[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3610-3615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01480]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0498; FRL-9971-94]
Flonicamid; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of
[[Page 3611]]
flonicamid in or on prickly pear, fruit and prickly pear, pads.
This action is in response to EPA's granting of an emergency
exemption under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) authorizing use of the pesticide on prickly pear, fruit and
prickly pear, pads. This regulation establishes a maximum permissible
level for residues of flonicamid in or on these commodities. The time-
limited tolerances expire on December 31, 2020.
DATES: This regulation is effective January 26, 2018. Objections and
requests for hearings must be received on or before March 27, 2018, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0498, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this
document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select
``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
You must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID EPA-HQ-OPP-2017-0498
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 March 27, 2018. Addresses
for mail and hand delivery of objections and hearing requests are
provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0498, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is
establishing time-limited tolerances for residues of insecticide
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide)
and its metabolites, TFNA (4-trifluoromethylnicotinic acid), TFNA-AM
(4-trifluoromethylnicotinamide), and TFNG (N-(4-
trifluoromethylnicotinoyl)glycine), calculated as the stoichiometric
equivalent of flonicamid, in or on prickly pear, fruit at 1.5 parts per
million (ppm) and prickly pear, pads at 1.5 ppm. These time-limited
tolerances expire on December 31, 2020.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
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
[[Page 3612]]
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Flonicamid on Prickly Pear, Fruit and
Prickly Pear, Pads and FFDCA Tolerances
The California Department of Pesticide Regulation (DPR) requested a
specific emergency exemption for the use of flonicamid on prickly pear
cactus fruit (Opuntia spp.) and nopalitos (pads) to control cochineal
(Dactylopius opuntiae) in Monterey County, California. Cochineal
insects are sap-sucking, aggressive scale insects that are considered
to be a major pest for prickly pear cactus. These insects damage the
cactus plant by inserting their mouth parts into the cactus and feeding
on the plant's sap. The feeding site of the cactus begins to swell and
discolor. Eventually, the outer pads of the plant will fall off and the
entire cactus plant dies. Cochineal colonies were first observed in the
Salinas Valley cactus plantations in 2003. Birds heavily feed on cactus
fruit, and while feeding on cochineal infected plants, the birds can
pick up the nymphs on their feet and aid in spreading of the
population. In 2013 and 2015 reduced amounts of precipitation in
Salinas, California caused the cochineal population to flourish and
build to uncontrollable levels. Even though 2016 and 2017 received
normal levels of rain, cochineal infestations have not been inhibited
due to the amount of cochineal present and the ineffective control from
registered alternatives. As a result, growers are experiencing
significant damage to their prickly pear cactus crops.
After having reviewed the submission, EPA determined that an
emergency condition exists for this State, and that the criteria for
approval of an emergency exemption are met. EPA has authorized a
specific exemption under FIFRA section 18 for the use of flonicamid on
prickly pear, fruit and prickly pear, pads for control of cochineal in
California.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of flonicamid in
or on prickly pear, fruit and prickly pear, pads. In doing so, EPA
considered the safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerances under FFDCA section 408(l)(6)
would be consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent, non-routine situation and to ensure that
the resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment as provided in FFDCA
section 408(l)(6). Although these time-limited tolerances expire on
December 31, 2020, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on prickly pear, fruit and prickly pear, pads after
that date will not be unlawful, provided the pesticide was applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by these time-limited tolerances at the time
of that application. EPA will take action to revoke these time-limited
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
flonicamid meets FIFRA's registration requirements for use on prickly
pear, fruit and prickly pear, pads or whether permanent tolerances for
this use would be appropriate. Under these circumstances, EPA does not
believe that this time-limited tolerance decision serves as a basis for
registration of flonicamid by a State for special local needs under
FIFRA section 24(c), nor does this tolerance by itself serve as the
authority for persons in any State other than California to use this
pesticide on the applicable crops under FIFRA section 18, absent the
issuance of an emergency exemption applicable within that State. For
additional information regarding the emergency exemption for
flonicamid, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with the factors specified in FFDCA section
408(b)(2)(D), EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of, and to make a determination on, aggregate
exposure expected as a result of this emergency exemption request and
the time-limited tolerances for residues of flonicamid on prickly pear,
fruit at 1.5 ppm and prickly pear, pads at 1.5 ppm. EPA's assessment of
exposures and risks associated with establishing time-limited
tolerances follows.
A. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
A summary of the toxicological endpoints for flonicamid used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of November 14, 2012 (77 FR 67771)
(FRL-9368-7).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flonicamid, EPA considered exposure expected under the
time-limited tolerances established by this action as well as all
existing flonicamid tolerances in 40 CFR 180.613. EPA assessed dietary
exposures from flonicamid in food as follows:
i. Acute exposure. No acute effects were observed at doses well
above those
[[Page 3613]]
likely to be encountered; therefore, an endpoint was not selected, and
a quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA Survey. For the proposed section 18 use of flonicamid on prickly
pear, fruit and pads, a dietary exposure assessment was not performed
because there was no consumption reported for either commodity in
NHANES/WWEIA. Due to the limited production and availability of prickly
pear commodities, any increase in flonicamid dietary exposure from
consumption of prickly pear commodities is expected to be insignificant
compared to the flonicamid exposures pursuant to existing tolerances
for flonicamid on various fruits and vegetables (40 CFR 180.613) which
are produced in significantly greater quantities that prickly pear.
These existing flonicamid tolerances are based on conservative
(protective) exposure assumptions including use of tolerance level
residues for all crops and 100% of the crops were treated. Therefore,
any additional chronic risks from exposures of residues of flonicamid
on prickly pear would likely be accounted for through the conservative
assumptions underlying the existing tolerances.
iii. Cancer. As discussed in Unit III.B. of the final rule
published in the Federal Register of November 14, 2012 (77 FR 67771),
EPA has concluded that a nonlinear RfD approach is appropriate for
assessing cancer risk to flonicamid. For the same reasons discussed in
Unit IV.B.ii., regarding chronic exposure, EPA believes that any
additional cancer risks from exposures of residues of flonicamid on
prickly pear would likely be accounted for through the conservative
assumptions underlying the existing tolerances.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for flonicamid. Tolerance level residues and 100% CT
were assumed for all food commodities included in the exposure
assessment.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flonicamid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flonicamid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Pesticide Root Zone Model Ground Water (PRZM GW), the
estimated drinking water concentrations (EDWCs) of flonicamid for
chronic exposures for non-cancer assessments are estimated to be 0.94
parts per billion (ppb) for surface water and 9.92 ppb for ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 9.92 ppb was used as the
flonicamid contribution from 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).
Flonicamid is not registered for any specific use patterns that would
result in residential exposure. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and'' other substances
that have a common mechanism of toxicity.''
EPA has not found flonicamid to share a common mechanism of
toxicity with any other substances, and flonicamid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flonicamid does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
C. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional SF when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for flonicamid includes prenatal developmental
toxicity studies in rats and rabbits and, a multi-generation
reproduction toxicity study in rats. There is no evidence that
flonicamid results in increased susceptibility (qualitative or
quantitative) in utero in rats or rabbits in the prenatal developmental
studies or in young rats in the multi-generation reproduction study. No
developmental effects were seen in rabbits. In the multi-generation
reproduction study, developmental delays in the offspring (decreased
body weights, delayed sexual maturation) were seen only in the presence
of prenatal toxicity (kidney and blood effects). Also, there are clear
NOAELs and LOAELs for all effects. The degree of concern for prenatal
and/or postnatal susceptibility is, therefore low due to the lack of
evidence of qualitative and quantitative susceptibility.
3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X, except where assessing risk from inhalation
exposure as discussed below. Those decisions are based on the following
findings:
i. The toxicity database for flonicamid is essentially complete,
except for an outstanding subchronic 28-day inhalation study. In the
absence of a subchronic inhalation study, EPA has retained a 10X FQPA
SF to assess risk from inhalation exposure, although at present,
residential inhalation exposure is not expected from existing or
pending uses of flonicamid.
ii. There is no indication that flonicamid is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iii. There is no evidence that flonicamid results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
[[Page 3614]]
iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary food exposure assessment was based on
100 PCT, tolerance-level residues and where applicable, default
processing factors. EPA made conservative (protective) assumptions in
the ground and surface water modeling used to assess exposure to
flonicamid in drinking water. These assessments will not underestimate
the exposure and risks posed by flonicamid.
D. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effects were observed to result from single
oral exposures at doses well above those likely to be encountered, and
therefore, flonicamid is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flonicamid from food and water will utilize 59% of the cPAD for
(children 1-2 years old), the population group receiving the greatest
exposure. There are no residential uses for flonicamid.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Flonicamid is
not registered for any use patterns that would result in short term
residential exposures.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term non-dietary, non-occupational
exposure plus chronic exposure to food and water (considered to be a
background exposure level). Flonicamid is not registered for any use
patterns that would result in intermediate-term residential exposures.
5. Aggregate cancer risk for U.S. population. Based on the
information referenced in Unit IV.A, EPA has concluded that the cPAD is
protective of possible cancer effects from flonicamid because, as noted
in Unit IV.D.2, aggregate chronic exposure to flonicamid is below the
cPAD.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to flonicamid residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology (FMC Method No. P-3561M, a
liquid chromatography with tandem mass spectrometry (LC/MS/MS) method
is available to enforce the tolerance expression for flonicamid and its
metabolites in or on plant commodities. 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 a MRL for flonicamid.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide)
and its metabolites, TFNA (4-trifluoromethylnicotinic acid), TFNA-AM
(4-trifluoromethylnicotinamide), and TFNG (N-(4-
trifluoromethylnicotinoyl)glycine), calculated as the stoichiometric
equivalent of flonicamid, in or on prickly pear, fruit at 1.5 ppm and
prickly pear, pads at 1.5 ppm. These tolerances expire on December 31,
2020.
VII. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This
action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
Since tolerances and exemptions that are established in accordance
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply
[[Page 3615]]
to this action. In addition, this action does not impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 28, 2017.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.613, revise paragraph (b) to read as follows:
Sec. [emsp14]180.613 Flonicamid; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide)
and its metabolites, TFNA (4-trifluoromethylnicotinic acid), TFNA-AM
(4-trifluoromethylnicotinamide), and TFNG (N-(4-
trifluoromethylnicotinoyl)glycine), calculated as the stoichiometric
equivalent of flonicamid, in or on the specified agricultural
commodities, resulting from use of the pesticide pursuant to FFIFRA
section 18 emergency exemptions. The tolerances expire on the date
specified in the table.
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Prickly pear, fruit........................... 1.5 12/31/2020
Prickly pear, pads............................ 1.5 12/31/2020
------------------------------------------------------------------------
* * * * *
[FR Doc. 2018-01480 Filed 1-25-18; 8:45 am]
BILLING CODE 6560-50-P