Fluxapyroxad; Pesticide Tolerances, 27019-27025 [2016-10581]
Download as PDF
Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations
Authority: 42 U.S.C. 7401 et seq.
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
Subpart N—Idaho
2. In § 52.670, the table in paragraph
(e) is amended by adding an entry at the
end of the table for ‘‘Interstate Transport
■
1. The authority citation for part 52
continues to read as follows:
■
27019
Requirements for the 2010 NO2
NAAQS’’ to read as follows:
§ 52.670
*
Identification of plan.
*
*
(e) * * *
*
*
EPA-APPROVED IDAHO NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES
Name of SIP provision
Applicable geographic or
non-attainment area
*
*
*
Interstate Transport Require- State-wide ............................
ments for the 2010 NO2
NAAQS.
*
*
*
*
State
submittal date
*
12/24/2015
EPA Approval date
*
5/5/2016 [Insert Federal
Register citation].
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0324; FRL–9945–48]
C. How can I file an objection or hearing
request?
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 6560–50–P
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2015–0324 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 July 5, 2016. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2015–0324, 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
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
Fluxapyroxad; Pesticide Tolerances
SUPPLEMENTARY INFORMATION:
Environmental Protection
Agency (EPA).
ACTION: Final rule.
I. General Information
This regulation establishes
tolerances for residues of fluxapyroxad
in or on multiple commodities which
are identified and discussed later in this
document. BASF Corporation requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
5, 2016. Objections and requests for
hearings must be received on or before
July 5, 2016, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0324, 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), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
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).
AGENCY:
ehiers on DSK5VPTVN1PROD with RULES
SUMMARY:
13:35 May 04, 2016
*
*
This action addresses the following
CAA
elements:
110(a)(2)(D)(i)(I).
information about the docket available
at https://www.epa.gov/dockets.
*
[FR Doc. 2016–10452 Filed 5–4–16; 8:45 am]
VerDate Sep<11>2014
Comments
Jkt 238001
A. Does this action apply to me?
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. To access the OCSPP test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
E:\FR\FM\05MYR1.SGM
05MYR1
27020
Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations
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.
ehiers on DSK5VPTVN1PROD with RULES
II. Summary of Petitioned-for Tolerance
In the Federal Register of August 26,
2015 (80 FR 51759) (FRL–9931–74),
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 5F8344) by BASF
Corporation, 26 Davis Drive, Research
Triangle Park, NC 27709. The petition
requested that 40 CFR 180.666 be
amended by establishing tolerances for
residues of the fungicide fluxapyroxad,
in or on citrus, dried pulp at 2.7 parts
per million (ppm); citrus oil at 19 ppm;
fruit, citrus group 10–10 at 1.0 ppm;
grass forage, fodder and hay group 17 at
30 ppm; non-grass animal feed, group
18 at 30 ppm; and poultry, fat at 0.005
ppm. The petition also requested that
the existing tolerance for residues of
fluxapyroxad on egg be amended from
0.002 ppm to 0.01 ppm and that the
tolerance for inadvertent residues of
fluxapyroxad on nongrass animal feeds,
group 18 at 0.3 ppm be removed upon
establishment of the superceding group
18 tolerance. 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
recommended tolerances for poultry
meat, poultry meat byproduct, and milk
fat for which there were no established
tolerances previously due to low dietary
burden and falling under category 3 of
CFR 180.6(a). The reason for these
changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
VerDate Sep<11>2014
13:35 May 04, 2016
Jkt 238001
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 fluxapyroxad
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with fluxapyroxad 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.
Fluxapyroxad is of low acute toxicity
by the oral, dermal and inhalation
routes, is not irritating to the eyes and
skin, and is not a dermal sensitizer. The
primary target organ for fluxapyroxad
exposure via the oral route is the liver
with secondary toxicity in the thyroid
for rats only. Liver toxicity was
observed in rats, mice, and dogs, with
rats as the most sensitive species for all
durations of exposure. In rats, adaptive
effects of hepatocellular hypertrophy
and increased liver weights and changes
in liver enzyme activities were first
observed. As the dose or duration of
exposure to fluxapyroxad increased,
clinical chemistry changes related to
liver function also occurred, followed
by hepatocellular necrosis, neoplastic
changes in the liver, and tumors.
Thyroid effects were observed only in
rats. These effects were secondary to
changes in liver enzyme regulation,
which increased metabolism of thyroid
hormone, resulting in changes in
thyroid hormones, thyroid follicular
hypertrophy and hyperplasia, and
thyroid tumor formation. Tumors were
not observed in species other than rats
or in organs other than the liver and
thyroid.
Fluxapyroxad is classified as ‘‘Not
likely to be Carcinogenic to Humans’’
based on convincing evidence that
carcinogenic effects are not likely below
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
a defined dose range. There is no
mutagenicity concern from in vivo or in
vitro assays. The hypothesized mode of
action (i.e., a non-genotoxic) for
treatment related tumors (i.e., the liver
and thyroid) was supported by a full
panel of in vitro and in vivo studies that
showed no evidence of genotoxicity,
together with mechanistic studies in the
liver and thyroid of rats that satisfied
stringent criteria for establishing
tumorigenic modes of action. The
studies clearly identified the sequence
of key events, dose-response
concordance and temporal relationship
to the tumor types. The Agency has
determined that the chronic population
adjusted dose (PAD) will adequately
account for all chronic effects, including
carcinogenicity that could result from
exposure to fluxapyroxad because the
points of departure (POD) for the
chronic population adjusted dose
(cPAD) is based on the most sensitive
endpoint, liver effects. Effects in the
liver preceded liver tumors and the
effects observed in the thyroid (in rats
only) were believed to be secondary to
the liver effects.
No evidence of neurotoxicity was
observed in response to repeated
administration of fluxapyroxad. An
acute neurotoxicity study showed
decreased rearing and motor activity.
This occurred on the day of dosing only
and in the absence of histopathological
effects or alterations in brain weights.
This indicated that any neurotoxic
effects of fluxapyroxad are likely to be
transient and reversible due to
alterations in neuropharmacology and
not from neuronal damage. There were
no neurotoxic effects observed in the
subchronic dietary toxicity study. No
evidence of reproductive toxicity was
observed. Developmental effects
observed in both rats and mice (thyroid
follicular hypertrophy and hyperplasia
in rats and decreased defecation, food
consumption, body weight/body weight
gain, and increased litter loss in rabbits)
occurred at the same doses as those that
caused adverse effects in maternal
animals, indicating no quantitative
susceptibility. Since the maternal
toxicities of thyroid hormone
perturbation in rats and systemic
toxicity in rabbits likely contributed to
the observed developmental effects
there is low concern for qualitative
susceptibility. An immunotoxicity study
in mice showed no evidence of
immunotoxic effects from fluxapyroxad.
Subchronic oral toxicity studies in
rats, developmental toxicity studies in
rabbits, and in vitro and in vivo
genotoxicity studies were performed for
fluxapyroxad metabolites F700F001,
M700F002, and M700F048. Like
E:\FR\FM\05MYR1.SGM
05MYR1
Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document,
‘‘Human Health Risk Assessment for
Use of Fluxaproxad on Citrus Crop
Group 10–10, Grass Crop Group 17, and
Non-Grass Crop Group 18.’’ on pp. 56 in
docket ID number EPA–HQ–OPP–2012–
0638.
fluxapyroxad, no genotoxic effects were
observed for any of these metabolites.
All three metabolites displayed lower
subchronic toxicity via the oral route
than fluxapyroxad, with evidence of
non-specific toxicity (decreased body
weight) observed only for M700F0048 at
the limit dose. Only M700F0048
exhibited developmental toxicity at
doses similar to those that caused
developmental effects in rabbits with
fluxapyroxad treatment. However, these
effects (abortions and resorptions) were
of a different nature than for
fluxapyroxad (paw hyperflexion) and
are considered secondary to maternal
toxicity. The Agency considers these
studies sufficient for hazard
identification and characterization and
concludes that these metabolites do not
have hazards that exceed those of
fluxapyroxad in nature, severity, or
potency.
Specific information on the studies
received and the nature of the adverse
effects caused by fluxapyroxad as well
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
27021
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.
Summary of the toxicological
endpoints for used for human risk
assessment is shown in Table 1 of this
unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUXAPYROXAD FOR USE IN DIETARY, RESIDENTIAL
AND NON-OCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS
RfD, PAD, level
of concern
for risk
assessment
Study and toxicological effects
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 1.25
mg/kg/day.
aPAD = 1.25 mg/
kg/day
Acute neurotoxicity study in rats.
LOAEL = 500 mg/kg/day based on decreased motor
activity (both sexes) and decreased rearing (males
only).
NOAEL = 2.1 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic
RfD = 0.021
mg/kg/day.
cPAD = 0.021 mg/
kg/day
Chronic toxicity/carcinogenicity study in rats.
LOAEL = 11 mg/kg/day based on non-neoplastic
changes in the liver (foci, masses).
NOAEL = 7.3mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Residential LOC
for MOE = 100.
90-day dietary study in rats.
MIRD 47923567.
LOAEL = 35.1 mg/kg/day based on thyroid follicular
hypertrophy/hyperplasia.
Uncertainty/FQPA
safety
factors
Exposure/scenario
Point of
departure
Acute Dietary (General Population, including Infants
and Children and Females 13–49 years of
age).
NOAEL = 125 mg/
kg/day.
Chronic Dietary (All Populations).
Incidental Oral Short-Term
(1–30 days).
Dermal Short- and Intermediate-Term.
Inhalation, Short-Term (1–
30 days) and Intermediate-term (1–6
months).
No hazard identified.
NOAEL = 7.3 mg/
kg/day.
ehiers on DSK5VPTVN1PROD with RULES
Cancer (oral, dermal, inhalation).
UFA = 10x
UFH = 10x
FQPA SF = 1x
Residential LOC
for MOE = 100.
90-day dietary study in rats.
MIRD 47923567.
LOAEL = 35.1 mg/kg/day based on thyroid follicular
hypertrophy/hyperplasia.
Classification: Not likely to be carcinogenic to humans below a defined dose range.
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect
level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOA = mode of action.
VerDate Sep<11>2014
17:38 May 04, 2016
Jkt 238001
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
E:\FR\FM\05MYR1.SGM
05MYR1
27022
Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations
ehiers on DSK5VPTVN1PROD with RULES
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fluxapyroxad, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing fluxapyroxad tolerances in 40
CFR 180.666. EPA assessed dietary
exposures from fluxapyroxad 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 fluxapyroxad. In estimating acute
dietary exposure, EPA used food
consumption information from the
United States Department of Agriculture
(USDA) 2003–2008 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels
in food, EPA used tolerance-level
residues adjusted to account for the
metabolites of concern (M700F008, and
M700F010 (milk only)) and 100 percent
crop treated (PCT) assumptions were
used. DEEM default and empirical
processing factors were used to modify
the tolerance values.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 2003–2008 CSFII. As to
residue levels in food, a moderately
refined chronic dietary exposure
analysis was performed for the general
U.S. population and various population
subgroups. Combined average residue
for parent and highest residue for
metabolite M700F008 and 100 PCT
assumptions were used. For livestock
commodities tolerance-level residues
adjusted to account for the metabolites
of concern (M700F008, M700F010) were
used. An assumption of 100 PCT was
also used for the chronic dietary
analysis. DEEM default and empirical
processing factors were used to modify
the tolerance values.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that fluxapyroxad does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. Section
408(b)(2)(E) of FFDCA authorizes EPA
to use available data and information on
the anticipated residue levels of
pesticide residues in food and the actual
levels of pesticide residues that have
been measured in food. If EPA relies on
such information, EPA must require
VerDate Sep<11>2014
13:35 May 04, 2016
Jkt 238001
pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the
tolerance is established, modified, or
left in effect, demonstrating that the
levels in food are not above the levels
anticipated. For the present action, EPA
will issue such data call-ins as are
required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section
408(f)(1). Data will be required to be
submitted no later than 5 years from the
date of issuance of these tolerances.
The Agency did not use PCT
information in the dietary assessment
for fluxapyroxad; 100 PCT was assumed
for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening-level
water exposure models in the dietary
exposure analysis and risk assessment
for fluxapyroxad in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
fluxapyroxad. 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 Ground Water (PRZM GW), the
estimated drinking water concentrations
(EDWCs) of fluxapyroxad for acute
exposures are 127 ppb parts per billion
(ppb) for surface water and 203 ppb for
ground water. The EDWCs for chronic
exposures for non-cancer assessments
are 127 ppb for surface water and 188
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 203 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration
value of 184 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,
indoor pest control, termiticides, and
flea and tick control on pets).
There are no residential exposure
associated with the proposed uses in
this action; however, there are existing
turf uses that were previously assessed
for fluxapyroxad. Although the Agency
had conducted a residential exposure
assessment for previous fluxapyroxad
actions, the Agency completed an
updated turf assessment to reflecting an
update in the single maximum
application rate from 2.47 pounds active
ingredient/gallon (lb ai/gallon) to 0.005
lb ai/gallon. The present assessment
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
assumed the following exposure
scenarios:
• Residential handler: The Agency
assessed inhalation exposures to adults
from applications only because
fluxapyroxad does not pose a dermal
risk. Residential handler exposure is
expected to be short-term in duration.
Intermediate-term exposures are not
likely because of the intermittent nature
of applications by homeowners.
• Post-application exposures: Dermal
exposures were not assessed because
there is no identified systemic dermal
hazard for fluxapyroxad. Postapplication inhalation exposure while
engaged in activities on or around
previously treated turf is generally not
quantitatively assessed. The
combination of low vapor pressure for
chemicals typically used as active
ingredients in outdoor residential
pesticide products and dilution in
outdoor air is likely to result in minimal
inhalation exposure. Incidental oral
exposure for children is anticipated.
The quantitative oral exposure/risk
assessment for residential postapplication exposures is based on the
incidental oral scenario for children
1<2.
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
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 fluxapyroxad to
share a common mechanism of toxicity
with any other substances, and
fluxapyroxad does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that fluxapyroxad 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
E:\FR\FM\05MYR1.SGM
05MYR1
ehiers on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations
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.
No evidence of quantitative
susceptibility was observed in a
reproductive and developmental
toxicity study in rats or in
developmental toxicity studies in rats
and rabbits. Developmental toxicity data
in rats showed decreased body weight
and body weight gain in the offspring at
the same dose levels that caused thyroid
follicular hypertrophy/hyperplasia in
parental animals. Effects in rabbits were
limited to paw hyperflexion, a
malformation that is not considered to
result from a single exposure and that
usually reverses as the animal matures.
Developmental effects observed in both
rats and rabbits occurred at the same
doses as those that caused adverse
effects in maternal animals, indicating
no quantitative susceptibility. The
Agency has low concern for
developmental toxicity because the
observed effects were of low severity,
were likely secondary to maternal
toxicity, and demonstrated clear
NOAELs. Further, the NOAELs for these
effects were at dose levels higher than
the points of departure selected for risk
assessment for repeat-exposure
scenarios. Therefore, based on the
available data and the selection of risk
assessment endpoints that are protective
of developmental effects, there are no
residual uncertainties with regard to
pre- and/or postnatal toxicity.
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
fluxapyroxad is complete.
ii. There is no indication that
fluxapyroxad is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity. Although an acute
neurotoxicity study showed decreased
rearing and motor activity, this occurred
on the day of dosing only in the absence
VerDate Sep<11>2014
13:35 May 04, 2016
Jkt 238001
of histopathological effects or alterations
in brain weights. This indicated that any
neurotoxic effects of fluxapyroxad are
likely to be transient and reversible due
to alterations in neuropharmacology and
not from neuronal damage. The Agency
has low concern for neurotoxic effects of
fluxapyroxad at any life stage.
iii. Based on the developmental and
reproductive toxicity studies discussed
in Unit III.D.2., there are no residual
uncertainties with regard to prenatal
and/or postnatal toxicity.
iv. There are no residual uncertainties
identified in the exposure databases.
The residue database is adequate. The
dietary risk assessment is conservative
and will not underestimate dietary
exposure to fluxapyroxad. There are
residential uses proposed for
fluxapyroxad and the assessment will
not underestimate residential exposure
via handler for adults and incidental
oral for children. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to fluxapyroxad
in drinking water. EPA used similarly
conservative assumptions to assess post
application exposure of children as well
as incidental oral exposure of toddlers.
There are residential uses proposed for
fluxapyroxad and the assessment will
not underestimate residential exposure
via handler for adults and incidental
oral for children.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
fluxapyroxad will occupy 12% of the
aPAD for children 1–2 years old, the
population group receiving the greatest
exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to fluxapyroxad
from food and water will utilize 66% of
the cPAD for infants (< 1 year old).
Based on the explanation in Unit
III.C.3., regarding residential use
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
27023
patterns, chronic residential exposure to
residues of fluxapyroxad 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).
Fluxapyroxad 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 fluxapyroxad. 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 1139 for
adults and 431 for children. Because
EPA’s level of concern for fluxapyroxad
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). An
intermediate-term adverse effect was
identified; however, fluxapyroxad is not
registered for any use patterns that
would result in intermediate-term
residential exposure. Intermediate-term
risk is assessed based on intermediateterm residential exposure plus chronic
dietary exposure. Because there is no
intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD (which is
at least as protective as the POD used to
assess intermediate-term risk), no
further assessment of intermediate-term
risk is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating intermediate-term risk for
fluxapyroxad.
5. Aggregate cancer risk for U.S.
population. As discussed in Unit III.A.,
EPA has classified fluxapyroxad as ‘‘Not
likely to be Carcinogenic to Humans’’
based on convincing evidence that
carcinogenic effects are not likely below
a defined dose range. The Agency has
determined that the quantification of
risk using the cPAD for fluxapyroxad
will adequately account for all chronic
toxicity, including carcinogenicity that
could result from exposure to
fluxapyroxad. Because the Agency has
determined fluxapyroxad will not cause
a chronic risk, the Agency concludes
that fluxapyroxad will not pose a cancer
risk for the U.S. population.
6. Determination of safety. Based on
these risk assessments, EPA concludes
E:\FR\FM\05MYR1.SGM
05MYR1
27024
Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to fluxapyroxad
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
There are suitable residue analytical
methods available for enforcement of
fluxapyroxad tolerances (BASF Methods
L0137/01 for plants and L0140/02 for
animal matrices) which have been
radio-validated and have underwent
successful validation by an independent
laboratory. These are liquid
chromatography with tandem mass
spectrometry (LC/MS/MS) methods and
monitor two ion transitions. The Limit
of Quantitation (LOQ) for BASF method
L0137/01 is 0.01 ppm for various
matrices. The LOQ for BASF method
L0140/02 is 0.01 ppm for liver and
muscle, and 0.001 ppm for milk and
eggs.
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
ehiers on DSK5VPTVN1PROD with RULES
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
There are no Codex MRLs for citrus or
grass and non-grass animal feed at
present. US and Codex use different
dietary burden evaluations and
calculations which result in US
tolerances for residues in ruminant meat
byproduct, milk, and milk fat generally
much lower than corresponding Codex
MRLs.
VerDate Sep<11>2014
13:35 May 04, 2016
Jkt 238001
C. Revisions to Petitioned-for Tolerances
EPA is establishing tolerances for
milk fat and poultry meat, and meat
byproduct that the applicant did not
request. There have been no established
tolerances for poultry tissues because
residues were not expected to be found
in those tissues due to the low dietary
burden; i.e., category 3 of 40 CFR
180.6(a) applied for those poultry
matrices previously. However, because
of expectation of higher residues on the
feed items associated with the proposed
uses (mainly grass and non-grass), the
livestock dietary burdens have
increased, and residues are now
expected to be transferred to poultry
tissues. Consequently, the Agency is
establishing poultry tolerances.
Similarly, due to the higher livestock
dietary burdens, EPA is establishing a
new tolerance for residues in milk fat,
and increasing current tolerances on
milk, ruminant fat and meat byproduct
(to include fat and meat byproduct of
cattle, goat, horse and sheep). EPA is
also establishing higher tolerances than
what the applicant proposed for grass
(group 17), citrus oil, dried pulp, and
poultry fat. The difference in the group
17 grass tolerance is due to the fact that
EPA is using residues from 0-day
postharvest interval (PHI) from grass
samples (instead of 14-day PHI used by
the applicant). With regard to citrus oil,
the difference between the petitionedfor and established tolerance is due to
the use of the highest average field trial
(HAFT) data by EPA (instead of median
used by the applicant), times processing
factor. Dried pulp tolerance difference is
due to EPA rounding of the calculated
tolerance. Lastly, the difference in the
tolerance in poultry fat is due to
recalculating dietary burden for
livestock, taking into account residues
on feed commodities from (0-day PHI)
grass, alfalfa and clover which resulted
in higher than previously calculated
dietary burdens and therefore higher
tolerances.
V. Conclusion
Therefore, tolerances are established
for residues of fluxapyroxad, in or on
cattle, fat at 0.06 ppm; cattle, meat
byproduct at 0.04 ppm; citrus, dried
pulp at 3.0 ppm; citrus, oil at 40 ppm;
fruit, citrus, group 10–10 at 1.0 ppm;
goat, fat at 0.06 ppm; goat, meat
byproduct at 0.04 ppm; grass, forage,
fodder, and hay, group 17 at 40 ppm;
horse, fat at 0.06 ppm; horse, meat
byproduct at 0.04 ppm; milk at 0.01
ppm; milk, fat at 0.15 ppm; non-grass
animal feeds, group 18 at 30 ppm;
poultry, fat, poultry, meat and meat
byproduct, each at 0.01 ppm; sheep, fat
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
at 0.06 ppm; and sheep, meat byproduct
at 0.04 ppm. Finally, the Agency is
removing the tolerance for inadvertent
residues of fluxapyroxad on non-grass
animal feeds, group 18 contained in
paragraph (d) of section 180.666, as it is
subsumed by the tolerance for non-grass
animal feeds, group 18 being established
in paragraph (a) of the same section.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
E:\FR\FM\05MYR1.SGM
05MYR1
Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: April 26, 2016.
Susan Lewis,
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 § 180.666, amend the table in
paragraph (a) as follows:
■ i. Add alphabetically the entries
‘‘Citrus, dried pulp’’, ‘‘Citrus, oil’’,
‘‘Fruit, citrus, group 10–10’’, ‘‘Grass
forage, fodder and hay, group 17’’,
‘‘Milk, fat’’, ‘‘Non-grass animal feed,
group 18’’, ‘‘Poultry, fat’’, ‘‘Poultry,
meat’’ and ‘‘Poultry, meat byproduct’’.
■ ii. Revise the following entries
‘‘Cattle, fat’’, ‘‘Cattle, meat byproduct’’,
‘‘Egg’’, ‘‘Goat, fat’’, ‘‘Goat, meat
byproduct’’, ‘‘Horse, fat’’, ‘‘Horse, meat
byproduct’’, ‘‘Milk’’, ‘‘Sheep, fat,’’ and
‘‘Sheep, meat byproduct’’.
■ iii. Remove from the table in
paragraph (d) the entry ‘‘non-grass
animal feeds, group 18’’.
ehiers on DSK5VPTVN1PROD with RULES
■
VerDate Sep<11>2014
13:35 May 04, 2016
Jkt 238001
The amendments read as follows:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of butanedioic
acid, 2-sulfo-, C-C9-11-isoalkyl esters,
C10-rich, disodium salts (CAS Reg. No.
815583–91–6) when used as an inert
ingredient (surfactant) in pesticides
applied to growing crops and raw
agricultural commodities after harvest
under 40 CFR 180.910 limited to
maximum concentration of 10% by
weight in pesticide formulations. Keller
and Heckman LLP on behalf of Cytec
Industries, Inc. submitted a petition to
EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting
establishment of an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of butanedioic acid,
2-sulfo-, C-C9-11-isoalkyl esters, C10rich, disodium salts.
DATES: This regulation is effective May
5, 2016. Objections and requests for
hearings must be received on or before
July 5, 2016, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
§ 180.666 Fluxapyroxad; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
27025
*
*
*
Cattle, fat ..............................
*
*
0.06
*
*
*
Cattle, meat byproduct .........
Citrus, dried pulp ..................
Citrus, oil ...............................
*
*
0.04
3.0
40
*
*
*
Egg .......................................
Fruit, citrus, group 10–10 .....
*
*
0.01
1.0
*
*
*
Grass, forage, fodder and
hay, group 17 ....................
Goat, fat ................................
*
*
*
*
*
Goat, meat byproduct ...........
*
*
0.04
*
*
*
Horse, fat ..............................
*
*
0.06
*
*
*
Horse, meat byproduct .........
Milk .......................................
Milk, fat .................................
Non-grass animal feed,
group 18 ............................
*
*
0.04
0.01
0.15
40
0.06
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0213, is
30 available at https://www.regulations.gov
or at the Office of Pesticide Programs
*
*
*
*
*
Regulatory Public Docket (OPP Docket)
Poultry, fat ............................
0.01
Poultry, meat ........................
0.01 in the Environmental Protection Agency
Poultry, meat byproduct .......
0.01 Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
*
*
*
*
*
Sheep, fat .............................
0.06 20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
*
*
*
*
*
Monday through Friday, excluding legal
Sheep, meat byproduct ........
0.04 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
[FR Doc. 2016–10581 Filed 5–4–16; 8:45 am]
information about the docket available
BILLING CODE 6560–50–P
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
ENVIRONMENTAL PROTECTION
(7505P), Office of Pesticide Programs,
AGENCY
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
40 CFR Part 180
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
[EPA–HQ–OPP–2015–0213; FRL–9945–58]
RDFRNotices@epa.gov.
Butanedioic Acid, 2-sulfo-, C-C9-11SUPPLEMENTARY INFORMATION:
isoalkyl esters, C10-rich, Disodium
I. General Information
Salts; Exemption From the
Requirement of a Tolerance
A. Does this action apply to me?
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
ADDRESSES:
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
E:\FR\FM\05MYR1.SGM
05MYR1
Agencies
[Federal Register Volume 81, Number 87 (Thursday, May 5, 2016)]
[Rules and Regulations]
[Pages 27019-27025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10581]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0324; FRL-9945-48]
Fluxapyroxad; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
fluxapyroxad in or on multiple commodities which are identified and
discussed later in this document. BASF Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 5, 2016. Objections and
requests for hearings must be received on or before July 5, 2016, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0324, 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), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (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: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@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. To access the OCSPP
test guidelines referenced in this document electronically, please go
to https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0324 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
July 5, 2016. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0324, 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
[[Page 27020]]
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.
II. Summary of Petitioned-for Tolerance
In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-
74), 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
5F8344) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.666 be amended by
establishing tolerances for residues of the fungicide fluxapyroxad, in
or on citrus, dried pulp at 2.7 parts per million (ppm); citrus oil at
19 ppm; fruit, citrus group 10-10 at 1.0 ppm; grass forage, fodder and
hay group 17 at 30 ppm; non-grass animal feed, group 18 at 30 ppm; and
poultry, fat at 0.005 ppm. The petition also requested that the
existing tolerance for residues of fluxapyroxad on egg be amended from
0.002 ppm to 0.01 ppm and that the tolerance for inadvertent residues
of fluxapyroxad on nongrass animal feeds, group 18 at 0.3 ppm be
removed upon establishment of the superceding group 18 tolerance. 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
recommended tolerances for poultry meat, poultry meat byproduct, and
milk fat for which there were no established tolerances previously due
to low dietary burden and falling under category 3 of CFR 180.6(a). The
reason for these changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.* *
*''
Consistent with 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 fluxapyroxad including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fluxapyroxad 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.
Fluxapyroxad is of low acute toxicity by the oral, dermal and
inhalation routes, is not irritating to the eyes and skin, and is not a
dermal sensitizer. The primary target organ for fluxapyroxad exposure
via the oral route is the liver with secondary toxicity in the thyroid
for rats only. Liver toxicity was observed in rats, mice, and dogs,
with rats as the most sensitive species for all durations of exposure.
In rats, adaptive effects of hepatocellular hypertrophy and increased
liver weights and changes in liver enzyme activities were first
observed. As the dose or duration of exposure to fluxapyroxad
increased, clinical chemistry changes related to liver function also
occurred, followed by hepatocellular necrosis, neoplastic changes in
the liver, and tumors. Thyroid effects were observed only in rats.
These effects were secondary to changes in liver enzyme regulation,
which increased metabolism of thyroid hormone, resulting in changes in
thyroid hormones, thyroid follicular hypertrophy and hyperplasia, and
thyroid tumor formation. Tumors were not observed in species other than
rats or in organs other than the liver and thyroid.
Fluxapyroxad is classified as ``Not likely to be Carcinogenic to
Humans'' based on convincing evidence that carcinogenic effects are not
likely below a defined dose range. There is no mutagenicity concern
from in vivo or in vitro assays. The hypothesized mode of action (i.e.,
a non-genotoxic) for treatment related tumors (i.e., the liver and
thyroid) was supported by a full panel of in vitro and in vivo studies
that showed no evidence of genotoxicity, together with mechanistic
studies in the liver and thyroid of rats that satisfied stringent
criteria for establishing tumorigenic modes of action. The studies
clearly identified the sequence of key events, dose-response
concordance and temporal relationship to the tumor types. The Agency
has determined that the chronic population adjusted dose (PAD) will
adequately account for all chronic effects, including carcinogenicity
that could result from exposure to fluxapyroxad because the points of
departure (POD) for the chronic population adjusted dose (cPAD) is
based on the most sensitive endpoint, liver effects. Effects in the
liver preceded liver tumors and the effects observed in the thyroid (in
rats only) were believed to be secondary to the liver effects.
No evidence of neurotoxicity was observed in response to repeated
administration of fluxapyroxad. An acute neurotoxicity study showed
decreased rearing and motor activity. This occurred on the day of
dosing only and in the absence of histopathological effects or
alterations in brain weights. This indicated that any neurotoxic
effects of fluxapyroxad are likely to be transient and reversible due
to alterations in neuropharmacology and not from neuronal damage. There
were no neurotoxic effects observed in the subchronic dietary toxicity
study. No evidence of reproductive toxicity was observed. Developmental
effects observed in both rats and mice (thyroid follicular hypertrophy
and hyperplasia in rats and decreased defecation, food consumption,
body weight/body weight gain, and increased litter loss in rabbits)
occurred at the same doses as those that caused adverse effects in
maternal animals, indicating no quantitative susceptibility. Since the
maternal toxicities of thyroid hormone perturbation in rats and
systemic toxicity in rabbits likely contributed to the observed
developmental effects there is low concern for qualitative
susceptibility. An immunotoxicity study in mice showed no evidence of
immunotoxic effects from fluxapyroxad.
Subchronic oral toxicity studies in rats, developmental toxicity
studies in rabbits, and in vitro and in vivo genotoxicity studies were
performed for fluxapyroxad metabolites F700F001, M700F002, and
M700F048. Like
[[Page 27021]]
fluxapyroxad, no genotoxic effects were observed for any of these
metabolites. All three metabolites displayed lower subchronic toxicity
via the oral route than fluxapyroxad, with evidence of non-specific
toxicity (decreased body weight) observed only for M700F0048 at the
limit dose. Only M700F0048 exhibited developmental toxicity at doses
similar to those that caused developmental effects in rabbits with
fluxapyroxad treatment. However, these effects (abortions and
resorptions) were of a different nature than for fluxapyroxad (paw
hyperflexion) and are considered secondary to maternal toxicity. The
Agency considers these studies sufficient for hazard identification and
characterization and concludes that these metabolites do not have
hazards that exceed those of fluxapyroxad in nature, severity, or
potency.
Specific information on the studies received and the nature of the
adverse effects caused by fluxapyroxad 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, ``Human Health Risk Assessment for Use
of Fluxaproxad on Citrus Crop Group 10-10, Grass Crop Group 17, and
Non-Grass Crop Group 18.'' on pp. 56 in docket ID number EPA-HQ-OPP-
2012-0638.
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.
Summary of the toxicological endpoints for used for human risk
assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Fluxapyroxad for Use in Dietary, Residential and Non-
Occupational Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
Uncertainty/ RfD, PAD, level
Exposure/scenario Point of FQPA safety of concern for Study and toxicological
departure factors risk assessment effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General NOAEL = 125 mg/ UFA = 10x Acute RfD = Acute neurotoxicity study in
Population, including kg/day. UFH = 10x...... 1.25 mg/kg/day. rats.
Infants and Children and FQPA SF = 1x... aPAD = 1.25 mg/ LOAEL = 500 mg/kg/day based on
Females 13-49 years of age). kg/day. decreased motor activity
(both sexes) and decreased
rearing (males only).
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All NOAEL = 2.1 mg/ UFA = 10x Chronic RfD = Chronic toxicity/
Populations). kg/day. UFH = 10x...... 0.021 mg/kg/ carcinogenicity study in
FQPA SF = 1x... day. rats.
cPAD = 0.021 mg/ LOAEL = 11 mg/kg/day based on
kg/day. non-neoplastic changes in the
liver (foci, masses).
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short-Term (1- NOAEL = 7.3mg/ UFA = 10x Residential LOC 90-day dietary study in rats.
30 days). kg/day. UFH = 10x...... for MOE = 100. MIRD 47923567.
FQPA SF = 1x... LOAEL = 35.1 mg/kg/day based
on thyroid follicular
hypertrophy/hyperplasia.
----------------------------------------------------------------------------------------------------------------
Dermal Short- and No hazard identified.
Intermediate-Term.
----------------------------------------------------------------------------------------------------------------
Inhalation, Short-Term (1-30 NOAEL = 7.3 mg/ UFA = 10x Residential LOC 90-day dietary study in rats.
days) and Intermediate-term kg/day. UFH = 10x...... for MOE = 100. MIRD 47923567.
(1-6 months). FQPA SF = 1x... LOAEL = 35.1 mg/kg/day based
on thyroid follicular
hypertrophy/hyperplasia.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, Classification: Not likely to be carcinogenic to humans below a defined dose
inhalation). range.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOA = mode of action.
[[Page 27022]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluxapyroxad, EPA considered exposure under the petitioned-
for tolerances as well as all existing fluxapyroxad tolerances in 40
CFR 180.666. EPA assessed dietary exposures from fluxapyroxad 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 fluxapyroxad. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 2003-2008 Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII). As to residue levels in food, EPA used
tolerance-level residues adjusted to account for the metabolites of
concern (M700F008, and M700F010 (milk only)) and 100 percent crop
treated (PCT) assumptions were used. DEEM default and empirical
processing factors were used to modify the tolerance values.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
CSFII. As to residue levels in food, a moderately refined chronic
dietary exposure analysis was performed for the general U.S. population
and various population subgroups. Combined average residue for parent
and highest residue for metabolite M700F008 and 100 PCT assumptions
were used. For livestock commodities tolerance-level residues adjusted
to account for the metabolites of concern (M700F008, M700F010) were
used. An assumption of 100 PCT was also used for the chronic dietary
analysis. DEEM default and empirical processing factors were used to
modify the tolerance values.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluxapyroxad does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
The Agency did not use PCT information in the dietary assessment
for fluxapyroxad; 100 PCT was assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for fluxapyroxad in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluxapyroxad. 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 Ground Water (PRZM GW), the
estimated drinking water concentrations (EDWCs) of fluxapyroxad for
acute exposures are 127 ppb parts per billion (ppb) for surface water
and 203 ppb for ground water. The EDWCs for chronic exposures for non-
cancer assessments are 127 ppb for surface water and 188 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 203 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 184 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).
There are no residential exposure associated with the proposed uses
in this action; however, there are existing turf uses that were
previously assessed for fluxapyroxad. Although the Agency had conducted
a residential exposure assessment for previous fluxapyroxad actions,
the Agency completed an updated turf assessment to reflecting an update
in the single maximum application rate from 2.47 pounds active
ingredient/gallon (lb ai/gallon) to 0.005 lb ai/gallon. The present
assessment assumed the following exposure scenarios:
Residential handler: The Agency assessed inhalation
exposures to adults from applications only because fluxapyroxad does
not pose a dermal risk. Residential handler exposure is expected to be
short-term in duration. Intermediate-term exposures are not likely
because of the intermittent nature of applications by homeowners.
Post-application exposures: Dermal exposures were not
assessed because there is no identified systemic dermal hazard for
fluxapyroxad. Post-application inhalation exposure while engaged in
activities on or around previously treated turf is generally not
quantitatively assessed. The combination of low vapor pressure for
chemicals typically used as active ingredients in outdoor residential
pesticide products and dilution in outdoor air is likely to result in
minimal inhalation exposure. Incidental oral exposure for children is
anticipated. The quantitative oral exposure/risk assessment for
residential post-application exposures is based on the incidental oral
scenario for children 1<2.
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 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 fluxapyroxad to share a common mechanism of
toxicity with any other substances, and fluxapyroxad does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluxapyroxad 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
[[Page 27023]]
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. No evidence of quantitative
susceptibility was observed in a reproductive and developmental
toxicity study in rats or in developmental toxicity studies in rats and
rabbits. Developmental toxicity data in rats showed decreased body
weight and body weight gain in the offspring at the same dose levels
that caused thyroid follicular hypertrophy/hyperplasia in parental
animals. Effects in rabbits were limited to paw hyperflexion, a
malformation that is not considered to result from a single exposure
and that usually reverses as the animal matures. Developmental effects
observed in both rats and rabbits occurred at the same doses as those
that caused adverse effects in maternal animals, indicating no
quantitative susceptibility. The Agency has low concern for
developmental toxicity because the observed effects were of low
severity, were likely secondary to maternal toxicity, and demonstrated
clear NOAELs. Further, the NOAELs for these effects were at dose levels
higher than the points of departure selected for risk assessment for
repeat-exposure scenarios. Therefore, based on the available data and
the selection of risk assessment endpoints that are protective of
developmental effects, there are no residual uncertainties with regard
to pre- and/or postnatal toxicity.
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 fluxapyroxad is complete.
ii. There is no indication that fluxapyroxad is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity. Although an acute
neurotoxicity study showed decreased rearing and motor activity, this
occurred on the day of dosing only in the absence of histopathological
effects or alterations in brain weights. This indicated that any
neurotoxic effects of fluxapyroxad are likely to be transient and
reversible due to alterations in neuropharmacology and not from
neuronal damage. The Agency has low concern for neurotoxic effects of
fluxapyroxad at any life stage.
iii. Based on the developmental and reproductive toxicity studies
discussed in Unit III.D.2., there are no residual uncertainties with
regard to prenatal and/or postnatal toxicity.
iv. There are no residual uncertainties identified in the exposure
databases. The residue database is adequate. The dietary risk
assessment is conservative and will not underestimate dietary exposure
to fluxapyroxad. There are residential uses proposed for fluxapyroxad
and the assessment will not underestimate residential exposure via
handler for adults and incidental oral for children. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to fluxapyroxad in drinking water. EPA
used similarly conservative assumptions to assess post application
exposure of children as well as incidental oral exposure of toddlers.
There are residential uses proposed for fluxapyroxad and the assessment
will not underestimate residential exposure via handler for adults and
incidental oral for children.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fluxapyroxad will occupy 12% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluxapyroxad from food and water will utilize 66% of the cPAD for
infants (< 1 year old). Based on the explanation in Unit III.C.3.,
regarding residential use patterns, chronic residential exposure to
residues of fluxapyroxad 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).
Fluxapyroxad 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 fluxapyroxad. 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 1139 for adults and 431 for
children. Because EPA's level of concern for fluxapyroxad 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). An intermediate-term adverse effect was identified; however,
fluxapyroxad is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
fluxapyroxad.
5. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A., EPA has classified fluxapyroxad as ``Not likely to be
Carcinogenic to Humans'' based on convincing evidence that carcinogenic
effects are not likely below a defined dose range. The Agency has
determined that the quantification of risk using the cPAD for
fluxapyroxad will adequately account for all chronic toxicity,
including carcinogenicity that could result from exposure to
fluxapyroxad. Because the Agency has determined fluxapyroxad will not
cause a chronic risk, the Agency concludes that fluxapyroxad will not
pose a cancer risk for the U.S. population.
6. Determination of safety. Based on these risk assessments, EPA
concludes
[[Page 27024]]
that there is a reasonable certainty that no harm will result to the
general population, or to infants and children from aggregate exposure
to fluxapyroxad residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
There are suitable residue analytical methods available for
enforcement of fluxapyroxad tolerances (BASF Methods L0137/01 for
plants and L0140/02 for animal matrices) which have been radio-
validated and have underwent successful validation by an independent
laboratory. These are liquid chromatography with tandem mass
spectrometry (LC/MS/MS) methods and monitor two ion transitions. The
Limit of Quantitation (LOQ) for BASF method L0137/01 is 0.01 ppm for
various matrices. The LOQ for BASF method L0140/02 is 0.01 ppm for
liver and muscle, and 0.001 ppm for milk and eggs.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
There are no Codex MRLs for citrus or grass and non-grass animal
feed at present. US and Codex use different dietary burden evaluations
and calculations which result in US tolerances for residues in ruminant
meat byproduct, milk, and milk fat generally much lower than
corresponding Codex MRLs.
C. Revisions to Petitioned-for Tolerances
EPA is establishing tolerances for milk fat and poultry meat, and
meat byproduct that the applicant did not request. There have been no
established tolerances for poultry tissues because residues were not
expected to be found in those tissues due to the low dietary burden;
i.e., category 3 of 40 CFR 180.6(a) applied for those poultry matrices
previously. However, because of expectation of higher residues on the
feed items associated with the proposed uses (mainly grass and non-
grass), the livestock dietary burdens have increased, and residues are
now expected to be transferred to poultry tissues. Consequently, the
Agency is establishing poultry tolerances. Similarly, due to the higher
livestock dietary burdens, EPA is establishing a new tolerance for
residues in milk fat, and increasing current tolerances on milk,
ruminant fat and meat byproduct (to include fat and meat byproduct of
cattle, goat, horse and sheep). EPA is also establishing higher
tolerances than what the applicant proposed for grass (group 17),
citrus oil, dried pulp, and poultry fat. The difference in the group 17
grass tolerance is due to the fact that EPA is using residues from 0-
day postharvest interval (PHI) from grass samples (instead of 14-day
PHI used by the applicant). With regard to citrus oil, the difference
between the petitioned-for and established tolerance is due to the use
of the highest average field trial (HAFT) data by EPA (instead of
median used by the applicant), times processing factor. Dried pulp
tolerance difference is due to EPA rounding of the calculated
tolerance. Lastly, the difference in the tolerance in poultry fat is
due to recalculating dietary burden for livestock, taking into account
residues on feed commodities from (0-day PHI) grass, alfalfa and clover
which resulted in higher than previously calculated dietary burdens and
therefore higher tolerances.
V. Conclusion
Therefore, tolerances are established for residues of fluxapyroxad,
in or on cattle, fat at 0.06 ppm; cattle, meat byproduct at 0.04 ppm;
citrus, dried pulp at 3.0 ppm; citrus, oil at 40 ppm; fruit, citrus,
group 10-10 at 1.0 ppm; goat, fat at 0.06 ppm; goat, meat byproduct at
0.04 ppm; grass, forage, fodder, and hay, group 17 at 40 ppm; horse,
fat at 0.06 ppm; horse, meat byproduct at 0.04 ppm; milk at 0.01 ppm;
milk, fat at 0.15 ppm; non-grass animal feeds, group 18 at 30 ppm;
poultry, fat, poultry, meat and meat byproduct, each at 0.01 ppm;
sheep, fat at 0.06 ppm; and sheep, meat byproduct at 0.04 ppm. Finally,
the Agency is removing the tolerance for inadvertent residues of
fluxapyroxad on non-grass animal feeds, group 18 contained in paragraph
(d) of section 180.666, as it is subsumed by the tolerance for non-
grass animal feeds, group 18 being established in paragraph (a) of the
same section.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined
[[Page 27025]]
that Executive Order 13132, entitled ``Federalism'' (64 FR 43255,
August 10, 1999) and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000) do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 26, 2016.
Susan Lewis,
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. 180.666, amend the table in paragraph (a) as follows:
0
i. Add alphabetically the entries ``Citrus, dried pulp'', ``Citrus,
oil'', ``Fruit, citrus, group 10-10'', ``Grass forage, fodder and hay,
group 17'', ``Milk, fat'', ``Non-grass animal feed, group 18'',
``Poultry, fat'', ``Poultry, meat'' and ``Poultry, meat byproduct''.
0
ii. Revise the following entries ``Cattle, fat'', ``Cattle, meat
byproduct'', ``Egg'', ``Goat, fat'', ``Goat, meat byproduct'', ``Horse,
fat'', ``Horse, meat byproduct'', ``Milk'', ``Sheep, fat,'' and
``Sheep, meat byproduct''.
0
iii. Remove from the table in paragraph (d) the entry ``non-grass
animal feeds, group 18''.
The amendments read as follows:
Sec. 180.666 Fluxapyroxad; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cattle, fat............................................. 0.06
* * * * *
Cattle, meat byproduct.................................. 0.04
Citrus, dried pulp...................................... 3.0
Citrus, oil............................................. 40
* * * * *
Egg..................................................... 0.01
Fruit, citrus, group 10-10.............................. 1.0
* * * * *
Grass, forage, fodder and hay, group 17................. 40
Goat, fat............................................... 0.06
* * * * *
Goat, meat byproduct.................................... 0.04
* * * * *
Horse, fat.............................................. 0.06
* * * * *
Horse, meat byproduct................................... 0.04
Milk.................................................... 0.01
Milk, fat............................................... 0.15
Non-grass animal feed, group 18......................... 30
* * * * *
Poultry, fat............................................ 0.01
Poultry, meat........................................... 0.01
Poultry, meat byproduct................................. 0.01
* * * * *
Sheep, fat.............................................. 0.06
* * * * *
Sheep, meat byproduct................................... 0.04
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2016-10581 Filed 5-4-16; 8:45 am]
BILLING CODE 6560-50-P