct and operate certain
interstate natural gas facilities in West Virginia and Virginia, known
as the Mountain Valley Project (MVP) in Docket Number CP16-10-000. The
MVP is designed to transport about 2 billion cubic feet per day (Bcf/d)
of natural gas from production areas in the Appalachian Basin to
markets in the Mid-Atlantic and Southeastern United States. Equitrans
requests authorization to construct and operate certain natural gas
facilities in Pennsylvania and West Virginia, known as the Equitrans
Expansion Project (EEP) in Docket No. CP16-13-000. The EEP is designed
to transport about 0.4 Bcf/d of natural gas, to improve system
flexibility and reliability, and serve markets in the Northeast, Mid-
Atlantic, and Southeast, through interconnections with various other
interstate systems, including the proposed MVP.
    The draft EIS assesses the potential environmental effects of the
construction and operation of the MVP and EEP in accordance with the
requirements of the National Environmental Policy Act (NEPA). The FERC
staff concludes that approval of the MVP and EEP would have some
adverse environmental impacts; however, these impacts would be reduced
with the implementation of Mountain Valley's and Equitrans' proposed
mitigation measures, and the additional measures recommended by the
FERC staff in the EIS.
    The United States Department of Agriculture Forest Service (FS),
U.S. Army Corps of Engineers (COE), U.S. Environmental Protection
Agency, U.S. Department of the Interior Bureau of Land Management
(BLM), U.S. Department of Transportation, West Virginia Department of
Environmental Protection, and West Virginia Division of Natural
Resources participated as cooperating agencies in the preparation of
the EIS. Cooperating agencies have jurisdiction by law or special
expertise with respect to resources potentially affected by the
proposals and participated in the NEPA analysis. The BLM, COE, and FS
may adopt and use the EIS when they consider the issuance of a Right-
of-Way Grant to Mountain Valley for the portion of the MVP that would
cross federal lands. Further, the FS may use the EIS when it considers
amendments to its Land and Resource Management Plan (LRMP) for the
proposed crossing of the Jefferson National Forest. Although the
cooperating agencies provided input to the conclusions and
recommendations presented in the draft EIS, the agencies will present
their own conclusions and recommendations in their respective permit
authorizations and Records of Decision (ROD) for the projects.

Proposed Facilities

    The draft EIS addresses the potential environmental effects of the
construction and operation of the proposed facilities. For the MVP,
facilities include:
     About 301 miles of new 42-inch-diameter pipeline extending
from the new Mobley Interconnect in Wetzel County, West Virginia to the
existing Transcontinental Gas Pipe Line Company LLC (Transco) Station
165 in Pittsylvania County, Virginia;
     3 new compressor stations (Bradshaw, Harris, Stallworth)
in West Virginia, totaling about 171,600 horsepower (hp);
     4 new meter and regulation stations and interconnections
(Mobley, Sherwood, WB, and Transco);
     2 new taps (Webster and Roanoke);
     5 pig \1\ launchers and receivers; and
---------------------------------------------------------------------------

    \1\ A ``pig'' is a device used to clean or inspect the interior
of a pipeline.
---------------------------------------------------------------------------

     36 mainline block valves.
    For the EEP, facilities include:
     About 8 miles total of new various diameter pipelines in
six segments;

     new Redhook Compressor Station, in Greene County,
Pennsylvania, with 31,300 hp of compression;
     4 new taps (Mobley, H-148, H-302, H-306) and 1 new
interconnection (Webster);
     4 pig launchers and receivers; and
     decommissioning and abandonment of the existing 4,800 hp
Pratt Compressor Station in Greene County, Pennsylvania.

Actions of the Bureau of Land Management and the Forest Service

    The BLM's purpose and need for the proposed action is to respond to
a Right-of-Way Grant application submitted by Mountain Valley on April
5, 2016. Under the Mineral Leasing Act of 1920 the Secretary of the
Interior has delegated authority to the BLM to grant a right-of-way in
response to the Mountain Valley application for natural gas
transmission on federal lands under the jurisdiction of two or more
federal agencies. Before issuing the Right-of-Way Grant, the BLM must
receive the written concurrence of the other surface managing federal
agencies (i.e., FS and COE) in accordance with Title 43 Code of Federal
Regulations (CFR) Part 2882.3(i). Through this concurrence process, the
FS and COE would submit to the BLM any specific stipulations applicable
to their lands, facilities, waterbodies, and easements for inclusion in
the Right-of-Way Grant.
    The FS's purpose and need for the proposed action is to consider
issuing a concurrence to the BLM for the Right-of-Way Grant and to
evaluate the amendments to the LRMP for the Jefferson National Forest
that would make provision for the MVP pipeline if the FS decides to
concur and BLM decides to issue a Right-of-Way Grant.
    The first type of LRMP amendment would be a ``plan-level
amendment'' that would change land allocations. This would change
future management direction for the lands reallocated to the new
management prescription (Rx) and is required by LRMP Standard FW-248.
    Proposed Amendment 1: The LRMP would be amended to reallocate 186
acres to the Management Prescription 5C--Designated Utility Corridors
from these Rxs: 4J--Urban/Suburban Interface (56 acres); 6C--Old Growth
Forest Communities-Disturbance Associated (19 ac); and 8A1--Mix of
Successional Habitats in Forested Landscapes (111 acres).
    Rx 5C--Designated Utility Corridors contain special uses which
serve a public benefit by providing a reliable supply of electricity,
natural gas, or water essential to local, regional, and national
economies. The new Rx 5C land allocation would be 500 feet wide (250
feet wide on each side of the pipeline), with two exceptions: (1) The
area where the pipeline crosses Rx 4A--Appalachian National Scenic
Trail Corridor would remain in Rx 4A; and (2) the new 5C area would not
cross into Peters Mountain Wilderness so the Rx 5C area would be less
than 500 feet wide along the boundary of the Wilderness.
    The second type of amendment would be a ``project-specific
amendment'' that would apply only to the construction and operation of
this pipeline. The following amendments would grant a temporary
`waiver' to allow the project to proceed. These amendments would not
change LRMP requirements for other projects or authorize any other
actions.
    Proposed Amendment 2: The LRMP would be amended to allow
construction of the MVP pipeline to exceed restrictions on soil
conditions and riparian corridor conditions as described in LRMP
standards FW-5, FW-9, FW-13, FW-14 and 11-017, provided that mitigation
measures or project requirements agreed upon by the Forest Service are
implemented as needed.
    Proposed Amendment 3: The LRMP would be amended to allow the
removal of old growth trees within the construction corridor of the MVP
pipeline. (reference LRMP Standard FW-77)
    Proposed Amendment 4: The LRMP would be amended to allow the MVP
pipeline to cross the Appalachian National Scenic Trail (ANST) on
Peters Mountain. The Scenic Integrity Objective (SIO) for the Rx 4A
area and the ANST will be changed from High to Moderate. This amendment
also requires the SIO of Moderate to be achieved within five to ten
years following completion of the project to allow for vegetation
growth. (reference LRMP Standards 4A-021 and 4A-028).
    The decision for a Right-of-Way Grant across federal lands would be
documented in a ROD issued by the BLM. The BLM's decision to issue,
condition, or deny a right-of-way would be subject to BLM
administrative review procedures established in 43 CFR 2881.10 and
Section 313(b) of the Energy Policy Act. The FS concurrence to BLM to
issue the Right-of-Way Grant would not be a decision subject to NEPA,
and therefore would not be subject to FS administrative review
procedures. The FS would issue its own ROD for the LRMP amendments. The
Forest Supervisor for the Jefferson National Forest would be the
Responsible Official for the LRMP amendments. Proposed Amendment 1 was
developed in accordance to 36 CFR 219 (2012 version) regulations and
would be subject to the administrative review procedures under 36 CFR
219 Subpart B. Proposed Amendments 2, 3 and 4 were developed in
accordance to 36 CFR 219 (2012) regulations but would be subject to the
administrative review procedures under 36 CFR 218 regulations Subparts
A and B, per 36 CFR 219.59(b).
    The BLM is requesting public comments on the issuance of a Right-
of-Way Grant that would allow the MVP pipeline to be constructed on
federal lands managed by the FS and COE. The FS is requesting public
comments on the consideration of submitting a concurrence to BLM and
the draft amendments of the LRMP to allow the MVP pipeline to cross the
Jefferson National Forest. All comments must be submitted to the FERC,
the lead federal agency, within the timeframe stated in this Notice of
Availability. Refer to Docket CP16-10-000 (MVP) in all correspondence
to ensure that your comments are correctly filed in the record. You may
submit comments to the FERC using one of the four methods listed below
in this notice. Before including your address, phone number, email
address, or other personal identifying information in your comments,
you should be aware that the entire text of your comments--including
your personal identifying information--would be publicly available
through the FERC eLibrary system, if you file your comments with the
Secretary of the Commission.

Distribution and Comments on the Draft Environmental Impact Statement

    The FERC staff mailed copies of the draft EIS to federal, state,
and local government representatives and agencies; elected officials;
regional environmental groups and non-governmental organizations;
potentially interested Native Americans and Indian tribes; affected
landowners; local newspapers and libraries; parties to this proceeding;
and members of the public who submitted comments about the projects.
Paper copy versions of this draft EIS were mailed to those specifically
requesting them; all others received a compact-disc version. In
addition, the draft EIS is available for public viewing on the FERC's
Web site (www.ferc.gov).\2\ A limited number of copies are available
for distribution and public inspection at: Federal Energy

Regulatory Commission, Public Reference Room, 888 First Street NE.,
Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
---------------------------------------------------------------------------

    \2\ Go to ``Documents & Filings,'' click on ``eLibrary,'' use
``General Search'' and put in the Docket numbers (CP16-10 or CP16-
13) and date of issuance (09/16/16).
---------------------------------------------------------------------------

    Any person wishing to comment on the draft EIS may do so. To ensure
consideration of your comments on the proposal in the final EIS, it is
important that the Commission receive your comments on or before
December 22, 2016.
    For your convenience, there are four methods you can use to submit
your comments to the Commission. The Commission will provide equal
consideration to all comments received, whether filed in written form
or provided verbally. The Commission encourages electronic filing of
comments and has expert staff available to assist you at<PHONE_NUMBER>
or<EMAIL_ADDRESS>Please carefully follow these instructions so that
your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents & Filings. This is an easy method for submitting brief, text-
only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents & Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' If you are filing a comment on a particular project,
please select ``Comment on a Filing'' as the filing type; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project docket number
(CP16-10-000 or CP16-13-000) with your submission: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Room 1A, Washington, DC 20426.
    (4) In lieu of sending written or electronic comments, the
Commission invites you to attend one of the public sessions its staff
will conduct in the project area to receive verbal comments on the
draft EIS. To ensure that interested parties have ample opportunity to
attend, the FERC staff has arranged for seven public sessions, at
venues spaced a reasonable driving distance apart, and scheduled as
listed below.
    There will not be a formal presentation by Commission staff at any
of the seven public comment sessions, although a format outline handout
will be made available. All public sessions will begin at 5:00 p.m.
Eastern time. If you wish to provide verbal comments, the Commission
staff will hand out numbers in the order of your arrival, and will
discontinue handing them out at 8:00 p.m. Comments will be taken until
10:00 p.m. However, if no additional numbers have been handed out and
all individuals who wish to provide comments have had an opportunity to
do so, staff may conclude the session at 8:00 p.m.
    The primary goal of the public sessions is to allow individuals to
provide verbal comments on the draft EIS. Individual verbal comments
will be taken on a one-on-one basis with a stenographer (with FERC
staff or representative present), called up in the order of the numbers
received. Because we anticipate considerable interest from concerned
citizens, this format is designed to receive the maximum amount of
verbal comments, in a convenient way during the timeframe allotted. If
many people are interested in providing verbal comments in the one-on-
one setting at any particular session, a time limit of 3 minutes may be
implemented for each commenter.
    Your verbal comments will be recorded by the stenographer.
Transcripts of all comments from the sessions will be placed into the
dockets for the projects, which are accessible for public viewing on
the FERC's Web site (at www.ferc.gov) through our eLibrary system.

 FERC Sponsored Public Sessions in the Project Area To Take Comments on
                              the Draft EIS
------------------------------------------------------------------------
               Date                             Location \a\
------------------------------------------------------------------------
Tuesday, November 1, 2016.........  Chatham High School, 100 Cavalier
                                     Circle, Chatham, VA 24531, 434-432-
                                     8305.
Tuesday, November 1, 2016.........  Lewis County High School, 205
                                     Minuteman Drive, Weston, WV 26452,
<PHONE_NUMBER>.
Wednesday, November 2, 2016.......  Franklin County High School, 700
                                     Taynard Road, Rocky Mount, VA
                                     24151,<PHONE_NUMBER>.
Wednesday, November 2, 2016.......  Nicholas County High School, 30
                                     Grizzly Road, Summersville, WV
                                     26651,<PHONE_NUMBER>.
Thursday, November 3, 2016........  Sheraton Hotel, 2801 Hershberger
                                     Road, Roanoke, VA 24017, 540-563-
                                     9300.
Thursday, November 3, 2016........  Peterstown Elementary School, 108
                                     College Drive, Peterstown, WV
                                     24963,<PHONE_NUMBER>.
Wednesday, November 9, 2016.......  California Area High School, 11
                                     Trojan Way, Coal Center, PA 15423,
<PHONE_NUMBER>.
------------------------------------------------------------------------
\a\ While we have agreements with the venues, contracts have not yet
  been finalized with the individual Boards of Education. If a School
  Board declines to sign the contract, the venue may change and the FERC
  would issue a revised notice to announce the replacement venue.

    Commission staff will be available at each venue of the public
sessions to answer questions about our environmental review process. It
is important to note that written comments mailed to the Commission and
those submitted electronically are reviewed by staff with the same
scrutiny and consideration as the verbal comments given at the public
sessions.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR part 385.214).\3\ Only intervenors have
the right to seek rehearing of the Commission's decision. The
Commission grants affected landowners and others with environmental
concerns intervenor status upon showing good cause by stating that they
have a clear and direct interest in this proceeding which no other
party can adequately represent. Simply filing environmental comments
will not give you intervenor status, but you do not need intervenor
status to have your comments considered.
---------------------------------------------------------------------------

    \3\ See the previous discussion on the methods for filing
comments.
---------------------------------------------------------------------------

Questions?

    Additional information about the projects is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov). The eLibrary link provides access to all
documents filed in a docket, in addition to the texts of formal
documents issued by the Commission, such as orders, notices, and
rulemakings. Go to ``Documents & Filings,'' click on the eLibrary link,
click on ``General Search,'' and enter the docket number excluding the
last three digits in the field (i.e., CP16-10). Be sure you have
selected an appropriate date range. For assistance, please

contact FERC Online Support at<EMAIL_ADDRESS>or toll free
at<PHONE_NUMBER>; for TTY, contact<PHONE_NUMBER>.
    In addition, the Commission offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: September 16, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-23237 Filed 9-26-16; 8:45 am]
 BILLING CODE 6717-01-P