[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27593]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Teflubenzuron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
2,6-difluorobenzamide] in or on multiple commodities which are
identified and discussed later in this document. BASF Corporation
requested these tolerances under the Federal Food, Drug, and Cosmetic
DATES: This regulation is effective October 30, 2015. Objections and
requests for hearings must be received on or before December 29, 2015,
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-2014-0600, 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: Susan Lewis, 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].
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
Publishing 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-2014-0600 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
December 29, 2015. 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-2014-0600, 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
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 January 28, 2015 (80 FR 4525) (FRL-9921-
55), 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
4E8230) by BASF Corporation, 26 Davis Dr., Research Triangle Park, NC
27709. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the insecticide teflubenzuron,
in or on apple at 0.5 parts per million (ppm); apple, wet pomace at 0.8
ppm; broccoli at 0.2 ppm; cattle, meat byproducts at 0.01 ppm; cattle,
muscle at 0.01 ppm; cauliflower at 0.01 ppm; citrus, oil at 90 ppm;
coffee, bean, green at 0.6 ppm; corn,
field, grain at 0.01 ppm; corn, field, refined oil at 0.02 ppm; egg at
0.01 ppm; goat, meat byproducts at 0.01 ppm; goat, muscle at 0.01 ppm;
horse, meat byproducts at 0.01 ppm; horse, muscle at 0.01 ppm; lemon at
0.9 ppm; mango at 1.5 ppm; melon, at 0.3 ppm; milk at 0.01 ppm; orange
at 0.6 ppm; papaya at 0.4 ppm; pineapple at 0.8 ppm; pork, muscle at
0.01 ppm; pork, meat byproducts at 0.01 ppm; poultry, meat byproducts
at 0.01 ppm; poultry, muscle at 0.01 ppm; sheep, meat byproducts at
0.01 ppm; sheep, muscle at 0.01 ppm; soybean, hulls at 0.4 ppm;
soybean, seed at 0.05 ppm; sugarcane, cane at 0.01 ppm; sunflower, seed
at 0.3 ppm; tomato at 1.5 ppm; and tomato, paste at 5 ppm. That
document referenced a summary of the petition prepared by BASF
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. No tolerance-related comments were submitted.
Based upon review of the data supporting the petition, EPA has edited
tolerance levels for some food commodities, and declined to grant
tolerances for others. The reasons for these changes are explained in
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 teflubenzuron including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with teflubenzuron
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. Exposure of animals to teflubenzuron has shown no evidence of
neurotoxicity, immunotoxicity, or genotoxicity. It is categorized as
having low acute lethality by oral, dermal and inhalation routes of
exposure. It is not a dermal sensitizer or eye irritant. In all species
tested, hepatotoxicity was indicated. The liver is the primary target
organ for teflubenzuron. In the mouse, which is the most sensitive
species compared to the rat and the dog, liver adenomas were observed
following chronic exposure. Increased enzyme release and numerous
microscopic indicators of liver injury (diffuse hypertrophy,
disseminated single-cell necrosis, patchy glycogen storage, Kupffer
cell proliferation, phagocytic foci, lipofuscin accumulation and
centrilobular fatty change) were observed in all species exposed to
The 2-generation reproductive study shows evidence of increased
quantitative offspring susceptibility. There were no effects of
teflubenzuron exposure on the parental generation, but effects on
offspring consisted of decreased F2 litter weights and
increased incidence of unilateral dilatation of the renal pelvis in
F1 offspring. There is no evidence of increased fetal
susceptibility in either the rat or rabbit developmental studies.
Because rare liver tumors were observed only in male mice and there
was no evidence of carcinogenicity from teflubenzuron in female mice or
in male or female rats, the Agency is using a non-linear approach (i.e.
reference dose (RfD)) to account for the observed carcinogenicity that
could result from exposure to teflubenzuron. Moreover, there is no
concern for mutagenicity.
Specific information on the studies received and the nature of the
adverse effects caused by teflubenzuron 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, ``Teflubenzuron: Human Health Risk
Assessment'' at pp. 4, 13, 21, and 22 in docket ID number EPA-HQ-OPP-
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 the NOAEL and the LOAEL are identified.
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 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://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for teflubenzuron used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Teflubenzuron for Use in Human Health Risk Assessment
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
Acute dietary (General population An endpoint of concern attributable to a single dose was not identified. An
including infants and children). acute RfD was not established.
Chronic dietary (All populations) NOAEL = 2.1 mg/kg/ Chronic RfD = 0.021 Carcinogenicity (mouse) LOAEL =
day. mg/kg/day. 10.5 mg/kg/day based on increased
UFA = 10x........... cPAD = 0.021 mg/kg/ microscopic lesions in the liver
UFH = 10x........... day. (diffuse hypertrophy,
FQPA SF = 1x........ centrilobular single-cell
necrosis, patchy glycogen
storage, Kupffer cell
proliferation, phagocytic foci,
and centrilobular fatty change)
associated with increased
relative liver weight.
Cancer (Oral, dermal, inhalation) The Agency is using a non-linear approach (i.e., RfD) that will adequately
account for all chronic toxicity, including carcinogenicity that could
result from exposure to teflubenzuron.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c
= chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
(interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to teflubenzuron, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
teflubenzuron 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. No such effects were
identified in the toxicological studies for teflubenzuron; therefore, 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 2003-2008
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA assumed
teflubenzuron residues are present in all commodities at tolerance
levels and that 100% of all crops are treated.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a non-linear RfD approach is appropriate for assessing
cancer risk to teflubenzuron. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii. chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for teflubenzuron. Tolerance-level residues and/or
100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. Because there are no
domestic agricultural or residential uses registered or proposed for
teflubenzuron, there will be no exposure in drinking water; therefore,
a drinking water assessment is not necessary.
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).
Teflubenzuron 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 teflubenzuron to share a common mechanism of
toxicity with any other substances, and teflubenzuron does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
teflubenzuron 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 Web site at http://
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 Food Quality
Protection Act Safety Factor (FQPA 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 rat 2-generation
reproductive study showed evidence of increased quantitative offspring
susceptibility to teflubenzuron. While there were no parental effects,
adverse offspring effects were observed and consisted of decreased
F2 litter weights and increased incidence of unilateral
dilatation of the renal pelvis in F1 offspring. There were
no effects of teflubenzuron in the developmental rat study up to the
highest dose tested. In the developmental rabbit study, maternal
effects were observed at the limit dose and were consistent with liver
toxicity; no fetal effects were observed.
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
i. The toxicity database for teflubenzuron is complete for
assessing the safety of tolerances for which there is no associated
U.S. pesticide registration.
ii. There is no indication that teflubenzuron is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors (UFs) to account for neurotoxicity.
iii. As discussed in Unit III.D.2., there is evidence of
quantitative susceptibility in the rat in the 2-generation reproductive
study. There is no residual concern or uncertainty regarding these
effects as the study established a clear NOAEL and LOAEL. Moreover, the
Agency is using a lower POD in its assessment, which will be protective
of these effects.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. There are no drinking water or
residential exposures as there are no U.S. registrations of pesticides
containing teflubenzuron. These assessments will not underestimate the
exposure and risks posed by teflubenzuron.
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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
teflubenzuron 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
teflubenzuron from food and water will utilize 50% of the cPAD for
children 1-2 years old the population group receiving the greatest
exposure. There are no residential uses for teflubenzuron.
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). Teflubenzuron
is for use on imported commodities only, no residential exposure or
chronic exposure from water is expected. Because no short-term adverse
effect was identified, teflubenzuron is not expected to pose a short-
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because no intermediate-term adverse effect was identified,
teflubenzuron is not expected to pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the results
of the chronic assessment, EPA concludes that teflubenzuron will not
pose a cancer risk for the U.S. population.
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 teflubenzuron residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The petitioner submitted a high-performance liquid chromatography
method with tandem mass-spectrometry detection (LC/MS/MS) analytical
method, BASF Method L0160/01, for analysis of residues of teflubenzuron
in/on dry and oily crop commodities. The method has been adequately
validated by the petitioner as well as by an independent laboratory,
and was also adequately radio validated using weathered samples
obtained from metabolism studies. In addition, the Quechers multi
residue method (MRM) is considered suitable for the analysis of
teflubenzuron in fruits and vegetables.
Adequate enforcement methodology (high-performance liquid
chromatography with tandem mass spectrometry) is available to enforce
the tolerance expression.
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 established a MRL for teflubenzuron in or on pome
fruit at 1.0 ppm. The U.S. tolerance being established for residues of
teflubenzuron on apples is harmonized with this value.
C. Revisions to Petitioned-For Tolerances
The petition requested tolerances for several livestock commodities
(cattle, meat byproducts; cattle, muscle; egg; goat, meat byproducts;
goat, muscle; horse, meat byproducts; horse, muscle; milk; pork, meat
byproducts; pork, muscle; poultry, meat byproducts; poultry, muscle;
sheep, meat byproducts; and sheep, muscle.) Based on the results of
livestock feeding studies, EPA is not establishing tolerances for these
commodities because there is no expectation of finite residues in
livestock commodities. The tolerance proposal for apple, wet pomace is
not being established because the commodity is not likely to be
imported. The petitioned-for tolerance for tomato, paste is not being
established because concentration of residues is not expected above the
tolerance established for tomato (1.5 ppm); the tolerance for tomato
will be adequate to cover any residues in tomato paste.
In the case of apple, EPA is establishing a higher tolerance (from
0.5 ppm to 1.0 ppm) to harmonize with the established Codex MRL. Based
on EPA's methods for calculating residue levels on processed
commodities, EPA is establishing a higher tolerance for citrus, oil (90
ppm to 100 ppm) and a lower tolerance for soybean, hulls (0.4 ppm to
0.15 ppm) than what was requested. Using the Organization for Economic
Cooperation and Development (OECD) calculation procedures, EPA is
establishing a higher tolerance for papaya tolerance (0.4 ppm to 0.5
ppm) and a lower tolerance for the lemon (0.90 ppm to 0.80 ppm) than
In addition, EPA is adding significant figures to tolerance levels
in accordance with EPA policy for the following commodities: Broccoli;
green; melon, subgroup 9A; orange; pineapple; and sunflower, seed. EPA
is also revising the commodity term ``corn, field'' to ``corn, field,
grain'' to be consistent with the food and feed commodity vocabulary
used for tolerances. Finally, EPA is establishing a tolerance for
``melon, subgroup 9A'' instead of ``melon'' as requested because the
regulatory definition of ``melon'' includes all commodities listed
under ``melon, subgroup 9A.''
Therefore, tolerances are established for residues of
teflubenzuron, in or on apple at 1.0 ppm; broccoli at 0.20 ppm;
cauliflower at 0.01 ppm; citrus, oil at 100 ppm; coffee, bean, green at
0.60 ppm; corn, field, grain at 0.01 ppm; corn, field, refined oil at
0.02 ppm; lemon at 0.80 ppm; mango at 1.5 ppm; melon, subgroup 9A at
0.30 ppm; orange at 0.60 ppm; papaya at 0.50 ppm; pineapple at 0.80
ppm; soybean, seed at 0.05 ppm; soybean, hulls at 0.15 ppm; sugarcane,
cane at 0.01 ppm; sunflower, seed at 0.30 ppm; and tomato at 1.5 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
Dated: October 20, 2015.
Jack E. Housenger,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add Sec. 180.687 to subpart C to read as follows:
Sec. 180.687 Teflubenzuron; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
insecticide teflubenzuron, including its metabolites and degradates, in
or on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only
Apple \1\................................................... 1.0
Broccoli \1\................................................ 0.20
Cauliflower \1\............................................. 0.01
Citrus, oil \1\............................................. 100
Coffee, bean, green \1\..................................... 0.60
Corn, field, grain \1\...................................... 0.01
Corn, field, refined oil \1\................................ 0.02
Lemon \1\................................................... 0.80
Mango \1\................................................... 1.5
Melon, subgroup 9A \1\...................................... 0.30
Orange \1\.................................................. 0.60
Papaya \1\.................................................. 0.50
Pineapple \1\............................................... 0.80
Soybean, seed \1\........................................... 0.05
Soybean, hulls \1\.......................................... 0.15
Sugarcane, cane \1\......................................... 0.01
Sunflower, seed \1\......................................... 0.30
Tomato \1\.................................................. 1.5
\1\ There are no U.S. registrations as of October 30, 2015.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2015-27593 Filed 10-29-15; 8:45 am]
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