[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Pages 7466-7472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02816]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0672; FRL-9939-59]


Diflubenzuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
diflubenzuron in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective February 12, 2016. Objections and 
requests for hearings must be received on or before April 12, 2016, and 
must be filed in accordance with the

[[Page 7467]]

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-2014-0672, 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: <a href="/cdn-cgi/l/email-protection#24766062766a4b504d474157644154450a434b52"><span class="__cf_email__" data-cfemail="d3819795819dbca7bab0b6a093b6a3b2fdb4bca5">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0672 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 
April 12, 2016. 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-2014-0672, by one of 
the following methods:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
    <bullet> 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 February 11, 2015 (80 FR 7559) (FRL-
9921-94), 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 
4E8306) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.377 be 
amended by: (1) Establishing tolerances in for the combined residues of 
the insecticide diflubenzuron N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide) and its metabolites 4-chlorophenlyurea and 4-
chloroaniline, in or on the raw agricultural commodities carrot, roots 
at 0.2 ppm; peach subgroup 12-12B at 0.5 ppm; plum subgroup 12-12C at 
0.5 ppm; plum, prune, dried at 0.5 ppm; nut, tree group 14-12 at 0.2 
ppm; pepper/eggplant subgroup 8-10 B at 1.0 ppm, and cottonseed 
subgroup 20C at 0.2 ppm; (2) upon the approval of these tolerances, 
removing established tolerances in or on fruit, stone, group 12, except 
cherry at 0.07 ppm; nut, tree, group 14 at 0.06 ppm; pistachio at 0.06 
ppm; pepper at 1.0 ppm; and cotton, undelinted seed at 0.2 ppm; (3) 
establishing regional tolerances for the combined residues of 
diflubenzuron and its metabolites 4-chlorophenlyurea and 4-
chloroaniline in or on the raw agricultural commodities alfalfa, forage 
at 6 ppm; alfalfa, hay at 20 ppm; and alfalfa, seed at 0.9 ppm; and (4) 
modifying the existing tolerances in or on the following raw 
agricultural commodities: Egg from 0.05 to 0.15 ppm; poultry, fat from 
0.05 to 0.15 ppm; and poultry, meat byproducts from 0.05 to 0.06 ppm. 
That document referenced a summary of the petition prepared by Chemtura 
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. A second notice of filing for the same petition 
(PP 4E8306) and same uses was inadvertently published in the Federal 
Register on December 2, 2015 (80 FR 75449) (FRL-9939-55). This notice 
of filing contained the same information as the previously published 
notice of filing. Comments were received in response to both notices of 
filing. EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which some of the tolerances are being 
established. The reason for these changes are explained in Unit IV.D.

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

[[Page 7468]]

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 diflubenzuron including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with diflubenzuron 
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.
    For diflubenzuron, the hemopoietic system is the target site with 
effects including increased sulfhemoglobin and/or methemoglobin levels 
in rat and dog studies. In subchronic and chronic feeding studies, the 
primary endpoint of concern was methemoglobinemia and/or 
sulfhemoglobinemia. These effects were evident in both sexes of mice, 
rats, and dogs and were produced by more than one route of 
administration in rats (i.e., oral, dermal and inhalation). The general 
consequence of methemoglobinemia and/or sulfhemoglobinemia is the 
impairment of the oxygen transportation capacity of the blood, which is 
generally known to be caused by aromatic amines in both humans and 
animals. Degradates of diflubenzuron with aromatic amines, CPU (4-
chlorophenylurea) and PCA (4-chloroaniline), are also included in the 
diflubenzuron non-cancer risk assessment. Monuron, an analog of CPU, 
does not affect methemoglobin formation but does produce tumors in the 
liver and kidneys of male rats. The non-cancer toxicities of CPU and 
PCA are understood. PCA is similar in potency to diflubenzuron on 
methemoglobin formation, while CPU is less toxic than PCA. Therefore, 
the non-cancer assessment will include diflubenzuron, CPU and PCA, and 
additional toxicity studies are not required on CPU and PCA.
    The toxicity data provide no indication of an increased 
susceptibility to rats or to rabbits from in utero or postnatal 
exposure to diflubenzuron. Developmental and reproduction studies in 
rats and rabbits indicate a very low hazard potential for adverse 
effects. Developmental studies were tested at the limit dose of 1,000 
milligrams/kilogram/day (mg/kg/day) without apparent effects in both 
dams and the fetuses. The reproduction study indicated that effects in 
offspring occurred at doses that were higher than the doses producing 
effects in parents. The requirements for acute and subchronic 
neurotoxicity studies were waived because there are no clear signs of 
neurotoxicity following subchronic or chronic dosing in multiple 
species in the diflubenzuron database. The toxicity profile of 
diflubenzuron shows that the principal toxic effects are the formation 
of methemoglobinemia and/or sulfhemoglobinemia in the blood. An 
immunotoxicity study has been reviewed and immunotoxicity was not 
observed above the limit dose.
    The Agency concluded that diflubenzuron is not carcinogenic in 
humans based on lack of evidence of carcinogenicity in rats and mice. 
PCA, a plant metabolite of diflubenzuron, tested positive for splenic 
tumors in male rats and hepatocellular adenomas/carcinomas in male mice 
in a National Toxicology Program (NTP) study.
    Therefore, EPA has classified PCA as a probable human carcinogen. 
CPU is the major degradate found in water and is a significant 
metabolite in milk. CPU is structurally related to monuron 
(N,Ndimethyl-CPU), a compound producing tumors of the kidney and liver 
in male rats. EPA has assumed CPU is a probable human carcinogen as 
well. However, based on methemoglobinemia observed only at high doses 
of monuron, a compound similar to CPU and PCA, the non-carcinogenic 
risk assessment will include diflubenzuron, CPU, and PCA.
    Specific information on the studies received and the nature of the 
adverse effects caused by diflubenzuron 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 the document titled ``Diflubenzuron: Human 
Health Risk Assessment for an Amended Section 3 Registration for 
Carrot, Peach Subgroup 12-12B, Plum Subgroup 12-12C, Pepper/Eggplant 
Subgroup 8-10B, Cottonseed Subgroup 20C, Alfalfa (Regional 
Restrictions) and R175 Crop Group Conversion for Tree Nut Group 14-12'' 
on page 45 in docket ID number EPA-HQ-OPP-2014-0672.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for diflubenzuron used for 
human risk assessment is discussed in Table 1 in Unit III.B. of the 
final rule published in the Federal Register of January 31, 2014 (79 FR 
5294) (FRL-9904-27).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to diflubenzuron, EPA considered exposure under the 
petitioned-for tolerances as well as all existing diflubenzuron 
tolerances in 40 CFR 180.377. EPA assessed dietary exposures from 
diflubenzuron 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 diflubenzuron; therefore, a

[[Page 7469]]

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 United States 
Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, ``What We Eat in America'' (NHANES/WWEIA) from 2003 
through 2008. As to residue levels in food, EPA used the assumption 
that diflubenzuron residues are present in most commodities at 
tolerance levels (including tolerances previously established as well 
as those established in this action) and that 100% of all crops are 
treated. Average field trial residues were assumed for grapefruit, 
lemon, and orange. Tolerances include residues of diflubenzuron, PCA, 
and CPU.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that diflubenzuron does not pose a cancer risk to humans. 
However, the metabolites CPU and PCA are considered probable 
carcinogens and have Q*s assigned to them. Individual cancer dietary 
exposure analyses were conducted for each metabolite. For PCA, average 
percent crop treated (PCT) was used for some commodities. One-half the 
Limit of Quantitation (LOQ) was used for estimating PCA residues on the 
majority of crops because most crops did not contain detectable 
residues of PCA. Average field trial residue was used for mushrooms. 
The CPU cancer dietary analysis focused on CPU residues in milk because 
metabolism studies indicate that diflubenzuron metabolizes to CPU in 
milk. EPA assumed that 100% of milk commodities contained CPU at \1/2\ 
the LOQ. One-half the LOQ was used since detectable residues of CPU 
were not found in the feeding study.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
    <bullet> Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
    <bullet> Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    <bullet> Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    For the cancer dietary exposure analysis, the Agency estimated the 
PCT for existing uses as follows:
    Soybeans (1%), peppers (2.5%), oranges (10%), tangerines (10%), 
grapefruit (25%), pear (5%), apricot (10%), peach (5%), almond, (10%), 
pecan (2.5%), rice (2.5%), wheat (1%), cotton (1%), artichoke (45%), 
peanut (10%), lemon (1%), plum (5%), and walnut (2.5%).
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6 to 7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which diflubenzuron may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for diflubenzuron and CPU in drinking water. PCA is only a 
minor metabolite in the environment and residues are not expected to be 
present in drinking water. These simulation models take into account 
data on the physical, chemical, and fate/transport characteristics of 
diflubenzuron. Further information regarding EPA drinking water models 
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    Based on the Surface Water Concentration Calculator model (SWCC) 
for surface water the Estimated Drinking Water Concentration (EDWC) of 
1.3 microgram/Liter ([mu]g/L) (including diflubenzuron and CPU) was 
used to assess chronic non-cancer dietary risk. Based on the Pesticide 
Root Zone Model-Groundwater (PRZM-GW) model for ground water the cancer 
risk for CPU was assessed using the EDWC of 8.02 [mu]g/L.
    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).
    Diflubenzuron 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

[[Page 7470]]

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 diflubenzuron to share a common mechanism of 
toxicity with any other substances, and diflubenzuron does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
diflubenzuron 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 FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. Based on the available 
developmental toxicity studies in rats and rabbits and the reproduction 
study, there is no increased susceptibility to fetuses exposed in 
utero. There was no indication of abnormalities in fetal development in 
the developmental toxicity studies in either rats or rabbits at the 
maternal limit doses of 1,000 mg/kg/day. In addition, there was no 
evidence of sensitivity following pre- and/or post-natal exposure in a 
two-generation reproduction study in rats.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicological database for diflubenzuron is adequate for 
risk assessment. The non-cancer toxicity of CPU and PCA is well 
understood. CPU is less toxic and does not affect methemoglobin. PCA 
does cause methemoglobin formation but is similar in potency to 
diflubenzuron. Therefore, assuming equal toxicity of CPU and PCA to 
diflubenzuron is health protective, additional toxicity studies are not 
required on the metabolites.
    ii. There are no clear signs of neurotoxicity following subchronic 
or chronic dosing in multiple species in the diflubenzuron database; 
therefore, there is no need for any neurotoxicity studies.
    iii. There is no evidence that diflubenzuron 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.
    iv. The dietary exposure assessment uses conservative assumptions 
which will not underestimate dietary exposure and EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to diflubenzuron in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
diflubenzuron.

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, 
diflubenzuron 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 
diflubenzuron from food and water will utilize 39% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. There are no residential uses for diflubenzuron.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Short- and intermediate-term adverse effects were identified; 
however, diflubenzuron is not registered for any use patterns that 
would result in short- or intermediate-term residential exposure. 
Short- and intermediate-term risk is assessed based on short- and 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no short- or intermediate-term residential exposure 
and chronic dietary exposure has already been assessed under the 
appropriately protective cPAD (which is at least as protective as the 
POD used to assess short-term risk), no further assessment of short- or 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for diflubenzuron.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, diflubenzuron is not expected to pose a cancer risk to humans. 
However, the metabolites CPU and PCA are considered probable 
carcinogens and have Q*s assigned to them. Individual cancer dietary 
exposure analyses were conducted for each metabolite. The cancer 
assessment for PCA includes food only (it is not expected to be present 
in drinking water). The cancer assessment for CPU includes milk and 
water only. For PCA, the cancer dietary exposure estimate for the U.S. 
population is 1.3 x 10<SUP>-6</SUP>. For CPU, the cancer dietary 
exposure estimate for the U.S. population is 2.8 x 10<SUP>-6</SUP>.
    EPA generally considers cancer risks in the range of 
10<SUP>-6</SUP> or less to be negligible. The precision which can be 
assumed for cancer risk estimates is best described by rounding to the 
nearest integral order of magnitude on the log scale; for example, 
risks falling between 3 x 10<SUP>-7</SUP> and 3 x 10<SUP>-6</SUP> are 
expressed as risks in the range of 10<SUP>-6</SUP>.
    Considering the precision with which cancer hazard can be 
estimated, the conservativeness of low-dose linear extrapolation, and 
the rounding procedure described above, cancer risk should generally 
not be assumed to exceed the benchmark level of concern of the range of 
10<SUP>-6</SUP> until the calculated risk exceeds approximately 3 x 
10<SUP>-6</SUP>. This is particularly the case where some conservatism 
is maintained in the exposure assessment. Although the PCA and CPU 
exposure risk assessment are refined, they retain significant 
conservatism in that residues in food

[[Page 7471]]

were estimated at \1/2\ LOQ even though no residues were detected in 
field trials and feeding studies, and for some commodities EPA assumed 
100 PCT. Accordingly, EPA has concluded the cancer risk for all 
existing diflubenzuron uses, and the uses associated with the 
tolerances established in this action fall within the range of 1 x 
10<SUP>-6</SUP> and are thus negligible.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to diflubenzuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement analytical methods are available for the 
enforcement of tolerances for residues of diflubenzuron and its 
metabolites in crop and livestock commodities. Three enforcement 
methods for diflubenzuron are published in PAM, Vol. II as Methods I, 
II, and III. Method I is a GC/ECD method that determines diflubenzuron 
in plants as derivatized 4-chloroaniline (PCA). Method II is a GC/ECD 
method that can separately determine residues of diflubenzuron, 4-
chlorophenylurea (CPU) and PCA in eggs, milk, and livestock tissues, 
each as derivatized PCA. Method III is an HPLC/UV method that 
determines diflubenzuron per se in eggs, milk, and livestock tissues. 
All three methods have undergone successful Agency validations.

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 MRLs for diflubenzuron in or on peach and 
nectarine at 0.5 ppm which is the same as the tolerance in the United 
States for the peach subgroup 12-12B at 0.50 ppm; a tolerance on plums 
at 0.5 ppm which is the same as the U.S. tolerance for the plum 
subgroup 12-12C at 0.5 ppm; and a tolerance on tree nuts at 0.2 ppm 
which is the same as the U.S. tolerance for the tree nut group 14-12 at 
0.20 ppm, and which was raised to harmonize with Codex.
    The Codex has established MRLs for diflubenzuron on chili peppers 
at 3 ppm, dried chili peppers at 20 ppm, and sweet peppers at 0.7 ppm 
which are different from the tolerances established in the U.S. for 
diflubenzuron on the pepper/eggplant subgroup 8-10B at 1.0 ppm. The 
pepper/eggplant subgroup 8-10B covers both bell and non-bell peppers 
and the Codex MRLs split them out into two separate tolerances which 
the U.S. does not do because the petition was for the entire subgroup. 
Based on the residue data submitted and reviewed for this action, it 
would not be appropriate for the U.S. tolerance to harmonize with 
either the chili pepper MRL of 3 ppm or the sweet pepper MRL of 0.7 
ppm. Also, in regards to the dried chili pepper MRL, this is not 
expected to be an issue since the U.S. does not set tolerances on dried 
fruits and vegetables, but instead the processed food is considered to 
be the whole processed commodity after compensating for or 
reconstituting the commodity's normal moisture content.

C. Response to Comments

    One comment was received in response to the February 11, 2015 
Notice of Filing, however, it related to a different chemical than 
diflubenzuron and therefore is not relevant to this action. Two 
comments were received in response to the December 2, 2015 Notice of 
Filing. One commenter opposed residues of this pesticide on food and 
argued that EPA should deny the petition. The Agency understands the 
commenter's concerns and recognizes that some individuals believe that 
pesticides should be banned on agricultural crops. However, the 
existing legal framework provided by section 408 of the Federal Food, 
Drug and Cosmetic Act (FFDCA) states that tolerances may be set when 
persons seeking such tolerances or exemptions have demonstrated that 
the pesticide meets the safety standard imposed by that statute. This 
citizen's comment appears to be directed at the underlying statute and 
not EPA's implementation of it; the citizen has made no contention that 
EPA has acted in violation of the statutory framework. The second 
comment stated that ``without long term studies of its effects on the 
environment and the toxic effects on aquatic invertebrates, then there 
should be a slight reduction in ppm of diflubenzuron used on crops.'' 
This comment is not relevant to the Agency's evaluation of safety of 
the diflubenzuron tolerances; section 408 of the FFDCA focuses on 
potential harms to human health and does not permit consideration of 
effects on the environment.

D. Revisions to Petitioned-For Tolerances

    Based on an evaluation of the residue data, the Agency modified the 
levels at which tolerances were proposed for the existing tolerances 
for egg, poultry fat, and poultry meat byproducts. In addition, the 
Agency determined that a separate tolerance is not required for the 
commodity ``plum, prune, dried'' since residues are not found to 
concentrate on prunes. Lastly, some of the tolerances levels were 
modified to reflect the correct significant figures.

V. Conclusion

    Therefore, tolerances are established, modified and removed for 
residues of diflubenzuron N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide) and its metabolites 4-chlorophenlyurea and 4-
chloroaniline, as follows:
    Under 180.377(a)(1) a tolerance is established for the cottonseed 
subgroup 20C at 0.20 ppm; existing tolerances are changed for egg to 
0.07 ppm; poultry, fat to 0.10 ppm; and poultry, meat byproducts to 
0.08 ppm; and the existing tolerance for cotton, undelinted seed at 0.2 
ppm is removed as unnecessary.
    Under 180.377(a)(2), tolerances are established in or on the raw 
agricultural commodities carrot, roots at 0.20 ppm; peach subgroup 12-
12B at 0.50 ppm; plum subgroup 12-12C at 0.50 ppm; nut, tree group 14-
12 at 0.20 ppm; the pepper/eggplant subgroup 8-10 B at 1.0 ppm; and the 
following existing tolerances are removed as unnecessary: Fruit, stone, 
group 12, except cherry at 0.07 ppm; nut, tree, group 14 at 0.06 ppm; 
pistachio at 0.06 ppm; and pepper at 1.0 ppm.
    Under 180.377(c) regional tolerances are established for the 
combined residues of diflubenzuron and its metabolites 4-
chlorophenlyurea and 4-chloroaniline in or on the raw agricultural 
commodities alfalfa, forage at 6 ppm; alfalfa, hay at 20 ppm; and 
alfalfa, seed at 0.9 ppm.

[[Page 7472]]

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: February 3, 2016.
Susan Lewis,
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.  180.377:


0
a. Remove the entries in the table in paragraph (a)(1) for ``Cotton, 
undelinted seed,'' ``Egg,'' ``Poultry, fat,'' and ``Poultry, meat 
byproducts.''
0
b. Add alphabetically the entries for ``Cottonseed subgroup 20C,'' 
``Egg,'' ``Poultry, fat,'' and ``Poultry, meat byproducts'' to the 
table in paragraph (a)(1).
0
c. Remove the entries in the table in paragraph (a)(2) for ``Fruit, 
stone, group 12, except cherry,'' ``Nut, tree, group 14,'' ``Pepper,'' 
and ``Pistachio.''
0
d. Add alphabetically the entries for ``Carrot, roots,'' ``Peach 
subgroup 12-12B,'' ``Pepper/Eggplant subgroup 8-10B,'' ``Plum subgroup 
12-12C,'' and ``Nut, tree, group 14-12'' to the table in paragraph 
(a)(2).
0
e. Revise paragraph (c).
    The additions and revision read as follows:


Sec.  180.377  Diflubenzuron; tolerances for residues.

    (a) General (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cottonseed subgroup 20C....................................         0.20
Egg........................................................         0.07
 
                                * * * * *
Poultry, fat...............................................         0.10
Poultry, meat byproducts...................................         0.08
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Carrot, roots..............................................         0.20
 
                                * * * * *
Peach subgroup 12-12B......................................         0.50
 
                                * * * * *
Pepper/Eggplant subgroup 8-10B.............................          1.0
 
                                * * * * *
Plum Subgroup 12-12C.......................................         0.50
Nut, tree, group 14-12.....................................         0.20
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registration are established for residues of the insecticide 
diflubenzuron (N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide), in or on the commodities in the table below. 
Compliance with the tolerance levels specified below is to be 
determined by measuring only the sum of diflubenzuron (N-[[(4-
chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide), 4-
chlorophenylyurea and 4-chloroaniline, calculated as the stoichiometric 
equivalent of diflubenzuron, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................          6.0
Alfalfa, hay...............................................           20
Alfalfa, seed..............................................         0.90
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-02816 Filed 2-11-16; 8:45 am]
 BILLING CODE 6560-50-P


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