
[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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at 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
----------------------------------------------------------------------------------------------------------------
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.
                                    ----------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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


