Document ID: EPA-HQ-OPP-2007-0446-0001
Agency: epa
Document Type: Rule
Title: Diflubenzuron; Pesticide Tolerances for Emergency Exemptions
Posted Date: 2007-07-25T04:00Z

[Federal Register: July 25, 2007 (Volume 72, Number 142)]
[Rules and Regulations]               
[Page 40754-40759]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy07-10]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0446; FRL-8136-7]

 
Diflubenzuron; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
diflubenzuron and its metabolites p-chlorophenylurea and p-
chloroaniline in or on lemon. This action is in response to EPA's 
granting of an emergency exemption under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of 
the pesticide on lemon. This regulation establishes a maximum 
permissible level for combined residues of diflubenzuron and its 
metabolites p-chlorophenylurea and p-chloroaniline, in this food 
commodity. The tolerance expires and is revoked on December 31, 2010.

DATES: This regulation is effective July 25, 2007. Objections and 
requests for hearings must be received on or before September 24, 2007, 
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:  EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0446. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. 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 either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office 

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The 
hours of operation of this Docket Facility are from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9364; e-mail address: pemberton.libby@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 code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://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 http://www.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-

[[Page 40755]]

OPP-2007-0446 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 September 24, 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-2007-0446, by one of the following methods:
     Federal eRulemaking Portal: http://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 
Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for of the insecticide, 
diflubenzuron and its metabolites p-chlorophenylurea and p-
chloroaniline, in or on lemon at 0.8 parts per million (ppm). This 
tolerance expires and is revoked on December 31, 2010. EPA will publish 
a document in the Federal Register to remove the revoked tolerance from 
the Code of Federal Regulations (CFR).
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the 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 the 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 the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.
    EPA is also revising the tolerance expression in Sec.  180.377(b) 
to be consistent with the preferable wording as expressed in Sec.  
180.377(a)(2).

III. Emergency Exemption for Diflubenzuron on Lemon and FFDCA 
Tolerances

    In the fall of 2005 and spring of 2006, active infestations of 
Diaprepes root weevil were detected including one lemon orchard (28 
acres) in commercial sites in Long Beach, Newport Beach, Carlsbad, 
Encintas, and La Jolla, California. The California Department of Food 
and Agriculture (CDFA) has quarantined these sites and has already 
initiated eradication treatments using products that impact various 
life stages of this insect. The emergency use of diflubenzuron is 
needed to treat the egg stage of the weevil when they are detected in 
lemon. The overall program involves treatment for larval and adult 
stages as well. EPA has authorized under FIFRA section 18 the use of 
diflubenzuron on lemon for control of Diaprepes root weevil in 
California. After having reviewed the submission, EPA concurs that 
emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of diflubenzuron in or on 
lemon. In doing so, EPA considered the safety standard in section 
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance 
under section 408(l)(6) of the FFDCA would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in section 408(l)(6) of the FFDCA. 
Although this tolerance expires and is revoked on December 31, 2007, 
under section 408(l)(5) of the FFDCA, residues of the pesticide not in 
excess of the amounts specified in the tolerance remaining in or on 
lemon after that date will not be unlawful, provided the pesticide is 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by this tolerance at the time of 
that application. EPA will take action to revoke this tolerance earlier 
if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether diflubenzuron 
meets EPA's registration requirements for use on lemon or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of diflubenzuron by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than California to use this pesticide on this 
crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR 
part 166. For additional information regarding the emergency exemption 
for diflubenzuron, contact the Agency's Registration Division at the 
address provided under FOR FURTHER INFORMATION CONTACT.

[[Page 40756]]

IV. Aggregate Risk Assessment and Determination of Safety

    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 http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    Consistent with section 408(b)(2)(D) of the 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 
diflubenzuron and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for a time-limited 
tolerance for combined residues of diflubenzuron in or on lemon at 0.8 
ppm. EPA's assessment of the dietary exposures and risks associated 
with establishing the tolerance follows.

A. 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 athttp://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).

B. 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 0.02-55.0 pm are established for 
residues in/on rice grain and straw; barley grain, straw, and hay; oat, 
forage, grain, hay, and straw; wheat forage, grain, hay, and straw; 
grain aspirated fractions; brassica, leafy greens, subgroup 5B; grass, 
forage, fodder, and hay, group 17; tree nuts (group 14); peanut, peanut 
hay and refined oil; pistachios; fruit, stone (group 12) except cherry; 
meat byproducts of cattle, goat, hog, horse, and sheep; pear; pepper; 
pummelo; turnip greens; 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:
    i. Acute exposure. Acute dietary 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 U.S. Department of Agriculture (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: A 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); http://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 assess dietary exposure to 
diflubenzuron in drinking water based on measured drinking water 
concentrations. 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 http://www.epa.gov/oppfed1/models/water/index.htm.
 Based on the Pesticide Root Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS) and Screening Concentrations in Ground 
Water (SCI-GROW) models, the estimated environmental concentrations 
(EECs) of diflubenzuron and the major degradate CPU for chronic 
exposures are estimated

[[Page 40757]]

to be 2.76 parts per billion (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 represent the drinking water 
contribution to chronic dietary exposure for diflubenzuron.
    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. In addition, certain residential 
use sites will be treated in association with this emergency exemption 
for the control of the Diaprepes root weevil. However, EPA considers 
the potential for post-application residential exposure to be low. 
Further, diflubenzuron has a low dermal absorption rate (0.5%) and will 
be only applied to the tree canopy.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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 OPP concerning 
common mechanism determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's website at 
http://www.epa.gov/pesticides/cumulative/.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the 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 database on toxicity and exposure 
unless EPA determines 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.
    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. There is a complete toxicity database for 
diflubenzuron and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. 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 database for diflubenzuron;
    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. 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.

D. Aggregate Risks and Determination of Safety

    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 will utilize 12% of the cPAD for the U.S. 
population, 12% of the cPAD for all infants less than 1 year old and 
38% 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).
    The aggregate risk is the sum of the risk from food and water, 
which do not exceed the Agency's LOC.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    The aggregate risk is the sum of the risk from food and water, 
which do not exceed the Agency's LOC.
    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); http://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.

V. 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 an approved rice petition (PP 8F4925). 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

[[Page 40758]]

gas chromatography/electron-capture detection (GC/ECD), CPU by GC/ECD, 
and PCA by GC/mass spectrometry (MS).

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 tolerance.

VI. Conclusion

    Therefore, the tolerance is established for of the insecticide 
diflubenzuron, (N-[[(4-chlorophenyl)amino]carbonyl]-2,6- 
difluorobenzamide and its metabolites 4-chlorophenylurea and 4-
chloroaniline in or on lemon at 0.8 ppm.

VII. 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, 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) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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., 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 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.
    This final rule 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 section 
408(n)(4) of FFDCA. 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 6, 
2000) do not apply to this rule. In addition, This rule does not 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).
    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).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: July 6, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

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Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

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2. Section 180.377, paragraph (b) is amended by:
    i. Revising the introductory text and
    ii. Alphabetically adding the commodity ``Lemon'' to the table to 
read as follows:

Sec. 180.377   Diflubenzuron; tolerances for residues.

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for of the insecticide diflubenzuron, (N-[[(4-
chlorophenyl)amino]carbonyl]-2,6- difluorobenzamide and its metabolites 
4-chlorophenylurea and 4-chloroaniline, in connection with use of the 
pesticide under section 18 emergency exemptions granted by EPA. The 
tolerances are specified in the following table, and will expire and 
are revoked on the dates specified.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
                                * * * * *
Lemon.............................                0.8         12/31/2010
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. E7-14161 Filed 7-24-07; 8:45 am]

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