[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Rules and Regulations]
[Pages 24071-24076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10765]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0143; FRL-9960-76]
Isopyrazam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
isopyrazam in or on pepper, bell; tomato; and vegetable, cucurbit,
subgroup 9A. Syngenta Crop Protection, LLC, 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-2016-0143, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, P.E., 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 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-2016-0143 in the subject line on the first
page of your submission. All
[[Page 24072]]
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-2016-0143, 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 August 29, 2016 (81 FR 59165) (FRL-9950-
22), 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
5E8433) by Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box
18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.654
be amended by establishing tolerances for residues of the fungicide
isopyrazam, in or on cucurbit crop subgroup 9A at 0.3 parts per million
(ppm); pepper, bell at 0.6 ppm; and tomato at 0.5 ppm. That document
referenced a summary of the petition prepared by Syngenta Crop
Protection, LLC, the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
Based upon review of the data supporting the petition, EPA is
establishing a lower tolerance than was requested for pepper, bell and
is revising the commodity terminology for vegetable, cucurbit, subgroup
9A. The reasons for these changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure 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 isopyrazam including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with isopyrazam 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.
Subchronic and chronic oral toxicity studies in the rat, mouse,
rabbit and dog demonstrate that the primary target organ for isopyrazam
is the liver (increased organ weight and centrilobular hepatocyte
hypertrophy). Liver toxicity is usually accompanied by reductions in
bodyweight and food consumption. Isopyrazam did not cause reproductive
toxicity. Effects seen in the offspring (decreased bodyweight during
lactation and increase liver weight at weaning) in the rat reproduction
study occurred at the same doses that cause general toxicity in the
parents. Developmental effects described as small eyes and/or
microphthalmia were observed in both the Himalayan and New Zealand
rabbit strains. However, in the Himalayan strain, the intraocular
abnormalities occur in the absence of maternal toxicity while in the
New Zealand strain, the ocular abnormalities occurred at doses that
were maternally toxic. Developmental effects observed in the rat
(increased post-implantation loss, reduced fetal weight, and a non- or
incomplete ossification or retardation of ossification) occurred at
doses that also produced maternal toxicity (mortality, decreased body
weights, body weight gains, and food consumption, increased liver
weights and microscopic findings in the liver).
No evidence of specific neurotoxicity was seen in acute and
subchronic oral neurotoxicity studies in rats. Clinical signs seen in
two subchronic dog studies (side-to-side head wobble, ataxia, reduced
stability) are consistent with neurotoxic effects. However, detailed
and specific neuropathological analyses were not conducted for the dog
studies (i.e., functional observational battery, motor activity,
detailed histopathology with special stains). Consequently, there is
uncertainty regarding whether the effects seen in the dog studies are
in fact signs of neurotoxicity. However, clear no observed adverse
effect levels (NOAELs)/lowest adverse effect levels (LOAELs) were
established for both subchronic dog studies. The point of departure
selected for the acute dietary assessment is based on clinical signs
seen on day 2 in one of four males in the subchronic dog study. This
study provides the lowest NOAEL in the database (most sensitive
endpoint) for a single dose effect. The dose used for the chronic
dietary risk assessment is eight times lower than the dose at which
clinical effects were seen at four weeks in the second subchronic dog
study.
There is no evidence of immunotoxicity based on a 28-day dietary
immunotoxicity study in mice. The LOAEL for immunotoxicity was not
identified and the NOAEL for immunotoxicity was 1,356 milligrams/
kilograms (mg/kg).
Isopyrazam is classified as ``Likely to be Carcinogenic to Humans''
based on increased incidence of uterine endometrial adenocarcinomas and
liver hepatocellular adenomas in female rats and increased incidence of
thyroid follicular cell adenomas and/or
[[Page 24073]]
carcinomas in male rats. Isopyrazam is not carcinogenic in the mouse.
There is no evidence of genotoxicity, mutagenicity, or clastogenicity
in the in vivo and in vitro studies. There are no structural
relationships with other known carcinogens. A linear low-dose approach
(Q1*) was used to extrapolate experimental animal tumor data
for the quantification of human cancer risk.
Isopyrazam is of low acute toxicity by the oral, dermal, and
inhalation routes and is not a skin or eye irritant.
Specific information on the studies received and the nature of the
adverse effects caused by isopyrazam as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Isopyrazam: Human Health Risk
Assessment for the Establishment of Tolerances with No U.S.
Registrations in/on Cucurbit Vegetables Crop Subgroup 9A, Bell Pepper
and Tomato Imported from Belgium, Greece, Italy, Spain and the United
Kingdom'' in docket ID number EPA-HQ-OPP-2016-0143.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for
isopyrazam used for human risk assessment is discussed in Table 1 of
the final rule published in the Federal Register of December 27, 2013
(78 FR 78740) (FRL-9903-53).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to isopyrazam, EPA considered exposure under the petitioned-
for tolerances as well as all existing isopyrazam tolerances in 40 CFR
180.654. EPA assessed dietary exposures from isopyrazam 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 isopyrazam. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in
food, maximum residues from field trials conducted at the maximum use
rates were used to estimate isopyrazam residues of concern and 100
percent crop treated (PCT) assumptions were used. Dietary Exposure
Evaluation Model (DEEM) default processing factors were used for all
processed commodities including dried apple (8.0), apple juice/cider
(1.3), dried banana/plantain (3.9), peanut butter (1.89), dried tomato
(14.3), tomato juice (1.5), tomato paste (5.4), and tomato puree (3.3).
In the absence of peanut processing data, the maximum theoretical
concentration factor was used for peanut oil (2.8).
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA used the average
residues from field trials conducted at the maximum use rates were used
to estimate isopyrazam and the same processing factors and PCT
assumptions as in the acute dietary exposure analysis.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that isopyrazam should be classified as ``Likely to be
Carcinogenic to Humans'' and a linear approach has been used to
quantify cancer risk. In evaluating the cancer risk, EPA used the same
residue levels, processing factors and PCT assumptions as in the
chronic dietary exposure analysis.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use PCT information in the dietary assessment for
isopyrazam. Maximum or average residue levels from field trials
conducted at the maximum use rates were assumed for all food
commodities.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
2. Dietary exposure from drinking water. An assessment of residues
in drinking water is not needed for isopyrazam because there is no
drinking water exposure for isopyrazam uses, which are all non-
domestic.
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). Isopyrazam is not
registered for any specific use patterns that would result in
residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found
isopyrazam to share a common mechanism of toxicity with any other
substances, and isopyrazam does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that isopyrazam does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's procedures for cumulating effects from
substances found to have a common mechanism of toxicity, see EPA's Web
site at http://www2.epa.gov/
[[Page 24074]]
pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-
risk-pesticides.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There are no residual
uncertainties for pre- and/or postnatal susceptibility even though
qualitative susceptibility was observed in the range-finding
developmental studies in rabbits. Developmental effects (eye
abnormalities) were observed in the absence of maternal toxicity in two
range finding developmental toxicity studies in the Himalayan rabbit.
However, the eye effects were only observed at relatively high doses
(200-400 mg/kg/day) with clear NOAELs/LOAELs established for the
developmental effects. Developmental effects observed in the rat
(increased post-implantation loss, reduced fetal weight and non-or
incomplete ossification or retardation of ossification) occurred only
at doses that also produced maternal toxicity (mortality, decreased
body weights, body weight gains, and food consumption). There was no
evidence of increased susceptibility in a 2-generation reproduction
study following pre- or postnatal exposure to isopyrazam. There was
also no evidence of neuropathology or abnormalities in the development
of the fetal nervous system from the available toxicity studies
conducted with isopyrazam. Clear NOAELs/LOAELs were established for the
developmental effects observed in rats and rabbits as well as for the
offspring effects (increased liver weights) seen in the 2-generation
reproduction study and a dose-response relationship for the effects of
concern is well characterized. The dose used for the acute dietary risk
assessment (30 mg/kg/day), based on effects seen in the subchronic dog
study, is protective of the developmental effects seen in rats (44.5
mg/kg/day) and rabbits (200 mg/kg/day). Based on these considerations,
there are no residual uncertainties for pre- and/or postnatal
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 isopyrazam is complete.
ii. As discussed in Unit III.A, there is no indication that
isopyrazam is a neurotoxic chemical and there is no need for a
developmental neurotoxicity study or additional uncertainty factors to
account for neurotoxicity.
iii. As discussed in Unit III.D.2, there are no residual
uncertainties for pre-and/or post-natal susceptibility.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and maximum or average residue levels from field trials
conducted at the maximum use rates. There are no currently registered
or proposed occupational or residential uses of isopyrazam in the U.S.
and adequate residue data are available. These assessments will not
underestimate the exposure and risks posed by isopyrazam.
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 to
isopyrazam at the 95th percentile will occupy 4.7% of the aPAD for
children 1-2 years 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
isopyrazam from food will utilize 5.0% of the cPAD for children 1-2
years old, the population group receiving the greatest exposure. There
are no residential uses for isopyrazam.
3. Short- and intermediate-term risk. Short- and intermediate-term
risk is assessed based on short- and intermediate-term residential
exposure plus chronic dietary exposure (which includes both food and
water and is considered to be a background exposure level). Isopyrazam
is not registered in the United States. Because there is no short- or
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD, no
further assessment of short- or intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
short- and intermediate-term risk for isopyrazam.
4. Aggregate cancer risk for U.S. population. Using the exposure
assumptions discussed in this unit for cancer exposure, the cancer
dietary risk estimate for the U.S. population is 3 x 10-6.
EPA generally considers cancer risks (expressed as the probability of
an increased cancer case) in the range of 1 in 1 million (or 1 x
10-6) or less to be negligible. The precision that can be
assumed for cancer risk estimates is best described by rounding to the
nearest integral order of magnitude on the logarithmic scale; for
example, risks falling between 3 x 10-7 and 3 x
10-6 are expressed as risks in the range of 10-6.
Considering the precision with which cancer hazard can be estimated,
the conservativeness of low-dose linear extrapolation, and the rounding
procedure described above, cancer risk should generally not be assumed
to exceed the benchmark level of concern of the range of
10-6 until the calculated risk exceeds approximately 3 x
10-6. This is particularly the case where some conservatism
is maintained in the exposure assessment. For isopyrazam, EPA's
exposure assessment assumes average residues of concern from field
trials reflecting the maximum use rates, default processing factors,
the maximum theoretical concentration for residues in peanut oil, and
100 PCT, which is highly conservative. Accordingly, EPA has concluded
the cancer risk from exposure to isopyrazam falls within the range of
10-6 and is thus negligible.
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 isopyrazam residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (GRM006.01B) is available to
enforce
[[Page 24075]]
the tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email
address: [email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established MRLs for isopyrazam in or on
vegetable, cucurbit, subgroup 9A; pepper, bell; and tomato.
C. Revisions to Petitioned-For Tolerances
Based on the residue levels observed in the field trial studies,
EPA is establishing a tolerance of 0.50 ppm in or on pepper, bell in
lieu of the 0.6 ppm as requested by the petitioner. The tolerance
requested for Cucurbit Crop Group 9A is also being established as
Vegetable, cucurbit, subgroup 9A, which is the standard commodity
description for these commodities. The petitioned-for tolerances for
residues of isopyrazam in/on cucurbit crop group 9A (0.3 ppm) and
tomato (0.5 ppm) are set at 0.30 ppm and 0.50 ppm, respectively,
consistent with the current practices for setting tolerances.
V. Conclusion
Therefore, tolerances are established for residues of isopyrazam,
(3-(difluoromethyl)-1-methyl-N-[1,2,3,4-tetrahydro-9-(1-methylethyl)-
1,4-methano-naphthalen-5-yl]-1H-pyrazole-4-carboxamide), determined as
the sum of its syn-isomer (3-(difluoromethyl)-1-methyl-N-[(1RS, 4SR,
9RS)-1,2,3,4-tetrahydro-9-(1-methylethyl)-1,4-methanonaphthalen-5-yl]-
1H-pyrazole-4-carboxamide) and anti-isomer (3-(difluoromethyl)-1-
methyl-N-[(1RS, 4SR, 9SR)-1,2,3,4-tetrahydro-9-(1-methylethyl)-1,4-
methano-naphthalen-5-yl]-1H-pyrazole-4-carboxamide), in or on
vegetable, cucurbit, subgroup 9A at 0.30 ppm; pepper, bell at 0.50 ppm;
and tomato at 0.50 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 25, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.654, add alphabetically the entries ``Pepper, bell'',
``Tomato'', and ``Vegetable, cucurbit, subgroup 9A'' to the table in
paragraph (a), and revise footnote 1 at the end of the table to read as
follows:
Sec. 180.654 Isopyrazam; tolerances for residues.
(a) * * *
[[Page 24076]]
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Pepper, bell \1\........................................... 0.50
Tomato \1\................................................. 0.50
Vegetable, cucurbit, subgroup 9A \1\....................... 0.30
------------------------------------------------------------------------
\1\ There are no U.S. registrations for use of isopyrazam on these
commodities.
* * * * *
[FR Doc. 2017-10765 Filed 5-24-17; 8:45 am]
BILLING CODE 6560-50-P