Document ID: EPA-HQ-OPP-2016-0112-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Flazasulfuron
Posted Date: 2017-05-25T04:00Z

[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Rules and Regulations]
[Pages 24062-24067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10763]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0112; FRL-9961-54]

Flazasulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective May 25, 2017. Objections and 
requests for hearings must be received on or before July 24, 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-2016-0112, 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

[[Page 24063]]

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-2016-0112 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 July 24, 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-2016-0112, 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 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 
6F8447) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, 
Concord, Ohio 44077. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the herbicide, 
flazasulfuron (N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-
(trifluoromethyl)-2-pyridinesulfonamide), in or on olive at 0.01 parts 
per million (ppm). That document referenced a summary of the petition 
prepared by ISK Biosciences Corporation, the registrant, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for flazasulfuron including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with flazasulfuron 
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 risk assessment for flazasulfuron is based on a well-
characterized and complete toxicology database. After oral 
administration to rats, more than 84% of the dose of flazasulfuron was 
excreted within 72 hours, mostly as parent compound. Urinary 
elimination accounted for about 80-90% of the dose and fecal 
elimination for about 10-20%. Females tended to eliminate more in the 
urine, and slightly more rapidly, than males. Tissue distribution was 
rapid but incomplete. While levels in tissue were generally low, the 
tissues with highest concentrations were the blood, liver, and muscle.
    The liver was the main target organ of flazasulfuron in most 
species tested, with effects ranging from non-adverse liver hypertrophy 
to more severe histopathological findings like inflammatory cell 
infiltration, hepatocellular necrosis and swelling, and bile duct 
proliferation. Rats also showed kidney toxicity (nephropathy) after 
chronic exposure. No adverse effects were observed in most short and 
intermediate duration (<=90 days) studies; only reduced body weight 
gain and non-adverse liver effects (increased weight and hepatocellular 
hypertrophy) were observed in some of the subchronic toxicity studies.
    Developmental toxicity was observed in rats and abortions in 
rabbits; however, findings in rats were not consistent across strains. 
A small increase in the incidence of intraventricular septal defect was 
observed in Wistar rats but not in Sprague-Dawley rats. Significant 
decreases in mean fetal body weight were observed in both rat strains 
at the limit dose. In these same studies in the rat, the maternal 
animals showed no adverse effects. A high incidence of abortion and 
decreased food consumption, but no specific fetal effects, were 
observed in rabbits. While the developmental studies indicate there is 
offspring susceptibility in rats, both rat studies provide clear no-
observed-adverse-effect levels (NOAELs) for the adverse fetal effects. 
Furthermore, the points of departure (PODs) used for risk assessment 
are lower than doses associated with fetal effects; therefore, the 
assessments are protective of the observed offspring effects.
    No increase in tumor incidence was seen in rats or mice. 
Flazasulfuron is not genotoxic. There was no evidence of neurotoxicity 
in the database. The acute toxicity data indicate that flazasulfuron 
has low acute oral, dermal, and inhalation toxicity. It was not found 
to be a skin irritant, but was a moderate eye irritant. Flazasulfuron 
was not a dermal sensitizer. Flazasulfuron is classified as ``not 
likely to be carcinogenic in humans'' based on the lack of carcinogenic 
effects in the rat and mouse carcinogenicity studies, and lack of a 
mutagenicity concern.
    Specific information on the studies received and the nature of the 
adverse effects caused by flazasulfuron as well as the NOAEL and the 
lowest-observed-

[[Page 24064]]

adverse-effect-level (LOAEL) from the toxicity studies can be found at 
http://www.regulations.gov in document titled ``Flazasulfuron. 
Aggregate Human Health Risk Assessment for the Proposed New Use on 
Olives'' at page 23 in docket ID number EPA-HQ-OPP-2016-0112.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for flazasulfuron used for 
human risk assessment is discussed in Unit II. B. of the final rule 
published in the Federal Register of September 5, 2014 (79 FR 52985) 
(FRL-9915-32).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to flazasulfuron, EPA considered exposure under the 
petitioned-for tolerances as well as all existing flazasulfuron 
tolerances in 40 CFR 180.655. EPA assessed dietary exposures from 
flazasulfuron 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 flazasulfuron. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) under the Continuing Survey of 
Food Intake by Individuals (CSFII) and the CDC under the National 
Health and Nutrition Examination Survey/What We Eat in America (NHANES/
WEIA) 2003-2008. The acute dietary exposure analyses incorporate 
tolerance-level residues of the currently registered and proposed crops 
combined with 100% crop treated (%CT) to determine the exposure and 
risk estimates. Residues of flazasulfuron were all http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW) for 
ground water and the Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS) for surface water, the estimated drinking 
water concentrations (EDWCs) of flazasulfuron for acute exposures are 
estimated to be 26.9 parts per billion (ppb) for surface water and 90.8 
ppb for ground water.
    For chronic exposures for non-cancer assessments EDWCs are 
estimated to be 4.67 ppb for surface water and 55.6 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of 
90.8 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 55.6 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).
    Flazasulfuron is currently registered for use on turf that could 
result in residential exposures. Residential exposure may occur by the 
dermal, oral, and inhalation routes of exposures. Flazasulfuron does 
not pose a dermal hazard; therefore, only inhalation (handler exposure 
for adults) and oral (post-application incidental oral for children) 
were assessed. Non-occupational exposures to flazasulfuron are expected 
to be for short-term durations only. The recommended residential 
exposure for use in the adult aggregate assessment reflects inhalation 
exposure from applications to turf via backpack or manually pressurized 
handwand. The recommended residential exposure for use in the children 
1 to <2 years old aggregate assessment reflects hand-to-mouth exposures 
from post-application exposure to turf treatments. A turf transferable 
residues (TTR) study is not required for flazasulfuron at this time 
since there was no dermal hazard

[[Page 24065]]

identified and the hand-to-mouth MOE is greater than 1,000 based on 
default values for the fraction of application rate available for 
transfer after a turf application. Further information regarding EPA 
standard assumptions and generic inputs for residential exposures may 
be found at http://www2.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.''
    In 2016, EPA's Office of Pesticide Programs released a guidance 
document entitled, ``Pesticide Cumulative Risk Assessment: Framework 
for Screening Analysis'' https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. This document provides guidance on how to screen groups of 
pesticides for cumulative evaluation using a two-step approach 
beginning with the evaluation of available toxicological information 
and if necessary, followed by a risk-based screening approach. This 
framework supplements the existing guidance documents for establishing 
common mechanism groups (CMGs) and conducting cumulative risk 
assessments (CRA). The Agency has utilized this framework for 
flazasulfuron and determined that although flazasulfuron shares some 
chemical and/or toxicological characteristics (e.g., chemical structure 
or apical endpoint) with other pesticides, the toxicological database 
does not support a testable hypothesis for a common mechanism of 
action. No further data is required to determine that no common 
mechanism of toxicity exists for flazasulfuron and other pesticides and 
no further cumulative evaluation is necessary for flazasulfuron.

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. The available data indicate 
that flazasulfuron produced developmental effects in the rabbit 
(increased abortions), and reproductive effects in the rat (decreased 
pup body weight), only at maternally/parentally toxic dose levels, and 
these developmental/offspring effects were not more severe than 
maternal/parental effects (increased abortions the rabbit, increased 
nephropathy and decreased pup body weight in the rat). While 
developmental effects (increased incidence of interventricular septal 
defect and reduced fetal weights) were seen in rats in the absence of 
maternal toxicity, an indication of quantitative and qualitative 
susceptibility, clear NOAELs and LOAELs have been established for these 
adverse fetal effects. Furthermore, the PODs used for risk assessment 
are lower than doses associated with these developmental effects. 
Therefore, the assessments are protective of the observed offspring 
effects, and the Agency has no concerns for quantitative or qualitative 
susceptibility.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for flazasulfuron is complete.
    ii. An acute neurotoxicity study was conducted with flazasulfuron 
at dose levels up to 2,000 mg/kg. Mean motor activity measurements at 
dose levels of 1,000 and 2,000 mg/kg for males and females were 
statistically significantly decreased from the respective control 
groups five hours post-dosing. Animals were less active with more 
resting time than controls. The effect was reversed by the next 
scheduled observation (Day 7). Neurohistopathologic evaluation did not 
demonstrate any test material related neurotoxic lesions following the 
examination of tissues from the central and peripheral nervous systems 
of high dose and control animals. The NOAEL was 50 mg/kg. A subchronic 
neurotoxicity study was conducted with flazasulfuron at up to 732 mg/kg 
bw/day in the diet for 90 days. No biologically relevant neurotoxic 
effects were observed at the dose levels tested. The available 
neurotoxicity battery, therefore, did not raise concern for 
neurotoxicity. Similarly, the subchronic and chronic data in the 
database did not show any adverse effects that could be considered as 
neurotoxicity.
    iii. While there is evidence of increased qualitative and 
quantitative susceptibility in the young based on rat malformations and 
decreased fetal weight in two rat developmental toxicity studies, the 
FQPA Safety Factor is reduced to 1X and is protective of the observed 
offspring susceptibility because there are clear NOAELs for the 
developmental effects in the two rat studies developmental toxicity 
studies and the PODs selected for risk assessment are protective of 
those effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The exposure databases are complete or are estimated based 
on data that reasonably account for potential exposures. The acute and 
chronic dietary food exposure assessment were conservatively based on 
tolerance-level residues on the currently registered and proposed 
crops, 100% CT assumptions, and conservative ground water drinking 
water modeling estimates. The Agency does not believe that the non-
dietary residential exposures are underestimated because they are also 
based on conservative assumptions. All of the exposure estimates are 
based on conservative assumptions and are not likely to result in 
underestimated risk.

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 flazasulfuron will occupy 3.1% of the aPAD for infants less than 
one-year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
flazasulfuron from food and water will utilize 23% of

[[Page 24066]]

the cPAD for infants less than one-year old, the population group 
receiving the greatest exposure. Based on the explanation in Unit 
III.C.3., regarding residential use patterns, chronic residential 
exposure to residues of flazasulfuron is not expected.
    3. Short- and intermediate-term aggregate risk. There is potential 
short-term aggregate exposure to flazasulfuron via the dietary pathway 
(which is considered background exposure) and the residential pathway 
(which is considered the primary pathway). Since intermediate-term 
residential exposures are not likely to occur, intermediate-term 
aggregate risks were not assessed. Since there is no dermal endpoint, 
the short-term aggregate exposure assessment for adults includes 
dietary (food and drinking water) and inhalation handler exposures and 
results in an aggregate MOE of 1,600. The short-term aggregate exposure 
assessment for children 1-2 years old includes dietary (food and 
drinking water) and post-application hand-to-mouth exposure from 
treated turf and results in an aggregate MOE of 810. Because EPA's 
level of concern for flazasulfuron is a MOE of 100 or below, these MOEs 
are not of concern.
    4. Aggregate cancer risk for U.S. population. A cancer aggregate 
risk assessment was not conducted because there was no evidence of 
carcinogenicity to humans based on lack of carcinogenic effects in the 
rat and mouse carcinogenicity studies.
    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 flazasulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement method is available. The method uses high 
performance liquid chromatography/tandem mass spectrometry with 
multiple reaction monitoring (HPLC/MS-MS/MRM). The LOQ is 0.01 ppm.

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 flazasulfuron.

V. Conclusion

    Therefore, tolerances are established for residues of 
flazasulfuron, herbicide, in or on olive at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under 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: April 26, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

0
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.  180.655, add alphabetically the entry ``Olive'' to the 
table in paragraph (a) to read as follows:

Sec.  180.655  Flazasulfuron; tolerances for residues.

    (a) * * *

[[Page 24067]]

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Olive...................................................            0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-10763 Filed 5-24-17; 8:45 am]
 BILLING CODE 6560-50-P