[Federal Register Volume 68, Number 166 (Wednesday, August 27, 2003)]
[Rules and Regulations]
[Pages 51479-51484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21935]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0279; FRL-7323-1]


Diflubenzuron; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of diflubenzuron in or on wheat and barley 
commodities. This action is in response to treatment of these crops 
under section 18 of the Federal Insecticide, Fungicide, and

[[Page 51480]]

Rodenticide Act (FIFRA). This regulation establishes maximum 
permissible levels for residues of diflubenzuron in these food 
commodities. The tolerances will expire and are revoked on December 31, 
2005.

DATES: This regulation is effective August 27, 2003. Objections and 
requests for hearings, identified by docket (ID) number OPP-2003-0279, 
must be received on or before October 27, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9356; e-mail address: [email protected].

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:
    [sbull] Crop producers (NAICS 111)
    [sbull] Animal producers (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification ID number OPP-2003-0279. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This 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.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_ 00/Title--40/4 0cfr180--00.html, 
a beta site currently under development.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

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 tolerances for combined residues of the 
insecticide diflubenzuron, [N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide and its metabolites 4-chlorophenlyurea and 4-
chloroaniline (CPU) and (PCA)], in or on wheat and barley grain at 0.05 
parts per million (ppm), wheat and barley straw at 0.50 ppm, wheat and 
barley hay at 1.0 ppm, wheat milled byproducts at 0.10 ppm, and 
aspirated grain fractions at 30 ppm. These tolerances will expire and 
are revoked on December 31, 2005. EPA will publish a document in the 
Federal Register to remove the revoked tolerances from the Code of 
Federal Regulations.
    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 (FQPA) 
1996. EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemptions for Diflubenzuron on Wheat and Barley and 
FFDCA Tolerances

    The requesting States (Idaho, Montana, and Washington) are 
experiencing severe outbreaks of grasshoppers in their wheat and barley 
fields this year. In most areas, densities of grasshoppers have reached 
40 or more per square yard, and without the use of diflubenzuron, the 
Applicants estimate that yield could drop by 50%,

[[Page 51481]]

resulting in severe crop devastation and significant economic impact to 
wheat and barley producers in these States. It is believed that the 
mild winters over the last several years have allowed grasshopper 
nymphs to survive the winter and multiply more rapidly in the spring, 
leading to population explosions of grasshoppers to levels of up to 60 
grasshoppers per square foot in some cases. The Applicants state that 
materials registered for grasshopper control either are not effective 
with populations at the current levels, are toxic to beneficial 
insects, or provide insufficient residual control, given the outbreak 
levels of grasshopper infestation. Under the crisis provisions (40 CFR 
166.40) of section 18 of FIFRA the Applicants used diflubenzuron on 
wheat and barley for control of grasshoppers.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of diflubenzuron in or on 
barley and wheat commodities. 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 will expire and 
is revoked on December 31, 2005, under section 408(l)(5) of the FFDCA, 
residues of the pesticide not in excess of the amounts specified in the 
tolerances remaining in or on barley and wheat commodities after that 
date will not be unlawful, provided it is demonstrated pursuant to 
section 408(l)(5) that the residues are the result of the application 
or the use of a pesticide at a time and in a manner that was lawful 
under FIFRA, and the residues do not exceed levels that were authorized 
by these tolerances at the time of that application or use. EPA will 
take action to revoke these tolerances earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues they allow are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether diflubenzuron 
meets EPA's registration requirements for use on barley and wheat or 
whether permanent tolerances for these uses would be appropriate. Under 
these circumstances, EPA does not believe that these tolerances serve 
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 States other than Montana, Washington, and Idaho 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.

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 the final rule on 
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).
    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 time-
limited tolerances for combined residues of diflubenzuron in or on 
wheat and barley grain at 0.05 ppm, wheat and barley straw at 0.50 ppm, 
wheat and barley hay at 1.0 ppm, wheat milled byproducts at 0.10 ppm, 
and aspirated grain fractions at 30 ppm.
    EPA has received objections to a separate tolerance-setting 
involving the use of diflubenzuron on pears. These objections were 
filed by the Natural Resources Defense Council (NRDC) and raised 
several issues regarding aggregate exposure estimates and the 
additional safety factor for the protection of infants and children. 
Although that proceeding remains ongoing, EPA has considered whether it 
is appropriate to establish the emergency exemption tolerances for 
diflubenzuron on wheat and barley commodities while the objections are 
still pending.
    Factors taken into account by EPA included how close the Agency is 
to concluding the proceedings on the objections, the nature of the 
current action, whether NRDC's objections raised non-frivolous issues, 
and the extent to which the issues raised by NRDC had already been 
considered by EPA. Although NRDC's objections are not frivolous, the 
other factors all support establishing these tolerances at this time. 
First, the objections proceeding is unlikely to conclude prior to when 
action is necessary on this petition. [NRDC's objections raise complex 
legal, scientific, policy, and factual matters and EPA initiated a 60 
day public comment period on them in the Federal Register on June 19, 
2002 (67 FR 41628) (FRL-7167-7). That comment period was extended until 
October 16, 2002 in the Federal Register of September 17, 2002 (67 FR 
58536) (FRL-7275-3),] and EPA is now examining the extensive comments 
received. Moreover, NRDC itself submitted further information to the 
Agency in June 2003, and the Agency is in the process of evaluating 
that information as well. Second, the nature of the current actions are 
extremely time-sensitive as they address emergency situations. Third, 
the issues raised by NRDC are not new matters but questions that 
already have been the subject of considerable evaluation by EPA and 
comment by stakeholders. Accordingly, EPA is proceeding with 
establishing these tolerances for diflubenzuron. EPA has determined at 
this time that these tolerances rest on a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residues involved. As suggested above, if during the life of these 
tolerances EPA determines that any experience with, scientific data on, 
or other relevant information on this pesticide indicates that the 
residues these tolerances allow are not safe, EPA will take action to 
revoke the tolerances prior to their otherwise applicable expiration 
date. The action EPA is taking at this time should not be construed to 
constitute action on NRDC's aforesaid objections. The Agency continues 
to consider those objections and information concerning them, including 
the new information which NRDC submitted in June 2003.
    The most recent estimated aggregate risks resulting from the use of 
diflubenzuron, are discussed in the Federal Register of September 19, 
2002 (67 FR 59017) (FRL-7200-4), final rule establishing tolerances for 
residues of diflubenzuron in/on grass forage, fodder, and hay; peppers; 
stone fruits; and tree nuts. In that prior action, risk was estimated 
using anticipated residue (AR) information based on field trial data 
and percent crop treated (PCT) information for some commodities. 
Available residue data indicate that the

[[Page 51482]]

use pattern for these emergency exemptions will not result in residues 
of diflubenzuron in excess of the following levels: Wheat and barley 
grain at 0.05 ppm, wheat and barley straw at 0.50 ppm, wheat and barley 
hay at 1.0 ppm, wheat milled byproducts at 0.10 ppm, and aspirated 
grain fractions at 30 ppm.
    Therefore, tolerances are being established for these commodities 
at these levels. The risk assessment related to incremental addition of 
these items at this level to dietary exposure is discussed below. Refer 
also to the September 19, 2002 Federal Register document for a detailed 
discussion of the aggregate risk assessments and determination of 
safety. EPA relies in part upon that risk assessment and the findings 
made in that Federal Register document in support of this action. Below 
is a brief summary of the aggregate risk assessment.
    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. A summary of the toxicological dose and endpoints for 
diflubenzuron for use in human risk assessment is discussed in the 
final rule mentioned above, published in the Federal Register of 
September 19, 2002 (67 FR 59017) (FRL-7200-4).
    EPA assessed risk scenarios for diflubenzuron under chronic 
exposures only. Chronic risk estimates were calculated for the residues 
of toxicological concern, the parent compound of the insecticide 
diflubenzuron (N-[[4-chlorophenyl)amino]-carbonyl]-2,6-
difluorobenzamide) and its metabolites, CPU and PCA. For the chronic 
analysis, ARs and PCT information for some commodities were also used. 
An acute dietary exposure analysis was not performed, because there 
were no acute toxicological endpoints identified (no effects of concern 
occurring as a result of a 1 day or single exposure). Short-term 
aggregate exposure, which takes into account residential exposure plus 
chronic exposure, was not assessed since diflubenzuron is not 
registered for use on any sites that would result in substantial 
residential exposure. Intermediate-term aggregate exposure, which takes 
into account residential exposure plus chronic exposure to food and 
water was not assessed, because intermediate-term exposure to 
diflubenzuron would not be expected from the registered and proposed 
use patterns. Aggregate cancer risk for the U.S. population was 
assessed, since the metabolite, CPU, is of concern for aggregate cancer 
risk and could be found in drinking water.
    A refined, chronic dietary exposure assessment was conducted for 
the general U.S. population and various population subgroups using the 
Dietary Exposure Evaluation Model (DEEMTM) Version 1.3. 
software with the Food Commodity Intake Database (FCID). The chronic 
analysis was performed using ARs and PCT information for several 
registered plant and livestock commodities, and recommended tolerance-
level residues and 100% CT information for all proposed commodities. 
The chronic dietary exposure estimates are below levels of concern 
(<100% of the chronic population adjusted dose (cPAD)) for that general 
U.S. population and all population subgroups. The most highly exposed 
population subgroups are all infants <1 year old and children 1-2 years 
old (both at 3% of the cPAD).
    A cancer dietary exposure assessment from consumption of PCA and 
CPU was conducted in the previous risk assessment. Based on the 
submitted metabolism studies, there are two possible sources for 
dietary exposure to PCA and CPU: Residues in fungi (mushrooms), and 
residues in animal commodities (milk and liver). As the wheat and 
barley uses will not result in additional dietary exposure to PCA and 
CPU, an updated cancer dietary exposure assessment was not needed to 
support the current section 18 request. The results of the previous 
cancer analysis indicated that the estimated cancer dietary risk 
associated with the use of diflubenzuron is below the Agency's level of 
concern
    Dietary exposure from drinking water. For the current use on wheat 
and barley, a chronic aggregate exposure (food + drinking water) 
assessment was performed. Acute, short-term and intermediate-term 
aggregate risk assessments were not performed because an acute dietary 
endpoint was not selected and there are no registered or proposed non-
food uses resulting in significant residential exposure, respectively. 
A cancer aggregate exposure (food + drinking water) assessment was not 
conducted because, as mentioned above, the current uses will not result 
in additional dietary exposure to CPU.
    Since EPA does not have ground water and surface water monitoring 
data to calculate a quantitative aggregate exposure, Drinking Water 
Levels of Concern (DWLOCs) were calculated. A DWLOC is a theoretical 
upper limit on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food, drinking water, and 
through residential uses. A DWLOC will vary depending on the toxic 
endpoint, drinking water consumption, body weights, and pesticide uses. 
Different populations will have different DWLOCs. EPA uses DWLOCs in 
the risk assessment process to assess potential concern for exposure 
associated with pesticides in drinking water. DWLOC values are not 
regulatory standards for drinking water. To calculate DWLOCs, the 
dietary food estimates (from DEEMTM-FCID) were subtracted 
from the population adjusted dose (PAD) value to obtain the maximum 
water exposure level. DWLOCs were then calculated using the standard 
body weights and drinking water consumption figures: 70kg/2L (U.S. 
population and adult male), 60 kg/2L (adult female and youth), and 
10kg/1L (infants and children). For chronic dietary exposure, EPA's 
level of concern is exceeded when estimated dietary risk exceeds 100% 
of the cPAD.
    The chronic drinking water assessment resulted in chronic DWLOCs 
for the overall U.S. population of 690 parts per billion (ppb), and for 
all infants (<1 year old) and children (1-2 years) of 190 ppb (the 
population subgroups with the lowest DWLOC). All chronic DWLOCs were 
well above the chronic estimated environmental concentration (EEC) for 
ground water of 0.067 ppb. The chronic DWLOCs were also above the 
chronic EEC for surface water of 0.32 ppb.
    Thus, results of the chronic analysis indicate that the estimated 
chronic dietary risk associated with the proposed use of diflubenzuron 
is below levels of concern, and chronic aggregate risk estimates are 
also below the level of concern.
    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

    Adequate methods are available for the analysis of diflubenzuron, 
PCA, and CPU in crops. Three enforcement methods for diflubenzuron are 
published in the Pesticide Analytical Method Volume II (PAM II) as 
Methods I, II, and III.

B. International Residue Limits

    There are no Codex proposals, Canadian, or Mexican limits for 
residues

[[Page 51483]]

of diflubenzuron on wheat and barley commodities. Therefore there are 
no compatibility issues associated with the proposed tolerances.

C. Conditions

    One application per growing season may be made of the pesticide, 
diflubenzuron, to wheat and barley, at a rate of 2.0 fl. oz. product 
(0.44 fl. oz. of active ingredient) per acre. Applications may be made 
by ground or aerial equipment. A preharvest interval of 45 days must be 
observed, and all label directions on the federally registered label, 
as well as the section 18 use directions must be followed.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of 
diflubenzuron, and its metabolites CPU and PCA, in or on wheat and 
barley grain at 0.05 ppm, wheat and barley straw at 0.50 ppm, wheat and 
barley hay at 1.0 ppm, wheat milled byproducts at 0.10 ppm, and 
aspirated grain fractions at 30 ppm.

VII. Objections and Hearing Requests

    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. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need To Do To File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0279 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 October 
27, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by the docket ID number OPP-2003-0279, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Statutory and Executive Order Reviews

    This final rule establishes time-limited tolerances under section 
408 of the FFDCA. 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

[[Page 51484]]

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 FIFRA 
section 18 exemption under section 408 of the 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. 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 the 
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.

IX. 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: August 18, 2003.
Debra Edwards,
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), 346(a) and 371.

0
2. Section 180.377 is amended by revising the table in paragraph (b) to 
read as follows:


Sec.  180.377  Diflubenzuron; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                               Parts
                  Commodity                     per       Expiration/
                                              million   revocation date
------------------------------------------------------------------------
Alfalfa, forage.............................      6.0            6/30/04
Alfalfa, hay................................      6.0            6/30/04
Barley, grain...............................     0.05           12/31/05
Barley, hay.................................      1.0           12/31/05
Barley, straw...............................     0.50           12/31/05
Wheat, aspirated grain fractions............       30           12/31/05
Wheat, grain................................     0.05           12/31/05
Wheat, hay..................................      1.0           12/31/05
Wheat, milled byproducts....................     0.10           12/31/05
Wheat, straw................................     0.50           12/31/05
------------------------------------------------------------------------

* * * * *

[FR Doc. 03-21935 Filed 8-26-03; 8:45 am]
BILLING CODE 6560-50-S