[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Rules and Regulations]
[Pages 78917-78923]
[FR Doc No: 2016-27206]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0722; FRL-9953-71]

Prothioconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
prothioconazole in or on cotton gin byproducts and the cottonseed
subgroup 20C. Bayer CropScience requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 10, 2016. Objections and
requests for hearings must be received on or before January 9, 2017,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0722, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0722 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
January 9, 2017. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0722, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of November 25, 2015 (80 FR 73695) (FRL-
9937-14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F8381) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive,
Research Triangle Park, NC. The petition requested that 40 CFR 180.626
be amended by establishing tolerances for residues of the fungicide,
prothioconazole in or on cotton, undelinted seed (crop subgroup 20C) at
0.4 parts per million (ppm) and to amend the existing tolerance in or
on sugar beet, roots from 0.25 ppm to 0.3 ppm. That document referenced
a summary of the petition prepared by Bayer CropScience, the
registrant, which is available in the docket, http://www.regulations.gov. A comment was received in response to the notice
of filing. EPA's response to this comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
determined that the sugar beet root tolerance does not need to be
increased to 0.30 ppm. The reason for this determination is explained
in Unit IV.D.
    In the Federal Register of August 29, 2016 (81 FR 59165) (FRL-9950-
22), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F8381) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive,
Research Triangle Park, NC. The petition requested that 40 CFR 180.626
be amended by establishing tolerances for residues of the fungicide,
prothioconazole in or on cotton, gin byproducts at 4.0 ppm. That
document referenced a summary of the petition prepared by Bayer
CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for prothioconazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with prothioconazole
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Prothioconazole degrades into different compounds in different
matrices, with prothioconazole-desthio (desthio) being the metabolite
and degradate of concern. The target organs of prothioconazole and the
desthio metabolite include the liver, kidney, bladder, thyroid and
blood. In addition, the chronic studies showed body weight and food
consumption changes, and toxicity to the lymphatic and gastrointestinal
systems.

    Developmental studies show that prothioconazole and its metabolites
produce adverse effects including malformations in the conceptus at
levels equal to or below maternally toxic levels, particularly those
studies conducted using prothioconazole-desthio. Reproduction studies
in the rat with prothioconazole and prothioconazole-desthio suggest
that these chemicals do not adversely affect reproductive parameters or
the offspring except at parentally toxic dose levels. Acute and
subchronic neurotoxicity studies, as well as a developmental
neurotoxicity study, raise no neurotoxicity concerns. Immunotoxicity
data show that prothioconazole is not an immunotoxicant.
    The available carcinogenicity and/or chronic studies in the mouse
and rat, using both prothioconazole and prothioconazole-desthio, show
no increase in tumor incidence and EPA has concluded that
prothioconazole and its metabolites are not carcinogenic.
    Specific information on the studies received and the nature of the
adverse effects caused by prothioconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Prothioconazole: Human
Health Risk Assessment for a Proposed Tolerance on Cottonseed Subgroup
20C, a Tolerance Amendment on Sugar Beet Roots, and New Use Requests
for Cotton, Sugar Beet, Soybean, and Dried Shelled Pea and Bean'' on
page 32 in docket ID number EPA-HQ-OPP-2015-0722.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for prothioconazole used
for human risk assessment is shown in Table 1. of this unit.

     Table 1--Summary of Toxicological Doses and Endpoints for Prothioconazole for Use in Human Health Risk
                                                   Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety    RfD, PAD, LOC for  risk  Study and toxicological
                                               factors                 assessment                effects
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Acute dietary (Females 13-50 years of  NOAEL = 2.0 mg/kg/day    Acute RfD = 0.02 mg/kg/  Developmental Toxicity
 age).                                  UFA = 10x.               day.                     study in rabbits.
                                       UFH = 10x..............  aPAD = 0.02 mg/kg/day..  LOAEL = 10 mg/kg/day
                                       FQPA SF = 1x...........                            based on structural
                                                                                alterations including
                                                                                malformed vertebral
                                                                                body and ribs,
                                                                                arthrogryposis, and
                                                                                multiple
                                                                                malformations.
                                      --------------------------------------------------------------------------
Acute dietary (General population         No observed effects could be attributable to a single dose exposure.
 including infants and children).          Therefore, a dose and endpoint were not selected for this exposure
                                                                        scenario.
                                      --------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 1.1 mg/kg/day    Chronic RfD = 0.01 mg/   Chronic/Carcinogenicity
                                        UFA = 10x.               kg/day.                  study in rats.
                                       UFH = 10x..............  cPAD = 0.01 mg/kg/day..  LOAEL = 8.0 mg/kg/day
                                       FQPA SF = 1x...........                            based on liver
                                                                                histopathology
                                                                                [hepatocellular
                                                                                vacuolation and fatty
                                                                                change (single cell,
                                                                                centrilobular, and
                                                                                periportal)].
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....       Not likely to be carcinogenic to humans based on the absence of
                                           significant tumor increases in two adequate rodent carcinogenicity
                                                                        studies.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day.
MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c
  = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to prothioconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing prothioconazole
tolerances in 40 CFR 180.626. EPA assessed dietary exposures from
prothioconazole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for prothioconazole for females 13-50
years old. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture's National

Health and Nutrition Examination Survey, What We Eat in America,
(NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed
tolerance-level values for the proposed new uses and existing
tolerances on berries and cucurbit vegetables, average field trial
residues for all other commodities and empirical processing factors.
With respect to sugar beet, the registrant-proposed tolerance value of
0.30 was incorporated in the dietary assessment, however, the Agency is
leaving the tolerance at 0.25 ppm. The use of this higher residue level
in the dietary assessment will serve as an overestimate of actual
exposure to residues in/on sugar beet roots. 100 percent crop treated
(PCT) was assumed for all proposed and established commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level
values for the proposed new uses and existing tolerances on berries and
cucurbit vegetables, average field trial residues for all other
commodities and empirical processing factors. With respect to sugar
beet, the registrant-proposed tolerance value of 0.30 was incorporated
in the dietary assessment; however, the Agency is leaving the existing
tolerance at 0.25 ppm. The use of this higher residue level in the
dietary assessment will serve as an overestimate of actual exposure to
residues in/on sugar beet roots. 100 PCT was assumed for all proposed
and established commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that prothioconazole does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk was not conducted.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for prothioconazole in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of prothioconazole. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW) models, the estimated drinking water concentrations (EDWCs) of
prothioconazole for acute exposures are estimated to be 109 parts per
billion (ppb) for surface water and 132 ppb for ground water and for
chronic exposures are estimated to be 97 ppb for surface water and 128
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 132 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 128 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). Prothioconazole is
not registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Prothioconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events in mammals (EPA, 2002). In the case of
conazoles, however, a variable pattern of toxicological responses is
found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce
thyroid tumors in rats. Some induce developmental, reproductive, and
neurological effects in rodents. Furthermore, the conazoles produce a
diverse range of biochemical events including altered cholesterol
levels, stress responses, and altered DNA methylation. It is not
clearly understood whether these biochemical events are directly
connected to their toxicological outcomes. Thus, there is currently no
evidence to indicate that prothioconazole shares a common mechanism of
toxicity with any other conazole pesticide, and EPA is not following a
cumulative risk approach for this tolerance action. For information
regarding EPA's procedures for cumulating effects from substances found
to have a common mechanism of toxicity, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
    Prothioconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazolylalanine and triazolylacetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including prothioconazole, EPA
conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazolylalanine, and triazolylacetic acid resulting from the
use of all current and pending uses of any triazole-derived fungicide.
The risk assessment is a highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). The Agency retained a 3X
for the LOAEL to NOAEL safety factor when the reproduction study was
used. In addition, the Agency retained a 10X for the lack of studies
including a developmental neurotoxicity (DNT) study. The assessment
includes evaluations of risks for various subgroups, including those
comprised of infants and children. The Agency's complete risk
assessment is found in the propiconazole reregistration docket at
http://www.regulations.gov, Docket

Identification (ID) Number EPA-HQ-OPP-2005-0497.
    An updated dietary exposure and risk analysis for the common
triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA),
triazolylacetic acid (TAA), and triazolylpyruvic acid (TP) was
completed on April 9, 2015, in association with registration requests
for several triazole fungicides, propiconazole, difenoconazole, and
flutriafol. That analysis concluded that risk estimates were below the
Agency's level of concern for all population groups. The proposed new
uses of prothioconazole are not expected to significantly increase the
dietary exposure estimates for free triazole or conjugated triazoles.
This assessment may be found on http://www.regulations.gov by searching
for the following title and docket number: ``Common Triazole
Metabolites: Updated Aggregate Human Health Risk Assessment to Address
The New Section 3 Registrations For Use of Propiconazole on Tea, Dill,
Mustard Greens, Radish, and Watercress; Use of Difenoconazole on Globe
Artichoke, Ginseng and Greenhouse Grown Cucumbers and Conversion of the
Established Foliar Uses/Tolerances for Stone Fruit and Tree Nut Crop
Groups to Fruit, Stone, Group 12-12 and the Nut, Tree, Group 14-12.;
and Use of Flutriafol on Hops'' (located in docket ID number EPA-HQ-
OPP-2014-0788).

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There are adequate data in
the prothioconazole/prothioconazole-desthio toxicological database to
characterize the potential for pre-natal or post-natal risks to infants
and children: Two-generation reproduction studies in rats;
developmental studies in rats and rabbits; and a DNT study in rats. The
effects seen in these studies suggest that offspring are more
susceptible: Offspring adverse effects were seen at levels below the
LOAELs for maternal toxicity and, in general, were of comparable or
greater severity compared to the effects observed in adults. However,
clear NOAELs are established for offspring and fetal effects. The most
sensitive effects (malformed vertebral body and ribs, anthrogryposis,
and other multiple malformations) seen in the fetuses of a rabbit
developmental study are established as the toxicity endpoints with a
POD of 2 mg/kg/day. This POD is protective all fetal and offspring
effects seen in the developmental toxicity and developmental
neurotoxicity studies.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for prothioconazole is complete.
    ii. No neurotoxicity was seen in acute and subchronic neurotoxicity
studies and other studies with prothioconazole or prothioconazole-
desthio. Although offspring neurotoxicity was found, characterized by
peripheral nerve lesions in the developmental neurotoxicity study on
prothioconazole-desthio, the increase was seen only in the highest dose
group at 105 mg/kg/day. Further, a NOAEL was established for the
peripheral nerve lesions and all of the PODs used in the risk
assessment were protective of this finding.
    iii. Evidence of quantitative and qualitative susceptibility of
offspring were observed in the developmental studies. However, basing
the POD on the offspring in the most sensitive of these studies
provides the needed protection of offspring.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and EPA-recommended tolerance values for all of the proposed
uses and existing tolerances on berries and cucurbit vegetables,
average field trial residue levels for the remaining uses, and
empirical processing factors. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to prothioconazole in drinking water. These assessments will
not underestimate the exposure and risks posed by prothioconazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to prothioconazole will occupy 40% of the aPAD for females 13-49 years
old, the only population group of concern.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
prothioconazole from food and water will utilize 77% of the cPAD for
all infants less than 1 year old, the population group receiving the
greatest exposure. There are no residential uses for prothioconazole.
    3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Both short- and intermediate-term adverse effects were identified;
however, prothioconazole is not registered for any use patterns that
would result in either short- or intermediate-term residential
exposure. Short- and intermediate-term risk is assessed based on short-
and intermediate-term residential exposure plus chronic dietary
exposure. Because there is no short- or intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess short-term risk), no further assessment of
short- or intermediate-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short- and intermediate-
term risk for prothioconazole.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, prothioconazole is not expected to pose a cancer risk to
humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children

from aggregate exposure to prothioconazole residues, including
aggregate exposure to residues of the common metabolites of
prothioconazole and other related conazole fungicides.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate liquid chromatography with tandem mass spectrometry (LC/
MS/MS) methods are available for enforcing prothioconazole tolerances
in crop and livestock commodities.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are no Codex MRLs established for prothioconazole in or on
cotton.
    The Codex has established MRLs for prothioconazole in or on sugar
beet roots at 0.3 ppm. This MRL is different than the tolerances
established for prothioconazole in the United States. The U.S. is
keeping the tolerance previously established in or on beet, sugar,
roots at 0.25 ppm based on an evaluation of the residue data and in
order to remain harmonized with Canada. The registrant, Bayer
CropScience, has indicated their wish is to harmonize with Canada.
Bayer cited data from the International Trade Macro Analysis Branch
within the Economic Indicators Division of the U.S. Census Bureau,
indicating that Canada and Mexico are the largest trade partners for
U.S. exports of processed and refined sugar beets. Therefore, it would
be more beneficial for U.S. growers if the U.S. tolerance is harmonized
with Canada instead of Codex.

C. Response to Comments

    A comment was submitted by the Center for Food Safety and was
primarily concerned about EPA's consideration of the impacts of
prothioconazole on the environment, pollinators, and endangered
species. This comment is not relevant to the Agency's evaluation of
safety of the prothioconazole tolerances under section 408 of the
FFDCA, which requires the Agency to evaluate the potential harms to
human health, not effects on the environment.

D. Revisions to Petitioned-For Tolerances

    Based on the review of the sugar beet residue data, EPA has
determined that increasing the existing tolerance in or on beet, sugar,
roots from 0.25 ppm to 0.30 ppm is not necessary, and therefore the
sugar beet root tolerance will remain at 0.25 ppm. The registrant has
indicated that they support this conclusion.

V. Conclusion

    Therefore, tolerances are established for residues of
prothioconazole in or on cotton gin byproducts at 4.0 ppm and the
cottonseed subgroup 20C at 0.4 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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 action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: November 2, 2016.
Michael Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.626, add alphabetically the commodities ``Cotton, gin
byproducts'' and ``Cottonseed subgroup 20C'' to the table in paragraph
(a)(1) to read as follows:

Sec.  180.626  Prothioconazole; tolerances for residues.

    (a) * * *
    (1) * * *

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

                                * * * * *
Cotton, gin byproducts..................................             4.0
Cottonseed subgroup 20C.................................             0.4

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

* * * * *
[FR Doc. 2016-27206 Filed 11-9-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 65 (Thursday, April 6, 2017)]
[Rules and Regulations]
[Pages 16736-16740]
[FR Doc No: 2017-06884]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2009-0234; FRL-9958-30-OAR]
RIN 2060-AS75

Mercury and Air Toxics Standards (MATS) Electronic Reporting
Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is amending the
electronic reporting requirements for the National Emission Standards
for Hazardous Air Pollutants: Coal- and Oil-Fired Electric Utility
Steam Generating Units (also known as the Mercury and Air Toxics
Standards (MATS)) to allow for the temporary submission, through June
30, 2018, of certain reports using the portable document file (PDF)
format and to correct inadvertent errors. With this action owners or
operators of Electric Utility Steam Generating Units (EGUs) will be
able to continue to use temporarily a single electronic reporting
system for MATS data submissions, to rely on correct language for
mercury (Hg) relative accuracy test audit (RATA) requirements, and to
rely on the correct acceptance criterion for ongoing quality assurance
test requirements for Hg RATAs. This extension will allow the EPA the
necessary time to develop, implement, and test the code necessary so
that all MATS reports required to be submitted electronically can be
submitted using the Emissions Collection and Monitoring Plan System
(ECMPS) Client Tool.

DATES: This final rule is effective on April 6, 2017.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2009-0234. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although listed in
the index, some information is not publicly available, e.g.,
confidential business information 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 electronically through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Mr. Barrett Parker, Sector Policies
and Programs Division, Office of Air Quality Planning and Standards
(D243-05), Environmental Protection Agency, Research Triangle Park, NC
27711; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Organization of the document.
    The information in this preamble is organized as follows:

I. Why is the EPA issuing this final rule?
II. General Information
    A. Does this final rule apply to me?
    B. What is the scope of these amendments?
    C. What is the purpose of these amendments?
    D. What action is the agency taking?
    E. What are the incremental costs and benefits of this action?
    F. Judicial Review and Administrative Reconsideration
    G. What is the effective date of this rule?
III. Statutory and Executive Orders Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act (CRA)

I. Why is the EPA issuing this final rule?

    As explained in the MATS Completion of Electronic Reporting
Requirements proposal (see 81 FR 67062, September 29, 2016), the EPA
proposed to amend the MATS electronic

reporting requirements by revising and streamlining the electronic data
reporting requirements for owners and operators of EGUs that use
performance stack testing or continuous monitoring to demonstrate
compliance. Such an approach, based on the ECMPS Client Tool only, was
requested by industry stakeholders and would increase data transparency
by providing the public and regulatory authorities with enhanced access
to MATS data. In addition to proposing a single electronic reporting
submission system, the proposal identified associated regulatory text
changes, proposed to correct inadvertent errors in appendix A of 40 CFR
part 63, subpart UUUUU carried over from the final Technical
Corrections rule (see 81 FR 20712, April 6, 2016), proposed to revise
appendix B to facilitate use of hydrogen chloride continuous emission
monitoring systems (CEMS) operating in accordance with newly-
promulgated Performance Specification 18, proposed to add appendices C
and D to identify reporting requirements for users of particulate
matter (PM) CEMS and PM continuous parameter monitoring systems (CPMS),
identified in appendix E the electronic data elements already required
to be reported, and proposed to require quarterly--rather than
semiannual--compliance reports. Based on requests for additional time
to prepare comments, the proposal's comment period was extended for an
additional 15 days (see 81 FR 75365, October 31, 2016).
    Commenters generally supported the proposal. They also provided
many ideas regarding merging the electronic submission systems. Many
commenters suggested extending the interim regulatory deadline (April
16, 2017) that allows submission of non-ECMPS ready reports in PDF
format. We originally established this deadline to allow temporary
submission in PDF format while we make and implement the changes to the
ECMPS Client Tool necessary for a single electronic reporting system.
After considering the comments received and factoring in the time
necessary to provide complete responses to all significant comments, we
have decided to take final action on just a portion of the proposal.
Specifically, we have decided to extend the interim submission
regulatory deadline and make two corrections to appendix A. We may take
final action on the other proposed changes in a separate rulemaking,
which would be conducted later.
    No comments were received in opposition to extending the interim
submission regulatory deadline from April 16, 2017, to December 31,
2017. However, a few commenters suggested replacing a date certain
deadline with a fixed time period after promulgation, in order to
provide a smooth transition to the single electronic reporting system.
We may choose to adapt such an approach at a future date, but for now,
we believe a deadline of June 30, 2018, will provide certainty to
industry stakeholders, third party programmers, regulatory authorities,
the public, and the EPA. We believe that date will give us adequate
time to complete our review, respond to comments, and promulgate a
separate final rule addressing the remaining issues in the September
29, 2016 proposal. In addition, we believe other important items, such
as guidance and programming, will be well on their way to completion by
that date. Moreover, that date coincides with the end of a reporting
period.
    No comments were received in opposition to making the two
corrections to appendix A. As many owners and operators of EGUs
currently rely on Hg CEMS for compliance purposes, we believe it
important to make these corrections at this time.

II. General Information

A. Does this final rule apply to me?

    Categories and entities potentially affected by this action
include:

------------------------------------------------------------------------
                                  NAICS code    Examples of potentially
            Category                  \1\          regulated entities
------------------------------------------------------------------------
Industry.......................        221112  Fossil fuel-fired
                                                electric utility steam
                                                generating units.
Federal government.............    \2\ 221122  Fossil fuel-fired
                                                electric utility steam
                                                generating units owned
                                                by the Federal
                                                government.
State/local/Tribal government..    \2\ 221122  Fossil fuel-fired
                                                electric utility steam
                                                generating units owned
                                                by municipalities.
                                       921150  Fossil fuel-fired
                                                electric utility steam
                                                generating units in
                                                Indian country.
------------------------------------------------------------------------
\1\ North American Industry Classification System.
\2\ Federal, State, or local government-owned and operated
  establishments are classified according to the activity in which they
  are engaged.

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that the EPA is now
aware could potentially be regulated by this action. Other types of
entities not listed in the table could also be regulated. To determine
whether an entity is regulated by this action, please examine the
applicability criteria found in 40 CFR 63.9981 of the rule. For
questions regarding the applicability of this action to a particular
entity, consult either the air permitting authority for the entity or
your EPA Regional representative as listed in 40 CFR 63.13.

B. What is the scope of these amendments?

    This rule extends the interim PDF reporting process described in 40
CFR 63.10031(f) from April 16, 2017, to June 30, 2018. In addition,
this rule amends the text in 40 CFR 63.10021(e)(9) and in 40 CFR
63.10031(f) related to this extension. Finally, this action clarifies
instructions in section <IP_ADDRESS>.2 of appendix A with regard to
calculating Hg RATA results and conditions described in Table A-2 of
appendix A for demonstrating compliance with ongoing Hg measurement
instrument quality assurance requirements.

C. What is the purpose of these amendments?

    As mentioned earlier, the purpose of these amendments is to extend
through June 30, 2018, the temporary submission of certain reports
using the PDF format and to correct inadvertent errors in appendix A.
Without this action, owners or operators of EGUs would have to use
separate electronic reporting systems for MATS submissions, rely on
incorrect language for Hg RATA requirements, or rely on an unclear
acceptance criterion for ongoing quality assurance test requirements
for Hg RATAs. This extension is intended to allow us the necessary time
to develop, implement, and test the code necessary so that all MATS
electronic reports can be submitted using the ECMPS Client Tool. The
corrections to appendix A are intended to ensure that owners and
operators of EGUs have clear and correct instructions with regard to
calculating Hg RATA results and demonstrating compliance with ongoing
Hg measurement instrument quality assurance requirements.

D. What action is the agency taking?

    This action amends parts of 40 CFR part 63, subpart UUUUU. The
amendments are discussed in the paragraphs below.
1. Revisions to Tune-Up Reporting Requirements in 40 CFR 63.10021
    The tune-up reporting section of MATS, i.e., 40 CFR 63.10021(e)(9),
is amended to extend through June 30, 2018, the temporary submission of
certain tune-up reports using the PDF format. Starting on and after
July 1, 2018, the tune-up reports must be submitted as described in 40
CFR 63.10031(f).
2. Revisions to Reporting Requirements in 40 CFR 63.10031
    The deadline for temporary submission of certain reports in PDF
format using the ECMPS Client Tool, as described in 40 CFR
63.10031(f)(6), is amended to extend through June 30, 2018. On and
after July 1, 2018, the performance test reports, CEMS performance
evaluation test reports, quarterly reports for PM or hazardous air
pollutant metals CEMS or PM CPMS, compliance reports, and notification
of compliance status reports, as described in 40 CFR 63.10031(f),
(f)(1), (f)(2), and (f)(4), must be submitted to the EPA's Compliance
and Emissions Data Reporting Interface that is accessed through EPA's
Central Data Exchange (www.epa.gov/cdx).
3. Revisions to Appendix A
    This rule makes two corrections to the Hg monitoring provisions of
appendix A.
    First, in the MATS Technical Corrections rule package, which was
published on April 6, 2016 (see 81 FR 20172, April 6, 2016), there is
language in section <IP_ADDRESS>.2 of appendix A describing an alternate way
to calculate and interpret RATA results when Hg emissions are less than
50 percent of the standard. This language was inadvertently carried
over from the MATS Technical Corrections proposed rule and conflicts
with the alternate relative accuracy (RA) specification in Table A-1 of
the final rule. That language is deleted.
    Second, the MATS Technical Corrections final rule contains an
inconsistency of the Hg RATA acceptance criteria in Table A-2 versus
that in Table A-1. This final rule amends Table A-2 to make it
consistent with Table A-1 so that the 20-percent RA specification in
Table A-1 may be applied at any reference method concentration level
and the alternate specification applies only when the average reference
method value (RMavg) is < 2.5 micrograms per standard cubic
meter ([micro]g/scm).

E. What are the incremental costs and benefits of this action?

    This action extends the deadline for temporary submission of
certain reports using the PDF format and corrects inadvertent errors in
appendix A. It does not promulgate substantive changes to the February
2012 final MATS rule (77 FR 9304). Therefore, there are no incremental
costs and benefits associated with this final action. The costs and
benefits associated with MATS are discussed in detail in the February
16, 2012, final MATS rule.

F. Judicial Review and Administrative Reconsideration

    Under CAA section 307(b)(1), judicial review of this final action
is available only by filing a petition for review in the United States
Court of Appeals for the District of Columbia Circuit by June 5, 2017.
Under CAA section 307(b)(2), the requirements established by these
final rules may not be challenged separately in any civil or criminal
proceedings brought by the EPA to enforce the requirements.
    Section 307(d)(7)(B) of the CAA further provides that ``[o]nly an
objection to a rule or procedure which was raised with reasonable
specificity during the period for public comment (including any public
hearing) may be raised during judicial review.'' This section also
provides a mechanism for the EPA to reconsider the rule ``[i]f the
person raising an objection can demonstrate to the Administrator that
it was impracticable to raise such objection within [the period for
public comment] or if the grounds for such objection arose after the
period for public comment (but within the time specified for judicial
review) and if such objection is of central relevance to the outcome of
the rule.'' Any person seeking to make such a demonstration should
submit a Petition for Reconsideration to the Office of the
Administrator, U.S. EPA, Room 3000, EPA WJC South Building, 1200
Pennsylvania Ave. NW., Washington, DC 20460, with a copy to both the
person(s) listed in the preceding FOR FURTHER INFORMATION CONTACT
section, and the Associate General Counsel for the Air and Radiation
Law Office, Office of General Counsel (Mail Code 2344A), U.S. EPA, 1200
Pennsylvania Ave., NW., Washington, DC 20460.

G. What is the effective date of this rule?

    We are making these amendments effective upon publication of this
action. This timeframe for the effective date is appropriate because
the EPA is issuing this final rule under section 307(d) of the CAA.
Section 553(d) of the Administrative Procedure Act (APA), 5 U.S.C.
Chapter 5, generally provides that rules may not take effect earlier
than 30 days after they are published in the Federal Register. CAA
section 307(d)(1) clarifies that: ``The provisions of section 553
through 557 * * * of Title 5 shall not, except as expressly provided in
this section, apply to actions to which this subsection applies.''
Thus, section 553(d) of the APA does not apply to this rule. Rather the
effective date of this rule is governed by CAA Section 112(d)(10),
which provides that ``Emission standards or other regulations
promulgated under this subsection shall be effective upon
promulgation.'' Accordingly, we are making this rule effective upon
publication in the Federal Register. Additionally, making this rule
effective upon publication in the Federal Register will allow the CFR
to be updated more quickly, which will provide greater notice of these
amendments to EGU owners or operators affected by this final action.

III. Statutory and Executive Orders Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www.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 Office of Management and Budget (OMB) for
review.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control number 2060-0567. The agency believes this action does not
impose an information collection burden because it does not change the
information collection requirements.

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. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may

certify that a rule will not have a significant economic impact on a
substantial number of small entities if the rule relieves regulatory
burden, has no net burden or otherwise has a positive economic effect
on the small entities subject to the rule. These amendments create no
new requirements or burdens, and no costs to small entities would be
associated with these amendments. We have therefore concluded that this
action will have no net regulatory burden for all directly regulated
small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local, or tribal governments or the
private sector.

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: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175. The final amendments would impose no
requirements on tribal governments. 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 concern an environmental
health risk or safety risk.

H. Executive Order 13211: Actions Concerning Regulations 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

    This rulemaking does not involve technical standards.

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

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority,
low-income, and/or indigenous peoples, as specified in Executive Order
12898 (59 FR 7629, February 16, 1994). This action does not affect the
level of protection provided to human health or the environment. The
final amendments are either alternate, temporary reporting instructions
or corrections which will neither increase nor decrease environmental
protection.

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).

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: March 29, 2017.
E. Scott Pruitt,
Administrator.
    For the reasons set forth in the preamble, EPA amends 40 CFR part
63 as follows:

PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES

0
1. The authority citation for part 63 continues to read as follows:

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

Subpart UUUUU--National Emission Standards for Hazardous Air
Pollutants: Coal- and Oil-Fired Electric Utility Steam Generating
Units

0
2. Section 63.10021 is amended by revising the first and second
sentences of paragraph (e)(9) to read as follows:

Sec.  63.10021   How do I demonstrate continuous compliance with the
emission limitations, operating limits, and work practice standards?

* * * * *
    (e) * * *
    (9) Report the dates of the initial and subsequent tune-ups in hard
copy, as specified in Sec.  63.10031(f)(5), through June 30, 2018. On
or after July 1, 2018, report the date of all tune-ups electronically,
in accordance with Sec.  63.10031(f). * * *
* * * * *

0
3. Section 63.10031 is amended by revising the first sentence of
paragraphs (f) introductory text, (f)(1), (2), and (4), and (f)(6)
introductory text.
    The revised text reads as follows:

Sec.  63.10031  What reports must I submit and when?

* * * * *
    (f) On or after July 1, 2018, within 60 days after the date of
completing each performance test, you must submit the performance test
reports required by this subpart to the EPA's WebFIRE database by using
the Compliance and Emissions Data Reporting Interface (CEDRI) that is
accessed through the EPA's Central Data Exchange (CDX) (www.epa.gov/cdx). * * *
    (1) On or after July 1, 2018, within 60 days after the date of
completing each CEMS (SO2, PM, HCl, HF, and Hg) performance
evaluation test, as defined in Sec.  63.2 and required by this subpart,
you must submit the relative accuracy test audit (RATA) data (or, for
PM CEMS, RCA and RRA data) required by this subpart to EPA's WebFIRE
database by using CEDRI that is accessed through EPA's CDX
(www.epa.gov/cdx). * * *
    (2) On or after July 1, 2018, for a PM CEMS, PM CPMS, or approved
alternative monitoring using a HAP metals CEMS, within 60 days after
the reporting periods ending on March 31st, June 30th, September 30th,
and December 31st, you must submit quarterly reports to the EPA's
WebFIRE database by using the CEDRI that is accessed through the EPA's
CDX (www.epa.gov/cdx). * * *
* * * * *
    (4) On or after July 1, 2018, submit the compliance reports
required under paragraphs (c) and (d) of this section and the
notification of compliance status required under Sec.  63.10030(e) to
the EPA's WebFIRE database by using the CEDRI that is accessed through
the EPA's CDX (www.epa.gov/cdx). * * *
* * * * *
    (6) Prior to July 1, 2018, all reports subject to electronic
submittal in paragraphs (f) introductory text, (f)(1),

(2), and (4) shall be submitted to the EPA at the frequency specified
in those paragraphs in electronic portable document format (PDF) using
the ECMPS Client Tool. * * *
* * * * *

0
4. Appendix A to Subpart UUUUU is amended by:
0
a. Revising section <IP_ADDRESS>.2; and
0
b. Revising the entry ``RATA'' in Table A-2.
    The revised text reads as follows:

Appendix A to Subpart UUUUU of Part 63--Hg Monitoring Provisions

* * * * *
    4. Certification and Recertification Requirements
* * * * *
    <IP_ADDRESS>.2 Calculation of RATA Results. Calculate the relative
accuracy (RA) of the monitoring system, on a [micro]g/scm basis, as
described in section 12 of Performance Specification (PS) 2 in
appendix B to part 60 of this chapter (see Equations 2--3 through 2-
6 of PS 2). For purposes of calculating the relative accuracy,
ensure that the reference method and monitoring system data are on a
consistent basis, either wet or dry. The CEMS must either meet the
main performance specification or the alternative specification in
Table A-1 of this appendix.
* * * * *
    5. Ongoing Quality Assurance (QA) and Data Validation
* * * * *

                              Table A-2--On-Going QA Test Requirements for Hg CEMS
----------------------------------------------------------------------------------------------------------------
                                                               With these qualifications
    Perform this type of QA test         At this frequency          and exceptions          Acceptance criteria
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
RATA................................  Annual \4\............   Test deadline may  <=20.0% RA or
                                                               be extended for ``non-QA   [bond]RM - C [bond] +
                                                               operating quarters,'' up    [bond]CC[bond] <= 0.5
                                                               to a maximum of 8           [micro]g/scm, if
                                                               quarters from the quarter   RMavg < 2.5 [micro]g/
                                                               of the previous test.       scm.
                                                               720 operating
                                                               hour grace period
                                                               available.
----------------------------------------------------------------------------------------------------------------
* * * * *
\4\ ``Annual'' means once every four QA operating quarters.
* * * * *

* * * * *

[FR Doc. 2017-06884 Filed 4-5-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37257-37258]
[FR Doc No: 2015-16032]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2014-0062; FRL-9920-89-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Pesticide Active Ingredient
Production (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NESHAP for Pesticide Active
Ingredient Production (40 CFR part 63, subpart MMM) (Renewal)'' (EPA
ICR No. 1807.08, OMB Control No. 2060-0370) to the Office of Management
and Budget (OMB) for review and approval in accordance with the
Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed
extension of the ICR, which is currently approved through June 30,
2015. Public comments were previously requested via the Federal
Register (79 FR 30117) on May 27, 2014 during a 60-day comment period.
This notice allows for an additional 30 days for public comments. A
fuller description of the ICR is given below, including its estimated
burden and cost to the public. An Agency may not conduct or sponsor and
a person is not required to respond to a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before July 30, 2015.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2014-0062, to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless

the comment includes profanity, threats, information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Respondents are owners and operators of pesticides active
ingredient production operations. Respondents must submit one-time
reports of initial compliance and either semiannual reports or
quarterly reports of compliance. Recordkeeping of parameters related to
process and air pollution control technologies is required. The reports
and records will be used to demonstrate compliance with the standards.
    Form Numbers: None.
    Respondents/affected entities: Owners and operators of pesticides
active ingredient production operations.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart MMM).
    Estimated number of respondents: 18 (total).
    Frequency of response: Initially, quarterly, and semiannually.
    Total estimated burden: 12,000 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $1,416,000 (per year), includes $236,000
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is an adjustment decrease in the
number of responses because this ICR removes leak detection and repair
(LDAR) reports. The regulation requires subject sources to include LDAR
information in periodic (i.e. semiannual or quarterly) reports. LDAR is
not separately reported to EPA; therefore, no additional responses are
associated with this activity.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-16032 Filed 6-29-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Notices]
[Pages 48833-48834]
[FR Doc No: 2011-20058]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-519-000]

El Paso Natural Gas Company; Notice of Application

    Take notice that on July 20, 2011, El Paso Natural Gas Company (El
Paso), P.O. Box 1087, Colorado Springs, Colorado 80944, filed in Docket
No. CP11-519-000, a request for authority, pursuant to 18 CFR part 157
and section 7(b) of the Natural Gas Act, to abandon, in place, El
Paso's El Paso-Douglas Line (Line No. 1004) in Dona Ana and Luna
Counties, New Mexico. Specifically, El Paso proposes to abandon
approximately 34.2 miles of 12.75-inch diameter pipeline Line No. 1004
and the related appurtenances between the Afton and Florida Compressor
Stations. El Paso states that the abandonment of Line No. 1004 will
have no impact on capacity and service, all as more fully set forth in
the application, which is on file with the Commission and open to
public inspection. The filing may also be viewed on the web at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this application should be directed to
Susan C. Stires, Director, Regulatory Affairs Department, Colorado
Interstate Gas Company, P.O. Box 1087, Colorado Springs, CO 80944,
telephone no.<PHONE_NUMBER>, facsimile no.<PHONE_NUMBER>, and e-mail:
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made in the proceeding with the Commission
and must mail a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in

determining the appropriate action to be taken, but the filing of a
comment alone will not serve to make the filer a party to the
proceeding. The Commission's rules require that persons filing comments
in opposition to the project provide copies of their protests only to
the party or parties directly involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: August 23, 2011.

    Dated: August 2, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-20058 Filed 8-8-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Notices]
[Pages 43209-43210]
[FR Doc No: 2010-18210]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a closed meeting on Wednesday, July
21, 2010 at 12:30 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the closed meeting.
Certain staff members who have an interest in the matter also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c), (5), (7), 9(B) and (10) and 17 CFR 200.402(a),
(5), (7), 9(ii) and (10), permit consideration of the scheduled matter
at the closed meeting.
    Commissioner Casey, as duty officer, voted to consider the item
listed for the Closed Meeting in closed session, and determined that no
earlier notice thereof was possible.
    The subject matter of the closed meeting scheduled for Wednesday,
July 21, 2010 will be:

Institution and settlement of injunctive actions.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:

The Office of the Secretary at<PHONE_NUMBER>.

    Dated: July 21, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-18210 Filed 7-21-10; 4:15 pm]
BILLING CODE 8010-01-P