Document ID: EPA-HQ-OPP-2017-0551-0001
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances; Emergency Exemptions: Indaziflam
Posted Date: 2018-02-23T05:00Z

[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Rules and Regulations]
[Pages 7998-8002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03673]

[[Page 7998]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0551; FRL-9973-10]

Indaziflam; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of indaziflam in or on rangeland, pastures, and areas subject 
to the Conservation Reserve Program (CRP). This action is in response 
to EPA's granting of an emergency exemption under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of 
the pesticide in or on grass, forage, fodder, and hay, group 17, forage 
and grass, forage, fodder, and hay, group 17, hay, grown in rangeland, 
pastures, and areas subject to the CRP. This regulation establishes a 
maximum permissible level for residues of indaziflam in or on these 
commodities. The time-limited tolerances expire on December 31, 2020.

DATES: This regulation is effective February 23, 2018. Objections and 
requests for hearings must be received on or before April 24, 2018, 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-2017-0551, 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, Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 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 guidelines referenced in this 
document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select 
``Test Methods and Guidelines.''

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

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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-
2017-0551 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 April 24, 2018. 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-2017-0551, 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets. Additional instructions on commenting or visiting the docket, 
along with more information about dockets generally, is available at 
http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing time-limited tolerances for residues of the herbicide 
indaziflam, N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-(1-
fluoroethyl)-1,3,5-triazine-2,4-diamine, including its metabolites and 
degradates in or on grass, forage, fodder, and hay, group 17, forage at 
30 parts per million (ppm) and grass, forage, fodder, and hay, group 
17, hay at 100 ppm from use on rangeland, pastures, and areas subject 
to the CRP. These time-limited tolerances expire on December 31, 2020.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.

[[Page 7999]]

    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. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Indaziflam on Rangeland, Pastures, and 
Areas Subject to the CRP

    The Wyoming Department of Agriculture (WDA) requested a specific 
emergency exemption for the use of indaziflam in rangeland, pastures, 
and areas subject to the conservation reserve program (CRP) to control 
medusahead (Taeniatherum caput-medusae) and ventenata (Ventenata dubia) 
in the Wyoming counties of Sheridan, Johnson, Cambell, Crook, and 
Weston. Medusahead and ventenata have recently become established in 
Wyoming. These pests are potentially two of the greatest risks to 
Wyoming cattle production because they degrade rangeland forage and hay 
production. Medusahead has reduced forage production by 80%. Visual 
assessments of areas invaded by ventenata suggest it offers very little 
forage. In addition to reducing the forage production, ventenata and 
medusahead also increase forage silica content by 1.5 and 4 times 
respectively. This produces poorer quality forage that is less 
palatable and harder for cattle to digest. If these pests are not 
controlled, potential statewide invasion can happen in less than 25 
years. After having reviewed the submission, EPA determined that an 
emergency condition exists for this State, and that the criteria for 
approval of an emergency exemption are met.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of indaziflam in 
or on rangeland, pastures, and areas subject to the CRP. In doing so, 
EPA considered the safety standard in FFDCA section 408(b)(2), and EPA 
decided that the necessary tolerances under FFDCA section 408(l)(6) 
would be consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent, non-routine situation and to ensure that 
the resulting food is safe and lawful, EPA is issuing these tolerances 
without notice and opportunity for public comment as provided in FFDCA 
section 408(l)(6). Although these time-limited tolerances expire on 
December 31, 2020, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on grass, forage, fodder, and hay, group 17, forage and 
grass, forage, fodder, and hay, group 17, hay on rangeland, pastures, 
and areas subject to the CRP after that date will not be unlawful, 
provided the pesticide was applied in a manner that was lawful under 
FIFRA, and the residues do not exceed a level that was authorized by 
these time-limited tolerances at the time of that application. EPA will 
take action to revoke these time-limited tolerances earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
indaziflam meets FIFRA's registration requirements for use on 
rangeland, pastures, and areas subject to the CRP or whether permanent 
tolerances for this use would be appropriate. Under these 
circumstances, EPA does not believe that this time-limited tolerance 
decision serves as a basis for registration of indaziflam by a State 
for special local needs under FIFRA section 24(c), nor does this 
tolerance by itself serve as the authority for persons in any State 
other than Wyoming to use this pesticide on the applicable crops under 
FIFRA section 18, absent the issuance of an emergency exemption 
applicable within that State. For additional information regarding the 
emergency exemption for indaziflam, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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 expected as a result of this emergency exemption request and 
the time-limited tolerances for residues of indaziflam on grass, 
forage, fodder, and hay, group 17, forage at 30 ppm and grass, forage, 
fodder, and hay, group 17, hay at 100 ppm from use on rangeland, 
pastures, and areas subject to the CRP. EPA's assessment of exposures 
and risks associated with establishing time-limited tolerances follows.

A. 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.
    A summary of the toxicological endpoints for indaziflam used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of January 29, 2014 (79 FR 4624) 
(FRL-9903-88).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary

[[Page 8000]]

exposure to indaziflam, EPA considered exposure under the time-limited 
tolerances established by this action as well as all existing 
indaziflam tolerances in 40 CFR 180.653. EPA assessed dietary exposures 
from indaziflam in food as follows:
    i. Acute and chronic exposures. Acute effects were identified for 
indaziflam. In estimating acute and chronic dietary exposures, EPA used 
food consumption information from the United States Department of 
Agriculture (USDA) National Health and Nutrition Examination Survey, 
What We Eat in America, (NHANES/WWEIA). As to residue levels in food, 
EPA notes that previous indaziflam assessments used screening-level 
assessments which assumed tolerance-level residues and 100% crop 
treated for all included commodities. There are no uses on human foods 
associated with this section 18 emergency use and there is no 
expectation of quantifiable residues in livestock commodities. This 
emergency exemption does not result in any changes to the previous 
dietary exposure and risk estimates.
    ii. Cancer. Based on the data summarized in Unit IV.A., EPA has 
concluded that indaziflam does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iii. Anticipated residue and percent crop treated (PCT) 
information. EPA did not use anticipated residue and/or PCT information 
in the dietary assessment for indaziflam. Tolerance level residues and 
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 indaziflam in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of indaziflam. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide in Water Calculator (PWC) and the Tier 1 
Rice model, the estimated drinking water concentrations (EDWCs) of 
indaziflam for acute exposures are estimated to be 84 parts per billion 
(ppb) for surface water and 3.7 ppb for ground water. For chronic 
exposures for non-cancer assessments are estimated to be 26 ppb for 
surface water and 3.7 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 84 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 26 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).
    Indaziflam is currently registered for the following uses that 
could result in residential exposures: Turf, gardens, and trees. EPA 
assessed residential exposure using the following assumptions: Short-
term dermal and inhalation handler exposure is expected for adults as a 
result of applying products containing indaziflam to lawns/turf and 
gardens/trees using a variety of application equipment. Short-term 
post-application dermal exposure is expected for adults, children 11 to 
16, and children 6 to 11 years old as a result of playing, mowing and/
or golfing on treated turf. Short-term dermal and incidental oral 
exposures (hand to mouth, object to mouth, incidental soil ingestion) 
are expected for children 1 to 2 years old as a result from playing on 
treated turf/lawns. Lastly, short-term post-application dermal exposure 
is expected for adults and children 6 to 11 years old as result of 
application to gardens and trees. The Agency selected only the most 
conservative residential adult and child scenarios to be included in 
the aggregate estimates, based on the lowest overall MOE (i.e., highest 
risk estimates). The most conservative residential exposure scenario 
for both adults and children resulted from short-term dermal and 
incidental oral (for children only) post-application exposure to 
treated turf.
    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 indaziflam to share a common mechanism of 
toxicity with any other substances, and indaziflam does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
indaziflam 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 website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

C. 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 SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No evidence of increased 
quantitative or qualitative susceptibility was seen in developmental 
toxicity studies in rats and rabbits, a developmental toxicity study in 
rats, or in a reproduction study in rats. In the rat developmental 
toxicity study, decreased fetal weight was observed in the presence of 
maternal effects that included decreased body weight gain and food 
consumption. No developmental effects were observed in rabbits up to 
maternally toxic dose levels. Decreased pup weight and delays in sexual 
maturation (preputial separation in males and vaginal patency in 
females) were observed in the rat 2-generation reproductive toxicity 
study, along with clinical signs of toxicity, at a dose causing 
parental toxicity that included coarse tremors, renal toxicity and 
decreased weight gain. In the developmental neurotoxicity study, 
transiently decreased motor activity on post-natal day (PND) 21 only in 
male offspring was observed and was considered a potential neurotoxic 
effect. It was observed at a dose that also caused clinical signs of 
neurotoxicity

[[Page 8001]]

along with decreased body weight in maternal animals.
    3. Conclusion. EPA has determined that reliable data show that 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 toxicity database for indaziflam is complete.
    ii. Evidence of neurotoxicity was observed in dogs and rats 
throughout the database, which included the dog subchronic toxicity 
study, the rat subchronic toxicity, the rat acute, subchronic, and 
developmental neurotoxicity screening batteries, the rat 2-generation 
reproduction study, the rat chronic toxicity study, and the rat 
combined carcinogenicity/chronic toxicity study. Evidence of 
neurotoxicity was manifested as neuropathology in dogs and as decreased 
motor activity and clinical signs (e.g., tremors) in rats. Evidence of 
neurotoxicity was the most consistent effect (seen in dogs and rats), 
the most sensitive toxicological finding (based on neuropathology in 
dogs), and was therefore used as the adverse effect of concern in the 
risk assessment. The endpoints selected for risk assessment are based 
on and protective of the neurotoxic effects seen in the guideline 
studies.
    iii. No developmental effects were observed in rabbits up to 
maternally toxic dose levels. Offspring effects in the developmental 
neurotoxicity study in rats and multi-generation toxicity studies only 
occurred at exposure levels that also produced maternal toxicity and 
these offspring effects were not considered more severe than the 
parental effects. In addition, clear NOAELs/LOAELs were identified for 
these studies. Therefore, EPA concluded that there is no evidence of 
increased quantitative or qualitative susceptibility to rat or rabbit 
fetuses exposed in utero and/or postnatally to indaziflam.
    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. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to indaziflam 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 
indaziflam.

D. 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 
document for acute exposure, the acute dietary exposure from food and 
water to indaziflam will occupy 19% of the aPAD for all infants, the 
population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
document for chronic exposure, EPA has concluded that chronic exposure 
to indaziflam from food and water will utilize 8% of the cPAD for all 
infants, the population group receiving the greatest exposure. Based on 
the explanation in the unit regarding residential use patterns, chronic 
residential exposure to residues of indaziflam is not expected.
    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).
    Indaziflam is currently registered for 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 indaziflam.
    Using the exposure assumptions described in this document for 
short-term exposures, EPA has concluded the combined short-term food, 
water, and residential exposures result in aggregate MOEs of 1,400 for 
adults and 580 for children. Because EPA's level of concern for 
indaziflam is a MOE of 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).
    An intermediate-term adverse effect was identified; however, 
indaziflam 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 
indaziflam.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, indaziflam 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 indaziflam residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology (liquid chromatography with 
tandem mass spectrometry detection (LC/MS/MS) method (DH-003-P07-02) 
for indaziflam and FDAT) 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: 
[email protected].

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

[[Page 8002]]

EPA explain the reasons for departing from the Codex level.
    The Codex has not established MRLs for indaziflam.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
the herbicide indaziflam, N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-
1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine, including its 
metabolites and degradates in or on grass, forage, fodder, and hay, 
group 17, forage at 30 parts per million (ppm) and grass, forage, 
fodder, and hay, group 17, hay at 100 ppm from use on rangeland, 
pastures, and areas subject to the CRP. These tolerances expire on 
December 31, 2020.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and 
408(l)(6). 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 in accordance 
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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).

VIII. 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: February 6, 2018.
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:

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

0
2. In Sec.  180.653, revise paragraph (b) to read as follows:

Sec.  [emsp14]180.653  Indaziflam; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
herbicide indaziflam, N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-
yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine, including its 
metabolites and degradates in or on the specified agricultural 
commodities, resulting from use of the pesticide pursuant to FIFRA 
section 18 emergency exemptions. Compliance with the tolerance levels 
specified in the table in this paragraph (b) is to be determined by 
measuring only indaziflam and FDAT, 6-[(1R)-1-fluoroethyl]-1,3,5-
triazine-2,4-diamine (converted to parent equivalents), in or on the 
commodity. The tolerances expire on the date specified in the table.

------------------------------------------------------------------------
             Commodity              Parts per million   Expiration date
------------------------------------------------------------------------
Grass, forage, fodder, and hay,                    30         12/31/2020
 Group 17, forage.................
Grass, forage, fodder, and hay,                   100         12/31/2020
 Group 17, hay....................
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-03673 Filed 2-22-18; 8:45 am]
 BILLING CODE 6560-50-P