Document ID: EPA-HQ-OPP-2008-0714-0001
Agency: epa
Document Type: Rule
Title: Diflubenzuron; Pesticide Tolerances for Emergency Exemptions
Posted Date: 2008-11-28T05:00Z

[Federal Register: November 28, 2008 (Volume 73, Number 230)]
[Rules and Regulations]               
[Page 72352-72357]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28no08-17]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0714; FRL-8388-9]

 
Diflubenzuron; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of diflubenzuron and its metabolites p-
chlorophenylurea and p-chloroaniline in or on alfalfa, forage and 
alfalfa, hay. 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 alfalfa and mixed grass/alfalfa fields. This regulation establishes 
a maximum permissible level for residues of diflubenzuron and its 
metabolites p-chlorophenylurea and p-chloroaniline, in these food 
commodities. The time-limited tolerances expire and are revoked on 
December 31, 2011.

DATES: This regulation is effective November 28, 2008. Objections and 
requests for hearings must be received on or before January 27, 2009, 
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-2008-0714. All documents in the 
docket are listed in the docket index available in http://
www.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 in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open 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:

[[Page 72353]]

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 electronically available documents 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 e-CFR site at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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. 
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-
2008-0714 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 27, 2009.
    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-2008-0714, 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 Facility'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 FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
time-limited tolerances for combined residues of the insecticide 
diflubenzuron and its metabolites p-chlorophenylurea and p-
chloroaniline, in or on alfalfa, forage and alfalfa, hay at 6 parts per 
million (ppm). These time-limited tolerances expire and are revoked on 
December 31, 2011. EPA will publish a document in the Federal Register 
to remove the revoked tolerances from the CFR.
    Section 408(l)(6) of 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 time-limited tolerances to set binding precedents 
for the application of section 408 of FFDCA and the new safety standard 
to other tolerances and exemptions. Section 408(e) of 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 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. . . 
.''
    Section 18 of 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.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Diflubenzuron on Alfalfa and FFDCA 
Tolerances

    The United States Department of Agriculture, Animal and Plant 
Health Inspection Service (USDA/APHIS) requested the use diflubenzuron 
to control Mormon crickets and grasshoppers on alfalfa grown for hay to 
protect pollinators of Spalding's catchfly, a threatened plant species 
endemic to the proposed treatment area in Montana. The alfalfa fields 
are interspersed within the rangeland spray blocks. EPA evaluated this 
request and found that USDA/APHIS had identified an emergency 
situation. Thus, EPA concurred on the request.
    In a separate action, the Oregon Department of Agricultural (ODA) 
declared a crisis emergency exemption for use of diflubenzuron to 
control the same pests on alfalfa grown for hay, and mixed grass/
alfalfa hay on June 30, 2008.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by combined residues of 
diflubenzuron in or on alfalfa, forage and alfalfa, hay. In doing so, 
EPA considered the safety

[[Page 72354]]

standard in section 408(b)(2) of FFDCA, and EPA decided that the 
necessary tolerance under section 408(l)(6) of FFDCA would be 
consistent with the safety standard and with FIFRA section 18. EPA has 
previously evaluated the use of diflubenzuron on alfalfa and 
established time-limited tolerances initially for a similar use in 
Federal Register: September 20, 2002 (67 FR 59177), OPP-2002-0253; FRL-
7273-7 in association with earlier emergency exemption request. This 
notice re-establishes those time-limited tolerances. 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 
FFDCA. Although these time-limited tolerances expire and are revoked on 
December 31, 2011, under section 408(l)(5) of FFDCA, residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on alfalfa, forage and alfalfa, hay after that date 
will not be unlawful, provided the pesticide was applied in a manner 
that was lawful under FIFRA, and the residues do not exceed a level 
that was authorized by these time-limited tolerances at the time of 
that application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether it 
meets FIFRA's registration requirements for use on alfalfa, forage and 
alfalfa, hay or whether permanent tolerances for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
time-limited tolerance decision 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 persons in any 
State other than USDA/ODA to use this pesticide on these crops under 
FIFRA section 18 absent the issuance of an emergency exemption 
applicable within that State. For additional information regarding the 
emergency exemption for diflubenzuron, contact the Agency's 
Registration Division at the address provided under FOR FURTHER 
INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with the factors specified in 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 expected as a result of this emergency exemption request and 
the time-limited tolerances for combined residues of diflubenzuron on 
alfalfa, forage and alfalfa, hay at 6 ppm. EPA's assessment of 
exposures and risk associated with establishing time-limited tolerances 
follows.

A. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    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 
greater than that 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 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. In evaluating dietary 
exposure to diflubenzuron, EPA considered exposure under the time-
limited tolerances established by this action 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. No such effects were identified in the 
toxicological studies for diflubenzuron, therefore, a quantitative 
acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA used the established/
recommended tolerances for all food commodities, 100 percent crop 
treated (PCT) information for all proposed and existing uses, and 
Dietary Exposure Evaluation Model (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

[[Page 72355]]

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 used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for diflubenzuron 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.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) 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\TM\-Food Commodity Intake 
Database (FCID), 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. 
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 
non-occupational exposure 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.''
    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 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 http://
www.epa.gov/pesticides/cumulative.

C. 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 SF when reliable data 
available to EPA support the choice of a different factor.
    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 has 
determined that reliable data show that 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 toxicity database for diflubenzuron is complete.
    ii. There is no indication that diflubenzuron is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    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. There are no residual uncertainties identified in the exposure 
databases EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to diflubenzuron in 
drinking water. EPA used similarly conservative assumptions to assess 
postapplication exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by diflubenzuron. 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. 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.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of

[[Page 72356]]

additional cancer cases 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 POD to 
ensure that the MOE called for by the product of all applicable UFs is 
not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified, therefore, 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 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.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Diflubenzuron is not registered for any use patterns that would 
result in residential exposure. Therefore, the short-term aggregate 
risk is the sum of the risk from exposure to diflubenzuron through food 
and water.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Diflubenzuron is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to diflubenzuron through food and water, which has already been 
addressed.
    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 IV.B.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); at 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, or 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 gas chromatography/
electron-capture detection (GC/ECD), CPU by GC/ECD, and PCA by GC/mass 
spectrometry (MS).

B. International Residue Limits

    There are no Codex maximum residue limits established for 
diflubenzuron on alfalfa forage and hay.

VI. Conclusion

    Therefore, time-limited tolerances are established for combined 
residues of the insecticide diflubenzuron, (N-[[(4-
chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide and its metabolites 
4-chlorophenylurea and 4-chloroaniline, in or on alfalfa, forage and 
alfalfa, hay at 6 ppm. These tolerances expire and are revoked on 
December 31, 2011.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under sections 408(e) and 
408(l)(6) 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 final 
rule has been exempted from review under Executive Order 12866, this 
final rule 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 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 in accordance 
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances 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 9, 2000) do not apply to this final rule. In addition, 
this final 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

[[Page 72357]]

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: November 7, 2008.
Deborah McCall,
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. In Sec.  180.377(b), amend the table under the heading ``Expiration/
Revocation Date'' by replacing the phrase ``6/30/07'' to read ``12/31/
11'' for the entries ``Alfalfa, forage'' and ``Alfalfa, hay.''

[FR Doc. E8-28308 Filed 11-26-08; 8:45 am]

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