[Federal Register: December 18, 2009 (Volume 74, Number 242)]
[Rules and Regulations]
[Page 67098-67104]
[DOCID:fr18de09-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0013; FRL-8803-1]

Dinotefuran; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of dinotefuran in or on Brassica, leafy greens, subgroup 5B and turnip,
greens. The Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective December 18, 2009. Objections and
requests for hearings must be received on or before February 16, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0013. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-7610; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

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

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. 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-
2009-0013 in the subject line on the first page of your submission. All
requests must be in writing, and must be mailed or delivered to the
Hearing Clerk as required by 40 CFR part 178 on or before February 16,
2010.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0013, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E7433) by IR-4, IR-4 Project Headquarters, 500 College Road East,
Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR
180.603 be amended by establishing tolerances for combined residues of
the insecticide dinotefuran, (RS)-1-methyl-2-nitro-3-((tetrahydro-3-
furanyl)methyl)guanidine and its major metabolites DN, 1-methyl-3-
(tetrahydro-3-furylmethyl)guanidine, and UF, 1-methyl-3-(tetrahydro-3-
furylmethyl)-urea, expressed as dinotefuran in or on Brassica, leafy
greens, subgroup 5B at 17 parts per million (ppm) and turnip, greens at
17.0 ppm. That notice referenced a summary of the petition prepared by
Valent USA Corporation and Mitsui Chemical Inc., the registrants on
behalf of IR-4, which is available to the public 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
revised the proposed tolerance of 17.0 ppm for both Brassica, leafy
greens, subgroup 5B, and turnip, greens to 15.0 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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for
tolerances for combined residues of dinotefuran in or on Brassica,
leafy greens, subgroup 5B at 15.0 ppm and turnip, greens at 15.0 ppm.
EPA's assessment of exposures and risks associated with establishing
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Dinotefuran has low acute toxicity by oral, dermal, and inhalation
exposure routes. It is not a dermal sensitizer, but causes a low level
of skin irritation. The main target tissues are the nervous system and
the immune system, with effects seen in several species. Nervous system
toxicity is manifested as clinical signs and decreased motor activity
seen after acute dosing (in both rats and rabbits) and increased motor
activity seen after repeated dosing; these findings are consistent with
effects on the nicotinic cholinergic nervous system. Immune system
toxicity is manifested as decreases in spleen and thymus weights, seen
in multiple studies and species (including dogs, rats, and mice). There
are also indications of endocrine-related toxicity, manifested in the
reproductive toxicity study (in rats) as decreases in primordial
follicles and altered cyclicity in females, and abnormal sperm
parameters in males at the Limit Dose; changes in testes or ovary
weight were also seen in several species (mouse, dog, and rat).
    No adverse effects in fetuses were seen in the developmental
toxicity studies in rats or rabbits, at maternally toxic doses, and
offspring effects in the reproduction study occurred at the same doses
causing parental effects. Acceptable oncogenicity and mutagenicity
studies provide no indication that dinotefuran is carcinogenic or
mutagenic.
    Review of available studies including developmental toxicity
studies in rats and rabbits, a reproductive toxicity study in rats, and
acute and subchronic neurotoxicity studies in rats led to the
conclusions that there is low concern for prenatal and/or postnatal
toxicity resulting from exposure to dinotefuran. However, there is a
concern for neurotoxicity and developmental neurotoxicity resulting
from exposure to dinotefuran. Considering the overall toxicity profile
and the doses and endpoints selected for risk assessment for
dinotefuran, the degree of concern for the effects observed in the rat
reproduction study is characterized as low, noting these effects
occurred in the presence of parental toxicity and only at the highest
dose tested. For all toxicity endpoints established for dinotefuran, a
NOAEL lower than this offspring NOAEL is used. No residual
uncertainties were identified.
    Specific information on the studies received and the nature of the
adverse effects caused by dinotefuran 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 ``Dinotefuran: Human Health Risk

Assessment for Proposed Uses on Brassica Leafy Vegetables Subgroup 5B
and Turnip Greens,'' dated August 6, 2009, page 11 in docket ID number
EPA-HQ-OPP-2009-0013-0004.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    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
greater than that 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 dinotefuran used for
human risk assessment can be found at http://www.regulations.gov in
document ``Dinotefuran: Human Health Risk Assessment for Proposed Uses
on Brassica Leafy Vegetables Subgroup 5B and Turnip Greens,'' dated
August 6, 2009, page 14 in docket ID number EPA-HQ-OPP-2009-0013-0004.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to dinotefuran, EPA considered exposure under the petitioned-
for tolerances as well as all existing dinotefuran tolerances in 40 CFR
180.603. EPA assessed dietary exposures from dinotefuran 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.
    In estimating acute dietary exposure, EPA used food consumption
information from the U.S. Department of Agriculture (USDA) 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed 100 percent crop
treated (PCT) and tolerance level residues of dinotefuran.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed 100 PCT and
tolerance level residues of dinotefuran in all registered raw
agricultural commodity uses.
    iii. Cancer. Dinotefuran is classified as ``not likely to be a
carcinogen'' based on the absence of significant tumor increases in two
acceptable rodent carcinogenicity studies. Therefore, no exposure
assessment for quantifying cancer risk was performed.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for dinotefuran. Tolerance level residues and/or 100 PCT 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 dinotefuran in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of dinotefuran. 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.
    The Agency has determined that it is appropriate to estimate for
parent dinotefuran and its metabolites/degradates MNG, DN, UF, and DN-
2-OH + DN-3-OH in drinking water.
    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
dinotefuran and its metabolites for acute exposures are estimated to be
75.78 parts per billion (ppb) for surface water and 2.75 ppb for ground
water.
    For chronic exposures, non-cancer assessments are estimated to be
20.97 ppb for surface water and 2.75 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 75.78 ppb was used to
assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration value
of 20.97 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).
    Dinotefuran is currently registered for the following uses that
could result in residential exposures: Professional turf management,
professional ornamental production, and residential lawns. The risk
assessment was conducted using the following residential exposure
assumptions: Outdoor uses for turf farms, golf courses, residential
lawns, and ornamentals.
    There is a potential for short-term and intermediate-term exposures
to homeowners in residential settings during the application of
pesticide products containing dinotefuran. There is also a potential
for exposure from entering areas previously treated with dinotefuran
such as lawns where children might play, or golf courses and home
gardens that could lead to exposures for adults (gardens) or adults and
youth (golf).
    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 dinotefuran to share a common mechanism of
toxicity with any other substances, and dinotefuran does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this

tolerance action, therefore, EPA has assumed that dinotefuran does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA 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. Prenatal developmental
toxicity studies in rats and rabbits provided no indication of
increased susceptibility (qualitative or quantitative) following in
utero exposure to dinotefuran. In the 2-generation reproduction study
in the rat there was evidence of increased qualitative susceptibility
in the offspring. However, the level of concern for the observed
susceptibility (decreased body weight, decreased thymus weight, and
decreased grip strength) is low because:
    i. Clear NOAELs and LOAELS are established for the endpoints of
concern for parental and offspring toxicity.
    ii. The effects in the offspring were seen in the presence of
parental toxicity.
    iii. The effects were seen only at the highest dose tested (Limit
Dose of 1,000 milligrams/kilograms/day (mg/kg/day).
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF was reduced to 1X for acute exposure, however, a safety factor
of 10X has been retained for assessing chronic dietary and short- and
intermediate-term inhalation exposure due to a lack of a NOAEL in the
chronic dietary (dog) and 28-day inhalation toxicity studies. That
decision is based on the following findings:
    i. The toxicity database for dinotefuran is complete except for
developmental neurotoxicity testing. The Agency has available a newly
submitted dose-range finding developmental neurotoxicity and
immunotoxicity study on dinotefuran in rats. Under the conditions of
the study, dinotefuran did not affect the distribution of splenocyte
subpopulations (total B cell, total T cells, helper/DTH T cells,
cytotoxic T cells, and natural killer cells) in the weanlings of
F1 generation. It did not affect the anti-SRBC antibody
forming cell response (humoral immunity) and NK cell activity (innate
immunity). Therefore, it was concluded that dinotefuran showed no
evidence of an effect on the functionality of the immune system in rats
that were exposed to dinotefuran during the prenatal, postnatal, and
post-weaning periods. Although, this study was a dose-range-finding
study for a developmental immunotoxicity study, it examined all the
parameters which would have been required in a regular developmental
immunotoxicity study and the highest tested dose (1,035 mg/kg) was
slightly greater than the limit dose (1,000 mg/kg). Considering the
results and conduct of the study, EPA believes that this range-finding
study provides sufficient data for understanding the immunotoxic
potential of dinotefuran in young animals and satisfies the data
requirement for a developmental immunotoxicity study. With respect to
the requirement for an adult immunotoxicity study, the Agency has
analyzed the entire data base of dinotefuran and that of a structurally
related chemical, clothianidin. Clothianidin was found to produce
similar effects on the thymus and spleen as dinotefuran in the repeated
dosing studies, and an immunotoxicity study was conducted in both adult
and the offspring animals. No immunotoxicity was found in either the
adults or the offspring treated with clothianidin. Based on the
available information, EPA believes that conducting an immunotoxicity
study in adult rats would probably not provide additional information
on the immunotoxicity of dinotefuran and certainly would not impact the
risk assessment of this pesticide.
    ii. There is concern for developmental neurotoxicity following
exposure to dinotefuran, and a developmental neurotoxicity (DNT) study
in rats is required. Evidence of neurotoxicity in the dinotefuran data
base includes changes in motor activity observed in acute and
subchronic neurotoxicity studies, decreased grip strength in adult
offspring in the 2-generation rat study and maternal clinical signs
(prone position and tremor) in the rabbit developmental study. These
effects occurred at doses ranging from approximately 300 to 1,500 mg/
kg/day. Because of a concern for these neurotoxic effects, EPA required
a DNT study to determine possible effects on the nervous system in the
developing young. However, the Agency determined that a database
uncertainty factor (UFDB) is not needed to account for the
lack of the DNT study based on the following:
     The developmental neurotoxicity data for other
neonicotinoid compounds (thiacloprid, imidacloprid and clothainadin)
where neurotoxicity (in the presence of decreased pup body weight) was
seen in only one compound (imidacloprid). Based on these data EPA
concluded that the results of the required dinotefuran DNT study would
not likely impact the regulatory doses selected for dinotefuran.
     No concerns for developmental neurotoxicity were seen in
the range-finding DNT study for dinotefuran where the offspring LOAEL
was the Limit Dose (1,035 mg/kg/day) based on decreased body weight and
the offspring NOAEL was 317 mg/kg/day. Establishment of such a high
LOAEL in the range-finding study clearly indicates that in order to
elicit toxicity, dose selection for the definitive DNT study will
likely result in a point of departure much higher than those currently
used for overall risk assessment (range from 2.0 to 125 mg/kg/day).
    In the current risk assessment, a point of departure for
neurotoxicity was used in two risk assessment scenarios: (1) A NOAEL of
125 mg/kg/day was used for general population acute dietary risk based
on transient clinical signs (prone position, tremor, erythema) seen at
300 mg/kg/day (LOAEL) following a single dose and no longer apparent
after 24 hours; (2) a NOAEL of 33 mg/kg/day was used for short-term
incidential oral risk based on increased motor activity seen at 327 mg/
kg/day following multiple doses. Similar or lower points of departure
for other systemic toxicities were used for the other risk assessment
scenarios: The NOAEL of 33 mg/kg/day, which was used for assessment of
short-term incidental oral risk, the chronic RfD is based on an
extrapolated NOAEL of 2.0 mg/kg/day based on decreased thymus weight,
the intermediate term incidental oral exposure is based on a NOAEL of
22 mg/kg/day based on changes in body weight/body weight gain, and the
short and the intermediate inhalation exposure endpoints are based on
an extrapolated NOAEL of 6.0 mg/

kg/day based on decreased body weight and food consumption.
    Therefore, the Agency believes there are reliable toxicity data
showing that the points of departures used for the overall risk
assessment of dinotefuran are protective of infants and children.
    iii. There is no evidence that dinotefuran results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies. Although there is evidence of increased
qualitative susceptibility in the two generation reproduction study in
the rat, the degree of concern is low and the Agency did not identify
any residual uncertainties after establishing toxicity endpoints and
traditional UFs to be used in the risk assessment of dinotefuran.
    iv. A safety factor of 10X has been retained for chronic dietary
and short- and intermediate-term inhalation exposure due to a lack of a
NOAEL in the chronic dietary (dog) and 28-day inhalation toxicity
studies. For the chronic Reference Dose (RfD) the default 10X UF was
deemed to be adequate based on the magnitude and the nature of response
at the LOAEL in the study: (1) At the LOAEL, the decreased thymus
weight was limited to one sex (males) with no corroborative
histopathological lesions in the thymus glands; (2) this appears to be
a species specific effect since no treatment-related effects on the
thymus (weight or histopathology) was seen following chronic exposures
to mice or rats; and (3) there is high confidence that the extrapolated
NOAEL of 2.0 mg/kg/day (LOAEL = 20 / 10; UF = 2.0) will be protective
of the systemic toxicity seen at higher doses in mice (LOAEL = 34 mg/
kg/day) and rats (LOAEL = 991 mg/kg/day) following chronic exposures.
    For the short- and intermediate-term inhalation exposures, the
default 10X UF is deemed to be adequate since following exposures for
28-days, no toxicity to the target organ (respiratory system) was seen
at any concentration; and the endpoint of concern was generalized
systemic toxicity characterized by decreased body weight gain and food
consumption in one sex (males).
    v. There are no residual uncertainties identified in the exposure
databases. The acute and chronic dietary food exposure assessment
utilized proposed and registered tolerance level residues and 100% crop
treated information for all commodities. By using these screening-level
assessments, acute and chronic exposure/risks will not be
underestimated. Furthermore, EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to dinotefuran in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by dinotefuran.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
dinotefuran will occupy 3.5% of the aPAD for children 1 to 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
dinotefuran from food and water will utilize 68% of the cPAD for
children 1 to 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
dinotefuran 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).
    Dinotefuran 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 dinotefuran. Because there are
existing residential uses of dinotefuran, short- and intermediate-term
aggregate risk assessments based on exposure from oral, inhalation, and
dermal routes were considered. However, the toxicological effects for
oral and inhalation routes of exposure are different (i.e.,
neurotoxicity for oral and decrease in body weight for inhalation); and
therefore, these exposure scenarios have not been combined. Also,
because no systemic toxicity was seen at the limit dose in a 28-day
dermal toxicity study, no quantification of short-term dermal risk is
required. Therefore, only short-term oral residential hand-to-mouth
exposures for toddlers need to be aggregated with chronic food and
drinking water exposures. However, these exposures were not aggregated,
and instead as a worst-case estimate of risk, intermediate-term dermal
and oral residential hand-to-mouth exposures for toddlers were
aggregated with chronic food and drinking water exposures. The point of
departure for intermediate-term dermal and oral exposures is a NOAEL of
22 mg/kg/day versus the point of departure for short-term oral
exposures which is 33 mg/kg/day.
    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). An intermediate-term aggregate risk assessment was performed as
a screening level assessment. Intermediate-term aggregate risk
assessments were performed for adults and children. For children, the
subgroup with the highest estimated chronic dietary exposure (children
1 to 2 years old) was aggregated with residential exposures to children
playing on treated lawns (dermal and oral hand-to-mouth exposures) in
order to calculate the worst case intermediate-term aggregate risk to
children. Intermediate term is a worst case because the short- and
intermediate-term incidental oral exposures are the same and the POD
for intermediate-term risk is lower than the POD for short term risk.
Further, intermediate dermal plus incidental oral exposures are
combined (same toxic effect), thus the total intermediate-term exposure
is higher than short term exposure.The reciprocal MOE method was used
to conduct the intermediate-term aggregate risk assessment for
children, since the levels of concern are identical for all MOEs in the
calculation. For adults, the aggregate risk index (ARI) method was
used, since levels of concern are not identical for all types of
exposure in the calculation. For children, the aggregate MOE is 430.
Because the level of concern is for

exposures with a MOE of less than 100, this MOE does not raise a safety
concern. For adults, the total aggregate ARI is 5.9. Because the level
of concern using the ARI approach is with an ARI of less than 1, the
total aggregate ARI for dinotefuran does not raise a safety concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenic effects in two acceptable carcinogenicity
studies, dinotefuran was classified as ``not likely to be carcinogenic
to humans'' and is not expected to pose a cancer risk to humans.
    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 dinotefuran residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Three methods for plants have been available for enforcement of
tolerances: A high performnce liquid chromatography mass spectrometry
(HPLC/MS/MS) method for the determination of residues of dinotefuran,
DN, and UF; a HPLC/UV method for the determination of dinotefuran; and
a HPLC/MS and HPLC/MS/MS method for the determination of DN and UF. An
additional LC/MS/MS method was developed by Wildlife International,
Ltd. (Project No. 236C-113), entitled ``Laboratory Validation of
Method(s) for the Analysis of MTI-446 and its metabolites DN and UF in
Multiple Crop Substrates,'' to quantitate residues in mustard greens.
The method was validated using untreated mustard greens fortified
separately with dinotefuran, DN and UF at 0.01 for each analyte.
Adequate recovery data were provided. Based on the method validation
data and concurrent recovery data, the submitted LC/MS/MS method for
leafy Brassica greens is adequate for enforcement and data collection
purposes.
    Adequate enforcement methodologies as described above are available
to enforce the tolerance expression. The methods may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican
maximum residue limits for residues of dinotefuran in or on plant
commodities.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the tolerance levels for residues of dinotefuran
from the, proposed 17 ppm for both Brassica, leafy greens, subgroup 5B
and turnip greens to 15 ppm each based on analysis of field trial data
and the North American Free Trade Agreement (NAFTA) MRL Spreadsheet.
    Additionally, EPA has revised the tolerance expression to clarify,
(1) that, as provided in section 408(a)(3) of FFDCA, the tolerance
covers metabolites and degradates of dinotefuran not specifically
mentioned; and (2) that compliance with the specified tolerance levels
is to be determined by measuring only the specific compounds mentioned
in the tolerance expression. These changes were made to both the
tolerance expressions for plant commodities and animal commodities.
They result in no substantive change to the meaning of the tolerance
but clarify the existing language.

V. Conclusion

    Therefore, tolerances are established for residues of dinotefuran,
(RS)-1-methyl-2-nitro-3-((tetrahydro-3-furanyl)methyl)guanidine,
including its metabolites and degradates, in or on the commodities
listed below in Sec.  180.603. Compliance with the tolerance levels
specified is to be determined by measuring only the sum of dinotefuran
and its metabolites DN, 1-methyl-3-(tetrahydro-3-furylmethyl)guanidine,
and UF, 1-methyl-3-(tetrahydro-3-furylmethyl)urea, calculated as the
stoichiometric equivalent of dinotefuran, in or on Brassica, leafy
greens, subgroup 5B at 15.0 ppm and turnip, greens at 15.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S.

Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of this final rule in the
Federal Register. This final rule is not a ``major rule'' as defined by
5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: December 10, 2009.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.603 is amended by revising the introductory text in
paragraphs (a)(1) and (2); and alphabetically adding ``Brassica, leafy
greens subgroup 5B'' and ``Turnip, greens'' to the table in paragraph
(a)(1) to read as follows:

Sec.  180.603  Dinotefuran; tolerances for residues.

    (a) * * * (1) Tolerances are established for residues of
dinotefuran, (RS)-1-methyl-2-nitro-3-((tetrahydro-3-
furanyl)methyl)guanidine, including its metabolites and degradates, in
or on the commodities listed in the following table. Compliance with
the tolerance levels specified below is to be determined by measuring
only the sum of dinotefuran and its metabolites DN, 1-methyl-3-
(tetrahydro-3-furylmethyl)guanidine, and UF, 1-methyl-3-(tetrahydro-3-
furylmethyl)urea, calculated as the stoichiometric equivalent of
dinotefuran, in or on the commodities listed in the table below:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Brassica, leafy greens, subgroup 5B..................               15.0
                                * * * * *
Turnip, greens.......................................               15.0
                                * * * * *
------------------------------------------------------------------------

    (2) Tolerances are established for residues of dinotefuran, (RS)-1-
methyl-2-nitro-3-((tetrahydro-3-furanyl)methyl)guanidine, including its
metabolites and degradates, in or on the commodities listed in the
following table. Compliance with the tolerance levels specified below
is to be determined by measuring only the sum of dinotefuran, (RS)-1-
methyl-2-nitro-3-((tetrahydro-3-furanyl)methyl)guanidine in or on the
commodities listed in the table below:
* * * * *
[FR Doc. E9-30131 Filed 12-17-09; 8:45 am]

BILLING CODE 6560-50-S


private, or foreign), they appeal to the Administrator unless they are in a State with an SOP, in which case, they appeal to the SOP's governing State official. If persons believe that they were adversely affected by a decision made by a representative of an SOP, they appeal such decision to the SOP's governing State official or such official's designee.


[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Page 51460]
[FR Doc No: 2016-18517]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2016-0019]

National Flood Insurance Program (NFIP); Assistance to Private
Sector Property Insurers, Availability of FY 2017 Arrangement

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: Each year, the Federal Emergency Management Agency (FEMA) is
required by the Write-Your-Own (WYO) Program Financial Assistance/
Subsidy Arrangement (Arrangement) to notify private insurance companies
(Companies) and to make available to the Companies the terms for
subscription or re-subscription to the Arrangement. In keeping with
that requirement, this notice provides the terms to the Companies to
subscribe or re-subscribe to the Arrangement.

FOR FURTHER INFORMATION CONTACT: Lloyd A. Hake, Product Delivery
Division Director, Federal Insurance and Mitigation Administration,
FEMA, 400 C. St. SW., Suite 313, Washington, DC 20472;<PHONE_NUMBER>
(phone),<PHONE_NUMBER> (facsimile), or<EMAIL_ADDRESS>(email).

SUPPLEMENTARY INFORMATION: Under the Write-Your-Own (WYO) Program
Financial Assistance/Subsidy Arrangement (Arrangement), 74 (as of July
27, 2016) private sector property insurers sell flood insurance
policies and adjust flood insurance claims under their own names based
on an Arrangement with the Federal Insurance and Mitigation
Administration (FIMA) published at 44 CFR part 62, Appendix A.
    The WYO insurers retain an expense allowance and remit the
remaining premium to the Federal Government. The WYO insurers pay flood
losses and pay loss adjustment expenses based on a fee schedule through
the regulated access of federal funds. In addition, under certain
circumstances, reimbursement for litigation costs, including court
costs, attorney fees, judgments, and settlements, are paid by FEMA
based on documentation submitted by the WYO insurers.
    The complete Arrangement is published in 44 CFR part 62, Appendix
A. Each year, FEMA is required to publish in the Federal Register and
make available to the Companies the terms for subscription or re-
subscription to the Arrangement. 44 CFR part 62, Appendix A, Article
V.B.
    Signatory Companies should remain aware that all requirements of
the Arrangement, including, but not limited to, financial accounting in
issues involving all transactions, must be met. As set forth in Article
II.A.1. of Appendix A to Part 62--Federal Emergency Management Agency,
Federal Insurance Administration, Financial Assistance/Subsidy
Arrangement, the Company is responsible for meeting all fiduciary
responsibilities for control and disbursement of funds in connection
with policy administration. This includes ensuring that all accounting
for policy administration is correct. If errors are made in policy
administration, the Company shall be responsible for reimbursing any
incorrect allocations, assessments, or other moneys compensated to that
company by the Federal Government.
    The Company is responsible for ensuring that all activities meet
the requirements of this Arrangement and of the NFIP Financial Control
Plan, 44 CFR part 62, Appendix B. The NFIP WYO Standards Committee may
take remedial action in the event any such conduct is not corrected.
    FEMA encourages all private insurance companies wishing to
participate in the WYO Program for FY 2017 to contact the NFIP at
<EMAIL_ADDRESS>by September 4, 2016. Prior participation in
the WYO Program does not guarantee that FEMA will approve continued
participation. FEMA will evaluate requests to participate in light of
publicly-available information, industry performance data, and other
criteria listed in 44 CFR 62.24 and the Arrangement, 44 CFR part 62,
Appendix A. Private insurance companies are encouraged to supplement
this information with customer satisfaction surveys, industry awards or
recognition, or other objective performance data. In addition, private
insurance companies should work with their vendors and subcontractor
involved in servicing and delivering their insurance lines to ensure
FEMA receives the information necessary to effectively evaluate the
criteria set forth in its regulations.
    FEMA will send a copy of the offer for the FY 2017 Arrangement,
together with related materials and submission instructions, to all
private insurance companies successfully evaluated by the NFIP. If
FEMA, after conducting its evaluation, chooses not to renew a Company's
participation, FEMA, at its option, may require the continued
performance of all or selected elements of the FY 2016 Arrangement for
a period required for orderly transfer or cessation of the business and
settlement of accounts, not to exceed 18 months, 44 CFR part 62,
Appendix A, Article V.C. All evaluations, whether successful or
unsuccessful, will inform both an overall assessment of the WYO Program
and any potential changes FEMA may consider regarding the Arrangement
in future fiscal years.
    Any private insurance company with questions may contact FEMA in
writing: DHS/FEMA, Federal Insurance and Mitigation Administration,
Attn: Lloyd A. Hake, Product Delivery Division Director, Federal
Insurance and Mitigation Administration, FEMA, 400 C. St. SW., Suite
313, Washington, DC 20472;<PHONE_NUMBER> (phone),<PHONE_NUMBER>
(facsimile), or<EMAIL_ADDRESS>(email).

    Authority: 44 CFR part 62, Appendix A, Article V.B.

    Dated: July 29, 2016.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Federal
Emergency Management Agency.
[FR Doc. 2016-18517 Filed 8-3-16; 8:45 am]
 BILLING CODE 9111-52-P


[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)]
[Notices]
[Pages 5009-5011]
[FR Doc No: 2014-01806]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71386; File No. SR-NYSEArca-2014-07]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change Updating the
Description of the Data Included in the ArcaBook Equities Data Feed

January 24, 2014.
    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 January 17, 2014, NYSE Arca, Inc. (the ``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. NYSE Arca 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

    The Exchange proposes to update the description of the data
included in the ArcaBook equities data feed. The text of the proposed
rule change is available on the Exchange's Web site at www.nyse.com, at
the principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to proposes to [sic] update the description
of the data included in the ArcaBook equities data feed. ArcaBook is a
real-time market data product that is a compilation of all limit orders
in the NYSE Arca limit order book. A 2010 rule filing stated that
Exchange [sic] also makes available real-time information relating to
transactions and limit orders in debt securities that are traded
through the Exchange's facilities as part of ArcaBook.\4\ The Exchange
currently does not trade debt securities, and the ArcaBook data feed
does not currently include any debt data. There are no separate or
additional fees for debt securities data described in the current
ArcaBook pricing structure. The Exchange notes that its affiliate, New
York Stock Exchange LLC (``NYSE''), lists and trades debt securities
under NYSE Rules 86-88. NYSE offers its debt security data for free.\5\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 63291 (Nov. 9,
2010), 75 FR 70311 (Nov. 17, 2010) (SR-NYSEArca-2010-97).
    \5\ See Securities Exchange Act Release No. 55496 (March 20,
2007), 72 FR 14631 (March 28, 2007) (SR-NYSE-2006-37).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) \6\ of the Act, in general, and furthers the
objectives of Section 6(b)(5) \7\ of the Act, in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system and,
in general, to protect investors and the public interest, and it is not
designed to permit unfair discrimination among customers, brokers, or
dealers. The Exchange believes that updating the description of the
ArcaBook product will benefit users by making clearer what data is
included. The proposed rule change will have no impact on NYSE's debt
data, which is provided free of charge.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In adopting Regulation NMS, the Commission granted self-regulatory
organizations and broker-dealers increased authority and flexibility to
offer new and unique market data to consumers of such data. It was
believed that this authority would expand the amount of data available
to users and consumers of such data and also spur innovation and
competition for the provision of market data. The Commission concluded
that Regulation NMS--by lessening regulation of the market in
proprietary data--would itself further the Act's goals of facilitating
efficiency and competition:

    [E]fficiency is promoted when broker-dealers who do not need the
data beyond the prices, sizes, market center identifications of the
NBBO and consolidated last sale information are not required to
receive (and pay for) such data. The Commission also believes that
efficiency is promoted when broker-dealers may choose to receive
(and pay for) additional market data based on their own internal
analysis of the need for such data.\8\
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005) (File No. S7-10-04).

By removing ``unnecessary regulatory restrictions'' on the ability of
exchanges to sell their own data, Regulation NMS advanced the goals of
the Act and the principles reflected in its legislative history.

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

    In accordance with Section 6(b)(8) of the Act,\9\ the Exchange does
not believe that the proposed rule change will impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The proposed rule change is not intended to
address any competitive issue but rather to update the description of
the ArcaBook product so that it reflects the included data elements.
The Exchange does not believe that the proposed rule change would
burden competition. The Exchange further notes that the debt securities
data of the Exchange's affiliate, NYSE, will continue to be available
from NYSE without charge.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

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

    No written comments were solicited or received with respect to the
proposed rule change.

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 \10\ and Rule 19b-
4(f)(6) thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    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-NYSEArca-2014-07 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.
All submissions should refer to File Number SR-NYSEArca-2014-07. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written

communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street NE., Washington, DC 20549, on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEArca-2014-07 and should be submitted on or before
February 20, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-01806 Filed 1-29-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 104 (Wednesday, May 30, 2018)]
[Notices]
[Page 24842]
[FR Doc No: 2018-11569]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Approval for Renewal and Revision of Information
Collection: High Density Traffic Airports: Slot Allocation and Transfer
Methods

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for renewal and revision to an
information collection. The Federal Register Notice with a 60-day
comment period soliciting comments on the following collection of
information was published on March 30, 2018. This information
collection is used to allocate airport landing and takeoff slots and
maintain accurate records of slot transfers at Ronald Reagan Washington
National Airport (DCA) under the High Density Rule. The FAA is
requesting a renewal for the DCA information collection and a revision
to include six additional airports managed under similar FAA programs
to manage congestion and delay: John F. Kennedy International Airport
(JFK), LaGuardia Airport (LGA), Los Angeles International Airport
(LAX), Newark Liberty International Airport (EWR), O'Hare International
Airport (ORD), and San Francisco International Airport (SFO). The
information collection is required from carriers and other operators at
the airports to assist the FAA in reducing delays at congested
airports.

DATES: Written comments should be submitted by June 29, 2018.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
[email protected], or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Barbara Hall at<PHONE_NUMBER>, or by
email at: [email protected].

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0524.
    Title: High Density Traffic Airports: Slot Allocation and Transfer
Methods.
    Form Numbers: There are no FAA forms associated with this
information collection.
    Type of Review: Renewal and revision of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on March 30, 2018 (83 FR 13809). Information is reported
to the FAA by air carriers or other persons holding slots at DCA in
accordance with 14 CFR part 93, subparts K and S. The respondents must
notify the FAA of: (1) Requests for confirmation of transferred slots;
(2) slots required to be returned or slots voluntarily returned; (3)
requests to be included in a lottery for available slots; (4) usage of
slots on a bi-monthly basis; and (5) requests for off-peak hour slots.
The FAA uses this information to allocate and withdraw takeoff and
landing slots at DCA, and to confirm transfers of slots made among the
operators, thus maintaining an accurate slot base at DCA. Information
also is reported by persons conducting unscheduled operations at DCA.
Those respondents must obtain a reservation from the FAA prior to
operating at the airport.
    The revision to the existing information collection approval would
include information from carriers holding a slot at JFK or LGA and by
unscheduled operators at LGA as required under FAA Orders establishing
limits on operations at those airports.\1\ Information would also be
provided by carriers operating scheduled flights at EWR, LAX, ORD, and
SFO where the FAA has established a voluntary process to review flight
schedules consistent with international, industry practices. At JFK,
carriers must notify the FAA of: (1) Requests for confirmation of
transferred slots; (2) requests for seasonal allocation of historic and
additional available slots consistent with Worldwide Slot Guidelines;
(3) usage of slots on a seasonal basis; (4) the return of slots; and
(5) changes to allocated slots. At LGA, carriers must notify the FAA
of: (1) Requests for confirmation of transferred slots; (2) compulsory
or voluntary slot returns; (3) requests to be included in a lottery for
available slots; and (4) usage of slots on a bi-monthly basis. At LGA,
unscheduled operators must request and obtain a reservation from the
FAA prior to conducting an operation. At EWR, LAX, ORD and SFO,
carriers are asked to notify the FAA of their intended operating
schedules during peak hours for each summer and winter scheduling
season and when there are significant schedule changes.
---------------------------------------------------------------------------

    \1\ Operating Limitations at John F. Kennedy International
Airport, 73 FR 3510 (Jan. 18, 2008), as most recently amended 81 FR
40167 (Jun. 21, 2016). Operating Limitations at New York LaGuardia
Airport, 71 FR 77854 (Dec. 27, 2006), as most recently amended 81 FR
33126 (May 25, 2016).
---------------------------------------------------------------------------

    Respondents: 140 carriers at various airports; unknown number of
operators with unscheduled flights at DCA and LGA.
    Frequency: Schedule requests are collected semiannually and
additionally as needed due to carrier changes; slot usage information
is reported four to six times per year depending on the airport; other
slot and schedule data are collected as needed.
    Estimated Average Burden per Response: 6 minutes per slot transfer;
6 minutes per slot return; 6 minutes per schedule update; 6 minutes per
request for inclusion in a lottery; 2 minutes per unscheduled slot
request; 1.5 hours per schedule submission; and 1 hour per slot usage
report.
    Estimated Total Annual Burden: 5,367 hours.

    Issued in Washington, DC, on May 23, 2018.
Jonathan Haupt,
Acting Manager, IT Strategy and Investment Portfolio Branch, ASP-120.
[FR Doc. 2018-11569 Filed 5-29-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Rules and Regulations]
[Pages 27125-27127]
[FR Doc No: 2017-12235]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0621; FRL-9962-57-Region 9]

Revisions to the California State Implementation Plan; Imperial
County Air Pollution Control District; Stationary Sources Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is finalizing action
on revisions to the Imperial County Air Pollution Control District
(ICAPCD or District) portion of the California State Implementation
Plan (SIP). We are finalizing full approval of two rules. Both rules
update and revise the District's New Source Review (NSR) permitting
program for new and modified sources of air pollution. We are also
finalizing a technical correction to a previous action that will remove
one rule from the SIP.

DATES: This rule will be effective on July 14, 2017.

ADDRESSES: The EPA has established a docket for this action under
Docket No. EPA-R09-OAR-2015-0621. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although it may be
listed in the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through http://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Thien Khoi Nguyen, EPA Region IX,
(415) 947-4120<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, the terms ``we,''
``us,'' and ``our'' refer to EPA.

Table of Contents

Definitions
I. Proposed Action
II. EPA Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The word or initials CAA mean or refer to the Clean Air Act,
unless the context indicates otherwise.
    (ii) The initials CARB mean or refer to the California Air
Resources Board.
    (iii) The initials CFR mean or refer to Code of Federal
Regulations.
    (iv) The initials or words EPA, we, us or our mean or refer to the
United States Environmental Protection Agency.
    (v) The word or initials ICAPCD or District mean or refer to the
Imperial County Air Pollution Control District, the agency with
jurisdiction over stationary sources within Imperial County.
    (vi) The initials NSR mean or refer to New Source Review.
    (vii) The initials SIP mean or refer to State Implementation Plan.

I. Proposed Action

    On December 19, 2016, the EPA proposed a full approval of two rules
and a limited approval and limited disapproval (LA/LD) of one rule (as
noted in Table 1) submitted by CARB for incorporation into the ICAPCD
portion of the California SIP. 81 FR 91895. Table 1 also lists the
dates the rules were adopted by ICAPCD and submitted by CARB, which is
the governor's designee for California SIP submittals.

                                          Table 1--Submitted NSR Rules
----------------------------------------------------------------------------------------------------------------
                                                                Adopted/
              Rule #                      Rule title             revised        Submitted      Proposed action
----------------------------------------------------------------------------------------------------------------
204..............................  Applications............         9/14/99        05/26/00  Full Approval.
206..............................  Processing of                   10/22/13        02/10/14  Full Approval.
                                    Applications.
207..............................  New and Modified                10/22/13         1/21/14  LA/LD.
                                    Stationary Source
                                    Review.
----------------------------------------------------------------------------------------------------------------

    The EPA proposed to approve Rules 204 and 206 as part of ICAPCD's
NSR permitting program because we determined that these rules meet the
statutory requirements for SIP revisions as specified in sections
110(l) and 193 of the CAA. Rules 204 and 206, together with Rule 207,
satisfy the substantive statutory and regulatory requirements for a NSR
permit program as contained in CAA section 110(a)(2)(c) and 40 CFR
51.160-51.164. We also proposed a limited approval and limited
disapproval of Rule 207. We do not intend to finalize that proposed
action. Instead, we intend to take a new rulemaking action to
conditionally approve Rule 207 into the Imperial County portion of the
California SIP. We also proposed to remove Rule 103 (Exemptions) as a
technical correction to a previous action approving Rule 202
(Exemptions) into the ICAPCD portion of the California SIP, which
superseded and replaced Rule 103. 76 FR 26615 (May 9, 2011).

II. EPA Action

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received no comments. Therefore, as authorized
by CAA section 110(k)(3) and 301(a), the EPA is finalizing approval of
Rule 204 (Applications) and Rule 206 (Processing of Applications) into
the ICAPCD portion of the California SIP. This action will incorporate
the submitted rules into the SIP.
    In this action we are also finalizing a technical correction to our
previous action approving Rule 202 into the ICAPCD portion of the
California SIP.\1\ In that action, our approval of Rule 202 into the
SIP superseded and replaced Rule 103, which EPA had previously approved
on May 31, 1972 (37 FR 10832), but we failed to include the necessary
regulatory text to effect this change. This final action includes the
necessary regulatory text to remove Rule 103 from the California SIP.
We did not seek public comment on this technical correction because
public participation requirements were satisfied as part of our action
approving Rule 202 into the SIP.
    In the proposed action, we also proposed a limited approval and
limited disapproval of Rule 207 (New and Modified Stationary Source
Review). We do not intend to finalize that proposed action. Instead, we
intend to take a new rulemaking action to conditionally approve Rule
207 into the Imperial County portion of the California SIP.
---------------------------------------------------------------------------

    \1\ 76 FR 26615 (May 9, 2011).
---------------------------------------------------------------------------

III. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
ICAPCD rules listed in Table 1 of this document. The EPA has made, and
will continue to make, these rules generally available electronically
through www.regulations.gov and in hard copy at the U.S. Environmental
Protection Agency, Region IX (Air -3), 75 Hawthorne Street, San
Francisco, CA 94105-3901.

IV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA because this action does not impose additional requirements
beyond those imposed by state law.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities beyond those
imposed by state law.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action does not impose additional requirements
beyond those imposed by state law. Accordingly, no additional costs to
State, local, or tribal governments, or to the private sector, will
result from this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175, because the SIP is not approved to apply on any
Indian reservation land or in any other area where the EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction, and will not
impose substantial direct costs on tribal governments or preempt tribal
law. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not impose additional
requirements beyond those imposed by state law.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA directs the EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. The EPA
believes that this action is not subject to the requirements of section
12(d) of the NTTAA because application of those requirements would be
inconsistent with the CAA.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Population

    The EPA lacks the discretionary authority to address environmental
justice in this rulemaking.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

L. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by August 14, 2017. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, New source review, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Volatile
organic compounds.

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

    Dated: May 19, 2017.
Alexis Strauss,
Acting Regional Administrator, Region IX.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (b)(14)(ii),
(c)(279)(i)(A)(15) and (16), and (c)(442)(i)(A)(4) to read as follows:

Sec.  52.220  Identification of plan-in part.

* * * * *
    (b) * * *
    (14) * * *
    (ii) Previously approved on May 31, 1972 in paragraph (b)(14) of
this section and now deleted with replacement in paragraph
(c)(351)(i)(A)(4) of this section, Rule 103.
* * * * *
    (c) * * *
    (279) * * *
    (i) * * *
    (A) * * *
    (15) Rule 204, ``Applications,'' revised on September 14, 1999.
    (16) Previously approved on January 3, 2007 in paragraph
(c)(279)(i)(A)(14) of this section and now deleted with replacement in
paragraph (c)(442)(i)(A)(4) of this section, Rule 206.
* * * * *
    (442) * * *
    (i) * * *
    (A) * * *
    (4) Rule 206, ``Processing of Applications,'' revised on October
22, 2013.
* * * * *
[FR Doc. 2017-12235 Filed 6-13-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 141 (Monday, July 23, 2012)]
[Proposed Rules]
[Page 43018]
[FR Doc No: 2012-17871]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1926

[Docket No. OSHA-2011-0184]
RIN 1218-AC65

Updating OSHA Construction Standards Based on National Consensus
Standards; Head Protection; Correction of Notice of Proposed Rulemaking

AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.

ACTION: Notice of proposed rulemaking; correction.

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

SUMMARY: OSHA is correcting a notice of proposed rulemaking (NPRM) with
regard to the construction industry head protection standards to
eliminate confusion resulting from a drafting error. OSHA published the
NPRM on June 22, 2012 (77 FR 37617). OSHA also is publishing a
correction to the direct final rule that it published the same day in
the Federal Register (77 FR 37587).

FOR FURTHER INFORMATION CONTACT:
    General information and press inquiries: Contact Frank Meilinger,
OSHA Office of Communications, Room N-3647, U.S. Department of Labor,
200 Constitution Ave. NW., Washington, DC 20210; telephone: (202) 693-
1999; email<EMAIL_ADDRESS>    Technical inquiries: Contact Kenneth Stevanus, Directorate of
Standards and Guidance, Room N-3609, OSHA, U.S. Department of Labor,
200 Constitution Ave. NW., Washington, DC 20210; telephone: (202) 693-
2260; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: OSHA is making the following correction in
FR document number 2012-15031, appearing on page 37630 in the Federal
Register of Friday, June 22, 2012:

Sec.  1926.100  [Corrected]

    On page 37630, correct instruction number 16, to read as follows:
    16. Amend Sec.  1926.100 as follows:
    a. Remove paragraph (c).
    b. Revise paragraph (b) to read as follows:

1926.100  Head protection.

* * * * *
    (b) Criteria for head protection. (1) The employer must provide
each employee with head protection that meets the specifications
contained in any of the following consensus standards:
    (i) American National Standards Institute (ANSI) Z89.1-2009,
``American National Standard for Industrial Head Protection,''
incorporated by reference in Sec.  1926.6;
    (ii) American National Standards Institute (ANSI) Z89.1-2003,
``American National Standard for Industrial Head Protection,''
incorporated by reference in Sec.  1926.6; or
    (iii) American National Standards Institute (ANSI) Z89.1-1997,
``American National Standard for Personnel Protection--Protective
Headwear for Industrial Workers--Requirements,'' incorporated by
reference in Sec.  1926.6.
    (2) The employer must ensure that the head protection provided for
each employee exposed to high-voltage electric shock and burns also
meets the specifications contained in Section 9.7 (``Electrical
Insulation'') of any of the consensus standards identified in paragraph
(b)(1) of this section.
    (3) OSHA will deem any head protection device that the employer
demonstrates is at least as effective as a head protection device
constructed in accordance with one of the consensus standards
identified in paragraph (b)(1) of this section to be in compliance with
the requirements of this section.

    Signed at Washington, DC on July 17, 2012.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2012-17871 Filed 7-20-12; 8:45 am]
BILLING CODE P


README FILE
 TCE.<IP_ADDRESS> Directory
 README.docx  -  This file
 TCE.evaluation.<IP_ADDRESS>.pop.model  -  MCSim model file for MCMC simulations
 TCE.risk<IP_ADDRESS>.3.pop.model  -  MCSim model file for dose metric predictions
 mcsimstd.TCE.evaluation.<IP_ADDRESS>.pop.exe  -  Windows executable for MCMC simulations
 mcsimstd.TCE.risk<IP_ADDRESS>.3.pop.exe  -  Windows executable for dose metric predictions
 ModelResults.R  -  R script for generating plots of model results
 funcdefs.R  -  R script with functions used in ModelResults.R script
 OutputVar-labels-plot.csv  -  CSV file with labels for model outputs
Mouse subdirectory
 Mouse.addldata.Kim.datalabs.txt  -  data labels for validation data from Kim et al.
 Mouse.check.addldata.Kim-rev.5.pdf  -  PDF of comparison of model with Kim et al.
 Mouse.check.x.5.pdf  -  PDF of comparison of distribution of model predictions with calibration data
 Mouse.checkone.5.pdf  -  PDF of comparison of single random prediction with calibration data
 Mouse.checkone.two.5.pdf  -  PDF of comparison of distribution of model predictions, and population mean predictions, with calibration data
 Mouse.datalabs.txt  -  data labels for calibration data
 TCE.<IP_ADDRESS>.Mouse.pop.1.5.in  -  MCMC in file (chain 1)
 TCE.<IP_ADDRESS>.Mouse.pop.1.5.out  -  MCMC out file (chain 1)
 TCE.<IP_ADDRESS>.Mouse.pop.2.5.in  -  MCMC in file (chain 2)
 TCE.<IP_ADDRESS>.Mouse.pop.2.5.out  -  MCMC out file (chain 2)
 TCE.<IP_ADDRESS>.Mouse.pop.3.5.in  -  MCMC in file (chain 3)
 TCE.<IP_ADDRESS>.Mouse.pop.3.5.out   -  MCMC out file (chain 3)
 TCE.<IP_ADDRESS>.Mouse.pop.4.5.in  -  MCMC in file (chain 4)
 TCE.<IP_ADDRESS>.Mouse.pop.4.5.out   -  MCMC out file (chain 4)
 TCE.<IP_ADDRESS>.Mouse.pop.check.x.5.in  -  in file to generate distribution of predictions
 TCE.<IP_ADDRESS>.Mouse.pop.check.x.5.out  -  out file with distribution of predictions
 TCE.<IP_ADDRESS>.Mouse.pop.checkone.1.5.in  -  in file to generate single random prediction
 TCE.<IP_ADDRESS>.Mouse.pop.checkone.1.5.out  -  out file with single random prediction
 TCE.<IP_ADDRESS>.Mouse.pop.mean.check.x.5.in  -  in file to generate population mean predictions
 TCE.<IP_ADDRESS>.Mouse.pop.mean.check.x.5.out  -  out file with population mean predictions
 TCE.<IP_ADDRESS>.Mouse.pop.mean.x.5.out  -  parameter file for population mean predictions
 TCE.1.2.3.Mouse.pop.1.4.restart.out  -  restart file (initial conditions) for MCMC chain 1
 TCE.1.2.3.Mouse.pop.2.4.restart.out  -  restart file (initial conditions) for MCMC chain 2
 TCE.1.2.3.Mouse.pop.3.4.restart.out  -  restart file (initial conditions) for MCMC chain 3
 TCE.1.2.3.Mouse.pop.4.4.restart.out  -  restart file (initial conditions) for MCMC chain 4
Mouse/Parms2 subdirectory:
 TCE.<IP_ADDRESS>.Mouse.pop.genparms.setpoints.parmsonly.x.5.out  -  out file for posterior parameter distributions
 TCE.<IP_ADDRESS>.Mouse.pop.genparms.setpoints.x.5.in  -  in file for parameter distributions
 TCE.<IP_ADDRESS>.Mouse.pop.posterior.x.5.dat  -  parameter file for parameter posteriors
 TCE.<IP_ADDRESS>.Mouse.pop.prior.x.5.dat  -  output file with prior summaries
 TCE.<IP_ADDRESS>.Mouse.pop.priors.genparms.setpoints.parmsonly.x.5.out  -  out file for prior parameter distributions
 TCE.<IP_ADDRESS>.Mouse.pop.priors.genparms.setpoints.x.5.in  -  in file for prior parameter distributions
 TCE.<IP_ADDRESS>.Mouse.pop.priors.mc.x.5.in  -  in file for generating prior scaling parameter
 TCE.<IP_ADDRESS>.Mouse.pop.priors.mc.x.5.out  -  out file of prior scaling parameters
 TCE.<IP_ADDRESS>.Mouse.pop.priors.rep500.x.5.out  -  out file with 500 replicates of scaling parameters

Mouse/PopPred subdirectory
 Mouse.posteriors.x.5.pdf  -  PDF of posterior population distributions
 TCE.<IP_ADDRESS>.Mouse.pop.genpop.setpoints.x.5.in  -  in file for posterior population distributions
 TCE.<IP_ADDRESS>.Mouse.pop.genpop.setpoints.x.5.out  -  out file for posterior population distributions
 TCE.<IP_ADDRESS>.Mouse.pop.poppred.addldata.Kim.x.5.out  -  out file for validation data
 TCE.<IP_ADDRESS>.Mouse.pop.poppred.x.5.in  -  in file for population predictions
 TCE.<IP_ADDRESS>.Mouse.pop.poppred.x.5.out  -  out file for population predictions
 TCE.<IP_ADDRESS>.Mouse.pop.x.5.out  -  parameter file with posterior parameters

Rat.seqpriors.test4 subdirectory
 Rat.seqpriors.test4.addldata.Liu.datalabs.txt  -  data labels for validation data from Liu et al.
 Rat.seqpriors.test4.addldata.datalabs.txt  -  data labels for validation data
 Rat.seqpriors.test4.check.addldata.10.pdf  -  PDF of comparison of model with Liu et al.
 Rat.seqpriors.test4.check.addldata.Liu.10.pdf  -  PDF of comparison of model with validation data
 Rat.seqpriors.test4.check.x.10.pdf  -  PDF of comparison of distribution of model predictions with calibration data
 Rat.seqpriors.test4.checkone.10.pdf  -  PDF of comparison of single random prediction with calibration data
 Rat.seqpriors.test4.checkone.two.10.pdf  -  PDF of comparison of distribution of model predictions, and population mean predictions, with calibration data
 Rat.seqpriors.test4.datalabs.txt  -  data labels for calibration data
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.1.10.in  -  MCMC in file (chain 1)
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.1.10.out  -  MCMC out file (chain 1)
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.2.10.in  -  MCMC in file (chain 2)
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.2.10.out  -  MCMC out file (chain 2)
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.3.10.in  -  MCMC in file (chain 3)
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.3.10.out   -  MCMC out file (chain 3)
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.4.10.in  -  MCMC in file (chain 4)
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.4.10.out   -  MCMC out file (chain 4)
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.check.x.10.in  -  in file to generate distribution of predictions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.check.x.10.out  -  out file with distribution of predictions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.checkone.1.10.in  -  in file to generate single random prediction
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.checkone.1.10.out  -  out file with single random prediction
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.mean.check.x.10.in  -  in file to generate population mean predictions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.mean.check.x.10.out  -  out file with population mean predictions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.mean.x.10.out   -  parameter file for population mean predictions

Rat.seqpriors.test4/Parms2 subdirectory
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.genparms.setpoints.parmsonly.x.10.out  -  out file for posterior parameter distributions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.genparms.setpoints.x.10.in  -  in file for parameter distributions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.posterior.x.10.dat  -  parameter file for parameter posteriors
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.prior.x.10.dat  -  output file with prior summaries
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.priors.genparms.setpoints.parmsonly.x.10.out  -  out file for prior parameter distributions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.priors.genparms.setpoints.x.10.in  -  in file for prior parameter distributions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.priors.mc.x.10.in   -  in file for generating prior scaling parameter
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.priors.mc.x.10.out  -  out file of prior scaling parameters
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.priors.rep500.x.10.out  -  out file with 500 replicates of scaling parameters

Rat.seqpriors.test4/PopPred subdirectory
 Rat.seqpriors.test4.posteriors.x.10.pdf  -  PDF of posterior population distributions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.genpop.setpoints.x.10.in   -  in file for posterior population distributions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.genpop.setpoints.x.10.out   -  out file for posterior population distributions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.poppred.addldata.Liu.x.10.out  -  out file for validation data
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.poppred.addldata.x.10.in  -  in file for validation data
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.poppred.addldata.x.10.out  -  out file for validation data
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.poppred.x.10.in   -  in file for population predictions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.poppred.x.10.out   -  out file for population predictions
 TCE.<IP_ADDRESS>.Rat.seqpriors.test4.pop.x.10.out  -  parameter file with posterior parameters

Human.seqpriors.v1 subdirectory
 Human.seqpriors.v1.addldata.datalabs.txt  -  data labels for validation data
 Human.seqpriors.v1.check.addldata.23.pdf  -  PDF of comparison of model with validation data
 Human.seqpriors.v1.check.x.23b.pdf  -  PDF of comparison of distribution of model predictions with calibration data
 Human.seqpriors.v1.checkone.9.pdf  -  PDF of comparison of single random prediction with calibration data
 Human.seqpriors.v1.checkone.two.23b.pdf  -  PDF of comparison of distribution of model predictions, and population mean predictions, with calibration data
 Human.seqpriors.v1.datalabs.txt
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.1.10.in  -  MCMC in file (chain 1)
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.1.23.out  -  MCMC out file (chain 1)
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.2.10.in  -  MCMC in file (chain 2)
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.2.23.out  -  MCMC out file (chain 2)
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.3.10.in  -  MCMC in file (chain 3)
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.3.23.out   -  MCMC out file (chain 3)
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.4.10.in  -  MCMC in file (chain 4)
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.4.123.out   -  MCMC out file (chain 4)
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.check.x.23.in  -  data labels for calibration data
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.check.x.23.out   -  in file to generate distribution of predictions
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.check.x.23b.out   -  out file with distribution of predictions
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.checkone.1.9.in  -  in file to generate single random prediction
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.checkone.1.9.out   -  out file with single random prediction
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.mean.check.x.23.in   -  in file to generate population mean predictions
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.mean.check.x.23.out  -  out file with population mean predictions
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.mean.x.23.out  -  parameter file for population mean predictions

Human.seqpriors.v1/Parms2 subdirectory
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.genparms.setpoints.parmsonly.x.23.out  -  out file for posterior parameter distributions
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.genparms.setpoints.x.23.in  -  in file for parameter distributions
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.posterior.x.23.dat  -  parameter file for parameter posteriors
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.prior.x.23.dat   -  output file with prior summaries
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.priors.genparms.setpoints.parmsonly.x.23.out out file for prior parameter distributions
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.priors.genparms.setpoints.x.23.in  -  in file for prior parameter distributions
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.priors.mc.x.23.in  -  in file for generating prior scaling parameter
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.priors.mc.x.23.out  -  out file of prior scaling parameters
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.priors.rep500.x.23.out   -  out file with 500 replicates of scaling parameters

ATSDR-comparison subdirectory
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.noncancer.3.1d.inter.setpoints.x.23.in  -  in file for 1 day intermittent exposure
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.noncancer.3.1d.inter.setpoints.x.23.out  -  out file for 1 day intermittent exposure
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.noncancer.3.3wks.inter.setpoints.x.23.in  -  in file for 3 week intermittent exposure
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.noncancer.3.3wks.inter.setpoints.x.23.out  -  out file for 3 week intermittent exposure
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.noncancer.3.40wks.inter.setpoints.x.23.in  -  in file for 40 week intermittent exposure
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.noncancer.3.40wks.inter.setpoints.x.23.out  -  out file for 40 week intermittent exposure
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.noncancer.3.52wks.setpoints.x.23.in  -  in file for 52 week continuous exposure
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.noncancer.3.52wks.setpoints.x.23.out  -  out file for 52 week continuous exposure
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.noncancer.3.setpoints.x.23.in  -  in file for 100 week continuous exposure
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.noncancer.3.setpoints.x.23.out  -  in file for 100 week continuous exposure (This file used to calculated summary statistics tabulated in HumanDoseMetricsSummary-forNCEA.xlsx)
 TCE.<IP_ADDRESS>.Human.seqpriors.v1.pop.x.23.out  -  posterior parameter file
 TCE.risk<IP_ADDRESS>.3.pop.model  -  Model file for dose metrics
 mcsimstd.TCE.risk<IP_ADDRESS>.3.pop.static.exe  -  Windows executable file for model