
[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Rules and Regulations]
[Pages 34877-34882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15717]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0405; FRL-9964-15]


Tolpyralate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tolpyralate in or on field corn, popcorn, and sweet corn. ISK 
Biosciences Corporation requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 27, 2017. Objections and 
requests for hearings must be received on or before September 25, 2017, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0405, 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-2015-0405 in the subject line on the first 
page of your submission. All

[[Page 34878]]

objections and requests for a hearing must be in writing, and must be 
received by the Hearing Clerk on or before September 25, 2017. 
Addresses for mail and hand delivery of objections and hearing requests 
are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0405, 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 
5F8359) by ISK Biosciences, Corporation, 7470 Auburn Rd., Suite A, 
Concord, OH 44077. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the herbicide, 
tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-
(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate, 
including its metabolite MT-2153, in or on the raw agricultural 
commodities of corn that include field corn (corn, field, grain; corn, 
field, forage; and corn, field, stover); sweet corn (corn, sweet, 
kernel + cob with husks removed; corn, sweet, forage; and corn, sweet, 
stover); and popcorn (corn, pop, grain and corn, pop, stover) at 0.01 
parts per million (ppm). That document referenced a summary of the 
petition prepared by ISK Biosciences, Corporation the registrant, which 
is available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.

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 tolpyralate including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with tolpyralate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The effects in the tolpyralate hazard database are similar to those 
seen with other hydroxyphenylpyruvate dioxygenase (HPPD) inhibiting 
chemicals, including eye opacity and developmental skeletal defects. 
The major target organs identified were the eyes, kidney, liver, 
thyroid and developing skeleton. Other effects included pancreatic 
acinar cell single cell necrosis, gall bladder calculi, fur loss and/or 
tactile hair loss, and decreased body weights. No systemic toxicity was 
observed following a 28-day dermal exposure in the rat.
    Neurotoxicity was not observed in the acute or subchronic 
neurotoxicity studies in the rat. There was no indication of 
neurotoxicity to the fetus in developmental studies or during early 
postnatal development in a rat reproductive toxicity study. However, 
with chronic exposure, rats and mice showed effects on the nervous 
system that were indicative of a temporally-dependent response for 
neurotoxicity. Similar findings were not seen in the one-year dog 
study.
    Developmental toxicity studies in the rat and rabbit showed that 
the main effects on fetuses in both species were skeletal variations 
that are consistent with those observed from exposure to other HPPD 
inhibitors. These skeletal effects are considered to be evidence of 
increased quantitative and qualitative prenatal susceptibility. No 
immunotoxic potential was observed in a mouse immunotoxicity study; 
however, in the dog, inflammation associated with hyperostosis and 
lymph node hyperplasia in males was observed.
    In the rat, an increase in the incidence of squamous cell 
carcinomas of the eye was observed. The increase in this tumor type is 
considered to be related to the eye opacities typically observed with 
compounds producing HPPD inhibition. The Agency has determined that 
tolpyralate shows ``suggestive evidence of carcinogenicity to humans'' 
based on an increase in the incidence of squamous cell carcinoma of the 
eye in male rats in the rat carcinogenicity study. There was no 
evidence of carcinogenicity in female rats or in the mouse. Most 
genotoxicity studies did not show evidence of mutagenicity or 
clastogenicity. A mouse lymphoma cell gene mutation assay showed a 
dose-dependent, reproducible increase in mutant colonies, but the 
results of this study are considered inconclusive due to the 
insolubility of the test compound. However, all other genotoxicity 
studies, including an in vivo mouse micronucleus assay, were negative. 
Therefore, when considered as a whole, the available mutagenicity and 
clastogenicity studies did not indicate genotoxic potential.
    The Agency concluded that the eye tumors resulted from long-term 
exposure to increased blood tyrosine levels as a result of HPPD 
inhibition. The eye is a target organ for HPPD inhibitors and causes 
opacities and keratitis with subchronic or chronic exposure. Eye tumors 
have been

[[Page 34879]]

reported in male rats following chronic exposure to some other HPPD 
inhibitors. Since the development of the eye tumors in the rat is 
considered to be dependent upon ocular toxicity, and not to a linear 
(non-threshold), genotoxic mechanism, tumors will not develop at doses 
that are protective of eye toxicity. Eye effects from exposure to 
tolpyralate were observed at the LOAEL in males in the rat chronic 
toxicity/carcinogenicity study but not at the NOAEL. The NOAEL from 
this study is therefore considered protective of this tumor type and 
was used as the basis of the chronic reference dose. Quantification of 
cancer risk is not required because the chronic reference dose, which 
is protective of eye toxicity, is considered to be protective of cancer 
risk.
    The acute toxicity of tolpyralate is low, and it is not an eye or 
skin irritant or a dermal sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by tolpyralate as well as the NOAELs and the 
LOAELs from the toxicity studies can be found at http://www.regulations.gov in document titled ``Tolpyralate--New Active 
Ingredient Human Health Risk Assessment for Proposed Uses on Sweet 
Corn, Field Corn, and Popcorn'' at page 35 in docket ID number EPA-HQ-
OPP-2015-405.

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 (LOC) 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    No adverse effects resulting from a single exposure and relevant 
for the general population were identified for tolpyralate; therefore, 
a point of departure for assessing acute risk for this population was 
not established. The fetal skeletal effects noted above are suitable 
for acute assessment of women of child-bearing age. The no-adverse 
effect level (NOAEL) for skeletal variations in the rabbit 
developmental toxicity study is 5 mg/kg body weight (bw)/day (lowest 
adverse effect level (LOAEL) = 50 mg/kg bw/day). Chronic exposure is 
being assessed based on the systemic effects (fur loss; eye opacity; 
liver; pancreas; kidney; thyroid and cerebellar effects) noted in the 
chronic oral toxicity study in rats, with a NOAEL of 0.93 mg/kg bw/day 
and a LOAEL of 97/126 (male/female) mg/kg bw/day. A summary of the 
toxicological endpoints for tolpyralate used for human risk assessment 
is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Tolpyralate for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (General population  ....................  ...................  An appropriate endpoint was not
 including infants and children).                                              identified for this exposure
                                                                               scenario. An adverse effect
                                                                               resulting from a single oral
                                                                               exposure was not identified for
                                                                               the general population.
Acute dietary (Females 13-49       NOAEL = 5 mg/kg/day.  Acute RfD = 0.05 mg/ Developmental toxicity study in
 years of age).                    UFA = 10x...........   kg/day.              the rabbit (gavage; range-finding
                                   UFH = 10x...........  aPAD = 0.05 mg/kg/    and main studies considered
                                   FQPA SF = 1x........   day.                 together).
                                                                              Developmental LOAEL = 50 mg/kg/day
                                                                               based an increased incidence of
                                                                               skeletal abnormalities (range-
                                                                               finding study).
Chronic dietary (All populations   NOAEL= 0.925 mg/kg/   Chronic RfD =        Chronic oral toxicity in the rat
 including infants and children     day.                  0.0093 mg/kg/day.    (dietary).
 and females 13-49 years of age).  UFA = 10x...........  cPAD = 0.0093 mg/kg/ LOAEL = 97/126 mg/kg/day based on
                                   UFH = 10x...........   day.                 fur loss, eye opacity/
                                   FQPA SF = 1x........                        neovascularization/keratitis,
                                                                               increased relative liver weight,
                                                                               thyroid follicular cell
                                                                               hypertrophy, hepatocellular
                                                                               centrilobular fatty change,
                                                                               increased pancreatic acinar cell
                                                                               necrosis, renal tubule basophilic
                                                                               change, increased molecular layer
                                                                               vacuolation in the cerebellum
                                                                               (males).
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)     Classification: Suggestive evidence of carcinogenic potential in humans,
                                    based on squamous cell carcinoma of the eye in male rats. The chronic RfD is
                                                           protective of carcinogenicity.
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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.
  UFH = potential variation in sensitivity among members of the human population (intraspecies). DAF = dermal
  absorption factor.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tolpyralate, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from tolpyralate in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for tolpyralate. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA)

[[Page 34880]]

under the Continuing Survey of Food Intake by Individuals (CSFII) and 
the CDC under the National Health and Nutrition Examination Survey/What 
We Eat in America (NHANES/WEIA) 2003-2008. EPA assumed tolerance-level 
residues for all commodities and 100% crop treated. There is no 
expectation of finite residues in either livestock commodities or 
rotational crops; therefore, no residues have been entered for these 
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/WEIA 
2003-2008. EPA assumed tolerance-level residues for all commodities and 
100% crop treated.
    iii. Cancer. The Agency has determined that quantification of risk 
using a non-linear approach (i.e., RfD), for tolpyralate will 
adequately account for all chronic toxicity, including carcinogenicity, 
that could result from exposure to tolpyralate. As a result, the 
chronic dietary exposure assessment is protective for potential cancer 
risk, and a separate cancer exposure assessment was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for tolpyralate. 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 tolpyralate in 
drinking water. These simulation models take into account data on the 
physical, chemical, and fate/transport characteristics of tolpyralate. 
Further information regarding EPA drinking water models used in 
pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    The groundwater value was generated using the Pesticide Root Zone 
Model for Groundwater (PRZM-GW) Model, and the surface water values 
were generated using the Pesticide Root Zone Model (PRZM5) and the 
Variable Volume Water Model (VVWM). The EDWCs of tolpyralate for acute 
exposures are estimated to be 6.75 parts per billion (ppb) for surface 
water and 11.53 ppb for ground water. For chronic exposures assessments 
are estimated to be 0.65 ppb for surface water and 10.18 ppb for ground 
water. Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of 
11.53 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 10.18 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).
    Tolpyralate 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.''
    Although tolpyralate belongs to the class of chemicals whose 
mechanism of toxicity is the inhibition of HPPD, EPA has not made a 
common mechanism of toxicity finding as to tolpyralate and other HPPD-
inhibiting substances. There are marked differences among species in 
the ocular toxicity and other effects typically associated with 
tolpyralate and other substances that the inhibit HPPD. Ocular effects 
following treatment with HPPD-inhibitor herbicides are seen in the rat 
but not in the mouse. Monkeys also seem to be recalcitrant to the 
ocular toxicity induced by HPPD inhibition. One explanation for this 
species-specific response in ocular opacity may be related to species 
differences in the clearance of tyrosine. A metabolic pathway that 
involves the liver enzyme tyrosine aminotransferase (TAT) exists to 
remove tyrosine from the blood. In contrast to rats where ocular 
toxicity is observed following exposure to HPPD-inhibiting herbicides, 
mice and humans are unlikely to achieve the levels of plasma tyrosine 
necessary to produce ocular opacities because the activity of TAT in 
these species is much greater compared to rats.
    HPPD inhibitors (e.g., nitisinone) are used as an effective 
therapeutic agent to treat patients suffering from rare genetic 
diseases of tyrosine catabolism. Treatment starts in childhood but is 
often sustained throughout patient's lifetime. The human experience 
indicates that a therapeutic dose (1 mg/kg/day dose) of nitisinone has 
an excellent safety record in infants, children, and adults and that 
serious adverse health outcomes have not been observed in a population 
followed for approximately a decade. Rarely, ocular effects are seen in 
patients with high plasma tyrosine levels; however, these effects are 
transient and can be readily reversed upon adherence to a restricted 
protein diet. This observation indicates that an HPPD inhibitor in and 
of itself cannot easily overwhelm the tyrosine-clearance mechanism in 
humans.
    Based on the available information about the potential mechanism of 
toxicity and the variability of effects between species, EPA has not 
assumed, for purposes of this tolerance action, that tolpyralate has a 
common mechanism of toxicity with other substances.

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. Quantitative and qualitative 
evidence of increased susceptibility, as compared to adults, of fetuses 
to in utero exposure to tolpyralate was observed in developmental 
toxicity studies in rats and rabbits. Concern for this evidence is low 
because (1) clear NOAELs/LOAELs were identified for the observed 
effects; (2) the relevant developmental effects were observed at LOAELs 
that were well above (10-fold greater) the NOAELs; and (3) the selected 
endpoints are protective of these effects.
    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 database for tolpyralate is considered complete with respect 
to FQPA assessment.
    ii. There is no concern for neurotoxicity from single or subchronic 
exposures. Although neuropathology was observed at the LOAELs in the 
rat

[[Page 34881]]

and the mouse long-term studies, the chronic LOAELs were almost 100-
fold greater than the chronic NOAELs. The POD and endpoint for chronic 
dietary exposure are selected from the rat chronic study. Therefore, 
the chronic PAD (cPAD) is protective of potential neuropathology. It is 
also protective of increased susceptibility of offspring for 
neurotoxicity in the absence of a developmental neurotoxicity study, 
since neurotoxicity in adult animals was only observed as an effect 
following long-term dosing. There was no neurotoxicity observed in the 
database with exposure up to 90 days, including no evidence of 
neurotoxicity in the rat or rabbit developmental toxicity studies or 
the rat reproductive toxicity study. An additional uncertainty factor 
to account for the absence of data or other data deficiency (10x UFDB) 
is therefore not needed to account for this study.
    iii. Evidence of quantitative and qualitative prenatal 
susceptibility was observed in the rat and rabbit developmental 
toxicity studies based on findings of fetal skeletal abnormalities at 
doses below those causing maternal toxicity. However, clear NOAELs and 
LOAELs were identified in both species and there are no residual 
uncertainties regarding the points of departure PODs or the endpoints 
of concern.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to tolpyralate in drinking water. These assessments 
will not underestimate the exposure and risks posed by tolpyralate.

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 cPAD. For linear cancer risks, EPA calculates the 
lifetime probability of acquiring cancer given the estimated aggregate 
exposure. Short-, intermediate-, and chronic-term risks are evaluated 
by comparing the estimated aggregate food, water, and residential 
exposure to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to tolpyralate will occupy 1.3% of the aPAD for females of child-
bearing age (13-49 years old), the only population relevant for 
assessing acute exposure to tolpyralate.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
tolpyralate from food and water will utilize 6.2% of the cPAD for all 
infants (<1 year-old), the population group receiving the greatest 
exposure. There are no residential uses for tolpyralate.
    3. Short-term risk. A short-term adverse effect was identified; 
however, tolpyralate 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 under the 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, and 
EPA relies on the chronic dietary risk assessment for evaluating short-
term risk for tolpyralate.
    4. Intermediate-term risk. An intermediate-term adverse effect was 
identified; however, tolpyralate 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 tolpyralate.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit III.A., the chronic dietary exposure assessment is 
protective for potential cancer risk.
    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 tolpyralate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (ISK Biosciences Method JSM0433) 
for plant commodities is a LC-MS/MS method that can be used to analyze 
for parent tolpyralate and the metabolite MT-2153 concurrently. It has 
been developed and independently validated, and is available to enforce 
the tolerance expression. For all matrices and analytes, the level of 
quantification (LOQ), defined as the lowest level of method validation 
(LLMV) or lowest spiking level where acceptable precision and accuracy 
data were obtained, was determined to be 0.01 ppm. The limit of 
detection (LOD) was 0.004 ppm.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established a MRL for tolpyralate.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide 
tolpyralate in or on field corn (corn, field, grain; corn, field, 
forage; and corn, field, stover), sweet corn (corn, sweet, kernel + cob 
with husks removed; corn, sweet, forage; and corn, sweet, stover), and 
popcorn (corn, pop, grain and corn, pop, stover) at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under

[[Page 34882]]

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: July 11, 2017.
Richard P. Keigwin, Jr.,
Director, 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.  180.696 to subpart C to read as follows:


Sec.  180.696  Tolpyralate; tolerances for residues.

    (a) General. Tolerances are established for residues of 
tolpyralate, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only tolpyralate, 1-
[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-(methylsulfonyl)benzoyl]-
1H-pyrazol-5-yl]oxy]ethyl methyl carbonate, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.01
Corn, field, grain..........................................        0.01
Corn, field, stover.........................................        0.01
Corn, pop, grain............................................        0.01
Corn, pop, stover...........................................        0.01
Corn, sweet, forage.........................................        0.01
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2017-15717 Filed 7-26-17; 8:45 am]
 BILLING CODE 6560-50-P


