[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Rules and Regulations]
[Pages 18995-19001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08357]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0226; FRL-9961-02]
Benzobicyclon; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
benzobicyclon in or on rice, grain. Gowan Company,
[[Page 18996]]
LLC requested this tolerance under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective April 25, 2017. Objections and
requests for hearings must be received on or before June 26, 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-2015-0226, is available at http://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 http://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:
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 http://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-2015-0226 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
June 26, 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-2015-0226, by one of
the following methods:
Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-
74), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F8343) by Gowan Company, LLC, P.O. Box 5569, Yuma, AZ 85366. The
petition requested that 40 CFR part 180 be amended by establishing
tolerances for residues of the herbicide benzobicyclon (3-[2-chloro-4-
(methylsulfonyl)benzoyl]-4-(phenylthio)bicyclo[3.2.1]oct-3-en-2-one),
in or on rice, grain and rice, straw at 0.1 parts per million (ppm).
That document referenced a summary of the petition prepared by Gowan
Company, LLC, the registrant, which is available in the docket (EPA-HQ-
OPP-2015-0226), http://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 is not
establishing a tolerance for rice, straw as requested. 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 benzobicyclon including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with benzobicyclon
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
[[Page 18997]]
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.
Benzobicyclon has low mammalian toxicity with no effects seen in
mice, dogs, and female rats following oral exposure or in rabbits
following dermal exposure. There is no evidence of neurotoxicity or
immunotoxicity. Parental effects in the reproduction toxicity study
were only observed at the highest dose tested and consisted of
increased incidence of hydropic degeneration (basophilic cells) in the
pituitaries of male rats only, and was observed at an increased
incidence for the F1 as compared to F0
generation. There was no evidence of increased quantitative or
qualitative fetal or offspring susceptibility in the developmental
toxicity and two-generation reproduction toxicity studies in rats with
no developmental, reproductive, or offspring effects observed.
Benzobicyclon was categorized as having low acute toxicity via the
oral, dermal, and inhalation routes of exposure. It produces minimal
but reversible eye irritation, but is not a dermal irritant or dermal
sensitizer. Benzobicyclon is classified as ``Not likely to be
Carcinogenic to Humans'' based on the absence of treatment-related
tumors in two adequate rodent carcinogenicity studies. There was no
concern for mutagenicity.
Benzobicyclon rapidly hydrolyzes to generate the anticipated
pesticidal active degradate, the triketone metabolite B (also referred
to as 1315P-070). For metabolite B, a limited amount of toxicological
data is available. An in vitro enzyme activity assay that was submitted
indicates that metabolite B is an inhibitor of 4-hydroxyphenylpyruvate
dioxygenase (HPPD). In mammals, HPPD is a key enzyme in the catabolism
of the amino acid tyrosine and inhibition of HPPD results in an
increase of blood tyrosine concentrations (tyrosinemia). In laboratory
animals, as a class, HPPD inhibitors produce ocular (opacities and
keratitis), liver, kidney, and developmental (skeletal abnormalities)
effects in rats. In a 90-day toxicity study in rats with metabolite B,
ocular effects (neovascularization and opacity of the cornea)
consistent with tyrosinemia were at a similar dose that elicited ocular
effects for tembotrione, the most potent HPPD inhibitor currently
registered. The study also demonstrated that metabolite B induces
treatment-related effects at lower doses than those required to elicit
effects for the parent, benzobicyclon. For metabolite B, the
toxicological database does not contain any carcinogenicity studies.
Some of the currently registered HPPD inhibitors have been shown to
cause tumors; however, cancer risk estimates tend to be low for this
class and the chronic risk assessment generally addresses this risk. A
bacterial reverse-mutation assay with metabolite B to evaluate
genotoxicity was found to be negative. Due to the incomplete database
for metabolite B, studies from the tembotrione database were used for
preliminary evaluation of risks from exposure to metabolite B, along
with the appropriate database uncertainty factors to ensure the
tembotrione database is protective for the proposed use pattern. Any
expansion in the use of benzobicyclon would require additional data to
further characterize the toxicological effects of metabolite B.
Specific information on the studies received and the nature of the
adverse effects caused by benzobicyclon and metabolite B as well as the
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies can be found at
http://www.regulations.gov in document Benzobicyclon Human Health Risk
Assessment for the Section 3 Registration Action on Rice and the
Establishment of Permanent Tolerances for Residues in/on Rice at page
36 in docket ID number EPA-HQ-OPP-2015-0226.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for benzobicyclon and
metabolite B used for human risk assessment is shown in Table 1 and
Table 2 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Benzobicyclon for Use in Human Health Risk Assessment
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Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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Acute dietary (All populations).... No appropriate toxicological effect attributable to a single dose was
observed. Therefore, a dose and endpoint were not identified for this risk
assessment.
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Chronic dietary (All populations).. NOAEL = 63.6 mg/kg/day Chronic RfD = 0.636 mg/ Two-Generation Reproduction
UFA = 10x............. kg/day. Toxicity Study (rat).
UFH = 10x............. ...................... LOAEL = 1,320 mg/kg/day
FQPA SF = 1x.......... cPAD = 0.636 mg/kg/day based on increased
incidence of hydropic
degeneration (basophilic
cells) in the pituitary.
Incidental oral Short-term (1 to 30 NOAEL = 63.6 mg/kg/day Residential LOC for Two-Generation Reproduction
days) and Intermediate-Term (1-6 UFA = 10x............. MOE <100. Toxicity Study (rat).
months). UFH = 10x............. LOAEL = 1,320 mg/kg/day
FQPA SF = 1x.......... based on increased
incidence of hydropic
degeneration (basophilic
cells) in the pituitary.
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[[Page 18998]]
Dermal Short-term (1 to 30 days) No hazard was identified for dermal exposure based on a dermal toxicity
and Intermediate-Term (1-6 months). study and there was no evidence of increased quantitative susceptibility;
therefore, a quantitative dermal assessment is not needed.
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Inhalation Short-term (1 to 30 Oral NOAEL = 63.6 mg/ Residential LOC for Two-Generation Reproduction
days) and Intermediate Term (1-6 kg/day. MOE = <100. Toxicity Study (rat).
months). UFA = 10x............. LOAEL = 1,320 mg/kg/day
UFH = 10x............. based on increased
FQPA SF = 1x.......... incidence of hydropic
degeneration (basophilic
cells) in the pituitary.
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Cancer (Oral, dermal, inhalation).. Classification: ``Not likely to be Carcinogenic to Humans: based on the
absence of treatment-related tumors in two adequate rodent carcinogenicity
studies.
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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. UF = uncertainty factor. UFA = extrapolation
from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose
(c = chronic). RfD = reference dose.
Table 2--Summary of Toxicological Doses and Endpoints for Metabolite B for Use in Human Health Risk Assessment
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Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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Acute Dietary (All Populations).... LOAEL = 0.8 mg/kg/day. Acute RfD = 0.00027 mg/ Developmental Neurotoxicity
UFA = 10x............. kg/day. Study for Tembotrione.
UFH = 10x............. ...................... Offspring NOAEL was not
FQPA SF = 30x \1\..... aPAD = 0.00027 mg/kg/ established. Offspring
day. LOAEL = 0.8 mg/kg/day
based on decreased
acoustic startle response
on PND 60 (males), and
brain morphometric changes
on PND 75 (males and
females).
Chronic dietary (All populations).. NOAEL = 0.04 mg/kg/day Chronic RfD = 0.00004 Chronic/Carcinogenicity
UFA = 10x............. mg/kg/day. Study (rat) for
UFH = 10x............. ...................... Tembotrione.
FQPA SF = 10x \2\..... cPAD = 0.00004 mg/kg/ LOAEL = 0.79 mg/kg/day
day. based on
neovascularization and
edema of the cornea and
snow flake-like corneal
opacity, unilateral or
bilateral keratitis of the
eye, decreased mean body
weight and mean bodyweight
gain, increased total
cholesterol, higher ketone
levels and lower pH
values, higher protein
levels, increased kidney
weight, kidney to body
weight and kidney to brain
weight ratios, chronic
nephropathy and atrophy of
the sciatic nerve.
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NOAEL = no-observed adverse-effect level. LOAEL = lowest-observed adverse-effect level. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population-adjusted dose
(a = acute, c = chronic). RfD = reference dose. PND = Postnatal Day
\1\ The FQPA SF accounts for the database uncertainty factor and the extrapolation of a LOAEL to NOAEL.
\2\ The FQPA SF accounts for the database uncertainty factor.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to benzobicyclon (parent), EPA considered exposure under the
petitioned-for tolerances. For metabolite B, there is no anticipated
exposure in food; metabolite B is only a residue of concern in drinking
water. EPA assessed dietary exposures from benzobicyclon in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for benzobicyclon; 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's 2003-2008
food consumption data from the U.S. Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, What We Eat
in America, (NHANES/WWEIA). As for residue levels of parent
benzobicyclon in food, EPA incorporated tolerance-level residues and
100 percent crop treated (PCT) for rice. For metabolite B, there is no
anticipated exposure in food; metabolite B is only a residue of concern
in drinking water therefore chronic dietary exposure was considered for
metabolite B separately.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that benzobicyclon 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 parent benzobicyclon so tolerance level residues
and 100% CT were assumed resulting in risk estimates that were less
than the LOC to EPA. For metabolite B, there is no anticipated exposure
in food; metabolite B is only a residue of concern in drinking water.
Because risk estimates for metabolite B in drinking water exceeded the
EPA's
[[Page 18999]]
LOC, a refined water exposure assessment was conducted which included a
10% CT assumption, which is described in detail in the following
section.
2. Dietary exposure from drinking water. The Agency used refined
water exposure models in the dietary exposure analysis and risk
assessment for benzobicyclon and metabolite B in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of benzobicyclon and metabolite B.
Further information regarding EPA drinking water models used in
pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Modeled estimates of drinking water concentrations based on the
Pesticide in Flooded Applications Model (PFAM; v2.0) were directly
entered into the dietary exposure model. Because no toxicological
effect attributable to a single dose was observed for benzobicyclon, an
acute exposure assessment was not done. Therefore, the acute dietary
risk assessment was conducted for metabolite B only (the parent
benzobicylon rapidly hydrolyzes to metabolite B) using the water
concentration value of 24.8 ppb to assess the metabolite B contribution
to drinking water. For chronic dietary risk assessment, the water
concentration of value 0.0031 ppb was used to assess the contribution
to drinking water for benzobicyclon and 3.0 ppb for metabolite B. Based
on the data summarized in Unit III.A., EPA has concluded dietary cancer
risk concerns due to long-term consumption of metabolite B residues are
adequately addressed by the chronic exposure analysis using the cPAD.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
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). Benzobicyclon 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 benzobicyclon to share a common mechanism of
toxicity with any other substances, and benzobicyclon does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
benzobicyclon does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/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. For benzobicyclon, there was
no evidence of increased quantitative or qualitative fetal or offspring
susceptibility in the developmental toxicity and two-generation
reproduction toxicity studies in rats with no developmental,
reproductive, or offspring effects observed. For metabolite B, there
are no available toxicity data to evaluate offspring sensitivity;
however, toxicological data are available from other HPPD inhibitors,
including developmental toxicity studies in rats and rabbits, two-
generation reproduction studies in rats, and developmental
neurotoxicity studies in rats. All of the selected endpoints for risk
assessment were protective of developmental and offspring effects and
tembotrione provided the most sensitive endpoint.
3. Conclusion. For metabolite B, the database in incomplete.
Nevertheless, sufficient data are available to confirm that metabolite
B is an HPPD inhibitor, which supports utilization of data from
tembotrione, the most potent HPPD inhibitor. To account for the lack of
data, the acute dietary assessment applies a 30X FQPA SF to account for
extrapolation of a LOAEL to NOAEL and the database uncertainty factor
for lack of studies. This safety factor is considered sufficient given
the LOAEL in the developmental neurotoxicity study for tembotrione is
considered conservative given the minimal changes seen at that dose.
The chronic dietary assessment applies a 10X FQPA SF to account for the
database uncertainty factor for lack of studies. These safety factors
will adequately account for any potential prenatal and postnatal
toxicity and address any residual uncertainty concerning the toxicity
database. The Agency's assessment of exposure to metabolite B was
conducted for drinking water only, as there is no anticipated exposure
in food. The modeled drinking water concentrations for metabolite B are
based on conservative modeled estimates.
For benzobicyclon, 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 SF. That decision is based on the following
findings:
i. The toxicity database for benzobicyclon is complete.
ii. There is no indication that benzobicyclon 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 benzobicyclon results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments for parent
benzobicyclon were performed based on 100% CT and tolerance-level
residues. For metabolite B, there is no anticipated exposure in food;
metabolite B is only a residue of concern in drinking water. Because
risk estimates for metabolite B in drinking water exceeded the EPA's
LOC, a refined water exposure assessment was conducted which includes a
10% CT assumption. EPA made conservative (protective) assumptions in
the ground and surface water modeling used to assess exposure to
benzobicyclon and metabolite B in drinking water. These assessments
will not underestimate the exposure and risks posed by benzobicyclon or
metabolite B.
[[Page 19000]]
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. For metabolite B, the dietary exposure analyses
included drinking water only and there are no uses that would result in
residential exposure; therefore, an aggregate assessment was only
necessary for the parent, benzobicyclon.
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,
benzobicyclon 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
benzobicyclon from food and water will result in risks of <1% of the
cPAD for all populations. There are no residential uses for
benzobicyclon.
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). A short-term
adverse effect was identified; however, benzobicyclon is not registered
for any use patterns that would result in short-term residential
exposure. Short-term risk is assessed based on short-term residential
exposure plus chronic dietary exposure. Because there is no short-term
residential exposure and chronic dietary exposure has already been
assessed and is appropriately protective cPAD (which is at least as
protective as the POD used to assess short-term risk); no further
assessment of short-term risk is necessary.
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,
benzobicyclon 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
benzobicyclon.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity, benzobicyclon is not expected to pose a
cancer risk to humans. Dietary cancer risk concerns due to long-term
consumption of metabolite B residues are adequately addressed by the
chronic exposure analysis using the cPAD.
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 benzobicyclon residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (a liquid chromatography-tandem
mass spectrometry (LC-MS/MS) method 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 benzobicyclon in or on the commodities associated
with this rule.
C. Revisions to Petitioned-For Tolerances
The petitioner requested a tolerance of 0.01 ppm for rice, straw
and rice, grain. However, based on OCSPP 860 Guidelines, Table 1
Feedstuffs, rice straw is not a regulated food commodity. Therefore, a
tolerance for rice, straw is not needed.
The registrant has proposed use only in California, and has
provided residue data for only California. The available residue data
for the establishment of a tolerance level for residues of
benzobicyclon support a value of 0.01 ppm in rice, grain.
V. Conclusion
Therefore, a tolerance associated with a regional registration in
California is established for residues of benzobicyclon, in or on rice,
grain at 0.01 ppm.
VI. Statutory and Executive Order Reviews
This action establishes a 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
[[Page 19001]]
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: April 5, 2017,
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. Add Sec. 180.693 to subpart C to read as follows:
Sec. [emsp14]180.693 Benzobicyclon; tolerances for residues.
(a) General. [Reserved]
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in Sec. [emsp14]180.1(l), are
established for residues of the herbicide benzobicyclon, including its
metabolites and degradates, in or on the commodity in the table below.
Compliance with the tolerance levels specified below is to be
determined by measuring only benzobicyclon, 3-[2-chloro-4-
(methylsulfonyl)benzoyl]-4-(phenylthio)bicyclo-[3.2.1]oct-3-en-2-one),
in or on the following raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Rice, grain............................................ 0.01
------------------------------------------------------------------------
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2017-08357 Filed 4-24-17; 8:45 am]
BILLING CODE 6560-50-P