Aluminum tris (O-ethylphosphonate); Pesticide Tolerances, 12260-12265 [2018-05642]
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Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Rules and Regulations
Products, Food and Drug
Administration, 301–796–5616,
melissa.burns@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
an immediately in effect guidance for
industry entitled ‘‘Compliance Policy
for Combination Product Postmarketing
Safety Reporting.’’ This guidance
describes FDA’s compliance policy for
combination product applicants and
constituent part applicants and
activities under 21 CFR part 4, subpart
B, which was published in the Federal
Register of December 20, 2016 (81 FR
92603) and addresses postmarketing
safety reporting for combination
products. We are issuing this guidance
consistent with our good guidance
practices (GGP) regulation (§ 10.115 (21
CFR 10.115)). We are implementing this
guidance without prior public comment,
because we have determined that prior
public participation is not feasible or
appropriate (see section 701(h)(1)(C)(i)
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371(h)(1)(C)(i)) and
§ 10.115(g)(2)). We made this
determination because FDA needs to
communicate its compliance policy in a
timely manner given the upcoming
compliance deadlines for certain
provisions in 21 CFR part 4, subpart B,
and the amount of time needed for firms
to prepare for them. Although this
guidance is immediately effective, it
remains subject to comment in
accordance with FDA’s GGP regulation.
[FR Doc. 2018–05798 Filed 3–20–18; 8:45 am]
BILLING CODE 1301–00–D
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0639; FRL–9974–63]
Aluminum tris (O-ethylphosphonate);
Pesticide Tolerances
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This regulation amends a
tolerance for residues of aluminum tris
(O-ethylphosphonate) in or on Fruit,
citrus, group 10. Fosetyl-al is the
common name for aluminum tris (O-
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II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 314.80(c) and (e), as well as for
21 CFR 314.81(b) are approved under
OMB control numbers 0910–0001,
0910–0230, and 0910–0291. The
information collection provisions for 21
CFR 600.80 and 600.81 are approved
under OMB control number 0910–0308.
Those for 21 CFR 606.170 are approved
under OMB control number 0910–0116.
Those for 21 CFR 606.171 are approved
under OMB control number 0910–0458.
The information collection provisions
for 21 CFR 803.50, 803.53, and 803.56
are approved under OMB control
numbers 0910–0291 and 0910–0437.
The information collection provisions
ethylphosphonate). Tessenderlo Kerley,
Inc requested the amended tolerance
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective
March 21, 2018. Objections and requests
for hearings must be received on or
before May 21, 2018, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0639, 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
ADDRESSES:
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY:
Published elsewhere in this issue of
the Federal Register, FDA is
announcing the availability of the draft
guidance entitled ‘‘Postmarketing Safety
Reporting for Combination Products.’’
This guidance represents the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
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for 21 CFR 806.10 and 806.20 are
approved under OMB control number
0910–0359. The information collection
provisions for §§ 4.102, 4.103, and 4.105
are approved under OMB control
number 0910–0834.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: March 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05688 Filed 3–20–18; 8:45 am]
BILLING CODE 4164–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 51
Requirements for Preparation,
Adoption, and Submittal of
Implementation Plans
CFR Correction
In Title 40 of the Code of Federal
Regulations, Parts 50 to 51, revised as of
July 1, 2017, on page 478, in Part 51,
Appendix M, following Reynolds
Number., Equation 10 is reinstated to
read as follows:
■
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:
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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).
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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–2016–0639 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 May 21, 2018. 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–
2016–0639, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
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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 July 26,
2017 (82 FR 34664) (FRL–9963–50),
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 6F8517) by
Tessenderlo Kerley, Inc, 2255 N. 44th
St., Suite 300, Phoenix, AZ 85008. The
petition requested that 40 CFR 180.415
be modified by amending tolerances for
residues of the fungicide aluminum tris
(O-ethylphosphonate), in or on fruit,
citrus, group 10 from 5.0 parts per
million (ppm) to 9.0 ppm. That
document referenced a summary of the
petition prepared by Tessenderlo
Kerley, Inc, the registrant, which is
available in the docket, https://
www.regulations.gov. No comments
were received on this notice of filing.
Because EPA does not issue group
tolerances for groups that have been
updated or superseded, the petitioner
submitted a revised petition, clarifying
that its request was to establish
tolerances for residues of the fungicide
aluminum tris (O-ethylphosphonate) in
or on the updated crop group fruit,
citrus, group 10–10 at 9.0 ppm. EPA
published notice of this revised petition
in the Federal Register on December 19,
2017 (82 FR 60167) (FRL–9971–11).
That document referenced a summary of
this updated petition, which is available
in the docket, https://
www.regulations.gov. Comments were
received on the notice of filing. EPA’s
response to these comments is
discussed 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.’’
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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 aluminum tris
(O-ethylphosphonate) including
exposure resulting from the tolerances
established by this action. EPA’s
assessment of exposures and risks
associated with aluminum tris (Oethylphosphonate) 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 major target organs following
repeated oral exposure to fosetyl-Al are
the reproductive system in the dog
(testicular degeneration: Spermatocytic
and/or spermatidic giant cells in the
lumen of the seminiferous tubules) and
the urinary system in the rat
(histopathological changes in the
kidney, impairment of calcium/
phosphorus metabolism, calculi and
hyperplasia in the urinary tract, bladder
tumors).
The prenatal developmental studies
in rabbits and rats and the 3-generation
reproduction study in rats showed no
indication of increased susceptibility
following in utero and/or postnatal
exposure to fosetyl-Al. Developmental
toxicity was not observed in the rat at
the limit dose or in the rabbit at the
highest dose tested (500 mg/kg/day).
Reproductive toxicity was not observed
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at the limit dose, and offspring toxicity
(decreased pup body weight at 600 mg/
kg/day) was observed at the same dose
as maternal toxicity (decreased body
weight gain and urinary tract changes).
The toxicology database for fosetyl-Al
does not show any evidence of
neurotoxicity.
Fosetyl-Al is classified as not likely to
be carcinogenic to humans since it was
negative for carcinogenicity except at
extremely high doses (>limit dose) in
rats and mice, and it did not show any
genotoxic potential. Fosetyl-Al is not
acutely toxic via the oral, dermal, and
inhalation routes, is not a skin irritant
or dermal sensitizer, but is a severe eye
irritant.
Specific information on the studies
received and the nature of the adverse
effects caused by aluminum tris (Oethylphosphonate) as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://
www.regulations.gov in document
Fosetyl-Aluminum (Fosetyl-AI): Human
Health Risk Assessment in Support of
the Amended Registration for the
Proposed 0-day Pre-Harvest Interval
(PHI) for Citrus Fruit Group 10–10 at
pages 9–14 in docket ID number EPA–
HQ–OPP–2016–0639.
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 aluminum tris (Oethylphosphonate) used for human risk
assessment is shown in Table 1 of this
unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ALUMINUM TRIS (O-ETHYLPHOSPHONATE) FOR USE
IN HUMAN HEALTH RISK ASSESSMENT
Exposure/scenario
Acute dietary (All populations) ..
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
No appropriate endpoint was identified. There were no adverse effects observed in oral toxicity studies that
could be attributed to a single-dose exposure.
Chronic dietary (All populations)
NOAEL = 250mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 2.5
mg/kg/day.
cPAD = 2.5 mg/kg/
day
Chronic oral toxicity (dog).
LOAEL = 500 mg/kg/day based on an increased incidence of
testicular degeneration (spermatocytic and/or spermatidic
giant cells in the lumen of the seminiferous tubules).
Incidental oral (Short- and intermediate-term).
NOAEL = 300 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Residential LOC for
MOE <100.
3-generation reproduction (rat).
LOAEL = 600 mg/kg/day based on decreased body weight
gains in the F2b generation and urinary tract changes in
adults and decreased pup body weights.
Dermal (All durations) ...............
No potential hazard via the dermal route, based on the lack of systemic effects following repeat dermal exposure of rabbits at dose levels up to 1,500 mg/kg/day, which is greater than the limit dose.
Inhalation (Short- and intermediate -term).
NOAEL = 300 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Residential and Occupational LOC for
MOE <100.
Cancer (Oral, dermal, inhalation).
3-generation reproduction (rat).
LOAEL = 600 mg/kg/day based on decreased body weight
gains in the F2b generation and urinary tract changes in
adults.
Not likely to be carcinogenic to humans.
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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 aluminum tris (Oethylphosphonate), EPA considered
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exposure under the petitioned-for
tolerances as well as all existing
aluminum tris (O-ethylphosphonate)
tolerances in 40 CFR 180.415. EPA
assessed dietary exposures from
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aluminum tris (O-ethylphosphonate) 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
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possibility of an effect of concern
occurring as a result of a 1-day or single
exposure. No such effects were
identified in the toxicological studies
for aluminum tris (Oethylphosphonate); therefore, a
quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA Nationwide Health and
Nutrition Examination Survey, What We
Eat in America (NHANES/WWEIA)
conducted from 2003–2008. As to
residue levels in food, the chronic
dietary analysis was obtained from the
Dietary Exposure Evaluation Model
using the Food Commodity Intake
Database (DEEM–FCID; version 3.16).
The unrefined chronic analysis is based
on tolerance-level residues and 100%
crop treated assumptions. Default
processing factors were used for all
crops, except for citrus where
processing studies showed no residue
concentration; thus, the processing
factor was set to one for processed citrus
commodities.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that aluminum tris (Oethylphosphonate) 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 and/or PCT
information in the dietary assessment
for aluminum tris (Oethylphosphonate). Tolerance-level
residues and/or 100% CT 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 aluminum tris (O-ethylphosphonate)
in drinking water. These simulation
models take into account data on the
physical, chemical, and fate/transport
characteristics of aluminum tris (Oethylphosphonate). 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.
Environmental fate properties suggest
that aluminum tris (Oethylphosphonate) is not likely to reach
ground or surface water under most
conditions, and if it does reach surface
water, it is expected to degrade rapidly.
However, if aluminum tris (Oethylphosphonate) reached
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groundwater, it could persist. Based on
the Screening Concentration in Ground
Water (SCI–GROW) model, the
estimated drinking water concentration
(EDWC) of aluminum tris (Oethylphosphonate) for chronic
exposures for non-cancer assessments is
estimated to be 0.006 ppb for ground
water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration of value 0.006 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).
Aluminum tris (O-ethylphosphonate) is
currently registered for the following
uses that could result in residential
exposures: Turf and ornamental plants.
EPA assessed residential exposure using
the following assumptions: Inhalation
exposure from the hose end sprayer for
turf applications, and incidental oral
exposure from post-application
exposure to treated turf. Because no
dermal endpoint was identified, nonoccupational dermal exposures were not
assessed. Further information regarding
EPA standard assumptions and generic
inputs for residential exposures may be
found at https://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/
standard-operating-proceduresresidential-pesticide.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found aluminum tris (Oethylphosphonate) to share a common
mechanism of toxicity with any other
substances, and aluminum tris (Oethylphosphonate) does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that aluminum tris (Oethylphosphonate) 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
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chemicals, see EPA’s website 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
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is no concern for increased
quantitative or qualitative susceptibility
of the young following in utero (rats and
rabbits) and post-natal exposure (rats) to
fosetyl-Al. Also, there is no evidence of
developmental toxicity, reproductive
toxicity, neurotoxicity, or
immunotoxicity at dose levels that do
not exceed the limit dose.
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 aluminum
tris (O-ethylphosphonate) is complete.
ii. There is no indication that
aluminum tris (O-ethylphosphonate) is
a neurotoxic chemical and there is no
need for a developmental neurotoxicity
study or additional UFs to account for
neurotoxicity.
iii. There is no evidence that
aluminum tris (O-ethylphosphonate)
results in increased susceptibility in in
utero rats or rabbits in the prenatal
developmental studies or in young rats
in the 3-generation reproduction study.
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 and are not
likely to underestimate risk. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to aluminum
tris (O-ethylphosphonate) in drinking
water. EPA used similarly conservative
assumptions to assess post-application
exposure of children as well as
incidental oral exposure of toddlers.
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These assessments will not
underestimate the exposure and risks
posed by aluminum tris (Oethylphosphonate).
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E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, aluminum tris (Oethylphosphonate) is not expected to
pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to aluminum tris
(O-ethylphosphonate) from food and
water will utilize 14% of the cPAD for
children 1–2 years old, the population
group receiving the greatest exposure.
Based on the explanation in Unit
III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of aluminum tris (Oethylphosphonate) 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).
Aluminum tris (O-ethylphosphonate)
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 aluminum tris (Oethylphosphonate).
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 3200 for male adults, 3300 for
female adults and 480 for children 1–2
years old. Because EPA’s level of
concern for aluminum tris (O-
VerDate Sep<11>2014
16:29 Mar 20, 2018
Jkt 244001
ethylphosphonate) 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, aluminum tris (Oethylphosphonate) 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 intermediateterm risk), no further assessment of
intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk
assessment for evaluating intermediateterm risk for aluminum tris (Oethylphosphonate).
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
aluminum tris (O-ethylphosphonate) is
not expected to pose a cancer risk to
humans.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to aluminum
tris (O-ethylphosphonate) residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(Pesticide Analytical Manual (PAM) II
method, which uses diazomethane as
the methylating agent and quantitation
of aluminum tris (O-ethylphosphonate)
by Gas Chromatography with Flame
Photometric Detector (GC/FPD)) is
available to enforce the tolerance
expression.
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
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level. The Codex has not
established a MRL for aluminum tris (Oethylphosphonate) on citrus fruit.
C. Response to Comments
EPA received five comments on the
second notice of filing. Two comments
pertained to the general concern over
addition of more chemicals to the daily
diet and onset of autoimmune diseases
but did not contain any specific
information relevant to the potential
risks from aluminum tris (Oethylphosphonate). In response, the
Agency explains that it has complied
with the requirements of the FFDCA,
which allow the Agency to establish or
modify tolerances if the Agency
determines they are safe. When new or
amended tolerances are requested for
the presence of the residues of a
pesticide and its toxicologically
significant metabolite(s) in food or feed,
the EPA, as is required by section 408
of the FFDCA, estimates the risk of the
potential exposure to these residues by
performing an aggregate risk assessment.
Such a risk assessment integrates the
individual assessments that are
conducted for food, drinking water, and
residential exposures. Additionally, the
Agency, as is further required by section
408 of the FFDCA, considers available
information concerning what are termed
the cumulative toxicological effects of
the residues of that pesticide and of
other substances having a common
mechanism of toxicity with it. The
Agency has concluded after this
assessment that there is a reasonable
certainty that no harm will result from
exposure to the residues of interest.
Therefore, the Agency may establish the
tolerances requested in this petition.
Another citizen was concerned about
the risk to pollinators. The commenter
stated this use should be denied due to
toxicity to pollinators and that keeping
them healthy should be our top priority.
The comment primarily appears
directed to the registration of the
pesticide under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)
and are not relevant to the underlying
safety finding made under the FFDCA;
therefore, the EPA will consider impacts
to the environment and non-target
species under the authority of FIFRA.
The remaining two comments were not
E:\FR\FM\21MRR1.SGM
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Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Rules and Regulations
germane to this action; therefore, no
further response from the Agency is
required.
sradovich on DSK3GMQ082PROD with RULES
V. Conclusion
Therefore, tolerances are amended for
residues of aluminum tris (Oethylphosphonate), in or on fruit, citrus,
group 10–10 at 9.0 ppm.
VI. Statutory and Executive Order
Reviews
This action amends and expands an
existing crop group tolerance 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
VerDate Sep<11>2014
16:29 Mar 20, 2018
Jkt 244001
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: March 7, 2018.
Michael Goodis,
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 § 180.415,
a. Remove the entry for ‘‘Fruit, citrus,
group 10’’ from the table in paragraph
(a).
■ b. Add alphabetically an entry to the
table in paragraph (a) for ‘‘Fruit, citrus,
group 10–10’’.
The addition reads as follows:
■
■
§ 180.415 Aluminum tris (Oethylphosphonate); tolerances for residues.
(a) *
PO 00000
*
Frm 00019
*
Fmt 4700
Sfmt 4700
Parts per
million
Commodity
*
*
*
*
Fruit, citrus, group 10–10 .............
*
*
*
*
*
*
*
*
*
9.0
*
*
[FR Doc. 2018–05642 Filed 3–20–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0817; FRL–9974–32]
Flutianil; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of flutianil in or
on multiple commodities that are
identified and discussed later in this
document and an exemption for indirect
or inadvertent residues of flutianil on
other crops rotated into fields
previously treated with flutianil. OAT
AGRIO Company, Ltd. requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
March 21, 2018. Objections and requests
for hearings must be received on or
before May 21, 2018, 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–2015–0817, 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 L. Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
SUMMARY:
E:\FR\FM\21MRR1.SGM
21MRR1
]]>Agencies
[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Rules and Regulations]
[Pages 12260-12265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05642]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0639; FRL-9974-63]
Aluminum tris (O-ethylphosphonate); Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends a tolerance for residues of aluminum
tris (O-ethylphosphonate) in or on Fruit, citrus, group 10. Fosetyl-al
is the common name for aluminum tris (O-ethylphosphonate). Tessenderlo
Kerley, Inc requested the amended tolerance under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 21, 2018. Objections and
requests for hearings must be received on or before May 21, 2018, 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-2016-0639, 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: [email protected].
SUPPLEMENTARY INFORMATION:
[[Page 12261]]
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0639 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
May 21, 2018. 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-2016-0639, 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 July 26, 2017 (82 FR 34664) (FRL-9963-
50), 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
6F8517) by Tessenderlo Kerley, Inc, 2255 N. 44th St., Suite 300,
Phoenix, AZ 85008. The petition requested that 40 CFR 180.415 be
modified by amending tolerances for residues of the fungicide aluminum
tris (O-ethylphosphonate), in or on fruit, citrus, group 10 from 5.0
parts per million (ppm) to 9.0 ppm. That document referenced a summary
of the petition prepared by Tessenderlo Kerley, Inc, the registrant,
which is available in the docket, https://www.regulations.gov. No
comments were received on this notice of filing.
Because EPA does not issue group tolerances for groups that have
been updated or superseded, the petitioner submitted a revised
petition, clarifying that its request was to establish tolerances for
residues of the fungicide aluminum tris (O-ethylphosphonate) in or on
the updated crop group fruit, citrus, group 10-10 at 9.0 ppm. EPA
published notice of this revised petition in the Federal Register on
December 19, 2017 (82 FR 60167) (FRL-9971-11). That document referenced
a summary of this updated petition, which is available in the docket,
https://www.regulations.gov. Comments were received on the notice of
filing. EPA's response to these comments is discussed 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 aluminum tris (O-
ethylphosphonate) including exposure resulting from the tolerances
established by this action. EPA's assessment of exposures and risks
associated with aluminum tris (O-ethylphosphonate) 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 major target organs following repeated oral exposure to
fosetyl-Al are the reproductive system in the dog (testicular
degeneration: Spermatocytic and/or spermatidic giant cells in the lumen
of the seminiferous tubules) and the urinary system in the rat
(histopathological changes in the kidney, impairment of calcium/
phosphorus metabolism, calculi and hyperplasia in the urinary tract,
bladder tumors).
The prenatal developmental studies in rabbits and rats and the 3-
generation reproduction study in rats showed no indication of increased
susceptibility following in utero and/or postnatal exposure to fosetyl-
Al. Developmental toxicity was not observed in the rat at the limit
dose or in the rabbit at the highest dose tested (500 mg/kg/day).
Reproductive toxicity was not observed
[[Page 12262]]
at the limit dose, and offspring toxicity (decreased pup body weight at
600 mg/kg/day) was observed at the same dose as maternal toxicity
(decreased body weight gain and urinary tract changes). The toxicology
database for fosetyl-Al does not show any evidence of neurotoxicity.
Fosetyl-Al is classified as not likely to be carcinogenic to humans
since it was negative for carcinogenicity except at extremely high
doses (>limit dose) in rats and mice, and it did not show any genotoxic
potential. Fosetyl-Al is not acutely toxic via the oral, dermal, and
inhalation routes, is not a skin irritant or dermal sensitizer, but is
a severe eye irritant.
Specific information on the studies received and the nature of the
adverse effects caused by aluminum tris (O-ethylphosphonate) 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 Fosetyl-Aluminum (Fosetyl-AI):
Human Health Risk Assessment in Support of the Amended Registration for
the Proposed 0-day Pre-Harvest Interval (PHI) for Citrus Fruit Group
10-10 at pages 9-14 in docket ID number EPA-HQ-OPP-2016-0639.
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 aluminum tris (O-
ethylphosphonate) used for human risk assessment is shown in Table 1 of
this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Aluminum tris (O-ethylphosphonate) 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 (All populations).. No appropriate endpoint was identified. There were no adverse effects
observed in oral toxicity studies that could be attributed to a single-dose
exposure.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 250mg/kg/day Chronic RfD = 2.5 Chronic oral toxicity (dog).
UFA = 10x........... mg/kg/day. LOAEL = 500 mg/kg/day based on an
UFH = 10x........... cPAD = 2.5 mg/kg/ increased incidence of testicular
FQPA SF = 1x........ day. degeneration (spermatocytic and/
or spermatidic giant cells in the
lumen of the seminiferous
tubules).
----------------------------------------------------------------------------------------------------------------
Incidental oral (Short- and NOAEL = 300 mg/kg/ Residential LOC for 3-generation reproduction (rat).
intermediate-term). day. MOE <100. LOAEL = 600 mg/kg/day based on
UFA = 10x.......... decreased body weight gains in
UFH = 10x........... the F2b generation and urinary
FQPA SF = 1x........ tract changes in adults and
decreased pup body weights.
----------------------------------------------------------------------------------------------------------------
Dermal (All durations)........... No potential hazard via the dermal route, based on the lack of systemic
effects following repeat dermal exposure of rabbits at dose levels up to
1,500 mg/kg/day, which is greater than the limit dose.
----------------------------------------------------------------------------------------------------------------
Inhalation (Short- and NOAEL = 300 mg/kg/ Residential and 3-generation reproduction (rat).
intermediate -term). day. Occupational LOC LOAEL = 600 mg/kg/day based on
UFA = 10x........... for MOE <100. decreased body weight gains in
UFH = 10x........... the F2b generation and urinary
FQPA SF = 1x........ tract changes in adults.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
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 aluminum tris (O-ethylphosphonate), EPA considered exposure
under the petitioned-for tolerances as well as all existing aluminum
tris (O-ethylphosphonate) tolerances in 40 CFR 180.415. EPA assessed
dietary exposures from aluminum tris (O-ethylphosphonate) 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
[[Page 12263]]
possibility of an effect of concern occurring as a result of a 1-day or
single exposure. No such effects were identified in the toxicological
studies for aluminum tris (O-ethylphosphonate); therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA Nationwide
Health and Nutrition Examination Survey, What We Eat in America
(NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food,
the chronic dietary analysis was obtained from the Dietary Exposure
Evaluation Model using the Food Commodity Intake Database (DEEM-FCID;
version 3.16). The unrefined chronic analysis is based on tolerance-
level residues and 100% crop treated assumptions. Default processing
factors were used for all crops, except for citrus where processing
studies showed no residue concentration; thus, the processing factor
was set to one for processed citrus commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that aluminum tris (O-ethylphosphonate) 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 and/or PCT information in the
dietary assessment for aluminum tris (O-ethylphosphonate). Tolerance-
level residues and/or 100% CT 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 aluminum tris (O-ethylphosphonate) in drinking water.
These simulation models take into account data on the physical,
chemical, and fate/transport characteristics of aluminum tris (O-
ethylphosphonate). 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.
Environmental fate properties suggest that aluminum tris (O-
ethylphosphonate) is not likely to reach ground or surface water under
most conditions, and if it does reach surface water, it is expected to
degrade rapidly. However, if aluminum tris (O-ethylphosphonate) reached
groundwater, it could persist. Based on the Screening Concentration in
Ground Water (SCI-GROW) model, the estimated drinking water
concentration (EDWC) of aluminum tris (O-ethylphosphonate) for chronic
exposures for non-cancer assessments is estimated to be 0.006 ppb for
ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 0.006 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). Aluminum tris (O-
ethylphosphonate) is currently registered for the following uses that
could result in residential exposures: Turf and ornamental plants. EPA
assessed residential exposure using the following assumptions:
Inhalation exposure from the hose end sprayer for turf applications,
and incidental oral exposure from post-application exposure to treated
turf. Because no dermal endpoint was identified, non-occupational
dermal exposures were not assessed. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found aluminum tris (O-ethylphosphonate) to share a
common mechanism of toxicity with any other substances, and aluminum
tris (O-ethylphosphonate) does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has assumed that aluminum tris (O-
ethylphosphonate) 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 website 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 FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There is no concern for
increased quantitative or qualitative susceptibility of the young
following in utero (rats and rabbits) and post-natal exposure (rats) to
fosetyl-Al. Also, there is no evidence of developmental toxicity,
reproductive toxicity, neurotoxicity, or immunotoxicity at dose levels
that do not exceed the limit dose.
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 aluminum tris (O-ethylphosphonate) is
complete.
ii. There is no indication that aluminum tris (O-ethylphosphonate)
is a neurotoxic chemical and there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that aluminum tris (O-ethylphosphonate)
results in increased susceptibility in in utero rats or rabbits in the
prenatal developmental studies or in young rats in the 3-generation
reproduction study.
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 and are not likely to
underestimate risk. EPA made conservative (protective) assumptions in
the ground and surface water modeling used to assess exposure to
aluminum tris (O-ethylphosphonate) in drinking water. EPA used
similarly conservative assumptions to assess post-application exposure
of children as well as incidental oral exposure of toddlers.
[[Page 12264]]
These assessments will not underestimate the exposure and risks posed
by aluminum tris (O-ethylphosphonate).
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
aluminum tris (O-ethylphosphonate) is not expected to pose an acute
risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
aluminum tris (O-ethylphosphonate) from food and water will utilize 14%
of the cPAD for children 1-2 years old, the population group receiving
the greatest exposure. Based on the explanation in Unit III.C.3.,
regarding residential use patterns, chronic residential exposure to
residues of aluminum tris (O-ethylphosphonate) 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).
Aluminum tris (O-ethylphosphonate) 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
aluminum tris (O-ethylphosphonate).
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 3200 for male
adults, 3300 for female adults and 480 for children 1-2 years old.
Because EPA's level of concern for aluminum tris (O-ethylphosphonate)
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,
aluminum tris (O-ethylphosphonate) 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 aluminum tris (O-ethylphosphonate).
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, aluminum tris (O-ethylphosphonate) is not expected to pose a
cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to aluminum tris (O-ethylphosphonate) residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (Pesticide Analytical Manual (PAM)
II method, which uses diazomethane as the methylating agent and
quantitation of aluminum tris (O-ethylphosphonate) by Gas
Chromatography with Flame Photometric Detector (GC/FPD)) is available
to enforce the tolerance expression.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for aluminum tris (O-ethylphosphonate) on citrus
fruit.
C. Response to Comments
EPA received five comments on the second notice of filing. Two
comments pertained to the general concern over addition of more
chemicals to the daily diet and onset of autoimmune diseases but did
not contain any specific information relevant to the potential risks
from aluminum tris (O-ethylphosphonate). In response, the Agency
explains that it has complied with the requirements of the FFDCA, which
allow the Agency to establish or modify tolerances if the Agency
determines they are safe. When new or amended tolerances are requested
for the presence of the residues of a pesticide and its toxicologically
significant metabolite(s) in food or feed, the EPA, as is required by
section 408 of the FFDCA, estimates the risk of the potential exposure
to these residues by performing an aggregate risk assessment. Such a
risk assessment integrates the individual assessments that are
conducted for food, drinking water, and residential exposures.
Additionally, the Agency, as is further required by section 408 of the
FFDCA, considers available information concerning what are termed the
cumulative toxicological effects of the residues of that pesticide and
of other substances having a common mechanism of toxicity with it. The
Agency has concluded after this assessment that there is a reasonable
certainty that no harm will result from exposure to the residues of
interest. Therefore, the Agency may establish the tolerances requested
in this petition.
Another citizen was concerned about the risk to pollinators. The
commenter stated this use should be denied due to toxicity to
pollinators and that keeping them healthy should be our top priority.
The comment primarily appears directed to the registration of the
pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) and are not relevant to the underlying safety finding made
under the FFDCA; therefore, the EPA will consider impacts to the
environment and non-target species under the authority of FIFRA. The
remaining two comments were not
[[Page 12265]]
germane to this action; therefore, no further response from the Agency
is required.
V. Conclusion
Therefore, tolerances are amended for residues of aluminum tris (O-
ethylphosphonate), in or on fruit, citrus, group 10-10 at 9.0 ppm.
VI. Statutory and Executive Order Reviews
This action amends and expands an existing crop group tolerance
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 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: March 7, 2018.
Michael 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. 180.415,
0
a. Remove the entry for ``Fruit, citrus, group 10'' from the table in
paragraph (a).
0
b. Add alphabetically an entry to the table in paragraph (a) for
``Fruit, citrus, group 10-10''.
The addition reads as follows:
Sec. 180.415 Aluminum tris (O-ethylphosphonate); tolerances for
residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Fruit, citrus, group 10-10................................... 9.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2018-05642 Filed 3-20-18; 8:45 am]
BILLING CODE 6560-50-P
