Diflubenzuron; Pesticide Tolerances, 69028-69033 [E6-20147]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 229 (Wednesday, November 29, 2006)]
[Rules and Regulations]
[Pages 69028-69033]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20147]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0181; FRL-8103-8]


Diflubenzuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of diflubenzuron and its metabolites 4-chlorophenylurea and 4-
chloroaniline in or on brassica, leafy greens subgroup 5B, turnip 
greens, peanut, peanut hay, peanut oil, barley grain, barley hay, 
barley straw, oat grain, oat forage, oat hay, oat straw, wheat grain, 
wheat forage, wheat hay, wheat straw, aspirated grain fractions, and 
pummelo. The Interregional Research Project 4 requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective November 29, 2006. Objections and 
requests for hearings must be received on or before January 29, 2007, 
and must be filed in accordance with the instructions provided in 40 
CFR part

[[Page 69029]]

178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:  EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0181. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at https://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: madden.barbara@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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at https://
www.epa.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2006-0181 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before January 29, 2007.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0181, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of April 12, 2006 (71 FR 18742) (FRL-7773-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
5E6965, PP 5E6966, and PP 5E6967) by Interregional Project Number 4, 
681 Highway 1 South, North Brunswick, NJ 08902-3390. The petitions 
requested that 40 CFR 180.377 be amended by establishing tolerances for 
residues of diflubenzuron, (N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide and metabolites convertible to p-chloroaniline 
expressed as diflubenzuron in or on the raw agricultural commodities 
barley grain, oat grain, wheat grain at 0.06 ppm; forage of barley, oat 
and wheat at 5.0 ppm; hay of barley, oat and wheat at 2.0 ppm; straw of 
barley, oat and wheat at 2.0 ppm; aspirated grain fractions of barley, 
oat and wheat at 3.0 ppm; and pummelo at 0.5 ppm (PP 5E6965), brassica, 
leafy greens subgroup 5B and turnip greens at 8.0 ppm, eggplant and 
okra at 1.0 ppm (PP 5E6966), and peanut at 0.2 ppm (PP 5E6967). That 
notice included a summary of the petition prepared by IR-4. There were 
no comments received in response to the notice of filing.
    Tolerances were later amended by IR-4 as follows: Barley, hay at 
3.0 ppm; barley, straw at 1.8 ppm; oat forage at 7.0 ppm; oat hay at 
6.0 ppm; oat straw at 3.5 ppm; wheat, forage at 7.0 ppm, wheat, hay at 
6.0 ppm, wheat, straw at 3.5 ppm; grain, aspirated fractions at 11 ppm 
(PP 5E6965); brassica, leafy greens, subgroup 5B and turnip greens at 
9.0 ppm (PP 5E6966); peanut at 0.10 ppm; peanut, hay at 55 ppm; peanut, 
refined oil at 0.20 ppm (PP 5E6967).
    In addition, the proposed tolerance for barley, forage (PP 5E6965) 
was deleted by IR-4 because this is not a raw agricultural commodity 
(RAC) of barley. Also, the proposed tolerances for eggplant and okra 
(PP 5E6966) were withdrawn by IR-4 because the Agency concluded that 
there are insufficient data to establish tolerances for

[[Page 69030]]

diflubenzuron residues in or on these commodities at this time.
    EPA is also deleting several established tolerances in Sec.  
180.377 (b) that are no longer needed as a result of this action. The 
tolerance deletions under Sec.  180.377 (b) are time-limited tolerances 
established under section 18 emergency exemptions that are superceded 
by the establishment of general tolerances for diflubenzuron and its 
metabolites under Sec.  180.377 (a)(2).
    The revisions to Sec.  180.377 (b) are as follows:
    1. Delete the time-limited tolerance for barley, grain at 0.05 ppm. 
A tolerance for barley, grain at 0.06 ppm is established by this action 
under Sec.  180.377(a)(2).
    2. Delete the time-limited tolerance for barley, hay at 1.0 ppm. A 
tolerance for barley, hay at 3.0 ppm is established by this action 
under Sec.  180.377(a)(2).
    3. Delete the time-limited tolerance for barley, straw at 0.50 ppm. 
A tolerance for barley, straw at 1.8 ppm is established by this action 
under Sec.  180.377 (a)(2).
    4. Delete the time-limited tolerance for wheat, grain at 0.05 ppm. 
A tolerance for wheat, grain at 0.06 ppm is established by this action 
under Sec.  180.377(a)(2).
    5. Delete the time-limited tolerance for wheat, hay at 1.0 ppm. A 
tolerance for wheat, hay at 6.0 ppm is established by this action under 
Sec.  180.377(a)(2).
    6. Delete the time-limited tolerance for wheat, straw at 0.50 ppm. 
A tolerance for wheat, straw at 3.5 ppm is established by this action 
under Sec.  180.377 (a)(2).
    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. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section 
408(a)(2) of FFDCA, for tolerances for combined residues of 
diflubenzuron, (N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide and its metabolites 4-chlorophenylurea and 4-
chloroaniline in or on the raw agricultural commodities barley, grain 
at 0.06 ppm; barley, hay at 3.0 ppm; barley, straw at 1.8 ppm; oat, 
grain at 0.06 ppm; oat forage at 7.0 ppm; oat hay at 6.0 ppm; oat straw 
at 3.5 ppm; wheat, grain at 0.06 ppm; wheat, forage at 7.0 ppm, wheat, 
hay at 6.0 ppm, wheat, straw at 3.5 ppm; grain, aspirated fractions at 
11 ppm; pummelo at 0.50 ppm; brassica, leafy greens, subgroup 5B at 9.0 
ppm; turnip greens at 9.0 ppm; peanut at 0.10 ppm; peanut, hay at 55 
ppm; peanut, refined oil at 0.20 ppm. EPA's assessment of exposures and 
risks associated with establishing the tolerance 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. Specific information on the studies received and the nature 
of the toxic 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 https://
www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-19/p23818.htm (67 FR 
59006).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at https://www.epa.gov/pesticides/health/human.htm.
    A summary of the toxicological endpoints for diflubenzuron used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of September 19, 2002 (67 FR 59006) 
(FRL-7200-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances for 
residues of diflubenzuron are established under 40 CFR 180.377. 
Tolerances listed in 40 CFR 180.377(a)(1) are expressed in terms of 
diflubenzuron per se. Under this section, tolerances of 0.05-6.0 ppm 
are established for residues in/on eggs; milk; fat and meat of cattle, 
goat, hog, horse, poultry, and sheep; poultry meat byproducts; 
cottonseed; mushroom; grapefruit, orange (sweet); tangerine; soybean 
hulls; and globe artichoke. Tolerances listed in 40 CFR 180.377(a)(2) 
are expressed in terms of the combined residues of diflubenzuron and 
its metabolites 4-chlorophenylurea (CPU) and 4-chloroaniline (PCA). 
Under this section, tolerances of 0.02-6.0 ppm are established for 
residues in/on rice grain; tree nuts (group 14); pistachios; fruit, 
stone (group 12) except cherry; meat byproducts of cattle, goat, hog, 
horse, and sheep; pear; rice straw; pepper; and almond hulls. Time-
limited tolerances listed in 40 CFR 180.377(b) are expressed in terms 
of the combined residues of diflubenzuron and its metabolites CPU and 
PCA, expressed as the parent diflubenzuron, in connection with use of 
the pesticide under Section 18 Emergency Exemptions granted by EPA. 
Risk assessments were conducted by EPA to assess dietary exposures from 
diflubenzuron in food as follows:

[[Page 69031]]

    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. The diflubenzuron toxicology 
studies indicated no possibility of such an effect for either the 
general U.S. population (including infants and children) or the females 
13-50 years old population subgroup for diflubenzuron; therefore, an 
acute dietary exposure analysis was not performed.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM-FCID\TM\) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1994-1996 and 1998 Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. The following assumptions were made 
for the chronic exposure assessments: For the chronic analysis a Tier 1 
chronic dietary-exposure assessment was conducted using the 
established/recommended tolerances for all food commodities, 100% CT 
information for all proposed and existing uses, and DEEM(\TM\) Version 
7.81 default processing factors for some processed commodities.
    iii. Cancer. The Agency has classified diflubenzuron as ``Group 
E,'' evidence of non-carcinogenicity for humans, based on lack of 
evidence of carcinogenicity in rats and mice. There are also two 
metabolites of diflubenzuron; PCA and CPU. PCA tested positive for 
splenic tumors in male rats and hepatocellular adenomas/carcinomas in 
male mice in a National Toxicology Program (NTP) study. Therefore, EPA 
classified PCA as a ``Group B2'' probable human carcinogen. The Agency 
determined for those commodities that contained PCA and CPU, the Q1* of 
PCA should be used to calculate the cancer risk from the sum of these 
two metabolites.
    Based on the submitted metabolism studies, there are two possible 
sources for dietary exposure to PCA and CPU: residues in mushrooms and 
residues in milk and liver. Because human exposure to PCA and CPU will 
not be affected by the proposed new uses, and EPA has previously 
concluded that exposure to these compounds is safe, therefore, the 
cancer dietary risk from PCA and CPU will not be addressed in this 
document. For a detailed discussion on the exposure and risks to PCA 
and CPU, please refer to the September, 2002 Federal Register document 
titled Diflubenzuron; Pesticide Tolerances (September 19, 2002, FR 67 
59006); https://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-19/
p23818.htm.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for diflubenzuron in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of diflubenzuron. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-
GROW) models, the estimated environmental concentrations (EECs) of 
diflubenzuron and the major degradate CPU for chronic exposures are 
estimated to be 2.76 ppb for surface water and 0.208 ppb for ground 
water.Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model (DEEM-FCID\TM\, Version 2.03). 
For chronic dietary risk assessment, the annual average concentration 
of 2.76 ppb was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Although there are no registered homeowner uses, there are 
registered uses for professional applications to outdoor residential 
and recreational areas to control mosquitoes, moths, and other insects. 
However, the potential for post-application residential exposure is 
expected to be limited, due to the low dermal absorption rate (0.5%) of 
diflubenzuron, and since it is only applied to the tree canopy, minimal 
bystander contact is expected.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to diflubenzuron and 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 not assumed that diflubenzuron has 
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 the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at https://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold 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 data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Based on the developmental 
and reproductive toxicity studies, there is no indication of increased 
susceptibility of rats or rabbits to in utero or postnatal exposure.
    3. Conclusion. Based on the reliable data available on 
diflubenzuron, EPA determined that the additional FQPA 10X safety 
factor to protect infants and children was not needed. This decision 
was based on the following:
    i. There is a complete toxicity data base for diflubenzuron

[[Page 69032]]

    ii. There is no indication of increased susceptibility of rats or 
rabbits to in utero or postnatal exposure;
    iii. A developmental neurotoxicity study (DNT) with diflubenzuron 
is not required;
    iv. Food and drinking water exposure assessments will not 
underestimate the potential exposure for infants and children; and
    v. There are currently no registered or proposed residential (non-
occupational) uses of diflubenzuron for homeowners. Although there are 
no registered homeowner uses, there is potential for professional 
applications to outdoor residential and recreational areas to control 
mosquitoes, moths, and other insects. However, the potential for post-
application residential exposures are expected to be limited. Due to 
the low dermal absorption rate (0.5%) of diflubenzuron, and since it is 
only applied to the tree canopy to control gypsy moths and mosquitoes, 
minimal bystander contact is expected.

E. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs) which are used 
as a point of comparison against estimated drinking water 
concentrations (EDWCs). The DWLOC values are not regulatory standards 
for drinking water, but are theoretical upper limits on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food and residential uses. More information on the use 
of DWLOCs in dietary aggregate risk assessments can be found at https://
www.epa.gov/oppfead1/trac/science/screeningsop.pdf.
    More recently the Agency has used another approach to estimate 
aggregate exposure through food, residential and drinking water 
pathways. In this approach, modeled surface and ground water EDWCs are 
directly incorporated into the dietary exposure analysis, along with 
food. This provides a more realistic estimate of exposure because 
actual body weights and water consumption from the CSFII are used. The 
combined food and water exposures are then added to estimated exposure 
from residential sources to calculate aggregate risks. The resulting 
exposure and risk estimates are still considered to be high end, due to 
the assumptions used in developing drinking water modeling inputs. The 
risk assessment for diflubenzuron used in this tolerance document uses 
this approach of incorporating water exposure directly into the dietary 
exposure analysis.
    1. Acute risk. Because there were no toxic effects attributable to 
a single dose of diflubenzuron, it 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 exposure to 
diflubenzuron from food and water will utilize 11% of the cPAD for the 
U.S. population, 12% of the cPAD for all infants less than 1 year old, 
and 37% of the cPAD for children 1-2 years old. There are no 
residential uses for diflubenzuron that result in chronic residential 
exposure to diflubenzuron. EPA does not expect the aggregate exposure 
to exceed 100% of the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Diflubenzuron is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Diflubenzuron is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    5. Aggregate cancer risk for U.S. population. Based on the 
available evidence, which included adequate carcinogenicity studies in 
rats and mice, and battery of negative mutagenicity studies, 
diflubenzuron has been classified as ``Group E,'' evidence of non-
carcinogenicity for humans, by the Agency.
    As noted in Unit III.C.1.iii. of this document, the Agency has 
concluded that human exposure to PCA and CPU (metabolites of 
diflubenzuron) will not be affected by the proposed new uses. EPA has 
previously found aggregate exposure to these compounds to be safe. 
(September 19, 2002, 67 FR 59006); https://www.epa.gov/fedrgstr/EPA-
PEST/2002/September/Day-19/p23818.htm
    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, and to infants and children from aggregate 
exposure to diflubenzuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There are adequate enforcement methods, published in the Pesticide 
Analytical Manual (PAM, Vol. II), for determining diflubenzuron 
residues of concern. In addition, a new analytical methodology for 
plant commodities was successfully validated by an independent 
laboratory as well as by Agency chemists at the Analytical Chemistry 
Branch (ACB)/Biological and Economics Analysis Division (BEAD) in 
conjunction with the approved rice petition (PP8F4925). The 
new methods were forwarded to the Food and Drug Administration (FDA) 
for publication in PAM Vol. II as Roman Numeral Methods. These methods 
can separately determine residues of diflubenzuron by gas 
chromatography/electron-capture detection (GC/ECD), CPU by GC/ECD, and 
PCA by GC/mass spectrometry (MS). The reported limit of quantitation 
(LOQ) for diflubenzuron in/on rice grain, straw, and bran is 0.01 ppm, 
and is 0.05 ppm in/on rice hull. In rice straw, the LOQ for CPU is 0.01 
ppm and 0.005 ppm for PCA.

B. International Residue Limits

    The Codex Alimentarius has established maximum residue limits 
(MRL), expressed in terms of diflubenzuron per se, for many commodities 
including: apple (5 ppm), citrus fruits (0.5 ppm), edible offal 
(mammalian) (0.1 ppm), eggs (0.05 ppm), meat (from mammals other than 
marine mammals) (0.1 ppm), milks (0.02 ppm), mushrooms (0.3 ppm), pear 
(5 ppm), pome fruits (5 ppm), poultry meat (0.05 ppm), rice (0.01 ppm), 
and rice straw and fodder (dry) 0.7 ppm). As the U.S. residue 
definition includes CPU and PCA, compatibility is not possible with the 
proposed tolerances.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
diflubenzuron, (N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide and its metabolites 4-chlorophenylurea and 4-
chloroaniline in or on the raw agricultural commodities barley, grain 
at 0.06 ppm; barley, hay at 3.0 ppm; barley, straw at 1.8 ppm; oat, 
grain at 0.06 ppm; oat forage at 7.0 ppm; oat hay at 6.0 ppm; oat straw 
at 3.5 ppm; wheat, grain at 0.06 ppm; wheat, forage at 7.0 ppm, wheat, 
hay at 6.0 ppm, wheat, straw at 3.5 ppm; grain, aspirated fractions at 
11 ppm; pummelo at 0.50 ppm; brassica, leafy greens, subgroup 5B

[[Page 69033]]

at 9.0 ppm; turnip greens at 9.0 ppm; peanut at 0.10 ppm; peanut, hay 
at 55 ppm; peanut, refined oil at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA 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 rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). 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); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. 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 this final rule in the Federal Register. This final 
rule 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: November 16, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.377 is amended by alphabetically adding commodities to 
the table in paragraph (a)(2) and removing from the table in paragraph 
(b), the commodities ``barley, grain''; ``barley, hay''; barley, 
straw''; ``wheat, grain''; ``wheat, hay''; and ``wheat, straw'' to read 
as follows:


Sec.  180.377  Diflubenzuron; tolerances for residues.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Barley, grain...........................................            0.06
Barley, hay.............................................             3.0
Barley, straw...........................................             1.8
Brassica, leafy greens, subgroup 5B.....................             9.0
                                * * * * *
Grain, aspirated fractions..............................              11
                                * * * * *
Oat, forage.............................................             7.0
Oat, grain..............................................            0.06
Oat, hay................................................             6.0
Oat, straw..............................................             3.5
Peanut..................................................            0.10
Peanut, hay.............................................              55
Peanut, refined oil.....................................            0.20
                                * * * * *
Pummelo.................................................            0.50
                                * * * * *
Turnip greens...........................................             9.0
Wheat, forage...........................................             7.0
Wheat, grain............................................            0.06
Wheat, hay..............................................             6.0
Wheat, straw............................................             3.5
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-20147 Filed 11-28-06; 8:45 am]
BILLING CODE 6560-50-S