
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Rules and Regulations]
[Pages 66805-66809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27593]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0600; FRL-9933-25]


Teflubenzuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
teflubenzuron [N-[[(3,5-dichloro-2,4-difluorophenyl)amino]carbonyl]-
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 
Act (FFDCA).

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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
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 
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 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,

[[Page 66806]]

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 
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 teflubenzuron including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with teflubenzuron 
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. 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 
teflubenzuron.
    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-
2014-0600.

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.

[[Page 66807]]



 Table 1--Summary of Toxicological Doses and Endpoints for Teflubenzuron for Use in Human Health Risk Assessment
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                                    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://
www.epa.gov/pesticides/cumulative.

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 
findings:

[[Page 66808]]

    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-
term risk.
    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 
was requested.
    In addition, EPA is adding significant figures to tolerance levels 
in accordance with EPA policy for the following commodities: Broccoli; 
coffee, bean,

[[Page 66809]]

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.''

V. Conclusion

    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 
recordkeeping requirements.

    Dated: October 20, 2015.
Jack E. Housenger,
Director, 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. 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 
teflubenzuron (N-[[(3,5-dichloro-2,4-difluorophenyl)amino]carbonyl]-
2,6-difluorobenzamide).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
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]
 BILLING CODE 6560-50-P


