Pyraclostrobin; Pesticide Tolerances, 53039-53047 [2013-20921]
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action, is indicating that it is more likely
than not that the State has corrected the
deficiency that started the sanctions
clocks. Therefore, it is not in the public
interest to initially impose sanctions or
to keep applied sanctions in place when
the State has most likely done all it can
to correct the deficiency that triggered
the sanctions clocks. Moreover, it would
be impracticable to go through noticeand-comment rulemaking on a finding
that the State has corrected the
deficiency prior to the rulemaking
approving the State’s submittal.
Therefore, EPA believes that it is
necessary to use the interim final
rulemaking process to stay and defer
sanctions while EPA completes its
rulemaking process on the approvability
of the State’s submittal. Moreover, with
respect to the effective date of this
action, EPA is invoking the good cause
exception to the 30-day notice
requirement of the APA because the
purpose of this notice is to relieve a
restriction (5 U.S.C. 553(d)(1)).
III. Statutory and Executive Order
Reviews
This action stays and defers federal
sanctions and imposes no additional
requirements.
Under Executive Order 12866 (58 FR
51735, October 4, 1993), this action is
not a ‘‘significant regulatory action’’ and
therefore is not subject to review by the
Office of Management and Budget.
This action is not subject to Executive
Order 13211, ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) because it is
not a significant regulatory action.
The Administrator certifies that this
action will not have a significant
economic impact on a substantial
number of small entities under the
Regulatory Flexibility Act (5 U.S.C. 601
et seq.).
This rule does not contain any
unfunded mandate or significantly or
uniquely affect small governments, as
described in the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4).
This rule does not have tribal
implications because it will not have a
substantial direct effect on one or more
Indian tribes, on the relationship
between the federal government and
Indian tribes, or on the distribution of
power and responsibilities between the
federal government and Indian tribes, as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
This action does not have federalism
implications because it does not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
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distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132 (64 FR 43255,
August 10, 1999).
This rule is not subject to Executive
Order 13045, ‘‘Protection of Children
from Environmental Health Risks and
Safety Risks’’ (62 FR 19885, April 23,
1997), because it is not economically
significant.
The requirements of section 12(d) of
the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C.
272) do not apply to this rule because
it imposes no standards.
This rule does not impose an
information collection burden under the
provisions of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to Congress and the
Comptroller General. However, section
808 provides that any rule for which the
issuing agency for good cause finds that
notice and public procedure thereon are
impracticable, unnecessary, or contrary
to the public interest, shall take effect at
such time as the agency promulgating
the rule determines. 5 U.S.C. 808(2).
EPA has made such a good cause
finding, including the reasons therefore,
and established an effective date of
August 28, 2013. 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. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This rule is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by October 28, 2013. Filing a
petition for reconsideration by the
Administrator of this final rule does not
affect the finality of this rule for the
purpose of judicial review nor does it
extend the time within which petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements (see section
307(b)(2)).
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
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53039
reference, Intergovernmental
regulations, Ozone, Particulate matter,
Reporting and recordkeeping
requirements.
Dated: August 15, 2013.
Jared Blumenfeld,
Regional Administrator, Region 9.
[FR Doc. 2013–21011 Filed 8–27–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0549; FRL–9395–5]
Pyraclostrobin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of pyraclostrobin
in or on multiple commodities which
are identified and discussed later in this
document. This regulation additionally
removes several permanent and timelimited tolerances that will be
superseded by tolerances established by
this action. Interregional Research
Project Number 4 (IR–4) and BASF
Corporation requested tolerances
associated with pesticide petition (PP)
numbers 2E8069 and 2F8038,
respectively, under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
August 28, 2013. Objections and
requests for hearings must be received
on or before October 28, 2013, 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–2012–0549, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois
Rossi, Registration Division (7505P),
SUMMARY:
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Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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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–2012–0549 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 October 28, 2013. 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
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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–
2012–0549, by one of the following
methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.htm.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at
https://www.epa.gov/dockets.
II. Summary of Petitioned-for
Tolerances
In the Federal Register of January 16,
2013 (78 FR 3377) (FRL–9375–4), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
petition (PP 2E8069) by IR–4, 500
College Road East, Suite 201 W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.582 be
amended by establishing tolerances for
residues of the fungicide pyraclostrobin,
carbamic acid, [2-[[[1-(4-chlorophenyl)1H-pyrazol-3yl]oxy]methyl]phenyl]methoxy-, methyl
ester and its metabolite methyl-N-[[[1(4-chlorophenyl) pyrazol-3yl]oxy]otolyl] carbamate (BF 500–3),
expressed as the parent compound, in or
on artichoke, globe at 3.0 parts per
million (ppm); endive, belgium at 3.0
ppm; and persimmon at 3.0 ppm. The
petition additionally requested that EPA
establish tolerances in or on vegetable,
bulb, group 3–07 at 0.9 ppm; vegetable,
fruiting, group 8–10 at 1.4 ppm; fruit,
citrus, group 10–10 at 2.0 ppm; fruit,
pome, group 11–10 at 1.5 ppm; oilseed,
group 20 at 0.45 ppm; caneberry
subgroup 13–07A at 4.0 ppm; bushberry
subgroup 13–07B at 4.0 ppm; small
fruit, vine climbing subgroup (except
fuzzy kiwi) 13–07F at 2.0 ppm; and low
growing berry subgroup 13–07G at 1.2
ppm. Further, upon approval of these
subgroup/crop group tolerances the
petition also requested that the
following existing tolerances be
removed for berry, group 13 at 4.0 ppm;
fruit, citrus, group 10 at 2.0 ppm; fruit,
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pome, group 11 at 1.5 ppm; grape at 2.0
ppm; strawberry at 1.2 ppm; vegetable,
bulb, group 3 at 0.9 ppm; vegetable,
fruiting, group 8 at 1.4 ppm; borage,
seed at 0.45 ppm; castor oil plant, seed
at 0.45 ppm; chinese tallowtree, seed at
0.45 ppm; crambe, seed at 0.45 ppm;
cuphea, seed at 0.45 ppm; echium, seed
at 0.45 ppm; euphorbia, seed at 0.45
ppm; evening primrose, seed at 0.45
ppm; flax seed at 0.45 ppm; gold of
pleasure, seed at 0.45 ppm; hare’s ear
mustard, seed at 0.45 ppm, jojoba, seed
at 0.45 ppm; lesquerella, seed at 0.45
ppm, lunaria, seed at 0.45 ppm;
meadowfoam, seed at 0.45 ppm;
milkweed, seed at 0.45 ppm; mustard,
seed at 0.45 ppm; niger seed, seed at
0.45 ppm; oil radish, seed at 0.45 ppm;
poppy, seed at 0.45 ppm; rapeseed, seed
at 0.45 ppm; rose hip, seed at 0.45 ppm;
safflower, seed at 0.45 ppm; sesame,
seed at 0.45 ppm; stokes aster, seed at
0.45 ppm; sunflower, seed at 0.45 ppm;
sweet rocket, seed at 0.45 ppm;
tallowwood, seed at 0.45 ppm; tea oil
plant, seed at 0.45 ppm; and ternonia,
seed at 0.45 ppm. That document
referenced a summary of the petition
prepared on behalf of IR–4 by BASF
Corporation, the registrant, which is
available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Additionally, in the Federal Register
of August 22, 2012 (77 FR 50661) (FRL–
9358–9), 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 2F8038) by
BASF Corporation, 26 Davis Drive, P.O.
Box 13528, Research Triangle Park, NC,
27709–3528. The petition requested that
40 CFR 180.582 be amended by
establishing tolerances for residues of
the fungicide pyraclostrobin, carbamic
acid, expressed as the parent
compound, in or on sugarcane, cane at
0.2 ppm. No tolerances were proposed
for the processed commodities refined
sugar and molasses, as no concentration
of pyraclostrobin residues are expected
in these commodities. That document
referenced a summary of the petition
prepared by BASF Corporation, the
registrant, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting the petition, EPA has revised
the proposed tolerance level in or on
endive, belgium. Further, the petitioner
later requested to amend low growing
berry subgroup 13–07G to exclude
cranberry. The reasons for these changes
are explained in Unit IV.C.
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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 pyraclostrobin
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with pyraclostrobin 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.
There are no concerns for
reproductive susceptibility,
neurotoxicity, mutagenicity,
genotoxicity, or immunotoxicity. The
most consistently observed effects
resulting from pyraclostrobin exposure
across species, genders, and treatment
durations were diarrhea and decreased
body weight, body weight gain, and
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food consumption. Pyraclostrobin also
causes intestinal disturbances, as
indicated by increased incidence of
diarrhea or duodenum mucosal
thickening. These intestinal effects
appeared to be related to the irritating
action on the mucus membranes as
demonstrated by irritation seen in the
primary eye irritation study. In the rat
acute and subchronic neurotoxicity
studies, neuropathology and behavior
changes were not observed.
In the rat developmental toxicity
study, developmental toxicity including
an increased incidence of dilated renal
pelvis and cervical ribs occurred at a
dose greater than the dose causing
maternal toxicity (including decreased
body weights and body weight gains
and reduced food consumption and
reduced food efficiency). The rabbit
developmental toxicity study indicates
qualitative evidence of increased
developmental susceptibility based on
increased resorptions per litter,
increased post-implantation loss and
dams with total resorptions, in the
presence of maternal toxicity (reduced
body weight gain, food consumption,
and food efficiency). In a dose rangefinding one-generation reproduction
study, systemic toxicity was manifested
as decreased body weight and body
weight gain in both the parents and
offspring. The effects occurred at the
same dose levels for both parental and
the offspring, but the decrease in pup
weight was more than that in the
parental animals. However, the body
weight effect was not found in the
guideline 2-generation reproduction
study in either parental or offspring
animals at similar dose level. No
reproductive toxicity was seen.
Pyraclostrobin has been classified as
not likely to be carcinogenic to humans
based on the lack of treated related
increase in tumor incidence in
adequately conducted carcinogenicity
studies in rats and mice. Pyraclostrobin
did not cause mutagenicity or
genotoxicity in the in vivo and in vitro
assays, nor did it cause immunotoxicity
in T-cell dependent antibody response
assays in mice with preliminary review.
Specific information on the studies
received and the nature of the adverse
effects caused by pyraclostrobin as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
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toxicity studies can be found at
https://www.regulations.gov in
document: ‘‘Pyraclostrobin—Human
Health Risk Assessment for a Section 3
Registration of New Uses on Sugarcane,
Globe Artichoke, Belgium Endive,
Persimmon, Greenhouse Grown Tomato
Transplants for Home Consumer
Market, and Residential Ornamentals,
Landscape Gardens, Fruit Trees, and
Nut Trees; Plus Crop Group Expansions/
Revisions for Bulb Vegetable Group 3–
07, Fruiting Vegetable Group 8–10,
Citrus Fruit Group 10–10, Pome Fruit
Group 11–10, Berry Subgroups 13–07A,
B, F, and G, and Oilseed Group 20’’ at
pages 43–49 in docket ID number EPA–
HQ–OPP–2012–0549.
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 https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for pyraclostrobin used for
human risk assessment is shown in
Table 1. of this unit.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYRACLOSTROBIN FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Acute dietary (Females 13–49
years of age).
Acute dietary (General population including infants and
children).
Chronic dietary (All populations)
Incidental oral short-term (1 to
30 days) and intermediateterm (1 to 6 months).
Dermal short-term (1 to 30
days) and intermediate-term
(1 to 6 months).
Inhalation short-term .................
(1 to 30 days) and intermediate-term (1 to 6 months).
Cancer (Oral, dermal, inhalation).
Point of departure
and uncertainty/safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
NOAEL = 5.0 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL = 300 mg/
kg/day.
UFA = 10 x
UFH = 10 x
FQPA SF = 1x
NOAEL= 3.4 mg/kg/
day.
UFA = 10x
UFH = 10 x
FQPA SF = 1x
NOAEL= 5.8 mg/kg/
day.
UFA = 10 x
UFH = 10x
FQPA SF = 1x
Oral study NOAEL =
5.0 mg/kg/day
(dermal absorption
rate = 14%).
UFA = 10 x
UFH = 10x
FQPA SF = 1x
Inhalation study
NOAEL = 0.23
mg/kg/day.
UFA = 10 x
UFH = 10 x
FQPA SF = 1x
Acute RfD = 0.05
mg/kg/day.
aPAD = 0.05 mg/kg/
day
Developmental toxicity—rabbit. LOAEL = 10.0 mg/kg/day
based on developmental toxicity findings of increased resorptions.
Acute RfD = 3.0 mg/
kg/day.
aPAD = 3.0 mg/kg/
day
Acute neurotoxicity—rat. LOAEL = 1000 mg/kg/day based on
decreased body weight gain in males.
Chronic RfD = 0.034
mg/kg/day.
cPAD = 0.034 mg/
kg/day
Carcinogenicity—rat. LOAEL = 9.2 mg/kg/day based on decreased body weight/body weight gain, kidney tubular casts
and atrophy in both sexes; increased incidence of liver necrosis and erosion/ulceration of the glandular-stomach and
fore-stomach in males.
Subchronic toxicity—dog. LOAEL = 12.9 mg/kg/day based on
increased incidence of diarrhea, clinical chemistry changes,
duodenum mucosal hypertrophy, and decreased body weight
and food intake/efficiency.
LOC for MOE = 100
LOC for MOE = 100
Developmental toxicity—rabbit. LOAEL = 10.0 mg/kg/day
based on developmental toxicity findings of increased resorptions and maternal toxicity based on decreased body weight
gain and decreased food intake/efficiency.
LOC for MOE = 100
Inhalation toxicity—rat. LOAEL = 6.9 mg/kg/day (air concentration = 0.03 mg/L) based on duodenum mucosal hyperplasia
and respiratory system findings including alveolar
histiocytosis and olfactory atrophy/necrosis in nasal tissue.
Classification: ‘‘not likely to be carcinogenic to humans’’ based on the absence of significant tumor increases
in two adequate rodent carcinogenicity studies.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to pyraclostrobin, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing pyraclostrobin tolerances in 40
CFR 180.582. EPA assessed dietary
exposures from pyraclostrobin 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 pyraclostrobin.
In estimating acute dietary exposure,
EPA used Dietary Exposure Evaluation
Model software with the Food
Commodity Intake Database (DEEM–
FCID) Version 3.16, which uses food
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consumption data from the U.S.
Department of Agriculture’s (USDA’s)
National Health and Nutrition
Examination Survey, What We Eat in
America (NHANES/WWEIA) from 2003
through 2008. As to residue levels in
food, EPA used tolerance-level residues
or highest field trial residues and
empirical or default processing factors.
Experimentally-derived processing
factors were used for fruit juices,
tomato, sugarcane, and wheat
commodities. For all other processed
commodities, DEEM default processing
factors were assumed.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA’s 2003–2008 NHANES/
WWEIA. As to residue levels in food,
EPA included tolerance-level or average
field trial residues, average percent crop
treated (PCT) estimates when available,
and empirical processing factors.
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Experimentally-derived processing
factors were used for fruit juices,
tomato, sugar cane, and wheat
commodities. For all other processed
commodities, DEEM default processing
factors were assumed.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that pyraclostrobin does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Percent crop treated (PCT)
information. 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.
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• 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, 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.
The following average PCT estimates
were used in the chronic dietary risk
assessments for the crops that are
currently registered for pyraclostrobin:
almonds 40%; apples 15%; apricots
25%; barley 10%; green beans 5%;
blueberries 45%; broccoli 5%; cabbage
10%; caneberries 50%; cantaloupes
15%; carrots 35%; cauliflower 2.5%;
celery 2.5%; cherries 50%; corn 10%;
cotton 2.5%; cucumber 5%; dry beans/
peas 10%; garlic 15%; grapefruit 25%;
grapes 30%; hazelnuts (filberts) 15%;
lemons 2.5%; lettuce 5%; nectarines
10%; onions 20%; oranges 5%; peaches
20%; peanuts 25%; pears 15%; green
peas 5%; pecans 2.5%; peppers 10%;
pistachios 30%; plums/prunes 5%;
potatoes 15%; pumpkins 20%; soybeans
5%; spinach 5%; squash 15%;
strawberries 65%; sugar beets 45%;
sweet corn 5%; tangelos 15%;
tangerines 10%; tomatoes 25%; walnuts
1%; watermelons 30%; wheat 5%.
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6–7 years. EPA uses an average
PCT for chronic dietary risk analysis.
The average PCT figure for each existing
use is derived by combining available
public and private market survey data
for that use, averaging across all
observations, and rounding to the
nearest 5%, except for those situations
in which the average PCT is less than
one. In those cases, 1% is used as the
average PCT and 2.5% is used as the
maximum PCT. EPA uses a maximum
PCT for acute dietary risk analysis. The
maximum PCT figure is the highest
observed maximum value reported
within the recent 6 years of available
public and private market survey data
for the existing use and rounded up to
the nearest multiple of 5%.
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
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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 pyraclostrobin 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 pyraclostrobin in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
pyraclostrobin. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening
Concentration in Ground Water (SCI–
GROW) models, the estimated drinking
water concentrations (EDWCs) of
pyraclostrobin for acute exposures are
estimated to be 35.6 parts per billion
(ppb) for surface water and 0.06 ppb for
ground water. Chronic exposures for
non-cancer assessments are estimated to
be 2.3 ppb for surface water and 0.02
ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 35.6 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 2.3 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 nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
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indoor pest control, termiticides, and
flea and tick control on pets).
Pyraclostrobin is currently registered for
the following uses and additional
proposed uses that could result in
residential handler and postapplication
exposures: Treated gardens, fruit or nut
trees, tomato transplants, and turf. EPA
assessed residential exposure using the
following assumptions: Short-term adult
handler exposures via the dermal and
inhalation routes resulting from
application of pyraclostrobin to gardens,
trees, and turf. Short-term dermal
postapplication exposures were
assessed for adults, youth 11 to 16 years
old, and children 6 to 11 years old.
Short-term dermal and incidental oral
exposures were assessed for children 1
to < 2 years old. Based on the registered
uses of pyraclostrobin on residential
and golf course turf, intermediate-term
postapplication exposures are possible.
However, since the short- and
intermediate-term endpoints and PODs
for dermal and oral routes are the same,
the short-term exposure and risk
estimates are considered to be protective
of potential intermediate-term exposure
and risk.
For the aggregate assessment,
inhalation and dermal exposures were
not aggregated together because the
toxicity effect from the inhalation route
of exposure was different than the effect
from the dermal route of exposure. The
scenarios with the highest residential
exposures that were used in the shortterm aggregate assessment for
pyraclostrobin are as follows:
• Adult short-term aggregate
assessment—Residential inhalation
exposure from application
pyraclostrobin to turf via manually
pressurized hand wand or backpack
sprayer; residential dermal
postapplication exposure via activities
on treated turf.
• Youth (11–16 years old) short-term
aggregate assessment—Residential
dermal exposure from postapplication
golfing on treated turf.
• Children (6–11 years old) shortterm aggregate assessment—Residential
dermal exposures from postapplication
activities in treated gardens.
• Children (1 < 2 years old) shortterm aggregate assessment—Residential
dermal and hand-to-mouth exposures
from postapplication exposure to treated
turf.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www.epa.gov/pesticides/
trac/science/trac6a05.pdf.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
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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 pyraclostrobin to
share a common mechanism of toxicity
with any other substances, and
pyraclostrobin does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that pyraclostrobin 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
https://www.epa.gov/pesticides/
cumulative.
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D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is no evidence that pyraclostrobin
results in increased susceptibility in rats
or rabbits in the prenatal developmental
studies or in young rats in the 2generation reproduction study.
Although there is qualitative evidence
of increased susceptibility in the
prenatal development study in rabbits,
the Agency did not identify any residual
uncertainties after establishing toxicity
endpoints and traditional UFs to be
used in the risk assessment of
pyraclostrobin. The degree of concern
for prenatal and/or postnatal toxicity is
low.
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:
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i. The toxicity database for
pyraclostrobin is complete.
ii. There is no indication that
pyraclostrobin is a neurotoxic chemical.
Effects seen in the acute and subchronic
neurotoxicity studies in rats are
considered to reflect perturbations in
mitochondrial respiration leading to
effects on energy production rather than
signs of neurotoxicity; therefore, there is
no need for a developmental
neurotoxicity study or additional UFs to
account for neurotoxicity
iii. There is no evidence that
pyraclostrobin results in increased
susceptibility in rats in the prenatal
developmental study or in young rats in
the 2-generation reproduction study.
The prenatal rabbit developmental
toxicity study showed qualitative
evidence of increased susceptibility to
prenatal rabbits; however, this study
was chosen for endpoint selection for
the acute dietary (females 13–49) and
short-term dermal exposure scenarios.
This study has a clearly defined NOAEL
of 5.0 mg/kg/day. EPA did not identify
any residual uncertainties after
establishing toxicity endpoints and
traditional UFs to be used in the risk
assessment of pyraclostrobin. The
degree of concern for prenatal and/or
postnatal toxicity is low.
iv. There are no residual uncertainties
identified in the exposure databases.
The acute dietary exposure assessments
were performed assuming 100 PCT and
tolerance-level or highest field trial
residues. The chronic dietary exposure
assessments were performed using
average PCT estimates, when available,
and tolerance-level or highest field trial
residues. These data are reliable and are
not expected to underestimate risks to
adults or children. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to
pyraclostrobin in drinking water. EPA
used similarly conservative assumptions
to assess postapplication exposure of
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by pyraclostrobin.
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
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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. Using the exposure assumptions
discussed in this unit for acute
exposure, the acute dietary exposure
from food and water to pyraclostrobin
will occupy 87% of the aPAD for
females 13–49 years old; and 2.8% for
children 1–2 years old, the population
group receiving the greatest exposure for
the general U.S. population, including
infants and children.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to pyraclostrobin
from food and water will utilize 27% of
the cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. Based on the explanation in
Unit III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of pyraclostrobin is not
expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Pyraclostrobin is
currently registered for uses that could
result in short-term residential
exposure, and the Agency has
determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to pyraclostrobin.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs of 120 for children 1–2 years old,
360 for children 6–11 years old, 1,500
for youth 11–16 years old, 760 for adult
handlers, and 230 for adults from
postapplication exposures. Because
EPA’s level of concern for
pyraclostrobin is a MOE of 100 or
below, these MOEs are not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Pyraclostrobin is currently registered for
uses that could result in intermediateterm residential exposure; however,
since the short- and intermediate-term
endpoints and PODs for dermal and oral
routes are the same, the short-term
exposure and risk estimates are
considered to be protective of potential
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intermediate-term exposure and risk
and an intermediate-term aggregate
assessment was not performed.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
pyraclostrobin is not expected to pose a
cancer risk to humans.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population or to infants and children
from aggregate exposure to
pyraclostrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Two adequate methods are available
to enforce the tolerance expression for
residues of pyraclostrobin and the
metabolite BF 500–3 in or on plant
commodities: A liquid chromatography
with tandem mass spectrometry (LC/
MS/MS) method, BASF Method D9908;
and a high-performance LC with
ultraviolet detection (HPLC/UV)
method, Method D9904. The methods
may be found in the Pesticide Analytical
Manual, Volume I.
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B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for pyraclostrobin in or on sugarcane,
endive, belgium, and persimmon. A
Codex MRL has been established for
pyraclostrobin in or on globe artichoke
at 2.0 ppm. EPA has determined that the
U.S. tolerance should be set at 3.0 ppm.
The field trials comprising the data set
used by Codex are from Europe, and
these trials were conducted under an
application rate and preharvest interval
different from that on the U.S. trials.
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The U.S. tolerance is based on
application of the Organization for
Economic Cooperation and
Development (OECD) tolerance
calculation procedures to the validated
field trial data, which shows that the
U.S. tolerance for globe artichoke must
be at 3.0 ppm to avoid violations for
crops treated in accordance with the
EPA approved label. These different
tolerance levels may be due, in part, to
the different residue definitions for
pyraclostrobin for the U.S. tolerances
and the Codex MRLs. Codex established
MRLs for residues of pyraclostrobin
only, and in the U.S. tolerances, are
currently established for parent and its
desmethoxy metabolite (methyl-N-[[[1(4-chlorophenyl)-1H-pyrazol-3yl]oxy]methyl] phenylcarbamate).
Currently, pyraclostrobin has over 100
tolerances for multiple commodities and
crop groups. When this chemical goes
through registration review the U.S.
EPA will determine if it is possible to
change the existing residue definition to
align with Codex which would
potentially allow for harmonization of
MRL and tolerance levels. However,
given the number of existing tolerances
it is not appropriate to consider such a
change for this petition only. Therefore,
because the residue definitions are
currently different and pyraclostrobin
field trials in the U.S. show higher
residue levels than Codex MRL levels, it
is not possible to harmonize the U.S.
tolerance for globe artichoke with the
Codex MRL. Additionally, the following
U.S. crop group tolerances established
in this action could not be harmonized
because of the difference in residue
definitions between U.S. tolerances for
pyraclostrobin and Codex MRLs. The
crop group tolerances which could not
be harmonized with Codex MRLs for
commodities in these crop group
tolerances include: The bulb vegetable
group 3–07; the fruiting vegetables
group 8–10; the pome fruit group 11–10;
the caneberry subgroup 13–07A; the
bushberry subgroup 13–07B; the small
fruit vine climbing subgroup 13–07F;
and the low growing berry subgroup 13–
07G. The Codex has established an MRL
for the Codex equivalent of the U.S.
citrus fruit group 10–10 and for the
oilseed group 20, but although the
numerical levels for the U.S. and Codex
crop groups are the same, the numerical
values refer to different residues.
C. Revisions to Petitioned-for Tolerances
Based on the data submitted with the
petition, EPA is revising the proposed
tolerance in or on endive, belgium from
3.0 ppm to 4.0 ppm. The Agency revised
this tolerance level based on analysis of
the residue field trial data using the
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OECD tolerance calculation procedures.
EPA is additionally removing the timelimited tolerance in or on sugarcane,
cane at 0.02 ppm as it will be
superseded by the permanent tolerance
at 0.2 ppm. Finally, EPA is removing the
time-limited tolerance in or on
sugarcane, molasses at 0.4 ppm, as the
Agency has determined that no
concentration of pyraclostrobin residues
are expected in these commodities and
the tolerance is therefore not necessary.
The information regarding sugarcane,
molasses was included in the August
22, 2012 (77 FR 50661) notice of filing
for PP number 2F8038.
V. Conclusion
Therefore, tolerances are established
for residues of pyraclostrobin, carbamic
acid, [2-[[[1-(4-chlorophenyl)-1Hpyrazol-3yl]oxy]methyl]phenyl]methoxy-, methyl
ester) and its desmethoxy metabolite
(methyl N-[[[1-(4-chlorophenyl)-1Hpyrazol-3-yl]oxy]methyl]phenyl
carbamate), calculated as the
stoichiometric equivalent of
pyraclostrobin in or on artichoke, globe
at 3.0 ppm; endive, belgium at 4.0 ppm;
persimmon at 3.0 ppm; sugarcane, cane
at 0.20 ppm; vegetable, bulb, group 3–
07 at 0.9 ppm; vegetable, fruiting, group
8–10 at 1.4 ppm; fruit, citrus, group 10–
10 at 2.0 ppm; fruit, pome, group 11–10
at 1.5 ppm; oilseed group 20 at 0.45
ppm; caneberry subgroup 13–07A at 4.0
ppm; bushberry subgroup 13–07B at 4.0
ppm; fruit, small vine climbing, except
fuzzy kiwifruit, subgroup 13–07F at 2.0
ppm; and berry, low growing, subgroup
13–07G, except cranberry at 1.2 ppm.
This regulation additionally removes
established tolerances in or on
vegetable, bulb, group 3; vegetable,
fruiting, group 8; fruit, citrus, group 10;
fruit, pome, group 11; cotton,
undelinted seed; borage, seed; castor oil
plant, seed; Chinese tallowtree, seed;
crambe, seed; cuphea, seed; echium,
seed; euphorbia, seed; evening
primrose, seed; flax, seed; gold of
pleasure, seed; hare’s ear mustard, seed;
jojoba, seed; lesquerella, seed; lunaria,
seed; meadowfoam, seed; milkweed,
seed; mustard, seed; niger seed, seed; oil
radish, seed; poppy, seed; rapeseed,
seed; rose hip, seed; safflower, seed;
sesame, seed; stokes aster, seed;
sunflower, seed; sweet rocket, seed;
tallowwood, seed; tea oil plant, seed;
vernonia, seed; berry, group 13; grape;
and strawberry. This regulation finally
removes the time-limited tolerances in
or on sugarcane, cane and sugarcane,
molasses.
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VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children From Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
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as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 14, 2013.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.582:
a. Revise the table in paragraph (a)(1).
b. Remove the commodities
‘‘Sugarcane, cane’’ and ‘‘Sugarcane,
molasses’’ in the table in paragraph (b).
■ c. Revise the table in paragraph (b).
The revisions read as follows:
■
■
■
§ 180.582 Pyraclostrobin; tolerances for
residues.
(a) General. (1) * * *
Commodity
Parts per million
Alfalfa, forage .....................
Alfalfa, hay ..........................
Almond, hulls ......................
Apple, wet pomace .............
Artichoke, globe ..................
Avocado ..............................
Banana ...............................
Barley, grain .......................
Barley, hay ..........................
Barley, straw .......................
Bean, succulent shelled .....
Beet, sugar, dried pulp .......
Beet, sugar, roots ...............
Beet, sugar, tops ................
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10
30
7.0
8.0
3.0
0.6
0.04
1.4
25
6.0
0.5
1.0
0.2
8.0
Commodity
Berry, low growing, subgroup 13–07G, except
cranberry .........................
Brassica, head and stem,
subgroup 5A ....................
Brassica, leafy greens, subgroup 5B .........................
Bushberry subgroup 13–
07B ..................................
Caneberry subgroup 13–
07A ..................................
Canistel ...............................
Citrus, dried pulp ................
Citrus, oil .............................
Coffee, green bean .............
Corn, field, forage ...............
Corn, field, grain .................
Corn, field, refined oil .........
Corn, field, stover ...............
Corn, pop, grain ..................
Corn, pop, stover ................
Corn, sweet, forage ............
Corn, sweet, kernel plus
cob with husks removed
Corn, sweet, stover ............
Cotton, gin byproducts .......
Endive, belgium ..................
Fruit, citrus, group 10–10 ...
Fruit, pome, group 11–10 ...
Fruit, small vine climbing,
except fuzzy kiwifruit,
subgroup 13–07F ............
Fruit, stone, group 12 .........
Grain, aspirated fractions ...
Grape, raisin .......................
Grass, forage ......................
Grass, hay ..........................
Grass, seed screenings ......
Grass, straw .......................
Hop, dried cones ................
Mango .................................
Nut, tree, group 14 .............
Oat, grain ............................
Oat, hay ..............................
Oat, straw ...........................
Oilseed group 20 ................
Papaya ................................
Pea, succulent ....................
Pea and bean, dried
shelled, except soybean,
subgroup 6C ...................
Peanut ................................
Peanut, refined oil ..............
Peppermint, tops ................
Persimmon ..........................
Pistachio .............................
Radish, tops ........................
Rye, grain ...........................
Rye, straw ...........................
Sapodilla .............................
Sapote, black ......................
Sapote, mamey ..................
Sorghum, grain, forage .......
Sorghum, grain, grain .........
Sorghum, grain, stover .......
Soybean, forage .................
Soybean, hay ......................
Soybean, hulls ....................
Soybean, seed ....................
Spearmint, tops ..................
Star apple ...........................
Sugarcane, cane ................
Vegetable, bulb, group 3–
07 ....................................
E:\FR\FM\28AUR1.SGM
28AUR1
Parts per million
1.2
5.0
16.0
4.0
4.0
0.6
12.5
9.0
1 0.3
5.0
0.1
0.2
17.0
0.1
17.0
5.0
0.04
23.0
30
4.0
2.0
1.5
2.0
2.5
2.5
7.0
10
4.5
27
14
23.0
0.6
0.04
1.2
18
15
0.45
0.6
0.2
0.5
0.05
0.1
8.0
3.0
0.7
16
0.04
0.5
0.6
0.6
0.6
5.0
0.60
0.80
11
14
0.06
0.04
8.0
0.6
0.20
0.9
Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations
Commodity
Parts per million
Vegetable, cucurbit, group
9 ......................................
Vegetable, foliage of legume, except soybean,
subgroup 7A ....................
Vegetable, fruiting, group
8–10 ................................
Vegetable, leafy, except
brassica, group 4 ............
0.5
25.0
1.4
29.0
Commodity
Parts per million
Vegetable, leaves of root
and tuber, group 2, except sugar beet ...............
Vegetable, legume, edible
podded, subgroup 6A .....
Vegetable, root, except
sugar beet, subgroup 1B
Vegetable, tuberous and
corm, subgroup 1C .........
16.0
0.5
Commodity
53047
Parts per million
Vegetables, foliage of legume, group 7 ...................
Wheat, grain .......................
Wheat, hay .........................
Wheat, straw .......................
25
0.02
6.0
8.5
*
*
*
*
(b) Section 18 emergency exemptions.
0.04 * * *
0.4
*
Commodity
Parts per
million
Expiration/revocation date
Endive, belgium .......................................................................................................................................................
11.0
12/31/13
*
*
*
*
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotice@epa.gov.
SUPPLEMENTARY INFORMATION:
*
[FR Doc. 2013–20921 Filed 8–27–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0586; FRL–9393–8]
Halosulfuron-methyl; Pesticide
Tolerances
I. General Information
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of halosulfuronmethyl in or on artichoke and caneberry
subgroup 13–07A. The Interregional
Research Project Number 4 (IR–4)
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective
August 28, 2013. Objections and
requests for hearings must be received
on or before October 28, 2013, 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–2012–0586, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
wreier-aviles on DSK5TPTVN1PROD with RULES
DATES:
VerDate Mar<15>2010
14:52 Aug 27, 2013
Jkt 229001
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&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
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
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–2012–0586 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 October 28, 2013. 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–
2012–0586, by one of the following
methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
E:\FR\FM\28AUR1.SGM
28AUR1
Agencies
[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Rules and Regulations]
[Pages 53039-53047]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20921]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0549; FRL-9395-5]
Pyraclostrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
pyraclostrobin in or on multiple commodities which are identified and
discussed later in this document. This regulation additionally removes
several permanent and time-limited tolerances that will be superseded
by tolerances established by this action. Interregional Research
Project Number 4 (IR-4) and BASF Corporation requested tolerances
associated with pesticide petition (PP) numbers 2E8069 and 2F8038,
respectively, under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 28, 2013. Objections and
requests for hearings must be received on or before October 28, 2013,
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-2012-0549, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P),
[[Page 53040]]
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 305-7090; email address: RDFNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://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-2012-0549 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
October 28, 2013. 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-2012-0549, by one of
the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-for Tolerances
In the Federal Register of January 16, 2013 (78 FR 3377) (FRL-9375-
4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2E8069) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.582 be amended by
establishing tolerances for residues of the fungicide pyraclostrobin,
carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester and its metabolite methyl-
N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]otolyl] carbamate (BF 500-3),
expressed as the parent compound, in or on artichoke, globe at 3.0
parts per million (ppm); endive, belgium at 3.0 ppm; and persimmon at
3.0 ppm. The petition additionally requested that EPA establish
tolerances in or on vegetable, bulb, group 3-07 at 0.9 ppm; vegetable,
fruiting, group 8-10 at 1.4 ppm; fruit, citrus, group 10-10 at 2.0 ppm;
fruit, pome, group 11-10 at 1.5 ppm; oilseed, group 20 at 0.45 ppm;
caneberry subgroup 13-07A at 4.0 ppm; bushberry subgroup 13-07B at 4.0
ppm; small fruit, vine climbing subgroup (except fuzzy kiwi) 13-07F at
2.0 ppm; and low growing berry subgroup 13-07G at 1.2 ppm. Further,
upon approval of these subgroup/crop group tolerances the petition also
requested that the following existing tolerances be removed for berry,
group 13 at 4.0 ppm; fruit, citrus, group 10 at 2.0 ppm; fruit, pome,
group 11 at 1.5 ppm; grape at 2.0 ppm; strawberry at 1.2 ppm;
vegetable, bulb, group 3 at 0.9 ppm; vegetable, fruiting, group 8 at
1.4 ppm; borage, seed at 0.45 ppm; castor oil plant, seed at 0.45 ppm;
chinese tallowtree, seed at 0.45 ppm; crambe, seed at 0.45 ppm; cuphea,
seed at 0.45 ppm; echium, seed at 0.45 ppm; euphorbia, seed at 0.45
ppm; evening primrose, seed at 0.45 ppm; flax seed at 0.45 ppm; gold of
pleasure, seed at 0.45 ppm; hare's ear mustard, seed at 0.45 ppm,
jojoba, seed at 0.45 ppm; lesquerella, seed at 0.45 ppm, lunaria, seed
at 0.45 ppm; meadowfoam, seed at 0.45 ppm; milkweed, seed at 0.45 ppm;
mustard, seed at 0.45 ppm; niger seed, seed at 0.45 ppm; oil radish,
seed at 0.45 ppm; poppy, seed at 0.45 ppm; rapeseed, seed at 0.45 ppm;
rose hip, seed at 0.45 ppm; safflower, seed at 0.45 ppm; sesame, seed
at 0.45 ppm; stokes aster, seed at 0.45 ppm; sunflower, seed at 0.45
ppm; sweet rocket, seed at 0.45 ppm; tallowwood, seed at 0.45 ppm; tea
oil plant, seed at 0.45 ppm; and ternonia, seed at 0.45 ppm. That
document referenced a summary of the petition prepared on behalf of IR-
4 by BASF Corporation, the registrant, which is available in the
docket, https://www.regulations.gov. There were no comments received in
response to the notice of filing.
Additionally, in the Federal Register of August 22, 2012 (77 FR
50661) (FRL-9358-9), 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 2F8038) by BASF Corporation, 26 Davis Drive, P.O. Box
13528, Research Triangle Park, NC, 27709-3528. The petition requested
that 40 CFR 180.582 be amended by establishing tolerances for residues
of the fungicide pyraclostrobin, carbamic acid, expressed as the parent
compound, in or on sugarcane, cane at 0.2 ppm. No tolerances were
proposed for the processed commodities refined sugar and molasses, as
no concentration of pyraclostrobin residues are expected in these
commodities. That document referenced a summary of the petition
prepared by BASF Corporation, the registrant, which is available in the
docket, https://www.regulations.gov. There were no comments received in
response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance level in or on endive, belgium. Further,
the petitioner later requested to amend low growing berry subgroup 13-
07G to exclude cranberry. The reasons for these changes are explained
in Unit IV.C.
[[Page 53041]]
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 pyraclostrobin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pyraclostrobin
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.
There are no concerns for reproductive susceptibility,
neurotoxicity, mutagenicity, genotoxicity, or immunotoxicity. The most
consistently observed effects resulting from pyraclostrobin exposure
across species, genders, and treatment durations were diarrhea and
decreased body weight, body weight gain, and food consumption.
Pyraclostrobin also causes intestinal disturbances, as indicated by
increased incidence of diarrhea or duodenum mucosal thickening. These
intestinal effects appeared to be related to the irritating action on
the mucus membranes as demonstrated by irritation seen in the primary
eye irritation study. In the rat acute and subchronic neurotoxicity
studies, neuropathology and behavior changes were not observed.
In the rat developmental toxicity study, developmental toxicity
including an increased incidence of dilated renal pelvis and cervical
ribs occurred at a dose greater than the dose causing maternal toxicity
(including decreased body weights and body weight gains and reduced
food consumption and reduced food efficiency). The rabbit developmental
toxicity study indicates qualitative evidence of increased
developmental susceptibility based on increased resorptions per litter,
increased post-implantation loss and dams with total resorptions, in
the presence of maternal toxicity (reduced body weight gain, food
consumption, and food efficiency). In a dose range-finding one-
generation reproduction study, systemic toxicity was manifested as
decreased body weight and body weight gain in both the parents and
offspring. The effects occurred at the same dose levels for both
parental and the offspring, but the decrease in pup weight was more
than that in the parental animals. However, the body weight effect was
not found in the guideline 2-generation reproduction study in either
parental or offspring animals at similar dose level. No reproductive
toxicity was seen.
Pyraclostrobin has been classified as not likely to be carcinogenic
to humans based on the lack of treated related increase in tumor
incidence in adequately conducted carcinogenicity studies in rats and
mice. Pyraclostrobin did not cause mutagenicity or genotoxicity in the
in vivo and in vitro assays, nor did it cause immunotoxicity in T-cell
dependent antibody response assays in mice with preliminary review.
Specific information on the studies received and the nature of the
adverse effects caused by pyraclostrobin 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 https://www.regulations.gov in document: ``Pyraclostrobin--Human Health Risk
Assessment for a Section 3 Registration of New Uses on Sugarcane, Globe
Artichoke, Belgium Endive, Persimmon, Greenhouse Grown Tomato
Transplants for Home Consumer Market, and Residential Ornamentals,
Landscape Gardens, Fruit Trees, and Nut Trees; Plus Crop Group
Expansions/Revisions for Bulb Vegetable Group 3-07, Fruiting Vegetable
Group 8-10, Citrus Fruit Group 10-10, Pome Fruit Group 11-10, Berry
Subgroups 13-07A, B, F, and G, and Oilseed Group 20'' at pages 43-49 in
docket ID number EPA-HQ-OPP-2012-0549.
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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for pyraclostrobin used
for human risk assessment is shown in Table 1. of this unit.
[[Page 53042]]
Table 1--Summary of Toxicological Doses and Endpoints for Pyraclostrobin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 NOAEL = 5.0 mg/kg/ Acute RfD = 0.05 mg/ Developmental toxicity--rabbit.
years of age). day. kg/day. LOAEL = 10.0 mg/kg/day based on
UFA = 10x........... aPAD = 0.05 mg/kg/ developmental toxicity findings
UFH = 10x........... day. of increased resorptions.
FQPA SF = 1x........
Acute dietary (General population NOAEL = 300 mg/kg/ Acute RfD = 3.0 mg/ Acute neurotoxicity--rat. LOAEL =
including infants and children). day. kg/day. 1000 mg/kg/day based on decreased
UFA = 10 x.......... aPAD = 3.0 mg/kg/ body weight gain in males.
UFH = 10 x.......... day.
FQPA SF = 1x........
Chronic dietary (All populations) NOAEL= 3.4 mg/kg/day Chronic RfD = 0.034 Carcinogenicity--rat. LOAEL = 9.2
UFA = 10x........... mg/kg/day. mg/kg/day based on decreased body
UFH = 10 x.......... cPAD = 0.034 mg/kg/ weight/body weight gain, kidney
FQPA SF = 1x........ day. tubular casts and atrophy in both
sexes; increased incidence of
liver necrosis and erosion/
ulceration of the glandular-
stomach and fore-stomach in
males.
Incidental oral short-term (1 to NOAEL= 5.8 mg/kg/day LOC for MOE = 100.. Subchronic toxicity--dog. LOAEL =
30 days) and intermediate-term UFA = 10 x.......... 12.9 mg/kg/day based on increased
(1 to 6 months). UFH = 10x........... incidence of diarrhea, clinical
FQPA SF = 1x........ chemistry changes, duodenum
mucosal hypertrophy, and
decreased body weight and food
intake/efficiency.
Dermal short-term (1 to 30 days) Oral study NOAEL = LOC for MOE = 100.. Developmental toxicity--rabbit.
and intermediate-term (1 to 6 5.0 mg/kg/day LOAEL = 10.0 mg/kg/day based on
months). (dermal absorption developmental toxicity findings
rate = 14%). of increased resorptions and
UFA = 10 x.......... maternal toxicity based on
UFH = 10x........... decreased body weight gain and
FQPA SF = 1x........ decreased food intake/efficiency.
Inhalation short-term............ Inhalation study LOC for MOE = 100.. Inhalation toxicity--rat. LOAEL =
(1 to 30 days) and intermediate- NOAEL = 0.23 mg/kg/ 6.9 mg/kg/day (air concentration
term (1 to 6 months). day. = 0.03 mg/L) based on duodenum
UFA = 10 x.......... mucosal hyperplasia and
UFH = 10 x.......... respiratory system findings
FQPA SF = 1x........ including alveolar histiocytosis
and olfactory atrophy/necrosis in
nasal tissue.
------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``not likely to be carcinogenic to humans'' based on the
absence of significant tumor increases in two adequate rodent
carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyraclostrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing pyraclostrobin
tolerances in 40 CFR 180.582. EPA assessed dietary exposures from
pyraclostrobin 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 pyraclostrobin.
In estimating acute dietary exposure, EPA used Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID) Version 3.16, which uses food consumption data from the
U.S. Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003
through 2008. As to residue levels in food, EPA used tolerance-level
residues or highest field trial residues and empirical or default
processing factors. Experimentally-derived processing factors were used
for fruit juices, tomato, sugarcane, and wheat commodities. For all
other processed commodities, DEEM default processing factors were
assumed.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA included tolerance-
level or average field trial residues, average percent crop treated
(PCT) estimates when available, and empirical processing factors.
Experimentally-derived processing factors were used for fruit juices,
tomato, sugar cane, and wheat commodities. For all other processed
commodities, DEEM default processing factors were assumed.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that pyraclostrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Percent crop treated (PCT) information. 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.
[[Page 53043]]
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, 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.
The following average PCT estimates were used in the chronic
dietary risk assessments for the crops that are currently registered
for pyraclostrobin: almonds 40%; apples 15%; apricots 25%; barley 10%;
green beans 5%; blueberries 45%; broccoli 5%; cabbage 10%; caneberries
50%; cantaloupes 15%; carrots 35%; cauliflower 2.5%; celery 2.5%;
cherries 50%; corn 10%; cotton 2.5%; cucumber 5%; dry beans/peas 10%;
garlic 15%; grapefruit 25%; grapes 30%; hazelnuts (filberts) 15%;
lemons 2.5%; lettuce 5%; nectarines 10%; onions 20%; oranges 5%;
peaches 20%; peanuts 25%; pears 15%; green peas 5%; pecans 2.5%;
peppers 10%; pistachios 30%; plums/prunes 5%; potatoes 15%; pumpkins
20%; soybeans 5%; spinach 5%; squash 15%; strawberries 65%; sugar beets
45%; sweet corn 5%; tangelos 15%; tangerines 10%; tomatoes 25%; walnuts
1%; watermelons 30%; wheat 5%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
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 pyraclostrobin 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 pyraclostrobin in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of pyraclostrobin. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
pyraclostrobin for acute exposures are estimated to be 35.6 parts per
billion (ppb) for surface water and 0.06 ppb for ground water. Chronic
exposures for non-cancer assessments are estimated to be 2.3 ppb for
surface water and 0.02 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 35.6 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 2.3 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). Pyraclostrobin is
currently registered for the following uses and additional proposed
uses that could result in residential handler and postapplication
exposures: Treated gardens, fruit or nut trees, tomato transplants, and
turf. EPA assessed residential exposure using the following
assumptions: Short-term adult handler exposures via the dermal and
inhalation routes resulting from application of pyraclostrobin to
gardens, trees, and turf. Short-term dermal postapplication exposures
were assessed for adults, youth 11 to 16 years old, and children 6 to
11 years old. Short-term dermal and incidental oral exposures were
assessed for children 1 to < 2 years old. Based on the registered uses
of pyraclostrobin on residential and golf course turf, intermediate-
term postapplication exposures are possible. However, since the short-
and intermediate-term endpoints and PODs for dermal and oral routes are
the same, the short-term exposure and risk estimates are considered to
be protective of potential intermediate-term exposure and risk.
For the aggregate assessment, inhalation and dermal exposures were
not aggregated together because the toxicity effect from the inhalation
route of exposure was different than the effect from the dermal route
of exposure. The scenarios with the highest residential exposures that
were used in the short-term aggregate assessment for pyraclostrobin are
as follows:
Adult short-term aggregate assessment--Residential
inhalation exposure from application pyraclostrobin to turf via
manually pressurized hand wand or backpack sprayer; residential dermal
postapplication exposure via activities on treated turf.
Youth (11-16 years old) short-term aggregate assessment--
Residential dermal exposure from postapplication golfing on treated
turf.
Children (6-11 years old) short-term aggregate
assessment--Residential dermal exposures from postapplication
activities in treated gardens.
Children (1 < 2 years old) short-term aggregate
assessment--Residential dermal and hand-to-mouth exposures from
postapplication exposure to treated turf.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA
[[Page 53044]]
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 pyraclostrobin to share a common mechanism of
toxicity with any other substances, and pyraclostrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
pyraclostrobin 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 https://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. There is no evidence that
pyraclostrobin results in increased susceptibility in rats or rabbits
in the prenatal developmental studies or in young rats in the 2-
generation reproduction study. Although there is qualitative evidence
of increased susceptibility in the prenatal development study in
rabbits, the Agency did not identify any residual uncertainties after
establishing toxicity endpoints and traditional UFs to be used in the
risk assessment of pyraclostrobin. The degree of concern for prenatal
and/or postnatal toxicity is low.
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 pyraclostrobin is complete.
ii. There is no indication that pyraclostrobin is a neurotoxic
chemical. Effects seen in the acute and subchronic neurotoxicity
studies in rats are considered to reflect perturbations in
mitochondrial respiration leading to effects on energy production
rather than signs of neurotoxicity; therefore, there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity
iii. There is no evidence that pyraclostrobin results in increased
susceptibility in rats in the prenatal developmental study or in young
rats in the 2-generation reproduction study. The prenatal rabbit
developmental toxicity study showed qualitative evidence of increased
susceptibility to prenatal rabbits; however, this study was chosen for
endpoint selection for the acute dietary (females 13-49) and short-term
dermal exposure scenarios. This study has a clearly defined NOAEL of
5.0 mg/kg/day. EPA did not identify any residual uncertainties after
establishing toxicity endpoints and traditional UFs to be used in the
risk assessment of pyraclostrobin. The degree of concern for prenatal
and/or postnatal toxicity is low.
iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary exposure assessments were performed
assuming 100 PCT and tolerance-level or highest field trial residues.
The chronic dietary exposure assessments were performed using average
PCT estimates, when available, and tolerance-level or highest field
trial residues. These data are reliable and are not expected to
underestimate risks to adults or children. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to pyraclostrobin in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
pyraclostrobin.
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. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
pyraclostrobin will occupy 87% of the aPAD for females 13-49 years old;
and 2.8% for children 1-2 years old, the population group receiving the
greatest exposure for the general U.S. population, including infants
and children.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyraclostrobin from food and water will utilize 27% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
pyraclostrobin is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Pyraclostrobin is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to pyraclostrobin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 120 for children
1-2 years old, 360 for children 6-11 years old, 1,500 for youth 11-16
years old, 760 for adult handlers, and 230 for adults from
postapplication exposures. Because EPA's level of concern for
pyraclostrobin is a MOE of 100 or below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Pyraclostrobin is currently registered for uses that could
result in intermediate-term residential exposure; however, since the
short- and intermediate-term endpoints and PODs for dermal and oral
routes are the same, the short-term exposure and risk estimates are
considered to be protective of potential
[[Page 53045]]
intermediate-term exposure and risk and an intermediate-term aggregate
assessment was not performed.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, pyraclostrobin is not expected to pose a cancer risk to
humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to pyraclostrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Two adequate methods are available to enforce the tolerance
expression for residues of pyraclostrobin and the metabolite BF 500-3
in or on plant commodities: A liquid chromatography with tandem mass
spectrometry (LC/MS/MS) method, BASF Method D9908; and a high-
performance LC with ultraviolet detection (HPLC/UV) method, Method
D9904. The methods may be found in the Pesticide Analytical Manual,
Volume I.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for pyraclostrobin in or on
sugarcane, endive, belgium, and persimmon. A Codex MRL has been
established for pyraclostrobin in or on globe artichoke at 2.0 ppm. EPA
has determined that the U.S. tolerance should be set at 3.0 ppm. The
field trials comprising the data set used by Codex are from Europe, and
these trials were conducted under an application rate and preharvest
interval different from that on the U.S. trials. The U.S. tolerance is
based on application of the Organization for Economic Cooperation and
Development (OECD) tolerance calculation procedures to the validated
field trial data, which shows that the U.S. tolerance for globe
artichoke must be at 3.0 ppm to avoid violations for crops treated in
accordance with the EPA approved label. These different tolerance
levels may be due, in part, to the different residue definitions for
pyraclostrobin for the U.S. tolerances and the Codex MRLs. Codex
established MRLs for residues of pyraclostrobin only, and in the U.S.
tolerances, are currently established for parent and its desmethoxy
metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]
phenylcarbamate). Currently, pyraclostrobin has over 100 tolerances for
multiple commodities and crop groups. When this chemical goes through
registration review the U.S. EPA will determine if it is possible to
change the existing residue definition to align with Codex which would
potentially allow for harmonization of MRL and tolerance levels.
However, given the number of existing tolerances it is not appropriate
to consider such a change for this petition only. Therefore, because
the residue definitions are currently different and pyraclostrobin
field trials in the U.S. show higher residue levels than Codex MRL
levels, it is not possible to harmonize the U.S. tolerance for globe
artichoke with the Codex MRL. Additionally, the following U.S. crop
group tolerances established in this action could not be harmonized
because of the difference in residue definitions between U.S.
tolerances for pyraclostrobin and Codex MRLs. The crop group tolerances
which could not be harmonized with Codex MRLs for commodities in these
crop group tolerances include: The bulb vegetable group 3-07; the
fruiting vegetables group 8-10; the pome fruit group 11-10; the
caneberry subgroup 13-07A; the bushberry subgroup 13-07B; the small
fruit vine climbing subgroup 13-07F; and the low growing berry subgroup
13-07G. The Codex has established an MRL for the Codex equivalent of
the U.S. citrus fruit group 10-10 and for the oilseed group 20, but
although the numerical levels for the U.S. and Codex crop groups are
the same, the numerical values refer to different residues.
C. Revisions to Petitioned-for Tolerances
Based on the data submitted with the petition, EPA is revising the
proposed tolerance in or on endive, belgium from 3.0 ppm to 4.0 ppm.
The Agency revised this tolerance level based on analysis of the
residue field trial data using the OECD tolerance calculation
procedures. EPA is additionally removing the time-limited tolerance in
or on sugarcane, cane at 0.02 ppm as it will be superseded by the
permanent tolerance at 0.2 ppm. Finally, EPA is removing the time-
limited tolerance in or on sugarcane, molasses at 0.4 ppm, as the
Agency has determined that no concentration of pyraclostrobin residues
are expected in these commodities and the tolerance is therefore not
necessary. The information regarding sugarcane, molasses was included
in the August 22, 2012 (77 FR 50661) notice of filing for PP number
2F8038.
V. Conclusion
Therefore, tolerances are established for residues of
pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H- pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy
metabolite (methyl N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl carbamate), calculated as the stoichiometric
equivalent of pyraclostrobin in or on artichoke, globe at 3.0 ppm;
endive, belgium at 4.0 ppm; persimmon at 3.0 ppm; sugarcane, cane at
0.20 ppm; vegetable, bulb, group 3-07 at 0.9 ppm; vegetable, fruiting,
group 8-10 at 1.4 ppm; fruit, citrus, group 10-10 at 2.0 ppm; fruit,
pome, group 11-10 at 1.5 ppm; oilseed group 20 at 0.45 ppm; caneberry
subgroup 13-07A at 4.0 ppm; bushberry subgroup 13-07B at 4.0 ppm;
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at
2.0 ppm; and berry, low growing, subgroup 13-07G, except cranberry at
1.2 ppm. This regulation additionally removes established tolerances in
or on vegetable, bulb, group 3; vegetable, fruiting, group 8; fruit,
citrus, group 10; fruit, pome, group 11; cotton, undelinted seed;
borage, seed; castor oil plant, seed; Chinese tallowtree, seed; crambe,
seed; cuphea, seed; echium, seed; euphorbia, seed; evening primrose,
seed; flax, seed; gold of pleasure, seed; hare's ear mustard, seed;
jojoba, seed; lesquerella, seed; lunaria, seed; meadowfoam, seed;
milkweed, seed; mustard, seed; niger seed, seed; oil radish, seed;
poppy, seed; rapeseed, seed; rose hip, seed; safflower, seed; sesame,
seed; stokes aster, seed; sunflower, seed; sweet rocket, seed;
tallowwood, seed; tea oil plant, seed; vernonia, seed; berry, group 13;
grape; and strawberry. This regulation finally removes the time-limited
tolerances in or on sugarcane, cane and sugarcane, molasses.
[[Page 53046]]
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children From Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 14, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.582:
0
a. Revise the table in paragraph (a)(1).
0
b. Remove the commodities ``Sugarcane, cane'' and ``Sugarcane,
molasses'' in the table in paragraph (b).
0
c. Revise the table in paragraph (b).
The revisions read as follows:
Sec. 180.582 Pyraclostrobin; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage......................................... 10
Alfalfa, hay............................................ 30
Almond, hulls........................................... 7.0
Apple, wet pomace....................................... 8.0
Artichoke, globe........................................ 3.0
Avocado................................................. 0.6
Banana.................................................. 0.04
Barley, grain........................................... 1.4
Barley, hay............................................. 25
Barley, straw........................................... 6.0
Bean, succulent shelled................................. 0.5
Beet, sugar, dried pulp................................. 1.0
Beet, sugar, roots...................................... 0.2
Beet, sugar, tops....................................... 8.0
Berry, low growing, subgroup 13-07G, except cranberry... 1.2
Brassica, head and stem, subgroup 5A.................... 5.0
Brassica, leafy greens, subgroup 5B..................... 16.0
Bushberry subgroup 13-07B............................... 4.0
Caneberry subgroup 13-07A............................... 4.0
Canistel................................................ 0.6
Citrus, dried pulp...................................... 12.5
Citrus, oil............................................. 9.0
Coffee, green bean...................................... \1\ 0.3
Corn, field, forage..................................... 5.0
Corn, field, grain...................................... 0.1
Corn, field, refined oil................................ 0.2
Corn, field, stover..................................... 17.0
Corn, pop, grain........................................ 0.1
Corn, pop, stover....................................... 17.0
Corn, sweet, forage..................................... 5.0
Corn, sweet, kernel plus cob with husks removed......... 0.04
Corn, sweet, stover..................................... 23.0
Cotton, gin byproducts.................................. 30
Endive, belgium......................................... 4.0
Fruit, citrus, group 10-10.............................. 2.0
Fruit, pome, group 11-10................................ 1.5
Fruit, small vine climbing, except fuzzy kiwifruit, 2.0
subgroup 13-07F........................................
Fruit, stone, group 12.................................. 2.5
Grain, aspirated fractions.............................. 2.5
Grape, raisin........................................... 7.0
Grass, forage........................................... 10
Grass, hay.............................................. 4.5
Grass, seed screenings.................................. 27
Grass, straw............................................ 14
Hop, dried cones........................................ 23.0
Mango................................................... 0.6
Nut, tree, group 14..................................... 0.04
Oat, grain.............................................. 1.2
Oat, hay................................................ 18
Oat, straw.............................................. 15
Oilseed group 20........................................ 0.45
Papaya.................................................. 0.6
Pea, succulent.......................................... 0.2
Pea and bean, dried shelled, except soybean, subgroup 6C 0.5
Peanut.................................................. 0.05
Peanut, refined oil..................................... 0.1
Peppermint, tops........................................ 8.0
Persimmon............................................... 3.0
Pistachio............................................... 0.7
Radish, tops............................................ 16
Rye, grain.............................................. 0.04
Rye, straw.............................................. 0.5
Sapodilla............................................... 0.6
Sapote, black........................................... 0.6
Sapote, mamey........................................... 0.6
Sorghum, grain, forage.................................. 5.0
Sorghum, grain, grain................................... 0.60
Sorghum, grain, stover.................................. 0.80
Soybean, forage......................................... 11
Soybean, hay............................................ 14
Soybean, hulls.......................................... 0.06
Soybean, seed........................................... 0.04
Spearmint, tops......................................... 8.0
Star apple.............................................. 0.6
Sugarcane, cane......................................... 0.20
Vegetable, bulb, group 3-07............................. 0.9
[[Page 53047]]
Vegetable, cucurbit, group 9............................ 0.5
Vegetable, foliage of legume, except soybean, subgroup 25.0
7A.....................................................
Vegetable, fruiting, group 8-10......................... 1.4
Vegetable, leafy, except brassica, group 4.............. 29.0
Vegetable, leaves of root and tuber, group 2, except 16.0
sugar beet.............................................
Vegetable, legume, edible podded, subgroup 6A........... 0.5
Vegetable, root, except sugar beet, subgroup 1B......... 0.4
Vegetable, tuberous and corm, subgroup 1C............... 0.04
Vegetables, foliage of legume, group 7.................. 25
Wheat, grain............................................ 0.02
Wheat, hay.............................................. 6.0
Wheat, straw............................................ 8.5
------------------------------------------------------------------------
* * * * *
(b) Section 18 emergency exemptions. * * *
------------------------------------------------------------------------
Parts per Expiration/
Commodity million revocation date
------------------------------------------------------------------------
Endive, belgium....................... 11.0 12/31/13
------------------------------------------------------------------------
* * * * *
[FR Doc. 2013-20921 Filed 8-27-13; 8:45 am]
BILLING CODE 6560-50-P