[Federal Register Volume 86, Number 64 (Tuesday, April 6, 2021)]
[Notices]
[Page 17831]
[FR Doc No: 2021-06984]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL21-61-000]

George Berka v. Governor Andrew M. Cuomo, North American Electric
Reliability Corporation, Northeast Power Coordinating Council, New York
Independent System Operator, New York Public Service Commission,
Entergy Corporation, Holtec Decommissioning International; Notice of
Complaint

    Take notice that on March 24, 2021, pursuant to Rules 206, 212, and
215(a)(1) of the Federal Energy Regulatory Commission's (Commission)
Rules of Practice and Procedure (18 CFR 385.206, .212, & .215(a)(1)),
George Berka filed a formal complaint against Governor Andrew M. Cuomo,
North American Electric Reliability Corporation, Northeast Power
Coordinating Council, New York Independent System Operator, New York
Public Service Commission, Entergy Corporation, and Holtec
Decommissioning International (Respondents) alleging that the
Respondents plan to discontinue operation of Units 2 and 3 of the
Indian Point Nuclear Power Plant. Mr. Berka requests that the
Commission order continued operation until at least the year 2035.
    The Complainant certifies that copies of the complaint were served
on the Respondents.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondents'
answer and all interventions, or protests must be filed on or before
the comment date. The Respondents' answer, motions to intervene, and
protests must be served on the Complainants.
    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 may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on April 13, 2021.

    Dated: March 30, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-06984 Filed 4-5-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 19, 2007 (Volume 72, Number 138)]
[Notices]
[Page 39613]
[DOCID:fr19jy07-35]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL07-71-000]

NSTAR Electric Company; Notice of Institution of Proceeding and
Refund Effective Date

July 12, 2007.
    On July 9, 2007, the Commission issued an order that instituted a
proceeding in the above-referenced docket, pursuant to section 206 of
the Federal Power Act (FPA) 16 U.S.C. 824e, concerning the justness and
reasonableness of NSTAR Electric Company's proposed rate decrease.
    The refund effective date in the above-docketed proceeding,
established pursuant to section 206(b) of the FPA, will be the date of
publication of this notice in the Federal Register.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-13970 Filed 7-18-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Rules and Regulations]
[Pages 60932-60937]
[FR Doc No: 2019-24267]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0094; FRL-10001-27]

Tebuconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
tebuconazole in or on multiple commodities which are identified and
discussed later in this document. In addition, this regulation removes
certain established tebuconazole tolerances that are superseded by new
tolerances established in this final rule. Interregional Research
Project Number 4 (IR-4) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 12, 2019. Objections and
requests for hearings must be received on or before January 13, 2020,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0094, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0094 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 13, 2020. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0094, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 24, 2018 (83 FR 34968) (FRL-9980-
31), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E8648) by IR-4 Project Headquarters, Rutgers, The State University of
New Jersey, 500 College Road, East, Suite 201 W, Princeton, NJ 08540.
The petition requested that 40 CFR 180.474 be amended by establishing
tolerances for residues of the fungicide tebuconazole, including its
metabolites and degradates, determined by measuring only alpha-[2-(4-
chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-
ethanol, in or on Brassica, leafy greens, subgroup 4-16B, except
watercress at 2.5 parts per million (ppm); Cottonseed, subgroup 20C at
2.0 ppm; Fruit, pome, group 11-10 at 1.0 ppm; Fruit, small, vine
climbing, except fuzzy kiwifruit, subgroup 13-07F at 6.0 ppm; Fruit,
stone, group 12-12, except cherry at 1.0 ppm; Nut, tree, group 14-12 at
0.05 ppm; Sunflower, subgroup 20B at 0.1 ppm; Tropical and subtropical,
small fruit, inedible peel, subgroup 24A at 1.6 ppm; and Watercress at
9.0 ppm.
    Upon establishment of the above tolerances, the petitioner
requested that the following established tolerances be removed from 40
CFR 180.474: Brassica, leafy greens, subgroup 5B at 2.5 ppm; Cotton,
undelinted seed at 2.0 ppm; Fruit, pome, group 11 at 0.05 ppm; Fruit,
stone, group 12, except cherry at 1.0 ppm; Grape at 5.0 ppm; Lychee at
1.6 ppm; Nut, tree, group 14 at 0.05 ppm; Peach at 1.0 ppm; Pistachio
at 0.05 ppm; Plum, pre- and post-harvest at 1.0 ppm; and Sunflower,
seed at 0.05 ppm, as they are superseded by this regulation. That
document referenced a summary of the petition prepared by Makhteshim
Agan of North America (``ADAMA''), the registrant, which is available
in the docket, http://www.regulations.gov. There were no comments
received in response to the notice of filing.

    Based upon review of the data supporting the petition, EPA is
establishing tolerances that vary slightly from what was requested. The
reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity database 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.
    A summary of the toxicological profile for tebuconazole can be
found in the final rule published in the Federal Register on November
15, 2013 (78 FR 68741) (FRL-9392-1). Specific information on the
studies received and the nature of the adverse effects caused by
tebuconazole as well as the no-observed-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies can be found at http://www.regulations.gov in document,
``Tebuconazole: Human Health Aggregate Risk Assessment for
Establishment of Registrations and a Permanent Tolerance for Residues
in/on Watercress, Add Greenhouse Tomato to Label and Crop Group
Conversions/Expansions to Brassica Leafy Greens, Subgroup 4-16B, Except
Watercress; Cottonseed, Subgroup 20C; Pome Fruit, Group 11-10, Stone
Fruit, Group 12-12, Except Cherry; Small Vine Climbing Fruit, Except
Fuzzy Kiwifruit, Subgroup 13-07F; Tropical and Subtropical Small Fruit,
Inedible Peel, Subgroup 24A, Tree Nut, Group 14-12 and Sunflower,
Subgroup 20B'' at pages 45-48 in docket ID number EPA-HQ-OPP-2018-0094.

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 tebuconazole used for
human risk assessment is discussed in Unit III of the final rule
published in the Federal Register of November 15, 2013 (78 FR 68741)
(FRL-9392-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tebuconazole, EPA considered exposure under the petitioned-
for tolerances as well as all existing tebuconazole tolerances in 40
CFR 180.474. EPA assessed dietary exposures from tebuconazole 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 tebuconazole. In estimating acute dietary exposure, EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID) Version 3.16. This software uses food
consumption information from the United States Department of
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in
food, a partially refined acute probabilistic dietary exposure
assessment was conducted for all existing and proposed uses of
tebuconazole. For the acute assessment, anticipated residues for
grapes, grape juice, tree nuts, pome fruits, fruiting vegetables,
cucurbit vegetables, banana, plantain, asparagus, hops, bulb onion and
green onion subgroups, lychee, Brassica leafy green subgroup, mango,
livestock commodities, and stone fruit were used. Data for peach,
grapes, and oranges were derived using the latest USDA Pesticide Data
Program (PDP) monitoring data. Anticipated residues for all other
registered and proposed food commodities were based on field trial data
or feeding studies. Anticipated residues for all current uses were
further refined using percent crop treated (PCT) data where available.
Percentage of imported orange juice and oranges were also provided.
DEEM 2018 default and some empirical processing factors were assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used DEEM-FCID, Version 3.16, which uses the food
consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue
levels in food, estimates from PDP data (mean residue levels) and
average residues from field trials were used. Mean residue levels from
PDP were used for apple, arugula, asparagus, snap bean, black bean,
broad been, cowpea, great northern bean, kidney bean, lima bean, mung
bean, navy bean, pinto bean, cantaloupe, cherry, chickpea, chives,
fresh leaves, crabapple, garden and upland cress, cucumber, garden beet
roots, goji berry, grape, raisin, grape juice, guar seed,

honeydew melon, leeks, lentil seed, loquat, milk, nectarine, mustard
greens, oats, oat bran, green onion, oranges, orange juice, orange
peel, peach, peach baby food, canned peach, peanut, peanut butter,
pear, bell peppers, non-bell peppers, plum, rape greens, shallot bulb,
shallot fresh leaves, soybean, summer squash, winter squash, tomatillo,
tomato, tree tomato, watermelon, wheat grain and flour. In some cases,
data were translated from representative commodities of their crop
group.
    iii. Cancer. Based on the data cited in Unit III.A. of the
previously referenced document, Federal Register, November 15, 2013 (78
FR 68741) (FRL-9392-1), EPA has concluded that a nonlinear RfD approach
is appropriate for assessing cancer risk to tebuconazole. The chronic
risk assessment or RfD approach is considered to be protective of any
cancer effects; therefore, a separate quantitative cancer risk
assessment is not required.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    For the acute dietary risk assessment, the Agency used the maximum
PCT estimates for the following crops that are currently registered for
tebuconazole: almonds 15%; apples 2.5%; apricots 20%; asparagus 30%;
barley 2.5%; beans, green 2.5%; cantaloupes 10%; cherries 45%; corn
2.5%; cotton 2.5%; cucumbers 2.5%; dry beans/peas 5%; garlic 95%;
grapes 40%; nectarines 30%; oats 2.5%; onions 5%; peaches 25%; peanuts
65%; pears 5%; pecans 25%; pistachios 15%; plums/prunes 5%; pumpkins
10%; soybeans 2.5%; squash 5%; sweet corn 5%; walnut 5%, and wheat 20%.
    In the chronic dietary risk assessment, EPA used the average
percent crop treated estimates for the following crops that are
currently registered for tebuconazole: almonds 5%; apples 2.5%;
apricots 10%; asparagus 5%; barley 2.5%; beans, green 1%; cantaloupes
2.5%; cherries 25%; corn 1%; cotton 1%; cucumbers 1%; dry beans/peas
2.5%; garlic 65%; grapes 25%; nectarines 20%; oats 2.5%; onions 5%;
peaches 10%; peanuts 45%; pears 5%; pecans 10%; pistachios 5%; plums/
prunes 2.5%; pumpkins 2.5%; soybeans 1%; squash 2.5%; sweet corn 2.5%;
walnuts 2.5%; watermelons 15%; and wheat 15%.
    The following estimated percent import estimates for the import
oranges were used: For acute risk, orange 16%; and orange juice 58%;
and for chronic risk: orange 12%; orange juice 46%. For all other crops
not listed above, EPA assumed 100 PCT.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figures for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which tebuconazole may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for tebuconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of tebuconazole. 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 Screening Concentration in Ground Water (SCI-
GROW) models, the EDWCs of tebuconazole for acute exposures are
estimated to be 87.7 parts per billion (ppb) for surface water and 1.56
ppb for ground water. For chronic exposures for non-cancer assessments
are estimated to be 68.8 ppb for surface water and 1.56 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, a

distribution of 30-year daily surface water concentration was estimated
for the EDWCs of tebuconazole. For chronic dietary risk assessment, the
water concentration of value 68.8 ppb was used to assess the
contribution to drinking water. The Agency is relying on the drinking
water residues used in the dietary risk assessment previously provided,
``Drinking water and ecological risk for new use of tebuconazole/
fluoxastrobin combination for turf and ornamental use'', which can be
found at http://regulations.gov, under docket ID number EPA-HQ-OPP-
2013-0653-0007.
    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).
    Tebuconazole is currently registered for the following uses that
could result in residential exposures: Golf course turf, flower
gardens, trees and ornamentals, and pressure treated wood that were
assessed previously. No new residential uses of tebuconazole are
associated with this petition.
    EPA assessed residential exposure using the following assumptions:
For residential handlers, exposure is expected to be short-term.
Intermediate-term exposures are not likely because of the intermittent
nature of applications by homeowners. For post-application exposures,
the Agency assessed residential dermal and incidental oral post-
application exposure for adults and children golfing, working in
gardens, and performing physical activities on pressure-treated wood
after application of tebuconazole as scenarios where homeowners may
receive exposure to tebuconazole residues. Post-application exposure is
expected to be short-term in duration. For assessment of both handler
and post-application exposures, dermal and inhalation exposures were
combined since the same endpoint and point of departure (POD) are used
for both routes of exposure.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticidescience-and-assessing-pesticide-risks/standard-operating-proceduresresidential-pesticide.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to tebuconazole and any other
substances. Previously, HED concluded that there are no conclusive data
that the conazoles share a common mechanism of toxicity; however, EPA
is in the process of re-examining these data as part of registration
review. Although the conazole fungicides (triazoles) produce 1,2,4
triazole and its acid-conjugated metabolites (triazolylalanine and
triazolylacetic acid), 1,2,4 triazole and its acid-conjugated
metabolites do not contribute to the toxicity of the parent conazole
fungicides (triazoles). Tebuconazole does not appear to produce any
other toxic metabolite produced by other substances. For the purposes
of this action, therefore, EPA has not assumed that tebuconazole has 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
    The Agency has assessed the aggregate risks from the 1,2,4 triazole
and its acid-conjugated metabolites (triazolylalanine and
triazolylacetic acid) separately. The most recent assessment is dated
August 8, 2018, titled, ``Common Triazole Metabolites: Updated
Aggregate Human Health Risk Assessment to Address New Section 3
Registrations for Use of Prothioconazole and Tebuconazole.'' EPA
concluded that the current uses of tebuconazole do not significantly
change the results of that aggregate human health risk assessment.
Therefore, the aggregate exposure to the triazole metabolites remains
below EPA's level of concern.

D. Safety Factor for Infants and Children

    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.
    EPA has determined that reliable data support reducing the FQPA SF
to 3X, as that factor will be safe for infants and children. Detailed
discussions of the Agency's FQPA SF rationale can be found in the final
rule published in the Federal Register on May 16, 2018 (83 FR 22995)
(FRL9976-62), which also established tolerances for tebuconazole in/on
various food commodities, and in the risk assessment document for the
subject rulemaking found in docket ID number EPA-HQ-OPP-2018-0094 at
http://www.regulations.gov, ``Tebuconazole: Human Health Aggregate Risk
Assessment for Establishment of Registrations and a Permanent Tolerance
for Residues in/on Watercress, Add Greenhouse Tomato to Label and Crop
Group Conversions/Expansions to Brassica Leafy Greens, Subgroup 4-16B,
Except Watercress; Cottonseed, Subgroup 20C; Pome Fruit, Group 11-10,
Stone Fruit, Group 12-12, Except Cherry; Small Vine Climbing Fruit,
Except Fuzzy Kiwifruit, Subgroup 13-07F; Tropical and Subtropical Small
Fruit, Inedible Peel, Subgroup 24A, Tree Nut, Group 14-12 and
Sunflower, Subgroup 20B''.

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. The acute aggregate risk assessment takes into
account acute exposure estimates from 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
tebuconazole will occupy 94% of the aPAD for children 1 to 2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. There are no residential use patterns that result
in chronic residential exposure to residues of tebuconazole. Dietary
(food and water) route of exposure alone is

relevant to chronic aggregate risk. The combined chronic dietary
exposure from food and drinking water is estimated to be 5.7% of the
cPAD for the general U.S. population and 14% of the cPAD for all
infants, the population subgroup with the highest estimated chronic
dietary exposure to tebuconazole.
    3. Short- and Intermediate-term risks. Short- and intermediate-term
aggregate exposure take into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). For short-term
aggregate risk assessments, a deterministic approach was used in which
point estimates of exposure from each source are added together; and
each of the point estimates used are in turn deterministic. Dietary
exposure estimates use point estimates for food and drinking water
residues (anticipated residues based on PDP data, field trial data,
tolerance level residues, and PCT) and the residential scenarios also
employ point estimates (central to high-end values considered
protective). Exposures are assumed to occur over the same time frame,
and no use frequency data are considered. There is the potential for
residential exposure to co-occur with background dietary exposure over
the short-term (1-30 days), whereas co-occurring intermediate exposures
(1-6 months) are less likely. However, since the POD employed for both
durations are the same, the aggregate assessments address both exposure
durations.
    EPA reassessed residential post-application exposure from
registered golf course use and the impact on aggregate risk using the
TTR study. Using data from the TTR study for non-irrigated and
irrigated plots, EPA calculated residential post-application exposure
and risk estimates for population subgroups including; adults, youths
11 to <16 years old, and children 6 to <11 years old. For these age
groups, the activity of golfing results in MOEs for irrigated turf
ranging from 2,100 in youth 6 to less than 11 years old to 2,500 in
adults. For non-irrigated turf, for the same population subgroups, MOEs
range from 560 to 660. Under the golfing scenario for both irrigated
and non-irrigated turf and for each population subgroup, resulting MOEs
were all greater than the level of concern (LOC) of 300. Residential
exposures and risk estimates from gardens, trees, ornamentals, and
pressure treated wood were unchanged from the most recent previous
assessments which reported MOEs greater than EPA's LOC of 300.
    4. Aggregate cancer risk for U.S. population. Based on the Agency's
determination that the chronic risk assessment will be protective of
any cancer effects, a separate quantitative cancer risk assessment was
not conducted. Because there is no chronic risk of concern from
aggregate exposure to tebuconazole, the Agency concludes that aggregate
exposure to tebuconazole will not result in cancer risks of concern.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to tebuconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate gas chromatographic methods with nitrogen/phosphorus
detection (GC/NPD) methods are available for enforcing tolerances in
plant and livestock commodities. These methods have undergone an
independent laboratory validation and a petition method validation
(PMV). The methods are available in the residue analytical method index
on EPA's website and may also 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. Tolerances established
in this rulemaking are harmonized with established Codex MRLs, except
for apricot. The Codex MRL for apricot is 2 ppm. EPA is establishing a
tolerance of 1 ppm for plum subgroup 12-12C, which harmonizes with the
Codex MRLs for eight commodities in that subgroup other than apricot.

C. Revisions to Petitioned-For Tolerances

    Instead of establishing a tolerance for Fruit, stone, group 12-12,
except cherry, EPA is establishing tolerances for the subgroups in
group 12-12 to harmonize with the relevant Codex MRLs. The Codex MRLs
for nectarine and peach are 2 ppm, so EPA is establishing a U.S.
tolerance for peach, subgroup 12-12B at 2 ppm. EPA is establishing a
U.S. tolerance of 1 ppm for plum, subgroup 12-12C, which is harmonized
with the Codex MRLs for eight commodities in that subgroup. In
addition, several tolerances are being established at different levels
than requested to conform with EPA rounding class practice by removing
the trailing zero.

V. Conclusion

    Therefore, tolerances are established for residues of tebuconazole,
including its metabolites and degradates, determined by measuring only
alpha-[2-(4-chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-
triazole-1-ethanol, in or on Brassica, leafy greens, subgroup 4-16B,
except watercress at 2.5 ppm; Cottonseed, subgroup 20C at 2 ppm; Fruit,
pome, group 11-10 at 1 ppm; Fruit, small, vine climbing, except fuzzy
kiwifruit, subgroup 13-07F at 6 ppm; Nut, tree, group 14-12 at 0.05;
Peach subgroup 12-12B at 2 ppm; Plum subgroup 12-12C at 1 ppm;
Sunflower, subgroup 20B at 0.1 ppm; Tropical and subtropical, small
fruit, inedible peel, subgroup 24A at 1.6 ppm; and Watercress at 9 ppm.
In addition, EPA is removing the following tolerances from paragraph
(a)(1) because they are superseded by the new tolerances being
established in this rulemaking: Brassica, leafy greens, subgroup 5B at
2.5 ppm; Cotton, undelinted seed at 2.0 ppm; Fruit, pome, group 11 at
0.05 ppm; Fruit, stone, group 12, except cherry at 1.0 ppm; Grape at
5.0 ppm; Lychee at 1.6 ppm; Nut, tree, group 14 at 0.05 ppm; Peach at
1.0 ppm; Pistachio at 0.05 ppm; Plum, pre- and post-harvest at 1.0 ppm;
and Sunflower, seed at 0.05 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), nor is it
considered a regulatory action under Executive Order 13771, entitled
``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339,
February 3, 2017). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any
technical standards that would require Agency consideration of
voluntary consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: October 25, 2019.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.474, amend the table in paragraph (a)(1) as follows:
0
a. Remove the entry for ``Brassica, leafy greens, subgroup 5B'';
0
b. Add alphabetically the entry for ``Brassica, leafy greens, subgroup
4-16B, except watercress'';
0
c. Remove the entry for ``Cotton, undelinted seed'';
0
d. Add alphabetically the entry for ``Cottonseed, subgroup 20C'';
0
e. Remove the entry for ``Fruit, pome, group 11'';
0
f. Add alphabetically the entries for ``Fruit, pome, group 11-10'' and
``Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-
07F'';
0
g. Remove the entries for ``Fruit, stone, group 12, except cherry'';
``Grape''; ``Lychee''; and ``Nut, tree, group 14'';
0
h. Add alphabetically the entry for ``Nut, tree, group 14-12'';
0
i. Remove the entry for ``Peach'';
0
j. Add alphabetically the entry for ``Peach subgroup 12-12B'';
0
k. Remove the entries for ``Pistachio'' and ``Plum, pre- and post-
harvest'';
0
l. Add alphabetically the entry for ``Plum subgroup 12-12C'';
0
m. Remove the entry for ``Sunflower, seed''; and
0
n. Add alphabetically the entries for ``Sunflower, subgroup 20B'';
``Tropical and subtropical, small fruit, inedible peel, subgroup 24A'';
and ``Watercress''.
    The additions read as follows:

Sec.  180.474  Tebuconazole; tolerances for residues.

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

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

                                * * * * *
Brassica, leafy greens, subgroup 4-16B, except watercress...         2.5

                                * * * * *
Cottonseed, subgroup 20C....................................           2
Fruit, pome, group 11-10....................................           1
Fruit, small, vine climbing, except fuzzy kiwifruit,                   6
 subgroup 13-07F............................................

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

                                * * * * *
Peach subgroup 12-12B.......................................           2

                                * * * * *
Plum subgroup 12-12C........................................           1

                                * * * * *
Sunflower, subgroup 20B.....................................         0.1
Tropical and subtropical, small fruit, inedible peel,                1.6
 subgroup 24A...............................................

                                * * * * *
Watercress..................................................           9

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

* * * * *
[FR Doc. 2019-24267 Filed 11-8-19; 8:45 am]
BILLING CODE 6560-50-P