
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35115-35120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15744]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0825; FRL-9960-37]


Topramezone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
topramezone in or on sugarcane, cane. BASF Corporation requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 28, 2017. Objections and 
requests for hearings must be received on or before September 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-2015-0825, 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-2015-0825 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
September 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-2015-0825, 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 June 22, 2016 (81 FR 40594) (FRL-9947-
32), 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 
5F8421) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, NC 27709. The petition requested that 40 CFR 180.612 be 
amended by establishing a tolerance for residues of the herbicide 
topramezone, [3-(4,5-dihydro-isoxazol-3-yl)-4-methylsulfonyl-2-
methylphenyl](5-hydroxyl-1-methyl-1H-pyrazol-4-yl)methanone, in or on 
sugarcane, cane at 0.01 parts per million (ppm). That document 
referenced a summary of the petition prepared by BASF Corporation, the 
registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure

[[Page 35116]]

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 topramezone including exposure 
resulting from the tolerance established by this action. EPA's 
assessment of exposures and risks associated with topramezone 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.
    Topramezone inhibits the enzyme 4-hydroxyphenylpyruvate dioxygenase 
(HPPD), which is involved in the catabolism of the amino acid tyrosine. 
HPPD-inhibition causes blood levels of tyrosine to rise (tyrosinemia), 
resulting in ocular, liver, kidney, and developmental effects in 
laboratory animals.
    Similar to other HPPD inhibiting chemicals, the rat was the most 
sensitive species and males were found to be more sensitive than 
females (in rats and dogs). In rat subchronic and chronic oral studies, 
topramezone produced ocular (corneal vascularization, opacity, and 
keratitis) and kidney (microscopic findings and increased organ 
weights) effects, which are consistent with the mammalian toxicity 
profile for HPPD inhibitors caused by high tyrosine levels in the 
blood. Histopathological findings in the thyroid were frequently 
observed in rats and dogs following topramezone exposure. Thyroid 
tumors via a non-linear mode of action involving thyroid hormone 
disruption were seen in the rat; however, topramezone is classified as 
``not likely to be carcinogenic to humans at doses that do not alter 
rat thyroid hormone homeostasis.'' Additional histopathological 
findings were seen in the pancreas of rats and the urinary bladder in 
dogs. Body weight decrements were also noted in all species, including 
the mouse, which did not exhibit any other adverse effects in the 
database.
    There was evidence of increased prenatal susceptibility following 
in utero exposure to topramezone in the developmental toxicity studies 
in rats and rabbits, with fetal skeletal variation and abnormalities 
observed in both species that were consistent with those reported in 
the toxicological databases for other HPPD inhibiting chemicals and 
typically seen in the absence of maternal toxicity or less severe 
maternal adverse effects. In the mouse developmental toxicity study, 
elevated tyrosine blood levels were noted in maternal animals; however, 
there were no developmental effects observed. There was evidence for 
increased qualitative offspring susceptibility in the rat developmental 
neurotoxicity study, where neurobehavioral and neuropathological 
changes were observed in the presence of limited maternal toxicity 
(corneal opacity). There was no evidence of increased pre- or postnatal 
susceptibility in the rat reproduction toxicity study.
    While neurobehavioral and neuropathological offspring effects were 
observed in the developmental neurotoxicity study, which are indicators 
of potential neurotoxicity, no neurotoxic effects were observed in the 
acute neurotoxicity study up to the limit dose or the subchronic 
neurotoxicity study, where systemic effects were consistent with the 
rest of the toxicological database.
    Topramezone is classified as having low acute toxicity (Toxicity 
Category III or IV) via the oral, dermal, and inhalation routes). It 
was found to be a slight eye and dermal irritant, but it was not found 
to be a dermal sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by topramezone 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 Topramezone: Human Health Risk 
Assessment for New Use on Sugarcane in docket ID number EPA-HQ-OPP-
2015-0825.

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-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for topramezone used for 
human risk assessment is shown in the Table of this unit.

   Table--Summary of Toxicological Doses and Endpoints for Topramezone for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/Scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety  factors      risk Assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49       NOAEL = 0.5 mg/kg/    aRfD = 0.005 mg/kg/  Rabbit Developmental Toxicity
 years old).                        day.                  day.                 Study
                                   UFA = 10x...........  aPAD = 0.005 mg/kg/  Developmental LOAEL = 5 mg/kg/day
                                   UFH = 10x...........   day.                 based on alterations in skeletal
                                   FQPA SF = 1x........                        ossification sites and increased
                                                                               number of pairs of ribs.

[[Page 35117]]

 
Acute dietary (General population  LOAEL = 8 mg/kg/day.  aRfD = 0.08 mg/kg/   Rat Developmental Neurotoxicity
 including infants and children,   UFA = 10x...........   day.                 Study
 excluding females 13-49 years     UFH = 10x...........  aPAD = 0.008 mg/kg/  LOAEL = 8 mg/kg/day based on
 old).                             FQPA SF/UFL = 10x...   day.                 decreased maximum auditory
                                                                               startle reflex response,
                                                                               decreased brain weights, and
                                                                               changes in brain morphology.
Chronic dietary (All populations)  NOAEL = 0.4 mg/kg/    cRfD = 0.004 mg/kg/  Rat Chronic Toxicity/
                                    day.                  day.                 Carcinogenicity Study
                                   UFA = 10x...........  cPAD = 0.004 mg/kg/  LOAEL = 3.6 mg/kg/day based on
                                   UFH = 10x...........   day.                 increased incidences of corneal
                                   FQPA SF = 1x........                        opacity, decreased body weight
                                                                               and body-weight gains in males
                                                                               and histopathological evaluations
                                                                               in the eyes, thyroid, and
                                                                               pancreas of both sexes.
Incidental oral short-term (1 to   NOAEL = 0.4 mg/kg/    LOC for MOE = <100.  Rat Two-Generation Reproduction
 30 days) and intermediate (1-6     day.                                       Study
 months) term.                     UFA = 10x...........                       Parental/Offspring LOAEL = 4.2 mg/
                                   UFH = 10x...........                        kg/day based on decreased body
                                   FQPA SF = 1x........                        weight, increased thyroid and
                                                                               kidney weights, and microscopic
                                                                               findings in eyes, kidney, and
                                                                               thyroid of both sexes (parental);
                                                                               and decreases in body weights in
                                                                               the F2 generation and increased
                                                                               time to preputial separation in
                                                                               the F1 male (offspring).
Dermal short-term (1 to 30 days)   NOAEL = 0.4 mg/kg/    LOC for MOE = <100.  Rat Two-Generation Reproduction
 and intermediate (1-6 months)      day (dermal                                Study in Rats]
 term.                              absorption rate =                         Parental/Offspring LOAEL = 4.2 mg/
                                    2.6%).                                     kg/day based on decreased body
                                   UFA = 10x...........                        weight, increased thyroid and
                                   UFH = 10x...........                        kidney weights, and microscopic
                                   FQPA SF = 1x........                        findings in eyes, kidney, and
                                                                               thyroid of both sexes (parental);
                                                                               and decreases in body weights in
                                                                               the F2 generation and increased
                                                                               time to preputial separation in
                                                                               the F1 male (offspring).
Inhalation short-term (1 to 30     NOAEL = 0.4 mg/kg/    LOC for MOE = <100.  Rat Two-Generation Reproduction
 days) and intermediate (1-6        day (inhalation                            Study in Rats]
 month) term.                       assumed equivalent                        Parental/Offspring LOAEL = 4.2 mg/
                                    to oral).                                  kg/day based on decreased body
                                   UFA = 10x...........                        weight, increased thyroid and
                                   UFH = 10x...........                        kidney weights, and microscopic
                                   FQPA SF = 1x........                        findings in eyes, kidney, and
                                                                               thyroid of both sexes (parental);
                                                                               and decreases in body weights in
                                                                               the F2 generation and increased
                                                                               time to preputial separation in
                                                                               the F1 male (offspring).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  In accordance with the 2005 EPA Guidelines for Carcinogen Risk assessment,
                                    topramezone was classified as ``not likely to be carcinogenic to humans at
                                    doses that do not alter rat thyroid hormone homeostasis.'' EPA has
                                    determined that the thyroid tumors arise through a non-linear mode of action
                                    and the cRfD of 0.004 mg/kg/day, which is derived from the NOAEL of 0.4 mg/
                                    kg/day from the rat chronic/carcinogenicity study, is not expected to alter
                                    thyroid hormone homeostasis nor result in thyroid tumor formation.
----------------------------------------------------------------------------------------------------------------
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 (a = acute, c = chronic).
  UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
  sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to topramezone, EPA considered exposure under the petitioned-
for tolerance as well as all existing topramezone tolerances in 40 CFR 
180.612. EPA assessed dietary exposure from topramezone 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 one-day or single exposure. Such effects were 
identified for topramezone. In estimating acute dietary exposure, EPA 
used food consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, EPA used tolerance levels and 100 percent crop treated (PCT) for 
the acute dietary exposure assessment.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA used tolerance levels 
and 100 PCT for the chronic dietary exposure assessment.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that topramezone 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 topramezone. Tolerance level residues and/or 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used the 
highest drinking water concentration expected to result from the 
currently-registered use of topramezone for direct, aquatic 
applications. Further information regarding EPA drinking water models 
used in pesticide exposure assessment can be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. For acute and chronic dietary 
risk assessments, the water concentration value of 45 ppb was used to 
assess the contribution to drinking water, based on the maximum 
allowable topramezone concentration in water bodies with potable water 
intakes from direct aquatic use.
    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).
    Topramezone is currently registered for turf and golf course uses 
that could result in residential exposures. Topramezone is also 
currently registered for use in direct aquatic applications that could 
result in exposure during recreational swimming activities. The 
following residential exposure scenarios were used for assessing 
aggregate exposures: Short-

[[Page 35118]]

term dermal post-application exposure resulting from the physical 
activities on turf for adults, short-term dermal and incidental oral 
(hand-to-mouth) post-application exposures resulting from the physical 
activities on turf for children 1 < 2 years, and intermediate-term 
incidental oral exposure resulting from soil ingestion from turf use 
for children 1 < 2 years. These post-application exposure estimates 
from the turf use are protective of post-application exposure for older 
children more likely to engage in recreational swimming activities. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found topramezone to share a common mechanism of 
toxicity with any other substances, and topramezone does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
topramezone 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 Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There was evidence of 
increased quantitative prenatal susceptibility following in utero 
exposures to rats and rabbits. Fetal skeletal variations and 
abnormalities were observed in all of the rat and rabbit developmental 
studies, typically in the absence of maternal toxicity or in the 
presence of less severe maternal effects. Increased qualitative 
susceptibility was also observed in the developmental neurotoxicity 
study where offspring neurobehavioral and neuropathological changes 
were observed in the presence of limited maternal toxicity (corneal 
opacity). Concern is low since the effects are well-characterized and 
endpoints selected for risk assessment are protective of all observed 
offspring effects. There was no evidence of increased offspring 
sensitivity in the two-generation rat reproduction toxicity study.
    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 for all exposure scenarios except for acute 
dietary exposure. The FQPA SF of 10X was retained for acute dietary 
exposure to account for the extrapolation of a NOAEL from a LOAEL. This 
decision is based on the following findings:
    i. The toxicity database for topramezone is adequate to assess the 
risk of aggregate exposure to topramezone. While a subchronic 
inhalation study is not available for topramezone, EPA concluded, using 
a weight-of-evidence approach, that this study is not required at this 
time.
    ii. Although there was evidence of potential neurotoxicity in the 
developmental neurotoxicity study (e.g., changes in neurobehavioral and 
neuropathological observations in offspring), there was no additional 
evidence of neurotoxicity in the rest of the toxicological database and 
the selected endpoints are protective of the observed effect up to the 
limit dose.
    iii. Although there was evidence of increased prenatal 
susceptibility as discussed in Unit III.D.2., there are clear NOAELs 
associated with those effects, and the Agency's selected points of 
departure are protective of those effects. Therefore, there is no need 
to retain the FQPA 10X SF to adequately protect infants and children 
from these effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. The maximum allowable 
concentration in potable water intakes was used to assess exposure to 
topramezone in drinking water. EPA used similarly conservative 
assumptions to assess post-application exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by topramezone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to topramezone will occupy 98% of the aPAD for all infants less than 1 
year old, the population group receiving the greatest exposure, and 50% 
of the aPAD for females 13-49 years old.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
topramezone from food and water will utilize 62% of the cPAD for all 
infants less than 1-year-old, the population group receiving the 
greatest exposure.
    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). Topramezone 
is currently registered for residential turf uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to topramezone. Using the 
exposure assumptions described in this unit for short-term exposures, 
EPA has concluded the combined short-term food, water, and residential 
exposures result in aggregate MOEs of 220 for adults and 120 for 
children 1-2 years old (a subgroup predicted to have the highest 
residential and aggregate exposure). Because EPA's level of concern for 
topramezone is a MOE of

[[Page 35119]]

100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Topramezone is currently registered for turf uses that could 
result in intermediate-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with intermediate-term residential exposures to 
topramezone for children that are 1-2 years old that may ingest soil on 
treated turf. Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in an 
aggregate MOE of 270 for children 1-2 years old. Because EPA's level of 
concern for topramezone is a MOE of 100 or below, this MOE is not of 
concern.
    5. Aggregate cancer risk for U.S. population. EPA has concluded 
that topramezone does not pose a cancer risk at exposure levels that do 
not alter thyroid hormone homeostasis. The chronic aggregate 
assessment, which utilized a cRfD that is protective of those effects 
did not indicate a chronic risk above EPA's level of concern; 
therefore, topramezone is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to topramezone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem 
mass-spectrometry detection (LC/MS/MS), BASF method D0007) is available 
to enforce the tolerance expression for sugarcane.

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 topramezone in or on 
sugarcane.

V. Conclusion

    Therefore, tolerances are established for residues of topramezone, 
including its metabolites and degradates, in or on the following 
commodity. Compliance with the following tolerance levels is to be 
determined by measuring only topramezone ([3-(4,5-dihydro-3-
isoxazolyl)-2-methyl-4-(methylsulfonyl)phenyl](5-hydroxy-1-methyl-1H-
pyrazol-4-yl)methanone) in or on the following commodity: Sugarcane, 
cane 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 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: May 15, 2017.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:


[[Page 35120]]


    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.612, add alphabetically ``Sugarcane, cane'' in the 
table in paragraph (a) to read as follows:


Sec.  180.612  Topramezone; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Sugarcane, cane.............................................        0.01
------------------------------------------------------------------------

* * * * *

[FR Doc. 2017-15744 Filed 7-27-17; 8:45 am]
 BILLING CODE 6560-50-P


