82_FR_24162 82 FR 24062 - Flazasulfuron; Pesticide Tolerances

82 FR 24062 - Flazasulfuron; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 100 (May 25, 2017)

Page Range24062-24067
FR Document2017-10763

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).

Federal Register, Volume 82 Issue 100 (Thursday, May 25, 2017)
[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Rules and Regulations]
[Pages 24062-24067]
From the Federal Register Online  [www.thefederalregister.org]
[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: [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 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



     24062              Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations

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         (e) * * *

                                                                        NEW HAMPSHIRE NONREGULATORY
                                                                             State
      Name of nonregulatory            Applicable geographic               submittal             EPA approved                                  Explanations
         SIP provision                 or nonattainment area             date/effective            date 3
                                                                             date


               *                         *                           *                      *                     *                     *                   *
     Infrastructure SIP for           Statewide .....................       12/31/2012     5/25/2017 [Insert Fed-       Items that were conditionally approved on 12/
        2008 ozone NAAQS.                                                                     eral Register cita-          16/15 are now fully approved.
                                                                                              tion].
     Infrastructure SIP for the       Statewide .....................        11/7/2011     5/25/2017 [Insert Fed-       Items that were conditionally approved on 12/
        2008 Lead NAAQS.                                                                      eral Register cita-          16/15 are now fully approved.
                                                                                              tion].
     Infrastructure SIP for the       Statewide .....................        1/28/2013     5/25/2017 [Insert Fed-       Items that were conditionally approved on 12/
        2010 NO2 NAAQS.                                                                       eral Register cita-          16/15 are now fully approved.
                                                                                              tion].
     Infrastructure SIP for the       Statewide .....................        7/13/2013     5/25/2017 [Insert Fed-       Items that were conditionally approved on 7/8/
        2010 SO2 NAAQS.                                                                       eral Register cita-          2016 are now fully approved.
                                                                                              tion].
     Infrastructure SIP for the       Statewide .....................          7/3/2012    5/25/2017 [Insert Fed-       Items that were conditionally approved on 12/
        1997 PM2.5 NAAQS.                                                                     eral Register cita-          16/15 are now fully approved.
                                                                                              tion].
     Infrastructure SIP for           Statewide .....................        9/18/2009     5/25/2017 [Insert Fed-       Items that were conditionally approved on 12/
        2006 PM2.5 NAAQS.                                                                     eral Register cita-          16/15 are now fully approved.
                                                                                              tion].

              *                          *                           *                      *                     *                        *                  *
     Transport SIP for the            Statewide .....................       11/17/2015     5/25/2017 [Insert Fed-
       2010 NO2 Standard.                                                                     eral Register cita-
                                                                                              tion].
       3 In order to determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this col-
     umn for the particular provision.


     [FR Doc. 2017–09536 Filed 5–24–17; 8:45 am]                  available at http://www.regulations.gov                pesticide manufacturer. The following
     BILLING CODE 6560–50–P                                       or at the Office of Pesticide Programs                 list of North American Industrial
                                                                  Regulatory Public Docket (OPP Docket)                  Classification System (NAICS) codes is
                                                                  in the Environmental Protection Agency                 not intended to be exhaustive, but rather
     ENVIRONMENTAL PROTECTION                                     Docket Center (EPA/DC), West William                   provides a guide to help readers
     AGENCY                                                       Jefferson Clinton Bldg., Rm. 3334, 1301                determine whether this document
                                                                  Constitution Ave. NW., Washington, DC                  applies to them. Potentially affected
     40 CFR Part 180                                              20460–0001. The Public Reading Room                    entities may include:
     [EPA–HQ–OPP–2016–0112; FRL–9961–54]                          is open from 8:30 a.m. to 4:30 p.m.,                      • Crop production (NAICS code 111).
                                                                  Monday through Friday, excluding legal                    • Animal production (NAICS code
     Flazasulfuron; Pesticide Tolerances                          holidays. The telephone number for the                 112).
                                                                  Public Reading Room is (202) 566–1744,                    • Food manufacturing (NAICS code
     AGENCY:  Environmental Protection
                                                                  and the telephone number for the OPP                   311).
     Agency (EPA).
                                                                  Docket is (703) 305–5805. Please review                   • Pesticide manufacturing (NAICS
     ACTION: Final rule.                                          the visitor instructions and additional                code 32532).
     SUMMARY:   This regulation establishes                       information about the docket available
                                                                                                                         B. How can I get electronic access to
     tolerances for residues of flazasulfuron                     at http://www.epa.gov/dockets.
                                                                                                                         other related information?
     in or on olives. ISK Biosciences                             FOR FURTHER INFORMATION CONTACT:
     Corporation requested these tolerances                       Michael Goodis, Registration Division                     You may access a frequently updated
     under the Federal Food, Drug, and                            (7505P), Office of Pesticide Programs,                 electronic version of EPA’s tolerance
     Cosmetic Act (FFDCA).                                        Environmental Protection Agency, 1200                  regulations at 40 CFR part 180 through
                                                                  Pennsylvania Ave. NW., Washington,                     the Government Printing Office’s e-CFR
     DATES: This regulation is effective May
                                                                  DC 20460–0001; main telephone                          site at http://www.ecfr.gov/cgi-bin/text-
     25, 2017. Objections and requests for                                                                               idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
     hearings must be received on or before                       number: (703) 305–7090; email address:
                                                                  RDFRNotices@epa.gov.                                   40tab_02.tpl.
     July 24, 2017, and must be filed in
     accordance with the instructions                             SUPPLEMENTARY INFORMATION:                             C. How can I file an objection or hearing
     provided in 40 CFR part 178 (see also                                                                               request?
                                                                  I. General Information
     Unit I.C. of the SUPPLEMENTARY                                                                                        Under FFDCA section 408(g), 21
     INFORMATION).                                                A. Does this action apply to me?                       U.S.C. 346a, any person may file an
     ADDRESSES: The docket for this action,                         You may be potentially affected by                   objection to any aspect of this regulation
     identified by docket identification (ID)                     this action if you are an agricultural                 and may also request a hearing on those
     number EPA–HQ–OPP–2016–0112, is                              producer, food manufacturer, or                        objections. You must file your objection


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                        Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations                                         24063

     or request a hearing on this regulation                 petition prepared by ISK Biosciences                  urine, and slightly more rapidly, than
     in accordance with the instructions                     Corporation, the registrant, which is                 males. Tissue distribution was rapid but
     provided in 40 CFR part 178. To ensure                  available in the docket, http://                      incomplete. While levels in tissue were
     proper receipt by EPA, you must                         www.regulations.gov. There were no                    generally low, the tissues with highest
     identify docket ID number EPA–HQ–                       comments received in response to the                  concentrations were the blood, liver,
     OPP–2016–0112 in the subject line on                    notice of filing.                                     and muscle.
     the first page of your submission. All                                                                           The liver was the main target organ of
                                                             III. Aggregate Risk Assessment and                    flazasulfuron in most species tested,
     objections and requests for a hearing
                                                             Determination of Safety                               with effects ranging from non-adverse
     must be in writing, and must be
     received by the Hearing Clerk on or                        Section 408(b)(2)(A)(i) of FFDCA                   liver hypertrophy to more severe
     before July 24, 2017. Addresses for mail                allows EPA to establish a tolerance (the              histopathological findings like
     and hand delivery of objections and                     legal limit for a pesticide chemical                  inflammatory cell infiltration,
     hearing requests are provided in 40 CFR                 residue in or on a food) only if EPA                  hepatocellular necrosis and swelling,
     178.25(b).                                              determines that the tolerance is ‘‘safe.’’            and bile duct proliferation. Rats also
       In addition to filing an objection or                 Section 408(b)(2)(A)(ii) of FFDCA                     showed kidney toxicity (nephropathy)
     hearing request with the Hearing Clerk                  defines ‘‘safe’’ to mean that ‘‘there is a            after chronic exposure. No adverse
     as described in 40 CFR part 178, please                 reasonable certainty that no harm will                effects were observed in most short and
     submit a copy of the filing (excluding                  result from aggregate exposure to the                 intermediate duration (≤90 days)
     any Confidential Business Information                   pesticide chemical residue, including                 studies; only reduced body weight gain
     (CBI)) for inclusion in the public docket.              all anticipated dietary exposures and all             and non-adverse liver effects (increased
     Information not marked confidential                     other exposures for which there is                    weight and hepatocellular hypertrophy)
     pursuant to 40 CFR part 2 may be                        reliable information.’’ This includes                 were observed in some of the
     disclosed publicly by EPA without prior                 exposure through drinking water and in                subchronic toxicity studies.
     notice. Submit the non-CBI copy of your                 residential settings, but does not include               Developmental toxicity was observed
     objection or hearing request, identified                occupational exposure. Section                        in rats and abortions in rabbits;
     by docket ID number EPA–HQ–OPP–                         408(b)(2)(C) of FFDCA requires EPA to                 however, findings in rats were not
     2016–0112, by one of the following                      give special consideration to exposure                consistent across strains. A small
     methods:                                                of infants and children to the pesticide              increase in the incidence of
       • Federal eRulemaking Portal: http://                 chemical residue in establishing a                    intraventricular septal defect was
     www.regulations.gov. Follow the online                  tolerance and to ‘‘ensure that there is a             observed in Wistar rats but not in
     instructions for submitting comments.                   reasonable certainty that no harm will                Sprague-Dawley rats. Significant
     Do not submit electronically any                        result to infants and children from                   decreases in mean fetal body weight
     information you consider to be CBI or                   aggregate exposure to the pesticide                   were observed in both rat strains at the
     other information whose disclosure is                   chemical residue. . . .’’                             limit dose. In these same studies in the
     restricted by statute.                                     Consistent with FFDCA section                      rat, the maternal animals showed no
       • Mail: OPP Docket, Environmental                     408(b)(2)(D), and the factors specified in            adverse effects. A high incidence of
     Protection Agency Docket Center (EPA/                   FFDCA section 408(b)(2)(D), EPA has                   abortion and decreased food
     DC), (28221T), 1200 Pennsylvania Ave.                   reviewed the available scientific data                consumption, but no specific fetal
     NW., Washington, DC 20460–0001.                         and other relevant information in                     effects, were observed in rabbits. While
       • Hand Delivery: To make special                      support of this action. EPA has                       the developmental studies indicate
     arrangements for hand delivery or                       sufficient data to assess the hazards of              there is offspring susceptibility in rats,
     delivery of boxed information, please                   and to make a determination on                        both rat studies provide clear no-
     follow the instructions at http://                      aggregate exposure for flazasulfuron                  observed-adverse-effect levels (NOAELs)
     www.epa.gov/dockets/contacts.html.                      including exposure resulting from the                 for the adverse fetal effects.
     Additional instructions on commenting                   tolerances established by this action.                Furthermore, the points of departure
     or visiting the docket, along with more                 EPA’s assessment of exposures and risks               (PODs) used for risk assessment are
     information about dockets generally, is                 associated with flazasulfuron follows.                lower than doses associated with fetal
     available at http://www.epa.gov/                                                                              effects; therefore, the assessments are
     dockets.                                                A. Toxicological Profile                              protective of the observed offspring
                                                                EPA has evaluated the available                    effects.
     II. Summary of Petitioned-For                           toxicity data and considered its validity,               No increase in tumor incidence was
     Tolerance                                               completeness, and reliability as well as              seen in rats or mice. Flazasulfuron is not
        In the Federal Register of April 25,                 the relationship of the results of the                genotoxic. There was no evidence of
     2016 (81 FR 24044) (FRL–9944–86),                       studies to human risk. EPA has also                   neurotoxicity in the database. The acute
     EPA issued a document pursuant to                       considered available information                      toxicity data indicate that flazasulfuron
     FFDCA section 408(d)(3), 21 U.S.C.                      concerning the variability of the                     has low acute oral, dermal, and
     346a(d)(3), announcing the filing of a                  sensitivities of major identifiable                   inhalation toxicity. It was not found to
     pesticide petition (PP 6F8447) by ISK                   subgroups of consumers, including                     be a skin irritant, but was a moderate
     Biosciences Corporation, 7470 Auburn                    infants and children.                                 eye irritant. Flazasulfuron was not a
     Road, Suite A, Concord, Ohio 44077.                        The risk assessment for flazasulfuron              dermal sensitizer. Flazasulfuron is
     The petition requested that 40 CFR part                 is based on a well-characterized and                  classified as ‘‘not likely to be
     180 be amended by establishing                          complete toxicology database. After oral              carcinogenic in humans’’ based on the
     tolerances for residues of the herbicide,               administration to rats, more than 84% of              lack of carcinogenic effects in the rat
     flazasulfuron (N-[[(4,6-dimethoxy-2-                    the dose of flazasulfuron was excreted                and mouse carcinogenicity studies, and
     pyrimidinyl)amino]carbonyl]-3-                          within 72 hours, mostly as parent                     lack of a mutagenicity concern.
     (trifluoromethyl)-2-                                    compound. Urinary elimination                            Specific information on the studies
     pyridinesulfonamide), in or on olive at                 accounted for about 80–90% of the dose                received and the nature of the adverse
     0.01 parts per million (ppm). That                      and fecal elimination for about 10–20%.               effects caused by flazasulfuron as well
     document referenced a summary of the                    Females tended to eliminate more in the               as the NOAEL and the lowest-observed-


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     24064              Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations

     adverse-effect-level (LOAEL) from the                   occurring as a result of a 1-day or single            These simulation models take into
     toxicity studies can be found at http://                exposure.                                             account data on the physical, chemical,
     www.regulations.gov in document titled                     Such effects were identified for                   and fate/transport characteristics of
     ‘‘Flazasulfuron. Aggregate Human                        flazasulfuron. In estimating acute                    flazasulfuron. Further information
     Health Risk Assessment for the                          dietary exposure, EPA used food                       regarding EPA drinking water models
     Proposed New Use on Olives’’ at page                    consumption information from the                      used in pesticide exposure assessment
     23 in docket ID number EPA–HQ–OPP–                      United States Department of Agriculture               can be found at http://www2.epa.gov/
     2016–0112.                                              (USDA) under the Continuing Survey of                 pesticide-science-and-assessing-
                                                             Food Intake by Individuals (CSFII) and                pesticide-risks/about-water-exposure-
     B. Toxicological Points of Departure/                   the CDC under the National Health and                 models-used-pesticide.
     Levels of Concern                                       Nutrition Examination Survey/What We                     Based on the Pesticide Root Zone
        Once a pesticide’s toxicological                     Eat in America (NHANES/WEIA) 2003–                    Model Ground Water (PRZM GW) for
     profile is determined, EPA identifies                   2008. The acute dietary exposure                      ground water and the Pesticide Root
     toxicological POD and levels of concern                 analyses incorporate tolerance-level                  Zone Model/Exposure Analysis
     to use in evaluating the risk posed by                  residues of the currently registered and              Modeling System (PRZM/EXAMS) for
     human exposure to the pesticide. For                    proposed crops combined with 100%                     surface water, the estimated drinking
     hazards that have a threshold below                     crop treated (%CT) to determine the                   water concentrations (EDWCs) of
     which there is no appreciable risk, the                 exposure and risk estimates. Residues of              flazasulfuron for acute exposures are
     toxicological POD is used as the basis                  flazasulfuron were all <Level of                      estimated to be 26.9 parts per billion
     for derivation of reference values for                  Quantification (LOQ) (<0.01 ppm) in/on                (ppb) for surface water and 90.8 ppb for
     risk assessment. PODs are developed                     olive fruit and olive oil; therefore,                 ground water.
     based on a careful analysis of the doses                processing factors could not be                          For chronic exposures for non-cancer
     in each toxicological study to determine                calculated. An acceptable method was                  assessments EDWCs are estimated to be
     the dose at which no adverse effects are                used for residue quantitation, and                    4.67 ppb for surface water and 55.6 ppb
     observed (the NOAEL) and the lowest                     adequate data were submitted to                       for ground water.
                                                             support sample storage intervals and                     Modeled estimates of drinking water
     dose at which adverse effects of concern
                                                             conditions. In the crop field trials, all             concentrations were directly entered
     are identified (the LOAEL). Uncertainty/
                                                             residues of parent flazasulfuron in olive             into the dietary exposure model.
     safety factors are used in conjunction                                                                           For acute dietary risk assessment, the
     with the POD to calculate a safe                        were nondetectable. Since all residues
                                                             were <LOQ, residue decline could not                  water concentration value of 90.8 ppb
     exposure level—generally referred to as                                                                       was used to assess the contribution to
     a population-adjusted dose (PAD) or a                   be assessed. Acceptable metabolism
                                                             studies on grapes, sugarcane, and                     drinking water.
     reference dose (RfD)—and a safe margin                                                                           For chronic dietary risk assessment,
     of exposure (MOE). For non-threshold                    tomatoes are available. Residues of
                                                             flazasulfuron were not detected in the                the water concentration of value 55.6
     risks, the Agency assumes that any                                                                            ppb was used to assess the contribution
     amount of exposure will lead to some                    tomato study and were only detected as
                                                             a trace or minor component in the grape               to drinking water.
     degree of risk. Thus, the Agency                                                                                 3. From non-dietary exposure. The
     estimates risk in terms of the probability              and sugarcane studies. Therefore, the
                                                             processing factors were set at 1 in the               term ‘‘residential exposure’’ is used in
     of an occurrence of the adverse effect                                                                        this document to refer to non-
                                                             dietary exposure assessment.
     expected in a lifetime. For more                                                                              occupational, non-dietary exposure
                                                                ii. Chronic exposure. In conducting
     information on the general principles                                                                         (e.g., for lawn and garden pest control,
                                                             the chronic dietary exposure assessment
     EPA uses in risk characterization and a                 EPA used the food consumption data                    indoor pest control, termiticides, and
     complete description of the risk                        from the USDA NHANES/WEIA 2003–                       flea and tick control on pets).
     assessment process, see http://                         2008. The chronic dietary exposure                       Flazasulfuron is currently registered
     www2.epa.gov/pesticide-science-and-                     analyses incorporate tolerance-level                  for use on turf that could result in
     assessing-pesticide-risks/assessing-                    residues of the currently registered and              residential exposures. Residential
     human-health-risk-pesticides.                           proposed crops combined with 100%CT                   exposure may occur by the dermal, oral,
        A summary of the toxicological                       to determine the exposure and risk                    and inhalation routes of exposures.
     endpoints for flazasulfuron used for                    estimates. Processing factors were set at             Flazasulfuron does not pose a dermal
     human risk assessment is discussed in                   1 in the dietary exposure assessment.                 hazard; therefore, only inhalation
     Unit II. B. of the final rule published in                 iii. Cancer. Based on the data                     (handler exposure for adults) and oral
     the Federal Register of September 5,                    summarized in Unit III.A., EPA has                    (post-application incidental oral for
     2014 (79 FR 52985) (FRL–9915–32).                       concluded that flazasulfuron does not                 children) were assessed. Non-
     C. Exposure Assessment                                  pose a cancer risk to humans. Therefore,              occupational exposures to flazasulfuron
                                                             a dietary exposure assessment for the                 are expected to be for short-term
        1. Dietary exposure from food and                    purpose of assessing cancer risk is                   durations only. The recommended
     feed uses. In evaluating dietary                        unnecessary.                                          residential exposure for use in the adult
     exposure to flazasulfuron, EPA                             iv. Anticipated residue and percent                aggregate assessment reflects inhalation
     considered exposure under the                           crop treated (PCT) information. EPA did               exposure from applications to turf via
     petitioned-for tolerances as well as all                not use anticipated residue and/or PCT                backpack or manually pressurized
     existing flazasulfuron tolerances in 40                 information in the dietary assessment                 handwand. The recommended
     CFR 180.655. EPA assessed dietary                       for flazasulfuron. Tolerance level                    residential exposure for use in the
     exposures from flazasulfuron in food as                 residues and/or 100% CT were assumed                  children 1 to <2 years old aggregate
     follows:                                                for all food commodities.                             assessment reflects hand-to-mouth
        i. Acute exposure. Quantitative acute                   2. Dietary exposure from drinking                  exposures from post-application
     dietary exposure and risk assessments                   water. The Agency used screening level                exposure to turf treatments. A turf
     are performed for a food-use pesticide,                 water exposure models in the dietary                  transferable residues (TTR) study is not
     if a toxicological study has indicated the              exposure analysis and risk assessment                 required for flazasulfuron at this time
     possibility of an effect of concern                     for flazasulfuron in drinking water.                  since there was no dermal hazard


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                        Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations                                         24065

     identified and the hand-to-mouth MOE                    margin of safety will be safe for infants             available neurotoxicity battery,
     is greater than 1,000 based on default                  and children. This additional margin of               therefore, did not raise concern for
     values for the fraction of application                  safety is commonly referred to as the                 neurotoxicity. Similarly, the subchronic
     rate available for transfer after a turf                FQPA Safety Factor (SF). In applying                  and chronic data in the database did not
     application. Further information                        this provision, EPA either retains the                show any adverse effects that could be
     regarding EPA standard assumptions                      default value of 10X, or uses a different             considered as neurotoxicity.
     and generic inputs for residential                      additional safety factor when reliable                   iii. While there is evidence of
     exposures may be found at http://                       data available to EPA support the choice              increased qualitative and quantitative
     www2.epa.gov/pesticide-science-and-                     of a different factor.                                susceptibility in the young based on rat
     assessing-pesticide-risks/standard-                        2. Prenatal and postnatal sensitivity.             malformations and decreased fetal
     operating-procedures-residential-                       The available data indicate that                      weight in two rat developmental
     pesticide.                                              flazasulfuron produced developmental                  toxicity studies, the FQPA Safety Factor
        4. Cumulative effects from substances                effects in the rabbit (increased                      is reduced to 1X and is protective of the
     with a common mechanism of toxicity.                    abortions), and reproductive effects in               observed offspring susceptibility
     Section 408(b)(2)(D)(v) of FFDCA                        the rat (decreased pup body weight),                  because there are clear NOAELs for the
     requires that, when considering whether                 only at maternally/parentally toxic dose              developmental effects in the two rat
     to establish, modify, or revoke a                       levels, and these developmental/                      studies developmental toxicity studies
     tolerance, the Agency consider                          offspring effects were not more severe                and the PODs selected for risk
     ‘‘available information’’ concerning the                than maternal/parental effects                        assessment are protective of those
     cumulative effects of a particular                      (increased abortions the rabbit,                      effects.
     pesticide’s residues and ‘‘other                        increased nephropathy and decreased                      iv. There are no residual uncertainties
     substances that have a common                           pup body weight in the rat). While                    identified in the exposure databases.
     mechanism of toxicity.’’                                developmental effects (increased                      The exposure databases are complete or
        In 2016, EPA’s Office of Pesticide                   incidence of interventricular septal                  are estimated based on data that
     Programs released a guidance document                   defect and reduced fetal weights) were                reasonably account for potential
     entitled, ‘‘Pesticide Cumulative Risk                   seen in rats in the absence of maternal               exposures. The acute and chronic
     Assessment: Framework for Screening                     toxicity, an indication of quantitative               dietary food exposure assessment were
     Analysis’’ https://www.epa.gov/                         and qualitative susceptibility, clear                 conservatively based on tolerance-level
     pesticide-science-and-assessing-                        NOAELs and LOAELs have been                           residues on the currently registered and
     pesticide-risks/pesticide-cumulative-                   established for these adverse fetal                   proposed crops, 100% CT assumptions,
     risk-assessment-framework. This                         effects. Furthermore, the PODs used for               and conservative ground water drinking
     document provides guidance on how to                    risk assessment are lower than doses                  water modeling estimates. The Agency
     screen groups of pesticides for                         associated with these developmental                   does not believe that the non-dietary
     cumulative evaluation using a two-step                  effects. Therefore, the assessments are               residential exposures are
     approach beginning with the evaluation                  protective of the observed offspring                  underestimated because they are also
     of available toxicological information                  effects, and the Agency has no concerns               based on conservative assumptions. All
     and if necessary, followed by a risk-                   for quantitative or qualitative                       of the exposure estimates are based on
     based screening approach. This                          susceptibility.                                       conservative assumptions and are not
     framework supplements the existing                         3. Conclusion. EPA has determined                  likely to result in underestimated risk.
     guidance documents for establishing                     that reliable data show the safety of
     common mechanism groups (CMGs) and                      infants and children would be                         E. Aggregate Risks and Determination of
     conducting cumulative risk assessments                  adequately protected if the FQPA SF                   Safety
     (CRA). The Agency has utilized this                     were reduced to 1X. That decision is                     EPA determines whether acute and
     framework for flazasulfuron and                         based on the following findings:                      chronic dietary pesticide exposures are
     determined that although flazasulfuron                     i. The toxicity database for                       safe by comparing aggregate exposure
     shares some chemical and/or                             flazasulfuron is complete.                            estimates to the acute PAD (aPAD) and
     toxicological characteristics (e.g.,                       ii. An acute neurotoxicity study was               chronic PAD (cPAD). For linear cancer
     chemical structure or apical endpoint)                  conducted with flazasulfuron at dose                  risks, EPA calculates the lifetime
     with other pesticides, the toxicological                levels up to 2,000 mg/kg. Mean motor                  probability of acquiring cancer given the
     database does not support a testable                    activity measurements at dose levels of               estimated aggregate exposure. Short-,
     hypothesis for a common mechanism of                    1,000 and 2,000 mg/kg for males and                   intermediate-, and chronic-term risks
     action. No further data is required to                  females were statistically significantly              are evaluated by comparing the
     determine that no common mechanism                      decreased from the respective control                 estimated aggregate food, water, and
     of toxicity exists for flazasulfuron and                groups five hours post-dosing. Animals                residential exposure to the appropriate
     other pesticides and no further                         were less active with more resting time               PODs to ensure that an adequate MOE
     cumulative evaluation is necessary for                  than controls. The effect was reversed                exists.
     flazasulfuron.                                          by the next scheduled observation (Day                   1. Acute risk. Using the exposure
                                                             7). Neurohistopathologic evaluation did               assumptions discussed in this unit for
     D. Safety Factor for Infants and                        not demonstrate any test material                     acute exposure, the acute dietary
     Children                                                related neurotoxic lesions following the              exposure from food and water to
       1. In general. Section 408(b)(2)(C) of                examination of tissues from the central               flazasulfuron will occupy 3.1% of the
     FFDCA provides that EPA shall apply                     and peripheral nervous systems of high                aPAD for infants less than one-year old,
     an additional tenfold (10X) margin of                   dose and control animals. The NOAEL                   the population group receiving the
     safety for infants and children in the                  was 50 mg/kg. A subchronic                            greatest exposure.
     case of threshold effects to account for                neurotoxicity study was conducted with                   2. Chronic risk. Using the exposure
     prenatal and postnatal toxicity and the                 flazasulfuron at up to 732 mg/kg bw/day               assumptions described in this unit for
     completeness of the database on toxicity                in the diet for 90 days. No biologically              chronic exposure, EPA has concluded
     and exposure unless EPA determines                      relevant neurotoxic effects were                      that chronic exposure to flazasulfuron
     based on reliable data that a different                 observed at the dose levels tested. The               from food and water will utilize 23% of


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     24066              Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations

     the cPAD for infants less than one-year                 United Nations Food and Agriculture                   has determined that this action will not
     old, the population group receiving the                 Organization/World Health                             have a substantial direct effect on States
     greatest exposure. Based on the                         Organization food standards program,                  or tribal governments, on the
     explanation in Unit III.C.3., regarding                 and it is recognized as an international              relationship between the national
     residential use patterns, chronic                       food safety standards-setting                         government and the States or tribal
     residential exposure to residues of                     organization in trade agreements to                   governments, or on the distribution of
     flazasulfuron is not expected.                          which the United States is a party. EPA               power and responsibilities among the
        3. Short- and intermediate-term                      may establish a tolerance that is                     various levels of government or between
     aggregate risk. There is potential short-               different from a Codex MRL; however,                  the Federal Government and Indian
     term aggregate exposure to flazasulfuron                FFDCA section 408(b)(4) requires that                 tribes. Thus, the Agency has determined
     via the dietary pathway (which is                       EPA explain the reasons for departing                 that Executive Order 13132, entitled
     considered background exposure) and                     from the Codex level.                                 ‘‘Federalism’’ (64 FR 43255, August 10,
     the residential pathway (which is                         The Codex has not established a MRL                 1999) and Executive Order 13175,
     considered the primary pathway). Since                  for flazasulfuron.                                    entitled ‘‘Consultation and Coordination
     intermediate-term residential exposures                 V. Conclusion                                         with Indian Tribal Governments’’ (65 FR
     are not likely to occur, intermediate-                                                                        67249, November 9, 2000) do not apply
     term aggregate risks were not assessed.                   Therefore, tolerances are established               to this action. In addition, this action
     Since there is no dermal endpoint, the                  for residues of flazasulfuron, herbicide,             does not impose any enforceable duty or
     short-term aggregate exposure                           in or on olive at 0.01 ppm.                           contain any unfunded mandate as
     assessment for adults includes dietary                  VI. Statutory and Executive Order                     described under Title II of the Unfunded
     (food and drinking water) and                           Reviews                                               Mandates Reform Act (UMRA) (2 U.S.C.
     inhalation handler exposures and                           This action establishes tolerances                 1501 et seq.).
     results in an aggregate MOE of 1,600.                   under FFDCA section 408(d) in                            This action does not involve any
     The short-term aggregate exposure                       response to a petition submitted to the               technical standards that would require
     assessment for children 1–2 years old                   Agency. The Office of Management and                  Agency consideration of voluntary
     includes dietary (food and drinking                     Budget (OMB) has exempted these types                 consensus standards pursuant to section
     water) and post-application hand-to-                    of actions from review under Executive                12(d) of the National Technology
     mouth exposure from treated turf and                    Order 12866, entitled ‘‘Regulatory                    Transfer and Advancement Act
     results in an aggregate MOE of 810.                     Planning and Review’’ (58 FR 51735,                   (NTTAA) (15 U.S.C. 272 note).
     Because EPA’s level of concern for                      October 4, 1993). Because this action
     flazasulfuron is a MOE of 100 or below,                                                                       VII. Congressional Review Act
                                                             has been exempted from review under
     these MOEs are not of concern.                          Executive Order 12866, this action is                   Pursuant to the Congressional Review
        4. Aggregate cancer risk for U.S.                    not subject to Executive Order 13211,                 Act (5 U.S.C. 801 et seq.), EPA will
     population. A cancer aggregate risk                     entitled ‘‘Actions Concerning                         submit a report containing this rule and
     assessment was not conducted because                    Regulations That Significantly Affect                 other required information to the U.S.
     there was no evidence of                                Energy Supply, Distribution, or Use’’ (66             Senate, the U.S. House of
     carcinogenicity to humans based on lack                 FR 28355, May 22, 2001) or Executive                  Representatives, and the Comptroller
     of carcinogenic effects in the rat and                  Order 13045, entitled ‘‘Protection of                 General of the United States prior to
     mouse carcinogenicity studies.                          Children from Environmental Health                    publication of the rule in the Federal
        5. Determination of safety. Based on                 Risks and Safety Risks’’ (62 FR 19885,                Register. This action is not a ‘‘major
     these risk assessments, EPA concludes                   April 23, 1997). This action does not                 rule’’ as defined by 5 U.S.C. 804(2).
     that there is a reasonable certainty that               contain any information collections
     no harm will result to the general                                                                            List of Subjects in 40 CFR Part 180
                                                             subject to OMB approval under the
     population, or to infants and children                  Paperwork Reduction Act (PRA) (44                       Environmental protection,
     from aggregate exposure to flazasulfuron                U.S.C. 3501 et seq.), nor does it require             Administrative practice and procedure,
     residues.                                               any special considerations under                      Agricultural commodities, Pesticides
     IV. Other Considerations                                Executive Order 12898, entitled                       and pests, Reporting and recordkeeping
                                                             ‘‘Federal Actions to Address                          requirements.
     A. Analytical Enforcement Methodology                   Environmental Justice in Minority                       Dated: April 26, 2017.
       An adequate enforcement method is                     Populations and Low-Income                            Michael Goodis,
     available. The method uses high                         Populations’’ (59 FR 7629, February 16,               Director, Registration Division, Office of
     performance liquid chromatography/                      1994).                                                Pesticide Programs.
     tandem mass spectrometry with                              Since tolerances and exemptions that
     multiple reaction monitoring (HPLC/                     are established on the basis of a petition            ■Therefore, 40 CFR chapter I is
     MS–MS/MRM). The LOQ is 0.01 ppm.                        under FFDCA section 408(d), such as                   amended as follows:
                                                             the tolerance in this final rule, do not
     B. International Residue Limits                                                                               PART 180—[AMENDED]
                                                             require the issuance of a proposed rule,
       In making its tolerance decisions, EPA                the requirements of the Regulatory                    ■ 1. The authority citation for part 180
     seeks to harmonize U.S. tolerances with                 Flexibility Act (RFA) (5 U.S.C. 601 et                continues to read as follows:
     international standards whenever                        seq.), do not apply.
     possible, consistent with U.S. food                        This action directly regulates growers,                Authority: 21 U.S.C. 321(q), 346a and 371.
     safety standards and agricultural                       food processors, food handlers, and food              ■ 2. In § 180.655, add alphabetically the
     practices. EPA considers the                            retailers, not States or tribes, nor does             entry ‘‘Olive’’ to the table in paragraph
     international maximum residue limits                    this action alter the relationships or                (a) to read as follows:
     (MRLs) established by the Codex                         distribution of power and
     Alimentarius Commission (Codex), as                     responsibilities established by Congress              § 180.655 Flazasulfuron; tolerances for
     required by FFDCA section 408(b)(4).                    in the preemption provisions of FFDCA                 residues.
     The Codex Alimentarius is a joint                       section 408(n)(4). As such, the Agency                    (a) * * *


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                              Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations                                                 24067

                                                        Parts per         SUPPLEMENTARY INFORMATION:                              • Federal eRulemaking Portal: http://
                  Commodity                              million                                                                www.regulations.gov. Follow the online
                                                                          I. General Information
                                                                                                                                instructions for submitting comments.
                                                                          A. Does this action apply to me?                      Do not submit electronically any
         *             *              *             *            *                                                              information you consider to be CBI or
     Olive ......................................                0.01        You may be potentially affected by
                                                                                                                                other information whose disclosure is
                                                                          this action if you are an agricultural
                                                                                                                                restricted by statute.
         *              *              *            *            *        producer, food manufacturer, or
                                                                                                                                  • Mail: OPP Docket, Environmental
                                                                          pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
     *        *        *         *         *                              list of North American Industrial
     [FR Doc. 2017–10763 Filed 5–24–17; 8:45 am]                                                                                DC), (28221T), 1200 Pennsylvania Ave.
                                                                          Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
     BILLING CODE 6560–50–P                                               not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                                                          provides a guide to help readers                      arrangements for hand delivery or
                                                                          determine whether this document                       delivery of boxed information, please
     ENVIRONMENTAL PROTECTION                                             applies to them. Potentially affected
     AGENCY                                                                                                                     follow the instructions at http://
                                                                          entities may include:                                 www.epa.gov/dockets/contacts.html.
                                                                             • Crop production (NAICS code 111).                Additional instructions on commenting
     40 CFR Part 180
                                                                             • Animal production (NAICS code                    or visiting the docket, along with more
     [EPA–HQ–OPP–2016–0029 FRL–9961–99]                                   112).                                                 information about dockets generally, is
                                                                             • Food manufacturing (NAICS code                   available at http://www.epa.gov/
     Fenazaquin; Pesticide Tolerances                                     311).                                                 dockets.
     AGENCY:  Environmental Protection                                       • Pesticide manufacturing (NAICS
                                                                          code 32532).                                          II. Summary of Petitioned-For
     Agency (EPA).                                                                                                              Tolerances
     ACTION: Final rule.                                                  B. How can I get electronic access to
                                                                                                                                   In the Federal Registers of March 16,
                                                                          other related information?
     SUMMARY:   This regulation establishes                                                                                     2016 (81 FR 14030) (FRL–9942–86);
     tolerances for residues of fenazaquin in                                You may access a frequently updated                May 19, 2016 (81 FR 31581) (FRL–9946–
     or on hop, dried cones; nuts, tree, group                            electronic version of EPA’s tolerance                 02); and August 12, 2016 (81 FR 53379)
     14–12; pineapple; and tea, dried. Gowan                              regulations at 40 CFR part 180 through                (FRL–9949–53) EPA issued documents
     Company requested these tolerances                                   the Government Printing Office’s e-CFR                pursuant to FFDCA section 408(d)(3), 21
     under the Federal Food, Drug, and                                    site at http://www.ecfr.gov/cgi-bin/text-             U.S.C. 346a(d)(3), announcing the filing
     Cosmetic Act (FFDCA).                                                idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  of pesticide petitions (PP 6F8442, PP
     DATES: This regulation is effective May                              40tab_02.tpl.                                         5F8429, and PP 6E8466) by Gowan
     25, 2017. Objections and requests for                                C. How can I file an objection or hearing             Company, P.O. Box 5569, Yuma, AZ
     hearings must be received on or before                               request?                                              85366–5569. The petitions requested
     July 24, 2017, and must be filed in                                                                                        that 40 CFR 180.632 be amended by
                                                                            Under FFDCA section 408(g), 21                      establishing tolerances for residues of
     accordance with the instructions
                                                                          U.S.C. 346a, any person may file an                   the miticide/insecticide fenazaquin, 4-
     provided in 40 CFR part 178 (see also
                                                                          objection to any aspect of this regulation            [2-[4-(1,1-dimethylethyl)
     Unit I.C. of the SUPPLEMENTARY
                                                                          and may also request a hearing on those               phenyl]ethoxy]quinazoline, in or on
     INFORMATION).
                                                                          objections. You must file your objection              hops at 30 parts per million (ppm) (PP
     ADDRESSES: The docket for this action,                               or request a hearing on this regulation               6F8442); nuts, tree, group 14–12 at 0.02
     identified by docket identification (ID)                             in accordance with the instructions                   ppm (PP 5F8429); pineapple at 0.2 ppm
     number EPA–HQ–OPP–2016–0029, is                                      provided in 40 CFR part 178. To ensure                (PP 6E8466); and tea at 9 ppm (PP
     available at http://www.regulations.gov                              proper receipt by EPA, you must                       6E8466). The petitions also requested
     or at the Office of Pesticide Programs                               identify docket ID number EPA–HQ–                     that the existing tolerance for almond at
     Regulatory Public Docket (OPP Docket)                                OPP–2016–0029 in the subject line on                  0.2 ppm be removed upon
     in the Environmental Protection Agency                               the first page of your submission. All                establishment of the above tolerance for
     Docket Center (EPA/DC), West William                                 objections and requests for a hearing                 nut, tree group 14–12. Those documents
     Jefferson Clinton Bldg., Rm. 3334, 1301                              must be in writing, and must be                       referenced summaries of the petitions
     Constitution Ave. NW., Washington, DC                                received by the Hearing Clerk on or                   prepared by Gowan Company, the
     20460–0001. The Public Reading Room                                  before July 24, 2017. Addresses for mail              registrant, which are available in the
     is open from 8:30 a.m. to 4:30 p.m.,                                 and hand delivery of objections and                   docket, http://www.regulations.gov.
     Monday through Friday, excluding legal                               hearing requests are provided in 40 CFR               Comments were received on the Notices
     holidays. The telephone number for the                               178.25(b).                                            of Filing. EPA’s response to these
     Public Reading Room is (202) 566–1744,                                 In addition to filing an objection or               comments is discussed in Unit IV.C.
     and the telephone number for the OPP                                 hearing request with the Hearing Clerk
     Docket is (703) 305–5805. Please review                              as described in 40 CFR part 178, please               III. Aggregate Risk Assessment and
     the visitor instructions and additional                              submit a copy of the filing (excluding                Determination of Safety
     information about the docket available                               any Confidential Business Information                    Section 408(b)(2)(A)(i) of FFDCA
     at http://www.epa.gov/dockets.                                       (CBI)) for inclusion in the public docket.            allows EPA to establish a tolerance (the
     FOR FURTHER INFORMATION CONTACT:                                     Information not marked confidential                   legal limit for a pesticide chemical
     Michael Goodis, Registration Division                                pursuant to 40 CFR part 2 may be                      residue in or on a food) only if EPA
     (7505P), Office of Pesticide Programs,                               disclosed publicly by EPA without prior               determines that the tolerance is ‘‘safe.’’
     Environmental Protection Agency, 1200                                notice. Submit the non-CBI copy of your               Section 408(b)(2)(A)(ii) of FFDCA
     Pennsylvania Ave. NW., Washington,                                   objection or hearing request, identified              defines ‘‘safe’’ to mean that ‘‘there is a
     DC 20460–0001; main telephone                                        by docket ID number EPA–HQ–OPP–                       reasonable certainty that no harm will
     number: (703) 305–7090; email address:                               2016–0029, by one of the following                    result from aggregate exposure to the
     RDFRNotices@epa.gov.                                                 methods:                                              pesticide chemical residue, including


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Document Created: 2018-11-08 08:52:41
Document Modified: 2018-11-08 08:52:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation82 FR 24062 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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