Fenpyroximate; Pesticide Tolerances, 34870-34875 [2017-15728]
Download as PDF
<![CDATA[
34870
Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations
10 Mitchell Method M5271, Revision 1.1. ‘‘Determination of Turbidity by Laser Nephelometry,’’ March 5, 2009. Available at https://www.nemi.gov or from Leck Mitchell, Ph.D., PE, 656 Independence Valley Dr., Grand Junction, CO 81507.
11 Mitchell Method M5331, Revision 1.1. ‘‘Determination of Turbidity by LED Nephelometry,’’ March 5, 2009. Available at https://www.nemi.gov or from Leck Mitchell, Ph.D., PE, 656 Independence Valley Dr., Grand Junction, CO 81507.
12 Orion Method AQ4500, Revision 1.0. ‘‘Determination of Turbidity by LED Nephelometry,’’ May 8, 2009. Available at https://www.nemi.gov or from Thermo Scientific, 166 Cummings Center, Beverly, MA 01915, https://www.thermo.com.
13 Modified ColitagTM Method. ‘‘Modified ColitagTM Test Method for the Simultaneous Detection of E. coli and other Total Coliforms in Water (ATP D05–0035),’’ August 28, 2009. Available at https://www.nemi.gov or from CPI International, 5580 Skylane Boulevard, Santa Rosa, CA 95403.
14 EPA Method 557. ‘‘Determination of Haloacetic Acids, Bromate, and Dalapon in Drinking Water by Ion Chromatography Electrospray Ionization Tandem Mass
Spectrometry (IC–ESI–MS/MS),’’ September 2009. EPA 815–B–09–012. Available at the National Service Center for Environmental Publications (www.epa.gov/
nscep). Search ‘‘815B09012’’.
15 AMI Turbiwell, ‘‘Continuous Measurement of Turbidity Using a SWAN AMI Turbiwell Turbidimeter,’’ August 2009. Available at https://www.nemi.gov or from
Markus Bernasconi, SWAN Analytische Instrumente AG, Studbachstrasse 13, CH–8340 Hinwil, Switzerland.
*
*
*
*
*
*
*
20 Readycult® Method, ‘‘Readycult® Coliforms 100 Presence/Absence Test for Detection and Identification of Coliform Bacteria and Escherichia coli in Finished
Waters,’’ January, 2007. Version 1.1. Available from EMD Millipore (division of Merck KGaA, Darmstadt, Germany), 290 Concord Road, Billerica, MA 01821.
21 Chromocult® Method, ‘‘Chromocult® Coliform Agar Presence/Absence Membrane Filter Test Method for Detection and Identification of Coliform Bacteria and
Escherichia coli in Finished Waters,’’ November, 2000. Version 1.0. EMD Millipore (division of Merck KGaA, Darmstadt, Germany), 290 Concord Road, Billerica, MA
01821.
*
*
*
*
*
*
*
23 Hach Company. ‘‘Hach Company TNTplusTM 835/836 Nitrate Method 10206—Spectrophotometric Measurement of Nitrate in Water and Wastewater,’’ January
2011. 5600 Lindbergh Drive, P.O. Box 389, Loveland, Colorado 80539. (Available at https://www.hach.com.)
*
*
*
*
*
*
*
28 Standard Methods for the Examination of Water and Wastewater, 22nd edition (2012). Available from American Public Health Association, 800 I Street NW.,
Washington, DC 20001–3710.
*
*
*
*
*
*
*
33 Tecta EC/TC. ‘‘TechtaTM EC/TC Medium and TechtaTM Instrument: A Presence/Absence Method for the Simultaneous Detection of Total Coliforms and Escherichia coli (E. coli) in Drinking Water,’’ version 1.0, May 2014. Available from Pathogen Detection Systems, Inc., 382 King Street East, Kingston, Ontario, Canada,
K7K 2Y2.
*
*
*
*
*
*
*
39 Hach Company. ‘‘Hach Method 10258—Determination of Turbidity by 360° Nephelometry,’’ January 2016. 5600 Lindbergh Drive, P.O. Box 389, Loveland, CO
80539. (Available at https://www.hach.com.)
40 Nitrate Elimination Company Inc. (NECi). ‘‘Method for Nitrate Reductase Nitrate-Nitrogen Analysis of Drinking Water,’’ February 2016. Superior Enzymes Inc.,
334 Hecla Street, Lake Linden, Michigan 49945.
41 Thermo Fisher. ‘‘Thermo Fisher Scientific Drinking Water Orthophosphate Method for Thermo Scientific Gallery Discrete Analyzer,’’ February 2016. Revision 5.
Thermo Fisher Scientific, Ratastie 2, 01620 Vantaa, Finland.
42 Mitchell Method M5331, Revision 1.2. ‘‘Determination of Turbidity by LED or Laser Nephelometry,’’ February 2016. Available from Leck Mitchell, Ph.D., PE, 656
Independence Valley Dr., Grand Junction, CO 81507.
43 Tecta EC/TC. ‘‘TectaTM EC/TC Medium and the TectaTM Instrument: A Presence/Absence Method for the Simultaneous Detection of Total Coliforms and Escherichia coli (E. coli) in Drinking Water,’’ version 2.0, February 2017. Available from Pathogen Detection Systems, Inc., 382 King Street East, Kingston, Ontario, Canada, K7K 2Y2.
44 Lovibond PTV 1000. ‘‘Continuous Measurement of Drinking Water Turbidity Using a Lovibond PTV 1000 White Light LED Turbidimeter,’’ December 2016. Revision 1.0. Available from Tintometer, Inc., 6456 Parkland Drive, Sarasota, FL 34243.
45 Lovibond PTV 2000. ‘‘Continuous Measurement of Drinking Water Turbidity Using a Lovibond PTV 2000 660–nm LED Turbidimeter,’’ December 2016. Revision
1.0. Available from Tintometer, Inc., 6456 Parkland Drive, Sarasota, FL 34243.
46 Lovibond PTV 6000. ‘‘Continuous Measurement of Drinking Water Turbidity Using a Lovibond PTV 6000 Laser Turbidimeter,’’ December 2016. Revision 1.0.
Available from Tintometer, Inc., 6456 Parkland Drive, Sarasota, FL 34243.
47 Thermo Fisher. ‘‘Thermo Fisher Method 557.1: Determination of Haloacetic Acids in Drinking Water using Two-Dimensional Ion Chromatography with Suppressed Conductivity Detection,’’ January 2017. Version 1.0. Available from Thermo Fisher Scientific, 490 Lakeside Dr., Sunnyvale, CA 94085 (Richard.jack@
thermofisher.com).
48 EPA Method 150.3. ‘‘Determination of pH in Drinking Water,’’ February 2017. EPA 815–B–17–001. Available at the National Service Center for Environmental
Publications (www.epa.gov/nscep).
[FR Doc. 2017–15380 Filed 7–26–17; 8:45 am]
Unit I.C. of the SUPPLEMENTARY
BILLING CODE 6560–50–P
INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0307, 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.
ADDRESSES:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0307; FRL–9963–22]
Fenpyroximate; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation increases
existing tolerances for residues of
fenpyroximate in or on dried citrus
pulp, citrus oil, and the citrus fruit
group 10–10. Nichino America, Inc.
requested these tolerance increases
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective July
27, 2017. Objections and requests for
hearings must be received on or before
September 25, 2017, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
mstockstill on DSK30JT082PROD with RULES
SUMMARY:
VerDate Sep<11>2014
17:57 Jul 26, 2017
Jkt 241001
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
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
E:\FR\FM\27JYR1.SGM
27JYR1
Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
mstockstill on DSK30JT082PROD with RULES
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–2016–0307 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 September 25, 2017. Addresses
for mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2016–0307, 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.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of August 29,
2016 (81 FR 59165) (FRL–9950–22),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
VerDate Sep<11>2014
17:07 Jul 26, 2017
Jkt 241001
pesticide petition (PP 6F8465) by
Nichino America, Inc., 4550 New
Linden Hill Road, Suite 501,
Wilmington, DE 19808. The petition
requested to increase the tolerances in
40 CFR 180.566 for residues of the
insecticide fenpyroximate in or on fruit,
citrus, group 10–10 to 1.0 parts per
million (ppm), citrus dried pulp to 4.0
ppm, and citrus oil to 14 ppm. That
document referenced a summary of the
petition prepared by Nichino America,
Inc., 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
modified the level of the citrus oil
tolerance from 14 ppm to 15 ppm. The
reason for this change is explained in
Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for fenpyroximate
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with fenpyroximate 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
PO 00000
Frm 00037
Fmt 4700
Sfmt 4700
34871
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.
The effects following repeated oral
exposures to fenpyroximate were based
on systemic toxicity (no specific target
organ/tissue identified). The most
sensitive species tested was the dog.
The effects reported in the dog included
slight bradycardia, deficits in food
consumption, body weight, body-weight
gain, and an increased incidence of
emesis and diarrhea. Emaciation and
torpor (sluggish inactivity) were
reported in female dogs at lower dose
levels than males. The highest dose
tested in the dog (50 milligram/kilogram
bodyweight/day (mg/kg bw/day))
resulted in first- and second-degree
heart block, increased urea
concentration, decreased glucose, and
altered plasma electrolyte levels among
other signs of toxicity. In subchronic
and chronic studies with rats, the
primary effect was decreased bodyweight gain in both sexes with
hematological changes (e.g., higher
counts of red blood cells) at higher
doses.
In a rat prenatal developmental
toxicity study, a dose level that
marginally affected maternal body
weight and food consumption also
resulted in an increased litter incidence
of increased thoracic ribs, indicating
increased prenatal (qualitative)
susceptibility. In the rabbits, there were
no developmental effects reported at the
levels tested. In the rat two-generation
reproductive toxicity study, maternal
toxicity (decreased body weight) and
offspring toxicity (decreased lactational
weight gain in both generations)
occurred at the same dose.
There is no evidence that
fenpyroximate specifically targets the
nervous or immune system based on the
results of recently submitted studies. In
the acute neurotoxicity study,
neurotoxicity signs such as decreases in
motor activity occurred in the presence
of other effects including decreases in
body weight and food consumption, and
in the absence of neuropathology.
Similar results were noted in a delayed
acute neurotoxicity study in the hen
where no effects (neurotoxic or
otherwise) were reported. The results of
the rat subchronic neurotoxicity study
did not indicate any neurotoxicityspecific effects; deficits in body weight
and food consumption were the main
effects reported. Similarly, the effects
reported in a rat immunotoxicity study
were limited to decreased body-weight
gain.
E:\FR\FM\27JYR1.SGM
27JYR1
34872
Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations
In a 21-day dermal toxicity study in
rats, there were clinical signs in females
consisting of red nose and mouth/nasal
discharge, decreased body weights,
body-weight gains, and food
consumption in males and females.
There were also increased liver weights
and hepatocellular necrosis reported in
females.
In a 4-week rat inhalation study,
treatment-related effects included
clinical observations (labored breathing
and rales), increased lung weights,
decreases in body-weight gain and food
consumption, and changes in
hematology parameters (increased
counts of erythrocytes and leukocytes).
There were also histopathology findings
in the nasal passage mucosa consisting
of atrophy and squamous metaplasia.
Fenpyroximate was classified as ‘‘not
likely to be carcinogenic to humans’’
based on the results of rat and mouse
carcinogenicity studies. Genotoxicity
studies including mutagenicity did not
demonstrate any genotoxic potential
associated with fenpyroximate.
Specific information on the studies
received and the nature of the adverse
effects caused by fenpyroximate as well
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 the document
titled ‘‘Fenpyroximate. Human-Health
Risk Assessment for Proposed Section 3
Uses on Stone Fruits (Group 12–12),
Tuberous and Corm Vegetables
(Subgroup 1C), and Small Vine
Climbing Fruits Except Kiwifruit
(Subgroup 13–07F)’’ on page 28 in
docket ID number EPA–HQ–OPP–2016–
0307.
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://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for fenpyroximate used for
human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENPYROXIMATE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
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 = 37.5 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 0.05
mg/kg/day.
aPAD = 0.05 mg/kg/
day
Prenatal Developmental Toxicity Study—Rat.
LOAEL = 25 mg/kg/day based on increase in the fetal incidence of additional thoracic ribs.
Acute RfD = 0.375
mg/kg/day.
aPAD = 0.375 mg/
kg/day
Chronic dietary (All populations)
NOAEL= 5.0 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.05
mg/kg/day.
cPAD = 0.05 mg/kg/
day
Acute Neurotoxicity Study—Rat.
LOAEL = 150 mg/kg bw based on decreased motor activity
(total activity counts and total time spent in movement) in
both sexes, and a reduction in auditory startle response in
females at 24 hours post dose, and mild dehydration in
males.
Chronic toxicity—Dog.
LOAEL = 15 mg/kg/day based on an increased incidence of
bradycardia, diarrhea, and decreases in cholesterol, bodyweight gain, and food consumption (M); vomiting, diarrhea,
excess salivation and decrease cholesterol in females.
Cancer (Oral, dermal, inhalation).
Classification: ‘‘Not likely to be carcinogen,’’ cancer risk assessment is not required
Exposure/scenario
Acute dietary (Females 13–50
years of age).
Acute dietary (General population including infants and
children).
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).
mstockstill on DSK30JT082PROD with RULES
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fenpyroximate, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing fenpyroximate tolerances in 40
CFR 180.566. EPA assessed dietary
VerDate Sep<11>2014
17:07 Jul 26, 2017
Jkt 241001
exposures from fenpyroximate 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
PO 00000
Frm 00038
Fmt 4700
Sfmt 4700
occurring as a result of a 1-day or single
exposure.
Such effects were identified for
fenpyroximate. In estimating acute
dietary exposure, EPA used food
consumption information from the
United States Department of Agriculture
(USDA) National Health and Nutrition
E:\FR\FM\27JYR1.SGM
27JYR1
mstockstill on DSK30JT082PROD with RULES
Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations
Examination Survey, What We Eat in
America, (NHANES/WWEIA; 2003–
2008). As to residue levels in food, EPA
assumed 100 percent crop treated (PCT)
and tolerance level residues for all
commodities.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA NHANES/WWEIA
(2003–2008). As to residue levels in
food, EPA assumed 100 PCT and
tolerance level residues for all
commodities.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that fenpyroximate 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. EPA did
not use anticipated residue or PCT
information in the dietary assessment
for fenpyroximate. Tolerance level
residues and 100 PCT were 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 fenpyroximate in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
fenpyroximate. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www2.epa.gov/
pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide.
Based on the Food Quality Protection
Act (FQPA) Index Reservoir Screening
Tool (FIRST) and a Provisional
Cranberry Model for fenpyroximate and
its metabolites (M1 and M3) in surface
water and with Screening Concentration
in Ground Water (SCI–GROW) for
ground water, the estimated drinking
water concentrations (EDWCs) of
fenpyroximate for acute exposures are
estimated to be 43 parts per billion
(ppb) for surface water and 0.27 ppb for
ground water, and for chronic exposures
are estimated to be 8.6 ppb for surface
water and 0.27 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 43 ppb was used
to assess the contribution to drinking
water and for the chronic dietary risk
assessment, the water concentration of
value 8.6 ppb was used to assess the
contribution to drinking water.
VerDate Sep<11>2014
17:07 Jul 26, 2017
Jkt 241001
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).
Fenpyroximate is not registered for any
specific use patterns that would result
in residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found fenpyroximate to
share a common mechanism of toxicity
with any other substances, and
fenpyroximate does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that fenpyroximate 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://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
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
Food Quality Protection Act Safety
Factor (FQPA SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional SF when reliable data
available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity.
There is evidence of increased prenatal
(qualitative) susceptibility in a rat
prenatal developmental toxicity study.
A dose level that marginally affected
maternal body weight and food
consumption also resulted in an
increased litter incidence of increased
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
34873
thoracic ribs. However, concern for
prenatal and postnatal toxicity to
fenpyroximate is low because:
i. There was a clear NOAEL in the rat
prenatal developmental toxicity study;
ii. The NOAEL for this developmental
study is being used as POD for the acute
dietary risk assessment for the
population of concern-females 13–49
years old;
iii. In the rabbit, there were no
developmental effects reported at the
levels tested; and
iv. In the rat 2-generation
reproductive toxicity study, there was
no indication of increased prenatal or
postnatal susceptibility.
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
fenpyroximate is complete.
ii. There is no indication that
fenpyroximate is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is evidence that
fenpyroximate results in increased
susceptibility in utero rats or rabbits in
the prenatal developmental studies or in
young rats in the two-generation
reproduction study. Increased
(qualitative) prenatal susceptibility was
seen following oral exposures in the rat
developmental toxicity study, but the
concern for these effects is low, for the
reasons noted in Unit III.D.2. Therefore,
a 10x FQPA SF is not necessary to
account for this increased susceptibility
of infants and children.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to
fenpyroximate in drinking water. These
assessments will not underestimate the
exposure and risks posed by
fenpyroximate.
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
E:\FR\FM\27JYR1.SGM
27JYR1
mstockstill on DSK30JT082PROD with RULES
34874
Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations
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
fenpyroximate will occupy 14% of the
aPAD for females 13–49 years old and
6.4% of the aPAD for children 1–2 years
old, the population groups with the
greatest risk estimate.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to fenpyroximate
from food and water will utilize 16% of
the cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. There are no residential uses
for fenpyroximate.
3. Short- and intermediate-term risk.
Short- and intermediate-term aggregate
exposure takes into account short- and
intermediate-term residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level). Short- and
intermediate-term adverse effects were
identified; however, fenpyroximate is
not registered for any use patterns that
would result in either short- or
intermediate-term residential exposure.
Short- and intermediate-term risk is
assessed based on short- and
intermediate-term residential exposure
plus chronic dietary exposure. Because
there is no short- or intermediate-term
residential exposure and chronic dietary
exposure has already been assessed
under the appropriately protective
cPAD (which is at least as protective as
the POD used to assess short- or
intermediate-term risk), no further
assessment of short- or intermediateterm risk is necessary, and EPA relies on
the chronic dietary risk assessment for
evaluating short- and intermediate-term
risk for fenpyroximate.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
chemical name is not expected to pose
a cancer risk to humans.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to
fenpyroximate residues.
VerDate Sep<11>2014
17:07 Jul 26, 2017
Jkt 241001
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography method with
nitrogen/phosphorus detection (GC/
NPD), Method S19) is available to
enforce the tolerance expression.
Method S19 has passed an Agency
validation and has a limit of
quantitation (LOQ) of 0.05 ppm for the
combined residues of fenpyroximate
and M–1 in snap beans and avocados.
A data-gathering liquid
chromatography/mass spectroscopy/
mass spectroscopy (LC/MS/MS) method
is also available.
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.
The Codex has established MRLs for
fenpyroximate in or on citrus fruits at
0.5 ppm. This MRLs is different than the
tolerance being established for
fenpyroximate in the United States,
however, harmonization with the Codex
MRL is not possible because the U.S.
tolerance expression includes an
additional isomer and the U.S. use
pattern requires a higher numerical
value.
C. Revisions to Petitioned-For
Tolerances
Based on the Organization for
Economic Co-operation and
Development (OECD) tolerancecalculation procedure, the Agency is
increasing the tolerance on citrus oil to
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
15 ppm rather than 14 ppm as proposed
by the registrant.
V. Conclusion
Therefore, existing tolerances for
residues of fenpyroximate are increased
in or on citrus, dried pulp from 2.5 ppm
to 4.0 ppm; citrus, oil from 10 ppm to
15 ppm; and fruit, citrus, group 10–10
from 0.50 ppm to 1.0 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
E:\FR\FM\27JYR1.SGM
27JYR1
Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
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 § 180.566, revise the entries for
‘‘Citrus, dried pulp’’, ‘‘Citrus, oil’’, and
‘‘Fruit, citrus, group 10–10’’ in the table
in paragraph (a)(1) to read as follows:
■
§ 180.566 Fenpyroximate; tolerances for
residues.
mstockstill on DSK30JT082PROD with RULES
(a) * * *
(1) * * *
Parts per
million
*
*
*
*
Citrus, dried pulp ........................
Citrus, oil .....................................
VerDate Sep<11>2014
17:07 Jul 26, 2017
Jkt 241001
*
*
*
*
Fruit, citrus, group 10–10 ...........
*
*
*
*
*
*
*
*
4.0
15
*
1.0
*
*
*
[FR Doc. 2017–15728 Filed 7–26–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0518; FRL–9963–04]
Ametoctradin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation amends a
tolerance for residues of ametoctradin in
or on hops. BASF Corporation requested
this tolerance amendment under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective July
27, 2017. Objections and requests for
hearings must be received on or before
September 25, 2017, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0518, 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:
Michael Goodis, 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:
ADDRESSES:
Dated: June 22, 2017.
Michael L. Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Commodity
Parts per
million
Commodity
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
34875
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.
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–2016–0518 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 September 25, 2017. Addresses
for mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2016–0518, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
E:\FR\FM\27JYR1.SGM
27JYR1
]]>Agencies
[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Rules and Regulations]
[Pages 34870-34875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15728]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0307; FRL-9963-22]
Fenpyroximate; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation increases existing tolerances for residues of
fenpyroximate in or on dried citrus pulp, citrus oil, and the citrus
fruit group 10-10. Nichino America, Inc. requested these tolerance
increases under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 27, 2017. Objections and
requests for hearings must be received on or before September 25, 2017,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0307, 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: Michael Goodis, 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
[[Page 34871]]
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-2016-0307 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
September 25, 2017. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0307, 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.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 29, 2016 (81 FR 59165) (FRL-9950-
22), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F8465) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501,
Wilmington, DE 19808. The petition requested to increase the tolerances
in 40 CFR 180.566 for residues of the insecticide fenpyroximate in or
on fruit, citrus, group 10-10 to 1.0 parts per million (ppm), citrus
dried pulp to 4.0 ppm, and citrus oil to 14 ppm. That document
referenced a summary of the petition prepared by Nichino America, Inc.,
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
modified the level of the citrus oil tolerance from 14 ppm to 15 ppm.
The reason for this change is explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for fenpyroximate including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fenpyroximate
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.
The effects following repeated oral exposures to fenpyroximate were
based on systemic toxicity (no specific target organ/tissue
identified). The most sensitive species tested was the dog. The effects
reported in the dog included slight bradycardia, deficits in food
consumption, body weight, body-weight gain, and an increased incidence
of emesis and diarrhea. Emaciation and torpor (sluggish inactivity)
were reported in female dogs at lower dose levels than males. The
highest dose tested in the dog (50 milligram/kilogram bodyweight/day
(mg/kg bw/day)) resulted in first- and second-degree heart block,
increased urea concentration, decreased glucose, and altered plasma
electrolyte levels among other signs of toxicity. In subchronic and
chronic studies with rats, the primary effect was decreased body-weight
gain in both sexes with hematological changes (e.g., higher counts of
red blood cells) at higher doses.
In a rat prenatal developmental toxicity study, a dose level that
marginally affected maternal body weight and food consumption also
resulted in an increased litter incidence of increased thoracic ribs,
indicating increased prenatal (qualitative) susceptibility. In the
rabbits, there were no developmental effects reported at the levels
tested. In the rat two-generation reproductive toxicity study, maternal
toxicity (decreased body weight) and offspring toxicity (decreased
lactational weight gain in both generations) occurred at the same dose.
There is no evidence that fenpyroximate specifically targets the
nervous or immune system based on the results of recently submitted
studies. In the acute neurotoxicity study, neurotoxicity signs such as
decreases in motor activity occurred in the presence of other effects
including decreases in body weight and food consumption, and in the
absence of neuropathology. Similar results were noted in a delayed
acute neurotoxicity study in the hen where no effects (neurotoxic or
otherwise) were reported. The results of the rat subchronic
neurotoxicity study did not indicate any neurotoxicity-specific
effects; deficits in body weight and food consumption were the main
effects reported. Similarly, the effects reported in a rat
immunotoxicity study were limited to decreased body-weight gain.
[[Page 34872]]
In a 21-day dermal toxicity study in rats, there were clinical
signs in females consisting of red nose and mouth/nasal discharge,
decreased body weights, body-weight gains, and food consumption in
males and females. There were also increased liver weights and
hepatocellular necrosis reported in females.
In a 4-week rat inhalation study, treatment-related effects
included clinical observations (labored breathing and rales), increased
lung weights, decreases in body-weight gain and food consumption, and
changes in hematology parameters (increased counts of erythrocytes and
leukocytes). There were also histopathology findings in the nasal
passage mucosa consisting of atrophy and squamous metaplasia.
Fenpyroximate was classified as ``not likely to be carcinogenic to
humans'' based on the results of rat and mouse carcinogenicity studies.
Genotoxicity studies including mutagenicity did not demonstrate any
genotoxic potential associated with fenpyroximate.
Specific information on the studies received and the nature of the
adverse effects caused by fenpyroximate 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 the document titled ``Fenpyroximate. Human-
Health Risk Assessment for Proposed Section 3 Uses on Stone Fruits
(Group 12-12), Tuberous and Corm Vegetables (Subgroup 1C), and Small
Vine Climbing Fruits Except Kiwifruit (Subgroup 13-07F)'' on page 28 in
docket ID number EPA-HQ-OPP-2016-0307.
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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for fenpyroximate used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Fenpyroximate 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 13-50 NOAEL = 5.0 mg/kg/ Acute RfD = 0.05 mg/ Prenatal Developmental Toxicity
years of age). day. kg/day. Study--Rat.
UFA = 10x........... aPAD = 0.05 mg/kg/ LOAEL = 25 mg/kg/day based on
UFH = 10x........... day. increase in the fetal incidence
FQPA SF = 1x........ of additional thoracic ribs.
Acute dietary (General population NOAEL = 37.5 mg/kg/ Acute RfD = 0.375 Acute Neurotoxicity Study--Rat.
including infants and children). day. mg/kg/day. LOAEL = 150 mg/kg bw based on
UFA = 10x........... aPAD = 0.375 mg/kg/ decreased motor activity (total
UFH = 10x........... day. activity counts and total time
FQPA SF = 1x........ spent in movement) in both sexes,
and a reduction in auditory
startle response in females at 24
hours post dose, and mild
dehydration in males.
Chronic dietary (All populations) NOAEL= 5.0 mg/kg/day Chronic RfD = 0.05 Chronic toxicity--Dog.
UFA = 10x........... mg/kg/day. LOAEL = 15 mg/kg/day based on an
UFH = 10x........... cPAD = 0.05 mg/kg/ increased incidence of
FQPA SF = 1x........ day. bradycardia, diarrhea, and
decreases in cholesterol, body-
weight gain, and food consumption
(M); vomiting, diarrhea, excess
salivation and decrease
cholesterol in females.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Cancer (Oral, dermal, inhalation) Classification: ``Not likely to be carcinogen,'' cancer risk assessment is
not required
----------------------------------------------------------------------------------------------------------------
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 fenpyroximate, EPA considered exposure under the
petitioned-for tolerances as well as all existing fenpyroximate
tolerances in 40 CFR 180.566. EPA assessed dietary exposures from
fenpyroximate 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 fenpyroximate. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) National Health and Nutrition
[[Page 34873]]
Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008).
As to residue levels in food, EPA assumed 100 percent crop treated
(PCT) and tolerance level residues for all commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA (2003-2008). As to residue levels in food, EPA assumed 100 PCT
and tolerance level residues for all commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fenpyroximate 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.
EPA did not use anticipated residue or PCT information in the dietary
assessment for fenpyroximate. Tolerance level residues and 100 PCT were
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 fenpyroximate in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fenpyroximate. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Food Quality Protection Act (FQPA) Index Reservoir
Screening Tool (FIRST) and a Provisional Cranberry Model for
fenpyroximate and its metabolites (M1 and M3) in surface water and with
Screening Concentration in Ground Water (SCI-GROW) for ground water,
the estimated drinking water concentrations (EDWCs) of fenpyroximate
for acute exposures are estimated to be 43 parts per billion (ppb) for
surface water and 0.27 ppb for ground water, and for chronic exposures
are estimated to be 8.6 ppb for surface water and 0.27 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 43 ppb was used to assess
the contribution to drinking water and for the chronic dietary risk
assessment, the water concentration of value 8.6 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). Fenpyroximate is not
registered for any specific use patterns that would result in
residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found fenpyroximate to share a common mechanism of
toxicity with any other substances, and fenpyroximate does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fenpyroximate 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
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 Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
SF when reliable data available to EPA support the choice of a
different factor.
2. Prenatal and postnatal sensitivity. There is evidence of
increased prenatal (qualitative) susceptibility in a rat prenatal
developmental toxicity study. A dose level that marginally affected
maternal body weight and food consumption also resulted in an increased
litter incidence of increased thoracic ribs. However, concern for
prenatal and postnatal toxicity to fenpyroximate is low because:
i. There was a clear NOAEL in the rat prenatal developmental
toxicity study;
ii. The NOAEL for this developmental study is being used as POD for
the acute dietary risk assessment for the population of concern-females
13-49 years old;
iii. In the rabbit, there were no developmental effects reported at
the levels tested; and
iv. In the rat 2-generation reproductive toxicity study, there was
no indication of increased prenatal or postnatal susceptibility.
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 fenpyroximate is complete.
ii. There is no indication that fenpyroximate is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is evidence that fenpyroximate results in increased
susceptibility in utero rats or rabbits in the prenatal developmental
studies or in young rats in the two-generation reproduction study.
Increased (qualitative) prenatal susceptibility was seen following oral
exposures in the rat developmental toxicity study, but the concern for
these effects is low, for the reasons noted in Unit III.D.2. Therefore,
a 10x FQPA SF is not necessary to account for this increased
susceptibility of infants and children.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to fenpyroximate in drinking water. These
assessments will not underestimate the exposure and risks posed by
fenpyroximate.
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
[[Page 34874]]
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 fenpyroximate will occupy 14% of the aPAD for females 13-49 years
old and 6.4% of the aPAD for children 1-2 years old, the population
groups with the greatest risk estimate.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fenpyroximate from food and water will utilize 16% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for fenpyroximate.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however,
fenpyroximate is not registered for any use patterns that would result
in either short- or intermediate-term residential exposure. Short- and
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. Because there
is no short- or intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess short- or intermediate-term risk), no further assessment of
short- or intermediate-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short- and intermediate-
term risk for fenpyroximate.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, chemical name is not expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fenpyroximate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography method with
nitrogen/phosphorus detection (GC/NPD), Method S19) is available to
enforce the tolerance expression. Method S19 has passed an Agency
validation and has a limit of quantitation (LOQ) of 0.05 ppm for the
combined residues of fenpyroximate and M-1 in snap beans and avocados.
A data-gathering liquid chromatography/mass spectroscopy/mass
spectroscopy (LC/MS/MS) method is also available.
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.
The Codex has established MRLs for fenpyroximate in or on citrus
fruits at 0.5 ppm. This MRLs is different than the tolerance being
established for fenpyroximate in the United States, however,
harmonization with the Codex MRL is not possible because the U.S.
tolerance expression includes an additional isomer and the U.S. use
pattern requires a higher numerical value.
C. Revisions to Petitioned-For Tolerances
Based on the Organization for Economic Co-operation and Development
(OECD) tolerance-calculation procedure, the Agency is increasing the
tolerance on citrus oil to 15 ppm rather than 14 ppm as proposed by the
registrant.
V. Conclusion
Therefore, existing tolerances for residues of fenpyroximate are
increased in or on citrus, dried pulp from 2.5 ppm to 4.0 ppm; citrus,
oil from 10 ppm to 15 ppm; and fruit, citrus, group 10-10 from 0.50 ppm
to 1.0 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian
[[Page 34875]]
tribes. Thus, the Agency has determined that Executive Order 13132,
entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive
Order 13175, entitled ``Consultation and Coordination with Indian
Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to
this action. In addition, this action does not impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 22, 2017.
Michael L. Goodis,
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. 180.566, revise the entries for ``Citrus, dried pulp'',
``Citrus, oil'', and ``Fruit, citrus, group 10-10'' in the table in
paragraph (a)(1) to read as follows:
Sec. 180.566 Fenpyroximate; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Citrus, dried pulp.......................................... 4.0
Citrus, oil................................................. 15
* * * * *
Fruit, citrus, group 10-10.................................. 1.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-15728 Filed 7-26-17; 8:45 am]
BILLING CODE 6560-50-P
