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Diflubenzuron. August 27, 2003.
Pesticide Tolerances for Emergency
Exemptions.
Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2003/August/Day-27/p21935.htm
[Federal Register: August 27, 2003 (Volume 68, Number 166)]
[Rules and Regulations]
[Page 51479-51484]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au03-15]
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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.
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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: conrath.andrea@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 producers (NAICS 111)
¥ Animal producers (NAICS 112)
¥ Food manufacturing (NAICS 311)
¥ 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_40/40cfr180_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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. 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 (59 FR 22951, 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.
¥ Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
¥ 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
¥ 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
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