[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Rules and Regulations]
[Pages 48000-48005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22356]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0142; FRL-9966-13]


Triflumezopyrim; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
triflumezopyrim in or on rice, grain and rice, hulls. E.I. Dupont de 
Nemours and Company requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 16, 2017. Objections and 
requests for hearings must be received on or before December 15, 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-2016-0142, 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 L. 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: 
<a href="/cdn-cgi/l/email-protection#16445250445879627f7573655673667738717960"><span class="__cf_email__" data-cfemail="16445250445879627f7573655673667738717960">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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. To access the OCSPP 
test

[[Page 48001]]

guidelines referenced in this document electronically, please go to 
http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2016-0142 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 
December 15, 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-2016-0142, by one of 
the following methods:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC 
20460-0001.
    <bullet> 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 April 25, 2016 (81 FR 24044) (FRL-9944-
86), 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 
6E8448) by E.I. Dupont de Nemours and Company, 974 Centre Road, 
Wilmington, DE 19805. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the insecticide 
triflumezopyrim (2,4-dioxo-1-(5-pyrimidinylmethyl)-3-[3-
(trifluoromethyl)phenyl]-2H-pyrido[1,2-a]pyrimidinium inner salt), in 
or on rice, grain at 0.20 parts per million (ppm). That document 
referenced a summary of the petition prepared by E.I. Dupont de Nemours 
and Company, the registrant, which is available in the docket, 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 has 
revised the tolerance for rice, grain to 0.40 ppm based on the OECD 
tolerance calculation procedure. Additionally, EPA is requiring a 
tolerance for rice, hull at 1.0 ppm. The reason for these changes are 
explained in Unit IV.D.

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 triflumezopyrim including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with triflumezopyrim 
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 most common adverse effect observed across the 
triflumezopyrim toxicological database was a decrease in absolute 
bodyweight in dogs and rats in both sexes following subchronic and 
chronic exposures. No additional non-cancer effects relevant for human 
health risk assessment were noted in the subchronic rat and dog oral 
toxicity studies. No effects were seen in the mice and rabbit studies, 
including the dermal toxicity study.
    Chronic exposures in rats resulted in an increased incidence of 
bile duct hyperplasia in the presence of decreases in absolute 
bodyweight (~70 milligrams/kilogram/day (mg/kg/day)). Additional 
lesions were seen in the liver, testes, and uterus at a higher dose 
(~400 mg/kg/day). The rat combined chronic/carcinogenicity study showed 
an increase in uterine and liver tumors at a dose of ~400 mg/kg/day, 
which is considered excessive for evaluating carcinogenic potential. 
The remaining doses were not considered excessive and did not show 
treatment-related tumors in either sex. Liver tumors in male mice 
during the mouse carcinogenicity study were considered treatment-
related. The proposed mode of action (constitutive androstane receptor 
(CAR)-mediated proliferation) for the liver tumors in male mice was 
adequately supported by mechanistic data that clearly identified the 
sequence of events, dose-response concordance and temporal relationship 
for this tumor type. Triflumezopyrim is classified as ``not likely to 
be carcinogenic to humans at dose levels that do not cause a 
significant induction in CYP2B activity.'' Based on the mechanistic 
studies provided, significant induction in CYP2B only occurred at 7,000 
ppm (727 mg/kg/day in male mice); the chronic reference dose used for 
the Agency's safety assessment is based on a no observed adverse effect 
level of 17 mg/kg/day. As a result, the Agency concludes that the 
chronic reference dose will be protective of potential carcinogenicity, 
which can be assessed through a non-linear approach. There is no 
mutagenicity concern based on the results from the in vitro and in vivo 
genetic toxicity studies.

[[Page 48002]]

    Evidence of increased quantitative susceptibility in the rat 
developmental toxicity study was observed in the form of incomplete 
ossification of the parietal skull in the fetuses of dams treated with 
a relatively high dose (200 mg/kg/day) in the absence of any maternal 
toxicity. There was no evidence of susceptibility in the rat 
reproduction toxicity or rabbit developmental toxicity study.
    Possible signs of neurotoxicity were observed in the acute 
neurotoxicity (ACN) in rats as well as in the 28-day subchronic oral 
toxicity study in dogs. An overall decrease in motor activity was 
observed in the ACN study on the day of dosing. Animals also showed 
slight decreases in body temperature and number of rearing movements, 
as well as increases in the incidence of high posture, at a dose 4x 
higher than what elicited the decrease in motor activity. The 28-day 
subchronic oral toxicity study in dogs showed neurobehavioral signs 
such as slight impairment of forelimb and/or hindlimb strength and 
effects on pupil constriction. However, the neurobehavioral signs were 
not seen in studies of longer duration in dogs.
    Although evidence of neurotoxicity was seen in the ACN study in 
rats and 28-day oral toxicity study in dogs, concern is low since: (1) 
Effects are well-characterized with clearly established NOAEL/LOAEL 
values; (2) no additional neurotoxic effects were seen in the 
toxicological database including the subchronic neurotoxicity study 
(SCN); (3) there were no corroborating neuropathological findings; (4) 
the neurobehavioral signs in the dog were not observed in studies of 
longer durations in dogs; and (5) the selected endpoints for risk 
assessment are protective of these effects.
    Specific information on the studies received and the nature of the 
adverse effects caused by Triflumezopyrim 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 Triflumezopyrim: Human Health Risk 
Assessment to Establish Tolerances for Rice Without U.S. Registration 
at page 21 in docket ID number EPA-HQ-OPP-2016-0142.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-human-health-risk-assessments-pesticides.
    A summary of the toxicological endpoints for Triflumezopyrim used 
for human risk assessment is shown in the Table below.

 Summary Table of Toxicological Doses and Endpoints for Triflumezopyrim for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..  NOAEL = 100 mg/kg/    aPAD = 1.0 mg/kg/    Acute neurotoxicity study (rats).
                                    day.                  day.                 LOAEL = 500 mg/kg/day based on
                                   UFA = 10x...........                        decreased motor activity on day
                                   UFH = 10x...........                        of dosing.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 17 mg/kg/day  cPAD = 0.17 mg/kg/   Combined chronic/carcinogenicity
                                   UFA = 10x...........   day.                 study (rats). LOAEL = 71/74 (M/F)
                                   UFH = 10x...........                        mg/kg/day based on decreased
                                   FQPA SF = 1x........                        absolute bodyweights in females
                                                                               and increased incidence of bile
                                                                               duct hyperplasia in males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)    Not likely to be carcinogenic to humans at dose levels that do not cause a
                                    significant induction in CYP2B activity. Quantification of risk using a non-
                                         linear approach (i.e., RfD) will adequately account for all chronic
                                                        toxicity, including carcinogenicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
  risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to triflumezopyrim, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
triflumezopyrim 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 triflumezopyrim. In estimating 
acute dietary exposure, EPA used food

[[Page 48003]]

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 an unrefined dietary analysis and incorporated 
tolerance-level residues and assumed 100% of all rice was treated.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
National Health and Nutrition Examination Survey, What We Eat In 
America (NHANES/WWEIA). As to residue levels in food, EPA used an 
unrefined dietary analysis and incorporated tolerance-level residues 
and assumed 100% of all rice was treated.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that triflumezopyrim is not likely to cause cancer to humans 
at dose levels that do not cause a significant increase in CYP2B 
activity. Additionally, there is no chronic risk from exposure to 
triflumezopyrim and the chronic reference dose is protective of 
potential carcinogenicity. 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 triflumezopyrim. Tolerance-level residues and/or 
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. Because there are no 
domestic registrations for triflumezopyrim in the United States, 
dietary exposure (acute and chronic) from imported commodities is the 
only source of exposure assessed. Residues from imported commodities 
are not expected to reach drinking water sources.
    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). Triflumezopyrim 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 triflumezopyrim to share a common mechanism of 
toxicity with any other substances, and triflumezopyrim does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
triflumezopyrim 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 http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased susceptibility in the rabbit developmental or the rat 
reproduction toxicity studies; however, there was evidence of increased 
quantitative susceptibility in the rat developmental study in rats 
where an increased incidence of incomplete ossification of the parietal 
skull was seen in the absence of maternal toxicity. Concern is low 
since: (1) The effect is well-characterized with clearly established 
NOAEL/LOAEL values; and (2) the selected endpoints for this chemical 
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 for assessing risks for all populations. 
That decision is based on the following findings:
    i. The toxicity database for triflumezopyrim is complete.
    ii. Although there is evidence of neurotoxicity in the ACN study in 
rats and 28-day oral toxicity study in dogs for triflumezopyrim, the 
concern is low since: (1) The effects are well-characterized with 
clearly established NOAEL/LOAEL values; (2) no additional neurotoxic 
effects were seen in the toxicological database including the SCN; (3) 
there were no corroborating neuropathological findings; (4) the 
neurobehavioral signs in the dog were not observed in studies of longer 
durations in dogs; and (5) the selected endpoints for this chemical are 
protective of these effects. As a result, there is no need to require a 
developmental neurotoxicity study or retain the 10X to account for 
potential neurotoxic effects.
    iii. Although there was evidence of increased quantitative 
susceptibility in the rat developmental toxicity study where incomplete 
ossification of the parietal skull in the fetuses of dams treated with 
a relatively high dose (200 mg/kg/day) was observed in the absence of 
any maternal toxicity, concern is low since: (1) The effect is well-
characterized with clearly established NOAEL/LOAEL values and (2) the 
selected endpoints for this chemical are protective of these effects. 
There was no evidence of increased susceptibility in the rabbit 
developmental or the rat reproduction toxicity studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on considering that 100% of all rice was treated and using tolerance-
level residues. Since the metabolites were found at insignificant 
levels in the metabolism studies, triflumezopyrim is considered the 
only residue of concern. These assessments will not underestimate the 
exposure and risks posed by triflumezopyrim.

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 triflumezopyrim will occupy <1% of the aPAD for all infants <1 year 
old, the population group receiving the greatest exposure.

[[Page 48004]]

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
triflumezopyrim from food will utilize <1% of the cPAD for all infants 
<1 year old, the population group receiving the greatest exposure. 
There are no residential uses for triflumezopyrim.
    3. Short-term and Intermediate-term risk. Triflumezopyrim is not 
registered for any use patterns that would result in short-term or 
intermediate-term residential exposure. Because there are no 
residential uses for triflumezopyrim, as a result, aggregate risk 
estimates for short- and intermediate-term exposure are equivalent to 
the chronic dietary risk estimates and are not of concern.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA has determined that triflumezopyrim is not likely to be 
carcinogenic to humans at doses that do not cause a significant 
induction in CYP2B activity. Because there is no chronic risk from 
exposure to triflumezopyrim and the chronic reference dose is 
protective of potential carcinogenicity, triflumezopyrim is not 
expected to pose a cancer risk.
    5. 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 triflumezopyrim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (DuPont Liquid chromatography Mass 
spectrometry/mass spectrometry (LC/MS/MS) methods 36348 and 45170) is 
available to enforce the tolerance expression. 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: <a href="/cdn-cgi/l/email-protection#1f6d7a6c767b6a7a727a6b77707b6c5f7a6f7e31787069"><span class="__cf_email__" data-cfemail="a9dbccdac0cddcccc4ccddc1c6cddae9ccd9c887cec6df">[email protected]</span></a>.

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 triflumezopyrim.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing a tolerance for rice, grain at 0.40 ppm, rather 
than at 0.20 ppm as requested, in addition to establishing a tolerance 
for rice, hulls of 1.0 ppm. The rice grain tolerance is based on the 
OECD tolerance calculation procedure with the inputted residues 
adjusted proportionally to reflect the maximum application rate. The 
raw agricultural commodity of ``rice, grain'' consists of the rice 
kernel, as well as the rice hull. The rice hull is considered a 
processed commodity for rice, and where residues concentrate in 
processed commodities, a higher tolerance to cover those residues is 
warranted. Because the available data indicates a higher level of 
residues on the rice hull, EPA is establishing a separate tolerance to 
cover those residues.

V. Conclusion

    Therefore, tolerances are established for residues of 
triflumezopyrim, (2,4-dioco-1-(5-pyrimidinylmethyl)-3-[3-
(trifluoromethyl)phenyl]-2H-pyrido[1,2-a]pyrimidinium inner salt), in 
or on rice, grain at 0.40 and rice, hulls at 1.0 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 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).

[[Page 48005]]

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 7, 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.  180.107 to subpart C to read as follows:


Sec.  [emsp14]180.107  Triflumezopyrim; tolerance for residues.

    (a) General. Tolerances are established for residues of the 
insecticide triflumezopyrim, including its metabolites and degradates, 
in or on the following food commodities in the table below. Compliance 
with the tolerance levels specified below is to be determined by 
measuring only triflumezopyrim (2,4-dioxo-1-(5-pyrimidinylmethyl)-3-[3-
(trifluoromethyl)phenyl]-2H-pyrido[1,2-a] pyrimidinium inner salt) in 
or on the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Rice, grain *...........................................            0.40
Rice, hulls *...........................................             1.0
------------------------------------------------------------------------
* There are no U.S. registrations for the use of triflumezopyrim on
  these commodities.

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

[FR Doc. 2017-22356 Filed 10-13-17; 8:45 am]
 BILLING CODE 6560-50-P


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