[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Rules and Regulations]
[Pages 82152-82157]
[FR Doc No: 2011-33480]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0283; FRL-9330-1]

Cyhalofop-butyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends tolerances for residues of cyhalofop-
butyl in or on rice, grain and rice, wild, grain. Dow AgroSciences, LLC
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective December 30, 2011. Objections and
requests for hearings must be received on or before February 28, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0283. All documents in the

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

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

I. General Information

A. Does this action apply to me?

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

B. How can I 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://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0283 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
February 28, 2012. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0283, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 20, 2011 (76 FR 22067) (FRL-8869-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1F7836) by Dow AgroSciences, LLC, 9330 Zionsville Road, Indianapolis,
IN 46268. The petition requested that 40 CFR 180.576 be amended by
reestablishing and making permanent tolerances for residues of the
herbicide, cyhalofop-butyl, R-(+)-n-butyl-2-(4(4-cyano-2-
fluorophenoxy)-phenoxy)propionate, plus cyhalofop acid, R-(+)-2-(4(4-
cyano-2-fluorophenoxy)-phenoxy)propionic acid) and the di-acid
metabolite, (2R)-4-[4-(1-carboxyethoxy)phenoxy]-3-fluorobenzoic acid,
in or on rice, grain and rice, wild, grain at 0.35 parts per million
(ppm), respectively. That notice referenced a summary of the petition
prepared by Dow AgroSciences, LLC, the registrant, which is available
in the docket, http://www.regulations.gov. There were no comments
received in response to the notice of filing. These amended tolerances
are required due to recent side-by-side field trial data submitted to
support a new formulation of cyhalofop-butyl, which resulted in higher
than anticipated residues associated with the currently registered
formulation with this active ingredient. Based upon review of the data
supporting the petition, EPA has increased the proposed tolerances from
0.35 ppm to 0.40 ppm and has revised the tolerance expression. The
reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will

result to infants and children from aggregate exposure to the pesticide
chemical residue. * * *''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for cyhalofop-butyl
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
cyhalofop-butyl 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.
    Cyhalofop-butyl has low or minimal acute toxicity via the oral,
dermal and inhalation routes of exposure. It is minimally irritating to
the eye, nonirritating to the skin and is not a dermal sensitizer.
    Kidney effects were observed after subchronic and chronic dosing of
the rat and mouse as well as in the rabbit developmental and rat
reproduction studies. In the 90-day rat study, lipofuscin pigment
deposition in proximal tubule kidney cells was noted in both sexes in
addition to hepatocyte eosinophilic granules (males only); and in the
90-day mouse study (females only), there was an increase in absolute
and relative kidney weights as well as swelling of the proximal tubule
cells. In the rabbit developmental study, 1/18 dams in the mid-dose
group and 9/18 dams in the high-dose group died or were sacrificed in
extremis after exhibiting hematuria (gross pathological examinations
revealed cloudy or dark colored kidneys). Slight kidney tubular cell
swelling was observed only in adult males in the rat reproductive
toxicity study. In the 18-month mouse carcinogenicity study, kidney
findings included tubular dilatation, chronic glomurulonephritis and
hyaline casts in females (not males). In both sexes in the chronic/
carcinogenicity rat study increased deposition of kidney changes (early
and increased deposition of the pigments lipofuscin and hemosiderin in
the renal proximal tubular cells) was observed. In addition, in females
only, renal mineralization was observed.
    Non-kidney effects observed following subchronic or chronic
exposure to cyhalofop-butyl included hyperplasia of the stomach mucosal
epithelium (male mice only) in the 18-month mouse carcinogenicity study
and brown and/or atrophied thymuses and decreased thymus weight in the
90-day dog study. The thymus effects, which could be an indication of
potential immunotoxicity, were not observed in the 1-year dog study or
in other species (rats, mice or rabbits) and were not seen in any
tested species following chronic exposure to cyhalofop-butyl.
    There was no evidence of developmental, reproductive or endocrine
toxicity in the toxicology studies for cyhalofop-butyl. In the rat
developmental toxicity study, there were no maternal or fetal effects
observed up to the limit dose. In the rabbit developmental toxicity
study, no fetal effects were observed up to the limit dose; whereas
kidney effects (deaths related to hematuria and the occurrence of
cloudy or dark colored kidneys on gross pathological examination) were
seen in maternal animals. Slight kidney tubular cell swelling was
observed in adult males in the rat reproductive toxicity study with no
evidence of treatment-related effects observed in females or offspring.
There were no systemic or neurotoxic effects noted at the limit dose in
the gavage acute neurotoxicity study or in the 90-day feeding
neurotoxicity study.
    In a previous 2002 risk assessment for cyhalofop-butyl, it was not
possible to assess the carcinogenic potential of cyhalofop-butyl due to
insufficient dosing in the rat and mouse carcinogenicity studies. In
the absence of acceptable data, EPA assumed that cyhalofop-butyl had
the same carcinogenic potential as the structural analog, diclofop-
methyl, and conducted an exposure assessment to evaluate cancer risk
using quantitative linear low-dose extrapolation and the Q1* for
diclofop-methyl of 2.3 x 10-1 (mg/kg/day)-1.
Subsequently, two specific mechanistic studies (Peroxisome Proliferator
Receptor-Alpha Reporter Assays) in the mouse were submitted to EPA.
Review of the mechanistic data indicated that cyhalofop-butyl is not a
liver toxicant/carcinogen for humans, since the rodent liver mode of
action is not likely to occur in humans; and that the doses in the
original long-term studies were approaching a maximum tolerated dose.
In addition, there were no positive effects in the battery of mutagenic
studies. Based on these findings, EPA has classified cyhalofop-butyl as
``Not Likely to be Carcinogenic to Humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by cyhalofop-butyl 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 ``Cyhalofop-butyl. Human Health Risk
Assessment for Proposed Amended Tolerances on Rice and Wild Rice,'' p.
8 in docket ID number EPA-HQ-OPP-2011-0283 and are also discussed in
the final rule published in the Federal Register of April 8, 2009 (74
FR 15876) (FRL-8406-8).

B. Toxicological Points of Departure/Levels of Concern

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

 Table--Summary of Toxicological Doses and Endpoints for Cyhalofop-butyl 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 (All Populations)....   No appropriate endpoint attributable to a single dose was available in the
                                         current database. Therefore, an acute RfD was not established for the
                                                  general U.S. population or any population subgroup.
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Chronic dietary (All populations)..  NOAEL= 1.0 mg/kg/day    Chronic RfD = 0.010 mg/ Carcinogenicity study in
                                      UFA = 10x.              kg/day.                 mice. LOAEL = 10.06/10.28
                                     UFH = 10x.............  cPAD = 0.010 mg/kg/day   mg/kg/day, M/F, based on
                                     FQPA SF = 1x..........                           kidney effects in females
                                                                                including tubular
                                                                                dilatation, chronic
                                                                                glomerulonephritis, and
                                                                                hyaline casts.
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Cancer (Oral, dermal, inhalation)..    Classified as ``not likely to be carcinogenic to humans'' in accordance
                                        with the EPA Final Guidelines for Carcinogen Risk Assessment (March 29,
                                                                        2005).
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyhalofop-butyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing cyhalofop-butyl
tolerances in 40 CFR 180.576. EPA assessed dietary exposures from
cyhalofop-butyl in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for cyhalofop-butyl; therefore,
a quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As
to residue levels in food, EPA assumed that all rice and wild rice
commodities would be treated with cyhalofop-butyl and contain
tolerance-level residues.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that cyhalofop-butyl does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for cyhalofop-butyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of cyhalofop-butyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Tier 1 Rice Model and Screening Concentration in
Ground Water (SCI-GROW) model, the estimated drinking water
concentrations (EDWCs) of cyhalofop-butyl for chronic exposures for
non-cancer assessments (the only dietary exposure scenario for which a
toxicological endpoint of concern was identified) are estimated to be
21 parts per billion (ppb) for surface water and 0.152 ppb for ground
water. Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 21 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). Cyhalofop-butyl 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.''
    EPA has not found cyhalofop-butyl to share a common mechanism of
toxicity with any other substances, and cyhalofop-butyl does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
cyhalofop-butyl does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicology data base for cyhalofop-butyl includes rat and rabbit
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. There were no treatment-related effects observed in
fetuses or offspring in any of these 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 cyhalofop-butyl is complete except for
immunotoxicity data. EPA has evaluated the available cyhalofop-butyl
toxicity data to determine whether an additional database uncertainty
factor is needed to account for potential immunotoxicity. Brown and/or
atrophied thymuses and decreased thymus weight were observed in the 90-
day dog study. However, these effects, which could be an indication of
potential immunotoxicity, were not observed in the 1-year dog study or
in other species (rats, mice or rabbits) and were not seen in any
tested species following chronic exposure to cyhalofop-butyl. Based on
these considerations, EPA has concluded that the doses and endpoints
selected for risk assessment (along with traditional uncertainty
factors) are protective of potential immunotoxicity and an additional
uncertainty factor is not needed. The required immunotoxicity study has
been received by EPA and is currently being reviewed. A screening-
level review of this study indicates that there are no immunotoxic
effects associated with cyhalofop-butyl.
    ii. There is no indication that cyhalofop-butyl is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that cyhalofop-butyl results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 percent crop treated and tolerance-level residues. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to cyhalofop-butyl in drinking water.
Residential exposure of infants and children is not expected. These
assessments will not underestimate the exposure and risks posed by
cyhalofop-butyl.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
cyhalofop-butyl is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyhalofop-butyl from food and water will utilize 18% of the cPAD for
All Infants (< 1 year old), the population group receiving the greatest
exposure. There are no residential uses for cyhalofop-butyl.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Cyhalofop-
butyl is not registered for any use patterns that would result in
residential exposure. Therefore, the short-term aggregate risk is the
sum of the risk from exposure to cyhalofop-butyl through food and water
and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Cyhalofop-butyl is not registered for any use patterns that
would result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to cyhalofop-butyl through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Based on the evidence
summarized in Unit III.A., cyhalofop-butyl is classified as ``not
likely to be carcinogenic to humans'' and is, therefore, not expected
to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to cyhalofop-butyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Gas Chromatography/Mass
Spectrometry (GC/MS) Method GRM 99.06) is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for cyhalofop-butyl.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the proposed tolerances levels. The petitioner
requested tolerances of 0.35 ppm based on the use of the North American
Free Trade Agreement (NAFTA) tolerance calculation procedures. Based on
the submitted rice data using the Organization for Economic Cooperation
and Development (OECD) tolerance calculation procedures that were
implemented in April 2011, EPA calculated that the rice, grain and wild
rice, grain tolerances should be 0.40 ppm.
    Also, EPA is revising the tolerance expression in order to make
clear that the tolerances cover residues of the herbicide cyhalofop-
butyl, including its metabolites and degradates. Compliance with the
tolerance levels is to be determined by measuring cyhalofop butyl,
cyhalofop acid, and the di-acid metabolite.

V. Conclusion

    Therefore, tolerances are established for residues of cyhalofop-
butyl, including its metabolites and degradates, as set forth in the
regulatory text.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: December 19, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.576 is amended by revising paragraph (a) to read as
follows:

Sec.  180.576  Cyhalofop-butyl; tolerances for residues.

    (a) General. Tolerances are established for residues of cyhalofop-
butyl, including its metabolites and degradates, in or on the
commodities listed in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring cyhalofop butyl
[R-(+)-n-butyl-2-(4(4-cyano-2-fluorophenoxy)-phenoxy)propionate],
cyhalofop acid [R-(+)-2-(4(4-cyano-2-fluorophenoxy)-phenoxy)propionic
acid], and the di-acid metabolite [(2R)-4-(4-(1-carboxyethoxy)phenoxy)-
3-fluorobenzoic acid].

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Rice, grain................................................         0.40
Wild rice, grain...........................................         0.40
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-33480 Filed 12-29-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48656-48657]
[FR Doc No: 2022-17128]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1218-050]

Georgia Power Company; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Request for temporary variance of Article 401.
    b. Project No: 1218-050.
    c. Date Filed: July 27, 2022.
    d. Applicant: Georgia Power Company (licensee).
    e. Name of Project: Flint River Hydroelectric Project.
    f. Location: The project is located on the Flint River, near the
City of Albany, in Lee and Dougherty counties, Georgia. The project
does not occupy federally owned lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Melissa Crabbe, Southern Company, 241 Ralph
McGill Boulevard, NE BIN 10193, Atlanta, GA 30308-3374,<PHONE_NUMBER>,
[email protected].

    i. FERC Contact: Jeremy Jessup,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, motions to intervene, and
protests: September 2, 2022.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include the docket number P-1218-050. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The applicant proposes a temporary
variance from the target water surface elevation requirements of
Article 401 of the license (181.8  0.5 feet Plant Datum
which is 0.37 foot above mean sea level) to facilitate a scheduled a
drawdown of the project impoundment, Lake Worth. The purpose of the
drawdown is to provide for installation of new shoreline structures and
maintenance of existing shoreline structures. The licensee will lower
Lake Worth approximately 3.5 feet from the lower limit of the normal
target elevation range, 181.3 feet, to an elevation of 177.8  0.5 feet. The drawdown is scheduled to begin on September 27,
2022, and the licensee proposes to utilize a drawdown rate of one half-
foot per day. The licensee anticipates reaching the target drawdown
elevation of 177.8 feet on October 3, 2022 and remain at the target
drawdown elevation for four weeks. The licensee plans to begin
refilling Lake Worth on November 1, 2022. The licensee states that the
completion of refilling the reservoir would be dependent on
precipitation and the releases from the upstream Lake Blackshear
Hydroelectric Project No. 659. The licensee will continue to operate to
comply with Article 401 run-of-river operations requirement when it
reaches the target drawdown elevation of 177.8 feet.
    l. Locations of the Application: This filing may be viewed on the
Commission's website 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. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: August 3, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-17128 Filed 8-9-22; 8:45 am]
BILLING CODE 6717-01-P


operating facilities with an affected facility subject to this subpart
and either:
    (i) The facilities employ more than 250 persons or have gross
annual sales or expenditures exceeding $25 million (in second quarter
1980 dollars); or
    (ii) The Administrator is notified of such delegation of authority
prior to the exercise of that authority. The Administrator reserves the
right to evaluate such delegation;
    (2) For a partnership (including but not limited to general
partnerships, limited partnerships, and limited liability partnerships)
or sole proprietorship: A general partner or the proprietor,
respectively. If a general partner is a corporation, the provisions of
paragraph (1) of this definition apply;
    (3) For a municipality, State, Federal, or other public agency:
Either a principal executive officer or ranking elected official. For
the purposes of this part, a principal executive officer of a Federal
agency includes the chief executive officer having responsibility

for the overall operations of a principal geographic unit of the agency
(e.g., a Regional Administrator of EPA); or
    (4) For affected facilities:
    (i) The designated representative in so far as actions, standards,
requirements, or prohibitions under title IV of the Clean Air Act or
the regulations promulgated thereunder are concerned; or
    (ii) The designated representative for any other purposes under
part 60.
    Coil tubing cleanout means the process where an operator runs a
string of coil tubing to the packed proppant within a well and jets the
well to dislodge the proppant and provide sufficient lift energy to
flow it to the surface.
* * * * *
    Custody meter means the meter where natural gas or hydrocarbon
liquids are measured for sales, transfers, and/or royalty
determination.
    Custody meter assembly means an assembly of fugitive emissions
components, including the custody meter, valves, flanges, and
connectors necessary for the proper operation of the custody meter.
* * * * *
    First attempt at repair means, for the purposes of fugitive
emissions components, an action taken for the purpose of stopping or
reducing fugitive emissions of methane or VOC to the atmosphere. First
attempts at repair include, but are not limited to, the following
practices where practicable and appropriate: Tightening bonnet bolts;
replacing bonnet bolts; tightening packing gland nuts; or injecting
lubricant into lubricated packing.
* * * * *
    Flowback means the process of allowing fluids and entrained solids
to flow from a well following a treatment, either in preparation for a
subsequent phase of treatment or in preparation for cleanup and
returning the well to production. The term flowback also means the
fluids and entrained solids that emerge from a well during the flowback
process. The flowback period begins when material introduced into the
well during the treatment returns to the surface following hydraulic
fracturing or refracturing. The flowback period ends when either the
well is shut in and permanently disconnected from the flowback
equipment or at the startup of production. The flowback period includes
the initial flowback stage and the separation flowback stage.
Screenouts, coil tubing cleanouts, and plug drill-outs are not
considered part of the flowback process.
    Fugitive emissions component means any component that has the
potential to emit fugitive emissions of methane or VOC at a well site
or compressor station, including valves, connectors, pressure relief
devices, open-ended lines, flanges, covers and closed vent systems not
subject to Sec. Sec.  60.5411 or 60.5411a, thief hatches or other
openings on a controlled storage vessel not subject to Sec. Sec.
60.5395 or 60.5395a, compressors, instruments, and meters. Devices that
vent as part of normal operations, such as natural gas-driven pneumatic
controllers or natural gas-driven pumps, are not fugitive emissions
components, insofar as the natural gas discharged from the device's
vent is not considered a fugitive emission. Emissions originating from
other than the device's vent, such as the thief hatch on a controlled
storage vessel, would be considered fugitive emissions.
* * * * *
    Low pressure well means a well that satisfies at least one of the
following conditions:
    (1) The static pressure at the wellhead following fracturing but
prior to the onset of flowback is less than the flow line pressure;
    (2) The pressure of flowback fluid immediately before it enters the
flow line, as determined under Sec.  60.5432a, is less than the flow
line pressure; or
    (3) Flowback of the fracture fluids will not occur without the use
of artificial lift equipment.
    Major production and processing equipment means compressors, glycol
dehydrators, heater/treaters, pneumatic pumps, pneumatic controllers,
separators, and storage vessels collecting crude oil, condensate,
intermediate hydrocarbon liquids, or produced water, for the purpose of
determining whether a well site is a wellhead only well site.
    Maximum average daily throughput means the throughput, determined
as described in (1) or (2), to an individual storage vessel over the
days that production is routed to that storage vessel during the 30-day
evaluation period specified in Sec.  60.5365a(e)(1).
    (1) If throughput to the individual storage vessel is measured on a
daily basis (e.g., via level gauge automation or daily manual gauging),
the maximum average daily throughput is the average of all daily
throughputs for days on which throughput was routed to that storage
vessel during the 30-day evaluation period; or
    (2) If throughput to the individual storage vessel is not measured
on a daily basis (e.g., via manual gauging at the start and end of
loadouts), the maximum average daily throughput is the highest, of the
average daily throughputs, determined for any production period to that
storage vessel during the 30-day evaluation period, as determined by
averaging total throughput to that storage vessel over each production
period. A production period begins when production begins to be routed
to a storage vessel and ends either when throughput is routed away from
that storage vessel or when a loadout occurs from that storage vessel,
whichever happens first.
    Regardless of the determination methodology, operators must not
include days during which throughput is not routed to an individual
storage vessel when calculating maximum average daily throughput for
that storage vessel.
* * * * *
    Permanent separator means a separator that handles flowback from a
well or wells beginning when the flowback period begins and continuing
to the startup of production.
    Plug drill-out means the removal of a plug (or plugs) that was used
to conducted hydraulic fracturing in different sections of the well.
* * * * *
    Repaired means, for the purposes of fugitive emissions components,
that fugitive emissions components are adjusted, replaced, or otherwise
altered, in order to eliminate fugitive emissions as defined in Sec.
60.5397a of this subpart and is resurveyed as specified in Sec.
60.5397a(h)(4) and it is verified that emissions from the fugitive
emissions components are below the applicable fugitive emissions
definition.
* * * * *
    Screenout means the first attempt to clear proppant from the
wellbore through flowing the well to a fracture tank in order to
achieve maximum velocity and carry the proppant out of the well.
* * * * *
    Startup of production means the beginning of initial flow following
the end of flowback when there is continuous recovery of salable
quality gas and separation and recovery of any crude oil, condensate or
produced water, except as otherwise provided herein. For the purposes
of the fugitive monitoring requirements of Sec.  60.5397a, startup of
production means the beginning of the continuous recovery of salable
quality gas and separation and recovery of any crude oil, condensate or
produced water.
* * * * *
    UIC Class II oilfield disposal well means a well with a UIC Class
II permit

where wastewater resulting from oil and natural gas production
operations is injected into underground porous rock formations not
productive of oil or gas, and sealed above and below by unbroken,
impermeable strata.
* * * * *
    Well site means one or more surface sites that are constructed for
the drilling and subsequent operation of any oil well, natural gas
well, or injection well. For purposes of the fugitive emissions
standards at Sec.  60.5397a, well site also means a separate tank
battery surface site collecting crude oil, condensate, intermediate
hydrocarbon liquids, or produced water from wells not located at the
well site (e.g., centralized tank batteries). Also, for the purposes of
the fugitive emissions standards at Sec.  60.5397a, a well site does
not include (1) UIC Class II oilfield disposal wells and disposal
facilities and (2) the flange upstream of the custody meter assembly
and equipment, including fugitive emissions components, located
downstream of this flange.
* * * * *
    Wellhead only well site means, for the purposes of the fugitive
emissions standards at Sec.  60.5397a, a well site that contains one or
more wellheads and no major production and processing equipment.
* * * * *
0
22. Table 3 to Subpart OOOOa of Part 60 is amended to revise the
explanations for sections 60.8 and 60.15 general provisions citation
entries to read as follows:

            Table 3 to Subpart OOOOa of Part 60--Applicability of General Provisions to Subpart OOOOa
----------------------------------------------------------------------------------------------------------------
   General provisions citation      Subject of citation  Applies to subpart?              Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Sec.   60.8......................  Performance tests...  Yes................  Performance testing is required
                                                                               for control devices used on
                                                                               storage vessels, centrifugal
                                                                               compressors, and pneumatic pumps,
                                                                               except that performance testing
                                                                               is not required for a control
                                                                               device used solely on pneumatic
                                                                               pump(s).

                                                  * * * * * * *
Sec.   60.15.....................  Reconstruction......  Yes................  Except that Sec.   60.15(d) does
                                                                               not apply to wells, pneumatic
                                                                               controllers, pneumatic pumps,
                                                                               centrifugal compressors,
                                                                               reciprocating compressors,
                                                                               storage vessels, or the
                                                                               collection of fugitive emissions
                                                                               components at a well site or the
                                                                               collection of fugitive emissions
                                                                               components at a compressor
                                                                               station.

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

[FR Doc. 2018-20961 Filed 10-12-18; 8:45 am]
 BILLING CODE 6560-50-P